Sepsis Mandates
Authors: Colin R. Cooke, Theodore J. Iwashyna
Journal: JAMA (2014)

The last decade has witnessed significant improvements in the care of acutely ill hospitalized patients. Elderly patients with an acute myocardial infarction (AMI) are now nearly twice as likely to receive evidence-based care and one-third less likely to die during their hospital stay compared to just ten years ago1,2. Similar trends exist for congestive heart failure (CHF) and pneumonia2. National public reporting and pay for performance (P4P) efforts, such as those implemented by the Centers for Medicare and Medicaid services (CMS), have contributed to improvements in care for these conditions1.

Since those CMS programs were developed, however, the epidemiology of hospital care has changed in the United States. Improvements in outpatient care have substantially reduced the incidence of hospitalization for the conditions on which CMS currently focuses, specifically AMI, CHF, and pneumonia. Moreover, fewer than 10% of patients with these three conditions now die during their hospital stay. Meanwhile, among inpatients, sepsis has become the most prevalent and most costly disease, and is associated with high in-hospital mortality rate3,4. The time has come for CMS to explicitly develop new quality mandates focused on sepsis.

By adding a specific focus on sepsis, CMS might achieve greater improvements in patient outcomes and advance the quality of hospital-based care. Sepsis is now the most common non-pregnancy related primary discharge diagnosis for Medicare and Medicaid, and in the top five for private payers2,3. These numbers underestimate the total burden of sepsis, as many patients admitted with other common diagnoses also have sepsis or develop sepsis during the hospital stay. With an increasing incidence and high case-fatality rate, sepsis now accounts for nearly half of all hospital deaths4. Yet, hospitals vary widely in their adherence to sepsis guidelines5. In marked contrast to adherence to treatment guidelines for AMI, CHF and pneumonia process measures, published reports routinely cite less than 35% compliance with current best practice for sepsis care5.

Some may suggest that the rollout of national accountability measures for sepsis is premature6. These concerns, however, are largely not empirically based. Some contend that claims-based definitions of sepsis lack adequate validity, but in fact the specificity for the most widely used claims-based definition for severe sepsis is greater than 96% and is comparable to that of other CMS conditions7. There are concerns that the increase in sepsis diagnoses may reflect “upcoding” (selection of billing codes intended to increase reimbursement) rather than a true change in incidence; mandates could improve the identification and appropriate care of true sepsis cases, and as an additional effect could allow more accurate epidemiology and policy monitoring. While there are concerns about whether outcomes for patients with sepsis can be improved, RCTs and observational studies have identified early recognition, timely antibiotic administration, and aggressive fluid resuscitation as effective in reducing sepsis-related mortality8. Moreover, sizeable improvements in mortality in sepsis can be achieved through quality initiatives that integrate these therapies9, in part because too few patients currently receive optimal care.

A next-generation quality improvement target like sepsis will require implementation of next-generation performance measures that build on what has been learned since public reporting and P4P began. Simply mandating reporting of 30-day risk-adjusted mortality, or even CMS’ recent decision to require hospitals to report adherence to the NQF’s severe sepsis and septic shock management bundle,10 may help, but will not be sufficient. In this, sepsis is not unique; other patients could benefit from more innovative approaches too. However, for CMS to maximally drive performance improvement, these changes are particularly important for sepsis.

First, new mandates to improve sepsis must address the reality that sepsis is frequently under-diagnosed7. Existing quality metrics for AMI, CHF and pneumonia capitalized on previous decades’ work to make accurate recognition of those conditions nearly universal. But quality improvement cannot be limited to only those conditions for which the diagnosis is already accurate. Quality improvement mandates could improve not only the completeness, but also the precision of sepsis diagnosis. A quality improvement focus on diagnostic accuracy could provide spillover benefits for non-sepsis patients as well. New sepsis mandates have the potential to advance the science and practice of quality improvement to face the common reality of diagnostic ambiguity or inadequacy.

Second, sepsis mandates should focus on catalyzing and aggregating local efforts for quality improvement. Increasing evidence suggests that current public reporting and P4P methods are insufficient tools to fully improve care11. Instead, CMS could scale up collaborative quality improvement using methods that incentivize gains in the culture of care, foster professionalism and sharing of best practices, and improve workflow of care processes—that is, work to target learning rather than only judging11. In doing so, CMS could promote sharing across hospital boundaries of how to better care for patients. This is particularly important for sepsis given the need to assess timely recognition10—whereas traditional mandates involving financial penalties would create perverse incentives to hide delayed diagnosis of sepsis, rather than to fix the problem.

Third, sepsis mandates should plan for phased implementation, improving the measures in select sites prior to national rollout. CMS has developed an Innovation Center as an infrastructure for the development and testing of healthcare payment and service delivery models. Alternatively, regional quality collaboratives, such as state wide multi-hospital networks, could be contracted by CMS to examine benefits and harms of specific sepsis mandates. Early adopters serve as laboratories for refining measurement and averting unintended consequences. Such early adopters can include those just beginning quality improvement, as well as longstanding leaders such as Kaiser Permanente and Intermountain Healthcare. Careful assessment of the challenges of implementing policy mandates in these settings brings to light the potential for harms when mandates are widely implemented, but does so in a way that helps develop solutions rather than simply documenting barriers.

Fourth, sepsis mandates must plan to be highly responsive to new evidence. Quality measurement seeks to ensure that every patient receives the currently recognized best possible care; therefore, when best care improves, quality measurement should improve in tandem. One NQF sepsis measure provides an optimistic example of such responsiveness: the ProCESS trial demonstrated that focus on recognition, early antibiotics, and fluid resuscitation may achieve equivalent sepsis outcomes to more complicated protocols that mandate central line placement8. NQF promptly revised its measure to remove the need for central venous catheterization. A new sepsis mandate must be equally responsive to new, yet-to-be-published evidence. Pragmatically this means planning for regular review of measures, having a system for putting some measures “on hiatus” pending a review of new data, and admitting that a single promulgation will not forever capture the state-of-the-art of a dynamic science.

Sepsis is a major public health problem and has become a dominant diagnosis and cause of death in US hospitals. Implementation of national programs that track and mandate improvements in care and outcomes of sepsis could improve the prognosis for patients with sepsis. National programs for sepsis are needed that improve imperfect diagnosis, that focus on learning rather than judging, that use phased implementation, and that have planned growth in response to new scientific evidence rather than static rules. Current practices mean that only one third of patients with sepsis will receive the excellent care. Clinicians--as well as the health care system--can do better if properly led, and now is the time to start to do so.