By Dorothy Brooks
A coalition of large healthcare associations, including the American College of Emergency Physicians (ACEP), is taking issue with a new rule from the Center for Medicare & Medicaid Services (CMS) that will require hospitals to meet the provisions outlined in the Severe Sepsis/Septic Shock Management Bundle, a series of labs, measurements, and therapies often referred to as SEP-1.
The rule, which was finalized by the Biden administration in August 2023, ties meeting the benchmarks outlined in the SEP-1 model with Medicare dollars, putting hospitals that fail to fully meet those metrics at risk of losing revenue. Notably, under a pay-for-reporting measure, hospitals have been required to report on their compliance with the SEP-1 metrics since 2015 — but as long as hospitals fully reported on their performance, no revenue was at risk, regardless of their compliance with SEP-1. With the new rule, that is set to change starting next fall.
In addition to ACEP, the coalition of healthcare organizations opposed to parts of the new rule includes the Infectious Diseases Society of America, Pediatric Infectious Diseases Society, the Society for Healthcare Epidemiology of America, the Society of Hospital Medicine, and the Society of Infectious Diseases Pharmacists. In a position paper outlining their concerns, the group suggested that increasing the focus on the SEP-1 bundle risks diverting attention and resources from more effective measures and comprehensive sepsis care.1 Instead, the group maintained that a better approach is for CMS to retire SEP-1 and focus on new sepsis metrics that focus on patient outcomes. The coalition offered some praise for CMS in this respect.
“CMS is developing a community-onset sepsis 30-day mortality electronic clinical quality measure (eCQM) that is an important step in this direction,” noted the authors of the position paper. “The eCQM preliminarily identifies sepsis using systemic inflammatory response syndrome (SIRS) criteria, antibiotic administrations or diagnosis codes for infection or sepsis, and clinical indicators of acute organ dysfunction.”
The coalition stated that while it supports the eCQM, it recommends removing the SIRS criteria and diagnosis codes to streamline implementation, decrease variability between hospitals, maintain vigilance for patients with sepsis, and avoid promoting antibiotic use in uninfected patients with SIRS.
“We further advocate for CMS to harmonize the eCQM with the Centers for Disease Control and Prevention’s (CDC) Adult Sepsis Event surveillance metric to promote unity in federal measures, decrease reporting burden for hospitals, and facilitate shared prevention initiatives.”
The coalition behind the position paper is not alone in opposing aspects of the new rule. In June 2023, before the rule was finalized, the American Hospital Association (AHA) sent a letter to CMS, outlining its similar concerns about the measure. “While the AHA shares CMS’ goal of improving sepsis care, we are concerned that the inclusion of the well-intentioned but flawed sepsis bundle measure in the HVBP [Hospital Value-Based Purchasing Program] may have too many negative unintended consequences,” wrote Stacey Hughes, the executive vice president of AHA. “We instead urge CMS to focus its efforts on the development of a sepsis outcome measure.”2
However, the new rule also has proponents. For example, the Sepsis Alliance, a large charitable organization that works toward promoting sepsis awareness and improved care, is in favor of the new rule.
Also, Faisal Masud, MD, FCCP, FCCM, director of the Center for Critical Care at Houston Methodist Hospital, tells ED Management that such rules and guidance act as incentives to people to do things differently.
“You need to look at the 350,000 deaths [from sepsis] and the 1.7 million sepsis cases [that occur] each year,” notes Masud. “There is a lot of work that needs to be done, and whether that is based on value-based purchasing or other guidance recommendations, one has to look at the fact that whatever has been done has not paid off yet.”
Masud acknowledges that the new rule is more stringent, and some institutions will no doubt struggle to comply, but he maintains that history has shown that when you put teeth behind such initiatives, they get results.
Masud points to the way providers used to accept central line-related bloodstream infections as simply being a part of what happens when you provide care. But once CMS put teeth behind the reporting requirements around such infections, the number of bloodstream infections dropped substantially. Masud believes the same positive results will happen with respect to sepsis care now that CMS dollars are at stake.
“There are always some patients who don’t fit the cookbook approach or who don’t fit exact definitions ... but I think this [new rule] has the potential to produce a positive impact on the majority of patients [with sepsis],” observes Masud.
There is no doubt that Masud speaks with experience on the issue, as he has been integrally involved with Houston Methodist’s multi-year effort to bring the hospital’s sepsis mortality rate from a high of 35% down into the single digits, an effort that recently won recognition from the Global Sepsis Alliance, an internationally focused group that was founded by the Sepsis Alliance. “We have saved 2,500 lives and more than $50 million in healthcare costs,” Masud says of the sepsis efforts at Houston Methodist.
To be sure, it has taken well over a decade to get these results, but Masud believes that lessons from his organization’s sepsis efforts can help other hospitals and EDs make progress on sepsis, comply with the new rule’s requirements, and save many lives.
For instance, Masud observes that one major key to his hospital’s highly successful sepsis initiative has been the ability to ensure that sepsis remains a top-level concern, and that frontline providers worry about the illness just as much as they worry about someone having a heart attack.
“What I tell people we have learned over this journey is that you have to keep on repeating the education and engagement because a whole new generation of nurses, doctors, and nurse practitioners keeps coming on, so you have to keep at it,” Masud says. “You have to share the outcomes regularly in an open and transparent manner and, most important, you have to sit down on a regular basis and listen to [providers and staff] when they discuss what is working, what needs to be tweaked, and what cannot be tweaked.”
Further, to keep sepsis constantly on the radar, the hospital has created learning modules that physicians and nurses need to go through annually. This is in addition to what Masud refers to as in-the-moment education. “This means that if we have something fall out — we are not perfect and we make mistakes — then you want the whole team to understand what happened, and so you educate them at the bedside,” he says. “Every one of us has competing priorities. You just have to make sure sepsis is still on the table.”
There also need to be mechanisms in place to ensure that all the requirements of the SEP-1 bundle are fulfilled on time. At Houston Methodist, such a process has been established and prioritized, explains Masud. “When sepsis is suspected, that automatically generates communication between the nurses, the doctors, and a sepsis nurse practitioner on the front lines, and they start activating all of the therapies,” he says.
For example, under SEP-1, antibiotics need to be administered quickly. To ensure that this happens, decisions need to be made ahead of time with the hospital pharmacy so that the most commonly used antibiotics for sepsis are ready and easily accessible to frontline providers. Given that there can be many steps to this process, Masud notes that it is important to find out where the delays are occurring, so that they can be tightened up. “We measure all of those things, and we engage the frontline team to help drive the solutions,” he says. “It is part of our culture now. I think if it becomes part of the culture, then it is not considered an extra hard step.”
Masud emphasizes that there are many models of sepsis care that can work well. It is a matter of finding out what works best, given the resources available to a specific institution. For example, while many large health systems have sepsis teams that can be activated to respond when a case of sepsis is suspected, that does not always make financial or practical sense in hospitals that do not see the same volume of patients.
Masud has found that actively engaging frontline providers in the sepsis care process and having automatic work orders for sepsis ready to be deployed to kick-start the care process (including all of the required tasks in SEP-1) has worked well for Houston Methodist. However, the hospital also has a nurse practitioner devoted to sepsis care who can be deployed to the ED or to an inpatient floor to assist providers and staff in carrying out the required sepsis care tasks.
“I know some institutions have dedicated sepsis teams ... but it can be cumbersome and very expensive [for a team of healthcare workers] to only do sepsis, and it becomes a hard sell,” observes Masud. However, he notes that when bedside nurses and physicians have an automated process that is supported by technology, then their work does not present an extraordinarily high burden. “Then, as needed, they can call on our nurse practitioner also, so it is a graduated response,” he says.
While the coalition of healthcare groups opposed to the new sepsis rule has cited the potential for antibiotic overuse as one of their concerns with relying on the SEP-1 bundle, Masud states that this has not proven problematic at Houston Methodist. This makes sense to Masud because, he says, a single dose of antibiotics is not going to lead to antibiotic resistance; it is the five-day or seven-day regimens that become more problematic in this regard.
“More often than not, by 12 hours or 24 hours you have already established whether the patient is septic or not,” states Masud. “We have an antibiotic stewardship committee that has been looking at [the issue], and that concern [of antibiotic resistance related to SEP-1] has not panned out.”
For hospital or ED leaders who remain concerned about the demands of the new rule, Masud urges them to set thoughts about the new regulation aside. Instead, focus on what is best for the patient. “It’s a whole different mindset,” he says. “If you want to do something, you can make it happen. If you have to do something, you may not always make it happen, and you may look for an excuse not to do it. If we have the patient’s best interest in mind, and this is what we would want for our own family members, then we need to be driven by that.”
REFERENCES
- Rhee C, Strich JR, Chiotos K, et al. Improving sepsis outcomes in the era of pay-for-performance and electronic quality measures: A joint EDSA/ACEP/PIDS/SHEA/SHM/SIDP position paper. Clin Infect Dis 2023; Oct 13. doi: 10.1093/cid/ciad447. [Online ahead of print].
- American Hospital Association. AHA Comment Letter on Inpatient Prospective Payment System FY 2024 Proposed Rule. June 9, 2023. https://www.aha.org/lettercomment/2023-06-09-aha-comment-letter-inpatient-prospective-payment-system-fy-2024-proposed-rule
A coalition of large healthcare associations, including the American College of Emergency Physicians, is taking issue with a new rule from the Center for Medicare & Medicaid Services that will require hospitals to meet the provisions outlined in the Severe Sepsis/Septic Shock Management Bundle, a series of labs, measurements, and therapies often referred to as SEP-1.
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