Treatment Patterns and Clinical Outcomes After the Introduction of the Medicare Sepsis Performance Measure (SEP-1)

Ann Intern Med. 2021 Jul;174(7):927-935. doi: 10.7326/M20-5043. Epub 2021 Apr 20.


Background: Medicare requires that hospitals report on their adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1).

Objective: To evaluate the effect of SEP-1 on treatment patterns and patient outcomes.

Design: Longitudinal study of hospitals using repeated cross-sectional cohorts of patients.

Setting: 11 hospitals within an integrated health system.

Patients: 54 225 encounters between January 2013 and December 2017 for adults with sepsis who were hospitalized through the emergency department.

Intervention: Onset of the SEP-1 reporting requirement in October 2015.

Measurements: Changes in SEP-1-targeted processes, including antibiotic administration, lactate measurement, and fluid administration at 3 hours from sepsis onset; repeated lactate and vasopressor administration for hypotension within 6 hours of sepsis onset; and sepsis outcomes, including risk-adjusted intensive care unit (ICU) admission, in-hospital mortality, and home discharge among survivors.

Results: Two years after its implementation, SEP-1 was associated with variable changes in process measures, with the greatest effect being an increase in lactate measurement within 3 hours of sepsis onset (absolute increase, 23.7 percentage points [95% CI, 20.7 to 26.7 percentage points]; P < 0.001). There were small increases in antibiotic administration (absolute increase, 4.7 percentage points [CI, 1.9 to 7.6 percentage points]; P = 0.001) and fluid administration of 30 mL/kg of body weight within 3 hours of sepsis onset (absolute increase, 3.4 percentage points [CI, 1.5 to 5.2 percentage points]; P < 0.001). There was no change in vasopressor administration. There was a small increase in ICU admissions (absolute increase, 2.0 percentage points [CI, 0 to 4.0 percentage points]; P = 0.055) and no changes in mortality (absolute change, 0.1 percentage points [CI, -0.9 to 1.1 percentage points]; P = 0.87) or discharge to home.

Limitation: Data are from a single health system.

Conclusion: Implementation of the SEP-1 mandatory reporting program was associated with variable changes in process measures, without improvements in clinical outcomes. Revising the measure may optimize its future effect.

Primary funding source: Agency for Healthcare Research and Quality.

Publication types

  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / therapeutic use
  • Cross-Sectional Studies
  • Female
  • Fluid Therapy
  • Guideline Adherence
  • Humans
  • Lactic Acid / blood
  • Longitudinal Studies
  • Male
  • Mandatory Reporting
  • Medicare / organization & administration*
  • Middle Aged
  • Outcome Assessment, Health Care*
  • Patient Care Bundles / standards*
  • Practice Guidelines as Topic
  • Quality Improvement
  • Sepsis / blood
  • Sepsis / therapy*
  • United States
  • Vasoconstrictor Agents / therapeutic use


  • Anti-Bacterial Agents
  • Vasoconstrictor Agents
  • Lactic Acid