Larry Beresford

Over the past few decades, the US Food and Drug Administration (FDA) has increasingly relied on surrogate measures such as blood tests instead of clinical outcomes for medication approvals. But critics say the agency lacks consistent standards to ensure the surrogate aligns with clinical outcomes that matter to patients — things like improvements in symptoms and gains in function.

Sometimes those decisions backfire. Consider: In July 2021, the FDA approved aducanumab for the treatment of Alzheimer’s disease, bucking the advice of an advisory panel for the agency that questioned the effectiveness of the medication. Regulators relied on data from the drugmaker, Biogen, showing the monoclonal antibody could reduce levels of amyloid beta plaques in blood — a surrogate marker officials hoped would translate to clinical benefit.

The FDA’s decision triggered significant controversy, and Biogen in January announced it is pulling it from the market this year, citing disappointing sales.

Although the case of aducanumab might seem extreme, given the stakes — Alzheimer’s remains a disease without an effective treatment — it’s far from unusual.

“When we prescribe a drug, there is an underlying assumption that the FDA has done its due diligence to confirm the drug is safe and of benefit,” said Reshma Ramachandran, MD, MPP, MHS, a researcher at Yale School of Medicine, New Haven, Connecticut, and a coauthor of a recent review of surrogate outcomes. “In fact, we found either no evidence or low-quality evidence.” Such markers are associated with clinical outcomes. “We just don’t know if they work meaningfully to treat the patient’s condition. The results were pretty shocking for us,” she said.

The FDA in 2018 released an Adult Surrogate Endpoint Table listing markers that can be used as substitutes for clinical outcomes to more quickly test, review, and approve new therapies. The analysis found the majority of these endpoints lacked subsequent confirmations, defined as published meta-analyses of clinical studies to validate the association between the marker and a clinical outcome important to patients.

In a paper published in JAMA, Dr. Ramachandran and her colleagues looked at 37 surrogate endpoints for nearly 3 dozen nononcologic diseases in the table.

Approval with surrogate markers implies responsibility for postapproval or validation studies — not just lab measures or imaging findings but mortality, morbidity, or improved quality of life, said Joshua D. Wallach, PhD, MS, assistant professor in the department of epidemiology at the Emory Rollins School of Public Health in Atlanta and lead author of the JAMA review.

Dr. Wallach said surrogate markers are easier to measure and do not require large and long trials. But the FDA has not provided clear rules for what makes a surrogate marker valid in clinical trials.

“They’ve said that at a minimum, it requires meta-analytical evidence from studies that have looked at the correlation or the association between the surrogate and the clinical outcome,” Dr. Wallach said. “Our understanding was that if that’s a minimum expectation, we should be able to find those studies in the literature. And the reality is that we were unable to find evidence from those types of studies supporting the association between the surrogate and the clinical outcome.”

Physicians generally do not receive training about the FDA approval process and the difference between biomarkers, surrogate markers, and clinical endpoints, Dr. Ramachandran said. “Our study shows that things are much more uncertain than we thought when it comes to the prescribing of new drugs,” she said.
 

Surrogate Markers on the Rise

Dr. Wallach’s group looked for published meta-analyses compiling randomized controlled trials reporting surrogate endpoints for more than 3 dozen chronic nononcologic conditions, including type 2 diabetes, Alzheimer’s, kidney disease, HIV, gout, and lupus. They found no meta-analyses at all for 59% of the surrogate markers, while for those that were studied, few reported high-strength evidence of an association with clinical outcomes.

The findings echo previous research. In a 2020 study in JAMA Network Open, researchers tallied primary endpoints for all FDA approvals of new drugs and therapies during three 3-year periods: 1995-1997, 2005-2007, and 2015-2017. The proportion of products whose approvals were based on the use of clinical endpoints decreased from 43.8% in 1995-1997 to 28.4% in 2005-2007 to 23.3% in 2015-2017. The share based on surrogate endpoints rose from 43.3% to roughly 60% over the same interval.

A 2017 study in the Journal of Health Economics found the use of “imperfect” surrogate endpoints helped support the approval of an average of 16 new drugs per year between 2010 and 2014 compared with six per year from 1998 to 2008.

Similar concerns about weak associations between surrogate markers and drugs used to treat cancer have been documented before, including in a 2020 study published in eClinicalMedicine. The researchers found the surrogate endpoints in the FDA table either were not tested or were tested but proven to be weak surrogates.

“And yet the FDA considered these as good enough not only for accelerated approval but also for regular approval,” said Bishal Gyawali, MD, PhD, associate professor in the department of oncology at Queen’s University, Kingston, Ontario, Canada, who led the group.

The use of surrogate endpoints is also increasing in Europe, said Huseyin Naci, MHS, PhD, associate professor of health policy at the London School of Economics and Political Science in England. He cited a cohort study of 298 randomized clinical trials (RCTs) in JAMA Oncology suggesting “contemporary oncology RCTs now largely measure putative surrogate endpoints.” Dr. Wallach called the FDA’s surrogate table “a great first step toward transparency. But a key column is missing from that table, telling us what is the basis for which the FDA allows drug companies to use the recognized surrogate markers. What is the evidence they are considering?”

If the agency allows companies the flexibility to validate surrogate endpoints, postmarketing studies designed to confirm the clinical utility of those endpoints should follow.

“We obviously want physicians to be guided by evidence when they’re selecting treatments, and they need to be able to interpret the clinical benefits of the drug that they’re prescribing,” he said. “This is really about having the research consumer, patients, and physicians, as well as industry, understand why certain markers are considered and not considered.”

Dr. Wallach reported receiving grants from the FDA (through the Yale University — Mayo Clinic Center of Excellence in Regulatory Science and Innovation), National Institute on Alcohol Abuse and Alcoholism (1K01AA028258), and Johnson & Johnson (through the Yale University Open Data Access Project); and consulting fees from Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC outside the submitted work. Dr. Ramachandran reported receiving grants from the Stavros Niarchos Foundation and FDA; receiving consulting fees from ReAct Action on Antibiotic Resistance strategy policy program outside the submitted work; and serving in an unpaid capacity as chair of the FDA task force for the nonprofit organization Doctors for America and in an unpaid capacity as board president for Universities Allied for Essential Medicines North America.
 

A version of this article appeared on Medscape.com.

Over the past few decades, the US Food and Drug Administration (FDA) has increasingly relied on surrogate measures such as blood tests instead of clinical outcomes for medication approvals. But critics say the agency lacks consistent standards to ensure the surrogate aligns with clinical outcomes that matter to patients — things like improvements in symptoms and gains in function.

Sometimes those decisions backfire. Consider: In July 2021, the FDA approved aducanumab for the treatment of Alzheimer’s disease, bucking the advice of an advisory panel for the agency that questioned the effectiveness of the medication. Regulators relied on data from the drugmaker, Biogen, showing the monoclonal antibody could reduce levels of amyloid beta plaques in blood — a surrogate marker officials hoped would translate to clinical benefit.

The FDA’s decision triggered significant controversy, and Biogen in January announced it is pulling it from the market this year, citing disappointing sales.

Although the case of aducanumab might seem extreme, given the stakes — Alzheimer’s remains a disease without an effective treatment — it’s far from unusual.

“When we prescribe a drug, there is an underlying assumption that the FDA has done its due diligence to confirm the drug is safe and of benefit,” said Reshma Ramachandran, MD, MPP, MHS, a researcher at Yale School of Medicine, New Haven, Connecticut, and a coauthor of a recent review of surrogate outcomes. “In fact, we found either no evidence or low-quality evidence.” Such markers are associated with clinical outcomes. “We just don’t know if they work meaningfully to treat the patient’s condition. The results were pretty shocking for us,” she said.

The FDA in 2018 released an Adult Surrogate Endpoint Table listing markers that can be used as substitutes for clinical outcomes to more quickly test, review, and approve new therapies. The analysis found the majority of these endpoints lacked subsequent confirmations, defined as published meta-analyses of clinical studies to validate the association between the marker and a clinical outcome important to patients.

In a paper published in JAMA, Dr. Ramachandran and her colleagues looked at 37 surrogate endpoints for nearly 3 dozen nononcologic diseases in the table.

Approval with surrogate markers implies responsibility for postapproval or validation studies — not just lab measures or imaging findings but mortality, morbidity, or improved quality of life, said Joshua D. Wallach, PhD, MS, assistant professor in the department of epidemiology at the Emory Rollins School of Public Health in Atlanta and lead author of the JAMA review.

Dr. Wallach said surrogate markers are easier to measure and do not require large and long trials. But the FDA has not provided clear rules for what makes a surrogate marker valid in clinical trials.

“They’ve said that at a minimum, it requires meta-analytical evidence from studies that have looked at the correlation or the association between the surrogate and the clinical outcome,” Dr. Wallach said. “Our understanding was that if that’s a minimum expectation, we should be able to find those studies in the literature. And the reality is that we were unable to find evidence from those types of studies supporting the association between the surrogate and the clinical outcome.”

Physicians generally do not receive training about the FDA approval process and the difference between biomarkers, surrogate markers, and clinical endpoints, Dr. Ramachandran said. “Our study shows that things are much more uncertain than we thought when it comes to the prescribing of new drugs,” she said.
 

Surrogate Markers on the Rise

Dr. Wallach’s group looked for published meta-analyses compiling randomized controlled trials reporting surrogate endpoints for more than 3 dozen chronic nononcologic conditions, including type 2 diabetes, Alzheimer’s, kidney disease, HIV, gout, and lupus. They found no meta-analyses at all for 59% of the surrogate markers, while for those that were studied, few reported high-strength evidence of an association with clinical outcomes.

The findings echo previous research. In a 2020 study in JAMA Network Open, researchers tallied primary endpoints for all FDA approvals of new drugs and therapies during three 3-year periods: 1995-1997, 2005-2007, and 2015-2017. The proportion of products whose approvals were based on the use of clinical endpoints decreased from 43.8% in 1995-1997 to 28.4% in 2005-2007 to 23.3% in 2015-2017. The share based on surrogate endpoints rose from 43.3% to roughly 60% over the same interval.

A 2017 study in the Journal of Health Economics found the use of “imperfect” surrogate endpoints helped support the approval of an average of 16 new drugs per year between 2010 and 2014 compared with six per year from 1998 to 2008.

Similar concerns about weak associations between surrogate markers and drugs used to treat cancer have been documented before, including in a 2020 study published in eClinicalMedicine. The researchers found the surrogate endpoints in the FDA table either were not tested or were tested but proven to be weak surrogates.

“And yet the FDA considered these as good enough not only for accelerated approval but also for regular approval,” said Bishal Gyawali, MD, PhD, associate professor in the department of oncology at Queen’s University, Kingston, Ontario, Canada, who led the group.

The use of surrogate endpoints is also increasing in Europe, said Huseyin Naci, MHS, PhD, associate professor of health policy at the London School of Economics and Political Science in England. He cited a cohort study of 298 randomized clinical trials (RCTs) in JAMA Oncology suggesting “contemporary oncology RCTs now largely measure putative surrogate endpoints.” Dr. Wallach called the FDA’s surrogate table “a great first step toward transparency. But a key column is missing from that table, telling us what is the basis for which the FDA allows drug companies to use the recognized surrogate markers. What is the evidence they are considering?”

If the agency allows companies the flexibility to validate surrogate endpoints, postmarketing studies designed to confirm the clinical utility of those endpoints should follow.

“We obviously want physicians to be guided by evidence when they’re selecting treatments, and they need to be able to interpret the clinical benefits of the drug that they’re prescribing,” he said. “This is really about having the research consumer, patients, and physicians, as well as industry, understand why certain markers are considered and not considered.”

Dr. Wallach reported receiving grants from the FDA (through the Yale University — Mayo Clinic Center of Excellence in Regulatory Science and Innovation), National Institute on Alcohol Abuse and Alcoholism (1K01AA028258), and Johnson & Johnson (through the Yale University Open Data Access Project); and consulting fees from Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC outside the submitted work. Dr. Ramachandran reported receiving grants from the Stavros Niarchos Foundation and FDA; receiving consulting fees from ReAct Action on Antibiotic Resistance strategy policy program outside the submitted work; and serving in an unpaid capacity as chair of the FDA task force for the nonprofit organization Doctors for America and in an unpaid capacity as board president for Universities Allied for Essential Medicines North America.
 

A version of this article appeared on Medscape.com.

Over the past few decades, the US Food and Drug Administration (FDA) has increasingly relied on surrogate measures such as blood tests instead of clinical outcomes for medication approvals. But critics say the agency lacks consistent standards to ensure the surrogate aligns with clinical outcomes that matter to patients — things like improvements in symptoms and gains in function.

Sometimes those decisions backfire. Consider: In July 2021, the FDA approved aducanumab for the treatment of Alzheimer’s disease, bucking the advice of an advisory panel for the agency that questioned the effectiveness of the medication. Regulators relied on data from the drugmaker, Biogen, showing the monoclonal antibody could reduce levels of amyloid beta plaques in blood — a surrogate marker officials hoped would translate to clinical benefit.

The FDA’s decision triggered significant controversy, and Biogen in January announced it is pulling it from the market this year, citing disappointing sales.

Although the case of aducanumab might seem extreme, given the stakes — Alzheimer’s remains a disease without an effective treatment — it’s far from unusual.

“When we prescribe a drug, there is an underlying assumption that the FDA has done its due diligence to confirm the drug is safe and of benefit,” said Reshma Ramachandran, MD, MPP, MHS, a researcher at Yale School of Medicine, New Haven, Connecticut, and a coauthor of a recent review of surrogate outcomes. “In fact, we found either no evidence or low-quality evidence.” Such markers are associated with clinical outcomes. “We just don’t know if they work meaningfully to treat the patient’s condition. The results were pretty shocking for us,” she said.

The FDA in 2018 released an Adult Surrogate Endpoint Table listing markers that can be used as substitutes for clinical outcomes to more quickly test, review, and approve new therapies. The analysis found the majority of these endpoints lacked subsequent confirmations, defined as published meta-analyses of clinical studies to validate the association between the marker and a clinical outcome important to patients.

In a paper published in JAMA, Dr. Ramachandran and her colleagues looked at 37 surrogate endpoints for nearly 3 dozen nononcologic diseases in the table.

Approval with surrogate markers implies responsibility for postapproval or validation studies — not just lab measures or imaging findings but mortality, morbidity, or improved quality of life, said Joshua D. Wallach, PhD, MS, assistant professor in the department of epidemiology at the Emory Rollins School of Public Health in Atlanta and lead author of the JAMA review.

Dr. Wallach said surrogate markers are easier to measure and do not require large and long trials. But the FDA has not provided clear rules for what makes a surrogate marker valid in clinical trials.

“They’ve said that at a minimum, it requires meta-analytical evidence from studies that have looked at the correlation or the association between the surrogate and the clinical outcome,” Dr. Wallach said. “Our understanding was that if that’s a minimum expectation, we should be able to find those studies in the literature. And the reality is that we were unable to find evidence from those types of studies supporting the association between the surrogate and the clinical outcome.”

Physicians generally do not receive training about the FDA approval process and the difference between biomarkers, surrogate markers, and clinical endpoints, Dr. Ramachandran said. “Our study shows that things are much more uncertain than we thought when it comes to the prescribing of new drugs,” she said.
 

Surrogate Markers on the Rise

Dr. Wallach’s group looked for published meta-analyses compiling randomized controlled trials reporting surrogate endpoints for more than 3 dozen chronic nononcologic conditions, including type 2 diabetes, Alzheimer’s, kidney disease, HIV, gout, and lupus. They found no meta-analyses at all for 59% of the surrogate markers, while for those that were studied, few reported high-strength evidence of an association with clinical outcomes.

The findings echo previous research. In a 2020 study in JAMA Network Open, researchers tallied primary endpoints for all FDA approvals of new drugs and therapies during three 3-year periods: 1995-1997, 2005-2007, and 2015-2017. The proportion of products whose approvals were based on the use of clinical endpoints decreased from 43.8% in 1995-1997 to 28.4% in 2005-2007 to 23.3% in 2015-2017. The share based on surrogate endpoints rose from 43.3% to roughly 60% over the same interval.

A 2017 study in the Journal of Health Economics found the use of “imperfect” surrogate endpoints helped support the approval of an average of 16 new drugs per year between 2010 and 2014 compared with six per year from 1998 to 2008.

Similar concerns about weak associations between surrogate markers and drugs used to treat cancer have been documented before, including in a 2020 study published in eClinicalMedicine. The researchers found the surrogate endpoints in the FDA table either were not tested or were tested but proven to be weak surrogates.

“And yet the FDA considered these as good enough not only for accelerated approval but also for regular approval,” said Bishal Gyawali, MD, PhD, associate professor in the department of oncology at Queen’s University, Kingston, Ontario, Canada, who led the group.

The use of surrogate endpoints is also increasing in Europe, said Huseyin Naci, MHS, PhD, associate professor of health policy at the London School of Economics and Political Science in England. He cited a cohort study of 298 randomized clinical trials (RCTs) in JAMA Oncology suggesting “contemporary oncology RCTs now largely measure putative surrogate endpoints.” Dr. Wallach called the FDA’s surrogate table “a great first step toward transparency. But a key column is missing from that table, telling us what is the basis for which the FDA allows drug companies to use the recognized surrogate markers. What is the evidence they are considering?”

If the agency allows companies the flexibility to validate surrogate endpoints, postmarketing studies designed to confirm the clinical utility of those endpoints should follow.

“We obviously want physicians to be guided by evidence when they’re selecting treatments, and they need to be able to interpret the clinical benefits of the drug that they’re prescribing,” he said. “This is really about having the research consumer, patients, and physicians, as well as industry, understand why certain markers are considered and not considered.”

Dr. Wallach reported receiving grants from the FDA (through the Yale University — Mayo Clinic Center of Excellence in Regulatory Science and Innovation), National Institute on Alcohol Abuse and Alcoholism (1K01AA028258), and Johnson & Johnson (through the Yale University Open Data Access Project); and consulting fees from Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC outside the submitted work. Dr. Ramachandran reported receiving grants from the Stavros Niarchos Foundation and FDA; receiving consulting fees from ReAct Action on Antibiotic Resistance strategy policy program outside the submitted work; and serving in an unpaid capacity as chair of the FDA task force for the nonprofit organization Doctors for America and in an unpaid capacity as board president for Universities Allied for Essential Medicines North America.
 

A version of this article appeared on Medscape.com.

Jason Black, MD, trained in family medicine, worked for Kaiser Permanente, and subsequently completed a fellowship in geriatrics. Today, he treats frail elderly patients, mostly residents of nursing homes and assisted living facilities or living in their own homes, for Gilchrist, a hospice and palliative care organization serving Baltimore and central Maryland.

“I’m practicing family medicine to the extent that I’m treating the family unit, including the anxieties of the adult children, and finding solutions for the parents,” said Dr. Black, one of Gilchrist’s 62 employed providers, one third of whom are physicians. One of his most important roles is medication reconciliation and deprescribing.

Palliative care, a medical specialty that focuses on clarifying the treatment goals of seriously ill patients, helping with end-of-life planning, and emphasizing pain and symptom management, has been growing in recent years. Already well-established in most US hospitals, it is expanding in community settings, often as an extension of hospice programs.

Now, by adding primary care physicians and practices to their service mix, palliative care groups are better meeting the needs of a neglected — and costly — population of frail elders. In doing so, they also are better able to find a niche in the rapidly evolving alphabet soup of value-based care and its varieties of shared savings for providers who post positive outcomes.

Most patients Dr. Black sees find it difficult to visit their doctors in a clinic setting, although they face a variety of medical needs and chronic conditions of aging. They may have a prognosis of several years to live and, thus, do not qualify for hospice care. To him, a palliative approach offers the satisfaction of focusing on what is most important to patients at this difficult time in their lives, rather than predetermined clinical metrics like blood pressure or blood glucose. “It takes a lot of work, but it feels important and rewarding,” he said.

A recent survey of community-dwelling older adults in Ontario, Canada, found most patients fail to receive this treatment homes in the final 3 months of life.
 

Continuums of Patients and Models

Gilchrist started as a nonprofit, hospital-affiliated hospice program in 1994 and in 2000 took on the management of a geriatric medicine practice for its parent, Greater Baltimore Medical Center. Today, its physicians and nurse practitioners see a range of patients in geriatric primary care, palliative medicine, and hospice, according to its chief medical officer, Mark J. Gloth, DO.

“As people progress in their disease, their location — where they call home — may change as well,” Dr. Gloth said. “We offer a continuum of care in order to not lose people through those transitions. That’s the core of our mission — making sure we are there to escort people through the difficult moments in their lives.”

Models for value-based care encompass accountable care organizations (ACOs), including the ACO REACH (Realizing Equity, Access, and Community Health) high-needs model for traditional Medicare patients, and Medicare Shared Savings Programs for fee-for-service beneficiaries. These value-based models offer a variety of opportunities for the palliative care organization to share in savings resulting from keeping the patient out of the hospital or emergency room and other quality and cost benchmarks.
 

Coming Together to Meet Needs

Gilchrist is one of nine hospice and palliative organizations that have joined to form their own multistate ACO, Responsive Care Solutions, focused on the clinical needs of frail elderly Medicare beneficiaries. Hospice of the Valley in Phoenix has Geriatric Solutions, a frail elder physician practice. And Capital Caring Health, a hospice and palliative care agency serving metro Washington, DC, has deployed several physicians and nurse practitioners on the road doing primary care at home, said Heidi Young, MD, its Primary Care at Home Lead Physician.

“Five years ago, we started our primary care practice under the umbrella of a 40-year-old hospice organization because we thought we needed to prepare for the changes that are coming to the hospice model,” Dr. Young said. “The thought was that we’re not just a hospice organization; we’re an advanced illness organization. We will come to your home, whatever that is, and provide your primary care.”

The greatest potential gains for a hospice organization are from assuming 100% risk for a large population of patients, keeping them out of the hospital to lower the costs of their care, then reaping those gains under a value-based profit-sharing model, Dr. Young said.

“Our program is still new and working toward getting more patients aligned into value-based models,” she said. “It’s a work in progress.”
 

A Foot in Each World

Agencies like Capital Caring and Gilchrist derive the largest share of their physician income from billing Medicare Part B and other insurers per visit. But that billing is not enough to break even on physician services.

With hopes for a value-based future, Gilchrist also gets grants from elder-facing charitable foundations to cover up to 40% of the costs of its home-based primary care, according to its president, Catherine Hamel. Hospice care continues to be paid on a per-diem basis by Medicare for eligible terminally ill patients, including Medicare Advantage patients, although the Centers for Medicare & Medicaid Services is reportedly considering new models for the hospice benefit.

The National Partnership for Healthcare and Hospice Innovation (NPHI) is a trade group representing more than 100 nonprofit, hospice-based organizations participating in palliative care and value-based care.

For a hospice to be successful in the evolving post–acute care/end-of-life care landscape, it can no longer rely solely on its hospice line of business, no matter how high-quality, said Ethan McChesney, policy director for the Washington, DC-based nonprofit.

NPHI members have developed their own palliative care programs, and perhaps, a quarter have primary care at home practices, Mr. McChesney said. Some of them acquired existing primary care practices in their service area with which they already had relationships; others created their own.

For hospice organizations building a continuum of services for the seriously ill, adding a primary care at home practice is a natural fit, he said. “You can provide all the services you would as a traditional primary care practice while you have the opportunity to establish long-term relationships with patients and their caregivers that lend themselves to palliative care referrals and then hospice referrals downstream [when the patient becomes eligible for hospice care].” Often, this primary medical care is a mix of in-person and telehealth.

Cameron Muir, MD, NPHI’s chief innovation officer, noted that the hamster wheel for primary care doctors has been spinning faster and faster, with reimbursement going down and costs going up.

But with home-based primary care for frail elders under value-based models, Dr. Muir said, the clinician is paid not for making more visits but for taking great care of the patient: “And I’m actually saving Medicare money and getting credit for the hospitalizations that were avoided.”
 

A version of this article appeared on Medscape.com.

Jason Black, MD, trained in family medicine, worked for Kaiser Permanente, and subsequently completed a fellowship in geriatrics. Today, he treats frail elderly patients, mostly residents of nursing homes and assisted living facilities or living in their own homes, for Gilchrist, a hospice and palliative care organization serving Baltimore and central Maryland.

“I’m practicing family medicine to the extent that I’m treating the family unit, including the anxieties of the adult children, and finding solutions for the parents,” said Dr. Black, one of Gilchrist’s 62 employed providers, one third of whom are physicians. One of his most important roles is medication reconciliation and deprescribing.

Palliative care, a medical specialty that focuses on clarifying the treatment goals of seriously ill patients, helping with end-of-life planning, and emphasizing pain and symptom management, has been growing in recent years. Already well-established in most US hospitals, it is expanding in community settings, often as an extension of hospice programs.

Now, by adding primary care physicians and practices to their service mix, palliative care groups are better meeting the needs of a neglected — and costly — population of frail elders. In doing so, they also are better able to find a niche in the rapidly evolving alphabet soup of value-based care and its varieties of shared savings for providers who post positive outcomes.

Most patients Dr. Black sees find it difficult to visit their doctors in a clinic setting, although they face a variety of medical needs and chronic conditions of aging. They may have a prognosis of several years to live and, thus, do not qualify for hospice care. To him, a palliative approach offers the satisfaction of focusing on what is most important to patients at this difficult time in their lives, rather than predetermined clinical metrics like blood pressure or blood glucose. “It takes a lot of work, but it feels important and rewarding,” he said.

A recent survey of community-dwelling older adults in Ontario, Canada, found most patients fail to receive this treatment homes in the final 3 months of life.
 

Continuums of Patients and Models

Gilchrist started as a nonprofit, hospital-affiliated hospice program in 1994 and in 2000 took on the management of a geriatric medicine practice for its parent, Greater Baltimore Medical Center. Today, its physicians and nurse practitioners see a range of patients in geriatric primary care, palliative medicine, and hospice, according to its chief medical officer, Mark J. Gloth, DO.

“As people progress in their disease, their location — where they call home — may change as well,” Dr. Gloth said. “We offer a continuum of care in order to not lose people through those transitions. That’s the core of our mission — making sure we are there to escort people through the difficult moments in their lives.”

Models for value-based care encompass accountable care organizations (ACOs), including the ACO REACH (Realizing Equity, Access, and Community Health) high-needs model for traditional Medicare patients, and Medicare Shared Savings Programs for fee-for-service beneficiaries. These value-based models offer a variety of opportunities for the palliative care organization to share in savings resulting from keeping the patient out of the hospital or emergency room and other quality and cost benchmarks.
 

Coming Together to Meet Needs

Gilchrist is one of nine hospice and palliative organizations that have joined to form their own multistate ACO, Responsive Care Solutions, focused on the clinical needs of frail elderly Medicare beneficiaries. Hospice of the Valley in Phoenix has Geriatric Solutions, a frail elder physician practice. And Capital Caring Health, a hospice and palliative care agency serving metro Washington, DC, has deployed several physicians and nurse practitioners on the road doing primary care at home, said Heidi Young, MD, its Primary Care at Home Lead Physician.

“Five years ago, we started our primary care practice under the umbrella of a 40-year-old hospice organization because we thought we needed to prepare for the changes that are coming to the hospice model,” Dr. Young said. “The thought was that we’re not just a hospice organization; we’re an advanced illness organization. We will come to your home, whatever that is, and provide your primary care.”

The greatest potential gains for a hospice organization are from assuming 100% risk for a large population of patients, keeping them out of the hospital to lower the costs of their care, then reaping those gains under a value-based profit-sharing model, Dr. Young said.

“Our program is still new and working toward getting more patients aligned into value-based models,” she said. “It’s a work in progress.”
 

A Foot in Each World

Agencies like Capital Caring and Gilchrist derive the largest share of their physician income from billing Medicare Part B and other insurers per visit. But that billing is not enough to break even on physician services.

With hopes for a value-based future, Gilchrist also gets grants from elder-facing charitable foundations to cover up to 40% of the costs of its home-based primary care, according to its president, Catherine Hamel. Hospice care continues to be paid on a per-diem basis by Medicare for eligible terminally ill patients, including Medicare Advantage patients, although the Centers for Medicare & Medicaid Services is reportedly considering new models for the hospice benefit.

The National Partnership for Healthcare and Hospice Innovation (NPHI) is a trade group representing more than 100 nonprofit, hospice-based organizations participating in palliative care and value-based care.

For a hospice to be successful in the evolving post–acute care/end-of-life care landscape, it can no longer rely solely on its hospice line of business, no matter how high-quality, said Ethan McChesney, policy director for the Washington, DC-based nonprofit.

NPHI members have developed their own palliative care programs, and perhaps, a quarter have primary care at home practices, Mr. McChesney said. Some of them acquired existing primary care practices in their service area with which they already had relationships; others created their own.

For hospice organizations building a continuum of services for the seriously ill, adding a primary care at home practice is a natural fit, he said. “You can provide all the services you would as a traditional primary care practice while you have the opportunity to establish long-term relationships with patients and their caregivers that lend themselves to palliative care referrals and then hospice referrals downstream [when the patient becomes eligible for hospice care].” Often, this primary medical care is a mix of in-person and telehealth.

Cameron Muir, MD, NPHI’s chief innovation officer, noted that the hamster wheel for primary care doctors has been spinning faster and faster, with reimbursement going down and costs going up.

But with home-based primary care for frail elders under value-based models, Dr. Muir said, the clinician is paid not for making more visits but for taking great care of the patient: “And I’m actually saving Medicare money and getting credit for the hospitalizations that were avoided.”
 

A version of this article appeared on Medscape.com.

Jason Black, MD, trained in family medicine, worked for Kaiser Permanente, and subsequently completed a fellowship in geriatrics. Today, he treats frail elderly patients, mostly residents of nursing homes and assisted living facilities or living in their own homes, for Gilchrist, a hospice and palliative care organization serving Baltimore and central Maryland.

“I’m practicing family medicine to the extent that I’m treating the family unit, including the anxieties of the adult children, and finding solutions for the parents,” said Dr. Black, one of Gilchrist’s 62 employed providers, one third of whom are physicians. One of his most important roles is medication reconciliation and deprescribing.

Palliative care, a medical specialty that focuses on clarifying the treatment goals of seriously ill patients, helping with end-of-life planning, and emphasizing pain and symptom management, has been growing in recent years. Already well-established in most US hospitals, it is expanding in community settings, often as an extension of hospice programs.

Now, by adding primary care physicians and practices to their service mix, palliative care groups are better meeting the needs of a neglected — and costly — population of frail elders. In doing so, they also are better able to find a niche in the rapidly evolving alphabet soup of value-based care and its varieties of shared savings for providers who post positive outcomes.

Most patients Dr. Black sees find it difficult to visit their doctors in a clinic setting, although they face a variety of medical needs and chronic conditions of aging. They may have a prognosis of several years to live and, thus, do not qualify for hospice care. To him, a palliative approach offers the satisfaction of focusing on what is most important to patients at this difficult time in their lives, rather than predetermined clinical metrics like blood pressure or blood glucose. “It takes a lot of work, but it feels important and rewarding,” he said.

A recent survey of community-dwelling older adults in Ontario, Canada, found most patients fail to receive this treatment homes in the final 3 months of life.
 

Continuums of Patients and Models

Gilchrist started as a nonprofit, hospital-affiliated hospice program in 1994 and in 2000 took on the management of a geriatric medicine practice for its parent, Greater Baltimore Medical Center. Today, its physicians and nurse practitioners see a range of patients in geriatric primary care, palliative medicine, and hospice, according to its chief medical officer, Mark J. Gloth, DO.

“As people progress in their disease, their location — where they call home — may change as well,” Dr. Gloth said. “We offer a continuum of care in order to not lose people through those transitions. That’s the core of our mission — making sure we are there to escort people through the difficult moments in their lives.”

Models for value-based care encompass accountable care organizations (ACOs), including the ACO REACH (Realizing Equity, Access, and Community Health) high-needs model for traditional Medicare patients, and Medicare Shared Savings Programs for fee-for-service beneficiaries. These value-based models offer a variety of opportunities for the palliative care organization to share in savings resulting from keeping the patient out of the hospital or emergency room and other quality and cost benchmarks.
 

Coming Together to Meet Needs

Gilchrist is one of nine hospice and palliative organizations that have joined to form their own multistate ACO, Responsive Care Solutions, focused on the clinical needs of frail elderly Medicare beneficiaries. Hospice of the Valley in Phoenix has Geriatric Solutions, a frail elder physician practice. And Capital Caring Health, a hospice and palliative care agency serving metro Washington, DC, has deployed several physicians and nurse practitioners on the road doing primary care at home, said Heidi Young, MD, its Primary Care at Home Lead Physician.

“Five years ago, we started our primary care practice under the umbrella of a 40-year-old hospice organization because we thought we needed to prepare for the changes that are coming to the hospice model,” Dr. Young said. “The thought was that we’re not just a hospice organization; we’re an advanced illness organization. We will come to your home, whatever that is, and provide your primary care.”

The greatest potential gains for a hospice organization are from assuming 100% risk for a large population of patients, keeping them out of the hospital to lower the costs of their care, then reaping those gains under a value-based profit-sharing model, Dr. Young said.

“Our program is still new and working toward getting more patients aligned into value-based models,” she said. “It’s a work in progress.”
 

A Foot in Each World

Agencies like Capital Caring and Gilchrist derive the largest share of their physician income from billing Medicare Part B and other insurers per visit. But that billing is not enough to break even on physician services.

With hopes for a value-based future, Gilchrist also gets grants from elder-facing charitable foundations to cover up to 40% of the costs of its home-based primary care, according to its president, Catherine Hamel. Hospice care continues to be paid on a per-diem basis by Medicare for eligible terminally ill patients, including Medicare Advantage patients, although the Centers for Medicare & Medicaid Services is reportedly considering new models for the hospice benefit.

The National Partnership for Healthcare and Hospice Innovation (NPHI) is a trade group representing more than 100 nonprofit, hospice-based organizations participating in palliative care and value-based care.

For a hospice to be successful in the evolving post–acute care/end-of-life care landscape, it can no longer rely solely on its hospice line of business, no matter how high-quality, said Ethan McChesney, policy director for the Washington, DC-based nonprofit.

NPHI members have developed their own palliative care programs, and perhaps, a quarter have primary care at home practices, Mr. McChesney said. Some of them acquired existing primary care practices in their service area with which they already had relationships; others created their own.

For hospice organizations building a continuum of services for the seriously ill, adding a primary care at home practice is a natural fit, he said. “You can provide all the services you would as a traditional primary care practice while you have the opportunity to establish long-term relationships with patients and their caregivers that lend themselves to palliative care referrals and then hospice referrals downstream [when the patient becomes eligible for hospice care].” Often, this primary medical care is a mix of in-person and telehealth.

Cameron Muir, MD, NPHI’s chief innovation officer, noted that the hamster wheel for primary care doctors has been spinning faster and faster, with reimbursement going down and costs going up.

But with home-based primary care for frail elders under value-based models, Dr. Muir said, the clinician is paid not for making more visits but for taking great care of the patient: “And I’m actually saving Medicare money and getting credit for the hospitalizations that were avoided.”
 

A version of this article appeared on Medscape.com.

SAN FRANCISCO – Various career paths open to newly board-certified rheumatologists – and some of the pros and cons for each – were explored at the 2023 Fellows Conference of the Coalition for State Rheumatology Organizations.

CSRO’s annual Fellows Conference aims to helps rheumatology fellows-in-training transition into future roles as practicing physicians, said Christopher Sonntag, MD, a 2nd-year rheumatology fellow at Roger Williams Medical Center, Providence, R.I., and the Fellow-At-Large representative on CSRO’s Board of Directors. He will launch his own career at Washington Regional Medical Center in Fayetteville, Ark., close to where he grew up, when his fellowship winds up in June.

“I started going to CSRO meetings in 2019, when I was still a resident,” said Dr. Sonntag, who fell in love with rheumatology in medical school. “This conference is a great opportunity for fellows. They can learn a lot of critical issues and skills that we just don’t get enough information about in our training, basic things we ought to know about: how insurance works, medical benefits, and the like.”

Job seekers in a specialty in short supply like rheumatology have some competitive advantages, but that varies by locality in a volatile health care market. “The job I ended up taking was not one where they were initially looking to hire another rheumatologist,” Dr. Sonntag told this news organization. The Fayetteville hospital already had two busy rheumatologists, but after Dr. Sonntag had unsatisfying interviews at six other groups, he called them back and they decided to go ahead and hire him. He said the position provides an acceptable work-life balance, as well as opportunities to teach. He hopes eventually to create a rheumatology fellowship program.

Models and Career Paths

Decisions about one’s career path are very important, said CSRO’s president, Gary Feldman, MD, a rheumatologist at Pacific Arthritis in Los Angeles. “We want your choice to work for you,” he told attendees. “We need you to be happy [in your jobs] for the next 30 years. You are the future.”

Dr. Feldman cited a recent Medscape salary survey of 13,000 full-time physicians from 29 specialties, which ranked rheumatologists 22nd in average annual income at $289,000. Total income may not be the first consideration in pursuing rheumatology as a career, Dr. Feldman noted. The same Medscape survey revealed that 60% of rheumatologists believe they are fairly compensated. “Something else is going on, something to do with work/life balance, which is complicated,” he said.

Other contributors to their career fulfillment may include the in-depth, long-term therapeutic relationships rheumatologists develop with their patients who have chronic, incurable illnesses; the ability with new treatments to make such a difference in managing their pain and discomfort; and engagement with giving good medical care that is centered on the patient’s experience.

“We have drugs that work to make our patients feel better. Patients come to us with no idea what’s going on, and we can turn their lives around,” Dr. Sonntag noted.

Other important career-oriented questions to ask, Dr. Feldman said, include:

What is important to you?

Who are you going to be working alongside?

How much autonomy, agency, security, or risk are you comfortable with?

What is your best balance between being a physician and an entrepreneur?
 

Finding your niche

Presenter Aaron Broadwell, MD, a rheumatologist in a private specialty practice of five physicians and five advanced practice providers in Shreveport, La., discussed the prospects for a career in private practice at the Fellows Conference. Private practice is not dead as a career choice, he observed, “despite what I continue to hear.” Data show that 70% of rheumatologists currently are in employed positions, but he sees signs of a movement back toward private practice.

Other basic career paths outlined by Dr. Broadwell include:

• Academic medicine, which offers opportunities to teach future physicians (although it’s also possible for rheumatologists practicing outside of academia to teach as well).
• Hospital employment, which has a higher starting salary but also a greater emphasis on RVUs (relative value units) and productivity, with less job security than it used to enjoy.
• Military/Veterans Administration positions, which may have antiquated office systems and salary caps.
• Other paths, including corporate medical director positions with pharmaceutical companies and insurance companies.

Newer options include concierge and direct specialty care models where physician-operated practices partner with their patients to provide specialty care services under a flat or periodic membership fee, and joining one of the large, multistate, rheumatology care management groups like United Rheumatology, LLC, and American Arthritis and Rheumatology Associates.

Private practice medical groups are both single specialty and multispecialty, both large and small – as well as solo rheumatology practices, Dr. Broadwell said. “People launch solo private practices all the time. It is good for some doctors. It has the highest risk and the highest potential reward.”

Becoming profitable in solo practice may take a year or two, while the doctor remains responsible 24/7, including the need to arrange for vacation and sick leave coverage. Solo practitioners need to be up to date on billing, coding, revenue cycles, bundled payments and the like, and eventually need to hire and supervise a team the doctor can trust.

What can young rheumatologists do to learn more of the nuances of these approaches? Dr. Broadwell recommended joining their state rheumatology society as well as the American College of Rheumatology. “The National Organization of Rheumatology Management is a phenomenal source of information, not just for your office manager but also for you,” he said. He also recommended linking up with colleagues through social media outlets such as the Rheumatology Private Practice Group on Facebook.

No relevant financial relationships were reported by the conference speakers.

A version of this article originally appeared on Medscape.com.

SAN FRANCISCO – Various career paths open to newly board-certified rheumatologists – and some of the pros and cons for each – were explored at the 2023 Fellows Conference of the Coalition for State Rheumatology Organizations.

CSRO’s annual Fellows Conference aims to helps rheumatology fellows-in-training transition into future roles as practicing physicians, said Christopher Sonntag, MD, a 2nd-year rheumatology fellow at Roger Williams Medical Center, Providence, R.I., and the Fellow-At-Large representative on CSRO’s Board of Directors. He will launch his own career at Washington Regional Medical Center in Fayetteville, Ark., close to where he grew up, when his fellowship winds up in June.

“I started going to CSRO meetings in 2019, when I was still a resident,” said Dr. Sonntag, who fell in love with rheumatology in medical school. “This conference is a great opportunity for fellows. They can learn a lot of critical issues and skills that we just don’t get enough information about in our training, basic things we ought to know about: how insurance works, medical benefits, and the like.”

Job seekers in a specialty in short supply like rheumatology have some competitive advantages, but that varies by locality in a volatile health care market. “The job I ended up taking was not one where they were initially looking to hire another rheumatologist,” Dr. Sonntag told this news organization. The Fayetteville hospital already had two busy rheumatologists, but after Dr. Sonntag had unsatisfying interviews at six other groups, he called them back and they decided to go ahead and hire him. He said the position provides an acceptable work-life balance, as well as opportunities to teach. He hopes eventually to create a rheumatology fellowship program.

Models and Career Paths

Decisions about one’s career path are very important, said CSRO’s president, Gary Feldman, MD, a rheumatologist at Pacific Arthritis in Los Angeles. “We want your choice to work for you,” he told attendees. “We need you to be happy [in your jobs] for the next 30 years. You are the future.”

Dr. Feldman cited a recent Medscape salary survey of 13,000 full-time physicians from 29 specialties, which ranked rheumatologists 22nd in average annual income at $289,000. Total income may not be the first consideration in pursuing rheumatology as a career, Dr. Feldman noted. The same Medscape survey revealed that 60% of rheumatologists believe they are fairly compensated. “Something else is going on, something to do with work/life balance, which is complicated,” he said.

Other contributors to their career fulfillment may include the in-depth, long-term therapeutic relationships rheumatologists develop with their patients who have chronic, incurable illnesses; the ability with new treatments to make such a difference in managing their pain and discomfort; and engagement with giving good medical care that is centered on the patient’s experience.

“We have drugs that work to make our patients feel better. Patients come to us with no idea what’s going on, and we can turn their lives around,” Dr. Sonntag noted.

Other important career-oriented questions to ask, Dr. Feldman said, include:

What is important to you?

Who are you going to be working alongside?

How much autonomy, agency, security, or risk are you comfortable with?

What is your best balance between being a physician and an entrepreneur?
 

Finding your niche

Presenter Aaron Broadwell, MD, a rheumatologist in a private specialty practice of five physicians and five advanced practice providers in Shreveport, La., discussed the prospects for a career in private practice at the Fellows Conference. Private practice is not dead as a career choice, he observed, “despite what I continue to hear.” Data show that 70% of rheumatologists currently are in employed positions, but he sees signs of a movement back toward private practice.

Other basic career paths outlined by Dr. Broadwell include:

• Academic medicine, which offers opportunities to teach future physicians (although it’s also possible for rheumatologists practicing outside of academia to teach as well).
• Hospital employment, which has a higher starting salary but also a greater emphasis on RVUs (relative value units) and productivity, with less job security than it used to enjoy.
• Military/Veterans Administration positions, which may have antiquated office systems and salary caps.
• Other paths, including corporate medical director positions with pharmaceutical companies and insurance companies.

Newer options include concierge and direct specialty care models where physician-operated practices partner with their patients to provide specialty care services under a flat or periodic membership fee, and joining one of the large, multistate, rheumatology care management groups like United Rheumatology, LLC, and American Arthritis and Rheumatology Associates.

Private practice medical groups are both single specialty and multispecialty, both large and small – as well as solo rheumatology practices, Dr. Broadwell said. “People launch solo private practices all the time. It is good for some doctors. It has the highest risk and the highest potential reward.”

Becoming profitable in solo practice may take a year or two, while the doctor remains responsible 24/7, including the need to arrange for vacation and sick leave coverage. Solo practitioners need to be up to date on billing, coding, revenue cycles, bundled payments and the like, and eventually need to hire and supervise a team the doctor can trust.

What can young rheumatologists do to learn more of the nuances of these approaches? Dr. Broadwell recommended joining their state rheumatology society as well as the American College of Rheumatology. “The National Organization of Rheumatology Management is a phenomenal source of information, not just for your office manager but also for you,” he said. He also recommended linking up with colleagues through social media outlets such as the Rheumatology Private Practice Group on Facebook.

No relevant financial relationships were reported by the conference speakers.

A version of this article originally appeared on Medscape.com.

SAN FRANCISCO – Various career paths open to newly board-certified rheumatologists – and some of the pros and cons for each – were explored at the 2023 Fellows Conference of the Coalition for State Rheumatology Organizations.

CSRO’s annual Fellows Conference aims to helps rheumatology fellows-in-training transition into future roles as practicing physicians, said Christopher Sonntag, MD, a 2nd-year rheumatology fellow at Roger Williams Medical Center, Providence, R.I., and the Fellow-At-Large representative on CSRO’s Board of Directors. He will launch his own career at Washington Regional Medical Center in Fayetteville, Ark., close to where he grew up, when his fellowship winds up in June.

“I started going to CSRO meetings in 2019, when I was still a resident,” said Dr. Sonntag, who fell in love with rheumatology in medical school. “This conference is a great opportunity for fellows. They can learn a lot of critical issues and skills that we just don’t get enough information about in our training, basic things we ought to know about: how insurance works, medical benefits, and the like.”

Job seekers in a specialty in short supply like rheumatology have some competitive advantages, but that varies by locality in a volatile health care market. “The job I ended up taking was not one where they were initially looking to hire another rheumatologist,” Dr. Sonntag told this news organization. The Fayetteville hospital already had two busy rheumatologists, but after Dr. Sonntag had unsatisfying interviews at six other groups, he called them back and they decided to go ahead and hire him. He said the position provides an acceptable work-life balance, as well as opportunities to teach. He hopes eventually to create a rheumatology fellowship program.

Models and Career Paths

Decisions about one’s career path are very important, said CSRO’s president, Gary Feldman, MD, a rheumatologist at Pacific Arthritis in Los Angeles. “We want your choice to work for you,” he told attendees. “We need you to be happy [in your jobs] for the next 30 years. You are the future.”

Dr. Feldman cited a recent Medscape salary survey of 13,000 full-time physicians from 29 specialties, which ranked rheumatologists 22nd in average annual income at $289,000. Total income may not be the first consideration in pursuing rheumatology as a career, Dr. Feldman noted. The same Medscape survey revealed that 60% of rheumatologists believe they are fairly compensated. “Something else is going on, something to do with work/life balance, which is complicated,” he said.

Other contributors to their career fulfillment may include the in-depth, long-term therapeutic relationships rheumatologists develop with their patients who have chronic, incurable illnesses; the ability with new treatments to make such a difference in managing their pain and discomfort; and engagement with giving good medical care that is centered on the patient’s experience.

“We have drugs that work to make our patients feel better. Patients come to us with no idea what’s going on, and we can turn their lives around,” Dr. Sonntag noted.

Other important career-oriented questions to ask, Dr. Feldman said, include:

What is important to you?

Who are you going to be working alongside?

How much autonomy, agency, security, or risk are you comfortable with?

What is your best balance between being a physician and an entrepreneur?
 

Finding your niche

Presenter Aaron Broadwell, MD, a rheumatologist in a private specialty practice of five physicians and five advanced practice providers in Shreveport, La., discussed the prospects for a career in private practice at the Fellows Conference. Private practice is not dead as a career choice, he observed, “despite what I continue to hear.” Data show that 70% of rheumatologists currently are in employed positions, but he sees signs of a movement back toward private practice.

Other basic career paths outlined by Dr. Broadwell include:

• Academic medicine, which offers opportunities to teach future physicians (although it’s also possible for rheumatologists practicing outside of academia to teach as well).
• Hospital employment, which has a higher starting salary but also a greater emphasis on RVUs (relative value units) and productivity, with less job security than it used to enjoy.
• Military/Veterans Administration positions, which may have antiquated office systems and salary caps.
• Other paths, including corporate medical director positions with pharmaceutical companies and insurance companies.

Newer options include concierge and direct specialty care models where physician-operated practices partner with their patients to provide specialty care services under a flat or periodic membership fee, and joining one of the large, multistate, rheumatology care management groups like United Rheumatology, LLC, and American Arthritis and Rheumatology Associates.

Private practice medical groups are both single specialty and multispecialty, both large and small – as well as solo rheumatology practices, Dr. Broadwell said. “People launch solo private practices all the time. It is good for some doctors. It has the highest risk and the highest potential reward.”

Becoming profitable in solo practice may take a year or two, while the doctor remains responsible 24/7, including the need to arrange for vacation and sick leave coverage. Solo practitioners need to be up to date on billing, coding, revenue cycles, bundled payments and the like, and eventually need to hire and supervise a team the doctor can trust.

What can young rheumatologists do to learn more of the nuances of these approaches? Dr. Broadwell recommended joining their state rheumatology society as well as the American College of Rheumatology. “The National Organization of Rheumatology Management is a phenomenal source of information, not just for your office manager but also for you,” he said. He also recommended linking up with colleagues through social media outlets such as the Rheumatology Private Practice Group on Facebook.

No relevant financial relationships were reported by the conference speakers.

A version of this article originally appeared on Medscape.com.

SAN FRANCISCO – New rheumatologists face a wide range of significant challenges brought on by the increasing complexity of insurance billing and rapid changes to managed care practices, especially techniques of utilization management and pharmacy benefit managers (PBMs), speakers said at the 2023 Fellows Conference of the Coalition for State Rheumatology Organizations (CSRO).

“We are seeing the impact of the environment eroding the patient-doctor relationship,” CSRO President Gary Feldman, MD, told participants.

Michael Saitta, MD, MBA, a rheumatologist in Fayetteville, Ark., said fellows should learn more about health insurance to take better care of their patients and their practice. “Your training includes a variable level of discourse on the health insurance market,” he said. Health insurance today is a mess. Costs have exploded. “Is anybody really happy with the current system?”

Although the health care system is sometimes compared to a dumpster fire, he said, a plate of spaghetti, with its multiple interconnected pathways, might be a better metaphor for understanding all that’s happening in the health care system and, more importantly, how it might be fixed.

Madelaine Feldman, MD, a rheumatologist in private practice in New Orleans and CSRO’s vice president of advocacy and government affairs, is a frequent advocate in Congress, state legislatures, and elsewhere regarding the utilization management techniques used by managed care and PBMs and how these are negatively affecting the ability of rheumatology patients to get the treatments they need. Such techniques include the following:

• Prior authorizations imposed by the health plan before a medication can be dispensed.
• Step therapy, which requires the patient to fail as many as three or four payer-preferred drugs before trying the one recommended by the rheumatologist.
• Nonmedical switching, in which a patient is forced to change medications for a nonmedical reason related to the PBM’s formulary.
• Accumulator adjustment programs, which increase the patient’s out-of-pocket and deductible commitments.

“There is very little transparency in how the money flows with PBMs,” Dr. Madelaine Feldman said. “In reality, PBMs are able to make profits by the perverse incentive of putting higher-priced drugs on their formularies, thus increasing the amount of rebates paid to them, without sharing any of the benefit with patients.”

CSRO

A version of this article originally appeared on Medscape.com.

SAN FRANCISCO – New rheumatologists face a wide range of significant challenges brought on by the increasing complexity of insurance billing and rapid changes to managed care practices, especially techniques of utilization management and pharmacy benefit managers (PBMs), speakers said at the 2023 Fellows Conference of the Coalition for State Rheumatology Organizations (CSRO).

“We are seeing the impact of the environment eroding the patient-doctor relationship,” CSRO President Gary Feldman, MD, told participants.

Michael Saitta, MD, MBA, a rheumatologist in Fayetteville, Ark., said fellows should learn more about health insurance to take better care of their patients and their practice. “Your training includes a variable level of discourse on the health insurance market,” he said. Health insurance today is a mess. Costs have exploded. “Is anybody really happy with the current system?”

Although the health care system is sometimes compared to a dumpster fire, he said, a plate of spaghetti, with its multiple interconnected pathways, might be a better metaphor for understanding all that’s happening in the health care system and, more importantly, how it might be fixed.

Madelaine Feldman, MD, a rheumatologist in private practice in New Orleans and CSRO’s vice president of advocacy and government affairs, is a frequent advocate in Congress, state legislatures, and elsewhere regarding the utilization management techniques used by managed care and PBMs and how these are negatively affecting the ability of rheumatology patients to get the treatments they need. Such techniques include the following:

• Prior authorizations imposed by the health plan before a medication can be dispensed.
• Step therapy, which requires the patient to fail as many as three or four payer-preferred drugs before trying the one recommended by the rheumatologist.
• Nonmedical switching, in which a patient is forced to change medications for a nonmedical reason related to the PBM’s formulary.
• Accumulator adjustment programs, which increase the patient’s out-of-pocket and deductible commitments.

“There is very little transparency in how the money flows with PBMs,” Dr. Madelaine Feldman said. “In reality, PBMs are able to make profits by the perverse incentive of putting higher-priced drugs on their formularies, thus increasing the amount of rebates paid to them, without sharing any of the benefit with patients.”

CSRO

A version of this article originally appeared on Medscape.com.

SAN FRANCISCO – New rheumatologists face a wide range of significant challenges brought on by the increasing complexity of insurance billing and rapid changes to managed care practices, especially techniques of utilization management and pharmacy benefit managers (PBMs), speakers said at the 2023 Fellows Conference of the Coalition for State Rheumatology Organizations (CSRO).

“We are seeing the impact of the environment eroding the patient-doctor relationship,” CSRO President Gary Feldman, MD, told participants.

Michael Saitta, MD, MBA, a rheumatologist in Fayetteville, Ark., said fellows should learn more about health insurance to take better care of their patients and their practice. “Your training includes a variable level of discourse on the health insurance market,” he said. Health insurance today is a mess. Costs have exploded. “Is anybody really happy with the current system?”

Although the health care system is sometimes compared to a dumpster fire, he said, a plate of spaghetti, with its multiple interconnected pathways, might be a better metaphor for understanding all that’s happening in the health care system and, more importantly, how it might be fixed.

Madelaine Feldman, MD, a rheumatologist in private practice in New Orleans and CSRO’s vice president of advocacy and government affairs, is a frequent advocate in Congress, state legislatures, and elsewhere regarding the utilization management techniques used by managed care and PBMs and how these are negatively affecting the ability of rheumatology patients to get the treatments they need. Such techniques include the following:

• Prior authorizations imposed by the health plan before a medication can be dispensed.
• Step therapy, which requires the patient to fail as many as three or four payer-preferred drugs before trying the one recommended by the rheumatologist.
• Nonmedical switching, in which a patient is forced to change medications for a nonmedical reason related to the PBM’s formulary.
• Accumulator adjustment programs, which increase the patient’s out-of-pocket and deductible commitments.

“There is very little transparency in how the money flows with PBMs,” Dr. Madelaine Feldman said. “In reality, PBMs are able to make profits by the perverse incentive of putting higher-priced drugs on their formularies, thus increasing the amount of rebates paid to them, without sharing any of the benefit with patients.”

CSRO

A version of this article originally appeared on Medscape.com.

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study provides evidence that two conditions that fall under the umbrella of spondyloarthritis – isolated axial disease in patients with psoriatic arthritis (PsA) and isolated axial disease in patients with ankylosing spondylitis (AS) accompanied by psoriasis – are different clinical entities and may need different treatments. These relatively rare rheumatologic conditions, defined by their back involvement, have considerable clinical overlap and are often lumped together under the label axial spondyloarthritis.

This is a hot topic and current matter of debate within the scientific community: Are axial PsA and axial AS two separate diseases or just two phenotypes under the spondyloarthritis umbrella? said Fabian Proft, MD, a rheumatologist and researcher at Charité Universitätsmedizin Berlin, commenting on the new study, which was published online in Annals of the Rheumatic Diseases.

Both conditions belong to the spectrum of spondyloarthritis, but with varying viewpoints on nomenclature. They have intersections and overlaps, but not all treatments are equally effective for both. “We need to better understand their differences and similarities,” Dr. Proft said, adding that the new study is noteworthy for the size of the population included, its long-term follow-up data, and the researchers’ depth of experience treating these patients.

The researchers are based at the University of Toronto, which has separate clinics dedicated to PsA and to AS, said Dafna D. Gladman, MD, professor of medicine at the university, codirector of the PsA clinic, and corresponding author for the new study. The two clinics follow the same standardized protocols, including clinical, radiographic, genetic, and laboratory assessments. Even though the patients present quite similarly, she credits referring physicians for recognizing the distinctions by their referrals to the PsA or AS clinic.

According to previous research, pure axial PsA, without peripheral involvement, is rare, affecting about 2%-5% of patients with PsA. For this study, an observational cohort of 1,576 patients from the PsA clinic included 31% (n = 495) with axial disease, 2% (n = 32) with isolated axial PsA, and 29% (n = 463) with both axial and peripheral involvement. A total of 25 of the patients with isolated axial PsA ultimately developed peripheral disease by their most recent clinic follow-up visit. In a second cohort of 1,688 patients with AS, nearly 5% (n = 68) had isolated axial disease with psoriasis.

“In our logistic regression analysis, isolated axial PsA was found to be a different clinical entity than isolated AS with psoriasis. They are not the same patients,” Dr. Gladman said. The patients with isolated axial PsA were older at diagnosis, more likely to have psoriatic nail lesions, and less likely to have inflammatory back pain than were patients with isolated axial AS and accompanying psoriasis.

When interviewed in early September, Dr. Gladman was preparing to fly to Ghent, Belgium, to participate in a debate at the International Congress on Spondyloarthritides, taking the pro position on the thesis: Is axial inflammation in PsA distinct from axial spondyloarthritis? Taking the con position was to be Robert Landewé, MD, PhD, of Amsterdam University Medical Center in the Netherlands.

“This is an old debate, splitters versus lumpers,” Dr. Gladman told this news organization. “My message is that when you place patients in more homogeneous groups, you can learn more and perhaps find better opportunities for treating their disease.” For example, even with the similarities, do these patients need to be treated with different medications? Medications for psoriasis, including those targeting the interleukin-23 cytokine, may not be effective for AS, but patients with axial PsA may not get them because of the association with axial AS.

“Now is the opportunity to really understand what – if any – are the differences between various components of this disease group. If you lump people together, you may miss the forest for the trees,” Dr. Gladman said. “If, at the end of the day, we find out these patients essentially are the same, I will lump. But until we have proved that there are no important differences, I will split.” She added that it is important for practicing rheumatologists to make the correct diagnosis so that they know to access certain drugs.

Dr. Proft credited Dr. Gladman and colleagues’ study for adding another piece of the puzzle to better understand differences and similarities for these two axial diseases. He noted, however, that the study did not include MRI scans for every participating patient, which could have given a deeper picture.

“International efforts are being made to recruit patients for a multinational, multicenter study of axial involvement in PsA,” which will include MRI data, Dr. Gladman said. She and Dr. Proft are both part of AXIS, the Axial Involvement in Psoriatic Arthritis cohort, now recruiting patients for such a study. AXIS is a joint project of the Assessment of SpondyloArthritis international Society and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“We don’t have final answers yet, although we have given evidence to support the differences.” The proof is in the pudding, she said, and that pudding will be the clinical trials.

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. The study authors declared no competing interests. Dr. Proft reported receiving research support from Novartis, Eli Lilly, and UCB, and fees for consulting and serving on speakers bureaus from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Hexal, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB.

A new study provides evidence that two conditions that fall under the umbrella of spondyloarthritis – isolated axial disease in patients with psoriatic arthritis (PsA) and isolated axial disease in patients with ankylosing spondylitis (AS) accompanied by psoriasis – are different clinical entities and may need different treatments. These relatively rare rheumatologic conditions, defined by their back involvement, have considerable clinical overlap and are often lumped together under the label axial spondyloarthritis.

This is a hot topic and current matter of debate within the scientific community: Are axial PsA and axial AS two separate diseases or just two phenotypes under the spondyloarthritis umbrella? said Fabian Proft, MD, a rheumatologist and researcher at Charité Universitätsmedizin Berlin, commenting on the new study, which was published online in Annals of the Rheumatic Diseases.

Both conditions belong to the spectrum of spondyloarthritis, but with varying viewpoints on nomenclature. They have intersections and overlaps, but not all treatments are equally effective for both. “We need to better understand their differences and similarities,” Dr. Proft said, adding that the new study is noteworthy for the size of the population included, its long-term follow-up data, and the researchers’ depth of experience treating these patients.

The researchers are based at the University of Toronto, which has separate clinics dedicated to PsA and to AS, said Dafna D. Gladman, MD, professor of medicine at the university, codirector of the PsA clinic, and corresponding author for the new study. The two clinics follow the same standardized protocols, including clinical, radiographic, genetic, and laboratory assessments. Even though the patients present quite similarly, she credits referring physicians for recognizing the distinctions by their referrals to the PsA or AS clinic.

According to previous research, pure axial PsA, without peripheral involvement, is rare, affecting about 2%-5% of patients with PsA. For this study, an observational cohort of 1,576 patients from the PsA clinic included 31% (n = 495) with axial disease, 2% (n = 32) with isolated axial PsA, and 29% (n = 463) with both axial and peripheral involvement. A total of 25 of the patients with isolated axial PsA ultimately developed peripheral disease by their most recent clinic follow-up visit. In a second cohort of 1,688 patients with AS, nearly 5% (n = 68) had isolated axial disease with psoriasis.

“In our logistic regression analysis, isolated axial PsA was found to be a different clinical entity than isolated AS with psoriasis. They are not the same patients,” Dr. Gladman said. The patients with isolated axial PsA were older at diagnosis, more likely to have psoriatic nail lesions, and less likely to have inflammatory back pain than were patients with isolated axial AS and accompanying psoriasis.

When interviewed in early September, Dr. Gladman was preparing to fly to Ghent, Belgium, to participate in a debate at the International Congress on Spondyloarthritides, taking the pro position on the thesis: Is axial inflammation in PsA distinct from axial spondyloarthritis? Taking the con position was to be Robert Landewé, MD, PhD, of Amsterdam University Medical Center in the Netherlands.

“This is an old debate, splitters versus lumpers,” Dr. Gladman told this news organization. “My message is that when you place patients in more homogeneous groups, you can learn more and perhaps find better opportunities for treating their disease.” For example, even with the similarities, do these patients need to be treated with different medications? Medications for psoriasis, including those targeting the interleukin-23 cytokine, may not be effective for AS, but patients with axial PsA may not get them because of the association with axial AS.

“Now is the opportunity to really understand what – if any – are the differences between various components of this disease group. If you lump people together, you may miss the forest for the trees,” Dr. Gladman said. “If, at the end of the day, we find out these patients essentially are the same, I will lump. But until we have proved that there are no important differences, I will split.” She added that it is important for practicing rheumatologists to make the correct diagnosis so that they know to access certain drugs.

Dr. Proft credited Dr. Gladman and colleagues’ study for adding another piece of the puzzle to better understand differences and similarities for these two axial diseases. He noted, however, that the study did not include MRI scans for every participating patient, which could have given a deeper picture.

“International efforts are being made to recruit patients for a multinational, multicenter study of axial involvement in PsA,” which will include MRI data, Dr. Gladman said. She and Dr. Proft are both part of AXIS, the Axial Involvement in Psoriatic Arthritis cohort, now recruiting patients for such a study. AXIS is a joint project of the Assessment of SpondyloArthritis international Society and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“We don’t have final answers yet, although we have given evidence to support the differences.” The proof is in the pudding, she said, and that pudding will be the clinical trials.

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. The study authors declared no competing interests. Dr. Proft reported receiving research support from Novartis, Eli Lilly, and UCB, and fees for consulting and serving on speakers bureaus from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Hexal, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB.

A new study provides evidence that two conditions that fall under the umbrella of spondyloarthritis – isolated axial disease in patients with psoriatic arthritis (PsA) and isolated axial disease in patients with ankylosing spondylitis (AS) accompanied by psoriasis – are different clinical entities and may need different treatments. These relatively rare rheumatologic conditions, defined by their back involvement, have considerable clinical overlap and are often lumped together under the label axial spondyloarthritis.

This is a hot topic and current matter of debate within the scientific community: Are axial PsA and axial AS two separate diseases or just two phenotypes under the spondyloarthritis umbrella? said Fabian Proft, MD, a rheumatologist and researcher at Charité Universitätsmedizin Berlin, commenting on the new study, which was published online in Annals of the Rheumatic Diseases.

Both conditions belong to the spectrum of spondyloarthritis, but with varying viewpoints on nomenclature. They have intersections and overlaps, but not all treatments are equally effective for both. “We need to better understand their differences and similarities,” Dr. Proft said, adding that the new study is noteworthy for the size of the population included, its long-term follow-up data, and the researchers’ depth of experience treating these patients.

The researchers are based at the University of Toronto, which has separate clinics dedicated to PsA and to AS, said Dafna D. Gladman, MD, professor of medicine at the university, codirector of the PsA clinic, and corresponding author for the new study. The two clinics follow the same standardized protocols, including clinical, radiographic, genetic, and laboratory assessments. Even though the patients present quite similarly, she credits referring physicians for recognizing the distinctions by their referrals to the PsA or AS clinic.

According to previous research, pure axial PsA, without peripheral involvement, is rare, affecting about 2%-5% of patients with PsA. For this study, an observational cohort of 1,576 patients from the PsA clinic included 31% (n = 495) with axial disease, 2% (n = 32) with isolated axial PsA, and 29% (n = 463) with both axial and peripheral involvement. A total of 25 of the patients with isolated axial PsA ultimately developed peripheral disease by their most recent clinic follow-up visit. In a second cohort of 1,688 patients with AS, nearly 5% (n = 68) had isolated axial disease with psoriasis.

“In our logistic regression analysis, isolated axial PsA was found to be a different clinical entity than isolated AS with psoriasis. They are not the same patients,” Dr. Gladman said. The patients with isolated axial PsA were older at diagnosis, more likely to have psoriatic nail lesions, and less likely to have inflammatory back pain than were patients with isolated axial AS and accompanying psoriasis.

When interviewed in early September, Dr. Gladman was preparing to fly to Ghent, Belgium, to participate in a debate at the International Congress on Spondyloarthritides, taking the pro position on the thesis: Is axial inflammation in PsA distinct from axial spondyloarthritis? Taking the con position was to be Robert Landewé, MD, PhD, of Amsterdam University Medical Center in the Netherlands.

“This is an old debate, splitters versus lumpers,” Dr. Gladman told this news organization. “My message is that when you place patients in more homogeneous groups, you can learn more and perhaps find better opportunities for treating their disease.” For example, even with the similarities, do these patients need to be treated with different medications? Medications for psoriasis, including those targeting the interleukin-23 cytokine, may not be effective for AS, but patients with axial PsA may not get them because of the association with axial AS.

“Now is the opportunity to really understand what – if any – are the differences between various components of this disease group. If you lump people together, you may miss the forest for the trees,” Dr. Gladman said. “If, at the end of the day, we find out these patients essentially are the same, I will lump. But until we have proved that there are no important differences, I will split.” She added that it is important for practicing rheumatologists to make the correct diagnosis so that they know to access certain drugs.

Dr. Proft credited Dr. Gladman and colleagues’ study for adding another piece of the puzzle to better understand differences and similarities for these two axial diseases. He noted, however, that the study did not include MRI scans for every participating patient, which could have given a deeper picture.

“International efforts are being made to recruit patients for a multinational, multicenter study of axial involvement in PsA,” which will include MRI data, Dr. Gladman said. She and Dr. Proft are both part of AXIS, the Axial Involvement in Psoriatic Arthritis cohort, now recruiting patients for such a study. AXIS is a joint project of the Assessment of SpondyloArthritis international Society and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“We don’t have final answers yet, although we have given evidence to support the differences.” The proof is in the pudding, she said, and that pudding will be the clinical trials.

The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. The study authors declared no competing interests. Dr. Proft reported receiving research support from Novartis, Eli Lilly, and UCB, and fees for consulting and serving on speakers bureaus from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Hexal, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB.

A new study in The Lancet Rheumatology examines the strength and duration of SARS-CoV-2 vaccine–induced immunoglobulin-G antibody responses over time for patients with a variety of autoimmune diseases, compared with healthy controls.

The presence of humoral antibodies to SARS-CoV-2 has been shown to correlate with protection against COVID infection. But for patients with immune-mediated inflammatory diseases (IMIDs), host response to COVID infection or to vaccination is affected by the immune dysfunction imposed by the IMID and by the use of immune-modulating drugs to treat it.

This new study finds a weaker – as shown previously – and less sustained immune response to SARS-CoV-2 vaccines in patients with a variety of IMIDs, including rheumatoid arthritis, spondyloarthritis, psoriasis, inflammatory bowel diseases, and other systemic autoimmune diseases such as lupus. It also points toward the possibility of adjusting treatment and vaccination schedules and strategies for these patients based on their antibody levels, among other factors, to preserve best protection against severe COVID.

Kmatta/Moment/Getty Images

“It is important to assess immune response in these patients to see if they still have protection against severe COVID infection,” said lead author David Simon, MD, senior clinical scientist in clinical immunology and rheumatology at University Hospital Erlangen (Germany). “We know that antibody response is an immune correlate. Therefore, it is important to see how large and durable the immune response is to the coronavirus vaccine in these IMID patients, and whether specific drugs or therapies have negative effects on their immune response.”
 

What was studied?

For this large prospective cohort study, researchers registered 5076 coronavirus-vaccinated individuals. They analyzed serum samples obtained between December 15, 2020, and December 1, 2021, from 2,535 patients diagnosed with IMIDs and participating in a prospective coronavirus study program at the Deutsches Zentrum Immuntherapie in Erlangen. The IMID patients had a mean age of 55.0 years, and 58.9% were women.

A healthy control group of 1,198 individuals without IMID who had a mean age of 40.7 years, including 53.8% men, was also recruited for the analysis. All approved coronavirus vaccines were included, following standard vaccination schedules. Antibody response was measured over time by an enzyme-linked immunosorbent assay from 8 weeks after first vaccination to week 40.

Among the findings, the healthy controls had higher postvaccine antibody levels than did those with IMIDs. But the majority of vaccinated patients with IMID were able to build up a humoral immune response to SARS-CoV-2. Patients who were taking B-cell inhibitors like rituximab (Rituxan, Genentech; and biosimilars) and T-cell inhibitors like abatacept (Orencia, Bristol Myers Squibb) for IMIDs had significantly poorer antibody response.

Greater age and the use of combination therapies for IMIDs, compared with monotherapy, further reduced immune response to the vaccine. In terms of vaccination modality, messenger RNA–based vaccines induced higher antibody levels than did vector-based vaccines. The researchers noted that patients with IMID who were given a third vaccine dose could actually catch up well with the antibody responses observed in healthy controls.

“We looked at whether different IMIDs had a different humoral response, and we also assessed if there are effects from different therapeutic strategies,” Dr. Simon explained. “It doesn’t matter so much what kind of IMID patients have; much more important is the specific drug treatment and its impact on their antibody response.” Some participants were advised to briefly stop taking some immunosuppressive treatments before or after vaccination.

One of Dr. Simon’s coauthors, statistician and rheumatologist Koray Tascilar, MD, added, “This research is important because we looked not only at who responded less, which has been previously established, but who are at greater risk of losing their immune response, and how quickly.”
 

Need to take care

“Most treatments we as rheumatologists give to our patients don’t affect their SARS-CoV-2 humoral response,” Dr. Simon said. “However, there are specific drugs that are associated with lower antibody response. With respect to those drugs, we have to be more careful.”

It is important to be able to tell patients which drugs are safe and won’t have a negative impact on their immune response to vaccinations, Dr. Tascilar said. “But it would be too strong to say we’re ready to choose therapies based on their potential impact on protection against COVID. Yes, there is a risk from catching COVID, but we need to balance that risk with the risk of not giving patients the medications that are necessary to treat their rheumatologic condition.”

These diseases are serious, sometimes life-threatening. “We might think of strategies for how to mitigate the risk of underprotection from COVID that is brought about by these treatments,” he said. For example, offering boosters sooner or more frequently, or prophylactically treating with monoclonal antibodies.

“This study, along other recent studies, has found that antibody levels in patients with immune-mediated diseases wane more rapidly than in healthy controls, and this is especially true of those on medications that interfere with the B and T cells and anticytokine therapies,” Rebecca Haberman, MD, assistant professor, division of rheumatology, New York University Langone Health, noted in an email to this news organization.

“While there is no known antibody level that specifically correlates with clinical protection, and each patient needs to be thought of individually, these findings support the use of supplemental booster dosing in patients with immune-mediated inflammatory diseases,” Dr. Haberman said, adding that her own research in this area has shown similar results.

“As a rheumatologist, I would be more likely to encourage my patients – especially those on immunomodulatory medications – to get boosted.”

Dr. Tascilar said his study does not directly answer the question of whether an earlier booster shot would be an effective strategy for patients with IMID. “In our department, we have an early boosting strategy, based on level of immune response.” But the decision of revaccination or not, and when, is based on a number of factors, not only on the level of antibodies. “It’s just part of the instruments we are using.”

The study was supported by the Deutsche Forschungsgemeinschaft. Dr. Simon and Dr. Tascilar declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study in The Lancet Rheumatology examines the strength and duration of SARS-CoV-2 vaccine–induced immunoglobulin-G antibody responses over time for patients with a variety of autoimmune diseases, compared with healthy controls.

The presence of humoral antibodies to SARS-CoV-2 has been shown to correlate with protection against COVID infection. But for patients with immune-mediated inflammatory diseases (IMIDs), host response to COVID infection or to vaccination is affected by the immune dysfunction imposed by the IMID and by the use of immune-modulating drugs to treat it.

This new study finds a weaker – as shown previously – and less sustained immune response to SARS-CoV-2 vaccines in patients with a variety of IMIDs, including rheumatoid arthritis, spondyloarthritis, psoriasis, inflammatory bowel diseases, and other systemic autoimmune diseases such as lupus. It also points toward the possibility of adjusting treatment and vaccination schedules and strategies for these patients based on their antibody levels, among other factors, to preserve best protection against severe COVID.

Kmatta/Moment/Getty Images

“It is important to assess immune response in these patients to see if they still have protection against severe COVID infection,” said lead author David Simon, MD, senior clinical scientist in clinical immunology and rheumatology at University Hospital Erlangen (Germany). “We know that antibody response is an immune correlate. Therefore, it is important to see how large and durable the immune response is to the coronavirus vaccine in these IMID patients, and whether specific drugs or therapies have negative effects on their immune response.”
 

What was studied?

For this large prospective cohort study, researchers registered 5076 coronavirus-vaccinated individuals. They analyzed serum samples obtained between December 15, 2020, and December 1, 2021, from 2,535 patients diagnosed with IMIDs and participating in a prospective coronavirus study program at the Deutsches Zentrum Immuntherapie in Erlangen. The IMID patients had a mean age of 55.0 years, and 58.9% were women.

A healthy control group of 1,198 individuals without IMID who had a mean age of 40.7 years, including 53.8% men, was also recruited for the analysis. All approved coronavirus vaccines were included, following standard vaccination schedules. Antibody response was measured over time by an enzyme-linked immunosorbent assay from 8 weeks after first vaccination to week 40.

Among the findings, the healthy controls had higher postvaccine antibody levels than did those with IMIDs. But the majority of vaccinated patients with IMID were able to build up a humoral immune response to SARS-CoV-2. Patients who were taking B-cell inhibitors like rituximab (Rituxan, Genentech; and biosimilars) and T-cell inhibitors like abatacept (Orencia, Bristol Myers Squibb) for IMIDs had significantly poorer antibody response.

Greater age and the use of combination therapies for IMIDs, compared with monotherapy, further reduced immune response to the vaccine. In terms of vaccination modality, messenger RNA–based vaccines induced higher antibody levels than did vector-based vaccines. The researchers noted that patients with IMID who were given a third vaccine dose could actually catch up well with the antibody responses observed in healthy controls.

“We looked at whether different IMIDs had a different humoral response, and we also assessed if there are effects from different therapeutic strategies,” Dr. Simon explained. “It doesn’t matter so much what kind of IMID patients have; much more important is the specific drug treatment and its impact on their antibody response.” Some participants were advised to briefly stop taking some immunosuppressive treatments before or after vaccination.

One of Dr. Simon’s coauthors, statistician and rheumatologist Koray Tascilar, MD, added, “This research is important because we looked not only at who responded less, which has been previously established, but who are at greater risk of losing their immune response, and how quickly.”
 

Need to take care

“Most treatments we as rheumatologists give to our patients don’t affect their SARS-CoV-2 humoral response,” Dr. Simon said. “However, there are specific drugs that are associated with lower antibody response. With respect to those drugs, we have to be more careful.”

It is important to be able to tell patients which drugs are safe and won’t have a negative impact on their immune response to vaccinations, Dr. Tascilar said. “But it would be too strong to say we’re ready to choose therapies based on their potential impact on protection against COVID. Yes, there is a risk from catching COVID, but we need to balance that risk with the risk of not giving patients the medications that are necessary to treat their rheumatologic condition.”

These diseases are serious, sometimes life-threatening. “We might think of strategies for how to mitigate the risk of underprotection from COVID that is brought about by these treatments,” he said. For example, offering boosters sooner or more frequently, or prophylactically treating with monoclonal antibodies.

“This study, along other recent studies, has found that antibody levels in patients with immune-mediated diseases wane more rapidly than in healthy controls, and this is especially true of those on medications that interfere with the B and T cells and anticytokine therapies,” Rebecca Haberman, MD, assistant professor, division of rheumatology, New York University Langone Health, noted in an email to this news organization.

“While there is no known antibody level that specifically correlates with clinical protection, and each patient needs to be thought of individually, these findings support the use of supplemental booster dosing in patients with immune-mediated inflammatory diseases,” Dr. Haberman said, adding that her own research in this area has shown similar results.

“As a rheumatologist, I would be more likely to encourage my patients – especially those on immunomodulatory medications – to get boosted.”

Dr. Tascilar said his study does not directly answer the question of whether an earlier booster shot would be an effective strategy for patients with IMID. “In our department, we have an early boosting strategy, based on level of immune response.” But the decision of revaccination or not, and when, is based on a number of factors, not only on the level of antibodies. “It’s just part of the instruments we are using.”

The study was supported by the Deutsche Forschungsgemeinschaft. Dr. Simon and Dr. Tascilar declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study in The Lancet Rheumatology examines the strength and duration of SARS-CoV-2 vaccine–induced immunoglobulin-G antibody responses over time for patients with a variety of autoimmune diseases, compared with healthy controls.

The presence of humoral antibodies to SARS-CoV-2 has been shown to correlate with protection against COVID infection. But for patients with immune-mediated inflammatory diseases (IMIDs), host response to COVID infection or to vaccination is affected by the immune dysfunction imposed by the IMID and by the use of immune-modulating drugs to treat it.

This new study finds a weaker – as shown previously – and less sustained immune response to SARS-CoV-2 vaccines in patients with a variety of IMIDs, including rheumatoid arthritis, spondyloarthritis, psoriasis, inflammatory bowel diseases, and other systemic autoimmune diseases such as lupus. It also points toward the possibility of adjusting treatment and vaccination schedules and strategies for these patients based on their antibody levels, among other factors, to preserve best protection against severe COVID.

Kmatta/Moment/Getty Images

“It is important to assess immune response in these patients to see if they still have protection against severe COVID infection,” said lead author David Simon, MD, senior clinical scientist in clinical immunology and rheumatology at University Hospital Erlangen (Germany). “We know that antibody response is an immune correlate. Therefore, it is important to see how large and durable the immune response is to the coronavirus vaccine in these IMID patients, and whether specific drugs or therapies have negative effects on their immune response.”
 

What was studied?

For this large prospective cohort study, researchers registered 5076 coronavirus-vaccinated individuals. They analyzed serum samples obtained between December 15, 2020, and December 1, 2021, from 2,535 patients diagnosed with IMIDs and participating in a prospective coronavirus study program at the Deutsches Zentrum Immuntherapie in Erlangen. The IMID patients had a mean age of 55.0 years, and 58.9% were women.

A healthy control group of 1,198 individuals without IMID who had a mean age of 40.7 years, including 53.8% men, was also recruited for the analysis. All approved coronavirus vaccines were included, following standard vaccination schedules. Antibody response was measured over time by an enzyme-linked immunosorbent assay from 8 weeks after first vaccination to week 40.

Among the findings, the healthy controls had higher postvaccine antibody levels than did those with IMIDs. But the majority of vaccinated patients with IMID were able to build up a humoral immune response to SARS-CoV-2. Patients who were taking B-cell inhibitors like rituximab (Rituxan, Genentech; and biosimilars) and T-cell inhibitors like abatacept (Orencia, Bristol Myers Squibb) for IMIDs had significantly poorer antibody response.

Greater age and the use of combination therapies for IMIDs, compared with monotherapy, further reduced immune response to the vaccine. In terms of vaccination modality, messenger RNA–based vaccines induced higher antibody levels than did vector-based vaccines. The researchers noted that patients with IMID who were given a third vaccine dose could actually catch up well with the antibody responses observed in healthy controls.

“We looked at whether different IMIDs had a different humoral response, and we also assessed if there are effects from different therapeutic strategies,” Dr. Simon explained. “It doesn’t matter so much what kind of IMID patients have; much more important is the specific drug treatment and its impact on their antibody response.” Some participants were advised to briefly stop taking some immunosuppressive treatments before or after vaccination.

One of Dr. Simon’s coauthors, statistician and rheumatologist Koray Tascilar, MD, added, “This research is important because we looked not only at who responded less, which has been previously established, but who are at greater risk of losing their immune response, and how quickly.”
 

Need to take care

“Most treatments we as rheumatologists give to our patients don’t affect their SARS-CoV-2 humoral response,” Dr. Simon said. “However, there are specific drugs that are associated with lower antibody response. With respect to those drugs, we have to be more careful.”

It is important to be able to tell patients which drugs are safe and won’t have a negative impact on their immune response to vaccinations, Dr. Tascilar said. “But it would be too strong to say we’re ready to choose therapies based on their potential impact on protection against COVID. Yes, there is a risk from catching COVID, but we need to balance that risk with the risk of not giving patients the medications that are necessary to treat their rheumatologic condition.”

These diseases are serious, sometimes life-threatening. “We might think of strategies for how to mitigate the risk of underprotection from COVID that is brought about by these treatments,” he said. For example, offering boosters sooner or more frequently, or prophylactically treating with monoclonal antibodies.

“This study, along other recent studies, has found that antibody levels in patients with immune-mediated diseases wane more rapidly than in healthy controls, and this is especially true of those on medications that interfere with the B and T cells and anticytokine therapies,” Rebecca Haberman, MD, assistant professor, division of rheumatology, New York University Langone Health, noted in an email to this news organization.

“While there is no known antibody level that specifically correlates with clinical protection, and each patient needs to be thought of individually, these findings support the use of supplemental booster dosing in patients with immune-mediated inflammatory diseases,” Dr. Haberman said, adding that her own research in this area has shown similar results.

“As a rheumatologist, I would be more likely to encourage my patients – especially those on immunomodulatory medications – to get boosted.”

Dr. Tascilar said his study does not directly answer the question of whether an earlier booster shot would be an effective strategy for patients with IMID. “In our department, we have an early boosting strategy, based on level of immune response.” But the decision of revaccination or not, and when, is based on a number of factors, not only on the level of antibodies. “It’s just part of the instruments we are using.”

The study was supported by the Deutsche Forschungsgemeinschaft. Dr. Simon and Dr. Tascilar declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

WASHINGTON – Speaker after speaker, veteran emergency department physicians and nurses approached the podium for a May 4 press conference on the U.S. Capitol lawn across from the East Senate steps to describe violent incidents – being bitten, punched, slapped, kicked, choked, spat on, threatened – that they have both observed and have been subject to while working in EDs.

The press conference was cosponsored by the American College of Emergency Physicians and the Emergency Nurses Association, which have partnered since 2019 on the No Silence on ED Violence campaign.

Fuse/thinkstockphotos.com

The numbers confirm their experience. A 2018 poll of 3,500 ED physicians nationwide, which was conducted by Marketing General and was reported at ACEP’s annual meeting, found that nearly half of respondents had been assaulted at work; 27% of them were injured from the assault. Nurses, who spend more time with patients, may face even higher rates.

Incidence was reported to be increasing in 2018, and that was before the social and psychological upheavals imposed by the COVID pandemic caused assaults on staff in the hospital to go up an estimated 200%-300%.

But what really grated was that more than 95% of such cases, mostly perpetrated by patients, were never prosecuted, said Jennifer Casaletto, MD, FACEP, a North Carolina emergency physician and president of the state’s ACEP chapter. “Hospital and law enforcement see violence as just part of the job in our EDs.”

It’s no secret that workplace violence is increasing, Dr. Casaletto said. Four weeks ago, she stitched up the face of a charge nurse who had been assaulted. The nurse didn’t report the incident because she didn’t believe anything would change.

“Listening to my colleagues, I know the terror they have felt in the moment – for themselves, their colleagues, their patients. I know that raw fear of being attacked, and the complex emotions that follow. I’ve been hit, bit, and punched and watched colleagues getting choked.”

Dr. Casaletto was present in the ED when an out-of-control patient clubbed a nurse with an IV pole as she tried to close the doors to other patients’ rooms. “Instinctively, I pulled my stethoscope from around my neck, hoping I wouldn’t be strangled with it.”

Tennessee emergency nurse Todd Haines, MSN, RN, AEMT, CEN, said he has stepped in to help pull patients off coworkers. “I’ve seen some staff so severely injured they could not return to the bedside. I’ve been verbally threatened. My family has been threatened by patients and their families,” he reported. “We’ve all seen it. And COVID has made some people even meaner. They just lose their minds, and ED staff take the brunt of their aggression. But then to report these incidents and hear: ‘It’s just part of your job,’ well, it’s not part of my job.”

Mr. Haines spent 10 years in law enforcement with a sheriff’s department in middle Tennessee and was on its special tactical response team before becoming an ED nurse. He said he saw many more verbal and physical assaults in 11 years in the ED than during his police career.

“I love emergency nursing at the bedside, but it got to the point where I took the first chance to leave the bedside. And I’m not alone. Other nurses are leaving in droves.” Mr. Haines now has a job directing a trauma program, and he volunteers on policy issues for the Tennessee ENA. But he worries about the toll of this violence on the ED workforce, with so many professionals already mulling over leaving the field because of job stress and burnout.

“We have to do something to keep experienced hospital emergency staff at the bedside.”

What’s the answer?

Also speaking at the press conference was Senator Tammy Baldwin (D-Wis.), who pledged to introduce the Workplace Violence Prevention for Health Care and Social Services Workers Act, which passed the House in April. This bill would direct the Occupational Health and Safety Administration to issue a standard requiring employers in health care and social services to develop and implement workplace violence prevention plans. It would cover a variety of health facilities but not doctor’s offices or home-based services.

An interim final standard would be due within a year of enactment, with a final version to follow. Covered employers would have 6 months to develop and implement their own comprehensive workplace violence prevention plans, with the meaningful participation of direct care employees, tailored for and specific to the conditions and hazards of their facility, informed by past violent incidents, and subject to the size and complexity of the setting.

The plan would also name an individual responsible for its implementation, would include staff training and education, and would require facilities to track incidents and prohibit retaliation against employees who reported incidents of workplace violence.

On Wednesday, Sen. Baldwin called for unanimous consent on the Senate floor to fast-track this bill, but that was opposed by Senator Mike Braun (R-Ind.). She will soon introduce legislation similar to HR 1195, which the House passed.

“This bill will provide long overdue protections and safety standards,” she said. It will ensure that workplaces adopt proven protection techniques, such as those in OSHA’s 2015 guideline for preventing health care workplace violence. The American Hospital Association opposed the House bill on the grounds that hospitals have already implemented policies and programs specifically tailored to address workplace violence, so the OSHA standards required by the bill are not warranted.

Another speaker at the press conference, Aisha Terry, MD, MPH, FACEP, an emergency physician for George Washington University and Veterans Affairs in Washington, D.C., and current vice president of ACEP, described an incident that occurred when she was at work. A patient punched the nurse caring for him in the face, knocking her unconscious to the floor. “I’ll never forget that sound,” Dr. Terry said. “To this day, it has impacted her career. She hasn’t known what to do.”

Many people don’t realize how bad workplace violence really is, Dr. Terry added. “You assume you can serve as the safety net of this country, taking care of patients in the context of the pandemic, and feel safe – and not have to worry about your own safety. It’s past due that we put an end to this.”
 

Biggest win

Mr. Haines called the workplace violence bill a game changer for ED professionals, now and into the future. “We’re not going to totally eliminate violence in the emergency department. That is part of our business. But this legislation will support us and give a safer environment for us to do the work we love,” he said.

“The biggest win for this legislation is that it will create a supportive, nonretaliatory environment. It will give us as nurses a structured way to report things.” And, when these incidents do get reported, staff will get the help they need, Mr. Haines said. “The legislation will help show the importance of implementing systems and processes in emergency settings to address the risks and hazards that makes us all vulnerable to violence.”

No relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

WASHINGTON – Speaker after speaker, veteran emergency department physicians and nurses approached the podium for a May 4 press conference on the U.S. Capitol lawn across from the East Senate steps to describe violent incidents – being bitten, punched, slapped, kicked, choked, spat on, threatened – that they have both observed and have been subject to while working in EDs.

The press conference was cosponsored by the American College of Emergency Physicians and the Emergency Nurses Association, which have partnered since 2019 on the No Silence on ED Violence campaign.

Fuse/thinkstockphotos.com

The numbers confirm their experience. A 2018 poll of 3,500 ED physicians nationwide, which was conducted by Marketing General and was reported at ACEP’s annual meeting, found that nearly half of respondents had been assaulted at work; 27% of them were injured from the assault. Nurses, who spend more time with patients, may face even higher rates.

Incidence was reported to be increasing in 2018, and that was before the social and psychological upheavals imposed by the COVID pandemic caused assaults on staff in the hospital to go up an estimated 200%-300%.

But what really grated was that more than 95% of such cases, mostly perpetrated by patients, were never prosecuted, said Jennifer Casaletto, MD, FACEP, a North Carolina emergency physician and president of the state’s ACEP chapter. “Hospital and law enforcement see violence as just part of the job in our EDs.”

It’s no secret that workplace violence is increasing, Dr. Casaletto said. Four weeks ago, she stitched up the face of a charge nurse who had been assaulted. The nurse didn’t report the incident because she didn’t believe anything would change.

“Listening to my colleagues, I know the terror they have felt in the moment – for themselves, their colleagues, their patients. I know that raw fear of being attacked, and the complex emotions that follow. I’ve been hit, bit, and punched and watched colleagues getting choked.”

Dr. Casaletto was present in the ED when an out-of-control patient clubbed a nurse with an IV pole as she tried to close the doors to other patients’ rooms. “Instinctively, I pulled my stethoscope from around my neck, hoping I wouldn’t be strangled with it.”

Tennessee emergency nurse Todd Haines, MSN, RN, AEMT, CEN, said he has stepped in to help pull patients off coworkers. “I’ve seen some staff so severely injured they could not return to the bedside. I’ve been verbally threatened. My family has been threatened by patients and their families,” he reported. “We’ve all seen it. And COVID has made some people even meaner. They just lose their minds, and ED staff take the brunt of their aggression. But then to report these incidents and hear: ‘It’s just part of your job,’ well, it’s not part of my job.”

Mr. Haines spent 10 years in law enforcement with a sheriff’s department in middle Tennessee and was on its special tactical response team before becoming an ED nurse. He said he saw many more verbal and physical assaults in 11 years in the ED than during his police career.

“I love emergency nursing at the bedside, but it got to the point where I took the first chance to leave the bedside. And I’m not alone. Other nurses are leaving in droves.” Mr. Haines now has a job directing a trauma program, and he volunteers on policy issues for the Tennessee ENA. But he worries about the toll of this violence on the ED workforce, with so many professionals already mulling over leaving the field because of job stress and burnout.

“We have to do something to keep experienced hospital emergency staff at the bedside.”

What’s the answer?

Also speaking at the press conference was Senator Tammy Baldwin (D-Wis.), who pledged to introduce the Workplace Violence Prevention for Health Care and Social Services Workers Act, which passed the House in April. This bill would direct the Occupational Health and Safety Administration to issue a standard requiring employers in health care and social services to develop and implement workplace violence prevention plans. It would cover a variety of health facilities but not doctor’s offices or home-based services.

An interim final standard would be due within a year of enactment, with a final version to follow. Covered employers would have 6 months to develop and implement their own comprehensive workplace violence prevention plans, with the meaningful participation of direct care employees, tailored for and specific to the conditions and hazards of their facility, informed by past violent incidents, and subject to the size and complexity of the setting.

The plan would also name an individual responsible for its implementation, would include staff training and education, and would require facilities to track incidents and prohibit retaliation against employees who reported incidents of workplace violence.

On Wednesday, Sen. Baldwin called for unanimous consent on the Senate floor to fast-track this bill, but that was opposed by Senator Mike Braun (R-Ind.). She will soon introduce legislation similar to HR 1195, which the House passed.

“This bill will provide long overdue protections and safety standards,” she said. It will ensure that workplaces adopt proven protection techniques, such as those in OSHA’s 2015 guideline for preventing health care workplace violence. The American Hospital Association opposed the House bill on the grounds that hospitals have already implemented policies and programs specifically tailored to address workplace violence, so the OSHA standards required by the bill are not warranted.

Another speaker at the press conference, Aisha Terry, MD, MPH, FACEP, an emergency physician for George Washington University and Veterans Affairs in Washington, D.C., and current vice president of ACEP, described an incident that occurred when she was at work. A patient punched the nurse caring for him in the face, knocking her unconscious to the floor. “I’ll never forget that sound,” Dr. Terry said. “To this day, it has impacted her career. She hasn’t known what to do.”

Many people don’t realize how bad workplace violence really is, Dr. Terry added. “You assume you can serve as the safety net of this country, taking care of patients in the context of the pandemic, and feel safe – and not have to worry about your own safety. It’s past due that we put an end to this.”
 

Biggest win

Mr. Haines called the workplace violence bill a game changer for ED professionals, now and into the future. “We’re not going to totally eliminate violence in the emergency department. That is part of our business. But this legislation will support us and give a safer environment for us to do the work we love,” he said.

“The biggest win for this legislation is that it will create a supportive, nonretaliatory environment. It will give us as nurses a structured way to report things.” And, when these incidents do get reported, staff will get the help they need, Mr. Haines said. “The legislation will help show the importance of implementing systems and processes in emergency settings to address the risks and hazards that makes us all vulnerable to violence.”

No relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

WASHINGTON – Speaker after speaker, veteran emergency department physicians and nurses approached the podium for a May 4 press conference on the U.S. Capitol lawn across from the East Senate steps to describe violent incidents – being bitten, punched, slapped, kicked, choked, spat on, threatened – that they have both observed and have been subject to while working in EDs.

The press conference was cosponsored by the American College of Emergency Physicians and the Emergency Nurses Association, which have partnered since 2019 on the No Silence on ED Violence campaign.

Fuse/thinkstockphotos.com

The numbers confirm their experience. A 2018 poll of 3,500 ED physicians nationwide, which was conducted by Marketing General and was reported at ACEP’s annual meeting, found that nearly half of respondents had been assaulted at work; 27% of them were injured from the assault. Nurses, who spend more time with patients, may face even higher rates.

Incidence was reported to be increasing in 2018, and that was before the social and psychological upheavals imposed by the COVID pandemic caused assaults on staff in the hospital to go up an estimated 200%-300%.

But what really grated was that more than 95% of such cases, mostly perpetrated by patients, were never prosecuted, said Jennifer Casaletto, MD, FACEP, a North Carolina emergency physician and president of the state’s ACEP chapter. “Hospital and law enforcement see violence as just part of the job in our EDs.”

It’s no secret that workplace violence is increasing, Dr. Casaletto said. Four weeks ago, she stitched up the face of a charge nurse who had been assaulted. The nurse didn’t report the incident because she didn’t believe anything would change.

“Listening to my colleagues, I know the terror they have felt in the moment – for themselves, their colleagues, their patients. I know that raw fear of being attacked, and the complex emotions that follow. I’ve been hit, bit, and punched and watched colleagues getting choked.”

Dr. Casaletto was present in the ED when an out-of-control patient clubbed a nurse with an IV pole as she tried to close the doors to other patients’ rooms. “Instinctively, I pulled my stethoscope from around my neck, hoping I wouldn’t be strangled with it.”

Tennessee emergency nurse Todd Haines, MSN, RN, AEMT, CEN, said he has stepped in to help pull patients off coworkers. “I’ve seen some staff so severely injured they could not return to the bedside. I’ve been verbally threatened. My family has been threatened by patients and their families,” he reported. “We’ve all seen it. And COVID has made some people even meaner. They just lose their minds, and ED staff take the brunt of their aggression. But then to report these incidents and hear: ‘It’s just part of your job,’ well, it’s not part of my job.”

Mr. Haines spent 10 years in law enforcement with a sheriff’s department in middle Tennessee and was on its special tactical response team before becoming an ED nurse. He said he saw many more verbal and physical assaults in 11 years in the ED than during his police career.

“I love emergency nursing at the bedside, but it got to the point where I took the first chance to leave the bedside. And I’m not alone. Other nurses are leaving in droves.” Mr. Haines now has a job directing a trauma program, and he volunteers on policy issues for the Tennessee ENA. But he worries about the toll of this violence on the ED workforce, with so many professionals already mulling over leaving the field because of job stress and burnout.

“We have to do something to keep experienced hospital emergency staff at the bedside.”

What’s the answer?

Also speaking at the press conference was Senator Tammy Baldwin (D-Wis.), who pledged to introduce the Workplace Violence Prevention for Health Care and Social Services Workers Act, which passed the House in April. This bill would direct the Occupational Health and Safety Administration to issue a standard requiring employers in health care and social services to develop and implement workplace violence prevention plans. It would cover a variety of health facilities but not doctor’s offices or home-based services.

An interim final standard would be due within a year of enactment, with a final version to follow. Covered employers would have 6 months to develop and implement their own comprehensive workplace violence prevention plans, with the meaningful participation of direct care employees, tailored for and specific to the conditions and hazards of their facility, informed by past violent incidents, and subject to the size and complexity of the setting.

The plan would also name an individual responsible for its implementation, would include staff training and education, and would require facilities to track incidents and prohibit retaliation against employees who reported incidents of workplace violence.

On Wednesday, Sen. Baldwin called for unanimous consent on the Senate floor to fast-track this bill, but that was opposed by Senator Mike Braun (R-Ind.). She will soon introduce legislation similar to HR 1195, which the House passed.

“This bill will provide long overdue protections and safety standards,” she said. It will ensure that workplaces adopt proven protection techniques, such as those in OSHA’s 2015 guideline for preventing health care workplace violence. The American Hospital Association opposed the House bill on the grounds that hospitals have already implemented policies and programs specifically tailored to address workplace violence, so the OSHA standards required by the bill are not warranted.

Another speaker at the press conference, Aisha Terry, MD, MPH, FACEP, an emergency physician for George Washington University and Veterans Affairs in Washington, D.C., and current vice president of ACEP, described an incident that occurred when she was at work. A patient punched the nurse caring for him in the face, knocking her unconscious to the floor. “I’ll never forget that sound,” Dr. Terry said. “To this day, it has impacted her career. She hasn’t known what to do.”

Many people don’t realize how bad workplace violence really is, Dr. Terry added. “You assume you can serve as the safety net of this country, taking care of patients in the context of the pandemic, and feel safe – and not have to worry about your own safety. It’s past due that we put an end to this.”
 

Biggest win

Mr. Haines called the workplace violence bill a game changer for ED professionals, now and into the future. “We’re not going to totally eliminate violence in the emergency department. That is part of our business. But this legislation will support us and give a safer environment for us to do the work we love,” he said.

“The biggest win for this legislation is that it will create a supportive, nonretaliatory environment. It will give us as nurses a structured way to report things.” And, when these incidents do get reported, staff will get the help they need, Mr. Haines said. “The legislation will help show the importance of implementing systems and processes in emergency settings to address the risks and hazards that makes us all vulnerable to violence.”

No relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

A recent study published in the Journal of Hospital Medicine examined patient discharges from hospitals in Ontario, Canada, to determine if morning discharges were associated with positive outcomes. Some hospitalist programs have embraced discharge before noon (DBN) initiatives like those studied in the article.¹ Unfortunately, the researchers concluded that the Canadian DBNs did not positively impact hospital length of stay, readmissions, or mortality rates.

DBN has been a quality improvement target for hospitals hoping to improve throughput and free up scarce beds, while promoting patient safety by encouraging discharge as soon as patients are ready to leave. Yet other researchers have questioned its actual impact on quality metrics. One author called DBN’s purported impact an “urban legend,”² while a JHM editorial accompanying the Ontario study noted, “Hospitals are delicate organisms; a singular focus on one metric will undoubtedly impact others.”³

Might DBN be an artificial target that doesn’t actually enhance throughput, but leads instead to unintended consequences, such as patients being held over for an additional night in the hospital, rather than being discharged when they are ready to go on the afternoon before, in order to boost DBN rates? A perennial debate in hospital medicine is likely to be reignited by the new findings.
 

‘No significant overall association’

Quality improvement initiatives targeting morning discharges have included stakeholder meetings, incentives programs, discharge-centered breakfast programs, and creation of deadlines for discharge orders, the new study’s authors noted. Although these initiatives have gained support, critics have suggested that their supporting evidence is not robust.

The Canadian researchers retrospectively reviewed all patient admissions to general internal medicine services (GIMs) – largely similar to hospital medicine services in the United States – at seven hospitals in Toronto and Mississauga over a 7-year period ending Oct. 31, 2017, counting all of these patients who were discharged alive between 8 a.m. and noon. DBN averaged 19% of total live discharges across the diverse hospitals, with their diverse discharge practices.

But they found no significant overall association between morning discharge and hospital or emergency department length of stay. “Our findings suggest that increasing the number of morning discharges alone is unlikely to substantially improve patient throughput in GIM, but further research is needed to determine the effectiveness of specific interventions,” they concluded.

“We used a very narrow lens, looking specifically at throughput for the hospitals and emergency departments and whether DBN makes it more efficient,” said corresponding author Amol Verma, MD, MPhil, FRCPC, clinician-scientist at St. Michael’s Hospital, University of Toronto, in a recent interview. “What we found was that, on days when more patients are discharged in the morning, patients do not flow more quickly through the hospital. That suggests that increasing morning discharges is unlikely to make a difference.”
 

What does DBN really mean?

The semantics of DBN deserve further exploration. Is DBN about the actual hour of discharge, or the time when the hospitalist signs a discharge order – which may be well before the patient actually gets a wheelchair ride down to the hospital’s front doors? And if DBN is an organized program promoting morning discharges, how is it incentivized or otherwise rewarded?

Other factors, such as arrival of medications from the pharmacy or results from clinical tests, access to an ambulance if needed, transport to the front door, and bed cleaning will impact how quickly a doctor’s discharge orders get acted upon – and how quickly the newly emptied bed is available for the next occupant.

The clinician’s views on discharge practices may diverge from hospital administrator or health system perspectives, with its imperatives for efficient throughput in order to bring in more patients, Dr. Verma said. The hospitalist is also concerned about whether the patient feels ready to go home. “We can all agree that patients should leave the hospital as soon as they are medically able to do so,” he said. Longer hospital stays are associated with increased rates of hospital-acquired infections and other iatrogenic complications.

But there is not agreement on the components of a safe discharge – or on the other dimensions of effective patient flow and transitions of care. How do we optimize treatments initiated in the hospital? Does the patient need one more CAT scan? And what about the concerns of patient-centered care? Does the patient have a caregiver able to help them when they get home? There is a lot of uncertainty, Dr. Verma said. “These kinds of decisions have to get made many times every day by hospitalists,” he noted.

“We find ourselves trying to mirror the ebbs and flows of the emergency department with what’s happening in the hospital,” said Venkat Gundareddy, MBBS, MPH, associate director of the division of hospital medicine at Johns Hopkins Medicine in Baltimore. “The majority of hospital discharges happen during business hours, but the emergency department doesn’t stop admitting overnight, thus creating a throughput challenge.” Discharges are also based on clinical outcomes and on patients transferring to other facilities that prefer patients to arrive earlier in the day.

“Hospitalists may not fully appreciate these dynamics, because we’re siloed on our units,” Dr. Gundareddy said. “There is a subset of patients who would fit the bill for early discharge, but other patients come into the hospital with greater complexities, and a need for more coordination. Their discharges are harder to predict, although it gets clearer as their care progresses.”

The hospitals included in the Ontario study are at 90% -100% capacity, so their flexibility is constrained and throughput is a critical issue, Dr. Verma said. “But if you start with the target of more efficient throughput, there is no logical or practical reason to assume that discharge before noon would help. If we believe someone is ready for discharge based on physiologic changes, their response to treatment, and the conclusion of medical investigations, none of these conform to the clock. It’s equally likely the patient achieves them in the afternoon or evening.”

Other views on morning discharge

An alternative perspective comes from New York University’s Langone Medical Center, which has published positive results, including earlier subsequent arrivals to the inpatient unit from the emergency department, from increasing its hospital’s DBN rate.⁴

The hospital has continued to encourage morning discharges, which have consistently run 35%-40% or more of total discharges on two acute inpatient units at Langone’s Tisch Hospital. A previous study described the multidisciplinary intervention that resulted in a statistically significant increase in DBN – from 11% to 38% in the first 13 months – while significantly reducing high-frequency admission peaks.⁵

“We’ve been doing DBN for a number of years,” said Benjamin Wertheimer, MD, a hospitalist at Langone Medical Center and one of the studies’ authors. It is an achievable – and sustainable – goal. “Many hospitals around the country have problems with the flow of patients. Many hospitals are full – even before accounting for the COVID pandemic.” There is good evidence that, for a patient who no longer requires hospitalization, getting them out as early as possible, with a safe plan for their discharge, is a good thing, he said. “We see DBN as an important operational metric.”

If the necessary work is done correctly on the afternoon before the discharge, then a DBN approach can push communication, coordination, and advance planning, Dr Wertheimer said. Otherwise, essential discharge tasks may lag until the last minute. “We try to put the pieces in place the day before through a better planned process. But it should never be that DBN takes precedence over when the patient is safely ready to go,” he said.

“Our true measure of success would be how well we are preparing, communicating, putting safe plans into place,” he added. “DBN does not in and of itself answer all the safety and quality concerns. We set priorities around specific quality targets. DBN is just one of our operational and safety measures.”

The DBN intervention at Langone started with a multidisciplinary kickoff event in which all team members received education on its importance, a clear description of roles in the DBN process, and a corresponding checklist of daily responsibilities. The checklist was utilized at newly implemented afternoon interdisciplinary rounds, scripted to identify next-day DBNs, and make sure everything is in place for them, he explained.

“We provide daily feedback to floor staff on the DBN percentage, celebrate success, and offer real-time opportunities for case review,” Dr. Wertheimer said. “We have been careful about how we message this goal. Quality and safety come first, and we want to be prepared for discharge in advance of when the patient is ready.”
 

A boost for discharges

Mark Williams, MD, MHM, recently appointed chief of hospital medicine at Washington University School of Medicine in St. Louis, and a principal investigator for Project BOOST (Better Outcomes by Optimizing Safe Transitions), SHM’s quality improvement mentoring initiative aimed at helping hospitals improve care transitions, said that debates about DBN have gone on for a long time in hospital medicine.

“Around 2002, consultants told the CEO of a community hospital affiliated with Emory Healthcare that if our hospitalists could discharge patients before noon it would improve throughput,” he recalled. The consultants came from the hospitality industry, where DBN is easier to achieve.

But in hospital medicine, he said, “We use the whole day of the discharge in delivering care. I said to the CEO, ‘I can get you 100% discharge before noon – I’ll just hold the patients overnight,’” he explained. “In our initial experience, we pushed DBN up to about 10% -15%, and it opened up a few beds, which rapidly filled.”

Project BOOST encouraged the goal of getting patients ready to go out as soon as they were clinically ready, but did not advocate specifically for DBN, Dr. Williams said. “The problem is that hospital throughput starts to gum up when occupancy goes over 80% or 90%, and many academic medical centers regularly reach occupancy rates greater than 100%, particularly in the afternoon.” The deluge of patients includes transfers from other hospitals, postsurgical patients, and admissions from the emergency department.

“Boarding in the ED is a real issue,” he said. “Right now, it’s a crisis of overoccupancy, and the problem is that the pipeline is pouring patients into the system faster than they can be discharged.”

Dr. Williams believes there needs to be bigger thinking about these issues. Could hospitals, health systems, and hospitalists practice more preventive medicine so that some of these patients don’t need to come to the hospital? “Can you better address high blood pressure to prevent strokes and make sure patients with heart disease risk factors are enrolled in exercise and nutrition programs? What about access to healthy foods and the other social determinants of health? What if we provided adequate, consistent housing and transportation to medical visits?” he wondered.

Hospital at home programs may also offer some relief, he said. “If suddenly there weren’t so many emergency room visits by patients who need to get admitted, we’d have enough beds in the hospital.”
 

A more holistic view

John Nelson, MD, MHM, hospital medicine pioneer and management consultant, has been studying hospital throughput and policies to improve it for a long time. His 2010 column in The Hospitalist, “The Earlier the Better,” said attaching a financial incentive for hospitalists to discharge patients by a preset hour has produced mixed results.⁶ But Dr. Nelson offered some easy steps hospitalists can take to maximize earlier discharges, including to write “probable discharge tomorrow” as an order in the patient’s medical record.

The afternoon before a planned discharge, the hospitalist could talk to a patient’s family members about the discharge plan and order any outstanding tests to be done that evening to be ready for morning rounds – which he suggested should start by 7:00 a.m. The hospitalist could dictate the discharge summary the afternoon before. Even if a discharge can’t proceed as planned, the time isn’t necessarily wasted.

In a recent interview, Dr. Nelson noted that the movement to reduce average length of stay in the hospital has complicated the discharge picture by reducing a hospital’s flexibility. But he added that it’s still worth tracking and collecting data on discharge times, and to keep the conversation going. “Just don’t lose sight of the real goal, which is not DBN but optimal length-of-stay management,” he said.

Dr. Gundareddy said that, as his group has dealt with these issues, some steps have emerged to help manage discharges and throughput. “We didn’t have case management and social work services over the weekend, but when we added that support, it changed how our Mondays went.”

He encourages hospitalists to focus on the actual processes that create bottlenecks preventing throughput. “A good example of effective restructuring is lab testing. It’s amazing to think that you could have lab test results available for 7:00 a.m. rounds. There are areas that deserve more attention and more research regarding DBN. What is the impact of discharge before noon programs on the patients who aren’t being planned for discharge that day? Do they get neglected? I feel that happens sometimes.”

The COVID pandemic has further complicated these questions, Dr. Gundareddy said. “Early on in the pandemic, we were unsure how things were going with discharges, since all of the focus was on the COVID crisis. A lot of outpatient and surgical services came to a standstill, and there weren’t enough of the right kinds of beds for COVID patients. It was hard to align staff appropriately with the new clinical goals and to train them during the crisis.” Now, patients who delayed care during the pandemic are turning up at the hospital with greater acuity.

As with all incentives, DBN can have unintended consequences – especially if you monetize the practice, Dr. Verma said. “Most hospitalists are already working so hard – making so many decisions every day. These incentives could push decisions that aren’t in anybody’s best interests.”

Various groups have created comprehensive packages of protocols for improving transitions of care, he said. Organized programs to maximize efficiency of transitions and patient flow, including Project BOOST and Project RED (Re-Engineered Discharge) at Boston University Medical Center, are important sources of tools and resources. “But we should stop flogging hospitalists to discharge patients before noon,” Dr. Verma said, “Discharge is more complex than that. Instead, we should work to improve discharges in more holistic ways.”
 

References

1. Kirubarajan A et al. Morning discharges and patient length of stay in inpatient general internal medicine. J Hosp Med. 2021 Jun;16(6):333-8. doi: 10.12788/jhm.3605.

2. Shine D. Discharge before noon: An urban legend. Am J Med. 2015 May;128(5):445-6. doi:10.1016/j.amjmed.2014.12.011.

3. Zorian A et al. Discharge by noon: Toward a better understanding of benefits and costs. J Hosp Med. 2021 Jun;16(6):384. doi: 10.12788/jhm.3613.

4. Wertheimer B et al. Discharge before noon: Effect on throughput and sustainability. J Hosp Med. 2015 Oct;10(10):664-9. doi: 10.1002/jhm.2412.

5. Wertheimer B et al. Discharge before noon: an achievable hospital goal. J Hosp Med. 2014 Apr;9(4):210-4. doi: 10.1002/jhm.2154.

6. Nelson J. The earlier, the better. The Hospitalist. 2010 May.

A recent study published in the Journal of Hospital Medicine examined patient discharges from hospitals in Ontario, Canada, to determine if morning discharges were associated with positive outcomes. Some hospitalist programs have embraced discharge before noon (DBN) initiatives like those studied in the article.¹ Unfortunately, the researchers concluded that the Canadian DBNs did not positively impact hospital length of stay, readmissions, or mortality rates.

DBN has been a quality improvement target for hospitals hoping to improve throughput and free up scarce beds, while promoting patient safety by encouraging discharge as soon as patients are ready to leave. Yet other researchers have questioned its actual impact on quality metrics. One author called DBN’s purported impact an “urban legend,”² while a JHM editorial accompanying the Ontario study noted, “Hospitals are delicate organisms; a singular focus on one metric will undoubtedly impact others.”³

Might DBN be an artificial target that doesn’t actually enhance throughput, but leads instead to unintended consequences, such as patients being held over for an additional night in the hospital, rather than being discharged when they are ready to go on the afternoon before, in order to boost DBN rates? A perennial debate in hospital medicine is likely to be reignited by the new findings.
 

‘No significant overall association’

Quality improvement initiatives targeting morning discharges have included stakeholder meetings, incentives programs, discharge-centered breakfast programs, and creation of deadlines for discharge orders, the new study’s authors noted. Although these initiatives have gained support, critics have suggested that their supporting evidence is not robust.

The Canadian researchers retrospectively reviewed all patient admissions to general internal medicine services (GIMs) – largely similar to hospital medicine services in the United States – at seven hospitals in Toronto and Mississauga over a 7-year period ending Oct. 31, 2017, counting all of these patients who were discharged alive between 8 a.m. and noon. DBN averaged 19% of total live discharges across the diverse hospitals, with their diverse discharge practices.

But they found no significant overall association between morning discharge and hospital or emergency department length of stay. “Our findings suggest that increasing the number of morning discharges alone is unlikely to substantially improve patient throughput in GIM, but further research is needed to determine the effectiveness of specific interventions,” they concluded.

“We used a very narrow lens, looking specifically at throughput for the hospitals and emergency departments and whether DBN makes it more efficient,” said corresponding author Amol Verma, MD, MPhil, FRCPC, clinician-scientist at St. Michael’s Hospital, University of Toronto, in a recent interview. “What we found was that, on days when more patients are discharged in the morning, patients do not flow more quickly through the hospital. That suggests that increasing morning discharges is unlikely to make a difference.”
 

What does DBN really mean?

The semantics of DBN deserve further exploration. Is DBN about the actual hour of discharge, or the time when the hospitalist signs a discharge order – which may be well before the patient actually gets a wheelchair ride down to the hospital’s front doors? And if DBN is an organized program promoting morning discharges, how is it incentivized or otherwise rewarded?

Other factors, such as arrival of medications from the pharmacy or results from clinical tests, access to an ambulance if needed, transport to the front door, and bed cleaning will impact how quickly a doctor’s discharge orders get acted upon – and how quickly the newly emptied bed is available for the next occupant.

The clinician’s views on discharge practices may diverge from hospital administrator or health system perspectives, with its imperatives for efficient throughput in order to bring in more patients, Dr. Verma said. The hospitalist is also concerned about whether the patient feels ready to go home. “We can all agree that patients should leave the hospital as soon as they are medically able to do so,” he said. Longer hospital stays are associated with increased rates of hospital-acquired infections and other iatrogenic complications.

But there is not agreement on the components of a safe discharge – or on the other dimensions of effective patient flow and transitions of care. How do we optimize treatments initiated in the hospital? Does the patient need one more CAT scan? And what about the concerns of patient-centered care? Does the patient have a caregiver able to help them when they get home? There is a lot of uncertainty, Dr. Verma said. “These kinds of decisions have to get made many times every day by hospitalists,” he noted.

“We find ourselves trying to mirror the ebbs and flows of the emergency department with what’s happening in the hospital,” said Venkat Gundareddy, MBBS, MPH, associate director of the division of hospital medicine at Johns Hopkins Medicine in Baltimore. “The majority of hospital discharges happen during business hours, but the emergency department doesn’t stop admitting overnight, thus creating a throughput challenge.” Discharges are also based on clinical outcomes and on patients transferring to other facilities that prefer patients to arrive earlier in the day.

“Hospitalists may not fully appreciate these dynamics, because we’re siloed on our units,” Dr. Gundareddy said. “There is a subset of patients who would fit the bill for early discharge, but other patients come into the hospital with greater complexities, and a need for more coordination. Their discharges are harder to predict, although it gets clearer as their care progresses.”

The hospitals included in the Ontario study are at 90% -100% capacity, so their flexibility is constrained and throughput is a critical issue, Dr. Verma said. “But if you start with the target of more efficient throughput, there is no logical or practical reason to assume that discharge before noon would help. If we believe someone is ready for discharge based on physiologic changes, their response to treatment, and the conclusion of medical investigations, none of these conform to the clock. It’s equally likely the patient achieves them in the afternoon or evening.”

Other views on morning discharge

An alternative perspective comes from New York University’s Langone Medical Center, which has published positive results, including earlier subsequent arrivals to the inpatient unit from the emergency department, from increasing its hospital’s DBN rate.⁴

The hospital has continued to encourage morning discharges, which have consistently run 35%-40% or more of total discharges on two acute inpatient units at Langone’s Tisch Hospital. A previous study described the multidisciplinary intervention that resulted in a statistically significant increase in DBN – from 11% to 38% in the first 13 months – while significantly reducing high-frequency admission peaks.⁵

“We’ve been doing DBN for a number of years,” said Benjamin Wertheimer, MD, a hospitalist at Langone Medical Center and one of the studies’ authors. It is an achievable – and sustainable – goal. “Many hospitals around the country have problems with the flow of patients. Many hospitals are full – even before accounting for the COVID pandemic.” There is good evidence that, for a patient who no longer requires hospitalization, getting them out as early as possible, with a safe plan for their discharge, is a good thing, he said. “We see DBN as an important operational metric.”

If the necessary work is done correctly on the afternoon before the discharge, then a DBN approach can push communication, coordination, and advance planning, Dr Wertheimer said. Otherwise, essential discharge tasks may lag until the last minute. “We try to put the pieces in place the day before through a better planned process. But it should never be that DBN takes precedence over when the patient is safely ready to go,” he said.

“Our true measure of success would be how well we are preparing, communicating, putting safe plans into place,” he added. “DBN does not in and of itself answer all the safety and quality concerns. We set priorities around specific quality targets. DBN is just one of our operational and safety measures.”

The DBN intervention at Langone started with a multidisciplinary kickoff event in which all team members received education on its importance, a clear description of roles in the DBN process, and a corresponding checklist of daily responsibilities. The checklist was utilized at newly implemented afternoon interdisciplinary rounds, scripted to identify next-day DBNs, and make sure everything is in place for them, he explained.

“We provide daily feedback to floor staff on the DBN percentage, celebrate success, and offer real-time opportunities for case review,” Dr. Wertheimer said. “We have been careful about how we message this goal. Quality and safety come first, and we want to be prepared for discharge in advance of when the patient is ready.”
 

A boost for discharges

Mark Williams, MD, MHM, recently appointed chief of hospital medicine at Washington University School of Medicine in St. Louis, and a principal investigator for Project BOOST (Better Outcomes by Optimizing Safe Transitions), SHM’s quality improvement mentoring initiative aimed at helping hospitals improve care transitions, said that debates about DBN have gone on for a long time in hospital medicine.

“Around 2002, consultants told the CEO of a community hospital affiliated with Emory Healthcare that if our hospitalists could discharge patients before noon it would improve throughput,” he recalled. The consultants came from the hospitality industry, where DBN is easier to achieve.

But in hospital medicine, he said, “We use the whole day of the discharge in delivering care. I said to the CEO, ‘I can get you 100% discharge before noon – I’ll just hold the patients overnight,’” he explained. “In our initial experience, we pushed DBN up to about 10% -15%, and it opened up a few beds, which rapidly filled.”

Project BOOST encouraged the goal of getting patients ready to go out as soon as they were clinically ready, but did not advocate specifically for DBN, Dr. Williams said. “The problem is that hospital throughput starts to gum up when occupancy goes over 80% or 90%, and many academic medical centers regularly reach occupancy rates greater than 100%, particularly in the afternoon.” The deluge of patients includes transfers from other hospitals, postsurgical patients, and admissions from the emergency department.

“Boarding in the ED is a real issue,” he said. “Right now, it’s a crisis of overoccupancy, and the problem is that the pipeline is pouring patients into the system faster than they can be discharged.”

Dr. Williams believes there needs to be bigger thinking about these issues. Could hospitals, health systems, and hospitalists practice more preventive medicine so that some of these patients don’t need to come to the hospital? “Can you better address high blood pressure to prevent strokes and make sure patients with heart disease risk factors are enrolled in exercise and nutrition programs? What about access to healthy foods and the other social determinants of health? What if we provided adequate, consistent housing and transportation to medical visits?” he wondered.

Hospital at home programs may also offer some relief, he said. “If suddenly there weren’t so many emergency room visits by patients who need to get admitted, we’d have enough beds in the hospital.”
 

A more holistic view

John Nelson, MD, MHM, hospital medicine pioneer and management consultant, has been studying hospital throughput and policies to improve it for a long time. His 2010 column in The Hospitalist, “The Earlier the Better,” said attaching a financial incentive for hospitalists to discharge patients by a preset hour has produced mixed results.⁶ But Dr. Nelson offered some easy steps hospitalists can take to maximize earlier discharges, including to write “probable discharge tomorrow” as an order in the patient’s medical record.

The afternoon before a planned discharge, the hospitalist could talk to a patient’s family members about the discharge plan and order any outstanding tests to be done that evening to be ready for morning rounds – which he suggested should start by 7:00 a.m. The hospitalist could dictate the discharge summary the afternoon before. Even if a discharge can’t proceed as planned, the time isn’t necessarily wasted.

In a recent interview, Dr. Nelson noted that the movement to reduce average length of stay in the hospital has complicated the discharge picture by reducing a hospital’s flexibility. But he added that it’s still worth tracking and collecting data on discharge times, and to keep the conversation going. “Just don’t lose sight of the real goal, which is not DBN but optimal length-of-stay management,” he said.

Dr. Gundareddy said that, as his group has dealt with these issues, some steps have emerged to help manage discharges and throughput. “We didn’t have case management and social work services over the weekend, but when we added that support, it changed how our Mondays went.”

He encourages hospitalists to focus on the actual processes that create bottlenecks preventing throughput. “A good example of effective restructuring is lab testing. It’s amazing to think that you could have lab test results available for 7:00 a.m. rounds. There are areas that deserve more attention and more research regarding DBN. What is the impact of discharge before noon programs on the patients who aren’t being planned for discharge that day? Do they get neglected? I feel that happens sometimes.”

The COVID pandemic has further complicated these questions, Dr. Gundareddy said. “Early on in the pandemic, we were unsure how things were going with discharges, since all of the focus was on the COVID crisis. A lot of outpatient and surgical services came to a standstill, and there weren’t enough of the right kinds of beds for COVID patients. It was hard to align staff appropriately with the new clinical goals and to train them during the crisis.” Now, patients who delayed care during the pandemic are turning up at the hospital with greater acuity.

As with all incentives, DBN can have unintended consequences – especially if you monetize the practice, Dr. Verma said. “Most hospitalists are already working so hard – making so many decisions every day. These incentives could push decisions that aren’t in anybody’s best interests.”

Various groups have created comprehensive packages of protocols for improving transitions of care, he said. Organized programs to maximize efficiency of transitions and patient flow, including Project BOOST and Project RED (Re-Engineered Discharge) at Boston University Medical Center, are important sources of tools and resources. “But we should stop flogging hospitalists to discharge patients before noon,” Dr. Verma said, “Discharge is more complex than that. Instead, we should work to improve discharges in more holistic ways.”
 

References

1. Kirubarajan A et al. Morning discharges and patient length of stay in inpatient general internal medicine. J Hosp Med. 2021 Jun;16(6):333-8. doi: 10.12788/jhm.3605.

2. Shine D. Discharge before noon: An urban legend. Am J Med. 2015 May;128(5):445-6. doi:10.1016/j.amjmed.2014.12.011.

3. Zorian A et al. Discharge by noon: Toward a better understanding of benefits and costs. J Hosp Med. 2021 Jun;16(6):384. doi: 10.12788/jhm.3613.

4. Wertheimer B et al. Discharge before noon: Effect on throughput and sustainability. J Hosp Med. 2015 Oct;10(10):664-9. doi: 10.1002/jhm.2412.

5. Wertheimer B et al. Discharge before noon: an achievable hospital goal. J Hosp Med. 2014 Apr;9(4):210-4. doi: 10.1002/jhm.2154.

6. Nelson J. The earlier, the better. The Hospitalist. 2010 May.

A recent study published in the Journal of Hospital Medicine examined patient discharges from hospitals in Ontario, Canada, to determine if morning discharges were associated with positive outcomes. Some hospitalist programs have embraced discharge before noon (DBN) initiatives like those studied in the article.¹ Unfortunately, the researchers concluded that the Canadian DBNs did not positively impact hospital length of stay, readmissions, or mortality rates.

DBN has been a quality improvement target for hospitals hoping to improve throughput and free up scarce beds, while promoting patient safety by encouraging discharge as soon as patients are ready to leave. Yet other researchers have questioned its actual impact on quality metrics. One author called DBN’s purported impact an “urban legend,”² while a JHM editorial accompanying the Ontario study noted, “Hospitals are delicate organisms; a singular focus on one metric will undoubtedly impact others.”³

Might DBN be an artificial target that doesn’t actually enhance throughput, but leads instead to unintended consequences, such as patients being held over for an additional night in the hospital, rather than being discharged when they are ready to go on the afternoon before, in order to boost DBN rates? A perennial debate in hospital medicine is likely to be reignited by the new findings.
 

‘No significant overall association’

Quality improvement initiatives targeting morning discharges have included stakeholder meetings, incentives programs, discharge-centered breakfast programs, and creation of deadlines for discharge orders, the new study’s authors noted. Although these initiatives have gained support, critics have suggested that their supporting evidence is not robust.

The Canadian researchers retrospectively reviewed all patient admissions to general internal medicine services (GIMs) – largely similar to hospital medicine services in the United States – at seven hospitals in Toronto and Mississauga over a 7-year period ending Oct. 31, 2017, counting all of these patients who were discharged alive between 8 a.m. and noon. DBN averaged 19% of total live discharges across the diverse hospitals, with their diverse discharge practices.

But they found no significant overall association between morning discharge and hospital or emergency department length of stay. “Our findings suggest that increasing the number of morning discharges alone is unlikely to substantially improve patient throughput in GIM, but further research is needed to determine the effectiveness of specific interventions,” they concluded.

“We used a very narrow lens, looking specifically at throughput for the hospitals and emergency departments and whether DBN makes it more efficient,” said corresponding author Amol Verma, MD, MPhil, FRCPC, clinician-scientist at St. Michael’s Hospital, University of Toronto, in a recent interview. “What we found was that, on days when more patients are discharged in the morning, patients do not flow more quickly through the hospital. That suggests that increasing morning discharges is unlikely to make a difference.”
 

What does DBN really mean?

The semantics of DBN deserve further exploration. Is DBN about the actual hour of discharge, or the time when the hospitalist signs a discharge order – which may be well before the patient actually gets a wheelchair ride down to the hospital’s front doors? And if DBN is an organized program promoting morning discharges, how is it incentivized or otherwise rewarded?

Other factors, such as arrival of medications from the pharmacy or results from clinical tests, access to an ambulance if needed, transport to the front door, and bed cleaning will impact how quickly a doctor’s discharge orders get acted upon – and how quickly the newly emptied bed is available for the next occupant.

The clinician’s views on discharge practices may diverge from hospital administrator or health system perspectives, with its imperatives for efficient throughput in order to bring in more patients, Dr. Verma said. The hospitalist is also concerned about whether the patient feels ready to go home. “We can all agree that patients should leave the hospital as soon as they are medically able to do so,” he said. Longer hospital stays are associated with increased rates of hospital-acquired infections and other iatrogenic complications.

But there is not agreement on the components of a safe discharge – or on the other dimensions of effective patient flow and transitions of care. How do we optimize treatments initiated in the hospital? Does the patient need one more CAT scan? And what about the concerns of patient-centered care? Does the patient have a caregiver able to help them when they get home? There is a lot of uncertainty, Dr. Verma said. “These kinds of decisions have to get made many times every day by hospitalists,” he noted.

“We find ourselves trying to mirror the ebbs and flows of the emergency department with what’s happening in the hospital,” said Venkat Gundareddy, MBBS, MPH, associate director of the division of hospital medicine at Johns Hopkins Medicine in Baltimore. “The majority of hospital discharges happen during business hours, but the emergency department doesn’t stop admitting overnight, thus creating a throughput challenge.” Discharges are also based on clinical outcomes and on patients transferring to other facilities that prefer patients to arrive earlier in the day.

“Hospitalists may not fully appreciate these dynamics, because we’re siloed on our units,” Dr. Gundareddy said. “There is a subset of patients who would fit the bill for early discharge, but other patients come into the hospital with greater complexities, and a need for more coordination. Their discharges are harder to predict, although it gets clearer as their care progresses.”

The hospitals included in the Ontario study are at 90% -100% capacity, so their flexibility is constrained and throughput is a critical issue, Dr. Verma said. “But if you start with the target of more efficient throughput, there is no logical or practical reason to assume that discharge before noon would help. If we believe someone is ready for discharge based on physiologic changes, their response to treatment, and the conclusion of medical investigations, none of these conform to the clock. It’s equally likely the patient achieves them in the afternoon or evening.”

Other views on morning discharge

An alternative perspective comes from New York University’s Langone Medical Center, which has published positive results, including earlier subsequent arrivals to the inpatient unit from the emergency department, from increasing its hospital’s DBN rate.⁴

The hospital has continued to encourage morning discharges, which have consistently run 35%-40% or more of total discharges on two acute inpatient units at Langone’s Tisch Hospital. A previous study described the multidisciplinary intervention that resulted in a statistically significant increase in DBN – from 11% to 38% in the first 13 months – while significantly reducing high-frequency admission peaks.⁵

“We’ve been doing DBN for a number of years,” said Benjamin Wertheimer, MD, a hospitalist at Langone Medical Center and one of the studies’ authors. It is an achievable – and sustainable – goal. “Many hospitals around the country have problems with the flow of patients. Many hospitals are full – even before accounting for the COVID pandemic.” There is good evidence that, for a patient who no longer requires hospitalization, getting them out as early as possible, with a safe plan for their discharge, is a good thing, he said. “We see DBN as an important operational metric.”

If the necessary work is done correctly on the afternoon before the discharge, then a DBN approach can push communication, coordination, and advance planning, Dr Wertheimer said. Otherwise, essential discharge tasks may lag until the last minute. “We try to put the pieces in place the day before through a better planned process. But it should never be that DBN takes precedence over when the patient is safely ready to go,” he said.

“Our true measure of success would be how well we are preparing, communicating, putting safe plans into place,” he added. “DBN does not in and of itself answer all the safety and quality concerns. We set priorities around specific quality targets. DBN is just one of our operational and safety measures.”

The DBN intervention at Langone started with a multidisciplinary kickoff event in which all team members received education on its importance, a clear description of roles in the DBN process, and a corresponding checklist of daily responsibilities. The checklist was utilized at newly implemented afternoon interdisciplinary rounds, scripted to identify next-day DBNs, and make sure everything is in place for them, he explained.

“We provide daily feedback to floor staff on the DBN percentage, celebrate success, and offer real-time opportunities for case review,” Dr. Wertheimer said. “We have been careful about how we message this goal. Quality and safety come first, and we want to be prepared for discharge in advance of when the patient is ready.”
 

A boost for discharges

Mark Williams, MD, MHM, recently appointed chief of hospital medicine at Washington University School of Medicine in St. Louis, and a principal investigator for Project BOOST (Better Outcomes by Optimizing Safe Transitions), SHM’s quality improvement mentoring initiative aimed at helping hospitals improve care transitions, said that debates about DBN have gone on for a long time in hospital medicine.

“Around 2002, consultants told the CEO of a community hospital affiliated with Emory Healthcare that if our hospitalists could discharge patients before noon it would improve throughput,” he recalled. The consultants came from the hospitality industry, where DBN is easier to achieve.

But in hospital medicine, he said, “We use the whole day of the discharge in delivering care. I said to the CEO, ‘I can get you 100% discharge before noon – I’ll just hold the patients overnight,’” he explained. “In our initial experience, we pushed DBN up to about 10% -15%, and it opened up a few beds, which rapidly filled.”

Project BOOST encouraged the goal of getting patients ready to go out as soon as they were clinically ready, but did not advocate specifically for DBN, Dr. Williams said. “The problem is that hospital throughput starts to gum up when occupancy goes over 80% or 90%, and many academic medical centers regularly reach occupancy rates greater than 100%, particularly in the afternoon.” The deluge of patients includes transfers from other hospitals, postsurgical patients, and admissions from the emergency department.

“Boarding in the ED is a real issue,” he said. “Right now, it’s a crisis of overoccupancy, and the problem is that the pipeline is pouring patients into the system faster than they can be discharged.”

Dr. Williams believes there needs to be bigger thinking about these issues. Could hospitals, health systems, and hospitalists practice more preventive medicine so that some of these patients don’t need to come to the hospital? “Can you better address high blood pressure to prevent strokes and make sure patients with heart disease risk factors are enrolled in exercise and nutrition programs? What about access to healthy foods and the other social determinants of health? What if we provided adequate, consistent housing and transportation to medical visits?” he wondered.

Hospital at home programs may also offer some relief, he said. “If suddenly there weren’t so many emergency room visits by patients who need to get admitted, we’d have enough beds in the hospital.”
 

A more holistic view

John Nelson, MD, MHM, hospital medicine pioneer and management consultant, has been studying hospital throughput and policies to improve it for a long time. His 2010 column in The Hospitalist, “The Earlier the Better,” said attaching a financial incentive for hospitalists to discharge patients by a preset hour has produced mixed results.⁶ But Dr. Nelson offered some easy steps hospitalists can take to maximize earlier discharges, including to write “probable discharge tomorrow” as an order in the patient’s medical record.

The afternoon before a planned discharge, the hospitalist could talk to a patient’s family members about the discharge plan and order any outstanding tests to be done that evening to be ready for morning rounds – which he suggested should start by 7:00 a.m. The hospitalist could dictate the discharge summary the afternoon before. Even if a discharge can’t proceed as planned, the time isn’t necessarily wasted.

In a recent interview, Dr. Nelson noted that the movement to reduce average length of stay in the hospital has complicated the discharge picture by reducing a hospital’s flexibility. But he added that it’s still worth tracking and collecting data on discharge times, and to keep the conversation going. “Just don’t lose sight of the real goal, which is not DBN but optimal length-of-stay management,” he said.

Dr. Gundareddy said that, as his group has dealt with these issues, some steps have emerged to help manage discharges and throughput. “We didn’t have case management and social work services over the weekend, but when we added that support, it changed how our Mondays went.”

He encourages hospitalists to focus on the actual processes that create bottlenecks preventing throughput. “A good example of effective restructuring is lab testing. It’s amazing to think that you could have lab test results available for 7:00 a.m. rounds. There are areas that deserve more attention and more research regarding DBN. What is the impact of discharge before noon programs on the patients who aren’t being planned for discharge that day? Do they get neglected? I feel that happens sometimes.”

The COVID pandemic has further complicated these questions, Dr. Gundareddy said. “Early on in the pandemic, we were unsure how things were going with discharges, since all of the focus was on the COVID crisis. A lot of outpatient and surgical services came to a standstill, and there weren’t enough of the right kinds of beds for COVID patients. It was hard to align staff appropriately with the new clinical goals and to train them during the crisis.” Now, patients who delayed care during the pandemic are turning up at the hospital with greater acuity.

As with all incentives, DBN can have unintended consequences – especially if you monetize the practice, Dr. Verma said. “Most hospitalists are already working so hard – making so many decisions every day. These incentives could push decisions that aren’t in anybody’s best interests.”

Various groups have created comprehensive packages of protocols for improving transitions of care, he said. Organized programs to maximize efficiency of transitions and patient flow, including Project BOOST and Project RED (Re-Engineered Discharge) at Boston University Medical Center, are important sources of tools and resources. “But we should stop flogging hospitalists to discharge patients before noon,” Dr. Verma said, “Discharge is more complex than that. Instead, we should work to improve discharges in more holistic ways.”
 

References

1. Kirubarajan A et al. Morning discharges and patient length of stay in inpatient general internal medicine. J Hosp Med. 2021 Jun;16(6):333-8. doi: 10.12788/jhm.3605.

2. Shine D. Discharge before noon: An urban legend. Am J Med. 2015 May;128(5):445-6. doi:10.1016/j.amjmed.2014.12.011.

3. Zorian A et al. Discharge by noon: Toward a better understanding of benefits and costs. J Hosp Med. 2021 Jun;16(6):384. doi: 10.12788/jhm.3613.

4. Wertheimer B et al. Discharge before noon: Effect on throughput and sustainability. J Hosp Med. 2015 Oct;10(10):664-9. doi: 10.1002/jhm.2412.

5. Wertheimer B et al. Discharge before noon: an achievable hospital goal. J Hosp Med. 2014 Apr;9(4):210-4. doi: 10.1002/jhm.2154.

6. Nelson J. The earlier, the better. The Hospitalist. 2010 May.

When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.

A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.

Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.

Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
 

Remote monitoring

Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.

If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.

Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.

“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.

Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.

At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”

MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.

Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.

“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”

Mr. Raine and Mr. Begue did not report any disclosures.

When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.

A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.

Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.

Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
 

Remote monitoring

Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.

If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.

Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.

“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.

Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.

At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”

MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.

Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.

“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”

Mr. Raine and Mr. Begue did not report any disclosures.

When the Winship Cancer Institute at Emory University, Atlanta, faced off against the pandemic in the spring of 2020, it opened a COVID urgent care clinic for Winship oncology patients who had a confirmed or suspected case of COVID, symptoms or a higher risk for the virus. The urgent care clinic, located in a relatively isolated bay of an infusion center, facilitated segregating COVID-suspected patients from other cancer patients while waiting for their polymerase chain reaction test results to show if they were COVID positive.

A strict triage system was also employed to make sure that the right patients were coming in to the new clinic and not those who either could be managed safely at home or were clinically unstable and belonged in the hospital, said Caleb Raine, PA-C, an oncology physician assistant and bone marrow transplant specialist at Winship. Mr. Raine, who manages the COVID urgent care clinic, shared his experience of “innovations worth keeping” from the pandemic for oncology practices during a panel discussion at the Journal of the Advanced Practitioner in Oncology annual conference, held online Oct. 7.

Telephonic triage was conducted by advanced practice providers (APPs) or nurses using an algorithm Mr. Raine developed incorporating COVID exposure with symptoms such as fever or loss of taste or smell. In order to promote consistency in admissions, he made the final decisions about which patients were brought into the clinic for evaluations, services such as supportive care or infusions, or to address cancer symptoms.

Mr. Raine said the triage process helped to enhance communication with other clinical teams at Winship. He hopes to preserve a strict approach to triaging in future program development, including a 14-bed immediate care center, projected to open next spring, building on experience with the COVID urgent care center. It will offer services similar to a day hospital for cancer patients but be open 24 hours with more capabilities than urgent care. It will target those with emergent needs or who otherwise might require a trip to the ED and provide care for those recently discharged from the hospital in need of follow-up.
 

Remote monitoring

Another conference speaker, Aaron Begue, MS, RN, CNP, vice president for advanced practice providers at Memorial Sloan Kettering Cancer Center in New York, described a pandemic telemedicine intervention for cancer patients implemented by MSKCC during the pandemic. Prior to in-person contact with the care team, patients were asked to complete a questionnaire on their symptoms using MSKCC’s secure online patient portal, MyMSK.

If symptom alerts reached a critical, color-coded threshold, it triggered a nurse or APP from MSKCC to contact the patient at home, typically by phone. APPs also did remote monitoring, including uploaded data from portable home pulse oximeters. A similar symptom tracker was later adapted for monitoring cancer symptoms.

Some APPs took turns working from their own home collecting data needed for inpatient visits and uploading it into the medical record. This helped to deploy clinical teams more efficiently and accommodate some staff who were at high risk of infection because of existing health conditions or quarantined for positive test results.

“We were able to flex our staffing,” Mr. Begue said. Even spending a day staffing a vaccination clinic could provide a break from the intensity of COVID care on the front lines. “All of us are still trying to figure out how to manage staff stress and burnout,” he added, but flexible scheduling seems to be an important strategy.

Early on, things like the crowds coming out in the evening to cheer for New York’s health care workers had a big impact for staff, showing the community’s support. “Later, when public schools were shut down, we worked with two of them to use their outdoor play areas for staff respite – places to sit down outside undisturbed and relax,” he said.

At the height of the COVID surge in New York, telemedicine was an essential component of care, but when it started to recede, Mr. Begue found that a lot of patients wanted in-person visits again. “We had assumed that telemedicine would be the wave of the future and cancer patients would love it,” he said. “We still do thousands of telemedicine visits, but they are no longer the majority.”

MSKCC also does remote telemonitoring visits with patients who live in other states but want to come to New York for surgeries or other procedures or yearly checkups at the hospital. But the logistical headaches of practicing telemedicine across state lines include trying to reconcile varying requirements for medical licensing.

Mr. Begue hopes in the future that some of these state requirements could be relaxed, which might also make it easier to enroll more people from across the country in clinical trials and encourage more collaboration between cancer centers.

“COVID taught us we have to be more forward thinking and prepared for crises,” Mr. Raine said. “In the future we need to be ready for when – not if – the next crisis comes along – although we’re not out of this one yet.”

Mr. Raine and Mr. Begue did not report any disclosures.