The CMS Sepsis Mandate: Right Disease, Wrong Measure
Authors: Michael Klompas, Chanu Rhee
Journal: Annals of Internal Medicine (2016)

Ideas and Opinions4 October 2016The CMS Sepsis Mandate: Right Disease, Wrong MeasureMichael Klompas, MD, MPH and Chanu Rhee, MD, MPHMichael Klompas, MD, MPHFrom Harvard Medical School, Harvard Pilgrim Health Care Institute, and Brigham and Women's Hospital, Boston, Massachusetts. and Chanu Rhee, MD, MPHFrom Harvard Medical School, Harvard Pilgrim Health Care Institute, and Brigham and Women's Hospital, Boston, Massachusetts.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M16-0588 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail According to a Centers for Medicare & Medicaid Services (CMS) mandate, hospitals were to begin reporting adherence to the "SEP-1" sepsis management bundle starting on 1 October 2015. Although the SEP-1 bundle addresses an important problem, it is rigid, onerous, and overly prescriptive. Is this the best way for CMS to improve sepsis recognition and care?The SEP-1 bundle requires clinicians to measure serum lactate, obtain blood cultures, and administer broad-spectrum antibiotics within 3 hours of sepsis onset or hospital presentation ("time zero"). Clinicians must recheck serum lactate within 6 hours if the initial level was elevated. For a patient ...References1. Houck PM, Bratzler DW, Nsa W, Ma A, Bartlett JG. Timing of antibiotic administration and outcomes for Medicare patients hospitalized with community-acquired pneumonia. Arch Intern Med. 2004;164:637-44. [PMID: 15037492] CrossrefMedlineGoogle Scholar2. Nicks BA, Manthey DE, Fitch MT. The Centers for Medicare and Medicaid Services (CMS) community-acquired pneumonia core measures lead to unnecessary antibiotic administration by emergency physicians. Acad Emerg Med. 2009;16:184-7. [PMID: 19133854] doi:10.1111/j.1553-2712.2008.00320.x CrossrefMedlineGoogle Scholar3. Welker JA, Huston M, McCue JD. Antibiotic timing and errors in diagnosing pneumonia. Arch Intern Med. 2008;168:351-6. [PMID: 18299488] doi:10.1001/archinternmed.2007.84 CrossrefMedlineGoogle Scholar4. Quattromani E, Powell ES, Khare RK, Cheema N, Sauser K, Periyanayagam U, et al. Hospital-reported data on the pneumonia quality measure "Time to First Antibiotic Dose" are not associated with inpatient mortality: results of a nationwide cross-sectional analysis. Acad Emerg Med. 2011;18:496-503. [PMID: 21545670] doi:10.1111/j.1553-2712.2011.01053.x CrossrefMedlineGoogle Scholar5. Klein Klouwenberg PM, Cremer OL, van Vught LA, Ong DS, Frencken JF, Schultz MJ, et al. Likelihood of infection in patients with presumed sepsis at the time of intensive care unit admission: a cohort study. Crit Care. 2015;19:319. [PMID: 26346055] doi:10.1186/s13054-015-1035-1 CrossrefMedlineGoogle Scholar6. Rhee C, Kadri SS, Danner RL, Suffredini AF, Massaro AF, Kitch BT, et al. Diagnosing sepsis is subjective and highly variable: a survey of intensivists using case vignettes. Crit Care. 2016;20:89. [PMID: 27048508] doi:10.1186/s13054-016-1266-9 CrossrefMedlineGoogle Scholar7. Angus DC, Barnato AE, Bell D, Bellomo R, Chong CR, Coats TJ, et al. A systematic review and meta-analysis of early goal-directed therapy for septic shock: the ARISE, ProCESS and ProMISe Investigators. Intensive Care Med. 2015;41:1549-60. [PMID: 25952825] doi:10.1007/s00134-015-3822-1 CrossrefMedlineGoogle Scholar8. Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA. 2016;315:801-10. [PMID: 26903338] doi:10.1001/jama.2016.0287 CrossrefMedlineGoogle Scholar9. Seymour CW, Coopersmith CM, Deutschman CS, Gesten F, Klompas M, Levy M, et al. Application of a framework to assess the usefulness of alternative sepsis criteria. Crit Care Med. 2016;44:e122-30. [PMID: 26901560] doi:10.1097/CCM.0000000000001724 CrossrefMedlineGoogle Scholar10. Rhee C, Kadri S, Huang SS, Murphy MV, Li L, Platt R, et al. Objective sepsis surveillance using electronic clinical data. Infect Control Hosp Epidemiol. 2016;37:163-71. [PMID: 26526737] doi:10.1017/ice.2015.264 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Harvard Medical School, Harvard Pilgrim Health Care Institute, and Brigham and Women's Hospital, Boston, Massachusetts.Disclosures: Drs. Klompas and Rhee received grant funding from the Centers for Disease Control and Prevention for research on sepsis surveillance. Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0588.Corresponding Author: Michael Klompas, MD, MPH, Department of Population Medicine, 401 Park Street, Suite 401, Boston, MA 02215; e-mail, [email protected]org.Current Author Addresses: Drs. Klompas and Rhee: Department of Population Medicine, 401 Park Drive, Suite 401 East, Boston, MA 02215.Author Contributions: Conception and design: M. Klompas, C. Rhee.Drafting of the article: M. Klompas.Critical revision for important intellectual content: M. Klompas, C. Rhee.Final approval of the article: M. Klompas, C. Rhee.Obtaining of funding: M. Klompas.This article was published at www.annals.org on 14 June 2016. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoAnnals On Call - Does the Sepsis Bundle Improve Outcomes? Robert M. Centor , Michael Klompas , and Chanu Rhee Metrics Cited byTreatment Patterns and Clinical Outcomes After the Introduction of the Medicare Sepsis Performance Measure (SEP-1)Ian J. Barbash, MD, MS, Billie S. Davis, PhD, Jonathan G. Yabes, PhD, Chris W. Seymour, MD, MSc, Derek C. Angus, MD, MPH, and Jeremy M. Kahn, MD, MSNonstationary multivariate Gaussian processes for electronic health recordsEarly Detection of Septic Shock Onset Using Interpretable Machine Learners2019 John M. Eisenberg Patient Safety and Quality Awards: A Model Cell for Transformational Redesign of Sepsis Identification and Treatment: Aligning Digital Tools with Innovative WorkflowsImpact of Risk Adjustment Using Clinical vs Administrative Data on Hospital Sepsis Mortality ComparisonsPrevalence of Antibiotic-Resistant Pathogens in Culture-Proven Sepsis and Outcomes Associated With Inadequate and Broad-Spectrum Empiric Antibiotic UseSepsis Bundles That Focus on Clinician Judgment and Proven Interventions Are Needed to Increase Bundle Compliance and Effectiveness*Association of Hospital Characteristics With Early SEP-1 PerformanceSepsis quality in safety-net hospitals: An analysis of Medicare's SEP-1 performance measureAntibiotic- and Fluid-Focused Bundles Potentially Improve Sepsis Management, but High-Quality Evidence Is Lacking for the Specificity Required in the Centers for Medicare and Medicaid Service's Sepsis Bundle (SEP-1)*National Performance on the Medicare SEP-1 Sepsis Quality MeasureDoes Use of Electronic Alerts for Systemic Inflammatory Response Syndrome (SIRS) to Identify Patients With Sepsis Improve Mortality?Does the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Improve Survival in Septic Adults?Variation in Identifying Sepsis and Organ Dysfunction Using Administrative Versus Electronic Clinical Data and Impact on Hospital Outcome Comparisons*Improving Sepsis Treatment by Embracing Diagnostic UncertaintyRisk Adjustment for Sepsis Mortality to Facilitate Hospital Comparisons Using Centers for Disease Control and Prevention's Adult Sepsis Event Criteria and Routine Electronic Clinical DataVariation in Sepsis-Related Mortality; Implications for Performance Improvement*Compliance With the National SEP-1 Quality Measure and Association With Sepsis OutcomesTrends in "usual care" for septic shockVariability in determining sepsis time zero and bundle compliance rates for the centers for medicare and medicaid services SEP-1 measureMortality Measures to Profile Hospital Performance for Patients With Septic Shock*Evidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1)Dominique J. Pepper, MBChB, MD, Charles Natanson, MD, and Peter Q. Eichacker, MDEvidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1) A Systematic ReviewDominique J. Pepper, MBChB, MD, Dharmvir Jaswal, MD, Junfeng Sun, PhD, Judith Welsh, BSN, MLS, Charles Natanson, MD, and Peter Q. Eichacker, MDSepsis: The Road AheadA quality improvement project to improve the Medicare and Medicaid Services (CMS) sepsis bundle compliance rate in a large healthcare systemReply: The Timing of Early Antibiotics and Hospital Mortality in Sepsis: Playing Devil's AdvocateNew Sepsis and Septic Shock DefinitionsTo SIRS With Love—An Open LetterWe Have Good Enough Data to Support Sepsis Performance Measurement 4 October 2016Volume 165, Issue 7Page: 517-518KeywordsAntibioticsDeath ratesDisclosureElectronic medical recordsLactatesMedicarePatientsPneumoniaResuscitationSepsis ePublished: 14 June 2016 Issue Published: 4 October 2016 Copyright & PermissionsCopyright © 2016 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...