In 2015, the Centers for Medicare and Medicaid Services (CMS) adopted SEP-1, a controversial sepsis quality metric drawn from the Surviving Sepsis Campaign (SSC) guidelines. Extensive focus on guideline evidence, covered well elsewhere, leaves out the details surrounding the process of its implementation. [1,2] This post will describe the process and address a misconception: contrary to what some say, adherence with the SSC guidelines does not affect CMS hospital payment.
The Makings of a Quality Metric
CMS collects data through the Hospital Inpatient Quality Reporting Program (IQR).  The Joint Commission and CMS collaborate on a common set of core quality improvement measures published in the Specifications Manual for National Hospital Inpatient Quality Measures (Specifications Manual).  For 2015, CMS added SEP-1, the “Early Management Bundle, Severe Sepsis/Septic Shock” to the Specifications Manual.5 SEP-1 originated from the SSC guidelines and was adopted based on National Quality Forum (NQF) recommendations (NQF #0500). 
The NQF, a nonprofit created in 1999 by public and private sector leaders, makes recommendations about quality guidelines. Measures ratified by NQF through their consensus development process are considered by CMS for public reporting and payment programs.  Any person may submit a performance measure for NQF consideration. NQF forms a committee of individuals or organizations who must be nominated and approved. Each measure then undergoes committee review, NQF member and public commenting, and finally endorsement by the Consensus Standards Approval Committee (CSAC). After publication of an endorsed measure, any person can appeal within 30 days, subject to the review of an appeal board appointed by the NQF Board of Directors. Physicians comprise 59% of NQF committee chairs. Specialty societies have developed 30% of NQF-endorsed measures. As of July 2018, the CSAC includes 17 members of whom ten hold clinical degrees.
What SEP-1 Does Do
Hospital performance on SEP-1 does not directly impact CMS inpatient hospital payment or hospital accreditation, so far. [2,7] CMS has the authority, granted by law, to adjust payment rates for successful submission of data through the IQR Program - the results of the data notwithstanding.8 While CMS does track certain metrics for payment, SEP-1 is not currently included in these programs. The Specifications Manual lists SEP-1 as a “CMS only” metric, meaning the Joint Commission does not use SEP-1 data in its accreditation process.[4,9]
Although CMS does not require adherence to SEP-1, there are many reasons for hospitals to pay attention. CMS has the authority to reduce payments for not submitting SEP-1 data (and other data included in the IQR) and the option to convert SEP-1 to a pay-for-performance metric. Here in New York State, the Department of Health has required hospitals to develop sepsis protocols and report performance data since 2014.  In July, CMS began publicly reporting sepsis performance data on Hospital Compare.  Additionally, endorsement of metrics by CMS might justify their use by other institutions that provide hospital funding. The frenzy over CMS’ implementation of the SSC guidelines via SEP-1 demonstrates the power of their edicts. The mere collection of data has motivated resource shifting in emergency departments and hospitals nationwide. 
Implications for Advocacy
For physician advocates, the process that created SEP-1 is equally relevant as the evidence underpinning it. Influential bureaucratic institutions including CMS and the Joint Commission listen to organizations like the NQF. Physicians need an accurate understanding of a policy, i.e. data submission versus payment metric, in order for intelligent advocacy. As much as we debate the clinical evidence in academic journals, we have to bring those opinions to the institutions that drive guideline creation, endorsement, and payment.
First posted on The Original Kings of County