Evidence Underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1)

Sean R. Townsend; Lemeneh Tefera; Emanuel P. Rivers

doi:10.7326/L18-0139

TO THE EDITOR:

As the measure stewards for the Centers for Medicare & Medicaid Services' (CMS') Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) measure (S.R.T. and E.P.R.) and a former policy advisor for CMS (L.T.), we were alarmed by Pepper and colleagues' (1) inaccuracies and misrepresentations about the role of SEP-1 in CMS quality reporting programs. The Severe Sepsis and Septic Shock Early Management Bundle is a measure in the Inpatient Quality Reporting (IQR) Program that requires hospitals to report measure data to CMS (2). As long as a hospital reports its data—even if none of its patients with sepsis were treated with SEP-1 interventions—that hospital would not be penalized. A hospital's reimbursement could be altered only if it failed to report its data. The authors' claim that clinicians “must do up to 7 interventions” is materially incorrect and misrepresents both SEP-1 and the IQR Program.

The authors refer to SEP-1 as a performance measure that “incentivize[s] hospitals to complete all of the interventions,” affecting hospital payment starting in 2018. This claim is false, and their citation to the Federal Register does not support it (3). The IQR Program is a reporting program, and a hospital's SEP-1 performance does not affect payment. If a hospital reports its data to CMS, this agency does not change that hospital's reimbursement regardless of its performance. Since SEP-1 was introduced, almost all hospitals nationally have successfully reported their data to CMS.

Pepper and colleagues' claim that The Joint Commission requires SEP-1 completion for hospital accreditation is also false. They cite a document that explicitly states that the measure is “CMS only,” not a Joint Commission requirement (4).

The title of Pepper and colleagues' review asserts that the U.S. government has “mandated” hemodynamic interventions. The Severe Sepsis and Septic Shock Early Management Bundle is a protocol-based measurement strategy for sepsis care rendered in acute care hospitals and does not “mandate” that a hospital or clinician take any specific intervention. There is no punishment, financial or otherwise, for failing to complete any action in SEP-1.

The authors incorrectly state that SEP-1 requires various hemodynamic measures, such as physical examination elements, central venous pressure measurement, dynamic assessment of volume responsiveness, and bedside cardiovascular ultrasonography. They reference the original 2015 SEP-1 specification manual (version 5.0a), which is now 3 years out of date. In more recent specification manuals from 2017, many data elements were made optional or removed (5).

Pepper and colleagues erroneously state that they evaluated the level of evidence supporting SEP-1 interventions by using the proper criteria and all relevant data. The National Quality Forum (NQF) requires that composite measures, such as SEP-1, be evaluated using specialized criteria beyond those cited in Supplement Table 1, which was reprinted from an outdated guide from 2013 (6). The current 2017 NQF guide includes advice for composite evaluation, which permits evaluation of evidence for a group of interventions tested simultaneously, and review of program data to date (7). The authors did not use the composite standards, reviewed interventions no longer required, and did not review program data submitted to the NQF for the 2017 reendorsement cycle.

The NQF endorsement process impanels a committee of national experts (vetted for conflicts of interest), is transparent, and includes an opportunity for an open notice and comment period to consider external expert and public feedback. In 2017, the NQF committee concluded that the level of evidence supporting the composite measure was “moderate.” The measure was ultimately reendorsed with 4, 9, and 0 members evaluating the evidence as high, moderate, and low, respectively (8). The NQF review was robust, evaluated the most up-to-date specification manual, and had input from a broad group of national experts.

References

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DJ
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Jaswal
D
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Sun
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Evidence underpinning the Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Management Bundle (SEP-1). A systematic review.
Ann Intern Med
2018
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Centers for Medicare & Medicaid Services. Hospital Inpatient Quality Reporting Program. Updated 9 September 2017. Accessed at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/HospitalRHQDAPU.html on 22 February 2018.
Centers for Medicare and Medicaid Services (CMS), HHS
Medicare program; hospital inpatient prospective payment systems for acute care hospitals and the long-term care hospital prospective payment system and policy changes and fiscal year 2017 rates; quality reporting requirements for specific providers; graduate medical education; hospital notification procedures applicable to beneficiaries receiving observation services; technical changes relating to costs to organizations and medicare cost reports; finalization of interim final rules with comment period on LTCH PPS payments for severe wounds, modifications of limitations on redesignation by the medicare geographic classification review board, and extensions of payments to MDHs and low-volume hospitals. Final rule
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The Joint Commission. Joint Commission Online. 2 September 2015. Accessed at www.jointcommission.org/assets/1/23/jconline_September_2_2015.pdf on 22 February 2018.
The Joint Commission. Specifications manual for national hospital inpatient quality measures. 2018. Accessed at www.jointcommission.org/specifications_manual_for_national_hospital_inpatient_quality_measures.aspx on 22 February 2018.
National Quality Forum. Review and update of guidance for evaluating evidence and measure testing. Technical report. 8 October 2013. Accessed at www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=74076 on 23 February 2018.
National Quality Forum. Measure evaluation criteria and guidance for evaluating measures for endorsement. Effective August 2017. 2017. Accessed at www.qualityforum.org/Measuring_Performance/Submitting_Standards/2017_Measure_Evaluation_Criteria.aspx on 23 February 2018.
National Quality Forum. Infectious disease final report. August 2017. Accessed at www.qualityforum.org/Publications/2017/08/Infectious_Disease_Final_Report.aspx on 1 March 2018.

This article was published at Annals.org on 15 March 2018.

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Letters |17 April 2018

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