New Mandated Centers for Medicare and Medicaid Services Requirements for Sepsis Reporting: Caution from the Field
Abstract
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. Objective Following a simulated reporting exercise, in which 50 charts underwent expert review, we aimed to detail the challenges of, and offer suggestions on how to rethink, measuring performance in severe sepsis and septic shock care. Discussion There were several challenges associated with the design and implementation of this measure. The ambiguous definition of severe sepsis and septic shock, prescriptive fluid volume requirements, rigid reassessment, and complex abstraction logic all raise significant concern. Conclusions Although SEP-1 represents an important first step in requiring hospitals to improve outcomes for patients with severe sepsis and septic shock, the current approach must be revisited. The volume and co…
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SEP-1's administrative burden and prescriptive timing rules may incentivize unnecessary broad-spectrum antibiotics or fixed-volume fluid administration in patients with tenuous cardiopulmonary reserve, shifting attention from physiology-driven resuscitation to documentation-driven completion.
“From the clinician perspective, strict requirements may incentivize unnecessary broad-spectrum antibiotics or fixed-volume fluid administration in patients with tenuous cardiopulmonary reserve, shifting attention from physiology-driven resuscitation to documentation-driven completion [7,18].”
From Artificial Intelligence to Facilitate SEP-1 Measure Compliance and Fluid Management in Sepsis (2026) · cites this paper as [18]
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A randomized trial of protocol-based care for early septic shock.
The ProCESS Investigators (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1401602 · Cited by 2,414 · see citing works
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Rhee, C., Kadri, S. S., Dekker, J. P., Danner, R. L., Chen, H.-C., Fram, D., Zhang, F., Wang, R., Klompas, M., & Program, F. T. C. P. E. (2020) · JAMA Network Open · doi:10.1001/jamanetworkopen.2020.2899 · Cited by 397 · see citing works
Rhee, C., Chiotos, K., Cosgrove, S. E., Heil, E. L., Kadri, S. S., Kalil, A. C., Gilbert, D. N., Masur, H., Septimus, E. J., Sweeney, D. A., et al. (2021) · Clinical Infectious Diseases · doi:10.1093/cid/ciaa059 · Cited by 191 · see citing works
Rhee, C., Brown, S. R., Jones, T. M., O’Brien, C., Pande, A., Hamad, Y., Bulger, A. L., Tobin, K. A., Massaro, A. F., Anderson, D. J., et al. (2018) · Infection Control & Hospital Epidemiology · doi:10.1017/ice.2018.134 · Cited by 51 · see citing works
Self-citationDriving blind: Instituting SEP-1 without high quality outcomes data
Wang, J., Strich, J. R., Applefeld, W. N., Sun, J., Cui, X., Natanson, C., & Eichacker, P. Q. (2020) · Journal of Thoracic Disease · doi:10.21037/jtd.2019.12.100 · Cited by 34 · see citing works
Artificial Intelligence to Facilitate SEP-1 Measure Compliance and Fluid Management in Sepsis
Nguyen, H. B., Krishtopaytis, E., Lopez, E., Farnoudi, N., Van, T., Kharalampova, V., & Coz Yataco, A. (2026) · Journal of Clinical Medicine · doi:10.3390/jcm15093477
“From the clinician perspective, strict requirements may incentivize unnecessary broad-spectrum antibiotics or fixed-volume fluid administration in patients with tenuous cardiopulmonary reserve, shifting attention from physiology-driven resuscitation to documentation-driven completion [7,18].”
- Authors
- Aaronson, E. L., Filbin, M. R., Brown, D. F. M., Tobin, K., & Mort, E. A.
- Affiliations
- Harvard University (US)
- Massachusetts General Hospital (US)
- Corresponding author
- Aaronson, Emily L.
- Venue
- The Journal of Emergency Medicine
- Publisher
- Elsevier BV
- Published
- 2017-01
- Volume
- 52
- Issue
- 1
- Pages
- 109-116
- ISSN
- 0736-4679 (ISSN-L)
- OpenAlex
- W2527946475
- Cited by
- 26
- References
- 1
- Citations by year
- 2026: 1 · 2024: 2 · 2021: 4 · 2020: 8 · 2019: 3 · 2018: 6 · 2017: 2
- FWCI
- 3.44
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Emergency Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
- Health Sciences › Health Professions › Health Information Management › Healthcare Quality and Management
- Health Sciences › Medicine › Emergency Medicine › Trauma and Emergency Care Studies
- Keywords
- severe sepsis, septic shock, quality of care measurement, hospital accountability, fluid resuscitation, data abstraction
- MeSH terms
- Humans, Research Design, United States, Centers for Medicare and Medicaid Services, U.S., Sepsis, Quality Indicators, Health Care
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