CMS sepsis measure a challenge to report

In October 2015, the Centers for Medicare & Medicaid Services implemented its first meaningful policy to attempt for addressing sepsis.

The condition – one of the leading causes of mortality among hospitalized patients – afflicts more than a million people each year in the United States, and between 15% and 30% of them die. Sepsis is one of the leading drivers of hospital readmissions, sending more patients back to the hospital than heart failure, pneumonia, and chronic obstructive pulmonary disease.¹

However, while providers seem to agree that time to address sepsis is past due, not everyone has embraced the Sepsis CMS Core Measure program, or SEP-1, as the means to best achieve it. This is, in part, because of discrepancies in how sepsis is defined, the burden of reporting, and what some consider to be arbitrary clinical requirements that may not correlate with better patient outcomes.

“Sepsis is indeed a critical public health problem, and it’s appropriate and valuable that Medicare and other policy makers are focusing on sepsis,” said Jeremy Kahn, MD, professor of critical care medicine and health policy and management at the University of Pittsburgh. “This was really the first approach at that … but at 85-pages long, it really is an enormous effort for hospitals to adhere to this measure.”

This is because of the tension between the “intense desire to improve sepsis outcomes” and the “incredible burden” of keeping up with the necessary documentation while also providing quality care, Dr. Kahn said.

In December 2017, Dr. Kahn helped lead a study published in the Journal of Hospital Medicine aimed at trying to understand hospital perceptions of SEP-1. Over the course of 29 interviews with randomly selected hospital quality leaders across the United States, including physicians and nurses, the results came as a surprise.²

 

“Generally, hospitals were very supportive of the concept, and there was no pushback on the idea that we should be measuring and reporting sepsis quality to CMS,” he said.

However, the research team found that respondents believed the program’s requirements with respect to treatment and documentation were complex and not always linked to patient-centered outcomes. Meeting the SEP-1 bundles consistently required hospitals to dedicate resources that not all may have, especially those in small, rural communities and those serving as urban safety nets.

Some, like emergency medicine physician Annahieta Kalantari, DO (who did not participate in the survey), feel that SEP-1 forces providers to practice “check-box” medicine and undermines successful efforts that don’t necessarily align with the CMS policy.

She arrived at her institution, Aria-Jefferson Health in Philadelphia, before CMS adopted SEP-1; at that time, she took note of the fact that the rate of sepsis mortalities in her hospital was, in her words, not great when compared with that at similar institutions. And then she helped do something about it.

“I thought, ‘We’re a Premier reporting hospital,’ so we did a gap analysis as to why and put together protocols for the hospital to follow with our sepsis patients, including a sepsis alert and a lot of education,” said Dr. Kalantari, associate program director for the emergency medicine residency program at Aria-Jefferson and a former chair of its sepsis management committee. “Before you knew it, mortalities were below benchmark.”

But once SEP-1 began, she said, the hospital was unable to check all of the boxes all of the time.

“We kept track, but we weren’t hitting all the bundles exactly within the periods of time recommended, but our mortalities were still amazing,” she said. “CMS basically picked definitions [for sepsis], and most of us don’t know what they’re basing them on because no one can agree on a definition anyway. Now they’re penalizing hospitals if they don’t hit the check marks in time, but we’d already demonstrated that our mortality and patient care was exceptional.”
She added: “I am extremely dissatisfied, as someone who provides frontline patient care, with how CMS is choosing to measure us.”

Dr. Kalantari wrote a piece in the Western Journal of Emergency Medicine in July 2017 in which she and coauthors outline the issues they take with SEP-1. They lay out the tension among the varied definitions of what sepsis is – and isn’t – and they also illuminate the apparent conflict between what CMS has officially defined and what evidence-based studies conducted since 2001 have suggested.³

In particular, CMS defines severe sepsis as an initial lactate above 2 mmol/L and septic shock as an initial lactate presentation of greater than 4 mmol/L. However, Dr. Kalantari and here coauthors argue in the paper that there is no standard definition of sepsis and that decades of attempts to achieve one have failed to reach consensus among providers. CMS, she said, fails to acknowledge this.

 

Defining sepsis

In fact, in 2016, another new definition of sepsis emerged by way of a 19-member task-force of experts: The Third International Consensus Definitions for Sepsis and Septic Shock, also called Sepsis-3.⁴ In March 2017, the Surviving Sepsis Campaign adopted this definition, which defined sepsis as a “life-threatening organ dysfunction caused by a dysregulated host response to infection.”⁵

“I think the definition has always been a challenging part of sepsis,” said Kencee Graves, MD, a hospitalist at the University of Utah, Salt Lake City. “The definitions came about for research purposes, so … they are not perfectly sensitive nor specific.”

However, Dr. Graves believes SEP-1 is a step in the right direction in that it brings awareness to sepsis and holds providers accountable. Several years ago, she and her colleague Devin Horton, MD, also a hospitalist at the University of Utah, embarked on a massive undertaking to address sepsis in their hospital. It was, at the time, lacking in “sepsis culture,” Dr. Horton said.

“One of the big things that motivated both of us was that we started doing chart review together and – it’s always easier with 20/20 hindsight – we were noticing that residents were missing the signs of sepsis,” Dr. Horton explained. “The clinical criteria would be there, but no one would say the word.” This is important, he said, because sepsis is time critical.

So the pair set out to create a cultural change by sharing data and collecting input from each service and unit, which relied heavily on nursing staff to perpetuate change. They created an early warning system in the medical record and worked with units to achieve flexibility in their criteria.

While the early warning system seemed helpful on the floor, SEP-1 adherence rates changed little in the emergency department. So Dr. Graves and Dr. Horton worked out an ED-specific process map that started at triage and was modeled after myocardial infarction STEMI protocols. From April through December 2016, the ED achieved between 29.5% adherence to the SEP-1 bundles, they said according to CMS abstractor data. After the change, between January and March 2017, the ED saw 52.2% adherence.

Dr. Kalantari would like to see CMS allow hospitals to evaluate and alter their processes more individually, with the required result being lower sepsis mortality. Hospitalists, said Dr. Kahn, are well poised to champion these sepsis improvement efforts.

“Hospitalists are uniquely positioned to lead in this area because they are a visible presence and a link between providers doing multidisciplinary acute care,” he said. “The other thing hospitalists can do is insist on rolling out approaches that are evidence based and not likely to cause harm by leading to over resuscitation, or ensuring patients are receiving central-line insertions only when needed.”

This is currently a moment for hospitals to innovate and provide meaningful feedback to CMS, which, he said, is listening.

“It’s a myth that CMS rolls out policy without listening to the clinical community, but what they want is constructive criticism, not just to hear ‘We’re not ready and we have to push this down the road,’ ” Dr. Kahn said. “The time is now in the era of accountability in health care.”

 

References

1. Sepsis. National Institute of General Medical Sciences. https://www.nigms.nih.gov/education/pages/factsheet_sepsis.aspx. Updated Sept 2017. Accessed Jan 4, 2018.

2. Barbash I et al. Hospital perceptions of Medicare’s sepsis quality reporting initiative. J Hosp Med. 2017;12;963-8.

3. Kalantari A et al. Sepsis Definitions: The search for gold and what CMS got wrong. West J Emerg Med. 2017 Aug;18(5):951-6.

4. Singer M et. al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10.

5. Rhodes A et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017;43:304.

In October 2015, the Centers for Medicare & Medicaid Services implemented its first meaningful policy to attempt for addressing sepsis.

The condition – one of the leading causes of mortality among hospitalized patients – afflicts more than a million people each year in the United States, and between 15% and 30% of them die. Sepsis is one of the leading drivers of hospital readmissions, sending more patients back to the hospital than heart failure, pneumonia, and chronic obstructive pulmonary disease.¹

However, while providers seem to agree that time to address sepsis is past due, not everyone has embraced the Sepsis CMS Core Measure program, or SEP-1, as the means to best achieve it. This is, in part, because of discrepancies in how sepsis is defined, the burden of reporting, and what some consider to be arbitrary clinical requirements that may not correlate with better patient outcomes.

“Sepsis is indeed a critical public health problem, and it’s appropriate and valuable that Medicare and other policy makers are focusing on sepsis,” said Jeremy Kahn, MD, professor of critical care medicine and health policy and management at the University of Pittsburgh. “This was really the first approach at that … but at 85-pages long, it really is an enormous effort for hospitals to adhere to this measure.”

This is because of the tension between the “intense desire to improve sepsis outcomes” and the “incredible burden” of keeping up with the necessary documentation while also providing quality care, Dr. Kahn said.

In December 2017, Dr. Kahn helped lead a study published in the Journal of Hospital Medicine aimed at trying to understand hospital perceptions of SEP-1. Over the course of 29 interviews with randomly selected hospital quality leaders across the United States, including physicians and nurses, the results came as a surprise.²

 

“Generally, hospitals were very supportive of the concept, and there was no pushback on the idea that we should be measuring and reporting sepsis quality to CMS,” he said.

However, the research team found that respondents believed the program’s requirements with respect to treatment and documentation were complex and not always linked to patient-centered outcomes. Meeting the SEP-1 bundles consistently required hospitals to dedicate resources that not all may have, especially those in small, rural communities and those serving as urban safety nets.

Some, like emergency medicine physician Annahieta Kalantari, DO (who did not participate in the survey), feel that SEP-1 forces providers to practice “check-box” medicine and undermines successful efforts that don’t necessarily align with the CMS policy.

She arrived at her institution, Aria-Jefferson Health in Philadelphia, before CMS adopted SEP-1; at that time, she took note of the fact that the rate of sepsis mortalities in her hospital was, in her words, not great when compared with that at similar institutions. And then she helped do something about it.

“I thought, ‘We’re a Premier reporting hospital,’ so we did a gap analysis as to why and put together protocols for the hospital to follow with our sepsis patients, including a sepsis alert and a lot of education,” said Dr. Kalantari, associate program director for the emergency medicine residency program at Aria-Jefferson and a former chair of its sepsis management committee. “Before you knew it, mortalities were below benchmark.”

But once SEP-1 began, she said, the hospital was unable to check all of the boxes all of the time.

“We kept track, but we weren’t hitting all the bundles exactly within the periods of time recommended, but our mortalities were still amazing,” she said. “CMS basically picked definitions [for sepsis], and most of us don’t know what they’re basing them on because no one can agree on a definition anyway. Now they’re penalizing hospitals if they don’t hit the check marks in time, but we’d already demonstrated that our mortality and patient care was exceptional.”
She added: “I am extremely dissatisfied, as someone who provides frontline patient care, with how CMS is choosing to measure us.”

Dr. Kalantari wrote a piece in the Western Journal of Emergency Medicine in July 2017 in which she and coauthors outline the issues they take with SEP-1. They lay out the tension among the varied definitions of what sepsis is – and isn’t – and they also illuminate the apparent conflict between what CMS has officially defined and what evidence-based studies conducted since 2001 have suggested.³

In particular, CMS defines severe sepsis as an initial lactate above 2 mmol/L and septic shock as an initial lactate presentation of greater than 4 mmol/L. However, Dr. Kalantari and here coauthors argue in the paper that there is no standard definition of sepsis and that decades of attempts to achieve one have failed to reach consensus among providers. CMS, she said, fails to acknowledge this.

 

Defining sepsis

In fact, in 2016, another new definition of sepsis emerged by way of a 19-member task-force of experts: The Third International Consensus Definitions for Sepsis and Septic Shock, also called Sepsis-3.⁴ In March 2017, the Surviving Sepsis Campaign adopted this definition, which defined sepsis as a “life-threatening organ dysfunction caused by a dysregulated host response to infection.”⁵

“I think the definition has always been a challenging part of sepsis,” said Kencee Graves, MD, a hospitalist at the University of Utah, Salt Lake City. “The definitions came about for research purposes, so … they are not perfectly sensitive nor specific.”

However, Dr. Graves believes SEP-1 is a step in the right direction in that it brings awareness to sepsis and holds providers accountable. Several years ago, she and her colleague Devin Horton, MD, also a hospitalist at the University of Utah, embarked on a massive undertaking to address sepsis in their hospital. It was, at the time, lacking in “sepsis culture,” Dr. Horton said.

“One of the big things that motivated both of us was that we started doing chart review together and – it’s always easier with 20/20 hindsight – we were noticing that residents were missing the signs of sepsis,” Dr. Horton explained. “The clinical criteria would be there, but no one would say the word.” This is important, he said, because sepsis is time critical.

So the pair set out to create a cultural change by sharing data and collecting input from each service and unit, which relied heavily on nursing staff to perpetuate change. They created an early warning system in the medical record and worked with units to achieve flexibility in their criteria.

While the early warning system seemed helpful on the floor, SEP-1 adherence rates changed little in the emergency department. So Dr. Graves and Dr. Horton worked out an ED-specific process map that started at triage and was modeled after myocardial infarction STEMI protocols. From April through December 2016, the ED achieved between 29.5% adherence to the SEP-1 bundles, they said according to CMS abstractor data. After the change, between January and March 2017, the ED saw 52.2% adherence.

Dr. Kalantari would like to see CMS allow hospitals to evaluate and alter their processes more individually, with the required result being lower sepsis mortality. Hospitalists, said Dr. Kahn, are well poised to champion these sepsis improvement efforts.

“Hospitalists are uniquely positioned to lead in this area because they are a visible presence and a link between providers doing multidisciplinary acute care,” he said. “The other thing hospitalists can do is insist on rolling out approaches that are evidence based and not likely to cause harm by leading to over resuscitation, or ensuring patients are receiving central-line insertions only when needed.”

This is currently a moment for hospitals to innovate and provide meaningful feedback to CMS, which, he said, is listening.

“It’s a myth that CMS rolls out policy without listening to the clinical community, but what they want is constructive criticism, not just to hear ‘We’re not ready and we have to push this down the road,’ ” Dr. Kahn said. “The time is now in the era of accountability in health care.”

 

References

1. Sepsis. National Institute of General Medical Sciences. https://www.nigms.nih.gov/education/pages/factsheet_sepsis.aspx. Updated Sept 2017. Accessed Jan 4, 2018.

2. Barbash I et al. Hospital perceptions of Medicare’s sepsis quality reporting initiative. J Hosp Med. 2017;12;963-8.

3. Kalantari A et al. Sepsis Definitions: The search for gold and what CMS got wrong. West J Emerg Med. 2017 Aug;18(5):951-6.

4. Singer M et. al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10.

5. Rhodes A et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017;43:304.

In October 2015, the Centers for Medicare & Medicaid Services implemented its first meaningful policy to attempt for addressing sepsis.

The condition – one of the leading causes of mortality among hospitalized patients – afflicts more than a million people each year in the United States, and between 15% and 30% of them die. Sepsis is one of the leading drivers of hospital readmissions, sending more patients back to the hospital than heart failure, pneumonia, and chronic obstructive pulmonary disease.¹

However, while providers seem to agree that time to address sepsis is past due, not everyone has embraced the Sepsis CMS Core Measure program, or SEP-1, as the means to best achieve it. This is, in part, because of discrepancies in how sepsis is defined, the burden of reporting, and what some consider to be arbitrary clinical requirements that may not correlate with better patient outcomes.

“Sepsis is indeed a critical public health problem, and it’s appropriate and valuable that Medicare and other policy makers are focusing on sepsis,” said Jeremy Kahn, MD, professor of critical care medicine and health policy and management at the University of Pittsburgh. “This was really the first approach at that … but at 85-pages long, it really is an enormous effort for hospitals to adhere to this measure.”

This is because of the tension between the “intense desire to improve sepsis outcomes” and the “incredible burden” of keeping up with the necessary documentation while also providing quality care, Dr. Kahn said.

In December 2017, Dr. Kahn helped lead a study published in the Journal of Hospital Medicine aimed at trying to understand hospital perceptions of SEP-1. Over the course of 29 interviews with randomly selected hospital quality leaders across the United States, including physicians and nurses, the results came as a surprise.²

 

“Generally, hospitals were very supportive of the concept, and there was no pushback on the idea that we should be measuring and reporting sepsis quality to CMS,” he said.

However, the research team found that respondents believed the program’s requirements with respect to treatment and documentation were complex and not always linked to patient-centered outcomes. Meeting the SEP-1 bundles consistently required hospitals to dedicate resources that not all may have, especially those in small, rural communities and those serving as urban safety nets.

Some, like emergency medicine physician Annahieta Kalantari, DO (who did not participate in the survey), feel that SEP-1 forces providers to practice “check-box” medicine and undermines successful efforts that don’t necessarily align with the CMS policy.

She arrived at her institution, Aria-Jefferson Health in Philadelphia, before CMS adopted SEP-1; at that time, she took note of the fact that the rate of sepsis mortalities in her hospital was, in her words, not great when compared with that at similar institutions. And then she helped do something about it.

“I thought, ‘We’re a Premier reporting hospital,’ so we did a gap analysis as to why and put together protocols for the hospital to follow with our sepsis patients, including a sepsis alert and a lot of education,” said Dr. Kalantari, associate program director for the emergency medicine residency program at Aria-Jefferson and a former chair of its sepsis management committee. “Before you knew it, mortalities were below benchmark.”

But once SEP-1 began, she said, the hospital was unable to check all of the boxes all of the time.

“We kept track, but we weren’t hitting all the bundles exactly within the periods of time recommended, but our mortalities were still amazing,” she said. “CMS basically picked definitions [for sepsis], and most of us don’t know what they’re basing them on because no one can agree on a definition anyway. Now they’re penalizing hospitals if they don’t hit the check marks in time, but we’d already demonstrated that our mortality and patient care was exceptional.”
She added: “I am extremely dissatisfied, as someone who provides frontline patient care, with how CMS is choosing to measure us.”

Dr. Kalantari wrote a piece in the Western Journal of Emergency Medicine in July 2017 in which she and coauthors outline the issues they take with SEP-1. They lay out the tension among the varied definitions of what sepsis is – and isn’t – and they also illuminate the apparent conflict between what CMS has officially defined and what evidence-based studies conducted since 2001 have suggested.³

In particular, CMS defines severe sepsis as an initial lactate above 2 mmol/L and septic shock as an initial lactate presentation of greater than 4 mmol/L. However, Dr. Kalantari and here coauthors argue in the paper that there is no standard definition of sepsis and that decades of attempts to achieve one have failed to reach consensus among providers. CMS, she said, fails to acknowledge this.

 

Defining sepsis

In fact, in 2016, another new definition of sepsis emerged by way of a 19-member task-force of experts: The Third International Consensus Definitions for Sepsis and Septic Shock, also called Sepsis-3.⁴ In March 2017, the Surviving Sepsis Campaign adopted this definition, which defined sepsis as a “life-threatening organ dysfunction caused by a dysregulated host response to infection.”⁵

“I think the definition has always been a challenging part of sepsis,” said Kencee Graves, MD, a hospitalist at the University of Utah, Salt Lake City. “The definitions came about for research purposes, so … they are not perfectly sensitive nor specific.”

However, Dr. Graves believes SEP-1 is a step in the right direction in that it brings awareness to sepsis and holds providers accountable. Several years ago, she and her colleague Devin Horton, MD, also a hospitalist at the University of Utah, embarked on a massive undertaking to address sepsis in their hospital. It was, at the time, lacking in “sepsis culture,” Dr. Horton said.

“One of the big things that motivated both of us was that we started doing chart review together and – it’s always easier with 20/20 hindsight – we were noticing that residents were missing the signs of sepsis,” Dr. Horton explained. “The clinical criteria would be there, but no one would say the word.” This is important, he said, because sepsis is time critical.

So the pair set out to create a cultural change by sharing data and collecting input from each service and unit, which relied heavily on nursing staff to perpetuate change. They created an early warning system in the medical record and worked with units to achieve flexibility in their criteria.

While the early warning system seemed helpful on the floor, SEP-1 adherence rates changed little in the emergency department. So Dr. Graves and Dr. Horton worked out an ED-specific process map that started at triage and was modeled after myocardial infarction STEMI protocols. From April through December 2016, the ED achieved between 29.5% adherence to the SEP-1 bundles, they said according to CMS abstractor data. After the change, between January and March 2017, the ED saw 52.2% adherence.

Dr. Kalantari would like to see CMS allow hospitals to evaluate and alter their processes more individually, with the required result being lower sepsis mortality. Hospitalists, said Dr. Kahn, are well poised to champion these sepsis improvement efforts.

“Hospitalists are uniquely positioned to lead in this area because they are a visible presence and a link between providers doing multidisciplinary acute care,” he said. “The other thing hospitalists can do is insist on rolling out approaches that are evidence based and not likely to cause harm by leading to over resuscitation, or ensuring patients are receiving central-line insertions only when needed.”

This is currently a moment for hospitals to innovate and provide meaningful feedback to CMS, which, he said, is listening.

“It’s a myth that CMS rolls out policy without listening to the clinical community, but what they want is constructive criticism, not just to hear ‘We’re not ready and we have to push this down the road,’ ” Dr. Kahn said. “The time is now in the era of accountability in health care.”

 

References

1. Sepsis. National Institute of General Medical Sciences. https://www.nigms.nih.gov/education/pages/factsheet_sepsis.aspx. Updated Sept 2017. Accessed Jan 4, 2018.

2. Barbash I et al. Hospital perceptions of Medicare’s sepsis quality reporting initiative. J Hosp Med. 2017;12;963-8.

3. Kalantari A et al. Sepsis Definitions: The search for gold and what CMS got wrong. West J Emerg Med. 2017 Aug;18(5):951-6.

4. Singer M et. al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10.

5. Rhodes A et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017;43:304.