Covid ICYMI

Overwhelmed. As if we weren’t already overwhelmed. For decades, hospitalists have been on the forefront of improving acute care amidst a rapidly changing environment. These last few decades have seen tremendous advances in medicine, technology, safety culture, innovations in payment models, transformation in business models, and a rising tide of health care policy. There was never a year we didn’t face major change … and adapt to it. Then 2020 came upon us.

This year, we adapt to more than a score and 4 years’ worth of change.

The two pandemics that have come upon us are like tsunamis. And many of us are drowning. We know of threats of pandemics: influenza, Ebola, and the like. But SARS-CoV-2 is new and like no other. We live in fear and isolation, each and every day learning new information and debunking others. We also know of racial injustice and racism, implicit or explicit in our nation, whether we live it or just read of it. George Floyd’s death in my hometown marked another tsunami, a great realization in our nation, and a great unmasking of our denial.

Yet our country is not united.

Hospital medicine is not immune to this disunity. At a time that we are all treading water, staying afloat in our own hospitals and communities, confronting these issues beyond our immediate spheres of influence is overwhelming. We are impacted by these pandemics, personally and professionally. And admittedly, we can be both victim and perpetrator.

In the face of a novel infectious agent, medicine responded quickly and pushed us beyond our limits. We have developed new infection prevention guidelines. We worked creatively to solve PPE shortages. We fashioned new work flows and new care models. We accelerated telehealth applications. We expanded the boundaries on home-based programs and reached out to vulnerable elderly in congregate living – an isolation no older person should have to endure. We cared for our colleagues, neighbors, and family members who fell ill, some who recovered, and sadly, some who fell. We developed best-practice guidelines, research protocols, created new order sets, note templates, and documentation standards. We flexed into EDs, ICUs, and field hospitals. Amidst the turmoil, we took pay cuts and saw colleagues go on furlough. And still, we mentored leaders in our schools, churches, synagogues, mosques, and civic communities.

And just when we thought we could endure no more, on May 25, we witnessed a black man in Minneapolis killed by a policeman’s knee. The same knee that divided Americans when black American athletes knelt to protest the injustice their people have endured for centuries. A knee that has been confused for insolence, when it was meant for justice ... yes, justice, for all. So, in early June, around the nation in support of black lives we also knelt, for almost 9 minutes.

This was the third time I cried during the pandemics.

For many of us, structural racism in America had finally been unmasked. The nation protested and rioted for weeks, and some communities have continued. Indeed, these two pandemics are still surging.

Side by side COVID-19 case conferences we lay transparent data demonstrating health disparities that we have tolerated for so long. We have vowed to resource equity work, and we opened dialogue, not only with patients and communities of color, but also with colleagues of color – some ready and some not yet ready to share and relive the traumas of their past and their present.

And still, we are not united.

While we physically mask to prevent the spread of COVID-19, we must make efforts to unmask the truths of SARS-CoV-2, the failings of our health system, the richness of our communities of color, and the injustice in the fabric of our society. More importantly, we must work together to create solutions. While we have diverse interests and priorities, at SHM, we can find common ground with kindred spirits, enhance the role of our specialty, and advance the health of our patients.

Let’s not be mistaken. These pandemics add to a growing list of interwoven issues in our society. In 2018, I wrote a piece on the role of hospitalists in addressing rural health disparities.¹ According to the Sheps Center for Health Services Research, 129 rural hospitals have closed since 2010, closures that have accelerated with the COVID-19 pandemic.² More than ever, we must stand above our inner and outer conflicts and be united to promote the health of our nation during these pandemics, because “all policy is health policy.”³

Most SHM presidents and president-elects come in with a platform, a priority for the specialty and for the society. This year, the platform has chosen us. For 20 years, I have witnessed SHM be a workshop for our members to address the pressing needs of our specialty and our patients. In 2020, we’ve continued to see SHM as a workshop for our members and a tour de force addressing these pandemics, from just in time publications of research and perspectives in the Journal of Hospital Medicine, to webinars and open access education in the Learning Portal, to advocacy on Capitol Hill. All of that work has been informed by you and for you. While there is still so much to do, we need not be overwhelmed when we do it together.

A score and 4 years ago, Robert Wachter, MD, and Lee Goldman, MD, dubbed us “hospitalists.” A year later, our shared workshop was born. Through one name change and now our first CEO transition from Larry Wellikson, MD, to Eric Howell, MD, SHM will continue to be where hospitalists both adapt and shape our nation through solutions that put an end to these pandemics. Let’s recommit to this work together.

Dr. Siy is division medical director, hospital specialties, in the departments of hospital medicine and community senior and palliative care, at HealthPartners in Bloomington, Minn. He is president-elect of SHM.

Sources

1. Hardeman RR et al. Stolen Breaths. N Engl J Med. 2020 Jul 16;383:197-9.

2. Siy JC. Reviving Rural Health Care. The Hospitalist. 2018 Sep 24.

3. The Cecil G. Sheps Center For Health Services Research. Rural Hospital Closures. 2014. https://www.shepscenter.unc.edu/programs-projects/rural-health/rural-hospital-closures/

Overwhelmed. As if we weren’t already overwhelmed. For decades, hospitalists have been on the forefront of improving acute care amidst a rapidly changing environment. These last few decades have seen tremendous advances in medicine, technology, safety culture, innovations in payment models, transformation in business models, and a rising tide of health care policy. There was never a year we didn’t face major change … and adapt to it. Then 2020 came upon us.

This year, we adapt to more than a score and 4 years’ worth of change.

The two pandemics that have come upon us are like tsunamis. And many of us are drowning. We know of threats of pandemics: influenza, Ebola, and the like. But SARS-CoV-2 is new and like no other. We live in fear and isolation, each and every day learning new information and debunking others. We also know of racial injustice and racism, implicit or explicit in our nation, whether we live it or just read of it. George Floyd’s death in my hometown marked another tsunami, a great realization in our nation, and a great unmasking of our denial.

Yet our country is not united.

Hospital medicine is not immune to this disunity. At a time that we are all treading water, staying afloat in our own hospitals and communities, confronting these issues beyond our immediate spheres of influence is overwhelming. We are impacted by these pandemics, personally and professionally. And admittedly, we can be both victim and perpetrator.

In the face of a novel infectious agent, medicine responded quickly and pushed us beyond our limits. We have developed new infection prevention guidelines. We worked creatively to solve PPE shortages. We fashioned new work flows and new care models. We accelerated telehealth applications. We expanded the boundaries on home-based programs and reached out to vulnerable elderly in congregate living – an isolation no older person should have to endure. We cared for our colleagues, neighbors, and family members who fell ill, some who recovered, and sadly, some who fell. We developed best-practice guidelines, research protocols, created new order sets, note templates, and documentation standards. We flexed into EDs, ICUs, and field hospitals. Amidst the turmoil, we took pay cuts and saw colleagues go on furlough. And still, we mentored leaders in our schools, churches, synagogues, mosques, and civic communities.

And just when we thought we could endure no more, on May 25, we witnessed a black man in Minneapolis killed by a policeman’s knee. The same knee that divided Americans when black American athletes knelt to protest the injustice their people have endured for centuries. A knee that has been confused for insolence, when it was meant for justice ... yes, justice, for all. So, in early June, around the nation in support of black lives we also knelt, for almost 9 minutes.

This was the third time I cried during the pandemics.

For many of us, structural racism in America had finally been unmasked. The nation protested and rioted for weeks, and some communities have continued. Indeed, these two pandemics are still surging.

Side by side COVID-19 case conferences we lay transparent data demonstrating health disparities that we have tolerated for so long. We have vowed to resource equity work, and we opened dialogue, not only with patients and communities of color, but also with colleagues of color – some ready and some not yet ready to share and relive the traumas of their past and their present.

And still, we are not united.

While we physically mask to prevent the spread of COVID-19, we must make efforts to unmask the truths of SARS-CoV-2, the failings of our health system, the richness of our communities of color, and the injustice in the fabric of our society. More importantly, we must work together to create solutions. While we have diverse interests and priorities, at SHM, we can find common ground with kindred spirits, enhance the role of our specialty, and advance the health of our patients.

Let’s not be mistaken. These pandemics add to a growing list of interwoven issues in our society. In 2018, I wrote a piece on the role of hospitalists in addressing rural health disparities.¹ According to the Sheps Center for Health Services Research, 129 rural hospitals have closed since 2010, closures that have accelerated with the COVID-19 pandemic.² More than ever, we must stand above our inner and outer conflicts and be united to promote the health of our nation during these pandemics, because “all policy is health policy.”³

Most SHM presidents and president-elects come in with a platform, a priority for the specialty and for the society. This year, the platform has chosen us. For 20 years, I have witnessed SHM be a workshop for our members to address the pressing needs of our specialty and our patients. In 2020, we’ve continued to see SHM as a workshop for our members and a tour de force addressing these pandemics, from just in time publications of research and perspectives in the Journal of Hospital Medicine, to webinars and open access education in the Learning Portal, to advocacy on Capitol Hill. All of that work has been informed by you and for you. While there is still so much to do, we need not be overwhelmed when we do it together.

A score and 4 years ago, Robert Wachter, MD, and Lee Goldman, MD, dubbed us “hospitalists.” A year later, our shared workshop was born. Through one name change and now our first CEO transition from Larry Wellikson, MD, to Eric Howell, MD, SHM will continue to be where hospitalists both adapt and shape our nation through solutions that put an end to these pandemics. Let’s recommit to this work together.

Dr. Siy is division medical director, hospital specialties, in the departments of hospital medicine and community senior and palliative care, at HealthPartners in Bloomington, Minn. He is president-elect of SHM.

Sources

1. Hardeman RR et al. Stolen Breaths. N Engl J Med. 2020 Jul 16;383:197-9.

2. Siy JC. Reviving Rural Health Care. The Hospitalist. 2018 Sep 24.

3. The Cecil G. Sheps Center For Health Services Research. Rural Hospital Closures. 2014. https://www.shepscenter.unc.edu/programs-projects/rural-health/rural-hospital-closures/

Overwhelmed. As if we weren’t already overwhelmed. For decades, hospitalists have been on the forefront of improving acute care amidst a rapidly changing environment. These last few decades have seen tremendous advances in medicine, technology, safety culture, innovations in payment models, transformation in business models, and a rising tide of health care policy. There was never a year we didn’t face major change … and adapt to it. Then 2020 came upon us.

This year, we adapt to more than a score and 4 years’ worth of change.

The two pandemics that have come upon us are like tsunamis. And many of us are drowning. We know of threats of pandemics: influenza, Ebola, and the like. But SARS-CoV-2 is new and like no other. We live in fear and isolation, each and every day learning new information and debunking others. We also know of racial injustice and racism, implicit or explicit in our nation, whether we live it or just read of it. George Floyd’s death in my hometown marked another tsunami, a great realization in our nation, and a great unmasking of our denial.

Yet our country is not united.

Hospital medicine is not immune to this disunity. At a time that we are all treading water, staying afloat in our own hospitals and communities, confronting these issues beyond our immediate spheres of influence is overwhelming. We are impacted by these pandemics, personally and professionally. And admittedly, we can be both victim and perpetrator.

In the face of a novel infectious agent, medicine responded quickly and pushed us beyond our limits. We have developed new infection prevention guidelines. We worked creatively to solve PPE shortages. We fashioned new work flows and new care models. We accelerated telehealth applications. We expanded the boundaries on home-based programs and reached out to vulnerable elderly in congregate living – an isolation no older person should have to endure. We cared for our colleagues, neighbors, and family members who fell ill, some who recovered, and sadly, some who fell. We developed best-practice guidelines, research protocols, created new order sets, note templates, and documentation standards. We flexed into EDs, ICUs, and field hospitals. Amidst the turmoil, we took pay cuts and saw colleagues go on furlough. And still, we mentored leaders in our schools, churches, synagogues, mosques, and civic communities.

And just when we thought we could endure no more, on May 25, we witnessed a black man in Minneapolis killed by a policeman’s knee. The same knee that divided Americans when black American athletes knelt to protest the injustice their people have endured for centuries. A knee that has been confused for insolence, when it was meant for justice ... yes, justice, for all. So, in early June, around the nation in support of black lives we also knelt, for almost 9 minutes.

This was the third time I cried during the pandemics.

For many of us, structural racism in America had finally been unmasked. The nation protested and rioted for weeks, and some communities have continued. Indeed, these two pandemics are still surging.

Side by side COVID-19 case conferences we lay transparent data demonstrating health disparities that we have tolerated for so long. We have vowed to resource equity work, and we opened dialogue, not only with patients and communities of color, but also with colleagues of color – some ready and some not yet ready to share and relive the traumas of their past and their present.

And still, we are not united.

While we physically mask to prevent the spread of COVID-19, we must make efforts to unmask the truths of SARS-CoV-2, the failings of our health system, the richness of our communities of color, and the injustice in the fabric of our society. More importantly, we must work together to create solutions. While we have diverse interests and priorities, at SHM, we can find common ground with kindred spirits, enhance the role of our specialty, and advance the health of our patients.

Let’s not be mistaken. These pandemics add to a growing list of interwoven issues in our society. In 2018, I wrote a piece on the role of hospitalists in addressing rural health disparities.¹ According to the Sheps Center for Health Services Research, 129 rural hospitals have closed since 2010, closures that have accelerated with the COVID-19 pandemic.² More than ever, we must stand above our inner and outer conflicts and be united to promote the health of our nation during these pandemics, because “all policy is health policy.”³

Most SHM presidents and president-elects come in with a platform, a priority for the specialty and for the society. This year, the platform has chosen us. For 20 years, I have witnessed SHM be a workshop for our members to address the pressing needs of our specialty and our patients. In 2020, we’ve continued to see SHM as a workshop for our members and a tour de force addressing these pandemics, from just in time publications of research and perspectives in the Journal of Hospital Medicine, to webinars and open access education in the Learning Portal, to advocacy on Capitol Hill. All of that work has been informed by you and for you. While there is still so much to do, we need not be overwhelmed when we do it together.

A score and 4 years ago, Robert Wachter, MD, and Lee Goldman, MD, dubbed us “hospitalists.” A year later, our shared workshop was born. Through one name change and now our first CEO transition from Larry Wellikson, MD, to Eric Howell, MD, SHM will continue to be where hospitalists both adapt and shape our nation through solutions that put an end to these pandemics. Let’s recommit to this work together.

Dr. Siy is division medical director, hospital specialties, in the departments of hospital medicine and community senior and palliative care, at HealthPartners in Bloomington, Minn. He is president-elect of SHM.

Sources

1. Hardeman RR et al. Stolen Breaths. N Engl J Med. 2020 Jul 16;383:197-9.

2. Siy JC. Reviving Rural Health Care. The Hospitalist. 2018 Sep 24.

3. The Cecil G. Sheps Center For Health Services Research. Rural Hospital Closures. 2014. https://www.shepscenter.unc.edu/programs-projects/rural-health/rural-hospital-closures/

Individuals are more worried about family members becoming ill with COVID-19 or about unknowingly transmitting the disease to family members than they are about contracting it themselves, results of a new survey show.

Investigators surveyed over 3,000 adults, using an online questionnaire. Of the respondents, about 20% were health care workers, and most were living in locations with active stay-at-home orders at the time of the survey.

Interactive platform

“The pandemic has provided a unique opportunity to study resilience in healthcare professionals and others,” said Barzilay, assistant professor at the Lifespan Brain Institute, a collaboration between CHOP and the University of Pennsylvania, under the directorship of Raquel Gur, MD, PhD.

“After the pandemic broke out in March, we launched a website in early April where we surveyed people for levels of resilience, mental health, and well-being during the outbreak,” he added.

Tend and befriend

Ten days into the survey, data were available on 3,042 participants (64% women, 54% with advanced education, 20.5% health care providers), who ranged in age from 18 to 70 years (mean [SD], 38.9 [11.9] years).

After accounting for covariates, the researchers found that participants reported more distress about family members contracting COVID-19 and about unknowingly infecting others than about getting COVID-19 themselves (48.5% and 36% vs. 19.9%, respectively; P < .0005).

Increased COVID-19-related worries were associated with 22% higher anxiety and 16.1% higher depression scores; women had higher scores than men on both.

Each 1-SD increase in the composite score of COVID-19 worries was associated with over twice the increased probability of generalized anxiety and depression (odds ratio, 2.23; 95% confidence interval, 1.88-2.65; and OR, 1.67; 95% CI, 1.41-1.98, respectively; for both, P < .001).

On the other hand, for every 1-SD increase in the resilience score, there was a 64.9% decrease in the possibility of screening positive for generalized anxiety disorder and a 69.3% decrease in the possibility of screening positive for depression (for both, P < .0001).

Compared to participants from Israel, US participants were “more stressed” about contracting, dying from, and currently having COVID-19 themselves. Overall, Israeli participants scored higher than US participants on the resilience scale.

Rates of anxiety and depression did not differ significantly between healthcare providers and others. Health care providers worried more about contracting COVID-19 themselves and worried less about finances after COVID-19.

The authors propose that survey participants were more worried about others than about themselves because of “prosocial behavior under stress” and “tend-and-befriend,” whereby, “in response to threat, humans tend to protect their close ones (tending) and seek out their social group for mutual defense (befriending).”

This type of altruistic behavior has been “described in acute situations throughout history” and has been “linked to mechanisms of resilience for overcoming adversity,” the authors indicate.
 

Demographic biases

Commenting on the findings for Medscape Medical News, Golnaz Tabibnia, PhD, a neuroscientist at the University of California, Irvine, who was not involved in the research, suggested that although higher resilience scores were associated with lower COVID-related worries, it is possible, “as the authors suggest, that having more resilience resources makes you less worried, but the causality could go the other direction as well, and less worry/rumination may lead to more resilience.”

Also commenting on the study for Medscape Medical News, Christiaan Vinkers, MD, PhD, a psychiatrist at the Amsterdam University Medical Center, Amsterdam, the Netherlands, said it was noteworthy that healthcare providers reported similar levels of mood and anxiety symptoms, compared to others.

“This is encouraging, as it suggests adequate resilience levels in professionals who work in the front lines of the COVID-19 pandemic,” he said.

Resilience occurs not only at the individual level but also at the community level, which may help explain the striking differences in COVID-19-related worries and anxiety between participants from the United States and Israel, Vinkers added.

E. Alison Holman, PhD, professor, Sue and Bill Gross School of Nursing, University of California, Irvine, noted that respondents were predominantly white, female, and had relatively high incomes, “suggesting strong demographic biases in those who chose to participate.”

This article first appeared on Medscape.com.

Individuals are more worried about family members becoming ill with COVID-19 or about unknowingly transmitting the disease to family members than they are about contracting it themselves, results of a new survey show.

Investigators surveyed over 3,000 adults, using an online questionnaire. Of the respondents, about 20% were health care workers, and most were living in locations with active stay-at-home orders at the time of the survey.

Interactive platform

“The pandemic has provided a unique opportunity to study resilience in healthcare professionals and others,” said Barzilay, assistant professor at the Lifespan Brain Institute, a collaboration between CHOP and the University of Pennsylvania, under the directorship of Raquel Gur, MD, PhD.

“After the pandemic broke out in March, we launched a website in early April where we surveyed people for levels of resilience, mental health, and well-being during the outbreak,” he added.

Tend and befriend

Ten days into the survey, data were available on 3,042 participants (64% women, 54% with advanced education, 20.5% health care providers), who ranged in age from 18 to 70 years (mean [SD], 38.9 [11.9] years).

After accounting for covariates, the researchers found that participants reported more distress about family members contracting COVID-19 and about unknowingly infecting others than about getting COVID-19 themselves (48.5% and 36% vs. 19.9%, respectively; P < .0005).

Increased COVID-19-related worries were associated with 22% higher anxiety and 16.1% higher depression scores; women had higher scores than men on both.

Each 1-SD increase in the composite score of COVID-19 worries was associated with over twice the increased probability of generalized anxiety and depression (odds ratio, 2.23; 95% confidence interval, 1.88-2.65; and OR, 1.67; 95% CI, 1.41-1.98, respectively; for both, P < .001).

On the other hand, for every 1-SD increase in the resilience score, there was a 64.9% decrease in the possibility of screening positive for generalized anxiety disorder and a 69.3% decrease in the possibility of screening positive for depression (for both, P < .0001).

Compared to participants from Israel, US participants were “more stressed” about contracting, dying from, and currently having COVID-19 themselves. Overall, Israeli participants scored higher than US participants on the resilience scale.

Rates of anxiety and depression did not differ significantly between healthcare providers and others. Health care providers worried more about contracting COVID-19 themselves and worried less about finances after COVID-19.

The authors propose that survey participants were more worried about others than about themselves because of “prosocial behavior under stress” and “tend-and-befriend,” whereby, “in response to threat, humans tend to protect their close ones (tending) and seek out their social group for mutual defense (befriending).”

This type of altruistic behavior has been “described in acute situations throughout history” and has been “linked to mechanisms of resilience for overcoming adversity,” the authors indicate.
 

Demographic biases

Commenting on the findings for Medscape Medical News, Golnaz Tabibnia, PhD, a neuroscientist at the University of California, Irvine, who was not involved in the research, suggested that although higher resilience scores were associated with lower COVID-related worries, it is possible, “as the authors suggest, that having more resilience resources makes you less worried, but the causality could go the other direction as well, and less worry/rumination may lead to more resilience.”

Also commenting on the study for Medscape Medical News, Christiaan Vinkers, MD, PhD, a psychiatrist at the Amsterdam University Medical Center, Amsterdam, the Netherlands, said it was noteworthy that healthcare providers reported similar levels of mood and anxiety symptoms, compared to others.

“This is encouraging, as it suggests adequate resilience levels in professionals who work in the front lines of the COVID-19 pandemic,” he said.

Resilience occurs not only at the individual level but also at the community level, which may help explain the striking differences in COVID-19-related worries and anxiety between participants from the United States and Israel, Vinkers added.

E. Alison Holman, PhD, professor, Sue and Bill Gross School of Nursing, University of California, Irvine, noted that respondents were predominantly white, female, and had relatively high incomes, “suggesting strong demographic biases in those who chose to participate.”

This article first appeared on Medscape.com.

Individuals are more worried about family members becoming ill with COVID-19 or about unknowingly transmitting the disease to family members than they are about contracting it themselves, results of a new survey show.

Investigators surveyed over 3,000 adults, using an online questionnaire. Of the respondents, about 20% were health care workers, and most were living in locations with active stay-at-home orders at the time of the survey.

Interactive platform

“The pandemic has provided a unique opportunity to study resilience in healthcare professionals and others,” said Barzilay, assistant professor at the Lifespan Brain Institute, a collaboration between CHOP and the University of Pennsylvania, under the directorship of Raquel Gur, MD, PhD.

“After the pandemic broke out in March, we launched a website in early April where we surveyed people for levels of resilience, mental health, and well-being during the outbreak,” he added.

Tend and befriend

Ten days into the survey, data were available on 3,042 participants (64% women, 54% with advanced education, 20.5% health care providers), who ranged in age from 18 to 70 years (mean [SD], 38.9 [11.9] years).

After accounting for covariates, the researchers found that participants reported more distress about family members contracting COVID-19 and about unknowingly infecting others than about getting COVID-19 themselves (48.5% and 36% vs. 19.9%, respectively; P < .0005).

Increased COVID-19-related worries were associated with 22% higher anxiety and 16.1% higher depression scores; women had higher scores than men on both.

Each 1-SD increase in the composite score of COVID-19 worries was associated with over twice the increased probability of generalized anxiety and depression (odds ratio, 2.23; 95% confidence interval, 1.88-2.65; and OR, 1.67; 95% CI, 1.41-1.98, respectively; for both, P < .001).

On the other hand, for every 1-SD increase in the resilience score, there was a 64.9% decrease in the possibility of screening positive for generalized anxiety disorder and a 69.3% decrease in the possibility of screening positive for depression (for both, P < .0001).

Compared to participants from Israel, US participants were “more stressed” about contracting, dying from, and currently having COVID-19 themselves. Overall, Israeli participants scored higher than US participants on the resilience scale.

Rates of anxiety and depression did not differ significantly between healthcare providers and others. Health care providers worried more about contracting COVID-19 themselves and worried less about finances after COVID-19.

The authors propose that survey participants were more worried about others than about themselves because of “prosocial behavior under stress” and “tend-and-befriend,” whereby, “in response to threat, humans tend to protect their close ones (tending) and seek out their social group for mutual defense (befriending).”

This type of altruistic behavior has been “described in acute situations throughout history” and has been “linked to mechanisms of resilience for overcoming adversity,” the authors indicate.
 

Demographic biases

Commenting on the findings for Medscape Medical News, Golnaz Tabibnia, PhD, a neuroscientist at the University of California, Irvine, who was not involved in the research, suggested that although higher resilience scores were associated with lower COVID-related worries, it is possible, “as the authors suggest, that having more resilience resources makes you less worried, but the causality could go the other direction as well, and less worry/rumination may lead to more resilience.”

Also commenting on the study for Medscape Medical News, Christiaan Vinkers, MD, PhD, a psychiatrist at the Amsterdam University Medical Center, Amsterdam, the Netherlands, said it was noteworthy that healthcare providers reported similar levels of mood and anxiety symptoms, compared to others.

“This is encouraging, as it suggests adequate resilience levels in professionals who work in the front lines of the COVID-19 pandemic,” he said.

Resilience occurs not only at the individual level but also at the community level, which may help explain the striking differences in COVID-19-related worries and anxiety between participants from the United States and Israel, Vinkers added.

E. Alison Holman, PhD, professor, Sue and Bill Gross School of Nursing, University of California, Irvine, noted that respondents were predominantly white, female, and had relatively high incomes, “suggesting strong demographic biases in those who chose to participate.”

This article first appeared on Medscape.com.

Two important lessons about managing patients with multiple sclerosis (MS) and COVID-19 have emerged from a hospital clinic in Madrid that managed COVID-infected patients with MS through the peak of the pandemic: Combined polymeric chain reaction and serology testing helped avoid disease reactivation in asymptomatic carriers during the pandemic peak, although after the peak PCR alone proved just as effective; and infected MS patients could stay on their MS medications while being treated for COVID-19, as fewer than one in five required hospitalization.

Virginia Meca-Lallana, MD, a neurologist and coordinator of the demyelinating diseases unit at the Hospital of the University of the Princess in Madrid, and colleagues presented their findings in two posters at the Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

“MS treatments don’t seem to make the prognosis of COVID-19 worse, but it is very important to evaluate other risk factors,” Dr. Meca-Lallana said in an interview. “MS treatments prevent the patients’ disability, and it is very important not to stop them if it isn’t necessary.”

The results arose from a multidisciplinary safety protocol involving neurology, microbiology, and preventive medicine that the University of Princess physicians developed to keep MS stable in patients diagnosed with SARS-CoV-2.

The researchers obtained 152 PCR nasopharyngeal swabs and 140 serology tests in 90 patients with MS over 3 months before starting a variety of MS treatments: Natalizumab (96 tests), ocrelizumab (36), rituximab (3), methylprednisolone (7), cladribine (4), and dimethyl fumarate (3). The protocol identified 7 asymptomatic carriers—7.8% of the total population—5 of whom had positive immunoglobulin M and G serology. The study also confirmed 5 patients with positive IgM+IgG serology post-infection, but no COVID-19 reactivations were detected after implementation of the protocol.

“The safety protocol reached its objective of avoiding disease reactivation and clinical activation in asymptomatic carriers,” Dr. Meca-Lallana said.

The second poster she presented reported on the real-world experience with SARS-CoV-2 in the MS unit at her hospital. The observational, prospective study included 41 cases, 38 of which were relapsing-remitting MS and the remainder progressive MS. The patients had MS for an average of 9 years.

“We need more patients to draw more robust conclusions, but in our patients, MS treatments seem safe in this situation,” Dr. Meca-Lallana said. “We did not discontinue treatments, and after our first results, we only delayed treatments in patients with any additional comorbidity or when coming to the hospital was not safe.”

A total of 39 patients were taking disease-modifying therapies (DMTs): 46.3% with oral agents, 39% with monoclonal antibodies, and 10% with injectable agents; 27 patients were previously treated with other DMTs. The median Expanded Disability Status Scale (EDSS) was 2.5, and 11 patients had clinical activity the previous year. Eighteen cases were confirmed by PCR or serology, or both, and 23 were diagnosed clinically.

Among the patients with MS and COVID-19, 17% were admitted to the hospital. Six patients had pneumonia, but none required admission to the intensive care unit, and no deaths occurred. Three patients had other comorbidities. Admitted patients tended to be older and had higher EDSS scores, although the difference was not statistically significant. MS worsened in 7 patients, and 10 patients stopped or paused DMTs because of the infection.

“Multiple sclerosis is a weakening illness,” Dr. Meca-Lallana said. “MS treatments do not seem to make the prognosis of COVID-19 worse, but it is very important to evaluate other risk factors.”

The SARS-CoV-2 infection does not seem to result in a more aggressive form of the disease in MS patients, and selective immunosuppression may improve their outcomes, she noted.

“MS treatments avoid the patient’s disability,” the investigator added, “and it is very important not to stop them if it isn’t necessary.”

Dr. Meca-Lallana had no relevant financial disclosures.

Two important lessons about managing patients with multiple sclerosis (MS) and COVID-19 have emerged from a hospital clinic in Madrid that managed COVID-infected patients with MS through the peak of the pandemic: Combined polymeric chain reaction and serology testing helped avoid disease reactivation in asymptomatic carriers during the pandemic peak, although after the peak PCR alone proved just as effective; and infected MS patients could stay on their MS medications while being treated for COVID-19, as fewer than one in five required hospitalization.

Virginia Meca-Lallana, MD, a neurologist and coordinator of the demyelinating diseases unit at the Hospital of the University of the Princess in Madrid, and colleagues presented their findings in two posters at the Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

“MS treatments don’t seem to make the prognosis of COVID-19 worse, but it is very important to evaluate other risk factors,” Dr. Meca-Lallana said in an interview. “MS treatments prevent the patients’ disability, and it is very important not to stop them if it isn’t necessary.”

The results arose from a multidisciplinary safety protocol involving neurology, microbiology, and preventive medicine that the University of Princess physicians developed to keep MS stable in patients diagnosed with SARS-CoV-2.

The researchers obtained 152 PCR nasopharyngeal swabs and 140 serology tests in 90 patients with MS over 3 months before starting a variety of MS treatments: Natalizumab (96 tests), ocrelizumab (36), rituximab (3), methylprednisolone (7), cladribine (4), and dimethyl fumarate (3). The protocol identified 7 asymptomatic carriers—7.8% of the total population—5 of whom had positive immunoglobulin M and G serology. The study also confirmed 5 patients with positive IgM+IgG serology post-infection, but no COVID-19 reactivations were detected after implementation of the protocol.

“The safety protocol reached its objective of avoiding disease reactivation and clinical activation in asymptomatic carriers,” Dr. Meca-Lallana said.

The second poster she presented reported on the real-world experience with SARS-CoV-2 in the MS unit at her hospital. The observational, prospective study included 41 cases, 38 of which were relapsing-remitting MS and the remainder progressive MS. The patients had MS for an average of 9 years.

“We need more patients to draw more robust conclusions, but in our patients, MS treatments seem safe in this situation,” Dr. Meca-Lallana said. “We did not discontinue treatments, and after our first results, we only delayed treatments in patients with any additional comorbidity or when coming to the hospital was not safe.”

A total of 39 patients were taking disease-modifying therapies (DMTs): 46.3% with oral agents, 39% with monoclonal antibodies, and 10% with injectable agents; 27 patients were previously treated with other DMTs. The median Expanded Disability Status Scale (EDSS) was 2.5, and 11 patients had clinical activity the previous year. Eighteen cases were confirmed by PCR or serology, or both, and 23 were diagnosed clinically.

Among the patients with MS and COVID-19, 17% were admitted to the hospital. Six patients had pneumonia, but none required admission to the intensive care unit, and no deaths occurred. Three patients had other comorbidities. Admitted patients tended to be older and had higher EDSS scores, although the difference was not statistically significant. MS worsened in 7 patients, and 10 patients stopped or paused DMTs because of the infection.

“Multiple sclerosis is a weakening illness,” Dr. Meca-Lallana said. “MS treatments do not seem to make the prognosis of COVID-19 worse, but it is very important to evaluate other risk factors.”

The SARS-CoV-2 infection does not seem to result in a more aggressive form of the disease in MS patients, and selective immunosuppression may improve their outcomes, she noted.

“MS treatments avoid the patient’s disability,” the investigator added, “and it is very important not to stop them if it isn’t necessary.”

Dr. Meca-Lallana had no relevant financial disclosures.

Two important lessons about managing patients with multiple sclerosis (MS) and COVID-19 have emerged from a hospital clinic in Madrid that managed COVID-infected patients with MS through the peak of the pandemic: Combined polymeric chain reaction and serology testing helped avoid disease reactivation in asymptomatic carriers during the pandemic peak, although after the peak PCR alone proved just as effective; and infected MS patients could stay on their MS medications while being treated for COVID-19, as fewer than one in five required hospitalization.

Virginia Meca-Lallana, MD, a neurologist and coordinator of the demyelinating diseases unit at the Hospital of the University of the Princess in Madrid, and colleagues presented their findings in two posters at the Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.

“MS treatments don’t seem to make the prognosis of COVID-19 worse, but it is very important to evaluate other risk factors,” Dr. Meca-Lallana said in an interview. “MS treatments prevent the patients’ disability, and it is very important not to stop them if it isn’t necessary.”

The results arose from a multidisciplinary safety protocol involving neurology, microbiology, and preventive medicine that the University of Princess physicians developed to keep MS stable in patients diagnosed with SARS-CoV-2.

The researchers obtained 152 PCR nasopharyngeal swabs and 140 serology tests in 90 patients with MS over 3 months before starting a variety of MS treatments: Natalizumab (96 tests), ocrelizumab (36), rituximab (3), methylprednisolone (7), cladribine (4), and dimethyl fumarate (3). The protocol identified 7 asymptomatic carriers—7.8% of the total population—5 of whom had positive immunoglobulin M and G serology. The study also confirmed 5 patients with positive IgM+IgG serology post-infection, but no COVID-19 reactivations were detected after implementation of the protocol.

“The safety protocol reached its objective of avoiding disease reactivation and clinical activation in asymptomatic carriers,” Dr. Meca-Lallana said.

The second poster she presented reported on the real-world experience with SARS-CoV-2 in the MS unit at her hospital. The observational, prospective study included 41 cases, 38 of which were relapsing-remitting MS and the remainder progressive MS. The patients had MS for an average of 9 years.

“We need more patients to draw more robust conclusions, but in our patients, MS treatments seem safe in this situation,” Dr. Meca-Lallana said. “We did not discontinue treatments, and after our first results, we only delayed treatments in patients with any additional comorbidity or when coming to the hospital was not safe.”

A total of 39 patients were taking disease-modifying therapies (DMTs): 46.3% with oral agents, 39% with monoclonal antibodies, and 10% with injectable agents; 27 patients were previously treated with other DMTs. The median Expanded Disability Status Scale (EDSS) was 2.5, and 11 patients had clinical activity the previous year. Eighteen cases were confirmed by PCR or serology, or both, and 23 were diagnosed clinically.

Among the patients with MS and COVID-19, 17% were admitted to the hospital. Six patients had pneumonia, but none required admission to the intensive care unit, and no deaths occurred. Three patients had other comorbidities. Admitted patients tended to be older and had higher EDSS scores, although the difference was not statistically significant. MS worsened in 7 patients, and 10 patients stopped or paused DMTs because of the infection.

“Multiple sclerosis is a weakening illness,” Dr. Meca-Lallana said. “MS treatments do not seem to make the prognosis of COVID-19 worse, but it is very important to evaluate other risk factors.”

The SARS-CoV-2 infection does not seem to result in a more aggressive form of the disease in MS patients, and selective immunosuppression may improve their outcomes, she noted.

“MS treatments avoid the patient’s disability,” the investigator added, “and it is very important not to stop them if it isn’t necessary.”

Dr. Meca-Lallana had no relevant financial disclosures.

In the early weeks and months of the COVID-19 pandemic, many people were trying to avoid the coronavirus by staying away from emergency rooms and medical offices. But how many people is “many”?

Turns out almost 41% of Americans delayed or avoided some form of medical care because of concerns about COVID-19, according to the results of a survey conducted June 24-30 by commercial survey company Qualtrics.

More specifically, the avoidance looks like this: 31.5% of the 4,975 adult respondents had avoided routine care and 12.0% had avoided urgent or emergency care, Mark E. Czeisler and associates said in the Morbidity and Mortality Weekly Report. The two categories were not mutually exclusive since respondents could select both routine care and urgent/emergency care.

There were, however, a number of significant disparities hidden among those numbers for the overall population. Blacks and Hispanics, with respective prevalences of 23.3% and 24.6%, were significantly more likely to delay or avoid urgent/emergency care than were Whites (6.7%), said Mr. Czeisler, a graduate student at Monash University, Melbourne, and associates.

Those differences “are especially concerning given increased COVID-19–associated mortality among Black adults and Hispanic adults,” they noted, adding that “age-adjusted COVID-19 hospitalization rates are approximately five times higher among Black persons and four times higher among Hispanic persons than” among Whites.

Other significant disparities in urgent/emergency care avoidance included the following:

• Unpaid caregivers for adults (29.8%) vs. noncaregivers (5.4%).
• Adults with two or more underlying conditions (22.7%) vs. those without such conditions (8.2%).
• Those with a disability (22.8%) vs. those without (8.9%).
• Those with health insurance (12.4%) vs. those without (7.8%).

The highest prevalence for all types of COVID-19–related delay and avoidance came from the adult caregivers (64.3%), followed by those with a disability (60.3%) and adults aged 18-24 years (57.2%). The lowest prevalence numbers were for adults with health insurance (24.8%) and those who were not caregivers for adults (32.2%), Mr. Czeisler and associates reported.

These reports of delayed and avoided care “might reflect adherence to community mitigation efforts such as stay-at-home orders, temporary closures of health facilities, or additional factors. However, if routine care avoidance were to be sustained, adults could miss opportunities for management of chronic conditions, receipt of routine vaccinations, or early detection of new conditions, which might worsen outcomes,” they wrote.

rfranki@mdedge.com

SOURCE: Czeisler ME et al. MMWR. 2020 Sep 11;69(36):1250-7.

In the early weeks and months of the COVID-19 pandemic, many people were trying to avoid the coronavirus by staying away from emergency rooms and medical offices. But how many people is “many”?

Turns out almost 41% of Americans delayed or avoided some form of medical care because of concerns about COVID-19, according to the results of a survey conducted June 24-30 by commercial survey company Qualtrics.

More specifically, the avoidance looks like this: 31.5% of the 4,975 adult respondents had avoided routine care and 12.0% had avoided urgent or emergency care, Mark E. Czeisler and associates said in the Morbidity and Mortality Weekly Report. The two categories were not mutually exclusive since respondents could select both routine care and urgent/emergency care.

There were, however, a number of significant disparities hidden among those numbers for the overall population. Blacks and Hispanics, with respective prevalences of 23.3% and 24.6%, were significantly more likely to delay or avoid urgent/emergency care than were Whites (6.7%), said Mr. Czeisler, a graduate student at Monash University, Melbourne, and associates.

Those differences “are especially concerning given increased COVID-19–associated mortality among Black adults and Hispanic adults,” they noted, adding that “age-adjusted COVID-19 hospitalization rates are approximately five times higher among Black persons and four times higher among Hispanic persons than” among Whites.

Other significant disparities in urgent/emergency care avoidance included the following:

• Unpaid caregivers for adults (29.8%) vs. noncaregivers (5.4%).
• Adults with two or more underlying conditions (22.7%) vs. those without such conditions (8.2%).
• Those with a disability (22.8%) vs. those without (8.9%).
• Those with health insurance (12.4%) vs. those without (7.8%).

The highest prevalence for all types of COVID-19–related delay and avoidance came from the adult caregivers (64.3%), followed by those with a disability (60.3%) and adults aged 18-24 years (57.2%). The lowest prevalence numbers were for adults with health insurance (24.8%) and those who were not caregivers for adults (32.2%), Mr. Czeisler and associates reported.

These reports of delayed and avoided care “might reflect adherence to community mitigation efforts such as stay-at-home orders, temporary closures of health facilities, or additional factors. However, if routine care avoidance were to be sustained, adults could miss opportunities for management of chronic conditions, receipt of routine vaccinations, or early detection of new conditions, which might worsen outcomes,” they wrote.

rfranki@mdedge.com

SOURCE: Czeisler ME et al. MMWR. 2020 Sep 11;69(36):1250-7.

In the early weeks and months of the COVID-19 pandemic, many people were trying to avoid the coronavirus by staying away from emergency rooms and medical offices. But how many people is “many”?

Turns out almost 41% of Americans delayed or avoided some form of medical care because of concerns about COVID-19, according to the results of a survey conducted June 24-30 by commercial survey company Qualtrics.

More specifically, the avoidance looks like this: 31.5% of the 4,975 adult respondents had avoided routine care and 12.0% had avoided urgent or emergency care, Mark E. Czeisler and associates said in the Morbidity and Mortality Weekly Report. The two categories were not mutually exclusive since respondents could select both routine care and urgent/emergency care.

There were, however, a number of significant disparities hidden among those numbers for the overall population. Blacks and Hispanics, with respective prevalences of 23.3% and 24.6%, were significantly more likely to delay or avoid urgent/emergency care than were Whites (6.7%), said Mr. Czeisler, a graduate student at Monash University, Melbourne, and associates.

Those differences “are especially concerning given increased COVID-19–associated mortality among Black adults and Hispanic adults,” they noted, adding that “age-adjusted COVID-19 hospitalization rates are approximately five times higher among Black persons and four times higher among Hispanic persons than” among Whites.

Other significant disparities in urgent/emergency care avoidance included the following:

• Unpaid caregivers for adults (29.8%) vs. noncaregivers (5.4%).
• Adults with two or more underlying conditions (22.7%) vs. those without such conditions (8.2%).
• Those with a disability (22.8%) vs. those without (8.9%).
• Those with health insurance (12.4%) vs. those without (7.8%).

The highest prevalence for all types of COVID-19–related delay and avoidance came from the adult caregivers (64.3%), followed by those with a disability (60.3%) and adults aged 18-24 years (57.2%). The lowest prevalence numbers were for adults with health insurance (24.8%) and those who were not caregivers for adults (32.2%), Mr. Czeisler and associates reported.

These reports of delayed and avoided care “might reflect adherence to community mitigation efforts such as stay-at-home orders, temporary closures of health facilities, or additional factors. However, if routine care avoidance were to be sustained, adults could miss opportunities for management of chronic conditions, receipt of routine vaccinations, or early detection of new conditions, which might worsen outcomes,” they wrote.

rfranki@mdedge.com

SOURCE: Czeisler ME et al. MMWR. 2020 Sep 11;69(36):1250-7.

The nation’s largest physician association is seeking to establish a path to payment for extra practice expenses required to care for patients during the COVID pandemic and possible future public health emergencies.

The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.

Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.

The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.

“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”

Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.

“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
 

Code looks ahead to future use

The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.

The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.

“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.

The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.

“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”

The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.

More information is available on the AMA website.

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

The nation’s largest physician association is seeking to establish a path to payment for extra practice expenses required to care for patients during the COVID pandemic and possible future public health emergencies.

The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.

Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.

The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.

“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”

Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.

“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
 

Code looks ahead to future use

The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.

The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.

“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.

The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.

“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”

The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.

More information is available on the AMA website.

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

The nation’s largest physician association is seeking to establish a path to payment for extra practice expenses required to care for patients during the COVID pandemic and possible future public health emergencies.

The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.

Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.

The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.

“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”

Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.

“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
 

Code looks ahead to future use

The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.

The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.

“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.

The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.

“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”

The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.

More information is available on the AMA website.

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

For children with COVID-19, rates of hospitalization, ICU admission, and ventilator use were similar to those of children with influenza, but rates differed in other respects, according to results of a study published online Sept. 11 in JAMA Network Open.

As winter approaches, distinguishing patients with COVID-19 from those with influenza will become a problem. To assist with that, Xiaoyan Song, PhD, director of the office of infection control and epidemiology at Children’s National Hospital in Washington, D.C., and colleagues investigated commonalities and differences between the clinical symptoms of COVID-19 and influenza in children.

“Distinguishing COVID-19 from flu and other respiratory viral infections remains a challenge to clinicians. Although our study showed that patients with COVID-19 were more likely than patients with flu to report fever, gastrointestinal, and other clinical symptoms at the time of diagnosis, the two groups do have many overlapping clinical symptoms,” Dr. Song said. “Until future data show us otherwise, clinicians need to prepare for managing coinfections of COVID-19 with flu and/or other respiratory viral infections in the upcoming flu season.”

The retrospective cohort study included 315 children diagnosed with laboratory-confirmed COVID-19 between March 25 and May 15, 2020, and 1,402 children diagnosed with laboratory-confirmed seasonal influenza A or influenza B between Oct. 1, 2019, and June 6, 2020, at Children’s National Hospital. The investigation excluded asymptomatic patients who tested positive for COVID-19.

Patients with COVID-19 and patients with influenza were similar with respect to rates of hospitalization (17% vs. 21%; odds ratio, 0.8; 95% confidence interval, 0.6-1.1; P = .15), admission to the ICU (6% vs. 7%; OR, 0.8; 95% CI, 0.5-1.3; P = .42), and use of mechanical ventilation (3% vs. 2%; OR, 1.5; 95% CI, 0.9-2.6; P =.17).

The difference in the duration of ventilation for the two groups was not statistically significant. None of the patients who had COVID-19 or influenza B died, but two patients with influenza A did.

No patients had coinfections, which the researchers attribute to the mid-March shutdown of many schools, which they believe limited the spread of seasonal influenza.

Patients who were hospitalized with COVID-19 were older (median age, 9.7 years; range, 0.06-23.2 years) than those hospitalized with either type of influenza (median age, 4.2 years; range, 0.04-23.1). Patients older than 15 years made up 37% of patients with COVID-19 but only 6% of those with influenza.

Among patients hospitalized with COVID-19, 65% had at least one underlying medical condition, compared with 42% of those hospitalized for either type of influenza (OR, 2.6; 95% CI, 1.4-4.7; P = .002).

The most common underlying condition was neurologic problems from global developmental delay or seizures, identified in 11 patients (20%) hospitalized with COVID-19 and in 24 patients (8%) hospitalized with influenza (OR, 2.8; 95% CI, 1.3-6.2; P = .002). There was no significant difference between the two groups with respect to a history of asthma, cardiac disease, hematologic disease, and cancer.

For both groups, fever and cough were the most frequently reported symptoms at the time of diagnosis. However, more patients hospitalized with COVID-19 reported fever (76% vs. 55%; OR, 2.6; 95% CI, 1.4-5.1; P = 01), diarrhea or vomiting (26% vs. 12%; OR, 2.5; 95% CI, 1.2-5.0; P = .01), headache (11% vs. 3%; OR, 3.9; 95% CI, 1.3-11.5; P = .01), myalgia (22% vs. 7%; OR, 3.9; 95% CI, 1.8-8.5; P = .001), or chest pain (11% vs. 3%; OR, 3.9; 95% CI, 1.3-11.5; P = .01).

The researchers found no statistically significant differences between the two groups in rates of cough, congestion, sore throat, or shortness of breath.

Comparison of the symptom spectrum between COVID-19 and flu differed with respect to influenza type. More patients with COVID-19 reported fever, cough, diarrhea and vomiting, and myalgia than patients hospitalized with influenza A. But rates of fever, cough, diarrhea or vomiting, headache, or chest pain didn’t differ significantly in patients with COVID-19 and those with influenza B.

Larry K. Kociolek, MD, medical director of infection prevention and control at Ann and Robert H. Lurie Children’s Hospital of Chicago, noted the lower age of patients with flu. “Differentiating the two infections, which is difficult if not impossible based on symptoms alone, may have prognostic implications, depending on the age of the child. Because this study was performed outside peak influenza season, when coinfections would be less likely to occur, we must be vigilant about the potential clinical implications of influenza and SARS-CoV-2 coinfection this fall and winter.”

Clinicians will still have to use a combination of symptoms, examinations, and testing to distinguish the two diseases, said Aimee Sznewajs, MD, medical director of the pediatric hospital medicine department at Children’s Minnesota, Minneapolis. “We will continue to test for influenza and COVID-19 prior to hospitalizations and make decisions about whether to hospitalize based on other clinical factors, such as dehydration, oxygen requirement, and vital sign changes.”

Dr. Sznewajs stressed the importance of maintaining public health strategies, including “ensuring all children get the flu vaccine, encouraging mask wearing and hand hygiene, adequate testing to determine which virus is present, and other mitigation measures if the prevalence of COVID-19 is increasing in the community.”

Dr. Song reiterated those points, noting that clinicians need to make the most of the options they have. “Clinicians already have many great tools on hand. It is extremely important to get the flu vaccine now, especially for kids with underlying medical conditions. Diagnostic tests are available for both COVID-19 and flu. Antiviral treatment for flu is available. Judicious use of these tools will protect the health of providers, kids, and well-being at large.”

The authors noted several limitations for the study, including its retrospective design, that the data came from a single center, and that different platforms were used to detect the viruses.

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

For children with COVID-19, rates of hospitalization, ICU admission, and ventilator use were similar to those of children with influenza, but rates differed in other respects, according to results of a study published online Sept. 11 in JAMA Network Open.

As winter approaches, distinguishing patients with COVID-19 from those with influenza will become a problem. To assist with that, Xiaoyan Song, PhD, director of the office of infection control and epidemiology at Children’s National Hospital in Washington, D.C., and colleagues investigated commonalities and differences between the clinical symptoms of COVID-19 and influenza in children.

“Distinguishing COVID-19 from flu and other respiratory viral infections remains a challenge to clinicians. Although our study showed that patients with COVID-19 were more likely than patients with flu to report fever, gastrointestinal, and other clinical symptoms at the time of diagnosis, the two groups do have many overlapping clinical symptoms,” Dr. Song said. “Until future data show us otherwise, clinicians need to prepare for managing coinfections of COVID-19 with flu and/or other respiratory viral infections in the upcoming flu season.”

The retrospective cohort study included 315 children diagnosed with laboratory-confirmed COVID-19 between March 25 and May 15, 2020, and 1,402 children diagnosed with laboratory-confirmed seasonal influenza A or influenza B between Oct. 1, 2019, and June 6, 2020, at Children’s National Hospital. The investigation excluded asymptomatic patients who tested positive for COVID-19.

Patients with COVID-19 and patients with influenza were similar with respect to rates of hospitalization (17% vs. 21%; odds ratio, 0.8; 95% confidence interval, 0.6-1.1; P = .15), admission to the ICU (6% vs. 7%; OR, 0.8; 95% CI, 0.5-1.3; P = .42), and use of mechanical ventilation (3% vs. 2%; OR, 1.5; 95% CI, 0.9-2.6; P =.17).

The difference in the duration of ventilation for the two groups was not statistically significant. None of the patients who had COVID-19 or influenza B died, but two patients with influenza A did.

No patients had coinfections, which the researchers attribute to the mid-March shutdown of many schools, which they believe limited the spread of seasonal influenza.

Patients who were hospitalized with COVID-19 were older (median age, 9.7 years; range, 0.06-23.2 years) than those hospitalized with either type of influenza (median age, 4.2 years; range, 0.04-23.1). Patients older than 15 years made up 37% of patients with COVID-19 but only 6% of those with influenza.

Among patients hospitalized with COVID-19, 65% had at least one underlying medical condition, compared with 42% of those hospitalized for either type of influenza (OR, 2.6; 95% CI, 1.4-4.7; P = .002).

The most common underlying condition was neurologic problems from global developmental delay or seizures, identified in 11 patients (20%) hospitalized with COVID-19 and in 24 patients (8%) hospitalized with influenza (OR, 2.8; 95% CI, 1.3-6.2; P = .002). There was no significant difference between the two groups with respect to a history of asthma, cardiac disease, hematologic disease, and cancer.

For both groups, fever and cough were the most frequently reported symptoms at the time of diagnosis. However, more patients hospitalized with COVID-19 reported fever (76% vs. 55%; OR, 2.6; 95% CI, 1.4-5.1; P = 01), diarrhea or vomiting (26% vs. 12%; OR, 2.5; 95% CI, 1.2-5.0; P = .01), headache (11% vs. 3%; OR, 3.9; 95% CI, 1.3-11.5; P = .01), myalgia (22% vs. 7%; OR, 3.9; 95% CI, 1.8-8.5; P = .001), or chest pain (11% vs. 3%; OR, 3.9; 95% CI, 1.3-11.5; P = .01).

The researchers found no statistically significant differences between the two groups in rates of cough, congestion, sore throat, or shortness of breath.

Comparison of the symptom spectrum between COVID-19 and flu differed with respect to influenza type. More patients with COVID-19 reported fever, cough, diarrhea and vomiting, and myalgia than patients hospitalized with influenza A. But rates of fever, cough, diarrhea or vomiting, headache, or chest pain didn’t differ significantly in patients with COVID-19 and those with influenza B.

Larry K. Kociolek, MD, medical director of infection prevention and control at Ann and Robert H. Lurie Children’s Hospital of Chicago, noted the lower age of patients with flu. “Differentiating the two infections, which is difficult if not impossible based on symptoms alone, may have prognostic implications, depending on the age of the child. Because this study was performed outside peak influenza season, when coinfections would be less likely to occur, we must be vigilant about the potential clinical implications of influenza and SARS-CoV-2 coinfection this fall and winter.”

Clinicians will still have to use a combination of symptoms, examinations, and testing to distinguish the two diseases, said Aimee Sznewajs, MD, medical director of the pediatric hospital medicine department at Children’s Minnesota, Minneapolis. “We will continue to test for influenza and COVID-19 prior to hospitalizations and make decisions about whether to hospitalize based on other clinical factors, such as dehydration, oxygen requirement, and vital sign changes.”

Dr. Sznewajs stressed the importance of maintaining public health strategies, including “ensuring all children get the flu vaccine, encouraging mask wearing and hand hygiene, adequate testing to determine which virus is present, and other mitigation measures if the prevalence of COVID-19 is increasing in the community.”

Dr. Song reiterated those points, noting that clinicians need to make the most of the options they have. “Clinicians already have many great tools on hand. It is extremely important to get the flu vaccine now, especially for kids with underlying medical conditions. Diagnostic tests are available for both COVID-19 and flu. Antiviral treatment for flu is available. Judicious use of these tools will protect the health of providers, kids, and well-being at large.”

The authors noted several limitations for the study, including its retrospective design, that the data came from a single center, and that different platforms were used to detect the viruses.

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

For children with COVID-19, rates of hospitalization, ICU admission, and ventilator use were similar to those of children with influenza, but rates differed in other respects, according to results of a study published online Sept. 11 in JAMA Network Open.

As winter approaches, distinguishing patients with COVID-19 from those with influenza will become a problem. To assist with that, Xiaoyan Song, PhD, director of the office of infection control and epidemiology at Children’s National Hospital in Washington, D.C., and colleagues investigated commonalities and differences between the clinical symptoms of COVID-19 and influenza in children.

“Distinguishing COVID-19 from flu and other respiratory viral infections remains a challenge to clinicians. Although our study showed that patients with COVID-19 were more likely than patients with flu to report fever, gastrointestinal, and other clinical symptoms at the time of diagnosis, the two groups do have many overlapping clinical symptoms,” Dr. Song said. “Until future data show us otherwise, clinicians need to prepare for managing coinfections of COVID-19 with flu and/or other respiratory viral infections in the upcoming flu season.”

The retrospective cohort study included 315 children diagnosed with laboratory-confirmed COVID-19 between March 25 and May 15, 2020, and 1,402 children diagnosed with laboratory-confirmed seasonal influenza A or influenza B between Oct. 1, 2019, and June 6, 2020, at Children’s National Hospital. The investigation excluded asymptomatic patients who tested positive for COVID-19.

Patients with COVID-19 and patients with influenza were similar with respect to rates of hospitalization (17% vs. 21%; odds ratio, 0.8; 95% confidence interval, 0.6-1.1; P = .15), admission to the ICU (6% vs. 7%; OR, 0.8; 95% CI, 0.5-1.3; P = .42), and use of mechanical ventilation (3% vs. 2%; OR, 1.5; 95% CI, 0.9-2.6; P =.17).

The difference in the duration of ventilation for the two groups was not statistically significant. None of the patients who had COVID-19 or influenza B died, but two patients with influenza A did.

No patients had coinfections, which the researchers attribute to the mid-March shutdown of many schools, which they believe limited the spread of seasonal influenza.

Patients who were hospitalized with COVID-19 were older (median age, 9.7 years; range, 0.06-23.2 years) than those hospitalized with either type of influenza (median age, 4.2 years; range, 0.04-23.1). Patients older than 15 years made up 37% of patients with COVID-19 but only 6% of those with influenza.

Among patients hospitalized with COVID-19, 65% had at least one underlying medical condition, compared with 42% of those hospitalized for either type of influenza (OR, 2.6; 95% CI, 1.4-4.7; P = .002).

The most common underlying condition was neurologic problems from global developmental delay or seizures, identified in 11 patients (20%) hospitalized with COVID-19 and in 24 patients (8%) hospitalized with influenza (OR, 2.8; 95% CI, 1.3-6.2; P = .002). There was no significant difference between the two groups with respect to a history of asthma, cardiac disease, hematologic disease, and cancer.

For both groups, fever and cough were the most frequently reported symptoms at the time of diagnosis. However, more patients hospitalized with COVID-19 reported fever (76% vs. 55%; OR, 2.6; 95% CI, 1.4-5.1; P = 01), diarrhea or vomiting (26% vs. 12%; OR, 2.5; 95% CI, 1.2-5.0; P = .01), headache (11% vs. 3%; OR, 3.9; 95% CI, 1.3-11.5; P = .01), myalgia (22% vs. 7%; OR, 3.9; 95% CI, 1.8-8.5; P = .001), or chest pain (11% vs. 3%; OR, 3.9; 95% CI, 1.3-11.5; P = .01).

The researchers found no statistically significant differences between the two groups in rates of cough, congestion, sore throat, or shortness of breath.

Comparison of the symptom spectrum between COVID-19 and flu differed with respect to influenza type. More patients with COVID-19 reported fever, cough, diarrhea and vomiting, and myalgia than patients hospitalized with influenza A. But rates of fever, cough, diarrhea or vomiting, headache, or chest pain didn’t differ significantly in patients with COVID-19 and those with influenza B.

Larry K. Kociolek, MD, medical director of infection prevention and control at Ann and Robert H. Lurie Children’s Hospital of Chicago, noted the lower age of patients with flu. “Differentiating the two infections, which is difficult if not impossible based on symptoms alone, may have prognostic implications, depending on the age of the child. Because this study was performed outside peak influenza season, when coinfections would be less likely to occur, we must be vigilant about the potential clinical implications of influenza and SARS-CoV-2 coinfection this fall and winter.”

Clinicians will still have to use a combination of symptoms, examinations, and testing to distinguish the two diseases, said Aimee Sznewajs, MD, medical director of the pediatric hospital medicine department at Children’s Minnesota, Minneapolis. “We will continue to test for influenza and COVID-19 prior to hospitalizations and make decisions about whether to hospitalize based on other clinical factors, such as dehydration, oxygen requirement, and vital sign changes.”

Dr. Sznewajs stressed the importance of maintaining public health strategies, including “ensuring all children get the flu vaccine, encouraging mask wearing and hand hygiene, adequate testing to determine which virus is present, and other mitigation measures if the prevalence of COVID-19 is increasing in the community.”

Dr. Song reiterated those points, noting that clinicians need to make the most of the options they have. “Clinicians already have many great tools on hand. It is extremely important to get the flu vaccine now, especially for kids with underlying medical conditions. Diagnostic tests are available for both COVID-19 and flu. Antiviral treatment for flu is available. Judicious use of these tools will protect the health of providers, kids, and well-being at large.”

The authors noted several limitations for the study, including its retrospective design, that the data came from a single center, and that different platforms were used to detect the viruses.

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

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Diagnoses of 12 common pediatric infectious diseases in a large pediatric primary care network declined significantly in the weeks after COVID-19 social distancing (SD) was enacted in Massachusetts, compared with the same time period in 2019, an analysis of EHR data has shown.

ArtMarie/E+

While declines in infectious disease transmission with SD are not surprising, “these data demonstrate the extent to which transmission of common pediatric infections can be altered when close contact with other children is eliminated,” Jonathan Hatoun, MD, MPH of the Pediatric Physicians’ Organization at Children’s in Brookline, Mass., and coauthors wrote in Pediatrics . “Notably, three of the studied diseases, namely, influenza, croup, and bronchiolitis, essentially disappeared with [social distancing].”

The researchers analyzed the weekly incidence of each diagnosis for similar calendar periods in 2019 and 2020. A pre-SD period was defined as week 1-9, starting on Jan. 1, and a post-SD period was defined as week 13-18. (The several-week gap represented an implementation period as social distancing was enacted in the state earlier in 2020, from a declared statewide state of emergency through school closures and stay-at-home advisories.)

To isolate the effect of widespread SD, they performed a “difference-in-differences regression analysis, with diagnosis count as a function of calendar year, time period (pre-SD versus post-SD) and the interaction between the two.” The Massachusetts pediatric network provides care for approximately 375,000 children in 100 locations around the state.

In their research brief, Dr. Hatoun and coauthors presented weekly rates expressed as diagnoses per 100,000 patients per day. The rate of bronchiolitis, for instance, was 18 and 8 in the pre- and post-SD–equivalent weeks of 2019, respectively, and 20 and 0.6 in the pre- and post-SD weeks of 2020. Their analysis showed the rate in the 2020 post-SD period to be 10 diagnoses per 100,000 patients per day lower than they would have expected based on the 2019 trend.

Rates of pneumonia, acute otitis media, and streptococcal pharyngitis were similarly 14, 85, and 31 diagnoses per 100,000 patients per day lower, respectively. The prevalence of each of the other conditions analyzed – the common cold, croup, gastroenteritis, nonstreptococcal pharyngitis, sinusitis, skin and soft tissue infections, and urinary tract infection (UTI) – also was significantly lower in the 2020 post-SD period than would be expected based on 2019 data (P < .001 for all diagnoses).
 

Putting things in perspective

“This study puts numbers to the sense that we have all had in pediatrics – that social distancing appears to have had a dramatic impact on the transmission of common childhood infectious diseases, especially other respiratory viral pathogens,” Audrey R. John, MD, PhD, chief of the division of pediatric infectious disease at Children’s Hospital of Philadelphia, said in an interview.

The authors acknowledged the possible role of families not seeking care, but said that a smaller decrease in diagnoses of UTI – generally not a contagious disease – “suggests that changes in care-seeking behavior had a relatively modest effect on the other observed declines.” (The rate of UTI for the pre- and post-SD periods was 3.3 and 3.7 per 100,000 patients per day in 2019, and 3.4 and 2.4 in 2020, for a difference in differences of –1.5).

In an accompanying editorial, David W. Kimberlin, MD and Erica C. Bjornstad, MD, PhD, MPH, of the University of Alabama at Birmingham, called the report “provocative” and wrote that similar observations of infections dropping during periods of isolation – namely, dramatic declines in influenza and other respiratory viruses in Seattle after a record snowstorm in 2019 – combined with findings from other modeling studies “suggest that the decline [reported in Boston] is indeed real” (Pediatrics 2020. doi: 10.1542/peds.2020-019232).

However, “we also now know that immunization rates for American children have plummeted since the onset of the SARS-CoV-2 pandemic [because of a] ... dramatic decrease in the use of health care during the first months of the pandemic,” they wrote. “Viewed through this lens,” the declines reported in Boston may reflect inflections going “undiagnosed and untreated.”

Ultimately, Dr. Kimberlin and Dr. Bjornstad said, “the verdict remains out.”

Dr. John said that she and others are “concerned about children not seeking care in a timely manner, and [concerned] that reductions in reported infections might be due to a lack of recognition rather than a lack of transmission.”

In Philadelphia, however, declines in admissions for asthma exacerbations, “which are often caused by respiratory viral infections, suggests that this may not be the case,” said Dr. John, who was asked to comment on the study.

In addition, she said, the Massachusetts data showing that UTI diagnoses “are nearly as common this year as in 2019” are “reassuring.”
 

Are there lessons for the future?

Coauthor Louis Vernacchio, MD, MSc, chief medical officer of the Pediatric Physicians’ Organization at Children’s network, said in an interview that beyond the pandemic, it’s likely that “more careful attention to proven infection control practices in daycares and schools could reduce the burden of common infectious diseases in children.”

Dr. John similarly sees a long-term value of quantifying the impact of social distancing. “We’ve always known [for instance] that bronchiolitis is the result of viral infection.” Findings like the Massachusetts data “will help us advise families who might be trying to protect their premature infants (at risk for severe bronchiolitis) through social distancing.”

The analysis covered both in-person and telemedicine encounters occurring on weekdays.

The authors of the research brief indicated they have no relevant financial disclosures and there was no external funding. The authors of the commentary also reported they have no relevant financial disclosures, and Dr. John said she had no relevant financial disclosures.

SOURCE: Hatoun J et al. Pediatrics. 2020. doi: 10.1542/peds.2020-006460.

Diagnoses of 12 common pediatric infectious diseases in a large pediatric primary care network declined significantly in the weeks after COVID-19 social distancing (SD) was enacted in Massachusetts, compared with the same time period in 2019, an analysis of EHR data has shown.

ArtMarie/E+

While declines in infectious disease transmission with SD are not surprising, “these data demonstrate the extent to which transmission of common pediatric infections can be altered when close contact with other children is eliminated,” Jonathan Hatoun, MD, MPH of the Pediatric Physicians’ Organization at Children’s in Brookline, Mass., and coauthors wrote in Pediatrics . “Notably, three of the studied diseases, namely, influenza, croup, and bronchiolitis, essentially disappeared with [social distancing].”

The researchers analyzed the weekly incidence of each diagnosis for similar calendar periods in 2019 and 2020. A pre-SD period was defined as week 1-9, starting on Jan. 1, and a post-SD period was defined as week 13-18. (The several-week gap represented an implementation period as social distancing was enacted in the state earlier in 2020, from a declared statewide state of emergency through school closures and stay-at-home advisories.)

To isolate the effect of widespread SD, they performed a “difference-in-differences regression analysis, with diagnosis count as a function of calendar year, time period (pre-SD versus post-SD) and the interaction between the two.” The Massachusetts pediatric network provides care for approximately 375,000 children in 100 locations around the state.

In their research brief, Dr. Hatoun and coauthors presented weekly rates expressed as diagnoses per 100,000 patients per day. The rate of bronchiolitis, for instance, was 18 and 8 in the pre- and post-SD–equivalent weeks of 2019, respectively, and 20 and 0.6 in the pre- and post-SD weeks of 2020. Their analysis showed the rate in the 2020 post-SD period to be 10 diagnoses per 100,000 patients per day lower than they would have expected based on the 2019 trend.

Rates of pneumonia, acute otitis media, and streptococcal pharyngitis were similarly 14, 85, and 31 diagnoses per 100,000 patients per day lower, respectively. The prevalence of each of the other conditions analyzed – the common cold, croup, gastroenteritis, nonstreptococcal pharyngitis, sinusitis, skin and soft tissue infections, and urinary tract infection (UTI) – also was significantly lower in the 2020 post-SD period than would be expected based on 2019 data (P < .001 for all diagnoses).
 

Putting things in perspective

“This study puts numbers to the sense that we have all had in pediatrics – that social distancing appears to have had a dramatic impact on the transmission of common childhood infectious diseases, especially other respiratory viral pathogens,” Audrey R. John, MD, PhD, chief of the division of pediatric infectious disease at Children’s Hospital of Philadelphia, said in an interview.

The authors acknowledged the possible role of families not seeking care, but said that a smaller decrease in diagnoses of UTI – generally not a contagious disease – “suggests that changes in care-seeking behavior had a relatively modest effect on the other observed declines.” (The rate of UTI for the pre- and post-SD periods was 3.3 and 3.7 per 100,000 patients per day in 2019, and 3.4 and 2.4 in 2020, for a difference in differences of –1.5).

In an accompanying editorial, David W. Kimberlin, MD and Erica C. Bjornstad, MD, PhD, MPH, of the University of Alabama at Birmingham, called the report “provocative” and wrote that similar observations of infections dropping during periods of isolation – namely, dramatic declines in influenza and other respiratory viruses in Seattle after a record snowstorm in 2019 – combined with findings from other modeling studies “suggest that the decline [reported in Boston] is indeed real” (Pediatrics 2020. doi: 10.1542/peds.2020-019232).

However, “we also now know that immunization rates for American children have plummeted since the onset of the SARS-CoV-2 pandemic [because of a] ... dramatic decrease in the use of health care during the first months of the pandemic,” they wrote. “Viewed through this lens,” the declines reported in Boston may reflect inflections going “undiagnosed and untreated.”

Ultimately, Dr. Kimberlin and Dr. Bjornstad said, “the verdict remains out.”

Dr. John said that she and others are “concerned about children not seeking care in a timely manner, and [concerned] that reductions in reported infections might be due to a lack of recognition rather than a lack of transmission.”

In Philadelphia, however, declines in admissions for asthma exacerbations, “which are often caused by respiratory viral infections, suggests that this may not be the case,” said Dr. John, who was asked to comment on the study.

In addition, she said, the Massachusetts data showing that UTI diagnoses “are nearly as common this year as in 2019” are “reassuring.”
 

Are there lessons for the future?

Coauthor Louis Vernacchio, MD, MSc, chief medical officer of the Pediatric Physicians’ Organization at Children’s network, said in an interview that beyond the pandemic, it’s likely that “more careful attention to proven infection control practices in daycares and schools could reduce the burden of common infectious diseases in children.”

Dr. John similarly sees a long-term value of quantifying the impact of social distancing. “We’ve always known [for instance] that bronchiolitis is the result of viral infection.” Findings like the Massachusetts data “will help us advise families who might be trying to protect their premature infants (at risk for severe bronchiolitis) through social distancing.”

The analysis covered both in-person and telemedicine encounters occurring on weekdays.

The authors of the research brief indicated they have no relevant financial disclosures and there was no external funding. The authors of the commentary also reported they have no relevant financial disclosures, and Dr. John said she had no relevant financial disclosures.

SOURCE: Hatoun J et al. Pediatrics. 2020. doi: 10.1542/peds.2020-006460.

Diagnoses of 12 common pediatric infectious diseases in a large pediatric primary care network declined significantly in the weeks after COVID-19 social distancing (SD) was enacted in Massachusetts, compared with the same time period in 2019, an analysis of EHR data has shown.

ArtMarie/E+

While declines in infectious disease transmission with SD are not surprising, “these data demonstrate the extent to which transmission of common pediatric infections can be altered when close contact with other children is eliminated,” Jonathan Hatoun, MD, MPH of the Pediatric Physicians’ Organization at Children’s in Brookline, Mass., and coauthors wrote in Pediatrics . “Notably, three of the studied diseases, namely, influenza, croup, and bronchiolitis, essentially disappeared with [social distancing].”

The researchers analyzed the weekly incidence of each diagnosis for similar calendar periods in 2019 and 2020. A pre-SD period was defined as week 1-9, starting on Jan. 1, and a post-SD period was defined as week 13-18. (The several-week gap represented an implementation period as social distancing was enacted in the state earlier in 2020, from a declared statewide state of emergency through school closures and stay-at-home advisories.)

To isolate the effect of widespread SD, they performed a “difference-in-differences regression analysis, with diagnosis count as a function of calendar year, time period (pre-SD versus post-SD) and the interaction between the two.” The Massachusetts pediatric network provides care for approximately 375,000 children in 100 locations around the state.

In their research brief, Dr. Hatoun and coauthors presented weekly rates expressed as diagnoses per 100,000 patients per day. The rate of bronchiolitis, for instance, was 18 and 8 in the pre- and post-SD–equivalent weeks of 2019, respectively, and 20 and 0.6 in the pre- and post-SD weeks of 2020. Their analysis showed the rate in the 2020 post-SD period to be 10 diagnoses per 100,000 patients per day lower than they would have expected based on the 2019 trend.

Rates of pneumonia, acute otitis media, and streptococcal pharyngitis were similarly 14, 85, and 31 diagnoses per 100,000 patients per day lower, respectively. The prevalence of each of the other conditions analyzed – the common cold, croup, gastroenteritis, nonstreptococcal pharyngitis, sinusitis, skin and soft tissue infections, and urinary tract infection (UTI) – also was significantly lower in the 2020 post-SD period than would be expected based on 2019 data (P < .001 for all diagnoses).
 

Putting things in perspective

“This study puts numbers to the sense that we have all had in pediatrics – that social distancing appears to have had a dramatic impact on the transmission of common childhood infectious diseases, especially other respiratory viral pathogens,” Audrey R. John, MD, PhD, chief of the division of pediatric infectious disease at Children’s Hospital of Philadelphia, said in an interview.

The authors acknowledged the possible role of families not seeking care, but said that a smaller decrease in diagnoses of UTI – generally not a contagious disease – “suggests that changes in care-seeking behavior had a relatively modest effect on the other observed declines.” (The rate of UTI for the pre- and post-SD periods was 3.3 and 3.7 per 100,000 patients per day in 2019, and 3.4 and 2.4 in 2020, for a difference in differences of –1.5).

In an accompanying editorial, David W. Kimberlin, MD and Erica C. Bjornstad, MD, PhD, MPH, of the University of Alabama at Birmingham, called the report “provocative” and wrote that similar observations of infections dropping during periods of isolation – namely, dramatic declines in influenza and other respiratory viruses in Seattle after a record snowstorm in 2019 – combined with findings from other modeling studies “suggest that the decline [reported in Boston] is indeed real” (Pediatrics 2020. doi: 10.1542/peds.2020-019232).

However, “we also now know that immunization rates for American children have plummeted since the onset of the SARS-CoV-2 pandemic [because of a] ... dramatic decrease in the use of health care during the first months of the pandemic,” they wrote. “Viewed through this lens,” the declines reported in Boston may reflect inflections going “undiagnosed and untreated.”

Ultimately, Dr. Kimberlin and Dr. Bjornstad said, “the verdict remains out.”

Dr. John said that she and others are “concerned about children not seeking care in a timely manner, and [concerned] that reductions in reported infections might be due to a lack of recognition rather than a lack of transmission.”

In Philadelphia, however, declines in admissions for asthma exacerbations, “which are often caused by respiratory viral infections, suggests that this may not be the case,” said Dr. John, who was asked to comment on the study.

In addition, she said, the Massachusetts data showing that UTI diagnoses “are nearly as common this year as in 2019” are “reassuring.”
 

Are there lessons for the future?

Coauthor Louis Vernacchio, MD, MSc, chief medical officer of the Pediatric Physicians’ Organization at Children’s network, said in an interview that beyond the pandemic, it’s likely that “more careful attention to proven infection control practices in daycares and schools could reduce the burden of common infectious diseases in children.”

Dr. John similarly sees a long-term value of quantifying the impact of social distancing. “We’ve always known [for instance] that bronchiolitis is the result of viral infection.” Findings like the Massachusetts data “will help us advise families who might be trying to protect their premature infants (at risk for severe bronchiolitis) through social distancing.”

The analysis covered both in-person and telemedicine encounters occurring on weekdays.

The authors of the research brief indicated they have no relevant financial disclosures and there was no external funding. The authors of the commentary also reported they have no relevant financial disclosures, and Dr. John said she had no relevant financial disclosures.

SOURCE: Hatoun J et al. Pediatrics. 2020. doi: 10.1542/peds.2020-006460.

No question, the COVID-19 pandemic has been a challenging time for medical practices across the United States. Uncertainty remains regarding bringing patients and services back into our offices. One factor that distinguishes many ObGyn practices from other specialties is that our practices have remained open—in some form—since the beginning of the pandemic. In various parts of the country, gynecologic surgeries and routine office visits have been significantly reduced; however, deliveries and gynecologic emergencies have continued.

In this article, I suggest a framework of strategies and resources to provide insight for outpatient operations. Individual practices will vary across the nation depending on local conditions. Full practice capacity may take on a different look than it had prior to the pandemic, and there is opportunity to change the way we operate.

Strategy 1: Consult regulatory requirements frequently

As the local status of COVID-19 evolves quickly, it is essential to examine the frequently updated recommendations from regulatory agencies at the federal, state, and local levels. Clinical practices that function within health systems need to demonstrate alignment with hospital or university policies and procedures. The Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and individual state departments of health provide dynamic resources that are easily accessible online.^1-3

The American College of Obstetricians and Gynecologists (ACOG) continues to be an excellent medical society resource.⁴ Subspecialty organizations that provide up-to-date guidance include the Society for Maternal-Fetal Medicine (SMFM), Society of Gynecologic Surgeons (SGS), AAGL (American Association of Gynecologic Laparoscopists), American Society for Reproductive Medicine (ASRM), and Society of Gynecologic Oncology (SGO).^5-9 These resources are updated as more information about COVID-19 emerges, and they may be modified to different local-regional conditions.

The professional liability insurance carrier is an important source of insight for a number of circumstances, including modifications to your office practice, such as returning to full-scope or part-time practice; operating outside normal clinical service arrangements (for example, assisting with emergency care); offering telehealth services; and adding extra hours or employees to accommodate the patient backlog. Business insurance coverage is a separate issue to consider. Reviewing the practice policy may protect your business from COVID-related liabilities.

Consulting with legal counselors can be helpful. They can assist with navigating various practice and personnel COVID-related changes, as well as developing a viable plan for patients who were previously insured pre–COVID-19 who are currently uninsured.

Continue to: Strategy 2: Reimagine schedule capacity...

 

 

Strategy 2: Reimagine schedule capacity

The waxing and waning of the COVID-19 crisis presents an opportunity to evaluate our office practices and make necessary and positive changes. The question becomes, do we operate our practices as usual or do we rethink our strategy for seeing patients and integrate lessons learned from the pandemic? Patients are deciding when they are comfortable to schedule elective surgeries and routine office encounters. This gives us the chance to break from the tradition of 100% in-person visits and change the way we care for women.

The coronavirus has accelerated the rise of telehealth/telemedicine and is, perhaps, a silver lining of the pandemic. Telehealth is a valuable tool for accessing health services when in-person visits are not possible. Evaluating and triaging patients for in-person versus telehealth visits is now a viable option for clinical practice and reduces exposure to COVID-19 infection.

Telemedicine is convenient, and clinicians can use it to counsel and screen for various health issues as well as to extend their reach to rural communities. Appropriate consent should be documented in the patient chart. As some areas continue to be without adequate access to WiFi, telephone contact also is currently acceptable. Telehealth does not replace the in-person visit but can be viewed as a complementary and supplementary service.

Consider a balance between telehealth and in-person visits by evaluating which visits can continue remotely and which can alternate with in-person visits. This offers tremendous flexibility and will expand delivery of essential health care to patients.¹⁰ Integrating telemedicine into clinical practice provides an additional benefit: It minimizes the exposure and transmission of COVID-19 to health care workers and patients and preserves supplies, including personal protective equipment (PPE).

Prioritize the backlog of patients who require follow-up testing, procedures, and surgeries. Communicate with patients that it is safe to be seen and important to not avoid routine and preventative visits that might reveal concerns or conditions that require treatment.

Strategy 3: Institute infection prevention and control measures

The importance of instituting and ensuring safety measures for office personnel and patients cannot be underestimated. Recently, a study from King’s College in London found that frontline health care workers with PPE still have 3 to 4 times the risk of contracting coronavirus compared with the general public.¹¹ Health care systems should ensure adequate PPE availability and develop additional strategies to protect health care workers from COVID-19. We have to be fanatical about cleanliness and PPE. We have to be diligent about how we space ourselves and our patients. Consider adjusting workflows to ensure that visits can be conducted as quickly and safely as possible.

Communicating updated safety plans and processes are invaluable for both patients and health care workers. Patients want to be reassured that safety precautions are in place to keep the environment safe and clean. Additionally, privacy and confidentiality concerns should be addressed.

Consider a modified office schedule that can reduce the number of people in the office, person-to-person contact, and COVID-19 transmission. Social distancing is improved and PPE and other supplies are preserved.

Continue to: Employees can work on alternating days...

• Employees can work on alternating days or during different parts of the day.
• Administrative staff who do not need to be physically present in the office might work remotely.
• Expanding office hours (early morning, evening, and weekends) spreads patient visits throughout the day and minimizes high-volume in-person visits.

Institute a daily COVID-19 symptom attestation and temperature check for employees on arrival at work.

Health care personnel with symptoms of COVID-19 should be prioritized for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) RNA testing with an approved nucleic acid or antigen detection assay. A negative result indicates that the person most likely did not have an active SARS-CoV-2 infection at the time the sample was collected. A second test for SARS-CoV-2 RNA may be performed at the discretion of the evaluating health care provider, particularly when a higher level of clinical suspicion for infection exists.

The return to work decision should be determined by an agreed on symptom-based approach to clearance. If needed on a case-by-case basis, a review can be performed with the individual’s health care provider.¹²

Require universal masking and appropriate protective equipment.

• All staff members, patients, and visitors must wear masks correctly in the facilities (except children under age 2).
• All clinical staff members must wear masks correctly and eye protection during every patient encounter.

Reconfigure the waiting room and patient flow.

• Configure waiting room furniture to reinforce 6 feet of physical distancing.
• Remove all books, magazines, and toys from all waiting areas.
• Laminate signage for display.
• Install plexiglass at the check-in desk to minimize virus transmission.
• If possible, ask patients to wait in their car until their appointment time or to go directly to their exam room on arrival if it is available.
• Implement virtual check-in and check-out so that patients reduce unnecessary contact with surfaces and staff.
• Limit a high volume of patients to maintain social distancing etiquette, avoid delays, and allow adequate cleaning time between patients.
• Permit visitors to accompany adult patients to their ambulatory appointments only if special assistance is required.
• Limit the number of staff members in the exam and treatment rooms and maintain at least 6 feet between people except during medical care activities.
• Consider patient flow in a one-way traffic pattern.

Focus on keeping the clinical practice clean. (Follow the instructions and disinfect with a registered disinfectant product that meets the US Environmental Protection Agency criteria for use against COVID-19.¹³)

• Clean waiting rooms and restrooms frequently.
• Coordinate patient appointments to allow for infection control measures.
• Frequently clean high-touch surfaces, including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
• Clinicians and all medical staff members should wash their hands before and after interacting with patients.
• Clean and disinfect the exam and treatment rooms before and after each patient.
• Use products that are effective against a range of organisms and viruses, including the coronavirus that causes COVID-19.
• Place signs indicating that rooms have been cleaned; this will assure and comfort patients. Take credit for your infection control processes.

Keep abreast of isolation and precaution guidelines. Based on data available at the time of this article’s publication, the CDC recommends ending isolation and transmission-based precautions for most people with COVID-19 using a symptom-based strategy.¹⁴ This limits unnecessary prolonged isolation and use of laboratory testing resources.

Generally, repeat SARS-CoV-2 polymerase chain reaction (PCR) testing is not recommended for “COVID-19 recovered” patients. Specifically, those patients with a prior positive SARS-CoV-2 PCR test result and who have met criteria for isolation discontinuation do not need a follow-up PCR test. A test-based strategy to discontinue isolation and transmission-based precautions is required only for severely immunocompromised patients.¹⁵

Prepare for a future COVID-19 surge and review your emergency plan and responses and revise as needed. Review handling of the current pandemic and best practices plus areas of improvement.

Symptom-based criteria for discontinuing transmission-based precautions include the following:

Patients with mild to moderate illness, not severely immunocompromised:

• at least 10 days have passed since symptoms first appeared and
• at least 24 hours have passed since last fever without fever-reducing medications and
• symptoms (cough, shortness of breath) have improved.

Note: For patients who are not severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 10 days have passed since the date of their first positive viral diagnostic test.

Patients with severe to critical illness, severely immunocompromised:

• at least 20 days have passed since symptoms first appeared and
• at least 24 hours have passed since last fever without fever-reducing medications and
• symptoms (cough, shortness of breath) have improved.

Note: For patients who are severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 20 days have passed since the date of their first positive viral diagnostic test.

Continue to: Strategy 4: Implement frequent employee communication and care...

Strategy 4: Implement frequent employee communication and care

The safety and well-being of our health care workers and patients in our clinical practices is paramount. Continuing to communicate this message and developing and sharing a plan may ameliorate the obvious toll on mental and emotional well-being. Frequent and effective communication with your clinical team is vital to reinforce policies and protocols, eliminate silos, and reduce errors.

Practice communication and care with these approaches:

• Offer regular employee COVID-19 testing.
• Re-educate staff about infection control protocols to ensure buy-in.
• Communicate with staff about the plan to address staffing shortages.
• Implement regular employee team huddles that can address accomplishments, challenges, areas for improvement, and top priorities.
• Perform regular celebrations for staff appreciation.
• Address mental health and chronic stress and offer empathy and coping resources and services to staff and clinicians. This will have a valuable, long-term benefit.

Patient communication. As the COVID-19 pandemic continues and stay-at-home policies are in place, patients should be encouraged to seek medical care if they are ill or have acute or chronic conditions. Communicate regularly with patients and let them know that their safety and well-being is the top priority. Prior to in-person visits, inform them of the safety processes that are in place to protect them.

Fostering an honest clinician-patient relationship enhances communication. Despite these efforts, some patients may not be forthcoming about their COVID-19 symptoms, illness, exposure, or travel. Health care staff can be encouraged to set a tone of tolerance and compassion and treat everyone with universal precautions.

Rising to the challenges

During the coronavirus pandemic, ObGyns continue to safely care for pregnant women and also triage and treat women who require timely office care as well as emergency and cancer-related surgeries.

The COVID-19 environment rapidly changes depending on the practice location. The strategies described represent a compilation of resources from key organizations that hopefully will prove useful and can be shaped to fit your practice. Local and regional recommendations vary, and no one can predict the course of the virus.

Consider reviewing your contingency plans regularly. As we have learned over the last several months, there is a science to maintaining a COVID-SAFE environment.

Practice operations likely will change to adapt to new conditions. The pandemic has challenged us to evolve, and we have responded with new capabilities and resilience while we continue to deliver superior and compassionate care for women.

For additional strategies on how to safeguard your practice against COVID-19, see the box below. ●

Continue to: Additional strategies on how to safeguard your practice against COVID-19...

No question, the COVID-19 pandemic has been a challenging time for medical practices across the United States. Uncertainty remains regarding bringing patients and services back into our offices. One factor that distinguishes many ObGyn practices from other specialties is that our practices have remained open—in some form—since the beginning of the pandemic. In various parts of the country, gynecologic surgeries and routine office visits have been significantly reduced; however, deliveries and gynecologic emergencies have continued.

In this article, I suggest a framework of strategies and resources to provide insight for outpatient operations. Individual practices will vary across the nation depending on local conditions. Full practice capacity may take on a different look than it had prior to the pandemic, and there is opportunity to change the way we operate.

Strategy 1: Consult regulatory requirements frequently

As the local status of COVID-19 evolves quickly, it is essential to examine the frequently updated recommendations from regulatory agencies at the federal, state, and local levels. Clinical practices that function within health systems need to demonstrate alignment with hospital or university policies and procedures. The Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and individual state departments of health provide dynamic resources that are easily accessible online.^1-3

The American College of Obstetricians and Gynecologists (ACOG) continues to be an excellent medical society resource.⁴ Subspecialty organizations that provide up-to-date guidance include the Society for Maternal-Fetal Medicine (SMFM), Society of Gynecologic Surgeons (SGS), AAGL (American Association of Gynecologic Laparoscopists), American Society for Reproductive Medicine (ASRM), and Society of Gynecologic Oncology (SGO).^5-9 These resources are updated as more information about COVID-19 emerges, and they may be modified to different local-regional conditions.

The professional liability insurance carrier is an important source of insight for a number of circumstances, including modifications to your office practice, such as returning to full-scope or part-time practice; operating outside normal clinical service arrangements (for example, assisting with emergency care); offering telehealth services; and adding extra hours or employees to accommodate the patient backlog. Business insurance coverage is a separate issue to consider. Reviewing the practice policy may protect your business from COVID-related liabilities.

Consulting with legal counselors can be helpful. They can assist with navigating various practice and personnel COVID-related changes, as well as developing a viable plan for patients who were previously insured pre–COVID-19 who are currently uninsured.

Continue to: Strategy 2: Reimagine schedule capacity...

 

 

Strategy 2: Reimagine schedule capacity

The waxing and waning of the COVID-19 crisis presents an opportunity to evaluate our office practices and make necessary and positive changes. The question becomes, do we operate our practices as usual or do we rethink our strategy for seeing patients and integrate lessons learned from the pandemic? Patients are deciding when they are comfortable to schedule elective surgeries and routine office encounters. This gives us the chance to break from the tradition of 100% in-person visits and change the way we care for women.

The coronavirus has accelerated the rise of telehealth/telemedicine and is, perhaps, a silver lining of the pandemic. Telehealth is a valuable tool for accessing health services when in-person visits are not possible. Evaluating and triaging patients for in-person versus telehealth visits is now a viable option for clinical practice and reduces exposure to COVID-19 infection.

Telemedicine is convenient, and clinicians can use it to counsel and screen for various health issues as well as to extend their reach to rural communities. Appropriate consent should be documented in the patient chart. As some areas continue to be without adequate access to WiFi, telephone contact also is currently acceptable. Telehealth does not replace the in-person visit but can be viewed as a complementary and supplementary service.

Consider a balance between telehealth and in-person visits by evaluating which visits can continue remotely and which can alternate with in-person visits. This offers tremendous flexibility and will expand delivery of essential health care to patients.¹⁰ Integrating telemedicine into clinical practice provides an additional benefit: It minimizes the exposure and transmission of COVID-19 to health care workers and patients and preserves supplies, including personal protective equipment (PPE).

Prioritize the backlog of patients who require follow-up testing, procedures, and surgeries. Communicate with patients that it is safe to be seen and important to not avoid routine and preventative visits that might reveal concerns or conditions that require treatment.

Strategy 3: Institute infection prevention and control measures

The importance of instituting and ensuring safety measures for office personnel and patients cannot be underestimated. Recently, a study from King’s College in London found that frontline health care workers with PPE still have 3 to 4 times the risk of contracting coronavirus compared with the general public.¹¹ Health care systems should ensure adequate PPE availability and develop additional strategies to protect health care workers from COVID-19. We have to be fanatical about cleanliness and PPE. We have to be diligent about how we space ourselves and our patients. Consider adjusting workflows to ensure that visits can be conducted as quickly and safely as possible.

Communicating updated safety plans and processes are invaluable for both patients and health care workers. Patients want to be reassured that safety precautions are in place to keep the environment safe and clean. Additionally, privacy and confidentiality concerns should be addressed.

Consider a modified office schedule that can reduce the number of people in the office, person-to-person contact, and COVID-19 transmission. Social distancing is improved and PPE and other supplies are preserved.

Continue to: Employees can work on alternating days...

• Employees can work on alternating days or during different parts of the day.
• Administrative staff who do not need to be physically present in the office might work remotely.
• Expanding office hours (early morning, evening, and weekends) spreads patient visits throughout the day and minimizes high-volume in-person visits.

Institute a daily COVID-19 symptom attestation and temperature check for employees on arrival at work.

Health care personnel with symptoms of COVID-19 should be prioritized for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) RNA testing with an approved nucleic acid or antigen detection assay. A negative result indicates that the person most likely did not have an active SARS-CoV-2 infection at the time the sample was collected. A second test for SARS-CoV-2 RNA may be performed at the discretion of the evaluating health care provider, particularly when a higher level of clinical suspicion for infection exists.

The return to work decision should be determined by an agreed on symptom-based approach to clearance. If needed on a case-by-case basis, a review can be performed with the individual’s health care provider.¹²

Require universal masking and appropriate protective equipment.

• All staff members, patients, and visitors must wear masks correctly in the facilities (except children under age 2).
• All clinical staff members must wear masks correctly and eye protection during every patient encounter.

Reconfigure the waiting room and patient flow.

• Configure waiting room furniture to reinforce 6 feet of physical distancing.
• Remove all books, magazines, and toys from all waiting areas.
• Laminate signage for display.
• Install plexiglass at the check-in desk to minimize virus transmission.
• If possible, ask patients to wait in their car until their appointment time or to go directly to their exam room on arrival if it is available.
• Implement virtual check-in and check-out so that patients reduce unnecessary contact with surfaces and staff.
• Limit a high volume of patients to maintain social distancing etiquette, avoid delays, and allow adequate cleaning time between patients.
• Permit visitors to accompany adult patients to their ambulatory appointments only if special assistance is required.
• Limit the number of staff members in the exam and treatment rooms and maintain at least 6 feet between people except during medical care activities.
• Consider patient flow in a one-way traffic pattern.

Focus on keeping the clinical practice clean. (Follow the instructions and disinfect with a registered disinfectant product that meets the US Environmental Protection Agency criteria for use against COVID-19.¹³)

• Clean waiting rooms and restrooms frequently.
• Coordinate patient appointments to allow for infection control measures.
• Frequently clean high-touch surfaces, including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
• Clinicians and all medical staff members should wash their hands before and after interacting with patients.
• Clean and disinfect the exam and treatment rooms before and after each patient.
• Use products that are effective against a range of organisms and viruses, including the coronavirus that causes COVID-19.
• Place signs indicating that rooms have been cleaned; this will assure and comfort patients. Take credit for your infection control processes.

Keep abreast of isolation and precaution guidelines. Based on data available at the time of this article’s publication, the CDC recommends ending isolation and transmission-based precautions for most people with COVID-19 using a symptom-based strategy.¹⁴ This limits unnecessary prolonged isolation and use of laboratory testing resources.

Generally, repeat SARS-CoV-2 polymerase chain reaction (PCR) testing is not recommended for “COVID-19 recovered” patients. Specifically, those patients with a prior positive SARS-CoV-2 PCR test result and who have met criteria for isolation discontinuation do not need a follow-up PCR test. A test-based strategy to discontinue isolation and transmission-based precautions is required only for severely immunocompromised patients.¹⁵

Prepare for a future COVID-19 surge and review your emergency plan and responses and revise as needed. Review handling of the current pandemic and best practices plus areas of improvement.

Symptom-based criteria for discontinuing transmission-based precautions include the following:

Patients with mild to moderate illness, not severely immunocompromised:

• at least 10 days have passed since symptoms first appeared and
• at least 24 hours have passed since last fever without fever-reducing medications and
• symptoms (cough, shortness of breath) have improved.

Note: For patients who are not severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 10 days have passed since the date of their first positive viral diagnostic test.

Patients with severe to critical illness, severely immunocompromised:

• at least 20 days have passed since symptoms first appeared and
• at least 24 hours have passed since last fever without fever-reducing medications and
• symptoms (cough, shortness of breath) have improved.

Note: For patients who are severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 20 days have passed since the date of their first positive viral diagnostic test.

Continue to: Strategy 4: Implement frequent employee communication and care...

Strategy 4: Implement frequent employee communication and care

The safety and well-being of our health care workers and patients in our clinical practices is paramount. Continuing to communicate this message and developing and sharing a plan may ameliorate the obvious toll on mental and emotional well-being. Frequent and effective communication with your clinical team is vital to reinforce policies and protocols, eliminate silos, and reduce errors.

Practice communication and care with these approaches:

• Offer regular employee COVID-19 testing.
• Re-educate staff about infection control protocols to ensure buy-in.
• Communicate with staff about the plan to address staffing shortages.
• Implement regular employee team huddles that can address accomplishments, challenges, areas for improvement, and top priorities.
• Perform regular celebrations for staff appreciation.
• Address mental health and chronic stress and offer empathy and coping resources and services to staff and clinicians. This will have a valuable, long-term benefit.

Patient communication. As the COVID-19 pandemic continues and stay-at-home policies are in place, patients should be encouraged to seek medical care if they are ill or have acute or chronic conditions. Communicate regularly with patients and let them know that their safety and well-being is the top priority. Prior to in-person visits, inform them of the safety processes that are in place to protect them.

Fostering an honest clinician-patient relationship enhances communication. Despite these efforts, some patients may not be forthcoming about their COVID-19 symptoms, illness, exposure, or travel. Health care staff can be encouraged to set a tone of tolerance and compassion and treat everyone with universal precautions.

Rising to the challenges

During the coronavirus pandemic, ObGyns continue to safely care for pregnant women and also triage and treat women who require timely office care as well as emergency and cancer-related surgeries.

The COVID-19 environment rapidly changes depending on the practice location. The strategies described represent a compilation of resources from key organizations that hopefully will prove useful and can be shaped to fit your practice. Local and regional recommendations vary, and no one can predict the course of the virus.

Consider reviewing your contingency plans regularly. As we have learned over the last several months, there is a science to maintaining a COVID-SAFE environment.

Practice operations likely will change to adapt to new conditions. The pandemic has challenged us to evolve, and we have responded with new capabilities and resilience while we continue to deliver superior and compassionate care for women.

For additional strategies on how to safeguard your practice against COVID-19, see the box below. ●

Continue to: Additional strategies on how to safeguard your practice against COVID-19...

No question, the COVID-19 pandemic has been a challenging time for medical practices across the United States. Uncertainty remains regarding bringing patients and services back into our offices. One factor that distinguishes many ObGyn practices from other specialties is that our practices have remained open—in some form—since the beginning of the pandemic. In various parts of the country, gynecologic surgeries and routine office visits have been significantly reduced; however, deliveries and gynecologic emergencies have continued.

In this article, I suggest a framework of strategies and resources to provide insight for outpatient operations. Individual practices will vary across the nation depending on local conditions. Full practice capacity may take on a different look than it had prior to the pandemic, and there is opportunity to change the way we operate.

Strategy 1: Consult regulatory requirements frequently

As the local status of COVID-19 evolves quickly, it is essential to examine the frequently updated recommendations from regulatory agencies at the federal, state, and local levels. Clinical practices that function within health systems need to demonstrate alignment with hospital or university policies and procedures. The Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and individual state departments of health provide dynamic resources that are easily accessible online.^1-3

The American College of Obstetricians and Gynecologists (ACOG) continues to be an excellent medical society resource.⁴ Subspecialty organizations that provide up-to-date guidance include the Society for Maternal-Fetal Medicine (SMFM), Society of Gynecologic Surgeons (SGS), AAGL (American Association of Gynecologic Laparoscopists), American Society for Reproductive Medicine (ASRM), and Society of Gynecologic Oncology (SGO).^5-9 These resources are updated as more information about COVID-19 emerges, and they may be modified to different local-regional conditions.

The professional liability insurance carrier is an important source of insight for a number of circumstances, including modifications to your office practice, such as returning to full-scope or part-time practice; operating outside normal clinical service arrangements (for example, assisting with emergency care); offering telehealth services; and adding extra hours or employees to accommodate the patient backlog. Business insurance coverage is a separate issue to consider. Reviewing the practice policy may protect your business from COVID-related liabilities.

Consulting with legal counselors can be helpful. They can assist with navigating various practice and personnel COVID-related changes, as well as developing a viable plan for patients who were previously insured pre–COVID-19 who are currently uninsured.

Continue to: Strategy 2: Reimagine schedule capacity...

 

 

Strategy 2: Reimagine schedule capacity

The waxing and waning of the COVID-19 crisis presents an opportunity to evaluate our office practices and make necessary and positive changes. The question becomes, do we operate our practices as usual or do we rethink our strategy for seeing patients and integrate lessons learned from the pandemic? Patients are deciding when they are comfortable to schedule elective surgeries and routine office encounters. This gives us the chance to break from the tradition of 100% in-person visits and change the way we care for women.

The coronavirus has accelerated the rise of telehealth/telemedicine and is, perhaps, a silver lining of the pandemic. Telehealth is a valuable tool for accessing health services when in-person visits are not possible. Evaluating and triaging patients for in-person versus telehealth visits is now a viable option for clinical practice and reduces exposure to COVID-19 infection.

Telemedicine is convenient, and clinicians can use it to counsel and screen for various health issues as well as to extend their reach to rural communities. Appropriate consent should be documented in the patient chart. As some areas continue to be without adequate access to WiFi, telephone contact also is currently acceptable. Telehealth does not replace the in-person visit but can be viewed as a complementary and supplementary service.

Consider a balance between telehealth and in-person visits by evaluating which visits can continue remotely and which can alternate with in-person visits. This offers tremendous flexibility and will expand delivery of essential health care to patients.¹⁰ Integrating telemedicine into clinical practice provides an additional benefit: It minimizes the exposure and transmission of COVID-19 to health care workers and patients and preserves supplies, including personal protective equipment (PPE).

Prioritize the backlog of patients who require follow-up testing, procedures, and surgeries. Communicate with patients that it is safe to be seen and important to not avoid routine and preventative visits that might reveal concerns or conditions that require treatment.

Strategy 3: Institute infection prevention and control measures

The importance of instituting and ensuring safety measures for office personnel and patients cannot be underestimated. Recently, a study from King’s College in London found that frontline health care workers with PPE still have 3 to 4 times the risk of contracting coronavirus compared with the general public.¹¹ Health care systems should ensure adequate PPE availability and develop additional strategies to protect health care workers from COVID-19. We have to be fanatical about cleanliness and PPE. We have to be diligent about how we space ourselves and our patients. Consider adjusting workflows to ensure that visits can be conducted as quickly and safely as possible.

Communicating updated safety plans and processes are invaluable for both patients and health care workers. Patients want to be reassured that safety precautions are in place to keep the environment safe and clean. Additionally, privacy and confidentiality concerns should be addressed.

Consider a modified office schedule that can reduce the number of people in the office, person-to-person contact, and COVID-19 transmission. Social distancing is improved and PPE and other supplies are preserved.

Continue to: Employees can work on alternating days...

• Employees can work on alternating days or during different parts of the day.
• Administrative staff who do not need to be physically present in the office might work remotely.
• Expanding office hours (early morning, evening, and weekends) spreads patient visits throughout the day and minimizes high-volume in-person visits.

Institute a daily COVID-19 symptom attestation and temperature check for employees on arrival at work.

Health care personnel with symptoms of COVID-19 should be prioritized for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) RNA testing with an approved nucleic acid or antigen detection assay. A negative result indicates that the person most likely did not have an active SARS-CoV-2 infection at the time the sample was collected. A second test for SARS-CoV-2 RNA may be performed at the discretion of the evaluating health care provider, particularly when a higher level of clinical suspicion for infection exists.

The return to work decision should be determined by an agreed on symptom-based approach to clearance. If needed on a case-by-case basis, a review can be performed with the individual’s health care provider.¹²

Require universal masking and appropriate protective equipment.

• All staff members, patients, and visitors must wear masks correctly in the facilities (except children under age 2).
• All clinical staff members must wear masks correctly and eye protection during every patient encounter.

Reconfigure the waiting room and patient flow.

• Configure waiting room furniture to reinforce 6 feet of physical distancing.
• Remove all books, magazines, and toys from all waiting areas.
• Laminate signage for display.
• Install plexiglass at the check-in desk to minimize virus transmission.
• If possible, ask patients to wait in their car until their appointment time or to go directly to their exam room on arrival if it is available.
• Implement virtual check-in and check-out so that patients reduce unnecessary contact with surfaces and staff.
• Limit a high volume of patients to maintain social distancing etiquette, avoid delays, and allow adequate cleaning time between patients.
• Permit visitors to accompany adult patients to their ambulatory appointments only if special assistance is required.
• Limit the number of staff members in the exam and treatment rooms and maintain at least 6 feet between people except during medical care activities.
• Consider patient flow in a one-way traffic pattern.

Focus on keeping the clinical practice clean. (Follow the instructions and disinfect with a registered disinfectant product that meets the US Environmental Protection Agency criteria for use against COVID-19.¹³)

• Clean waiting rooms and restrooms frequently.
• Coordinate patient appointments to allow for infection control measures.
• Frequently clean high-touch surfaces, including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
• Clinicians and all medical staff members should wash their hands before and after interacting with patients.
• Clean and disinfect the exam and treatment rooms before and after each patient.
• Use products that are effective against a range of organisms and viruses, including the coronavirus that causes COVID-19.
• Place signs indicating that rooms have been cleaned; this will assure and comfort patients. Take credit for your infection control processes.

Keep abreast of isolation and precaution guidelines. Based on data available at the time of this article’s publication, the CDC recommends ending isolation and transmission-based precautions for most people with COVID-19 using a symptom-based strategy.¹⁴ This limits unnecessary prolonged isolation and use of laboratory testing resources.

Generally, repeat SARS-CoV-2 polymerase chain reaction (PCR) testing is not recommended for “COVID-19 recovered” patients. Specifically, those patients with a prior positive SARS-CoV-2 PCR test result and who have met criteria for isolation discontinuation do not need a follow-up PCR test. A test-based strategy to discontinue isolation and transmission-based precautions is required only for severely immunocompromised patients.¹⁵

Prepare for a future COVID-19 surge and review your emergency plan and responses and revise as needed. Review handling of the current pandemic and best practices plus areas of improvement.

Symptom-based criteria for discontinuing transmission-based precautions include the following:

Patients with mild to moderate illness, not severely immunocompromised:

• at least 10 days have passed since symptoms first appeared and
• at least 24 hours have passed since last fever without fever-reducing medications and
• symptoms (cough, shortness of breath) have improved.

Note: For patients who are not severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 10 days have passed since the date of their first positive viral diagnostic test.

Patients with severe to critical illness, severely immunocompromised:

• at least 20 days have passed since symptoms first appeared and
• at least 24 hours have passed since last fever without fever-reducing medications and
• symptoms (cough, shortness of breath) have improved.

Note: For patients who are severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 20 days have passed since the date of their first positive viral diagnostic test.

Continue to: Strategy 4: Implement frequent employee communication and care...

Strategy 4: Implement frequent employee communication and care

The safety and well-being of our health care workers and patients in our clinical practices is paramount. Continuing to communicate this message and developing and sharing a plan may ameliorate the obvious toll on mental and emotional well-being. Frequent and effective communication with your clinical team is vital to reinforce policies and protocols, eliminate silos, and reduce errors.

Practice communication and care with these approaches:

• Offer regular employee COVID-19 testing.
• Re-educate staff about infection control protocols to ensure buy-in.
• Communicate with staff about the plan to address staffing shortages.
• Implement regular employee team huddles that can address accomplishments, challenges, areas for improvement, and top priorities.
• Perform regular celebrations for staff appreciation.
• Address mental health and chronic stress and offer empathy and coping resources and services to staff and clinicians. This will have a valuable, long-term benefit.

Patient communication. As the COVID-19 pandemic continues and stay-at-home policies are in place, patients should be encouraged to seek medical care if they are ill or have acute or chronic conditions. Communicate regularly with patients and let them know that their safety and well-being is the top priority. Prior to in-person visits, inform them of the safety processes that are in place to protect them.

Fostering an honest clinician-patient relationship enhances communication. Despite these efforts, some patients may not be forthcoming about their COVID-19 symptoms, illness, exposure, or travel. Health care staff can be encouraged to set a tone of tolerance and compassion and treat everyone with universal precautions.

Rising to the challenges

During the coronavirus pandemic, ObGyns continue to safely care for pregnant women and also triage and treat women who require timely office care as well as emergency and cancer-related surgeries.

The COVID-19 environment rapidly changes depending on the practice location. The strategies described represent a compilation of resources from key organizations that hopefully will prove useful and can be shaped to fit your practice. Local and regional recommendations vary, and no one can predict the course of the virus.

Consider reviewing your contingency plans regularly. As we have learned over the last several months, there is a science to maintaining a COVID-SAFE environment.

Practice operations likely will change to adapt to new conditions. The pandemic has challenged us to evolve, and we have responded with new capabilities and resilience while we continue to deliver superior and compassionate care for women.

For additional strategies on how to safeguard your practice against COVID-19, see the box below. ●

Continue to: Additional strategies on how to safeguard your practice against COVID-19...

Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.^1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.³ The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.⁴ Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.⁵
 

The issue

The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.

Are mifepristone requirements fairly applied?

The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.⁶ The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.⁷

These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.⁸

Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient. 

REMS changes during the COVID-19 pandemic

The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.⁹ Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.¹⁰

Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.¹¹ By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments. 

As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus. 

The lawsuit

On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.

The verdict

On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.

What the outcome means

This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail.  Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission. 

What now?

The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.

ACTION ITEMS

• Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction. 
• Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
• Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.

Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.^1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.³ The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.⁴ Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.⁵
 

The issue

The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.

Are mifepristone requirements fairly applied?

The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.⁶ The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.⁷

These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.⁸

Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient. 

REMS changes during the COVID-19 pandemic

The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.⁹ Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.¹⁰

Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.¹¹ By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments. 

As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus. 

The lawsuit

On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.

The verdict

On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.

What the outcome means

This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail.  Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission. 

What now?

The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.

ACTION ITEMS

• Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction. 
• Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
• Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.

Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.^1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.³ The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.⁴ Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.⁵
 

The issue

The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.

Are mifepristone requirements fairly applied?

The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.⁶ The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.⁷

These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.⁸

Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient. 

REMS changes during the COVID-19 pandemic

The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.⁹ Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.¹⁰

Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.¹¹ By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments. 

As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus. 

The lawsuit

On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.

The verdict

On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.

What the outcome means

This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail.  Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission. 

What now?

The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.

ACTION ITEMS

• Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction. 
• Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
• Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.