Worries about care quality and antibiotic resistance are growing as a financial component is added to hospital compliance with federal requirements designed to reduce sepsis cases.
The severe sepsis and septic shock management metrics were added to the Centers for Medicare and Medicaid Services' Hospital Inpatient Quality Reporting Program in 2015 and require facilities to report their sepsis treatment performance. Starting in January, hospitals will have to improve their compliance with the metrics to receive full points and avoid a penalty under the Hospital Value-Based Purchasing Program.
How many points hospitals receive as part of the program is determined by their ability to improve performance on a variety of measures. Hospitals must reach a certain total score across all measures to receive full reimbursement.
No widespread requirements around sepsis care existed prior to the introduction of CMS’ measure in 2015. More than 1.7 million U.S. adults develop sepsis each year, according to the Centers for Disease Control and Prevention.
Some clinicians and medical groups want to see the SEP-1 bundle, as the metrics are called, replaced by a measure focused on improving patient outcomes, as well as comprehensive guidelines that allow for more freedom in how providers treat patients.
In response to this feedback, CMS has begun collaborating with the CDC to develop an electronic clinical quality measure for sepsis outcomes that is less burdensome on providers and gives a better picture of how hospitals are performing on metrics like 30-day mortality.
“What we know about sepsis care is that it can present quite differently depending on the patient you're treating,” said Akin Demehin, senior director for quality and safety policy with the American Hospital Association. “Not all of those individual parameters within the sepsis bundle measure make sense for every patient.”
To comply with the measure, which is part of CMS’ Inpatient Quality Reporting Program, providers must meet and document timed requirements for each sepsis patient around lactate measurements, blood cultures and administration of broad-spectrum antibiotics and intravenous fluids. In particular, all patients identified with sepsis must receive broad-spectrum antibiotics within three hours of diagnosis.
Because the SEP-1 bundle does not track patient outcomes, a low or high compliance rate is not necessarily the best reflection of a hospital’s performance when it comes to reducing sepsis-related mortality or readmissions, Demehin said.
There also are concerns about timing. Requiring providers to take action within a certain time frame doesn’t leave enough time to determine which antibiotics, if any, a patient needs, said Dr. Chanu Rhee, infectious disease and critical care physician at Brigham and Women's Hospital and an associate professor at Harvard Medical School.
Giving sepsis patients unnecessary antibiotics runs the risk of them developing a resistance to antibiotics, Rhee said. Improper antibiotic use can also lead to kidney damage, various infections, hypersensitivity reactions and increased mortality rates.
Nationwide, more than 2.8 million antimicrobial-resistant infections occur annually, leading to 35,000 deaths, according to 2019 data from the Centers for Disease Control and Prevention.
Though CMS understands and supports the focus on antimicrobial stewardship, the agency is not aware of any evidence proving its sepsis measure has contributed to antibiotic overutilization, a spokesperson said in an email statement.
While Brigham and Women’s Hospital typically performs well on timely antibiotic administration, it often struggles to comply with the requirements concerning the intravenous administration of fluids, as it would not be safe in many cases for patients with cardiac issues or borderline respiratory failure to be treated with so many fluids, Rhee said.
“I don't think trying to shoot for 100% compliance makes sense, because to get to 100% compliance, you're going to have to do a lot of overtreatment,” she said. “Do we focus on trying to increase our hospital's SEP-1 scores just for payment purposes when we don't think they're going to actually lead to better patient outcomes?”
On average, hospitals in 2022 were in compliance with the 2015 requirements for 59% of sepsis patients, according to CMS. Only six hospitals out of nearly 3,000 were in compliance for 100% of their patients.
At Henry Ford Hospital in Detroit, compliance with the sepsis measure and detecting cases of sepsis early have helped the facility improve rates of patient deterioration and mortality.
The hospital will continue to track both its sepsis-related patient outcomes and its compliance with the SEP-1 bundle, said Dr. Edward Pollak, chief quality officer at Henry Ford Hospital and Henry Ford Medical Group. For every case of non-compliance, Henry Ford has a cross-functional team of physicians, nurses and quality team members investigate whether sepsis could have been addressed sooner.
Pollak said sometimes there are opportunities to improve compliance without compromising patient care, and sometimes there aren’t.
Some providers believe the requirements are associated with better patient outcomes, despite worries that the SEP-1 bundle becoming a pay-for-performance measure will force more clinicians to adopt sepsis treatment protocols that are too rigid.
CMS has cited several studies that suggest immediate antibiotic administration, specifically in patients with septic shock, has led to reductions in mortality, readmissions and hospital length of stay.
For the last nine months, the University of Kansas Medical Center, in Kansas City, has been in compliance with the bundle for 100% of patients coming into its emergency department with sepsis.
“Even though our mortality rate was already sitting at 5% for those patients, it's [gone] down even further since we got ourselves more compliant, into the 3% range,” said Dr. Steven Simpson, board chair of the Sepsis Alliance and professor of medicine at the University of Kansas.
Adding a financial component to the measure will ensure even more hospitals spend more time and effort on adequate sepsis treatment for patients, Simpson said.
“We need hospitals in America to be doing the basics uniformly,” he said. “Then we can talk about adding on more complexity or personalized medicine layered on top.”
Rather than dictating what providers can and cannot do with regard to sepsis treatment, organizations like the Infectious Diseases Society of America and American Hospital Association have recommended CMS offer more detailed guidance around infection control processes, antibiotic de-escalation, and diagnostic tests that can more quickly identify sepsis causes.
Hospitals should also be required to track and report how long it takes to administer antibiotics from the time they are ordered for a patient with septic shock, Rhee said.
“Early recognition and treatment matter, but there are a lot of steps along the way that are important and ultimately affect the outcome of patients with sepsis,” she said.