Adult Community-Onset (CO) Sepsis Standardized Mortality Ratio (SMR)

A good friend and neighbor has contracted sepsis they had her on IV antibiotics and 3 days ago was sent home just would be curious trying to do the neighborly thing we're all senior citizens here where I live is it contagious enough to where I should be careful on my wife as well for this is her girlfriend what would the precautions be as for this

CMS should clarify whether a standardized, validated risk-adjustment model will be used to predict mortality, as consistency in methodology is essential for fair comparison across hospitals.

Agree with outcome data for sepsis care.  To this point, CMS quality programs have only used sepsis bundle performance as a marker for "good care" of sepsis patients, and some of the criteria is outdated clinically.  Internally we have been monitoring sepsis readmission, mortality, length of stay and cost of care to measure outcomes for this population. Support endorsement of this measure!

Rationale: This measure would provide facilities with a nationally benchmarked metric of community-onset sepsis mortality outcomes, which can be used to measure their progress to improving the care of patients with sepsis. Sepsis is a leading cause of death in hospitals. Each year, according to the Centers for Disease Control and Prevention (CDC), at least 1.7 million adults in the U.S. develop sepsis, and at least 350,000 die as a result. Accurate tracking of sepsis incidence and outcomes is challenging due to the lack of a definitive diagnostic test and wide variation in diagnosis and coding practices. A measure assessing the community-onset sepsis standardized mortality ratio is essential for producing timely, consistent, and clinically meaningful comparisons across hospitals.

ECRI, a global nonprofit advancing evidence-based healthcare, has submitted the attached comments on the MUC with an emphasis on measures most relevant to patient safety and diagnostic excellence. 

ECRI supports the CMS Measures Under Consideration (MUC) List and its role in advancing meaningful, high-value measurement. Of particular significance are the measures focused on chronic disease management and diagnostic safety. Strengthening measurements in these domains supports more efficient, timely, and coordinated care across the healthcare system to better serve patients. 

The attached comments from ECRI include recommendations on the importance of patient-reported outcomes, minimizing unnecessary reporting burdens, and feedback in support of the following measures: 

• Timely Follow-up on Abnormal Screening Mammograms for Breast Cancer Detection (MUC2025-042)
• Timely Follow-up on Positive Stool-based Tests for Colorectal Cancer Detection (MUC2025-043)
• Adult Community-Onset (CO) Sepsis Standardized Mortality Ratio (MUC2025-045)
• Hospital Sepsis Program Core Elements Score (MUC2025-047)
• Hospital 30-Day, All-Cause, Risk-Standardized Readmission Rate Following Sepsis Hospitalization (MUC2025-055)
• Hospital Harm - Postoperative Venous Thromboembolism (MUC2025-067)

SHEA supports the adoption of the Adult Community-Onset Sepsis Standardized Mortality Ratio (SMR) as a national outcome measure, recognizing its potential to address a longstanding gap in sepsis quality measurement. Risk-standardized mortality measurement is essential for evaluating the effectiveness of care, identifying unwanted variation, and enabling meaningful comparisons across facilities to guide system-level improvement. While mortality is an imperfect outcome influenced by case mix, baseline risk, and care decisions beyond the acute episode, when rigorously risk-adjusted and interpreted alongside complementary measures, it provides critical accountability and insight into sepsis outcomes. We emphasize that robust risk adjustment and reliable electronic data extraction will be vital to the measure’s validity, particularly given concerns such as the inclusion of hospice discharges in the numerator, which could inadvertently discourage appropriate palliative care consultations and goals-of-care discussions for chronically ill patients. Additionally, we acknowledge the technical and implementation challenges associated with operationalizing the CDC Adult Sepsis Event (ASE) definition using FHIR-based data extraction, particularly during early adoption. These challenges, while not unique to sepsis, can be mitigated through phased implementation, technical guidance, validation efforts, and collaboration among CMS, CDC, EHR vendors, and health systems. The use of a clinically grounded, electronically scalable definition represents a significant advance over prior approaches and provides a strong foundation for transparent, fair, and meaningful sepsis outcome measurement.

I support this measure.  Will this be publicly reported for one year, or more, before being incorporated in HVBP to give hospitals time to react or respond?  Was this tested in any rural hospitals,  where patients may be severely septic before arriving at the hospital for treatment?  Without seeing the risk model, it is unclear if there are higher risks in rural settings.  Thank you. 

The American College of Emergency Physicians (ACEP) and our partnering societies support adoption of the Adult Community-Onset Sepsis SMR as a national outcome measure. This measure aligns closely with a prior IDSA and multi-society–endorsed position paper (PMID: 37831591) calling for broader, risk-adjusted sepsis outcome measurement to complement process-based approaches and drive system-level improvement across the full continuum of sepsis care. Risk-standardized mortality measurement is essential for assessing effectiveness of care, identifying unwanted variation, and enabling more meaningful comparisons across facilities, thereby guiding quality improvement. Extending this approach to sepsis addresses a longstanding gap in national quality measurement. We recognize that mortality is an imperfect outcome that is influenced by case mix, baseline risk, and care decisions beyond the acute episode; nonetheless, when rigorously risk-adjusted and interpreted alongside complementary measures, it provides critical accountability and insight into sepsis outcomes. 

We also recognize that operationalizing the CDC Adult Sepsis Event (ASE) definition using FHIR-based data extraction presents technical and implementation challenges, particularly during early adoption. These challenges are not unique to sepsis and are inherent to the evolution of electronically specified quality measures. We believe they can be addressed through phased implementation, technical guidance, validation efforts, and ongoing collaboration between CMS, CDC, EHR vendors, and health systems. The use of a clinically grounded, electronically scalable definition represents a major advance over prior approaches and provides a strong foundation for transparent, fair, and meaningful sepsis outcome measurement

Bon Secours Mercy Health is supportive of a sepsis mortality measure but suggest  discharge to hospice be considered a measure exclusion to support patient and family changes in goals of care. 

The Adult Community-Onset (CO) Sepsis Standardized Mortality Ratio specifically raises concerns regarding  the influence of pre-hospital and community-based factors that are outside of a hospital’s control.  

On behalf of the Michigan Hospital Medicine Safety Consortium (HMS) Coordinating Center, we support the adoption of the Annual Risk-Adjusted Standardized Mortality Ratio (SMR) for community-onset sepsis. HMS is a statewide collaborative of 68 diverse Michigan hospitals working to improve sepsis care since launching our sepsis initiative in 2021. Through our detailed sepsis registry and quality improvement work, we have seen the value of this reliable, clinically-based mortality measurement in supporting improvement efforts across diverse hospital settings. Sepsis affects at least 1.7 million adults annually with at least 350,000 resulting deaths. A standardized mortality measure using objective clinical data can provide hospitals with consistent and clinically meaningful benchmarking to assess their progress in improving sepsis care.

We believe outcome measures like the Sepsis SMR provide important insights into the ultimate goal of sepsis care—preventing deaths. However, outcome measures are most effective when paired with structural measures (such as the Hospital Sepsis Program Core Elements) that build program capacity and process measures like SEP-1 that ensure timely, evidence-based care delivery. Maintaining all three elements of measurement—structure, process, and outcomes—provides the most comprehensive approach to protecting patients and improving sepsis care nationwide.

SHM supports adoption of the Adult Community-Onset Sepsis SMR as a national outcome measure. This measure aligns closely with a prior IDSA and multi-society–endorsed position paper (PMID: 37831591) calling for broader, risk-adjusted sepsis outcome measurement to complement process-based approaches and drive system-level improvement across the full continuum of sepsis care. Risk-standardized mortality measurement is essential for assessing effectiveness of care, identifying unwanted variation, and enabling more meaningful comparisons across facilities, thereby guiding quality improvement. Extending this approach to sepsis addresses a longstanding gap in national quality measurement. We recognize that mortality is an imperfect outcome that is influenced by case mix, baseline risk, and care decisions beyond the acute episode; nonetheless, when rigorously risk-adjusted and interpreted alongside complementary measures, it provides critical accountability and insight into sepsis outcomes. 

We also recognize that operationalizing the CDC Adult Sepsis Event (ASE) definition using FHIR-based data extraction presents technical and implementation challenges, particularly during early adoption. These challenges are not unique to sepsis and are inherent to the evolution of electronically specified quality measures. We believe they can be addressed through phased implementation, technical guidance, validation efforts, and ongoing collaboration between CMS, CDC, EHR vendors, and health systems. The use of a clinically grounded, electronically scalable definition represents a major advance over prior approaches and provides a strong foundation for transparent, fair, and meaningful sepsis outcome measurement

I am submitting my comments as a dual-certified hospitalist nurse practitioner, former ED nurse, and sepsis program coordinator for a large academic health system. My comments are not endorsed by my hospital.

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes. I applaud CMS for proposing new sepsis policies to help transform sepsis care and save lives.  I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.  

Implementing the CDC Core Elements measure will promote hospital leadership accountability while facilitating implementation of standardized sepsis screening to help ensure early recognition, guideline-based care, adequate data tracking and reporting, and education for healthcare providers as well as patients and their families. Implementing sepsis mortality and readmission measures are practical and will likely be complemented by the CDC Core Element measure.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability. New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.  While I do support SEP-1, I advocate for CMS to modify the  SEP-1 measures:

        IVF: The 30mL/kg IVF recommendation for hypotension or lactate >4 is not evidenced-based; therefore it is extremely difficult to get providers to buy-in. If provider does not want to give 30ml/kg, they have to specify their reasoning AND document the volume that they are giving instead in their note. A case could fail if the provider does not specify reasoning or volume, or if the amount of IVF ordered does not exactly match the documentation. Additionally, if a patient receives IVF prehospital, often their prehospital fluids are not able to be counted towards the CMS target volume due to the documentation requirements. Furthermore, many health systems do not have real-time access to prehospital documentation. This leads to confusion for caregivers who are often working in highly stressful and resource-strained emergency departments. A patient can receive timely and exceptional clinical care for sepsis; however can fail the sepsis bundle for these reasons. Please consider keeping the IVF measure, however consider modifying to make it less rigid to pass in an effort to accurately reflect the clinical care given.

        Provider reassessment: This measure is very important; however, the criteria are too firm. As a clinician—if I am re-evaluating my potentially septic patient after they receive their initial IVF bolus, timestamped documentation regarding repeat blood pressures or downtrending lactate levels should suffice this element. If I am documenting blood pressure response to fluids, I should not have to also document a review of additional four parameters as outlined in the CMS specifications manual. Additionally, the acceptable documentation of "review of systems completed" should not suffice this measure as this is systematic inquiry focused on subjective data only - it often would not indicate repeat volume status or inadequate tissue perfusion which is the goal of this measure. Please consider keeping the provider reassessment measure, however, consider modifying to make it less rigid to pass in an effort to accurately reflect the clinical care given.

Instead of SEP-1 being an "all or nothing" measure, consider modifying the SEP-1 measure to offer "partial credit" for bundle element requirements to accurately validate the clinical care that was provided. In current state, a patient case could fail the sepsis bundle if repeat blood pressures are documented one minute after the 60-minute window post IVF completion has expired (for the persistent hypotension measure), despite that patient having an early provider evaluation, lactate levels drawn, blood cultures sent, and antibiotics and fluids administered all within an hour of presentation. Please consider harmonizing with the CDC and Surviving Sepsis Campaign/Society of Critical Care Medicine to promote unity in federal measures, decrease reporting burden for hospitals, and to ultimately decrease morbidity and mortality from sepsis and septic shock.

The American Medical Association (AMA) is more supportive of this mortality measure since it is limited to what occurs within the hospitalization and may remove many of the negative unintended consequences that we believe that the other 30-day measures have. Because this measure leverages data from electronic health record systems (EHRs), we would like to see additional information on the feasibility for the required data elements as well as details on what data element validity testing has been completed. We also recommend that a case minimum is set to ensure that the measure produces a reliability score (ideally 0.6 or higher for all hospitals since we consider the minimum achieved with 25 admissions (0.081 with just 11 patients) to be too low. Finally, we agree that a measure that examines the outcomes that patients with a diagnosis of sepsis is preferable to continuing to require reporting on measures such as the sepsis bundle (SEP-1), which is extremely burdensome to report and has not yet demonstrated a link to improving patient outcomes. 

The AHA appreciates the opportunity to review this measure that assesses hospital sepsis mortality. The measure appears thoughtfully specified and in alignment with CMS’s goal to develop its digital quality measure enterprise. We hope that CMS can provide more information about its longer-term strategy on addressing sepsis through its measurement programs, including the likely timeline for adoption of this measure following completion of testing; interaction with the existing SEP-1 bundle; and how it might complement the other sepsis-related measures under consideration. We urge the agency to allow sufficient time for robust development and implementation of this complex clinical measure; it addresses a critical topic, and is thus worth doing in a way that meaningfully improves quality of care and patient outcomes. 

In addition, due to the complexity of the health IT requirements to populate this measure, we encourage CMS to learn from its experiences with other similar dQMS that are either under development or currently deployed in CMS programs including the hybrid Hospital-wide Readmissions and Morality measures, Hospital-onset Bacteremia measure, and Hypoglycemia measure. That includes ensuring clinical data elements and reporting interfaces are accessible to hospitals including those with fewer health IT resources.

The Infectious Diseases Society of America (IDSA), together with our partnering professional societies representing clinicians and researchers involved in sepsis care across healthcare settings, strongly supports CMS’s efforts to advance national sepsis quality measurement. We recognize that no individual measure will be perfect at inception, and that each will require thoughtful implementation, monitoring, and refinement over time. Nonetheless, we believe the propose measure represents an important, necessary step toward improving sepsis care and outcomes.  We support CMS moving forward while continuing to engage stakeholders to address implementation challenges, unintended incentives, and equity implications informed by prior experience with national quality measures. 

IDSA and our partnering societies support adoption of the Adult Community-Onset Sepsis SMR as a national outcome measure. This measure aligns closely with a prior IDSA and multi-society–endorsed position paper (PMID: 37831591) calling for broader, risk-adjusted sepsis outcome measurement to complement process-based approaches and drive system-level improvement across the full continuum of sepsis care. Risk-standardized mortality measurement is essential for assessing effectiveness of care, identifying unwanted variation, and enabling more meaningful comparisons across facilities, thereby guiding quality improvement. Extending this approach to sepsis addresses a longstanding gap in national quality measurement. 

We strongly support the use of CDC’s Adult Sepsis Event (ASE) definition as the basis for sepsis mortality measurement. ASE represents a major advance over prior claims-based approaches by relying on objective, clinically grounded criteria derived from routinely captured EHR data. Importantly, the proposed measure leverages clinical data elements for both sepsis identification and risk adjustment, supplemented by claims data, thereby improving validity, reducing susceptibility to documentation-driven variation, and providing a strong foundation for fair and meaningful sepsis outcome measurement. 

We recognize that operationalizing this measure using FHIR-based data extraction will present technical and implementation challenges, particularly during early adoption. We believe they can be addressed through phased implementation, technical guidance, validation efforts, and ongoing collaboration between CMS, CDC, EHR vendors, and health systems. Transparency in risk-adjustment methods and continued validation will be essential to ensure that measured performance reflects true differences in care and outcomes, and that documentation, data capture, or coding practices do not unduly influence risk adjustment or measured performance. 

Vizient supports the agency’s efforts to identify measures to help improve sepsis care. However, the MUC2025-045: Adult Community-Onset (CO) Sepsis Standardized Mortality Ratio (SMR) measure under consideration, which includes patients with a sepsis diagnosis, may be unnecessary. For example, several of the contemplated measures introduce new requirements which appear to overlap with existing measures that hospitals report, such as the Severe Sepsis and Septic Shock: Management Bundle (SEP‑1). Vizient is concerned that introducing multiple new sepsis‑related measures, especially if existing measures are retained, risks increasing burden without clear evidence regarding which measurement approach, if any, will be most beneficial in the context of patient care.

We are also concerned that this and other sepsis-related measures currently under consideration suggest that CMS is seeking to add several measures to different quality programs, which runs counter to the agency’s aims to reduce the overall number of measures, decrease burden and streamline program requirements. Given the overlap with SEP-1 and the significant burden associated with SEP‑1, we suggest retiring SEP‑1 and replacing it with significantly fewer measures. 

Vizient also notes that the considered sepsis measures would benefit from undergoing additional review, as these measures have not been used in CMS programs or thoroughly vetted or tested by hospitals. Vizient cautions against advancing measures that have not been rigorously evaluated by experts and tested, as such measures may not achieve their desired outcome, create unintended consequences or prove unworkable in real‑world settings. Vizient believes additional analysis and testing would help to better understand the impacts of these measures, including whether similar benefits can be achieved with fewer measures. 

We would recommend that discharges to hospice not be in the denominator, would recommend that they are excluded to avoid inappropriate attribution of poor outcomes. Patients who are transferred in from another hospital – suggest excluding patients with an early death (<48 hours after transfer), as well as consideration for patients and family who elect for comfort measures only.  

Premier has concerns that the proposed measure population does not align with other Risk Standardized Mortality Rate Measures or the cohort for MUC2025-055, Risk Standardized Readmission Rate following Sepsis Hospitalization. When the “same” population is measured, the cohorts should align. It creates undue administrative burden for hospitals to create multiple populations to mirror CMS measure denominators for the same condition. It is also inappropriate to consider this for the HVBP program until results have been publicly reported through the Hospital IQR program to allow hospitals time to understand the measure and work improvement. CMS should not implement this measure as currently specified until these issues have been addressed.

Premier questions the application of this quality measure for improvement purposes when the data lags by two years. This can impact both the observed performance by not reflecting today’s outcomes and the risk adjustment by using older data to create expected values for more recent patients. Premier has also observed that the risk standardized results do not change much over time and may not reflect performance improvement because it is heavily driven by the random effect in the model. The use of the Predicted to Expected ratio rather than the Observed to Expected ratio, while helpful to reduce undue influence from outliers, does not provide a good reflection of actual performance. Consequently, CMS should emphasize that this methodology is best suited for payment purposes and not quality improvement purposes. The utility of the measure is further hindered by the facility level hierarchical methodology, which does not allow for drill downs into further subgroups, e.g. by physician grouping.   

Concerns regarding the appropriateness of this measure for Hospital Value-Based Purchasing. Outcomesmay be significantly influenced by pre-hospital and community-based factors that are outside the hospital’s control. ​High level of variability depending on community vs tertiary care hospitals, primary care access, and geographical location. 

I am writing as a member of the Board of Directors of Sepsis Alliance to offer my appreciation for the work being done to improve outcomes for patients with sepsis and reduce the financial and human cost of sepsis in the United States.  I believe that the proposed measures, if adopted in addition to the existing process measure, SEP-1, will help achieve this goal.  If, however, the proposed measures are adopted as a replacement to the existing accountability measure represented by SEP-1, we will do a disservice to patients with sepsis. 

Sepsis is a medical emergency that requires timely recognition and treatment. During the first Trump Administration, important work was done by CMS to analyze the cost to Medicare of care for patients with sepsis.  That tabulation documented a cost in excess of $40 billion per year in costs for in-patient hospital admission and subsequent skilled nursing facility admission for Medicare patients.  Clearly, this is a significant problem that must be addressed.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.  Quality measurement must reflect structure, process, and outcomes.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients, saving lives, reducing costs and improving sepsis care nationwide.

The Society of Infectious Diseases Pharmacists (SIDP), together with our partnering professional societies representing clinicians and researchers involved in sepsis care across healthcare settings, strongly supports CMS’s efforts to advance national sepsis quality measurement. We recognize that no individual measure will be perfect at inception, and that each will require thoughtful implementation, monitoring, and refinement over time. Nonetheless, we believe the proposed measure represents an important, necessary step toward improving sepsis care and outcomes.  We support CMS moving forward while continuing to engage stakeholders to address implementation challenges, unintended incentives, and equity implications informed by prior experience with national quality measures.

SIDP and our partnering societies support adoption of the Adult Community-Onset Sepsis SMR as a national outcome measure. This measure aligns closely with a prior IDSA, SIDP, and multi-society–endorsed position paper (PMID: 37831591) calling for broader, risk-adjusted sepsis outcome measurement to complement process-based approaches and drive system-level improvement across the full continuum of sepsis care. Risk-standardized mortality measurement is essential for assessing effectiveness of care, identifying unwanted variation, and enabling more meaningful comparisons across facilities, thereby guiding quality improvement. Extending this approach to sepsis addresses a longstanding gap in national quality measurement. 

We strongly support the use of CDC’s Adult Sepsis Event (ASE) definition as the basis for sepsis mortality measurement. ASE represents a major advance over prior claims-based approaches by relying on objective, clinically grounded criteria derived from routinely captured EHR data. Importantly, the proposed measure leverages clinical data elements for both sepsis identification and risk adjustment, supplemented by claims data, thereby improving validity, reducing susceptibility to documentation-driven variation, and providing a strong foundation for fair and meaningful sepsis outcome measurement. 

We recognize that operationalizing this measure using FHIR-based data extraction will present technical and implementation challenges, particularly during early adoption. We believe they can be addressed through phased implementation, technical guidance, validation efforts, and ongoing collaboration between CMS, CDC, EHR vendors, and health systems. Transparency in risk-adjustment methods and continued validation will be essential to ensure that measured performance reflects true differences in care and outcomes, and that documentation, data capture, or coding practices do not unduly influence risk adjustment or measured performance. 

Do not support: Outcomes are highly sensitive and environmental impacts. Recommend enhanced risk adjustement and stratification reporting. 

We support CMS’s ongoing efforts to advance timely, evidence-based sepsis care and to use outcome measures to drive meaningful quality improvement. However, we have concerns regarding the appropriateness of the Community-Onset Sepsis Mortality measure for inclusion in the Hospital Value-Based Purchasing (HVBP) Program, given the degree to which outcomes may be influenced by pre-hospital and community-based factors that are outside of a hospital’s control.

Mortality among patients with community-onset sepsis is often affected by factors such as timing of symptom recognition, access to care, pre-hospital clinical decision-making, and recent healthcare encounters, including outpatient or emergency care prior to admission. These upstream factors may significantly influence patient condition at presentation and subsequent outcomes, regardless of the quality of inpatient sepsis care delivered.

Without adequate consideration of pre-hospital influences, there is concern that the measure may inappropriately attribute outcomes to hospital performance, potentially disadvantaging hospitals that serve populations with barriers to timely access to care, challenges with care adherence, or that operate in geographic areas with multiple healthcare systems, where limited interoperability and visibility across EHR platforms may constrain access to complete pre-hospital clinical information.

While continuing to support high-quality sepsis care and improvement efforts, we encourage CMS to consider whether the measure sufficiently accounts for recent healthcare utilization prior to hospitalization, such as evaluation by a primary care provider or another healthcare entity in the days or week preceding admission. Incorporating or acknowledging these contextual factors may improve risk adjustment, attribution, and fairness, particularly if the measure is used for payment determination under the Hospital Value-Based Purchasing (HVBP) Program.

I am retired research microbiologist and member of the Sepsis Alliance Advisory Board. From my 26 years of experience in Pharma developing new antibiotics and vaccines to prevent the devasting impact of Sepsis pathogens, I welcome new policies that seek better outcomes for patients at risk of developing sepsis. 

It is vital that hospitals and insurance companies are held accountable for rigorous sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. However, these new proposed measures are important but not sufficient on their own. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability. New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide. I urge those responsible for setting policy at the federal level to ensure that SEP-1 remains a core element of sepsis control policy.

Robert G.K. Donald Ph.D.

Independent Research Consultant

I am a practicing academic Pulmonary and Critical Care physician and the Chair of the Board of Directors of Sepsis Alliance. Sepsis Alliance represents the millions of patients and their families who are affected by sepsis every year. I founded the Kansas Sepsis Project (statewide) and the Sepsis QI initiative at the University of Kansas Hospital. 

From the start, we assessed our standardized mortality ratio for sepsis in my own hospital and found it to be abysmal. Ten years before there was a sepsis core measure (SEP-1) we set out to alter that by implementing best practices at the bedside, and we were highly successful at bringing our severe sepsis mortality to below 5% - clearly not completely successful, but a vast improvement over where we began. Measuring mortality is crucial to understanding whether a hospital's structures and process measures are effective. 

As Sepsis Alliance board chair, both I and the organization strongly support implementation of the sepsis mortality measure alongside the current SEP-1 process measure. It is the right thing to do for patients and the denizens of the United States. 

I am a pulmonary/critical care physician who has cared for 1000s of sepsis patients.  I am also a board member of Sepsis Alliance.  

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.  For SMR, you have excluded patients transferred to another acute care hospital.  However, including those transferred into another acute care hospital will likely skew the receiving hospital's SMR as there is selection bias in who is transferred.  

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Jim O'Brien, MS, MD

 I  speak to you today as a sepsis survivor, the father of a 23-year-old daughter who died from septic shock after a hemorroidectomy, a brother who died from a UTI, and the Founder of the Sepsis Alliance.  I know professionally that lives are saved when sepsis is recognized early and treated with timely, evidence-based care.

Sepsis is a medical emergency. Delays of even hours lead to organ failure, amputations, cognitive decline, prolonged ICU stays, and death. Families are left with lifelong consequences—whether from loss, disability, or trauma—when timely care doesI know—personally and not happen.

That is why, how we measure sepsis care matters.

Quality measurement must include structure, process, and outcomes. I support the CDC Core Elements that assess sepsis care infrastructure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are essential—but they tell us only what happened after the fact.

Process measures ensure action in the moment. They help make sure that a patient with worsening vital signs or altered mental status receives timely antibiotics, fluids, and escalation of care when every hour matters. SEP-1 is currently the only nationally standardized sepsis process measure, and it provides essential accountability for bedside care—especially for patients who cannot advocate for themselves.

Weakening or replacing process measurement would have real consequences: more missed sepsis, more delayed treatment, more preventable organ failure, and more families facing outcomes that did not have to happen.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

I am writing to you as the father of Sam Terblanche, a 20 year-old student at Columbia University who died in his dorm room in September 2023 after he went to the emergency department of a leading New York hospital two nights in a row and triggered the hospital’s sepsis alert the second night.  He was discharged despite the hospital’s automated alert system initiating its sepsis alert after he presented with classic sepsis symptoms.  Like so many of the 350,000 annual sepsis deaths in the United States, Sam’s death was preventable.  We need better hospital systems, better process measures and better outcomes measures.  Critically, we need all three these conditions in place to fight sepsis in a meaningful way.

I come from a non-medical background, but with over 30 years extensive expereince on the regulation of time-sensitive, dangerous and complex industries such as nuclear safety, civil aviation, toll roads and telecommunications networks.  Compared to medicine, these industries have far superior customer (patient) safety records.  They succeed because they focus aggresively on their equivalent of hospital systems, process measures and outcomes measures.  In particular, they have superior process measures (their equivalent of SEP-1) because they understand that reliance on outcomes measures alone means they only investigate fallen planes and melted down nuclear reactors.  Put differently, reliance on outcomes measures in time-sensitive life-and-death industries means we often measure outcomes after the patient died.   That is too late.       

With the foregoing critical caveat, I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.  While SEP-1 itself may need to be updated and digitized in the near term, it saves thousands of lives and without it we could expect a catastrophic increase in preventable sepsis deaths.  

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Hi My name is Angela Craig MS,APN,CCNS,CCRN,CNMAP and I am a board member for Sepsis Alliance.  I have also worked with sepsis initiatives for many years.  I have seen the difference that having required elements for hospitals can make.  

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

I support the development of new sepsis quality measures through the Partnership for Quality Measurement (PQM) process while maintaining the SEP-1 measure during this transition. Sepsis remains a major cause of morbidity and mortality, and continued measurement is critical to ensuring timely, evidence-based care.
I also share this comment as someone who has lost a loved one to sepsis, underscoring the importance of sustained focus, accountability, and improvement in sepsis care. Maintaining SEP-1 during the transition helps preserve progress while new measures are thoughtfully developed.
Thank you for the opportunity to comment and for your commitment to improving sepsis outcomes.

I'm a Member of the Board of Sepsis Alliance and a career diagnostics Expert who has worked on easily Sepsis Diagnostics and intervention. Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

My name is Jackie Duda and I'm a member of the Sepsis Alliance Advisory Board. Four years ago, I nearly died from septic shock, https://www.washingtonpost.com/wellness/2023/09/16/sepsis-septic-shock-experience-near-death/ . 

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sincerely,

Jackie Duda

As the daughter of a Sepsis survivor and a nurse with over a decade of experience in building Sepsis programs, I have learned that successful quality measurement reflect structure, process, and outcomes. 

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide. Neglecting to include SEP-1 has the potential of impacting timeliness of care. Let's build upon what we have achieved so far.

To Whom It May Concern,

I support CMS’s proposed Hospital Sepsis Program Core Elements measure as an important and necessary first step toward improving sepsis care nationwide. Establishing clear expectations for hospital sepsis programs appropriately signals that sepsis requires organized, system level attention.

At the same time, as written, this measure functions as an unfunded mandate. It requires hospitals to establish and maintain sepsis capabilities without providing a payment pathway for the diagnostic capability required to make those systems effective.

Sepsis outcomes cannot improve without diagnosis, and diagnosis requires diagnostics. Sepsis is not a condition that can be reliably addressed through documentation, staffing, or protocols alone. Meaningful improvement in sepsis outcomes depends on earlier and more accurate identification of infection and host response, most often in the emergency department where sepsis is first evaluated.

This measure explicitly evaluates whether hospitals have the infrastructure and processes in place to manage sepsis. Diagnostic capability is a foundational component of that infrastructure. A sepsis program that cannot reliably identify high risk patients early is structurally incomplete. Requiring hospitals to score well on sepsis program elements while bundling the diagnostics that make such programs effective embeds an unfunded requirement directly into a structural measure.

Under current OPPS policy, many laboratory diagnostics used in sepsis evaluation, whether long established or newly developed, are assigned Status Indicator Q4 (conditionally packaged) when billed in typical emergency department and outpatient encounters. As a result, these diagnostics are bundled into facility payments and are not paid separately in the very settings where early sepsis decisions are made.

From a value perspective, paying for sepsis diagnostics is cost effective. Even modest improvements in early diagnosis translate into reduced mortality, fewer ICU admissions, and meaningful gains in quality adjusted life years. The cost of diagnostics is small relative to the clinical and economic burden of sepsis.

If CMS intends this measure to meaningfully strengthen sepsis care, diagnostics used for sepsis evaluation should be unbundled. CMS should remove sepsis diagnostics from OPPS Q4 conditional packaging and allow separate payment when these diagnostics are used in emergency department and outpatient sepsis care.

I am a practicing clinician, a sepsis researcher, and the Chief Executive Officer of Inflammatix, a molecular diagnostics company focused on improving early identification and risk stratification of patients with suspected infection and sepsis. Inflammatix develops host response diagnostics intended to support clinical decision making at the point of care. My comments reflect experience in clinical practice, sepsis research, and the real world development and implementation of sepsis diagnostics.

Sincerely,
Tim Sweeney, MD, PhD
CEO, Inflammatix

As a septic shock survivor, Sepsis Alliance board member, multiple amputee from sepsis and patient advocate, this issue is extremely important to me. Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

I am on the Sepsis Alliance advisory board. As a registered nurse (RN) with over 40 years of clinical and leadership experience, I have seen firsthand how standardized care with measured outcomes, improves sepsis mortality and morbidity.  I was the administrative director for the infection prevention team and know the work they did in teaching, reviewing and measuring the success of the sepsis program.  Going forward, the standardization of the clinical care MUST be in conjunction with SEP-1

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

==============

Sepsis is the #1 cause of hospital deaths in the U.S. and is the #1 cost of acute care. It is also the #1 cause for expensive and burdensome hospital readmissions with 40% of survivors requiring readmission within 90 days. Further, sepsis is the #2 cause of maternal mortality in the U.S., takes more children's lives than cancer, and disproportionately burdens our underserved communities across the nation. 

We have to do better.

Sepsis is a medical emergency that requires timely recognition and treatment. 

If we are going to be serious about reduce harm from sepsis, quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability. Research has show SEP-1 to be effective at saving lives without increasing the use of antimicrobials. Its addition to VBP will further secure its place as a critical component of sepsis care in the United States, and we look forward to continuing to revise and improve this measure as we continue to learn more about sepsis and we have more tools to assist it its diagnosis.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement via these four measures is essential to protecting patients and improving sepsis care nationwide.

I lost my 8 month old Hadley Rae Fowler to Sepsis that was originally diagnosed as the flu. Given multiple different measures and protocols that were in placed, Hadley's symptoms were not on the "list" to introduce the Sepsis protocol or question " Could this be sepsis?"

I do know that if there was more time- sensitive measures that took place and more questions asked about if it could be sepsis, Hadley's life may have been saved. 

It's been 7 years since she passed from Klebsiella Oxytocca Bacteria infection that led to sepsis. I have experienced multiple instances where it feels at times the hospitals and pediatric facilities have to be talked into checking if they have done blood work and are checking for sepsis with the severity of the illness. Is sepsis top of mind? What if something is missed because of the minimu  measures in place and documentation needed. 

This is just one step to so many things that could improve the response time and current sepsis protocols. #HadleysLegacy

My mother died of sepsis.  I have spent 3 decades working in health policy-some of those in measure development.  My mother had to be transferred hospitals before her death because the first hospital didn't catch an escalating situation that resulted in her demise from sepsis.  We need to retain metrics that help hospitals and physicians to detect and treat sepsis before it escalates and kills more Americans.  

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Having had a mother suffer from sepsis twice, countless colleagues and friends suffer from sepsis as well as working in mortality improvement work for a national healthcare performance improvement organization, I have a personal relationship with sepsis and efforts to improve outcomes for us all. 

Sepsis is a medical emergency that requires timely recognition and treatment. Quality measurement must reflect structure, process, and outcomes.

I support the CDC Core Elements to assess sepsis care structure and outcome measures such as risk-adjusted mortality and 30-day all-cause readmissions. These measures are important but not sufficient on their own.

Process measures remain essential to ensure timely and appropriate care for individual patients. SEP-1 is the only nationally standardized process measure for sepsis and provides critical accountability.

New structural and outcome measures should be adopted alongside SEP-1, not in place of it. Maintaining all three elements of measurement is essential to protecting patients and improving sepsis care nationwide.

Sincerely, 

Shannon Hale

On behalf of Sepsis Alliance, the nation’s leading nonprofit organization dedicated to saving lives and limbs from sepsis, we appreciate the opportunity to comment on CMS’s approach to sepsis quality measurement. We represent millions of sepsis survivors, caregivers, and families, and work closely with clinicians and policymakers to improve sepsis care across the country.

The quality improvement framework established by Avedis Donabedian emphasizes three essential components of high-quality care: structure, process, and outcomes. Sepsis Alliance supports the CDC Core Elements as an effective framework for measuring the structure of sepsis care, and we endorse the proposed outcome measures of risk-adjusted mortality and 30-day all-cause readmissions, with minor refinements.

However, structural and outcome measures alone are insufficient. They do not assess the processes of care delivered to individual patients, which are critical in a time-sensitive condition such as sepsis. These measures cannot replace SEP-1, which remains the only nationally standardized process measure holding hospitals accountable for timely and appropriate sepsis care.

Sepsis Alliance strongly supports adoption of the proposed structural and outcome measures alongside SEP-1, not in place of it. Maintaining all three domains of measurement is essential to ensure accountability, consistency, and continued improvement in sepsis care. If CMS adopts and sustains this comprehensive approach, it will be fulfilling its duty to the American public.

I 100% support the outcome measure for sepsis.  As an advanced practice nurse, I have been working on sepsis programs since 2004.  It has taken too long to change practice without an incentive to do so