According to UHC’s Network Bulletin posted in October 2018, UHC has adopted the third international consensus definitions for sepsis and septic shock (SEPSIS 3), effective January 1st, 2019 [1].
The Network Bulletin adds that UHC will be reviewing hospital DRG claims and adjusting hospital payments based on the presence and treatment of sepsis and septic shock, per the SEPSIS 3 definition. The scope of this performance measure will include commercial plans, Medicare Advantage, and Medicaid plans [1]. The adoption by the largest commercial health plan, across all service lines and with significant dollars at risk for hospitals and providers, is a precedent setting pivot. To the best of the authors’ knowledge, no other health plan incorporates performance measures for sepsis, including Medicare Part B, which has rejected incorporating SEPSIS 3 into their Sepsis Core Measure Bundle [2].
The negative implications for hospital DRG reimbursement may be immediately significant while there are significant unknowns including the impact on ED professional fee reimbursement, issues of “double documentation” for UHC patients, malpractice concerns, and other coding and billing compliance liabilities.
Independent of the sepsis protocol adopted, sepsis is a critical public health concern, accounting for more than $20 billion (5.2%) of total US hospital costs in 2011 [3]. The incidence of sepsis is increasing, likely due to an aging population and heightened awareness. [3, 4]. In fact, sepsis may be leading cause of mortality and critical illness worldwide [3].
The evolution of the definition of sepsis, and subsequent treatment recommendations is beyond the scope of this article. A simplified review would begin In 1991, when the American College of Chest Physicians (ACCP) and Society of Critical Care Medicine (SCCM) first proposed a formal definition for sepsis. in 2001 this same work group further elaborated/clarified the work that was performed in the 1991 consensus conference. The Surviving Sepsis Campaign (SSC) offered guidelines for the management of severe sepsis and septic shock first in 2002, and then in 2004, 2008, 2012, and 2016 [5]. In October 2015, the Centers for Medicare and Medicaid Services (CMS) used the SEP-1 definition as part of the core measure, SEP-1: Early Management Bundle, Severe Sepsis/Septic Shock. This bundle is mandatory and requires public reporting by all hospitals. That information can be found at https://www.medicare.gov/hospitalcompare/search.html. The 2015 SEP-1 measure was a principle driver to raising awareness and decreasing mortality nationwide. As of 2018, the national compliance to the SEP-1 measure is at 50%, demonstrating the challenges of operationalizing a national sepsis bundle. So, with hospitals struggling to achieve satisfactory compliance with SEP-1 for many years, what would motivate UHC to move to a new standard that has not been vetted or accepted by the relevant clinical specialties or CMS? A 2016 letter to the editor discussed these challenges, noting it took years of scientific validation of SEP-1 and converting this over to a performance measure [2]. This is in stark contrast to what is being proposed by UHC.
Of particular note, the SEPSIS 3 definition, which represents the foundation of the potential new measure proposed by UHC, lacks a specific bundle to inform physicians of treatment goals. The SEP-1 criteria not only provides physicians a working definition of sepsis allowing them to identify patients who meet treatment thresholds, but offers a 3 and 6-hour treatment bundle to guide therapy. The measure proposed by UHC lacks this transparency. While they state they will be using the SEPSIS 3 definition, they do not explicitly define the treatment criteria by which compliance will be judged. Will it be the same bundles used by the SEP-1 criteria? Will they be employing the 2012 SSC’s 3 and 6-hour bundles or even the highly controversial 2018 1-hr bundle, which even the SCC has stated is not ready for clinical use?
In Addition, the SEPSIS 3 definition lacks the endorsement of the specialty societies affected most – including the Emergency Medicine community. If the main purpose of the SEP-1 bundle was early identification and treatment of septic patients, and most cases are identified in the Emergency Department [6], compared to a floor or ICU [6], that the EM community and others were not involved raises some very serious questions.
SEPSIS 3, compared to previous definitions, employed data analytics in addition to clinical expertise, rather than expert opinion alone, uses a standardized process, and incorporates more up to date understanding of the conditions and outcomes involved. The main difference between SEP-1 and SEPSIS 3, is the later removes the “severe sepsis” definition and as opposed to SIRS, focuses on the SOFA (or qSOFA) score. The value of SEPSIS 3 is still unclear, as advocates and critics are widespread.
To measure quality of care and guide pay-for-performance, CMS currently tracks 30 day readmissions for heart failure, acute myocardial infarction, COPD (chronic obstructive pulmonary disease), and pneumonia. Sepsis is not part of that matrix. After reviewing data from the 2013 Nationwide Readmission Database, Mayr et. al. determined that sepsis accounted for 12.2% of 30-day unplanned hospital readmissions, compared to heart failure (6.7%), pneumonia (5.2%), COPD (4.6%), and acute myocardial infarction (1.2%). Other variables considered, such as duration of unplanned admission and mean cost per readmission, were also higher for the sepsis group than any of the others. This study estimated that sepsis care alone could account for up to 14.5% of the total cost of all readmissions studied [7].
The implications of the UHC policy with an adjustable rate for sepsis care are broad and deep. Other than referencing two original publications, there is little information publicly available regarding the relative weight and percent at risk for the facility DRG. Just as important, SEPSIS 3 represents a new definition for sepsis, but there is little visibility into how to operationalize this definition into a measure.
The Network Bulletin implies a two-way measure adjustment, affecting those patients who qualify for sepsis or septic shock and were not treated according to SEPSIS 3, and those who should have been, but were not. This could extend into professional coding as well. Complicating matters, CMS is not removing the Core Measure Sepsis Bundle, leaving hospitals and providers with a potential burden of dual documentation and performance measurements for the same condition. The documentation burden, compliance concerns, and malpractice implications are beyond recuse. Many hospitals have worked with their Clinical Documentation Improvement (CDI) teams to accurately capture the work performed. If, by virtue of SEPSIS 3 definition that excludes “severe sepsis” in their nomenclature, leaving only “sepsis” and “septic shock” available, how are those CDI teams able to reconcile a dual reporting mechanism to satisfy CMS and UHC? With the apparent costs of SEPSIS 3 outweighing the benefits which are unknown in part because of its lack of vetting and analysis by the clinical community, hospitals are simply stuck with the “Hobson’s Choice” for UHC patients—and what of the emergency physicians who because of EMTALA are not expected to know who is or is not a UHC patient?
Having an insurer unilaterally dictate a potential new standard of care raises more questions than it does answers. First, why would UHC adopt a clinical standard, particularly for its Medicare Advantage and Medicaid service lines, that was considered and specifically rejected by CMS two years ago? Second, how does the potential for double documentation and treatment protocols impair patient care on such an impactful disease process for the ED and for inpatient providers? Third, how would coders and billers be trained to change how they code and bill for sepsis when SEPSIS 3 eliminates severe sepsis and causes additional ICD-10 issues for pre and post billing? What of the professional fee RCM process as well for the same reasons? But most importantly, how will this all affect patient care?
We believe that UHC should reconsider its unprecedented decision to adopt SEP-3 and suspend its bulletin implementation date for the many reasons stated above until sufficient dialogue with the clinical and hospital stakeholders and the SEP-3 standards have been fully vetted by the relevant specialty societies and clinical representatives.
- https://www.uhcprovider.com/content/dam/provider/docs/public/resources/news/2018/network-bulletin/October-Interactive-Network-Bulletin-2018.pdf. Retrieved 12/1/2018.
- JAMA. 2016;316(4):457-458. doi:10.1001/jama.2016.6374 (this is a letter to the editor, specific response by Emanuel Rivers.
- JAMA. 2016;315(8):801-810. doi:10.1001/jama.2016.0287 The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
- Gaieski DF, Edwards JM, Kallan MJ, Carr BG. Benchmarking the incidence and mortality of severe sepsis in the United States. Crit Care Med. 2013;41(5):1167-1174.
- Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2016. March 2017 - Volume 45 - Issue 3
- Acepnow. Sepsis then & now:part 1. November 2018. Volume 37. Number 11. Tiffany Osborn, MD, MPH.
- JAMA. 2017;317(5):530-531. doi:10.1001/jama.2016.20468. Proportion and cost of unplanned 30-day readmissions after sepsis compared with other medical conditions