The Hospitalist

“We heard you and will continue listening.”

Those were the words that Andrew Slavitt, then-acting administrator of the Centers for Medicare and Medicaid Services, used in a blog post on Oct. 14, 2016.¹ (Slavitt no longer maintains that title since the new federal administration took office on Jan. 20, 2017.)

• Heart failure: ACE inhibitor/angiotensin receptor blocker for left ventricular systolic dysfunction
• Heart failure: Beta-blocker for LVSD
• Stroke: DC on antithrombotic therapy
• Advance Care Plan
• Prevention of catheter-related bloodstream infection: CVC (central venous catheter) Insertion Protocol
• Documentation of current medications
• Appropriate treatment of methicillin-susceptible Staphylococcus aureus bacteremia

“Of the seven available, not all will be reportable because hospitalist practices have a lot of variation, both in their practices and in their patient mix,” Dr. Greeno said. “Most hospitalists will only be able to successfully report on four measures, but we are seeking clarification on what they call a validation test and how that will function.”

In the final rule, CMS said that it will perform that “validation test” to evaluate physicians who cannot report the minimum number of measures to ensure they are not penalized for it.

In addition to Quality, the other reporting categories under the umbrella of MIPS include Advancing Care Information, Cost, and Improvement Activities. For 2017, CMS gave physicians the option to “pick your pace.”⁴ As long as doctors report just one quality measure, one improvement activity, or the required advancing care information measures (most hospitalists will be exempt from this category), they will avoid a penalty.^1,5 Cost will not be included for 2017, the first performance year for MIPS. This year’s reporting will be used to determine payments in 2019, though all physicians will see a 0.5 percent fee increase between now and 2019.

Additionally, just for this year, physicians can choose to report for either a full or partial year (90 days). They will not be subject to the penalty and may be eligible for a positive payment adjustment. However, those who submit nothing are subject to a negative 4% adjustment penalty.

Alternative payment models

While MIPS is the pathway most physicians expect to find themselves on in 2017, the other option is the Alternative Payment Models (APMs) pathway, which moves away from the pay-for-performance, semi-fee-for-service structure of MIPS and, instead, follows the rules established by the models themselves, which include select qualified accountable care organizations and patient-centered medical homes.⁷ Participating physicians are eligible for a 5% incentive payment in 2019. Many health experts say that it’s clear CMS would like to ultimately steer most physicians from MIPS to APMs.

However, very few – if any – hospitalists will find themselves on an APM track. This is, in part, because models considered APMs require the use of Certified Electronic Health Record Technology (CEHRT) and must present “more than nominal risk” to providers.

“Right now, the only alternative payment model where hospitalists can directly take risk is BPCI [Bundled Payments for Care Improvement], but it does not qualify as an APM,” Dr. Greeno said.

It will also be difficult because CMS requires patient and payer thresholds under APMs that hospitalists simply are not poised to meet. In 2019, this means 25% of Medicare payments must come from an Advanced APM in 2017, or 20% of providers’ Medicare patients must be seen through an Advanced APM.⁸

Advanced APMs are those with which, at least in 2019 and 2020, providers face the risk of losing the lesser of 8% of their revenue or repaying CMS up to 3% of their total Medicare expenditures, if expenditures are higher than expected.^8,9

“It is going to be very difficult for hospitalists to qualify for APMs because we’re not in the position to hit the thresholds,” said Dr. Dutta.

However, SHM has urged CMS to consider other BPCI models for qualification as APMs, and Dr. Greeno said that CMS is currently looking into developing bundles that may be appropriate for hospitalists. For instance, Dr. Dutta said, “What we do often in medicine is chronic disease management, and the time is coming to get into chronic disease bundles, such as [those for] management of heart failure or kidney disease.”

In December, SHM submitted a letter to PTAC (the Physician-Focused Payment Model Technical Advisory Committee) to show support for a model created by the American College of Surgeons, called ACS-Brandeis, which they hope will be considered as an Advanced Alternative Payment Model. In the proposal that ACS submitted, the authors noted, “The core model is focused on procedure episodes but can easily be expanded to include acute and chronic conditions.”

The SHM notes in its letter that, while the initial proposal is intended for surgical patients, the term-based nature of surgical care provides a platform for expanding the model more broadly to hospitalists and other specialties.
 

Some skepticism remains

Even if BPCI or other models are accepted as APMs, hospitalists may still be challenged to meet the required payment or patient thresholds, Dr. Greeno said. Additionally, Dr. Berenson is skeptical of bundled payments, particularly for hospitalists.

“Are hospitalists the right organization to be held accountable for the total cost of care for 90 days of spending, any more than oncologists under Oncology Care Models should be accountable for the total cost of cancer where some patients are getting palliative care and that’s not a driver of healthcare costs?” he asked. “I could see that as problematic for hospitalists.”

While he believes there are many positive aspects to MACRA, in general, Dr. Berenson considers it bad policy. While he does not want to see the Sustainable Growth Rate return, he believes many physicians would have seen reimbursement reductions sooner without MACRA (under the prior quality measurement programs) and that the law provides some perverse incentives.

For one thing, the Quality Payment Program is budget neutral, which means that, for every winner, there is also a loser. Before CMS expanded exemptions for smaller and rural practices, Dr. Berenson said that some larger groups – which are often better equipped to pursue APMs – were planning to stay in MIPS because they figured they were more likely to be the winners when compared with smaller physician practices. And MIPS comes with a 9% payment boost by 2022 (or 9% penalty), plus the possibility of an extra bonus for top performers, compared with the 5% incentive of APMs that same year.⁷

“There were literally groups saying they were going to go for the MIPS pathway because it’s a bigger upside,” Dr. Berenson said. “When CMS said it was exempting those [smaller, rural] groups, the [larger] groups turned around and said [that the smaller, rural groups] were the downside. ... That kind of game theory is bad public policy.”

Dr. Berenson also believes MACRA will be detrimental to some small and independent practices. Others may decide not to bill Medicare altogether, though that is not an option open to most hospitalists who care to stay in practice. It could, however, drive more hospitalists to consolidate or to become employees of their hospitals.¹⁰

“I don’t think there is any doubt this is going to drive consolidation,” Dr. Greeno said, citing numbers released by CMS that show an inverse relationship between practice size and the negative impact of MACRA.¹¹ “I think it’s going to be pretty tough unless you’re big enough to commit the resources you need to do it right.”

At TeamHealth, where Dr. Greeno is senior advisor of medical affairs, he said that they have invested in information technology compliance, developed systems and trained providers to ensure the creation of favorable metrics for the organization’ and built the infrastructure to gather, report, and validate data. These are steps that may be out of reach for most smaller practices.

As Dr. Greeno said, no one expected this to be easy. “You’re trying to get doctors to change the way they practice. Anybody who has ever worked with doctors knows that’s not an easy things to do,” he said. “CMS is changing things to create enough incentive so the pain of not changing becomes greater than the pain of changing.”

While hospitalists may bear more of the pressure than other physician specialties, by virtue of their role in improving the quality of care in hospitals, they were born from reform efforts of the past, Dr. Greeno adds.

“If there had never been an attempt to change the way that physicians were paid, hospitalists wouldn’t exist,” he said. “We were created by physician groups who took capitated payments from HMOs, who had to find more efficient ways to treat patients in the hospital or go out of business.”

“Hospitalists are a delivery system reform and people look to us to lead. We can create a tremendous amount of value for whomever we work for,” Dr. Greeno said.

This is also why SHM continues to work with CMS to advocate for all its members. Dr. Greeno is in Washington at least once a month, participating in critical meetings and helping to guide decisions.

“The Public Policy Committee has to get into the weeds and get involved in advocating for measures that truly get at the work we do and push back on metrics and categories that do not relate to the care we are delivering for our patients,” said Dr. Dutta. “The group worked hard to push back on having to comply with Meaningful Use standards for hospitalists, and now we’re exempt from that category. CMS does listen. It sometimes just takes a while.”
 

References

1. Slavitt A. (2016 Oct 14). A letter from CMS to Medicare clinicians in the Quality Payment Program: We heard you and will continue listening. The CMS Blog (archived). Retrieved from http://wayback.archive-it.org/2744/20161109123921/https://blog.cms.gov/2016/10/14/a-letter-from-cms-to-medicare-clinicians-in-the-quality-payment-program/.

2. Department of Health & Human Services and Centers for Medicare & Medicaid Services. (2016 Oct 14). Quality Payment Program executive summary. Retrieved from https://qpp.cms.gov/docs/QPP_Executive_Summary_of_Final_Rule.pdf.

3. American Medical Association. (2016 Oct 19). Medicare Access and CHIP Reauthorization Act (MACRA) Quality Payment Program final rule AMA summary. Retrieved from https://www.ama-assn.org/sites/default/files/media-browser/public/physicians/macra/macra-qpp-summary.pdf.

4. Slavitt A. (2016 Sept 8). Plans for the Quality Payment Program in 2017: Pick your pace. The CMS Blog (archived). Retrieved from http://wayback.archive-it.org/2744/20161109123909/https://blog.cms.gov/2016/09/08/qualitypaymentprogram-pickyourpace/.

5. The Society of Hospital Medicine. Medicare physician payments are changing. Retrieved from http://www.macraforhm.org/.

6. Department of Health & Human Services and Centers for Medicare & Medicaid Services. (2016 Oct 14). Quality Payment Program fact sheet. Retrieved from https://qpp.cms.gov/docs/QPP_Small_Practice.pdf.

7. The Society of Hospital Medicine. (2017). MACRA and the Quality Payment Program. Retrieved from http://www.macraforhm.org/MACRA_FAQ_m1_final.pdf.

8. Department of Health & Human Services and Centers for Medicare & Medicaid Services. Quality Payment Program: Modernizing Medicare to provide better care and smarter spending for a healthier America. Retrieved from https://qpp.cms.gov/.

9. Wynne B. (2016 Oct 17). MACRA Final Rule: CMS strikes a balance; will docs hang on? Retrieved from http://healthaffairs.org/blog/2016/10/17/macra-final-rule-cms-strikes-a-balance-will-docs-hang-on/.

10. Quinn R. (2015 Aug). TeamHealth-IPC Deal Latest in consolidation trend. The Hospitalist. 2015(8). Retrieved from http://www.the-hospitalist.org/hospitalist/article/122210/teamhealth-ipc-deal-latest-consolidation-trend

11. Barkholz D. (2016 Jun 30). Potential MACRA byproduct: physician consolidation. Retrieved from http://www.modernhealthcare.com/article/20160630/NEWS/160639995.

“We heard you and will continue listening.”

Those were the words that Andrew Slavitt, then-acting administrator of the Centers for Medicare and Medicaid Services, used in a blog post on Oct. 14, 2016.¹ (Slavitt no longer maintains that title since the new federal administration took office on Jan. 20, 2017.)

• Heart failure: ACE inhibitor/angiotensin receptor blocker for left ventricular systolic dysfunction
• Heart failure: Beta-blocker for LVSD
• Stroke: DC on antithrombotic therapy
• Advance Care Plan
• Prevention of catheter-related bloodstream infection: CVC (central venous catheter) Insertion Protocol
• Documentation of current medications
• Appropriate treatment of methicillin-susceptible Staphylococcus aureus bacteremia

“Of the seven available, not all will be reportable because hospitalist practices have a lot of variation, both in their practices and in their patient mix,” Dr. Greeno said. “Most hospitalists will only be able to successfully report on four measures, but we are seeking clarification on what they call a validation test and how that will function.”

In the final rule, CMS said that it will perform that “validation test” to evaluate physicians who cannot report the minimum number of measures to ensure they are not penalized for it.

In addition to Quality, the other reporting categories under the umbrella of MIPS include Advancing Care Information, Cost, and Improvement Activities. For 2017, CMS gave physicians the option to “pick your pace.”⁴ As long as doctors report just one quality measure, one improvement activity, or the required advancing care information measures (most hospitalists will be exempt from this category), they will avoid a penalty.^1,5 Cost will not be included for 2017, the first performance year for MIPS. This year’s reporting will be used to determine payments in 2019, though all physicians will see a 0.5 percent fee increase between now and 2019.

Additionally, just for this year, physicians can choose to report for either a full or partial year (90 days). They will not be subject to the penalty and may be eligible for a positive payment adjustment. However, those who submit nothing are subject to a negative 4% adjustment penalty.

Alternative payment models

While MIPS is the pathway most physicians expect to find themselves on in 2017, the other option is the Alternative Payment Models (APMs) pathway, which moves away from the pay-for-performance, semi-fee-for-service structure of MIPS and, instead, follows the rules established by the models themselves, which include select qualified accountable care organizations and patient-centered medical homes.⁷ Participating physicians are eligible for a 5% incentive payment in 2019. Many health experts say that it’s clear CMS would like to ultimately steer most physicians from MIPS to APMs.

However, very few – if any – hospitalists will find themselves on an APM track. This is, in part, because models considered APMs require the use of Certified Electronic Health Record Technology (CEHRT) and must present “more than nominal risk” to providers.

“Right now, the only alternative payment model where hospitalists can directly take risk is BPCI [Bundled Payments for Care Improvement], but it does not qualify as an APM,” Dr. Greeno said.

It will also be difficult because CMS requires patient and payer thresholds under APMs that hospitalists simply are not poised to meet. In 2019, this means 25% of Medicare payments must come from an Advanced APM in 2017, or 20% of providers’ Medicare patients must be seen through an Advanced APM.⁸

Advanced APMs are those with which, at least in 2019 and 2020, providers face the risk of losing the lesser of 8% of their revenue or repaying CMS up to 3% of their total Medicare expenditures, if expenditures are higher than expected.^8,9

“It is going to be very difficult for hospitalists to qualify for APMs because we’re not in the position to hit the thresholds,” said Dr. Dutta.

However, SHM has urged CMS to consider other BPCI models for qualification as APMs, and Dr. Greeno said that CMS is currently looking into developing bundles that may be appropriate for hospitalists. For instance, Dr. Dutta said, “What we do often in medicine is chronic disease management, and the time is coming to get into chronic disease bundles, such as [those for] management of heart failure or kidney disease.”

In December, SHM submitted a letter to PTAC (the Physician-Focused Payment Model Technical Advisory Committee) to show support for a model created by the American College of Surgeons, called ACS-Brandeis, which they hope will be considered as an Advanced Alternative Payment Model. In the proposal that ACS submitted, the authors noted, “The core model is focused on procedure episodes but can easily be expanded to include acute and chronic conditions.”

The SHM notes in its letter that, while the initial proposal is intended for surgical patients, the term-based nature of surgical care provides a platform for expanding the model more broadly to hospitalists and other specialties.
 

Some skepticism remains

Even if BPCI or other models are accepted as APMs, hospitalists may still be challenged to meet the required payment or patient thresholds, Dr. Greeno said. Additionally, Dr. Berenson is skeptical of bundled payments, particularly for hospitalists.

“Are hospitalists the right organization to be held accountable for the total cost of care for 90 days of spending, any more than oncologists under Oncology Care Models should be accountable for the total cost of cancer where some patients are getting palliative care and that’s not a driver of healthcare costs?” he asked. “I could see that as problematic for hospitalists.”

While he believes there are many positive aspects to MACRA, in general, Dr. Berenson considers it bad policy. While he does not want to see the Sustainable Growth Rate return, he believes many physicians would have seen reimbursement reductions sooner without MACRA (under the prior quality measurement programs) and that the law provides some perverse incentives.

For one thing, the Quality Payment Program is budget neutral, which means that, for every winner, there is also a loser. Before CMS expanded exemptions for smaller and rural practices, Dr. Berenson said that some larger groups – which are often better equipped to pursue APMs – were planning to stay in MIPS because they figured they were more likely to be the winners when compared with smaller physician practices. And MIPS comes with a 9% payment boost by 2022 (or 9% penalty), plus the possibility of an extra bonus for top performers, compared with the 5% incentive of APMs that same year.⁷

“There were literally groups saying they were going to go for the MIPS pathway because it’s a bigger upside,” Dr. Berenson said. “When CMS said it was exempting those [smaller, rural] groups, the [larger] groups turned around and said [that the smaller, rural groups] were the downside. ... That kind of game theory is bad public policy.”

Dr. Berenson also believes MACRA will be detrimental to some small and independent practices. Others may decide not to bill Medicare altogether, though that is not an option open to most hospitalists who care to stay in practice. It could, however, drive more hospitalists to consolidate or to become employees of their hospitals.¹⁰

“I don’t think there is any doubt this is going to drive consolidation,” Dr. Greeno said, citing numbers released by CMS that show an inverse relationship between practice size and the negative impact of MACRA.¹¹ “I think it’s going to be pretty tough unless you’re big enough to commit the resources you need to do it right.”

At TeamHealth, where Dr. Greeno is senior advisor of medical affairs, he said that they have invested in information technology compliance, developed systems and trained providers to ensure the creation of favorable metrics for the organization’ and built the infrastructure to gather, report, and validate data. These are steps that may be out of reach for most smaller practices.

As Dr. Greeno said, no one expected this to be easy. “You’re trying to get doctors to change the way they practice. Anybody who has ever worked with doctors knows that’s not an easy things to do,” he said. “CMS is changing things to create enough incentive so the pain of not changing becomes greater than the pain of changing.”

While hospitalists may bear more of the pressure than other physician specialties, by virtue of their role in improving the quality of care in hospitals, they were born from reform efforts of the past, Dr. Greeno adds.

“If there had never been an attempt to change the way that physicians were paid, hospitalists wouldn’t exist,” he said. “We were created by physician groups who took capitated payments from HMOs, who had to find more efficient ways to treat patients in the hospital or go out of business.”

“Hospitalists are a delivery system reform and people look to us to lead. We can create a tremendous amount of value for whomever we work for,” Dr. Greeno said.

This is also why SHM continues to work with CMS to advocate for all its members. Dr. Greeno is in Washington at least once a month, participating in critical meetings and helping to guide decisions.

“The Public Policy Committee has to get into the weeds and get involved in advocating for measures that truly get at the work we do and push back on metrics and categories that do not relate to the care we are delivering for our patients,” said Dr. Dutta. “The group worked hard to push back on having to comply with Meaningful Use standards for hospitalists, and now we’re exempt from that category. CMS does listen. It sometimes just takes a while.”
 

References

1. Slavitt A. (2016 Oct 14). A letter from CMS to Medicare clinicians in the Quality Payment Program: We heard you and will continue listening. The CMS Blog (archived). Retrieved from http://wayback.archive-it.org/2744/20161109123921/https://blog.cms.gov/2016/10/14/a-letter-from-cms-to-medicare-clinicians-in-the-quality-payment-program/.

2. Department of Health & Human Services and Centers for Medicare & Medicaid Services. (2016 Oct 14). Quality Payment Program executive summary. Retrieved from https://qpp.cms.gov/docs/QPP_Executive_Summary_of_Final_Rule.pdf.

3. American Medical Association. (2016 Oct 19). Medicare Access and CHIP Reauthorization Act (MACRA) Quality Payment Program final rule AMA summary. Retrieved from https://www.ama-assn.org/sites/default/files/media-browser/public/physicians/macra/macra-qpp-summary.pdf.

4. Slavitt A. (2016 Sept 8). Plans for the Quality Payment Program in 2017: Pick your pace. The CMS Blog (archived). Retrieved from http://wayback.archive-it.org/2744/20161109123909/https://blog.cms.gov/2016/09/08/qualitypaymentprogram-pickyourpace/.

5. The Society of Hospital Medicine. Medicare physician payments are changing. Retrieved from http://www.macraforhm.org/.

6. Department of Health & Human Services and Centers for Medicare & Medicaid Services. (2016 Oct 14). Quality Payment Program fact sheet. Retrieved from https://qpp.cms.gov/docs/QPP_Small_Practice.pdf.

7. The Society of Hospital Medicine. (2017). MACRA and the Quality Payment Program. Retrieved from http://www.macraforhm.org/MACRA_FAQ_m1_final.pdf.

8. Department of Health & Human Services and Centers for Medicare & Medicaid Services. Quality Payment Program: Modernizing Medicare to provide better care and smarter spending for a healthier America. Retrieved from https://qpp.cms.gov/.

9. Wynne B. (2016 Oct 17). MACRA Final Rule: CMS strikes a balance; will docs hang on? Retrieved from http://healthaffairs.org/blog/2016/10/17/macra-final-rule-cms-strikes-a-balance-will-docs-hang-on/.

10. Quinn R. (2015 Aug). TeamHealth-IPC Deal Latest in consolidation trend. The Hospitalist. 2015(8). Retrieved from http://www.the-hospitalist.org/hospitalist/article/122210/teamhealth-ipc-deal-latest-consolidation-trend

11. Barkholz D. (2016 Jun 30). Potential MACRA byproduct: physician consolidation. Retrieved from http://www.modernhealthcare.com/article/20160630/NEWS/160639995.

“We heard you and will continue listening.”

Those were the words that Andrew Slavitt, then-acting administrator of the Centers for Medicare and Medicaid Services, used in a blog post on Oct. 14, 2016.¹ (Slavitt no longer maintains that title since the new federal administration took office on Jan. 20, 2017.)

• Heart failure: ACE inhibitor/angiotensin receptor blocker for left ventricular systolic dysfunction
• Heart failure: Beta-blocker for LVSD
• Stroke: DC on antithrombotic therapy
• Advance Care Plan
• Prevention of catheter-related bloodstream infection: CVC (central venous catheter) Insertion Protocol
• Documentation of current medications
• Appropriate treatment of methicillin-susceptible Staphylococcus aureus bacteremia

“Of the seven available, not all will be reportable because hospitalist practices have a lot of variation, both in their practices and in their patient mix,” Dr. Greeno said. “Most hospitalists will only be able to successfully report on four measures, but we are seeking clarification on what they call a validation test and how that will function.”

In the final rule, CMS said that it will perform that “validation test” to evaluate physicians who cannot report the minimum number of measures to ensure they are not penalized for it.

In addition to Quality, the other reporting categories under the umbrella of MIPS include Advancing Care Information, Cost, and Improvement Activities. For 2017, CMS gave physicians the option to “pick your pace.”⁴ As long as doctors report just one quality measure, one improvement activity, or the required advancing care information measures (most hospitalists will be exempt from this category), they will avoid a penalty.^1,5 Cost will not be included for 2017, the first performance year for MIPS. This year’s reporting will be used to determine payments in 2019, though all physicians will see a 0.5 percent fee increase between now and 2019.

Additionally, just for this year, physicians can choose to report for either a full or partial year (90 days). They will not be subject to the penalty and may be eligible for a positive payment adjustment. However, those who submit nothing are subject to a negative 4% adjustment penalty.

Alternative payment models

While MIPS is the pathway most physicians expect to find themselves on in 2017, the other option is the Alternative Payment Models (APMs) pathway, which moves away from the pay-for-performance, semi-fee-for-service structure of MIPS and, instead, follows the rules established by the models themselves, which include select qualified accountable care organizations and patient-centered medical homes.⁷ Participating physicians are eligible for a 5% incentive payment in 2019. Many health experts say that it’s clear CMS would like to ultimately steer most physicians from MIPS to APMs.

However, very few – if any – hospitalists will find themselves on an APM track. This is, in part, because models considered APMs require the use of Certified Electronic Health Record Technology (CEHRT) and must present “more than nominal risk” to providers.

“Right now, the only alternative payment model where hospitalists can directly take risk is BPCI [Bundled Payments for Care Improvement], but it does not qualify as an APM,” Dr. Greeno said.

It will also be difficult because CMS requires patient and payer thresholds under APMs that hospitalists simply are not poised to meet. In 2019, this means 25% of Medicare payments must come from an Advanced APM in 2017, or 20% of providers’ Medicare patients must be seen through an Advanced APM.⁸

Advanced APMs are those with which, at least in 2019 and 2020, providers face the risk of losing the lesser of 8% of their revenue or repaying CMS up to 3% of their total Medicare expenditures, if expenditures are higher than expected.^8,9

“It is going to be very difficult for hospitalists to qualify for APMs because we’re not in the position to hit the thresholds,” said Dr. Dutta.

However, SHM has urged CMS to consider other BPCI models for qualification as APMs, and Dr. Greeno said that CMS is currently looking into developing bundles that may be appropriate for hospitalists. For instance, Dr. Dutta said, “What we do often in medicine is chronic disease management, and the time is coming to get into chronic disease bundles, such as [those for] management of heart failure or kidney disease.”

In December, SHM submitted a letter to PTAC (the Physician-Focused Payment Model Technical Advisory Committee) to show support for a model created by the American College of Surgeons, called ACS-Brandeis, which they hope will be considered as an Advanced Alternative Payment Model. In the proposal that ACS submitted, the authors noted, “The core model is focused on procedure episodes but can easily be expanded to include acute and chronic conditions.”

The SHM notes in its letter that, while the initial proposal is intended for surgical patients, the term-based nature of surgical care provides a platform for expanding the model more broadly to hospitalists and other specialties.
 

Some skepticism remains

Even if BPCI or other models are accepted as APMs, hospitalists may still be challenged to meet the required payment or patient thresholds, Dr. Greeno said. Additionally, Dr. Berenson is skeptical of bundled payments, particularly for hospitalists.

“Are hospitalists the right organization to be held accountable for the total cost of care for 90 days of spending, any more than oncologists under Oncology Care Models should be accountable for the total cost of cancer where some patients are getting palliative care and that’s not a driver of healthcare costs?” he asked. “I could see that as problematic for hospitalists.”

While he believes there are many positive aspects to MACRA, in general, Dr. Berenson considers it bad policy. While he does not want to see the Sustainable Growth Rate return, he believes many physicians would have seen reimbursement reductions sooner without MACRA (under the prior quality measurement programs) and that the law provides some perverse incentives.

For one thing, the Quality Payment Program is budget neutral, which means that, for every winner, there is also a loser. Before CMS expanded exemptions for smaller and rural practices, Dr. Berenson said that some larger groups – which are often better equipped to pursue APMs – were planning to stay in MIPS because they figured they were more likely to be the winners when compared with smaller physician practices. And MIPS comes with a 9% payment boost by 2022 (or 9% penalty), plus the possibility of an extra bonus for top performers, compared with the 5% incentive of APMs that same year.⁷

“There were literally groups saying they were going to go for the MIPS pathway because it’s a bigger upside,” Dr. Berenson said. “When CMS said it was exempting those [smaller, rural] groups, the [larger] groups turned around and said [that the smaller, rural groups] were the downside. ... That kind of game theory is bad public policy.”

Dr. Berenson also believes MACRA will be detrimental to some small and independent practices. Others may decide not to bill Medicare altogether, though that is not an option open to most hospitalists who care to stay in practice. It could, however, drive more hospitalists to consolidate or to become employees of their hospitals.¹⁰

“I don’t think there is any doubt this is going to drive consolidation,” Dr. Greeno said, citing numbers released by CMS that show an inverse relationship between practice size and the negative impact of MACRA.¹¹ “I think it’s going to be pretty tough unless you’re big enough to commit the resources you need to do it right.”

At TeamHealth, where Dr. Greeno is senior advisor of medical affairs, he said that they have invested in information technology compliance, developed systems and trained providers to ensure the creation of favorable metrics for the organization’ and built the infrastructure to gather, report, and validate data. These are steps that may be out of reach for most smaller practices.

As Dr. Greeno said, no one expected this to be easy. “You’re trying to get doctors to change the way they practice. Anybody who has ever worked with doctors knows that’s not an easy things to do,” he said. “CMS is changing things to create enough incentive so the pain of not changing becomes greater than the pain of changing.”

While hospitalists may bear more of the pressure than other physician specialties, by virtue of their role in improving the quality of care in hospitals, they were born from reform efforts of the past, Dr. Greeno adds.

“If there had never been an attempt to change the way that physicians were paid, hospitalists wouldn’t exist,” he said. “We were created by physician groups who took capitated payments from HMOs, who had to find more efficient ways to treat patients in the hospital or go out of business.”

“Hospitalists are a delivery system reform and people look to us to lead. We can create a tremendous amount of value for whomever we work for,” Dr. Greeno said.

This is also why SHM continues to work with CMS to advocate for all its members. Dr. Greeno is in Washington at least once a month, participating in critical meetings and helping to guide decisions.

“The Public Policy Committee has to get into the weeds and get involved in advocating for measures that truly get at the work we do and push back on metrics and categories that do not relate to the care we are delivering for our patients,” said Dr. Dutta. “The group worked hard to push back on having to comply with Meaningful Use standards for hospitalists, and now we’re exempt from that category. CMS does listen. It sometimes just takes a while.”
 

References

1. Slavitt A. (2016 Oct 14). A letter from CMS to Medicare clinicians in the Quality Payment Program: We heard you and will continue listening. The CMS Blog (archived). Retrieved from http://wayback.archive-it.org/2744/20161109123921/https://blog.cms.gov/2016/10/14/a-letter-from-cms-to-medicare-clinicians-in-the-quality-payment-program/.

2. Department of Health & Human Services and Centers for Medicare & Medicaid Services. (2016 Oct 14). Quality Payment Program executive summary. Retrieved from https://qpp.cms.gov/docs/QPP_Executive_Summary_of_Final_Rule.pdf.

3. American Medical Association. (2016 Oct 19). Medicare Access and CHIP Reauthorization Act (MACRA) Quality Payment Program final rule AMA summary. Retrieved from https://www.ama-assn.org/sites/default/files/media-browser/public/physicians/macra/macra-qpp-summary.pdf.

4. Slavitt A. (2016 Sept 8). Plans for the Quality Payment Program in 2017: Pick your pace. The CMS Blog (archived). Retrieved from http://wayback.archive-it.org/2744/20161109123909/https://blog.cms.gov/2016/09/08/qualitypaymentprogram-pickyourpace/.

5. The Society of Hospital Medicine. Medicare physician payments are changing. Retrieved from http://www.macraforhm.org/.

6. Department of Health & Human Services and Centers for Medicare & Medicaid Services. (2016 Oct 14). Quality Payment Program fact sheet. Retrieved from https://qpp.cms.gov/docs/QPP_Small_Practice.pdf.

7. The Society of Hospital Medicine. (2017). MACRA and the Quality Payment Program. Retrieved from http://www.macraforhm.org/MACRA_FAQ_m1_final.pdf.

8. Department of Health & Human Services and Centers for Medicare & Medicaid Services. Quality Payment Program: Modernizing Medicare to provide better care and smarter spending for a healthier America. Retrieved from https://qpp.cms.gov/.

9. Wynne B. (2016 Oct 17). MACRA Final Rule: CMS strikes a balance; will docs hang on? Retrieved from http://healthaffairs.org/blog/2016/10/17/macra-final-rule-cms-strikes-a-balance-will-docs-hang-on/.

10. Quinn R. (2015 Aug). TeamHealth-IPC Deal Latest in consolidation trend. The Hospitalist. 2015(8). Retrieved from http://www.the-hospitalist.org/hospitalist/article/122210/teamhealth-ipc-deal-latest-consolidation-trend

11. Barkholz D. (2016 Jun 30). Potential MACRA byproduct: physician consolidation. Retrieved from http://www.modernhealthcare.com/article/20160630/NEWS/160639995.

The long wait for the introduction of the C6 hospitalist specialty code has ended. If you are a provider, hospital, or hospitalist administrator, this new specialty designation is important.

The Centers for Medicare & Medicaid Services tracks specialty utilization and compares providers across the country using codes attached to medical specialties, such as cardiology, emergency medicine, pediatrics, etc. Until the CMS designated hospital medicine as a unique specialty, hospitalists were grouped together with office-based internal medicine physicians and general practitioners. This lack of recognition of the hospitalist specialty created two issues.

• Paper: Initial enrollment in the Medicare program on form CMS-855I or CMS 855O (https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms-List.html).

• Electronically: Utilizing the PECOS system, provider credentialing offices can update existing specialty codes to C6 (https://pecos.cms.hhs.gov/PECOSWebMaintenance.htm).

This major milestone for hospital medicine demonstrates the continued growth and impact of the specialty. Ensure your self-election in the PECOS system reflects “C6,” your specialty as a hospitalist and your commitment to the hospital medicine movement.

For more information, visit www.hospitalmedicine.org/C6.
 

Dea Robinson is a member of SHM’s Practice Management Committee, Cultural Competency Workgroup and Physician Burnout Workgroup.

Reference: MLN Matters Number: MM9716 ( https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9716.pdf)

The long wait for the introduction of the C6 hospitalist specialty code has ended. If you are a provider, hospital, or hospitalist administrator, this new specialty designation is important.

The Centers for Medicare & Medicaid Services tracks specialty utilization and compares providers across the country using codes attached to medical specialties, such as cardiology, emergency medicine, pediatrics, etc. Until the CMS designated hospital medicine as a unique specialty, hospitalists were grouped together with office-based internal medicine physicians and general practitioners. This lack of recognition of the hospitalist specialty created two issues.

• Paper: Initial enrollment in the Medicare program on form CMS-855I or CMS 855O (https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms-List.html).

• Electronically: Utilizing the PECOS system, provider credentialing offices can update existing specialty codes to C6 (https://pecos.cms.hhs.gov/PECOSWebMaintenance.htm).

This major milestone for hospital medicine demonstrates the continued growth and impact of the specialty. Ensure your self-election in the PECOS system reflects “C6,” your specialty as a hospitalist and your commitment to the hospital medicine movement.

For more information, visit www.hospitalmedicine.org/C6.
 

Dea Robinson is a member of SHM’s Practice Management Committee, Cultural Competency Workgroup and Physician Burnout Workgroup.

Reference: MLN Matters Number: MM9716 ( https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9716.pdf)

The long wait for the introduction of the C6 hospitalist specialty code has ended. If you are a provider, hospital, or hospitalist administrator, this new specialty designation is important.

The Centers for Medicare & Medicaid Services tracks specialty utilization and compares providers across the country using codes attached to medical specialties, such as cardiology, emergency medicine, pediatrics, etc. Until the CMS designated hospital medicine as a unique specialty, hospitalists were grouped together with office-based internal medicine physicians and general practitioners. This lack of recognition of the hospitalist specialty created two issues.

• Paper: Initial enrollment in the Medicare program on form CMS-855I or CMS 855O (https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms-List.html).

• Electronically: Utilizing the PECOS system, provider credentialing offices can update existing specialty codes to C6 (https://pecos.cms.hhs.gov/PECOSWebMaintenance.htm).

This major milestone for hospital medicine demonstrates the continued growth and impact of the specialty. Ensure your self-election in the PECOS system reflects “C6,” your specialty as a hospitalist and your commitment to the hospital medicine movement.

For more information, visit www.hospitalmedicine.org/C6.
 

Dea Robinson is a member of SHM’s Practice Management Committee, Cultural Competency Workgroup and Physician Burnout Workgroup.

Reference: MLN Matters Number: MM9716 ( https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9716.pdf)

The Society of Hospital Medicine is part of a patient safety research group that received the prestigious 2016 John M. Eisenberg Award for Innovation in Patient Safety and Quality presented annually by The Joint Commission and the National Quality Forum, two leading organizations that set standards in patient care as part of the I-PASS Study Group.

I-PASS comprises a suite of educational materials and interventions dedicated to improving patient safety by reducing miscommunication during patient handoffs that can lead to harmful medical errors. The team in SHM’s Center for Quality Improvement has been instrumental in supporting the I-PASS Study Group, which represents more than 50 hospitals from across North America.

“The Eisenberg Award for Innovation represents the highest patient safety and quality award in the country, and we are honored to be recognized for our role in this important program,” said Jenna Goldstein, director of SHM’s Center for Quality Improvement. “Our team’s participation in developing and sustaining the SHM I-PASS mentored implementation demonstrates our commitment to ensure safe and high-quality care for hospitalized patients.”

SHM previously won the 2011 Eisenberg Award at the national level for its mentored implementation program model. Through its mentored implementation framework and project management, SHM has supported the I-PASS program across the country at 32 hospitals of varying types, including pediatric and adult hospitals, academic medical centers, and community-based hospitals. SHM has offered both an I-PASS mentored implementation program, in which a physician mentor coaches hospital team members on evidence-based best practices in process improvement and culture change for safe patient handoffs, and an implementation guide, which contains strategies and tools needed to lead the quality improvement effort in the hospital.

In a large multicenter study published in the New England Journal of Medicine, implementation of I-PASS was associated with a 30% reduction in medical errors that harm patients. An estimated 80% of the most serious medical errors can be linked to communication failures, particularly during patient handoffs.

In addition to its work with I-PASS, SHM’s Center for Quality Improvement plays a prominent role in developing tools that empower clinicians to lead quality improvement efforts in their institutions.

Brett Radler is SHM’s communications specialist.

The Society of Hospital Medicine is part of a patient safety research group that received the prestigious 2016 John M. Eisenberg Award for Innovation in Patient Safety and Quality presented annually by The Joint Commission and the National Quality Forum, two leading organizations that set standards in patient care as part of the I-PASS Study Group.

I-PASS comprises a suite of educational materials and interventions dedicated to improving patient safety by reducing miscommunication during patient handoffs that can lead to harmful medical errors. The team in SHM’s Center for Quality Improvement has been instrumental in supporting the I-PASS Study Group, which represents more than 50 hospitals from across North America.

“The Eisenberg Award for Innovation represents the highest patient safety and quality award in the country, and we are honored to be recognized for our role in this important program,” said Jenna Goldstein, director of SHM’s Center for Quality Improvement. “Our team’s participation in developing and sustaining the SHM I-PASS mentored implementation demonstrates our commitment to ensure safe and high-quality care for hospitalized patients.”

SHM previously won the 2011 Eisenberg Award at the national level for its mentored implementation program model. Through its mentored implementation framework and project management, SHM has supported the I-PASS program across the country at 32 hospitals of varying types, including pediatric and adult hospitals, academic medical centers, and community-based hospitals. SHM has offered both an I-PASS mentored implementation program, in which a physician mentor coaches hospital team members on evidence-based best practices in process improvement and culture change for safe patient handoffs, and an implementation guide, which contains strategies and tools needed to lead the quality improvement effort in the hospital.

In a large multicenter study published in the New England Journal of Medicine, implementation of I-PASS was associated with a 30% reduction in medical errors that harm patients. An estimated 80% of the most serious medical errors can be linked to communication failures, particularly during patient handoffs.

In addition to its work with I-PASS, SHM’s Center for Quality Improvement plays a prominent role in developing tools that empower clinicians to lead quality improvement efforts in their institutions.

Brett Radler is SHM’s communications specialist.

The Society of Hospital Medicine is part of a patient safety research group that received the prestigious 2016 John M. Eisenberg Award for Innovation in Patient Safety and Quality presented annually by The Joint Commission and the National Quality Forum, two leading organizations that set standards in patient care as part of the I-PASS Study Group.

I-PASS comprises a suite of educational materials and interventions dedicated to improving patient safety by reducing miscommunication during patient handoffs that can lead to harmful medical errors. The team in SHM’s Center for Quality Improvement has been instrumental in supporting the I-PASS Study Group, which represents more than 50 hospitals from across North America.

“The Eisenberg Award for Innovation represents the highest patient safety and quality award in the country, and we are honored to be recognized for our role in this important program,” said Jenna Goldstein, director of SHM’s Center for Quality Improvement. “Our team’s participation in developing and sustaining the SHM I-PASS mentored implementation demonstrates our commitment to ensure safe and high-quality care for hospitalized patients.”

SHM previously won the 2011 Eisenberg Award at the national level for its mentored implementation program model. Through its mentored implementation framework and project management, SHM has supported the I-PASS program across the country at 32 hospitals of varying types, including pediatric and adult hospitals, academic medical centers, and community-based hospitals. SHM has offered both an I-PASS mentored implementation program, in which a physician mentor coaches hospital team members on evidence-based best practices in process improvement and culture change for safe patient handoffs, and an implementation guide, which contains strategies and tools needed to lead the quality improvement effort in the hospital.

In a large multicenter study published in the New England Journal of Medicine, implementation of I-PASS was associated with a 30% reduction in medical errors that harm patients. An estimated 80% of the most serious medical errors can be linked to communication failures, particularly during patient handoffs.

In addition to its work with I-PASS, SHM’s Center for Quality Improvement plays a prominent role in developing tools that empower clinicians to lead quality improvement efforts in their institutions.

Brett Radler is SHM’s communications specialist.

CLINICAL QUESTION: Is there variation in patient-to-intensivist ratios (PIR) across ICUs, and does that ratio affect hospital mortality?

BACKGROUND: Most studies show that intensivists improve ICU patient outcomes. With increasing ICU patients but stable intensivist staffing, patient-to-intensivist ratios are increasing. It is unclear if that rising ratio is adversely affecting patient mortality.

STUDY DESIGN: Multicenter retrospective cohort analysis.

SETTING: ICUs in the United Kingdom from 2010 to 2013.

The median PIR was 8.5 but varied substantially – PIRs were often larger. The association between PIR and mortality was U shaped. There was a decrease in mortality as the PIR reached 7.5, after which the mortality increased again. The higher mortality with very low PIRs could reflect a volume-outcome relationship. Less patients could mean less experience, different levels of ancillary staff, and so on.

This study did not take into account the possible differences in the multidisciplinary makeup of the ICU teams that would affect the intensivist’s level of responsibility.

BOTTOM LINE: There seems to be an optimal PIR for mortality, though that optimal number would likely depend on the ancillary staff, level of trainees, and patient acuity.

CITATIONS: Gershengorn HB, Harrison DA, Garland A, et al. “Association of Intensive Care Unit Patient-to-Intensivist Ratios With Hospital Mortality.” JAMA Intern Med. 2017 Mar 1;177(3):388-96.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

CLINICAL QUESTION: Is there variation in patient-to-intensivist ratios (PIR) across ICUs, and does that ratio affect hospital mortality?

BACKGROUND: Most studies show that intensivists improve ICU patient outcomes. With increasing ICU patients but stable intensivist staffing, patient-to-intensivist ratios are increasing. It is unclear if that rising ratio is adversely affecting patient mortality.

STUDY DESIGN: Multicenter retrospective cohort analysis.

SETTING: ICUs in the United Kingdom from 2010 to 2013.

The median PIR was 8.5 but varied substantially – PIRs were often larger. The association between PIR and mortality was U shaped. There was a decrease in mortality as the PIR reached 7.5, after which the mortality increased again. The higher mortality with very low PIRs could reflect a volume-outcome relationship. Less patients could mean less experience, different levels of ancillary staff, and so on.

This study did not take into account the possible differences in the multidisciplinary makeup of the ICU teams that would affect the intensivist’s level of responsibility.

BOTTOM LINE: There seems to be an optimal PIR for mortality, though that optimal number would likely depend on the ancillary staff, level of trainees, and patient acuity.

CITATIONS: Gershengorn HB, Harrison DA, Garland A, et al. “Association of Intensive Care Unit Patient-to-Intensivist Ratios With Hospital Mortality.” JAMA Intern Med. 2017 Mar 1;177(3):388-96.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

CLINICAL QUESTION: Is there variation in patient-to-intensivist ratios (PIR) across ICUs, and does that ratio affect hospital mortality?

BACKGROUND: Most studies show that intensivists improve ICU patient outcomes. With increasing ICU patients but stable intensivist staffing, patient-to-intensivist ratios are increasing. It is unclear if that rising ratio is adversely affecting patient mortality.

STUDY DESIGN: Multicenter retrospective cohort analysis.

SETTING: ICUs in the United Kingdom from 2010 to 2013.

The median PIR was 8.5 but varied substantially – PIRs were often larger. The association between PIR and mortality was U shaped. There was a decrease in mortality as the PIR reached 7.5, after which the mortality increased again. The higher mortality with very low PIRs could reflect a volume-outcome relationship. Less patients could mean less experience, different levels of ancillary staff, and so on.

This study did not take into account the possible differences in the multidisciplinary makeup of the ICU teams that would affect the intensivist’s level of responsibility.

BOTTOM LINE: There seems to be an optimal PIR for mortality, though that optimal number would likely depend on the ancillary staff, level of trainees, and patient acuity.

CITATIONS: Gershengorn HB, Harrison DA, Garland A, et al. “Association of Intensive Care Unit Patient-to-Intensivist Ratios With Hospital Mortality.” JAMA Intern Med. 2017 Mar 1;177(3):388-96.

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

CLINICAL QUESTION: What are the accuracy and clinical utility of risk scoring systems in the assessment of patients with upper gastrointestinal (GI) bleeding?

BACKGROUND: There are several pre- and postendoscopy risk scores to predict clinically relevant outcomes such as transfusion, mortality, endoscopy treatment, surgery, and length of hospital stay for upper GI bleeding. The accuracy and applicability of these risk scores has not been well established.

STUDY DESIGN: International multicenter prospective study.

SETTING: Six large hospitals in Europe, North America, Asia, and Oceania.

SYNOPSIS: This is a prospective study comparing three pre-endoscopy scoring systems (Rockall, AIMS65, Glasgow Blatchford) and two postendoscopy scoring systems (PNED, full Rockall) in 3,012 patients with upper GI bleeding over six hospitals. It examined clinically relevant outcomes: intervention (transfusion, endoscopy, interventional radiology, surgery), mortality, rebleeding, and length of hospital stay.

The Glasgow Blatchford risk score was the most accurate at predicting the need for hospitalization and death across all hospitals, compared with the other scoring systems. It was determined that a Glasgow Blatchford score of less than 1 is an optimal threshold for outpatient management, with a 98.6% sensitivity in identifying those who would not require intervention or die. The utility of these scores to direct management in high-risk patients is limited and needs further studies. No scoring system predicted rebleeding or length of hospital stay.

A weakness of the study is that patients who bled while already inpatients were excluded.

BOTTOM LINE: The Glasgow Blatchford risk score can help direct care of very low risk patients (score, less than 1) with upper GI bleeding toward outpatient management.

CITATIONS: Stanley AJ, Laine L, Dalton HR, et al. “Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: International multicenter prospective study.” BMJ. 2017 Jan 4;356:i6432.
 

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

CLINICAL QUESTION: What are the accuracy and clinical utility of risk scoring systems in the assessment of patients with upper gastrointestinal (GI) bleeding?

BACKGROUND: There are several pre- and postendoscopy risk scores to predict clinically relevant outcomes such as transfusion, mortality, endoscopy treatment, surgery, and length of hospital stay for upper GI bleeding. The accuracy and applicability of these risk scores has not been well established.

STUDY DESIGN: International multicenter prospective study.

SETTING: Six large hospitals in Europe, North America, Asia, and Oceania.

SYNOPSIS: This is a prospective study comparing three pre-endoscopy scoring systems (Rockall, AIMS65, Glasgow Blatchford) and two postendoscopy scoring systems (PNED, full Rockall) in 3,012 patients with upper GI bleeding over six hospitals. It examined clinically relevant outcomes: intervention (transfusion, endoscopy, interventional radiology, surgery), mortality, rebleeding, and length of hospital stay.

The Glasgow Blatchford risk score was the most accurate at predicting the need for hospitalization and death across all hospitals, compared with the other scoring systems. It was determined that a Glasgow Blatchford score of less than 1 is an optimal threshold for outpatient management, with a 98.6% sensitivity in identifying those who would not require intervention or die. The utility of these scores to direct management in high-risk patients is limited and needs further studies. No scoring system predicted rebleeding or length of hospital stay.

A weakness of the study is that patients who bled while already inpatients were excluded.

BOTTOM LINE: The Glasgow Blatchford risk score can help direct care of very low risk patients (score, less than 1) with upper GI bleeding toward outpatient management.

CITATIONS: Stanley AJ, Laine L, Dalton HR, et al. “Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: International multicenter prospective study.” BMJ. 2017 Jan 4;356:i6432.
 

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

CLINICAL QUESTION: What are the accuracy and clinical utility of risk scoring systems in the assessment of patients with upper gastrointestinal (GI) bleeding?

BACKGROUND: There are several pre- and postendoscopy risk scores to predict clinically relevant outcomes such as transfusion, mortality, endoscopy treatment, surgery, and length of hospital stay for upper GI bleeding. The accuracy and applicability of these risk scores has not been well established.

STUDY DESIGN: International multicenter prospective study.

SETTING: Six large hospitals in Europe, North America, Asia, and Oceania.

SYNOPSIS: This is a prospective study comparing three pre-endoscopy scoring systems (Rockall, AIMS65, Glasgow Blatchford) and two postendoscopy scoring systems (PNED, full Rockall) in 3,012 patients with upper GI bleeding over six hospitals. It examined clinically relevant outcomes: intervention (transfusion, endoscopy, interventional radiology, surgery), mortality, rebleeding, and length of hospital stay.

The Glasgow Blatchford risk score was the most accurate at predicting the need for hospitalization and death across all hospitals, compared with the other scoring systems. It was determined that a Glasgow Blatchford score of less than 1 is an optimal threshold for outpatient management, with a 98.6% sensitivity in identifying those who would not require intervention or die. The utility of these scores to direct management in high-risk patients is limited and needs further studies. No scoring system predicted rebleeding or length of hospital stay.

A weakness of the study is that patients who bled while already inpatients were excluded.

BOTTOM LINE: The Glasgow Blatchford risk score can help direct care of very low risk patients (score, less than 1) with upper GI bleeding toward outpatient management.

CITATIONS: Stanley AJ, Laine L, Dalton HR, et al. “Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: International multicenter prospective study.” BMJ. 2017 Jan 4;356:i6432.
 

Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

I was rounding on the inpatient general medicine teaching service last weekend and offered to meet my team of students and residents in the “resident library” on Saturday morning. (Although it holds the name “library,” there were no books or periodicals to be seen.) I had not been in the library for many months and was struck by a few things as I entered.

It is a dimly lit space, lined on three of the four walls with rickety desks and desktop computers all facing the walls. The walls are painted an off-white color with innumerable dings and nicks, presumably accumulated over the course of years. There was a string of garland in the shape of a Christmas tree pinned to the wall (P.S. It is March), the entire left side of which was sagging and misshapen. There were various tattered and coffee-stained papers scattered haphazardly throughout the room, including what appeared to be progress notes and test results printed from the EHR; a few worn ECGs; a telemetry strip; even a few (REALLY old, no doubt) chest x-ray films. Lining the fourth wall was a large foldable table, topped with crumbs and food scraps, a half-eaten chocolate Bundt cake, and scattered napkins and utensils, some of which appeared to be used. The one exterior-facing wall had a row of windows with crinkled blinds, some completely closed, others opened at awkward angles and seemingly stuck in place. There was a cadre of chairs in the room, none matching, all in various stages of disrepair, with one completely missing an armrest and another tucked in the corner, probably needing the addition of a handwritten sign “BRokEn.”

This library is a place where the students, interns, and residents go for a bit of a safe haven. They can take their coats off, sit down, have their own computer space, answer pages, and complain about their woes. They can bounce questions off each other, vent frustrations, find the humor in a situation, and just be themselves. So,But what struck me about their sanctuary is that it is totally and utterly depressing. And it was as if they didn’t even notice the chaos and filth laying everywhere around them. I find it impossible to believe that it does not have an effect on their mood and outlook. Although we are all social animals, and we have a real need to congregate and connect with one another, is this really the best environment to do that?

Read the full text of this blog post at hospitalleader.org.
 

Dr. Scheurer is a clinical hospitalist and the medical director of quality and safety at the Medical University of South Carolina in Charleston.

Also on The Hospital Leader…

• Should Overuse Be Considered an Adverse Event By Chris Moriates, MD
• Pulling the Welcome Mat Out from Under Our Colleagues By Brett Hendel-Paterson, MD
• The Upside of Anger By Tracy Cardin, ACNP-BC, SFHM
• Does Your Onboarding Process Really Get Folks on Board? By Leslie Flores, MH, SFHM
• A GIF Is Worth 3000 Words: Introducing #Visual Abstract for #JHMChat By Charlie Wray, DO

I was rounding on the inpatient general medicine teaching service last weekend and offered to meet my team of students and residents in the “resident library” on Saturday morning. (Although it holds the name “library,” there were no books or periodicals to be seen.) I had not been in the library for many months and was struck by a few things as I entered.

It is a dimly lit space, lined on three of the four walls with rickety desks and desktop computers all facing the walls. The walls are painted an off-white color with innumerable dings and nicks, presumably accumulated over the course of years. There was a string of garland in the shape of a Christmas tree pinned to the wall (P.S. It is March), the entire left side of which was sagging and misshapen. There were various tattered and coffee-stained papers scattered haphazardly throughout the room, including what appeared to be progress notes and test results printed from the EHR; a few worn ECGs; a telemetry strip; even a few (REALLY old, no doubt) chest x-ray films. Lining the fourth wall was a large foldable table, topped with crumbs and food scraps, a half-eaten chocolate Bundt cake, and scattered napkins and utensils, some of which appeared to be used. The one exterior-facing wall had a row of windows with crinkled blinds, some completely closed, others opened at awkward angles and seemingly stuck in place. There was a cadre of chairs in the room, none matching, all in various stages of disrepair, with one completely missing an armrest and another tucked in the corner, probably needing the addition of a handwritten sign “BRokEn.”

This library is a place where the students, interns, and residents go for a bit of a safe haven. They can take their coats off, sit down, have their own computer space, answer pages, and complain about their woes. They can bounce questions off each other, vent frustrations, find the humor in a situation, and just be themselves. So,But what struck me about their sanctuary is that it is totally and utterly depressing. And it was as if they didn’t even notice the chaos and filth laying everywhere around them. I find it impossible to believe that it does not have an effect on their mood and outlook. Although we are all social animals, and we have a real need to congregate and connect with one another, is this really the best environment to do that?

Read the full text of this blog post at hospitalleader.org.
 

Dr. Scheurer is a clinical hospitalist and the medical director of quality and safety at the Medical University of South Carolina in Charleston.

Also on The Hospital Leader…

• Should Overuse Be Considered an Adverse Event By Chris Moriates, MD
• Pulling the Welcome Mat Out from Under Our Colleagues By Brett Hendel-Paterson, MD
• The Upside of Anger By Tracy Cardin, ACNP-BC, SFHM
• Does Your Onboarding Process Really Get Folks on Board? By Leslie Flores, MH, SFHM
• A GIF Is Worth 3000 Words: Introducing #Visual Abstract for #JHMChat By Charlie Wray, DO

I was rounding on the inpatient general medicine teaching service last weekend and offered to meet my team of students and residents in the “resident library” on Saturday morning. (Although it holds the name “library,” there were no books or periodicals to be seen.) I had not been in the library for many months and was struck by a few things as I entered.

It is a dimly lit space, lined on three of the four walls with rickety desks and desktop computers all facing the walls. The walls are painted an off-white color with innumerable dings and nicks, presumably accumulated over the course of years. There was a string of garland in the shape of a Christmas tree pinned to the wall (P.S. It is March), the entire left side of which was sagging and misshapen. There were various tattered and coffee-stained papers scattered haphazardly throughout the room, including what appeared to be progress notes and test results printed from the EHR; a few worn ECGs; a telemetry strip; even a few (REALLY old, no doubt) chest x-ray films. Lining the fourth wall was a large foldable table, topped with crumbs and food scraps, a half-eaten chocolate Bundt cake, and scattered napkins and utensils, some of which appeared to be used. The one exterior-facing wall had a row of windows with crinkled blinds, some completely closed, others opened at awkward angles and seemingly stuck in place. There was a cadre of chairs in the room, none matching, all in various stages of disrepair, with one completely missing an armrest and another tucked in the corner, probably needing the addition of a handwritten sign “BRokEn.”

This library is a place where the students, interns, and residents go for a bit of a safe haven. They can take their coats off, sit down, have their own computer space, answer pages, and complain about their woes. They can bounce questions off each other, vent frustrations, find the humor in a situation, and just be themselves. So,But what struck me about their sanctuary is that it is totally and utterly depressing. And it was as if they didn’t even notice the chaos and filth laying everywhere around them. I find it impossible to believe that it does not have an effect on their mood and outlook. Although we are all social animals, and we have a real need to congregate and connect with one another, is this really the best environment to do that?

Read the full text of this blog post at hospitalleader.org.
 

Dr. Scheurer is a clinical hospitalist and the medical director of quality and safety at the Medical University of South Carolina in Charleston.

Also on The Hospital Leader…

• Should Overuse Be Considered an Adverse Event By Chris Moriates, MD
• Pulling the Welcome Mat Out from Under Our Colleagues By Brett Hendel-Paterson, MD
• The Upside of Anger By Tracy Cardin, ACNP-BC, SFHM
• Does Your Onboarding Process Really Get Folks on Board? By Leslie Flores, MH, SFHM
• A GIF Is Worth 3000 Words: Introducing #Visual Abstract for #JHMChat By Charlie Wray, DO

WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.

“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.

Bruce Jancin/Frontline Medical News

The good news

• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.

The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.

• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).

The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.

“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.

• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).

“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.

On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.

• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.

“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”

The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.

“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.

• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.

The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.

The bad news

• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).

• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.

Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.

“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.

• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.

• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).

“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.

• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”

Sleep apnea studies show silver lining

Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).

This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.

As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.

He reported having no financial conflicts.

[email protected]
 

WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.

“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.

Bruce Jancin/Frontline Medical News

The good news

• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.

The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.

• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).

The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.

“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.

• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).

“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.

On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.

• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.

“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”

The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.

“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.

• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.

The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.

The bad news

• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).

• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.

Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.

“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.

• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.

• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).

“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.

• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”

Sleep apnea studies show silver lining

Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).

This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.

As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.

He reported having no financial conflicts.

[email protected]
 

WASHINGTON – It’s been a “relatively positive” year for heart failure research and advances in patient care, Christopher M. O’Connor, MD, said at the annual meeting of the American College of Cardiology.

“Having been in this field for 30 years looking at clinical trials, generally for every 10 important trials done in a year, 1 has been positive and 9 have been negative; if we look at the past year, it’s more like 5 and 6. So, not a bad year for cardiomyopathy,” declared Dr. O’Connor, CEO and executive director of the Inova Heart and Vascular Institute in Falls Church, Va., and president-elect of the Heart Failure Society of America.

Bruce Jancin/Frontline Medical News

The good news

• Empagliflozin (Jardiance) earns FDA approval for reduction in risk of cardiovascular death in type 2 diabetes patients. “This is one of the most amazing stories in heart failure,” said Dr. O’Connor, who is also professor of medicine at Duke University in Durham, N.C.

The pivotal EMPA-REG OUTCOME study showed a highly significant 35% reduction in the secondary endpoint of risk of hospitalization for heart failure, as well the decrease in cardiovascular mortality which was the primary endpoint and proved persuasive to the FDA (N Engl J Med. 2015 Nov 26;373[22]:2117-28).

“It was a remarkable development. Because of this trial, there are now a number of ongoing phase III clinical trials looking at this class of drugs in heart failure patients with and without diabetes, which makes this a very important research movement. We are now looking deeper at phenotypes and trying to get more specific with these drug therapies,” he said.

• A new and improved LVAD. This fully magnetically levitated centrifugal-flow pump type of left ventricular assist device for advanced heart failure showed superior event-free survival, compared with a commercially available axial continuous-flow pump LVAD in the randomized MOMENTUM-3 trial (N Engl J Med. 2017 Feb 2;376[5]:440-50).

The novel pump was designed to overcome a significant problem with axial continuous-flow LVADs: a proclivity for pump thrombosis. The magnetically levitated centrifugal-flow pump proved a smashing success in this regard, with zero cases of pump thrombosis occurring during the 6-month study.

“This may be the first time in the history of heart failure research that the engineers have beaten the biologists in important clinical outcomes,” the cardiologist quipped.

• Omecamtiv mecarbil successfully addresses impaired contractility in heart failure with reduced ejection fraction (HFrEF). This drug, a selective cardiac myosin activator, resulted in increased duration of systole and improved stroke volume accompanied by reductions in heart rate, left ventricular end-diastolic and -systolic dimensions, and NT-proBNP in the 87-site, 13-country, phase II COSMIC-HF study (Lancet. 2016 Dec 10;388[10062]:2895-903).

“This is probably the most novel new drug mechanism out there in clinical trials,” according to Dr. O’Connor.

On the basis of the highly encouraging results for the surrogate endpoints assessed in COSMIC-HF, a large phase III clinical trial known as GALACTIC is underway.

• Palliative care gets a welcome boost. Dr. O’Connor was a coinvestigator in PAL-HF, a single-center study presented at the 2016 annual meeting of the Heart Failure Society of America.

“This is a very important trial of palliative care in advanced heart failure. We probably don’t have as much evidence in this space as we should,” he observed. “This was a multidisciplinary intervention in which we gave the patients a medical tool kit to alleviate pain, dyspnea, and discomfort. The tool kit included benzodiazepines, sleep medications, sublingual nitroglycerin, and morphinelike products, all very carefully monitored by staff coordinators.”

The primary outcome was change in two validated heart failure quality of life measures. Both instruments documented significant improvement compared with usual care.

“There was no decrease in mortality, which wasn’t a goal in this advanced heart failure population, and no reduction in heart failure hospitalizations, but there were significant reductions in depression and anxiety,” Dr. O’Connor said.

• Vericiguat. This oral soluble cyclic guanylate cyclase stimulator missed its primary endpoint in the phase II dose-escalation SOCRATES-REDUCED trial in patients with HFrEF (JAMA. 2015 Dec 1;314[21]:2251-62), but showed an impressive improvement in quality of life. It is now the subject of the ongoing, randomized, phase III VICTORIA trial involving a planned 4,000 patients with HFrEF with the composite primary endpoint of cardiovascular death or heart failure hospitalization.

The phase II SOCRATES-PRESERVED trial also missed its primary endpoint but showed a clinically meaningful improvement in quality of life in patients with heart failure with preserved ejection fraction (HFpEF) (Eur Heart J. 2017 Mar 22. doi: 10.1093/eurheartj/ehw593). Discussions are ongoing as to whether the next step should be a confirmatory phase II study or a move straight to phase III.

The bad news

• NSAIDs linked to increased risk of heart failure. European investigators analyzed five population-based databases totaling more than 8.3 million individuals and determined that current use of any of more than two dozen NSAIDs was associated with significantly increased risk of hospital admission for heart failure. The risk appeared to be dose dependent and varied between individual agents, ranging from a 16% increased risk with naproxen to an 83% increase with ketorolac (Toradol) (BMJ. 2016 Sep 28. doi: 10.1136/bmj.4857).

• Therapeutic natriuretic peptides hit bottom. The negative results for the investigational agent ularitide in patients with acute decompensated heart failure in the large phase III TRUE-AHF trial presented at the 2016 meeting of the American Heart Association, following upon an earlier negative study of the related drug nesiritide (Natrecor) in more than 7,100 acute heart failure patients (N Engl J Med. 2011 Jul 7; 365:32-43), probably spells the end of the line for this strategy of boosting outcomes in acute heart failure, according to Dr. O’Connor.

Moreover, Novartis has announced that the phase III RELAX-AHF-2 trial of serelaxin in 6,600 patients with acute heart failure failed to meet its primary endpoints of reduced cardiovascular deaths or reduced worsening of heart failure. The trial will be formally presented later this year.

“Ularitide seemed to show an early improvement in heart failure events that was not sustained in-hospital, and there was absolutely no difference in mortality. The drug probably acts like a pharmacologic tourniquet, in my view. So I think this field of therapeutic natriuretic peptides is probably closed,” he said.

• ICDs don’t reduce mortality in patients with nonischemic heart failure. This was the conclusion reached in the DANISH trial, in which more than 1,100 patients with symptomatic systolic heart failure were randomized to an ICD or usual care (N Engl J Med. 2016 Sep 29;375[13]:1221-30).

“This study really shook up the field, raising the question, ‘Are we using defibrillators too frequently in this population?’ It has stimulated a lot of discussion, including within the guidelines committee,” according to Dr. O’Connor.

• Tolvaptan nixed for acute decompensated heart failure. The TACTICS-HF trial studied the use of tolvaptan (Samsca), an oral vasopressin-2 receptor antagonist, to reduce dyspnea in patients hospitalized with acute decompensated heart failure. Dr. O’Connor was a coinvestigator in the study, which showed that tolvaptan was no better than placebo at 8 and 24 hours (J Am Coll Cardiol. 2017 Mar 21;69[11]:1399-406).

“For now, the routine use of vasopressin antagonists in acute heart failure is not to be encouraged, although there may still be subsets where it’s worth trying – certainly in severe hyponatremia,” the cardiologist said.

• GUIDE-IT gets lost. This was a roughly 1,000-patient randomized trial of a treatment strategy aimed at improving clinical outcomes by aggressively titrating evidence-based heart failure therapies in order to suppress natriuretic peptide biomarkers. GUIDE-IT was stopped early by the data safety monitoring board due to a lack of discernible difference in outcomes, compared with usual care. Dr. O’Connor, a coinvestigator, termed the soon-to-be-published study “a disappointment.”

Sleep apnea studies show silver lining

Sleep apnea is common in patients with heart failure and is associated with worse clinical heart failure outcomes. But in the large, randomized SERVE-HF trial, investigators showed that treatment of central sleep apnea with adaptive servo-ventilation in patients with HFrEF unexpectedly increased mortality, compared with optimal medical therapy (N Engl J Med. 2015 Sep 17;373:1095-105). In a more recent secondary analysis, however, the SERVE-HF investigators found that the increased risk for cardiovascular death associated with adaptive servo-ventilation was actually restricted to patients with a very poor left ventricular ejection fraction of 30% or less, and there was a signal of possible benefit in patients in the top tier of LVEF, at 36%-45% (Lancet Respir Med. 2016 Nov; 4[11]:873-81).

This observation dovetails nicely with the findings of the CAT-HF trial presented by Dr. O’Connor at the 2016 World Congress on Heart Failure. In this phase II study, 215 patients with acute decompensated heart failure and either obstructive or central sleep apnea were randomized to optimal medical therapy alone or in combination with adaptive servo-ventilation. There was no overall difference in outcome between the two groups; however, in the subgroup of patients with HFpEF, the risk of the primary composite endpoint was reduced by 62% with adaptive servo-ventilation.

As a result of these intriguing findings from SERVE-HF and CAT-HF, a registry and/or randomized clinical trial of adaptive servo-ventilation in patients with HFpEF is now being considered under NIH sponsorship, according to Dr. O’Connor.

He reported having no financial conflicts.

[email protected]
 

The case

A 72-year-old male with COPD presents to the emergency department with increased dyspnea and cough. He is afebrile, and oxygen saturation is 87% on room air. WBC count is 9.5 with a normal differential, and chest x-ray is read by the radiologist as atelectasis versus early consolidation in the left lower lobe. Should antibiotics be initiated?

Background

The problem: Antibiotic overuse

With the increasing prevalence of antibiotic resistance in our nation’s hospitals, the need for robust antibiotic stewardship programs has continued to rise in importance. In 2016, the CDC reported a fatal case of septic shock due to a carbapenem-resistant strain of Klebsiella resistant to all tested antibiotics.¹ This case received much media coverage; moreover, this patient represented only one of the approximately 23,000 patients infected with antibiotic-resistant bacteria in the United States who die each year. Although various approaches to curbing antibiotic resistance are being pursued, judicious antibiotic use is central to success. Current evidence suggests that up to 30% of antibiotics are not optimally prescribed,² leaving a significant opportunity for improvement.

Lower respiratory infections account for a substantial proportion of antibiotic utilization in the United States. In a recent study, acute respiratory conditions generated 221 antibiotic prescriptions per 1,000 population, but only half of these were deemed appropriate.² The inability to reliably discern viral from bacterial etiology is a driver of excess antibiotic use.

Dr Graham Beards/en.wikipedia/CC BY-SA 4.0

What is procalcitonin?

Thyroidal c-cells convert the prohormone procalcitonin to calcitonin, which is stored in secretory granules for release in response to fluctuations in calcium levels via a classical neuroendocrine feedback loop. Alternatively, procalcitonin can be synthesized in nonthyroidal parenchymal cells, and high levels of proinflammatory mediators secreted in response to bacterial endotoxin drive increased procalcitonin production. Interestingly, interferon gamma, up-regulated in viral infections, reduces procalcitonin production. Nonthyroidal parenchymal cells lack mechanisms for efficient conversion of procalcitonin to calcitonin and do not contain secretory granules to facilitate its regulated release. Hence bacterial infections correlate with higher serum procalcitonin levels.³ 

Evidence

Can procalcitonin guide antibiotic therapy in patients with acute respiratory illness while reducing antibiotic utilization?

The ability of procalcitonin to selectively identify bacterial infection makes it a potentially promising tool to advance the antibiotic stewardship agenda. Multiple randomized controlled trials have explored the use of procalcitonin-guided antibiotic therapy for treatment of lower respiratory tract infections such as acute bronchitis, exacerbations of COPD, and pneumonia. Each study discussed below was done in Switzerland, involved the same key investigator (Mirjam Christ-Crain, MD, PhD), and shared a similar design in which a threshold for low procalcitonin values (less than 0.1 mcg/L) and high procalcitonin values (greater than 0.25 mcg/L) was prespecified. Antibiotic therapy was strongly discouraged for patients with low procalcitonin and encouraged for those with high procalcitonin; antibiotics were not recommended for patients with intermediate values, but the treating physician was allowed ultimate discretion (Figure 1). All studies compared a procalcitonin-guided treatment group to a standard care group, in which antibiotics were prescribed by the treating physician based on established clinical guidelines.

Figure 1. Procalcitonin treatment algorithm

Figure 1. Procalcitonin treatment algorithm

In a study focusing on outpatients presenting to their primary care physicians with acute respiratory tract infection, 53 primary care physicians in Switzerland recruited 458 patients. There was no significant difference in time to symptom resolution, as determined by patient report during an interview 14 days after initial presentation; however, 97% of patients in the standard-care group received antibiotics, compared with 25% in the procalcitonin-guided group. Equal numbers of patients (30% in each group) reported persistent symptoms at 28-day follow-up. Among the cohort of patients with upper respiratory infections or acute bronchitis, procalcitonin guidance reduced antibiotic prescriptions by 80%.⁴

In a blinded, single-center, randomized, controlled trial of 226 patients presenting to a university hospital with a COPD exacerbation severe enough to require a change in the baseline medication regimen, procalcitonin-guided therapy allowed for an absolute reduction of antibiotic use by 32% without an impact on outcomes. Rates of clinical improvement, ICU utilization, recurrent exacerbations, hospital length of stay, and mortality did not differ between the groups.⁵

Is there evidence for using procalcitonin to guide treatment in the broader population of ICU patients?

While there is good evidence for using procalcitonin to guide antibiotic use in patients with acute respiratory illness, the evidence for using procalcitonin in the broader cohort of critically-ill patients with sepsis is less well established.

The most promising results were reported by the Stop Antibiotics on Procalcitonin guidance Study (SAPS). Published in July 2016, this was a prospective, multicenter, randomized, controlled, open-label study of patients admitted to the ICU (not limited to respiratory illness) in the Netherlands. A total of 1,575 patients were assigned to the procalcitonin-guided group or the standard-of-care group. In the procalcitonin-guided group, procalcitonin levels were checked daily, and physicians were given nonbinding advice to discontinue antibiotics if procalcitonin levels decreased by greater than 80% from peak levels or to below 0.5 mcg/L.

Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0

Back to the case

The case illustrates a common emergency department presentation where clinical and radiographic features are not convincing for bacterial infection. This patient has an acute respiratory illness, but is afebrile and lacks leukocytosis with left shift, and x-rays are indeterminate for pneumonia. The differential diagnosis also includes COPD exacerbation, viral infection, or noninfectious triggers of dyspnea.

In this scenario, obtaining procalcitonin levels is useful in the decision to initiate or withhold antibiotic treatment. An elevated procalcitonin level suggests a bacterial infection and would favor initiation of antibiotics for pneumonia. A low procalcitonin level makes a bacterial infection less likely, and a clinician may consider withholding antibiotics and consider alternate etiologies for the patient’s presentation.

Bottom line

Procalcitonin can be safely used to guide the decision to initiate antibiotics in patients presenting with acute respiratory illness. Use of the procalcitonin assay has been shown to reduce antibiotic utilization without an increase in adverse outcomes. There is potential but less conclusive evidence for procalcitonin usage in the broader population of ICU patients with sepsis.
 

Bryan J. Huang, MD, FHM, and Gregory B. Seymann, MD, SFHM, are in the division of hospital medicine, University of California, San Diego.

• Key Points
• Elevated procalcitonin levels suggest the presence of bacterial infection.
• In patients presenting with acute respiratory illness, procalcitonin levels can be used to guide the decision to initiate or withhold antibiotics, improving antibiotic stewardship.
• Sequential monitoring of procalcitonin levels may help guide duration of antibiotic therapy.
• There is potential but less conclusive evidence for procalcitonin usage in the broader population of ICU patients with sepsis.


•  

References

1. Chen L, Todd R, Kiehlbauch J, Walters M, Kallen A. Notes from the field: pan-resistant New Delhi metallo-beta-lactamase-producing Klebsiella pneumoniae – Washoe County, Nevada, 2016. MMWR Morb Mortal Wkly Rep 2017; 66(1):33.

2. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010-2011. JAMA 2016;315(17):1864-73.

3. Christ-Crain M, Muller B. Procalcitonin in bacterial infections – hype, hope, more or less? Swiss Med Wkly. 2005;135(31-32):451-60.

4. Briel M, Schuetz P, Mueller B, et al. Procalcitonin-guided antibiotic use vs. a standard approach for acute respiratory tract infections in primary care. Arch Intern Med. 2008; 168(18): 2000-7.

5. Stolz D, Christ-Crain M, Bingisser R, et al. Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest 2007;131(1): 9-19.

6. Christ-Crain M, Stolz D, Bingisser R, et al. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006;174(1):84-93.

7. Schuetz P, Christ-Crain M, Thomann R, et al. Effect of procalcitonin-based guidelines vs. standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA 2009; 302(10): 1059-66.

8. Uranga A, Espana PP, Bilbao A, et al. Duration of antibiotic treatment in community-acquired pneumonia: a multicenter randomized clinical trial. JAMA Intern Med. 2016;176(9):1257-65.

9. de Jong E, van Oers JA, Beishiozen A, et al. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016;16(7):819-27.

10. Bouadma L, Luyt CE, Tubach F, et al. Use of procalcitonin to reduce patients’ exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet 2010;375(9713):463-74.

11. Jensen J-U, Lundgren B, Hein L, et al. The procalcitonin and survival study (PASS) – a randomised multicenter investigator-initiated trial to investigate whether daily measurements biomarker procalcitonin and proactive diagnostic and therapeutic responses to abnormal procalcitonin levels, can improve survival in intensive care unit patients. BMC infectious diseases. 2008;8:91-100.

Additional reading

1. Schuetz P, Christ-Crain M, Thomann R, et al. Effect of procalcitonin-based guidelines vs. standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA 2009;302(10):1059-66.

2. de Jong E, van Oers JA, Beishiozen A, et al. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016;16(7):819-27.

3. Schuetz P, Muller B, Christ-Crain M, et al. Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections. Cochrane Database Syst Rev. 2012;(9):CD007498.

The case

A 72-year-old male with COPD presents to the emergency department with increased dyspnea and cough. He is afebrile, and oxygen saturation is 87% on room air. WBC count is 9.5 with a normal differential, and chest x-ray is read by the radiologist as atelectasis versus early consolidation in the left lower lobe. Should antibiotics be initiated?

Background

The problem: Antibiotic overuse

With the increasing prevalence of antibiotic resistance in our nation’s hospitals, the need for robust antibiotic stewardship programs has continued to rise in importance. In 2016, the CDC reported a fatal case of septic shock due to a carbapenem-resistant strain of Klebsiella resistant to all tested antibiotics.¹ This case received much media coverage; moreover, this patient represented only one of the approximately 23,000 patients infected with antibiotic-resistant bacteria in the United States who die each year. Although various approaches to curbing antibiotic resistance are being pursued, judicious antibiotic use is central to success. Current evidence suggests that up to 30% of antibiotics are not optimally prescribed,² leaving a significant opportunity for improvement.

Lower respiratory infections account for a substantial proportion of antibiotic utilization in the United States. In a recent study, acute respiratory conditions generated 221 antibiotic prescriptions per 1,000 population, but only half of these were deemed appropriate.² The inability to reliably discern viral from bacterial etiology is a driver of excess antibiotic use.

Dr Graham Beards/en.wikipedia/CC BY-SA 4.0

What is procalcitonin?

Thyroidal c-cells convert the prohormone procalcitonin to calcitonin, which is stored in secretory granules for release in response to fluctuations in calcium levels via a classical neuroendocrine feedback loop. Alternatively, procalcitonin can be synthesized in nonthyroidal parenchymal cells, and high levels of proinflammatory mediators secreted in response to bacterial endotoxin drive increased procalcitonin production. Interestingly, interferon gamma, up-regulated in viral infections, reduces procalcitonin production. Nonthyroidal parenchymal cells lack mechanisms for efficient conversion of procalcitonin to calcitonin and do not contain secretory granules to facilitate its regulated release. Hence bacterial infections correlate with higher serum procalcitonin levels.³ 

Evidence

Can procalcitonin guide antibiotic therapy in patients with acute respiratory illness while reducing antibiotic utilization?

The ability of procalcitonin to selectively identify bacterial infection makes it a potentially promising tool to advance the antibiotic stewardship agenda. Multiple randomized controlled trials have explored the use of procalcitonin-guided antibiotic therapy for treatment of lower respiratory tract infections such as acute bronchitis, exacerbations of COPD, and pneumonia. Each study discussed below was done in Switzerland, involved the same key investigator (Mirjam Christ-Crain, MD, PhD), and shared a similar design in which a threshold for low procalcitonin values (less than 0.1 mcg/L) and high procalcitonin values (greater than 0.25 mcg/L) was prespecified. Antibiotic therapy was strongly discouraged for patients with low procalcitonin and encouraged for those with high procalcitonin; antibiotics were not recommended for patients with intermediate values, but the treating physician was allowed ultimate discretion (Figure 1). All studies compared a procalcitonin-guided treatment group to a standard care group, in which antibiotics were prescribed by the treating physician based on established clinical guidelines.

Figure 1. Procalcitonin treatment algorithm

Figure 1. Procalcitonin treatment algorithm

In a study focusing on outpatients presenting to their primary care physicians with acute respiratory tract infection, 53 primary care physicians in Switzerland recruited 458 patients. There was no significant difference in time to symptom resolution, as determined by patient report during an interview 14 days after initial presentation; however, 97% of patients in the standard-care group received antibiotics, compared with 25% in the procalcitonin-guided group. Equal numbers of patients (30% in each group) reported persistent symptoms at 28-day follow-up. Among the cohort of patients with upper respiratory infections or acute bronchitis, procalcitonin guidance reduced antibiotic prescriptions by 80%.⁴

In a blinded, single-center, randomized, controlled trial of 226 patients presenting to a university hospital with a COPD exacerbation severe enough to require a change in the baseline medication regimen, procalcitonin-guided therapy allowed for an absolute reduction of antibiotic use by 32% without an impact on outcomes. Rates of clinical improvement, ICU utilization, recurrent exacerbations, hospital length of stay, and mortality did not differ between the groups.⁵

Is there evidence for using procalcitonin to guide treatment in the broader population of ICU patients?

While there is good evidence for using procalcitonin to guide antibiotic use in patients with acute respiratory illness, the evidence for using procalcitonin in the broader cohort of critically-ill patients with sepsis is less well established.

The most promising results were reported by the Stop Antibiotics on Procalcitonin guidance Study (SAPS). Published in July 2016, this was a prospective, multicenter, randomized, controlled, open-label study of patients admitted to the ICU (not limited to respiratory illness) in the Netherlands. A total of 1,575 patients were assigned to the procalcitonin-guided group or the standard-of-care group. In the procalcitonin-guided group, procalcitonin levels were checked daily, and physicians were given nonbinding advice to discontinue antibiotics if procalcitonin levels decreased by greater than 80% from peak levels or to below 0.5 mcg/L.

Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0

Back to the case

The case illustrates a common emergency department presentation where clinical and radiographic features are not convincing for bacterial infection. This patient has an acute respiratory illness, but is afebrile and lacks leukocytosis with left shift, and x-rays are indeterminate for pneumonia. The differential diagnosis also includes COPD exacerbation, viral infection, or noninfectious triggers of dyspnea.

In this scenario, obtaining procalcitonin levels is useful in the decision to initiate or withhold antibiotic treatment. An elevated procalcitonin level suggests a bacterial infection and would favor initiation of antibiotics for pneumonia. A low procalcitonin level makes a bacterial infection less likely, and a clinician may consider withholding antibiotics and consider alternate etiologies for the patient’s presentation.

Bottom line

Procalcitonin can be safely used to guide the decision to initiate antibiotics in patients presenting with acute respiratory illness. Use of the procalcitonin assay has been shown to reduce antibiotic utilization without an increase in adverse outcomes. There is potential but less conclusive evidence for procalcitonin usage in the broader population of ICU patients with sepsis.
 

Bryan J. Huang, MD, FHM, and Gregory B. Seymann, MD, SFHM, are in the division of hospital medicine, University of California, San Diego.

• Key Points
• Elevated procalcitonin levels suggest the presence of bacterial infection.
• In patients presenting with acute respiratory illness, procalcitonin levels can be used to guide the decision to initiate or withhold antibiotics, improving antibiotic stewardship.
• Sequential monitoring of procalcitonin levels may help guide duration of antibiotic therapy.
• There is potential but less conclusive evidence for procalcitonin usage in the broader population of ICU patients with sepsis.


•  

References

1. Chen L, Todd R, Kiehlbauch J, Walters M, Kallen A. Notes from the field: pan-resistant New Delhi metallo-beta-lactamase-producing Klebsiella pneumoniae – Washoe County, Nevada, 2016. MMWR Morb Mortal Wkly Rep 2017; 66(1):33.

2. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010-2011. JAMA 2016;315(17):1864-73.

3. Christ-Crain M, Muller B. Procalcitonin in bacterial infections – hype, hope, more or less? Swiss Med Wkly. 2005;135(31-32):451-60.

4. Briel M, Schuetz P, Mueller B, et al. Procalcitonin-guided antibiotic use vs. a standard approach for acute respiratory tract infections in primary care. Arch Intern Med. 2008; 168(18): 2000-7.

5. Stolz D, Christ-Crain M, Bingisser R, et al. Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest 2007;131(1): 9-19.

6. Christ-Crain M, Stolz D, Bingisser R, et al. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006;174(1):84-93.

7. Schuetz P, Christ-Crain M, Thomann R, et al. Effect of procalcitonin-based guidelines vs. standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA 2009; 302(10): 1059-66.

8. Uranga A, Espana PP, Bilbao A, et al. Duration of antibiotic treatment in community-acquired pneumonia: a multicenter randomized clinical trial. JAMA Intern Med. 2016;176(9):1257-65.

9. de Jong E, van Oers JA, Beishiozen A, et al. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016;16(7):819-27.

10. Bouadma L, Luyt CE, Tubach F, et al. Use of procalcitonin to reduce patients’ exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet 2010;375(9713):463-74.

11. Jensen J-U, Lundgren B, Hein L, et al. The procalcitonin and survival study (PASS) – a randomised multicenter investigator-initiated trial to investigate whether daily measurements biomarker procalcitonin and proactive diagnostic and therapeutic responses to abnormal procalcitonin levels, can improve survival in intensive care unit patients. BMC infectious diseases. 2008;8:91-100.

Additional reading

1. Schuetz P, Christ-Crain M, Thomann R, et al. Effect of procalcitonin-based guidelines vs. standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA 2009;302(10):1059-66.

2. de Jong E, van Oers JA, Beishiozen A, et al. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016;16(7):819-27.

3. Schuetz P, Muller B, Christ-Crain M, et al. Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections. Cochrane Database Syst Rev. 2012;(9):CD007498.

The case

A 72-year-old male with COPD presents to the emergency department with increased dyspnea and cough. He is afebrile, and oxygen saturation is 87% on room air. WBC count is 9.5 with a normal differential, and chest x-ray is read by the radiologist as atelectasis versus early consolidation in the left lower lobe. Should antibiotics be initiated?

Background

The problem: Antibiotic overuse

With the increasing prevalence of antibiotic resistance in our nation’s hospitals, the need for robust antibiotic stewardship programs has continued to rise in importance. In 2016, the CDC reported a fatal case of septic shock due to a carbapenem-resistant strain of Klebsiella resistant to all tested antibiotics.¹ This case received much media coverage; moreover, this patient represented only one of the approximately 23,000 patients infected with antibiotic-resistant bacteria in the United States who die each year. Although various approaches to curbing antibiotic resistance are being pursued, judicious antibiotic use is central to success. Current evidence suggests that up to 30% of antibiotics are not optimally prescribed,² leaving a significant opportunity for improvement.

Lower respiratory infections account for a substantial proportion of antibiotic utilization in the United States. In a recent study, acute respiratory conditions generated 221 antibiotic prescriptions per 1,000 population, but only half of these were deemed appropriate.² The inability to reliably discern viral from bacterial etiology is a driver of excess antibiotic use.

Dr Graham Beards/en.wikipedia/CC BY-SA 4.0

What is procalcitonin?

Thyroidal c-cells convert the prohormone procalcitonin to calcitonin, which is stored in secretory granules for release in response to fluctuations in calcium levels via a classical neuroendocrine feedback loop. Alternatively, procalcitonin can be synthesized in nonthyroidal parenchymal cells, and high levels of proinflammatory mediators secreted in response to bacterial endotoxin drive increased procalcitonin production. Interestingly, interferon gamma, up-regulated in viral infections, reduces procalcitonin production. Nonthyroidal parenchymal cells lack mechanisms for efficient conversion of procalcitonin to calcitonin and do not contain secretory granules to facilitate its regulated release. Hence bacterial infections correlate with higher serum procalcitonin levels.³ 

Evidence

Can procalcitonin guide antibiotic therapy in patients with acute respiratory illness while reducing antibiotic utilization?

The ability of procalcitonin to selectively identify bacterial infection makes it a potentially promising tool to advance the antibiotic stewardship agenda. Multiple randomized controlled trials have explored the use of procalcitonin-guided antibiotic therapy for treatment of lower respiratory tract infections such as acute bronchitis, exacerbations of COPD, and pneumonia. Each study discussed below was done in Switzerland, involved the same key investigator (Mirjam Christ-Crain, MD, PhD), and shared a similar design in which a threshold for low procalcitonin values (less than 0.1 mcg/L) and high procalcitonin values (greater than 0.25 mcg/L) was prespecified. Antibiotic therapy was strongly discouraged for patients with low procalcitonin and encouraged for those with high procalcitonin; antibiotics were not recommended for patients with intermediate values, but the treating physician was allowed ultimate discretion (Figure 1). All studies compared a procalcitonin-guided treatment group to a standard care group, in which antibiotics were prescribed by the treating physician based on established clinical guidelines.

Figure 1. Procalcitonin treatment algorithm

Figure 1. Procalcitonin treatment algorithm

In a study focusing on outpatients presenting to their primary care physicians with acute respiratory tract infection, 53 primary care physicians in Switzerland recruited 458 patients. There was no significant difference in time to symptom resolution, as determined by patient report during an interview 14 days after initial presentation; however, 97% of patients in the standard-care group received antibiotics, compared with 25% in the procalcitonin-guided group. Equal numbers of patients (30% in each group) reported persistent symptoms at 28-day follow-up. Among the cohort of patients with upper respiratory infections or acute bronchitis, procalcitonin guidance reduced antibiotic prescriptions by 80%.⁴

In a blinded, single-center, randomized, controlled trial of 226 patients presenting to a university hospital with a COPD exacerbation severe enough to require a change in the baseline medication regimen, procalcitonin-guided therapy allowed for an absolute reduction of antibiotic use by 32% without an impact on outcomes. Rates of clinical improvement, ICU utilization, recurrent exacerbations, hospital length of stay, and mortality did not differ between the groups.⁵

Is there evidence for using procalcitonin to guide treatment in the broader population of ICU patients?

While there is good evidence for using procalcitonin to guide antibiotic use in patients with acute respiratory illness, the evidence for using procalcitonin in the broader cohort of critically-ill patients with sepsis is less well established.

The most promising results were reported by the Stop Antibiotics on Procalcitonin guidance Study (SAPS). Published in July 2016, this was a prospective, multicenter, randomized, controlled, open-label study of patients admitted to the ICU (not limited to respiratory illness) in the Netherlands. A total of 1,575 patients were assigned to the procalcitonin-guided group or the standard-of-care group. In the procalcitonin-guided group, procalcitonin levels were checked daily, and physicians were given nonbinding advice to discontinue antibiotics if procalcitonin levels decreased by greater than 80% from peak levels or to below 0.5 mcg/L.

Sheep purple/flickr/CC BY 2.0 /en.wikipedia/CC BY-SA 4.0

Back to the case

The case illustrates a common emergency department presentation where clinical and radiographic features are not convincing for bacterial infection. This patient has an acute respiratory illness, but is afebrile and lacks leukocytosis with left shift, and x-rays are indeterminate for pneumonia. The differential diagnosis also includes COPD exacerbation, viral infection, or noninfectious triggers of dyspnea.

In this scenario, obtaining procalcitonin levels is useful in the decision to initiate or withhold antibiotic treatment. An elevated procalcitonin level suggests a bacterial infection and would favor initiation of antibiotics for pneumonia. A low procalcitonin level makes a bacterial infection less likely, and a clinician may consider withholding antibiotics and consider alternate etiologies for the patient’s presentation.

Bottom line

Procalcitonin can be safely used to guide the decision to initiate antibiotics in patients presenting with acute respiratory illness. Use of the procalcitonin assay has been shown to reduce antibiotic utilization without an increase in adverse outcomes. There is potential but less conclusive evidence for procalcitonin usage in the broader population of ICU patients with sepsis.
 

Bryan J. Huang, MD, FHM, and Gregory B. Seymann, MD, SFHM, are in the division of hospital medicine, University of California, San Diego.

• Key Points
• Elevated procalcitonin levels suggest the presence of bacterial infection.
• In patients presenting with acute respiratory illness, procalcitonin levels can be used to guide the decision to initiate or withhold antibiotics, improving antibiotic stewardship.
• Sequential monitoring of procalcitonin levels may help guide duration of antibiotic therapy.
• There is potential but less conclusive evidence for procalcitonin usage in the broader population of ICU patients with sepsis.


•  

References

1. Chen L, Todd R, Kiehlbauch J, Walters M, Kallen A. Notes from the field: pan-resistant New Delhi metallo-beta-lactamase-producing Klebsiella pneumoniae – Washoe County, Nevada, 2016. MMWR Morb Mortal Wkly Rep 2017; 66(1):33.

2. Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010-2011. JAMA 2016;315(17):1864-73.

3. Christ-Crain M, Muller B. Procalcitonin in bacterial infections – hype, hope, more or less? Swiss Med Wkly. 2005;135(31-32):451-60.

4. Briel M, Schuetz P, Mueller B, et al. Procalcitonin-guided antibiotic use vs. a standard approach for acute respiratory tract infections in primary care. Arch Intern Med. 2008; 168(18): 2000-7.

5. Stolz D, Christ-Crain M, Bingisser R, et al. Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest 2007;131(1): 9-19.

6. Christ-Crain M, Stolz D, Bingisser R, et al. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006;174(1):84-93.

7. Schuetz P, Christ-Crain M, Thomann R, et al. Effect of procalcitonin-based guidelines vs. standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA 2009; 302(10): 1059-66.

8. Uranga A, Espana PP, Bilbao A, et al. Duration of antibiotic treatment in community-acquired pneumonia: a multicenter randomized clinical trial. JAMA Intern Med. 2016;176(9):1257-65.

9. de Jong E, van Oers JA, Beishiozen A, et al. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016;16(7):819-27.

10. Bouadma L, Luyt CE, Tubach F, et al. Use of procalcitonin to reduce patients’ exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet 2010;375(9713):463-74.

11. Jensen J-U, Lundgren B, Hein L, et al. The procalcitonin and survival study (PASS) – a randomised multicenter investigator-initiated trial to investigate whether daily measurements biomarker procalcitonin and proactive diagnostic and therapeutic responses to abnormal procalcitonin levels, can improve survival in intensive care unit patients. BMC infectious diseases. 2008;8:91-100.

Additional reading

1. Schuetz P, Christ-Crain M, Thomann R, et al. Effect of procalcitonin-based guidelines vs. standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA 2009;302(10):1059-66.

2. de Jong E, van Oers JA, Beishiozen A, et al. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016;16(7):819-27.

3. Schuetz P, Muller B, Christ-Crain M, et al. Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections. Cochrane Database Syst Rev. 2012;(9):CD007498.

By now, nearly all hospitals are developing networks of postacute facilities for some or all of their patients, such as those in ACOs, bundled payments, or other value-based programs. Commonly referred to as preferred providers, performance networks, narrow networks, or similar, these networks of skilled nursing facilities (SNFs) and other entities that provide postacute care (like home health agencies) are usually chosen because they have demonstrated that they provide high quality, cost-effective care for patients after they leave the hospital.

While case managers are often the ones who counsel patients and caregivers on the details of the network, hospitalists should have at least a high-level grasp of which facilities are on the list and what the network selection criteria are. I would argue that hospitalists should lead the discussion with patients on postacute facility selection as it relates to which facilities are in the network and why going to a network facility is advantageous. Why? Because as hospitalist practices begin to share clinical and financial risk for patients, or at least become eligible to share in savings as MACRA encourages, they will have a vested interest in network facilities’ performance.
 

Postacute care network selection criteria

There is a range of criteria – usually incorporating measures of quality and efficiency – for including providers like SNFs in networks. In terms of quality, criteria can include physician/provider availability, star ratings on Nursing Home Compare, care transitions measures, Department of Public Health inspection survey scores, Joint Commission accreditation, etc.

A few caveats regarding specific selection criteria:

Star ratings on Nursing Home Compare

These are derived from nursing staffing ratios, health inspections, and 16 quality measures. More than half of the quality measures pertain to long-stay residents who typically are not in the ACO or bundled payment program for which the network was created (these are usually short-stay patients).

SNF length of stay

High readmission rates from a SNF can actually lower its length of stay, so including “balancing” measures such as readmissions should be considered.
 

What about patient choice?

Narrow postacute networks are not only becoming the norm, but there is also broad recognition from CMS, MedPAC, and industry leaders that value-based payment programs require such networks to succeed. That said, case managers and other discharge planners may still resist networks on the grounds that they might be perceived as restricting patient choice. One approach to balancing differing views on patient choice is to give patients the traditional longer list of available postacute providers, and also furnish the shorter network list accompanied by an explanation of why certain SNFs are in the network. Thankfully, as ACOs and bundles become widespread, resistance to narrow networks is dying down.

What role should hospitalists play in network referrals?

High functioning hospitalist practices should lead the discussion with patients and the health care team on referrals to network SNFs. Why? Patients are looking for their doctors to guide them on such decisions. Only if the physician opts not to have the discussion will patients look to the case manager for direction on which postacute facility to choose. A better option still would be for the hospitalists to partner with case managers to have the conversation with patients. In such a scenario, the hospitalist can begin the discussion and cover the major points, and the case manager can follow with more detailed information. For less mature hospitalist practices, the case manager can play a larger role in the discussion. In any case, as value-based models become ubiquitous, and shared savings become a driver of hospitalist revenue, hospitalists’ knowledge of and active participation in conversations around narrow networks and referrals will be necessary.

Dr. Whitcomb is chief medical officer at Remedy Partners in Darien, Conn. He is a cofounder and past president of SHM.

By now, nearly all hospitals are developing networks of postacute facilities for some or all of their patients, such as those in ACOs, bundled payments, or other value-based programs. Commonly referred to as preferred providers, performance networks, narrow networks, or similar, these networks of skilled nursing facilities (SNFs) and other entities that provide postacute care (like home health agencies) are usually chosen because they have demonstrated that they provide high quality, cost-effective care for patients after they leave the hospital.

While case managers are often the ones who counsel patients and caregivers on the details of the network, hospitalists should have at least a high-level grasp of which facilities are on the list and what the network selection criteria are. I would argue that hospitalists should lead the discussion with patients on postacute facility selection as it relates to which facilities are in the network and why going to a network facility is advantageous. Why? Because as hospitalist practices begin to share clinical and financial risk for patients, or at least become eligible to share in savings as MACRA encourages, they will have a vested interest in network facilities’ performance.
 

Postacute care network selection criteria

There is a range of criteria – usually incorporating measures of quality and efficiency – for including providers like SNFs in networks. In terms of quality, criteria can include physician/provider availability, star ratings on Nursing Home Compare, care transitions measures, Department of Public Health inspection survey scores, Joint Commission accreditation, etc.

A few caveats regarding specific selection criteria:

Star ratings on Nursing Home Compare

These are derived from nursing staffing ratios, health inspections, and 16 quality measures. More than half of the quality measures pertain to long-stay residents who typically are not in the ACO or bundled payment program for which the network was created (these are usually short-stay patients).

SNF length of stay

High readmission rates from a SNF can actually lower its length of stay, so including “balancing” measures such as readmissions should be considered.
 

What about patient choice?

Narrow postacute networks are not only becoming the norm, but there is also broad recognition from CMS, MedPAC, and industry leaders that value-based payment programs require such networks to succeed. That said, case managers and other discharge planners may still resist networks on the grounds that they might be perceived as restricting patient choice. One approach to balancing differing views on patient choice is to give patients the traditional longer list of available postacute providers, and also furnish the shorter network list accompanied by an explanation of why certain SNFs are in the network. Thankfully, as ACOs and bundles become widespread, resistance to narrow networks is dying down.

What role should hospitalists play in network referrals?

High functioning hospitalist practices should lead the discussion with patients and the health care team on referrals to network SNFs. Why? Patients are looking for their doctors to guide them on such decisions. Only if the physician opts not to have the discussion will patients look to the case manager for direction on which postacute facility to choose. A better option still would be for the hospitalists to partner with case managers to have the conversation with patients. In such a scenario, the hospitalist can begin the discussion and cover the major points, and the case manager can follow with more detailed information. For less mature hospitalist practices, the case manager can play a larger role in the discussion. In any case, as value-based models become ubiquitous, and shared savings become a driver of hospitalist revenue, hospitalists’ knowledge of and active participation in conversations around narrow networks and referrals will be necessary.

Dr. Whitcomb is chief medical officer at Remedy Partners in Darien, Conn. He is a cofounder and past president of SHM.

By now, nearly all hospitals are developing networks of postacute facilities for some or all of their patients, such as those in ACOs, bundled payments, or other value-based programs. Commonly referred to as preferred providers, performance networks, narrow networks, or similar, these networks of skilled nursing facilities (SNFs) and other entities that provide postacute care (like home health agencies) are usually chosen because they have demonstrated that they provide high quality, cost-effective care for patients after they leave the hospital.

While case managers are often the ones who counsel patients and caregivers on the details of the network, hospitalists should have at least a high-level grasp of which facilities are on the list and what the network selection criteria are. I would argue that hospitalists should lead the discussion with patients on postacute facility selection as it relates to which facilities are in the network and why going to a network facility is advantageous. Why? Because as hospitalist practices begin to share clinical and financial risk for patients, or at least become eligible to share in savings as MACRA encourages, they will have a vested interest in network facilities’ performance.
 

Postacute care network selection criteria

There is a range of criteria – usually incorporating measures of quality and efficiency – for including providers like SNFs in networks. In terms of quality, criteria can include physician/provider availability, star ratings on Nursing Home Compare, care transitions measures, Department of Public Health inspection survey scores, Joint Commission accreditation, etc.

A few caveats regarding specific selection criteria:

Star ratings on Nursing Home Compare

These are derived from nursing staffing ratios, health inspections, and 16 quality measures. More than half of the quality measures pertain to long-stay residents who typically are not in the ACO or bundled payment program for which the network was created (these are usually short-stay patients).

SNF length of stay

High readmission rates from a SNF can actually lower its length of stay, so including “balancing” measures such as readmissions should be considered.
 

What about patient choice?

Narrow postacute networks are not only becoming the norm, but there is also broad recognition from CMS, MedPAC, and industry leaders that value-based payment programs require such networks to succeed. That said, case managers and other discharge planners may still resist networks on the grounds that they might be perceived as restricting patient choice. One approach to balancing differing views on patient choice is to give patients the traditional longer list of available postacute providers, and also furnish the shorter network list accompanied by an explanation of why certain SNFs are in the network. Thankfully, as ACOs and bundles become widespread, resistance to narrow networks is dying down.

What role should hospitalists play in network referrals?

High functioning hospitalist practices should lead the discussion with patients and the health care team on referrals to network SNFs. Why? Patients are looking for their doctors to guide them on such decisions. Only if the physician opts not to have the discussion will patients look to the case manager for direction on which postacute facility to choose. A better option still would be for the hospitalists to partner with case managers to have the conversation with patients. In such a scenario, the hospitalist can begin the discussion and cover the major points, and the case manager can follow with more detailed information. For less mature hospitalist practices, the case manager can play a larger role in the discussion. In any case, as value-based models become ubiquitous, and shared savings become a driver of hospitalist revenue, hospitalists’ knowledge of and active participation in conversations around narrow networks and referrals will be necessary.

Dr. Whitcomb is chief medical officer at Remedy Partners in Darien, Conn. He is a cofounder and past president of SHM.