Trusting the Sepsis Measure “Analysis”
Trusting the Sepsis Measure “Analysis”
As original developers (ST, ER, ML, RPD) and stewards (ST, ER) for the Centers for Medicare and Medicaid Services’ (CMS) Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) measure and as a former policy advisor for CMS (LT), we provide the following corrections for Jaswal and colleagues’ multiple false and erroneous statements in “Endorsing performance measures is a matter of trust” (1).
SEP-1 is a measure in the Inpatient Quality Reporting (IQR) program, which only requires hospitals to report measure data to CMS; it is not a performance-based program (2). No link exists between a hospital’s performance on SEP-1 and payment. CMS publishes detailed information about the IQR program that the authors may not have reviewed (2, 3). The CMS web page cited by the authors pertains to the health insurance market and does not mention SEP-1. The references do not support the authors’ premise that CMS uses SEP-1 “to regulate US healthcare” by withholding reimbursement (4).
The authors confuse the IQR program (which houses the SEP-1 measure) with the CMS value-based purchasing (VBP) programs (5). These programs operate under different rules that are described publicly and updated annually through the government rulemaking process, including notice and comment periods (5).
The authors also claim that poor performance on SEP-1 jeopardizes hospital accreditation status. This claim is false. Neither reporting nor performance on SEP-1 affects a hospital’s accreditation status (6).
The authors assert that with the “compelling incentives” dispatched above, CMS has “mandate[d]” care approaches in SEP-1. This claim is false. SEP-1 is a protocol-based strategy to measure sepsis care rendered in 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 mislead readers to believe that reassessment of volume status and tissue perfusion necessitates the use of central venous pressure (CVP) and central venous oxygen saturation (ScvO2) monitoring. The current publicly available specification manual from 2017 (version 5.3a) clearly states that these variables are not required (6). As now specified, the reassessment requirement is satisfied if a clinician states that a reassessment was performed. There is no need to document the means by which the clinician completed the reassessment (7). We note the authors relied on a legacy specification manual (version 5.0a). Although now 3 years out-of-date, even then the measurement of CVP and ScvO2 was a matter of clinician choice with alternatives to satisfy the measure, among which was simply a focused physical exam.
Also of concern, the authors advance the fallacy that because the measure previously held out CVP and ScvO2 as variables that could satisfy the reassessment requirement, the developers (or perhaps NQF, or CMS) promoted the sale of Edwards Lifescience’s proprietary oximetry catheter. In fact, the two physiologic measurements can be obtained from a central line made by any manufacturer. If one were to endorse the authors’ reasoning which includes allegations of inappropriate intent and industry contamination, then SEP-1 corruptly supports many industries: pharmaceuticals (by recommending the use of antibiotics), manufacturers of intravenous tubing and crystalloid vendors (by recommending intravenous fluids), point-of-care manufacturers (by including lactate measurement), and perhaps support laboratory supply vendors too (by requiring blood cultures). The authors not only make a false allegation, but reach an illogical conclusion. The SEP-1 measure does not endorse any private entity and solely exists to promote sepsis quality care improvement.
Finally, these authors have falsely claimed that at least one developer “continued to receive financial support from Edwards Lifesciences,” and have attempted to disparage two others by referring to their past publicly disclosed affiliations with the firm. The claim of any continuing relationship is false. The authors’ citation to a web page without an associated publication date does not validate their claim. The standard by which conflicts of interests are adjudicated in medicine is disclosure. In this case that standard has been met and exceeded as none of the developers had relationship with Edwards in 2012 when the measure first included hemodynamic variables.
The authors, from the National Institutes of Health, are familiar with the need to resolve conflicts of interest, and they should be cognizant of the damage false and defamatory statements can do to respected institutions and individuals alike (8).
Because of the egregious nature of these multiple false or erroneous claims, we believe this publication should be retracted.
Sean R. Townsend MD
Lemeneh Tefera MD MSc
Emanuel P. Rivers MD MPH
Mitchell M. Levy MD
R. Philip Dellinger, MD
1. Jaswal SJ, Natanson C, Eichacker PQ. Endorsing Performance Measures is a Matter of Trust. BMJ. 2018 Feb 23;360:k703. doi: 10.1136/bmj.k703.
2. Centers for Medicare & Medicaid Services. Hospital Inpatient Quality Reporting Program. 9 September 2017 Accessed at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/... on 22 February 2018.
3. Social Security Act § 1886(b)(3)(B)(vii)-(viii); 42 CFR § 412.64(d)(2); 81 Fed. Reg. 56939 (August 22, 2016).
4. Centers for Medicare & Medicaid Services. Health Insurance Marketplaces. Accessed at https://www.cms.gov/CCIIO/Programs-and-Initiatives/Insurance-Programs/ on 28 February 2018.
5. Centers for Medicare & Medicaid Services. Hospital Inpatient Quality Reporting Program. 11 September 2017 Accessed at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Inst... on 27 February 2018.
6. The Joint Commission. Specifications Manual for National Hospital Inpatient Quality Measures. Accessed at www.jointcommission.org/specifications_manual_for_national_hospital_inpa... on 22 February 2018.
7. QualityNet. Fact Sheets for Measure Changes. Accessed at https://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic/... on 28 February 2018.
8. The Wall Street Journal. Blood-Study Author Didn’t Disclose Conflicts. 14 July 2008. Accessed at https://www.wsj.com/articles/SB121598988902149353 on 28 February 2018.
Competing interests: No competing interests