Cardiology News is an independent news source that provides cardiologists with timely and relevant news and commentary about clinical developments and the impact of health care policy on cardiology and the cardiologist's practice. Cardiology News Digital Network is the online destination and multimedia properties of Cardiology News, the independent news publication for cardiologists. Cardiology news is the leading source of news and commentary about clinical developments in cardiology as well as health care policy and regulations that affect the cardiologist's practice. Cardiology News Digital Network is owned by Frontline Medical Communications.

Theme
medstat_card
Top Sections
Resources
Best Practices
card
Main menu
CARD Main Menu
Explore menu
CARD Explore Menu
Proclivity ID
18806001
Unpublish
Altmetric
Article Authors "autobrand" affiliation
Cardiology News
DSM Affiliated
Display in offset block
Disqus Exclude
Best Practices
CE/CME
Medical Education Library
Education Center
Enable Disqus
Display Author and Disclosure Link
Publication Type
News
Slot System
Featured Buckets
Disable Sticky Ads
Disable Ad Block Mitigation
Featured Buckets Admin
Non-Overridden Topics
Show Ads on this Publication's Homepage
Consolidated Pub
Show Article Page Numbers on TOC
Use larger logo size
Off
publication_blueconic_enabled
Off
Show More Destinations Menu
Disable Adhesion on Publication
On

Large study of COVID-19 N.Y.C. hospital cases shows high mortality

Article Type
Changed
Thu, 08/26/2021 - 16:10

A study of 5,700 patients hospitalized with confirmed COVID-19 in New York City revealed a 21% mortality rate among the 2,634 patients whose outcomes were known at the study’s end, according to a report published in JAMA (2020 Apr 22. doi: 10.1001/jama.2020.6775).

The study, which represents the largest cohort of hospitalized patients with COVID-19 in the United States thus far, confirmed that the highest-risk groups are older, male, and those with preexisting hypertension, diabetes, or obesity.

Mortality rates are difficult to compare between studies, emphasizes corresponding author Karina W. Davidson, PhD. Health care systems and resources can affect outcomes as well as patient demographics and the prevalence of comorbidities. In addition, “the speed with which people present with symptoms and where they are in the course of disease” differ between patient series, said Dr. Davidson, professor and senior vice president at the Feinstein Institutes for Medical Research and senior vice president of research, Northwell Health, Manhasset, N.Y.

“But given all of those, we know that our study represents a fairly large sample of consecutive patients. This is what the mortality rate looks like among those requiring hospitalization at the early stage of the pandemic,” Dr. Davidson said.

The large patient sample reflects the diversity of the city and its environs. “It’s a large representative sample of very diverse patients ranging in age from zero (under a year) to 107, from all walks of life and socioeconomic levels,” Dr. Davidson continued. Eight of the 12 participating N.Y.C.–area hospitals are on Long Island, one each in Manhattan and Staten Island, and two in Queens.

For the study, first author Safiya Richardson, MD, MPH, and colleagues in the Northwell COVID-19 Research Consortium analyzed EHRs of 5,700 patients hospitalized with confirmed COVID-19 during March 1, 2020–April 4, 2020.

Overall, 1,151 (20.2%) of the 5,700 patients required mechanical ventilation. As of April 4, 831 (72.2%) of these patients remained in the hospital, 38 (3.3%) were discharged, and 282 (24.5%) had died.

When the authors restricted their analysis to the 2,634 patients whose outcomes (discharge or death) were known at the end of the study, 373 (14.2%) had been treated in the intensive care unit, 320 (12.2%) received invasive mechanical ventilation, 81 (3.2%) received dialysis, and 553 (21%) died.

As seen in other COVID-19 studies, increasing age was associated with a higher risk of death. Of patients receiving mechanical ventilation and whose outcomes (discharge or death) were known, 88.1% died. When stratified by age, the mortality rates for ventilated patients were 76.4% for those aged 18-65 years and 97.2% for those older than 65 years.

Among those who did not require mechanical ventilation and whose outcomes (discharge or death) were known, 19.8% of patients aged 18-65 years died, as did 26.6% of those older than 65 years. No patient under 18 years died during the study period.

“There can be risks with mechanical ventilation, like the development of ventilator-associated pneumonia (VAP), which occurs in 10%-25% of ventilated patients and tends to occur within 5 days. The authors didn’t report data on VAP, but it seems that the mortality for ventilated patients would most likely be attributable to disease severity rather than the ventilation itself,” said Cindy Prins, PhD, director of the Master of Public Health program and clinical associate professor of epidemiology at the University of Florida, Gainesville.

The median follow-up time after discharge was 4.4 days. During the study period, 45 (2.2%) patients were readmitted, with median time to readmission of 3 days.

The most common comorbidities among all 5,700 patients were hypertension (57%), obesity (41%), and diabetes (34%). As has been seen in other patient series, male sex and increasing age were associated with a higher risk for death.

The most surprising finding, Dr. Davidson said, was that fever was uncommon. “Of 5,700 patients requiring admission because of respiratory distress, only a third had fever. So fever should not be a single symptom upon which people make a decision to seek help.”

Dr. Prins was intrigued by the observation that 2% of the patients tested positive for a respiratory virus panel as well as for COVID-19. “Because of a shortage of COVID-19 testing supplies, some hospitals have been running respiratory panels before testing for COVID-19. But this study provides more evidence that a positive result on a respiratory panel does not rule out COVID-19 infection.”

The clinical situation is constantly in flux. “We’ve been seeing since March 8 that the severity of patients has lessened dramatically, and they are coming in later in the disease. Many things are changing, we hope for the better,” Dr. Davidson said.

This article was first published on Medscape.com.

Publications
Topics
Sections

A study of 5,700 patients hospitalized with confirmed COVID-19 in New York City revealed a 21% mortality rate among the 2,634 patients whose outcomes were known at the study’s end, according to a report published in JAMA (2020 Apr 22. doi: 10.1001/jama.2020.6775).

The study, which represents the largest cohort of hospitalized patients with COVID-19 in the United States thus far, confirmed that the highest-risk groups are older, male, and those with preexisting hypertension, diabetes, or obesity.

Mortality rates are difficult to compare between studies, emphasizes corresponding author Karina W. Davidson, PhD. Health care systems and resources can affect outcomes as well as patient demographics and the prevalence of comorbidities. In addition, “the speed with which people present with symptoms and where they are in the course of disease” differ between patient series, said Dr. Davidson, professor and senior vice president at the Feinstein Institutes for Medical Research and senior vice president of research, Northwell Health, Manhasset, N.Y.

“But given all of those, we know that our study represents a fairly large sample of consecutive patients. This is what the mortality rate looks like among those requiring hospitalization at the early stage of the pandemic,” Dr. Davidson said.

The large patient sample reflects the diversity of the city and its environs. “It’s a large representative sample of very diverse patients ranging in age from zero (under a year) to 107, from all walks of life and socioeconomic levels,” Dr. Davidson continued. Eight of the 12 participating N.Y.C.–area hospitals are on Long Island, one each in Manhattan and Staten Island, and two in Queens.

For the study, first author Safiya Richardson, MD, MPH, and colleagues in the Northwell COVID-19 Research Consortium analyzed EHRs of 5,700 patients hospitalized with confirmed COVID-19 during March 1, 2020–April 4, 2020.

Overall, 1,151 (20.2%) of the 5,700 patients required mechanical ventilation. As of April 4, 831 (72.2%) of these patients remained in the hospital, 38 (3.3%) were discharged, and 282 (24.5%) had died.

When the authors restricted their analysis to the 2,634 patients whose outcomes (discharge or death) were known at the end of the study, 373 (14.2%) had been treated in the intensive care unit, 320 (12.2%) received invasive mechanical ventilation, 81 (3.2%) received dialysis, and 553 (21%) died.

As seen in other COVID-19 studies, increasing age was associated with a higher risk of death. Of patients receiving mechanical ventilation and whose outcomes (discharge or death) were known, 88.1% died. When stratified by age, the mortality rates for ventilated patients were 76.4% for those aged 18-65 years and 97.2% for those older than 65 years.

Among those who did not require mechanical ventilation and whose outcomes (discharge or death) were known, 19.8% of patients aged 18-65 years died, as did 26.6% of those older than 65 years. No patient under 18 years died during the study period.

“There can be risks with mechanical ventilation, like the development of ventilator-associated pneumonia (VAP), which occurs in 10%-25% of ventilated patients and tends to occur within 5 days. The authors didn’t report data on VAP, but it seems that the mortality for ventilated patients would most likely be attributable to disease severity rather than the ventilation itself,” said Cindy Prins, PhD, director of the Master of Public Health program and clinical associate professor of epidemiology at the University of Florida, Gainesville.

The median follow-up time after discharge was 4.4 days. During the study period, 45 (2.2%) patients were readmitted, with median time to readmission of 3 days.

The most common comorbidities among all 5,700 patients were hypertension (57%), obesity (41%), and diabetes (34%). As has been seen in other patient series, male sex and increasing age were associated with a higher risk for death.

The most surprising finding, Dr. Davidson said, was that fever was uncommon. “Of 5,700 patients requiring admission because of respiratory distress, only a third had fever. So fever should not be a single symptom upon which people make a decision to seek help.”

Dr. Prins was intrigued by the observation that 2% of the patients tested positive for a respiratory virus panel as well as for COVID-19. “Because of a shortage of COVID-19 testing supplies, some hospitals have been running respiratory panels before testing for COVID-19. But this study provides more evidence that a positive result on a respiratory panel does not rule out COVID-19 infection.”

The clinical situation is constantly in flux. “We’ve been seeing since March 8 that the severity of patients has lessened dramatically, and they are coming in later in the disease. Many things are changing, we hope for the better,” Dr. Davidson said.

This article was first published on Medscape.com.

A study of 5,700 patients hospitalized with confirmed COVID-19 in New York City revealed a 21% mortality rate among the 2,634 patients whose outcomes were known at the study’s end, according to a report published in JAMA (2020 Apr 22. doi: 10.1001/jama.2020.6775).

The study, which represents the largest cohort of hospitalized patients with COVID-19 in the United States thus far, confirmed that the highest-risk groups are older, male, and those with preexisting hypertension, diabetes, or obesity.

Mortality rates are difficult to compare between studies, emphasizes corresponding author Karina W. Davidson, PhD. Health care systems and resources can affect outcomes as well as patient demographics and the prevalence of comorbidities. In addition, “the speed with which people present with symptoms and where they are in the course of disease” differ between patient series, said Dr. Davidson, professor and senior vice president at the Feinstein Institutes for Medical Research and senior vice president of research, Northwell Health, Manhasset, N.Y.

“But given all of those, we know that our study represents a fairly large sample of consecutive patients. This is what the mortality rate looks like among those requiring hospitalization at the early stage of the pandemic,” Dr. Davidson said.

The large patient sample reflects the diversity of the city and its environs. “It’s a large representative sample of very diverse patients ranging in age from zero (under a year) to 107, from all walks of life and socioeconomic levels,” Dr. Davidson continued. Eight of the 12 participating N.Y.C.–area hospitals are on Long Island, one each in Manhattan and Staten Island, and two in Queens.

For the study, first author Safiya Richardson, MD, MPH, and colleagues in the Northwell COVID-19 Research Consortium analyzed EHRs of 5,700 patients hospitalized with confirmed COVID-19 during March 1, 2020–April 4, 2020.

Overall, 1,151 (20.2%) of the 5,700 patients required mechanical ventilation. As of April 4, 831 (72.2%) of these patients remained in the hospital, 38 (3.3%) were discharged, and 282 (24.5%) had died.

When the authors restricted their analysis to the 2,634 patients whose outcomes (discharge or death) were known at the end of the study, 373 (14.2%) had been treated in the intensive care unit, 320 (12.2%) received invasive mechanical ventilation, 81 (3.2%) received dialysis, and 553 (21%) died.

As seen in other COVID-19 studies, increasing age was associated with a higher risk of death. Of patients receiving mechanical ventilation and whose outcomes (discharge or death) were known, 88.1% died. When stratified by age, the mortality rates for ventilated patients were 76.4% for those aged 18-65 years and 97.2% for those older than 65 years.

Among those who did not require mechanical ventilation and whose outcomes (discharge or death) were known, 19.8% of patients aged 18-65 years died, as did 26.6% of those older than 65 years. No patient under 18 years died during the study period.

“There can be risks with mechanical ventilation, like the development of ventilator-associated pneumonia (VAP), which occurs in 10%-25% of ventilated patients and tends to occur within 5 days. The authors didn’t report data on VAP, but it seems that the mortality for ventilated patients would most likely be attributable to disease severity rather than the ventilation itself,” said Cindy Prins, PhD, director of the Master of Public Health program and clinical associate professor of epidemiology at the University of Florida, Gainesville.

The median follow-up time after discharge was 4.4 days. During the study period, 45 (2.2%) patients were readmitted, with median time to readmission of 3 days.

The most common comorbidities among all 5,700 patients were hypertension (57%), obesity (41%), and diabetes (34%). As has been seen in other patient series, male sex and increasing age were associated with a higher risk for death.

The most surprising finding, Dr. Davidson said, was that fever was uncommon. “Of 5,700 patients requiring admission because of respiratory distress, only a third had fever. So fever should not be a single symptom upon which people make a decision to seek help.”

Dr. Prins was intrigued by the observation that 2% of the patients tested positive for a respiratory virus panel as well as for COVID-19. “Because of a shortage of COVID-19 testing supplies, some hospitals have been running respiratory panels before testing for COVID-19. But this study provides more evidence that a positive result on a respiratory panel does not rule out COVID-19 infection.”

The clinical situation is constantly in flux. “We’ve been seeing since March 8 that the severity of patients has lessened dramatically, and they are coming in later in the disease. Many things are changing, we hope for the better,” Dr. Davidson said.

This article was first published on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

Chest imaging guidelines released for pediatric COVID-19

Article Type
Changed
Tue, 02/14/2023 - 13:02

Differences are emerging between chest imaging findings in adults and children with COVID-19 pneumonia, according to a new international consensus statement published online April 23 in Radiology: Cardiothoracic Imaging.

“Chest imaging plays an important role in evaluation of pediatric patients with COVID-19, however there is currently little information available describing imaging manifestations of pediatric COVID-19 and even less discussing utilization of imaging studies in pediatric patients,” write Alexandra M. Foust, DO, from the Department of Radiology, Boston Children’s Hospital and Harvard Medical School, Massachusetts, and colleagues.

The authors wrote the consensus statement to help clinicians evaluate children with potential COVID-19, interpret chest imaging findings, and determine the best treatment for these patients.

As a dedicated pediatric radiologist in tertiary care, senior author Edward Y. Lee, MD, MPH, also from Boston Children’s Hospital, said he works with many international pediatric chest radiologists, and the document provides an international perspective. Information on chest imaging for pediatric patients with COVID-19 is scarce, and clinicians are clamoring for information to inform clinical decisions, he said. He noted that the recommendations are practical and easy to use.

The first step in evaluating a child with suspected COVID-19 is to consider the larger clinical picture. “You really have to look at the patient as a person, and when you look at them, [consider] their underlying risk factors – some people we know are prone to have more serious infection from COVID-19 because they have underlying medical problems,” Lee said.

Certain findings on chest x-ray (CXR) are more specific for COVID-19 pneumonia, whereas CT is better for characterizing and confirming and for differentiating one lung infection from another, Lee explained.
 

Structured reporting

Toward this end, the authors developed tables that provide standardized language to describe imaging findings in patients with suspected COVID-19 pneumonia. Advantages of this type of “structured reporting” include improved understanding and clarity between the radiologist and the ordering provider.

The authors note that structured reporting is likely to be most useful in regions where COVID-19 is highly prevalent. The COVID-19 imaging presentation in children overlaps with some other ailments, including influenza, e-cigarette vaping–associated lung injury, and eosinophilic lung disease. Thus, the use of structured reporting in low-incidence settings could lead to false positive findings.

Commonly seen CXR findings in children with COVID-19 pneumonia include bilaterally distributed peripheral and/or subpleural ground-glass opacities (GGOs) and/or consolidation. Nonspecific findings include “unilateral peripheral or peripheral and central ground-glass opacities and/or consolidation; bilateral peribronchial thickening and/or peribronchial opacities; and multifocal or diffuse GGOs and/or consolidation without specific distribution.”

On CT, commonly seen findings in pediatric COVID-19 pneumonia include “bilateral, peripheral and/or subpleural GGOs and/or consolidation in lower lobe predominant pattern; and ‘halo’ sign early” in the disease course. Indeterminate CT findings include “unilateral peripheral or peripheral and central GGOs and/or consolidation; bilateral peribronchial thickening and/or peribronchial opacities; multivocal or diffuse GGOs and/or consolidation without specific distribution; and ‘crazy paving’ sign.”
 

Imaging recommendations

Initial chest imaging is not generally recommended for screening of symptomatic or asymptomatic children with suspected COVID-19, nor for children with mild clinical symptoms unless the child is at risk for disease progression or worsens clinically.

An initial CXR may be appropriate for children with moderate to severe clinical symptoms – regardless of whether they have COVID-19 – and the patient may undergo a chest CT if the results could influence clinical management.

A repeat reverse transcription polymerase chain reaction (RT-PCR) test for COVID-19 should be considered for children with moderate to severe symptoms whose initial laboratory result was negative but whose chest imaging findings are consistent with COVID-19.

Chest imaging may be used as a first step in the workup for suspected COVID-19 patients in resource-constrained environments where rapid triage may be needed to spare other resources, such as hospital beds and staffing.

It may be appropriate to conduct sequential CXR examinations for pediatric patients with COVID-19 to assess therapeutic response, evaluate clinical worsening, or determine positioning of life support devices, according to the authors.

Post-recovery follow-up chest imaging is not recommended for asymptomatic pediatric patients after recovery from disease that followed a mild course. Post-recovery imaging may be appropriate for asymptomatic children who initially had moderate to severe illness; the decision should be based on clinical concern that the patient may develop long-term lung injury.

Post-recovery follow-up imaging may be appropriate for children whose symptoms persist or worsen regardless of initial illness severity.

Lee and coauthors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Publications
Topics
Sections

Differences are emerging between chest imaging findings in adults and children with COVID-19 pneumonia, according to a new international consensus statement published online April 23 in Radiology: Cardiothoracic Imaging.

“Chest imaging plays an important role in evaluation of pediatric patients with COVID-19, however there is currently little information available describing imaging manifestations of pediatric COVID-19 and even less discussing utilization of imaging studies in pediatric patients,” write Alexandra M. Foust, DO, from the Department of Radiology, Boston Children’s Hospital and Harvard Medical School, Massachusetts, and colleagues.

The authors wrote the consensus statement to help clinicians evaluate children with potential COVID-19, interpret chest imaging findings, and determine the best treatment for these patients.

As a dedicated pediatric radiologist in tertiary care, senior author Edward Y. Lee, MD, MPH, also from Boston Children’s Hospital, said he works with many international pediatric chest radiologists, and the document provides an international perspective. Information on chest imaging for pediatric patients with COVID-19 is scarce, and clinicians are clamoring for information to inform clinical decisions, he said. He noted that the recommendations are practical and easy to use.

The first step in evaluating a child with suspected COVID-19 is to consider the larger clinical picture. “You really have to look at the patient as a person, and when you look at them, [consider] their underlying risk factors – some people we know are prone to have more serious infection from COVID-19 because they have underlying medical problems,” Lee said.

Certain findings on chest x-ray (CXR) are more specific for COVID-19 pneumonia, whereas CT is better for characterizing and confirming and for differentiating one lung infection from another, Lee explained.
 

Structured reporting

Toward this end, the authors developed tables that provide standardized language to describe imaging findings in patients with suspected COVID-19 pneumonia. Advantages of this type of “structured reporting” include improved understanding and clarity between the radiologist and the ordering provider.

The authors note that structured reporting is likely to be most useful in regions where COVID-19 is highly prevalent. The COVID-19 imaging presentation in children overlaps with some other ailments, including influenza, e-cigarette vaping–associated lung injury, and eosinophilic lung disease. Thus, the use of structured reporting in low-incidence settings could lead to false positive findings.

Commonly seen CXR findings in children with COVID-19 pneumonia include bilaterally distributed peripheral and/or subpleural ground-glass opacities (GGOs) and/or consolidation. Nonspecific findings include “unilateral peripheral or peripheral and central ground-glass opacities and/or consolidation; bilateral peribronchial thickening and/or peribronchial opacities; and multifocal or diffuse GGOs and/or consolidation without specific distribution.”

On CT, commonly seen findings in pediatric COVID-19 pneumonia include “bilateral, peripheral and/or subpleural GGOs and/or consolidation in lower lobe predominant pattern; and ‘halo’ sign early” in the disease course. Indeterminate CT findings include “unilateral peripheral or peripheral and central GGOs and/or consolidation; bilateral peribronchial thickening and/or peribronchial opacities; multivocal or diffuse GGOs and/or consolidation without specific distribution; and ‘crazy paving’ sign.”
 

Imaging recommendations

Initial chest imaging is not generally recommended for screening of symptomatic or asymptomatic children with suspected COVID-19, nor for children with mild clinical symptoms unless the child is at risk for disease progression or worsens clinically.

An initial CXR may be appropriate for children with moderate to severe clinical symptoms – regardless of whether they have COVID-19 – and the patient may undergo a chest CT if the results could influence clinical management.

A repeat reverse transcription polymerase chain reaction (RT-PCR) test for COVID-19 should be considered for children with moderate to severe symptoms whose initial laboratory result was negative but whose chest imaging findings are consistent with COVID-19.

Chest imaging may be used as a first step in the workup for suspected COVID-19 patients in resource-constrained environments where rapid triage may be needed to spare other resources, such as hospital beds and staffing.

It may be appropriate to conduct sequential CXR examinations for pediatric patients with COVID-19 to assess therapeutic response, evaluate clinical worsening, or determine positioning of life support devices, according to the authors.

Post-recovery follow-up chest imaging is not recommended for asymptomatic pediatric patients after recovery from disease that followed a mild course. Post-recovery imaging may be appropriate for asymptomatic children who initially had moderate to severe illness; the decision should be based on clinical concern that the patient may develop long-term lung injury.

Post-recovery follow-up imaging may be appropriate for children whose symptoms persist or worsen regardless of initial illness severity.

Lee and coauthors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Differences are emerging between chest imaging findings in adults and children with COVID-19 pneumonia, according to a new international consensus statement published online April 23 in Radiology: Cardiothoracic Imaging.

“Chest imaging plays an important role in evaluation of pediatric patients with COVID-19, however there is currently little information available describing imaging manifestations of pediatric COVID-19 and even less discussing utilization of imaging studies in pediatric patients,” write Alexandra M. Foust, DO, from the Department of Radiology, Boston Children’s Hospital and Harvard Medical School, Massachusetts, and colleagues.

The authors wrote the consensus statement to help clinicians evaluate children with potential COVID-19, interpret chest imaging findings, and determine the best treatment for these patients.

As a dedicated pediatric radiologist in tertiary care, senior author Edward Y. Lee, MD, MPH, also from Boston Children’s Hospital, said he works with many international pediatric chest radiologists, and the document provides an international perspective. Information on chest imaging for pediatric patients with COVID-19 is scarce, and clinicians are clamoring for information to inform clinical decisions, he said. He noted that the recommendations are practical and easy to use.

The first step in evaluating a child with suspected COVID-19 is to consider the larger clinical picture. “You really have to look at the patient as a person, and when you look at them, [consider] their underlying risk factors – some people we know are prone to have more serious infection from COVID-19 because they have underlying medical problems,” Lee said.

Certain findings on chest x-ray (CXR) are more specific for COVID-19 pneumonia, whereas CT is better for characterizing and confirming and for differentiating one lung infection from another, Lee explained.
 

Structured reporting

Toward this end, the authors developed tables that provide standardized language to describe imaging findings in patients with suspected COVID-19 pneumonia. Advantages of this type of “structured reporting” include improved understanding and clarity between the radiologist and the ordering provider.

The authors note that structured reporting is likely to be most useful in regions where COVID-19 is highly prevalent. The COVID-19 imaging presentation in children overlaps with some other ailments, including influenza, e-cigarette vaping–associated lung injury, and eosinophilic lung disease. Thus, the use of structured reporting in low-incidence settings could lead to false positive findings.

Commonly seen CXR findings in children with COVID-19 pneumonia include bilaterally distributed peripheral and/or subpleural ground-glass opacities (GGOs) and/or consolidation. Nonspecific findings include “unilateral peripheral or peripheral and central ground-glass opacities and/or consolidation; bilateral peribronchial thickening and/or peribronchial opacities; and multifocal or diffuse GGOs and/or consolidation without specific distribution.”

On CT, commonly seen findings in pediatric COVID-19 pneumonia include “bilateral, peripheral and/or subpleural GGOs and/or consolidation in lower lobe predominant pattern; and ‘halo’ sign early” in the disease course. Indeterminate CT findings include “unilateral peripheral or peripheral and central GGOs and/or consolidation; bilateral peribronchial thickening and/or peribronchial opacities; multivocal or diffuse GGOs and/or consolidation without specific distribution; and ‘crazy paving’ sign.”
 

Imaging recommendations

Initial chest imaging is not generally recommended for screening of symptomatic or asymptomatic children with suspected COVID-19, nor for children with mild clinical symptoms unless the child is at risk for disease progression or worsens clinically.

An initial CXR may be appropriate for children with moderate to severe clinical symptoms – regardless of whether they have COVID-19 – and the patient may undergo a chest CT if the results could influence clinical management.

A repeat reverse transcription polymerase chain reaction (RT-PCR) test for COVID-19 should be considered for children with moderate to severe symptoms whose initial laboratory result was negative but whose chest imaging findings are consistent with COVID-19.

Chest imaging may be used as a first step in the workup for suspected COVID-19 patients in resource-constrained environments where rapid triage may be needed to spare other resources, such as hospital beds and staffing.

It may be appropriate to conduct sequential CXR examinations for pediatric patients with COVID-19 to assess therapeutic response, evaluate clinical worsening, or determine positioning of life support devices, according to the authors.

Post-recovery follow-up chest imaging is not recommended for asymptomatic pediatric patients after recovery from disease that followed a mild course. Post-recovery imaging may be appropriate for asymptomatic children who initially had moderate to severe illness; the decision should be based on clinical concern that the patient may develop long-term lung injury.

Post-recovery follow-up imaging may be appropriate for children whose symptoms persist or worsen regardless of initial illness severity.

Lee and coauthors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Medscape Article

COVID-19: Employers cut doc pay and bonuses: What’s your recourse?

Article Type
Changed
Thu, 08/26/2021 - 16:10

Employed physicians have had to take large pay cuts, give up bonuses, go on leave, or have even been terminated. In many cases, these actions violate their contract. How can they fight them?
 

Michael D., MD, a colorectal surgeon employed in a large surgical practice in Georgia, is still trying to make sense of a late-night directive from the practice, received in late March.

The practice had just started seeing a steep decline in appointments because of the COVID-19 pandemic. In a hastily arranged group phone call at 11:00 p.m., the CEO told the group what would have to be done.

They would be taking a 50% reduction in salaries, their bonuses for work already done were being withheld, and they would have to use their paid time off (PTO) in order to get their full March salary.

“It’s been over 2 weeks now, and still we’ve seen nothing formalized in writing,” said Dr. D., who asked that his name not be used because he was told that, under no circumstances, should anyone talk to the media.

“They have not told us anything more since then,” he said. “There’s just been a lot of hearsay and speculation.”

Dr. D. has been in touch with employed physicians at other practices, and their experiences run the gamut. One doctor at a large multispecialty group said his salary hadn’t been reduced at all, but a cardiologist was just told he will be laid off in 60 days.

Asking for big sacrifices

As the pandemic has intensified, employed physicians have started to see massive changes in their payment arrangements. They have had to take large pay cuts, give up bonuses, go on leave, and have even been terminated.

“In my 11 years of work on physician contracts, I have never seen changes as drastic as these,” said Kyle Claussen, a physician contract attorney and CEO of Resolve, a company that advises physicians on their careers. The company is based in Columbia, Mo.

He has heard from more than 100 doctors about these proposed changes in their contracts and related matters. Even graduating residents, he said, are being told that the start dates for their new jobs will be delayed.

In many cases, these actions violate the employed physicians’ contracts, said Ericka Adler, a physician contract attorney at Roetzel & Andress in Chicago.

“Some employers are acting out of desperation and are not making legally sound decisions,” Ms. Adler said. “It’s especially upsetting when they do not try to even talk to or work with the doctor first.”

Employers making unfounded unilateral changes

Ms. Adler said some employers are simply issuing a letter to all doctors. “It goes something like, ‘Just to let you know, we are cutting compensation effective immediately,’ and this may apply across the board to all doctors,” she said.

“But the problem with letters is that this is a contractual matter,” she said. “The employer needs to renegotiate each doctor’s contract.”

Employers might insist that the unilateral changes are based on terms in the contract, but this is usually unfounded, both lawyers said. A “force majeure” clause in contracts would allow the employer to set aside terms under certain specified emergencies, and the pandemic might be one of them. But Mr. Claussen said force majeure clauses are rare in physician contracts, and Ms. Adler said she has never seen one.

Lacking a force majeure clause, employers may try to turn to a common law doctrine that allows employers to set aside a contract when it is impossible to perform its terms, owing, for example, to “an unexpected intervening event.” But this tactic is also questionable, says Ms. Adler, who also represents the employer’s side of the contract. “This is a very high standard and unlikely to be satisfied,” she said.

 

 

Employers are desperate to amend contracts

Lacking a cause to take unilateral action, many employers are desperately trying to amend their physician contracts – the subject of the plaintive emails that employed physicians started receiving in mid-March.

“Doctors are trying to decide how they will react to these documents,” Mr. Claussen said. “If they don’t sign, they run the risk of being terminated.” He is expecting termination letters for some of these doctors to start coming in 2-3 weeks.

In response to these amendments, “doctors want to reach out to their employers and see if something can be negotiated,” he said. “Some employers have been amenable, but others have so far not been.”

Ms. Adler said the amendments typically offer open-ended arrangements favoring the employer. “The document might call for a temporary pay cut until the employer thinks they can restore the old salary, but it is up to the employer to decide when that would be,” she said.

Also, when the employer owes the physician for services already performed, the amendments don’t promise to pay them the full amount owed, she said.

Ms. Adler advises doctors to ask for a provision that restoration of their original salary will occur at a definite point in time, such as 30 days after the organization is back at previous volume. And if the doctor is owed money, the doctor should ask for full payment – and to sweeten that offer, allow the employer to pay the doctor back over a period, she says.

Just in the past month, employers have been pushing for several specific changes in doctors’ employment status. Here are some changes that Mr. Claussen and Ms. Adler have been seeing.
 

Withholding quarterly bonuses

In March, just before quarterly bonus payments were due, employed physicians started getting notices that they would not get the bonus, Mr. Claussen said. This covered work already done, and it amounted to a lot of money because practices were busy then.

“Not paying bonuses is a very big deal because they can make up to 50% of a physician’s total compensation,” Mr. Claussen said. He added that unilaterally withholding those funds, without a change in the contract, is legally questionable.

In addition to these changes on past bonuses, he said employers are now trying to temporarily end bonuses going forward through the contract amendments. “It’s not a good idea to sign this,” he said.
 

Doctors paid on pure production are left in the lurch

As volume falls, some hospitals and practices are shutting down doctors’ offices for all but emergencies, leaving their employed doctors with practically nothing to do. Doctors paid purely on their productivity are devastated by this change because their income virtually goes to zero, Mr. Claussen said.

He said office shutdowns are particularly common for specialists because hospitals have been stopping elective procedures during the pandemic, but they can also happen in primary care, which has seen steep declines in patient volume, too.

Having doctors on pure production means that employers can keep doctors hired without having to pay them, Mr. Claussen said. He has seen some employers try to shift more doctors into pure production through the amended contracts.

But Ms. Adler said having doctors on pure production is actually disadvantageous for employers in the current climate. The employer may end up being owed money because of advance payments they have already made to these doctors, she said.

In any case, both lawyers agreed that doctors on a pure production model are in an untenable situation right now. Ms. Adler said they are not earning money but are still technically at work, so they cannot collect unemployment compensation, which would give them some income.

 

 

Forcing doctors to use paid time off

To provide some pay for doctors who have no volume, many employers are forcing these doctors to use up their PTO days, which typically amount to about 4 weeks, Mr. Claussen said. “These doctors have no choice in the matter,” he said.

Furthermore, while on PTO, they are being required to take call. Employers are still obligated to cover call, and there may not be enough doctors still working to fill the call schedule. But making doctors do this work on their time off may be a violation of the contract, Mr. Claussen said.

Terminating physicians

Doctors who have little to do are often put on furlough. This means they don’t get paid but they keep their benefits, Ms. Adler said. The next step, she said, is to lay them off, with the stated intention of rehiring them.

Once laid off, she said, they can get unemployment payments. “Unemployment payments may not be anywhere near what they were earning before, but they are better than not earning anything,” Ms. Adler said.

In some cases, employers are just terminating them and are offering no prospect of rehiring them, she said. Ms. Adler said terminations can be a big problem for doctors. Physicians might have to repay a signing bonus or they might lose their malpractice coverage, forcing them to buy a tail. They could also be subject to a noncompete clause, which would not allow them to practice in the area, she said.

Terminating without cause typically requires 60-90 days’ notice, which both sides might use to negotiate some changes in the contract. But Ms. Adler said some employers are firing doctors with cause, and are using legally questionable reasons to do so.

“In most cases, these employers are grasping at straws,” she said. As a result, she expects many fired doctors will file wrongful termination lawsuits. She thinks employers are better advised to negotiate with the physicians.
 

Delaying start dates for new physicians

Typically, graduating residents and fellows signed with their new employers months ago and are ready to start working on July 1. But some employers are pushing back the start date for several months, Mr. Claussen said.

Mr. Claussen has been helping several clients in this situation. He said these delays are often a clear violation of the employment contract. Most contracts require an amendment to change the start date, he said.

Mr. Claussen said some employers have agreed to a new start date in an amended contract, giving the new physicians a solid date to work with. Not having work can be a real problem for graduating residents, who typically have to start paying off loans.

Now physicians won’t become a new partner

Mr. Claussen said physicians who are up for becoming partner are now being told that the deal is off. With less money coming in, existing partners are not willing to share it with a new partner, and there is no work for a new partner.

“The promise to make them partner is usually a verbal promise, so it is much less likely to be a breach of contract,” he said. “It is frustrating for physicians who were expecting to become partner.”

What can physicians do?

When employers present changes to them, physicians often feel their hands are tied, Ms. Adler said. In these dangerous times, they are expected to make sacrifices to keep the organization from going out of business.

Even if they wanted to file suits against their employer, “they can’t go to court right now because the courts are closed,” Ms. Adler said. “Employers are banking on doctors not doing anything.”

In most cases, however, doctors don’t have to act right away, she said. “Just because you have not reacted to the new situation does not mean you accepted it,” she said. “You can wait months, even years to file a lawsuit, depending on the state and the cause of action.”

Ms. Adler recommended that doctors make it clear that they don’t agree with the changes. An attorney experienced in physician contracts can review the changes being made and the amended contracts being offered.

Thanks to recent federal changes, employers have to have some ways to continue paying physicians, Ms. Adler said. Medical practices with fewer than 500 employees can get loans from the federal government that would not have to be repaid if they met certain stipulations, such as hiring back all the employees they terminate, she said.

Mr. Claussen said physicians should resist the obvious dangers, such as a shift to a pure production salary, denying bonus payments for work already done, and forcing physicians you use up PTO days.

He also suggested persuading employers to postpone rather than eliminate payments. “Some employers have agreed to postpone payments until a date later in 2020 rather than eliminate them,” he said. “The aim is that the organization will be back on its feet at that time.”

Mr. Claussen said he is trying to limit the contract amendments to 1 or 2 months. Because the situation caused by the pandemic is so fluid, “this allows for flexibility,” he said. “We can revisit the situation and come up with different changes.”

Ms. Adler doubts employers would accept short-term changes with a definite end date because such changes would not be in the employer’s interest. But Mr. Claussen said one employer has agreed to reevaluate its contracts in June.

Both lawyers agreed that many employers are trying to work with their physicians. “In 90% of the cases I have seen, both sides cooperate,” Ms. Adler said. “Because of the situation, people are being much more conciliatory than they would have been.”

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

Publications
Topics
Sections

Employed physicians have had to take large pay cuts, give up bonuses, go on leave, or have even been terminated. In many cases, these actions violate their contract. How can they fight them?
 

Michael D., MD, a colorectal surgeon employed in a large surgical practice in Georgia, is still trying to make sense of a late-night directive from the practice, received in late March.

The practice had just started seeing a steep decline in appointments because of the COVID-19 pandemic. In a hastily arranged group phone call at 11:00 p.m., the CEO told the group what would have to be done.

They would be taking a 50% reduction in salaries, their bonuses for work already done were being withheld, and they would have to use their paid time off (PTO) in order to get their full March salary.

“It’s been over 2 weeks now, and still we’ve seen nothing formalized in writing,” said Dr. D., who asked that his name not be used because he was told that, under no circumstances, should anyone talk to the media.

“They have not told us anything more since then,” he said. “There’s just been a lot of hearsay and speculation.”

Dr. D. has been in touch with employed physicians at other practices, and their experiences run the gamut. One doctor at a large multispecialty group said his salary hadn’t been reduced at all, but a cardiologist was just told he will be laid off in 60 days.

Asking for big sacrifices

As the pandemic has intensified, employed physicians have started to see massive changes in their payment arrangements. They have had to take large pay cuts, give up bonuses, go on leave, and have even been terminated.

“In my 11 years of work on physician contracts, I have never seen changes as drastic as these,” said Kyle Claussen, a physician contract attorney and CEO of Resolve, a company that advises physicians on their careers. The company is based in Columbia, Mo.

He has heard from more than 100 doctors about these proposed changes in their contracts and related matters. Even graduating residents, he said, are being told that the start dates for their new jobs will be delayed.

In many cases, these actions violate the employed physicians’ contracts, said Ericka Adler, a physician contract attorney at Roetzel & Andress in Chicago.

“Some employers are acting out of desperation and are not making legally sound decisions,” Ms. Adler said. “It’s especially upsetting when they do not try to even talk to or work with the doctor first.”

Employers making unfounded unilateral changes

Ms. Adler said some employers are simply issuing a letter to all doctors. “It goes something like, ‘Just to let you know, we are cutting compensation effective immediately,’ and this may apply across the board to all doctors,” she said.

“But the problem with letters is that this is a contractual matter,” she said. “The employer needs to renegotiate each doctor’s contract.”

Employers might insist that the unilateral changes are based on terms in the contract, but this is usually unfounded, both lawyers said. A “force majeure” clause in contracts would allow the employer to set aside terms under certain specified emergencies, and the pandemic might be one of them. But Mr. Claussen said force majeure clauses are rare in physician contracts, and Ms. Adler said she has never seen one.

Lacking a force majeure clause, employers may try to turn to a common law doctrine that allows employers to set aside a contract when it is impossible to perform its terms, owing, for example, to “an unexpected intervening event.” But this tactic is also questionable, says Ms. Adler, who also represents the employer’s side of the contract. “This is a very high standard and unlikely to be satisfied,” she said.

 

 

Employers are desperate to amend contracts

Lacking a cause to take unilateral action, many employers are desperately trying to amend their physician contracts – the subject of the plaintive emails that employed physicians started receiving in mid-March.

“Doctors are trying to decide how they will react to these documents,” Mr. Claussen said. “If they don’t sign, they run the risk of being terminated.” He is expecting termination letters for some of these doctors to start coming in 2-3 weeks.

In response to these amendments, “doctors want to reach out to their employers and see if something can be negotiated,” he said. “Some employers have been amenable, but others have so far not been.”

Ms. Adler said the amendments typically offer open-ended arrangements favoring the employer. “The document might call for a temporary pay cut until the employer thinks they can restore the old salary, but it is up to the employer to decide when that would be,” she said.

Also, when the employer owes the physician for services already performed, the amendments don’t promise to pay them the full amount owed, she said.

Ms. Adler advises doctors to ask for a provision that restoration of their original salary will occur at a definite point in time, such as 30 days after the organization is back at previous volume. And if the doctor is owed money, the doctor should ask for full payment – and to sweeten that offer, allow the employer to pay the doctor back over a period, she says.

Just in the past month, employers have been pushing for several specific changes in doctors’ employment status. Here are some changes that Mr. Claussen and Ms. Adler have been seeing.
 

Withholding quarterly bonuses

In March, just before quarterly bonus payments were due, employed physicians started getting notices that they would not get the bonus, Mr. Claussen said. This covered work already done, and it amounted to a lot of money because practices were busy then.

“Not paying bonuses is a very big deal because they can make up to 50% of a physician’s total compensation,” Mr. Claussen said. He added that unilaterally withholding those funds, without a change in the contract, is legally questionable.

In addition to these changes on past bonuses, he said employers are now trying to temporarily end bonuses going forward through the contract amendments. “It’s not a good idea to sign this,” he said.
 

Doctors paid on pure production are left in the lurch

As volume falls, some hospitals and practices are shutting down doctors’ offices for all but emergencies, leaving their employed doctors with practically nothing to do. Doctors paid purely on their productivity are devastated by this change because their income virtually goes to zero, Mr. Claussen said.

He said office shutdowns are particularly common for specialists because hospitals have been stopping elective procedures during the pandemic, but they can also happen in primary care, which has seen steep declines in patient volume, too.

Having doctors on pure production means that employers can keep doctors hired without having to pay them, Mr. Claussen said. He has seen some employers try to shift more doctors into pure production through the amended contracts.

But Ms. Adler said having doctors on pure production is actually disadvantageous for employers in the current climate. The employer may end up being owed money because of advance payments they have already made to these doctors, she said.

In any case, both lawyers agreed that doctors on a pure production model are in an untenable situation right now. Ms. Adler said they are not earning money but are still technically at work, so they cannot collect unemployment compensation, which would give them some income.

 

 

Forcing doctors to use paid time off

To provide some pay for doctors who have no volume, many employers are forcing these doctors to use up their PTO days, which typically amount to about 4 weeks, Mr. Claussen said. “These doctors have no choice in the matter,” he said.

Furthermore, while on PTO, they are being required to take call. Employers are still obligated to cover call, and there may not be enough doctors still working to fill the call schedule. But making doctors do this work on their time off may be a violation of the contract, Mr. Claussen said.

Terminating physicians

Doctors who have little to do are often put on furlough. This means they don’t get paid but they keep their benefits, Ms. Adler said. The next step, she said, is to lay them off, with the stated intention of rehiring them.

Once laid off, she said, they can get unemployment payments. “Unemployment payments may not be anywhere near what they were earning before, but they are better than not earning anything,” Ms. Adler said.

In some cases, employers are just terminating them and are offering no prospect of rehiring them, she said. Ms. Adler said terminations can be a big problem for doctors. Physicians might have to repay a signing bonus or they might lose their malpractice coverage, forcing them to buy a tail. They could also be subject to a noncompete clause, which would not allow them to practice in the area, she said.

Terminating without cause typically requires 60-90 days’ notice, which both sides might use to negotiate some changes in the contract. But Ms. Adler said some employers are firing doctors with cause, and are using legally questionable reasons to do so.

“In most cases, these employers are grasping at straws,” she said. As a result, she expects many fired doctors will file wrongful termination lawsuits. She thinks employers are better advised to negotiate with the physicians.
 

Delaying start dates for new physicians

Typically, graduating residents and fellows signed with their new employers months ago and are ready to start working on July 1. But some employers are pushing back the start date for several months, Mr. Claussen said.

Mr. Claussen has been helping several clients in this situation. He said these delays are often a clear violation of the employment contract. Most contracts require an amendment to change the start date, he said.

Mr. Claussen said some employers have agreed to a new start date in an amended contract, giving the new physicians a solid date to work with. Not having work can be a real problem for graduating residents, who typically have to start paying off loans.

Now physicians won’t become a new partner

Mr. Claussen said physicians who are up for becoming partner are now being told that the deal is off. With less money coming in, existing partners are not willing to share it with a new partner, and there is no work for a new partner.

“The promise to make them partner is usually a verbal promise, so it is much less likely to be a breach of contract,” he said. “It is frustrating for physicians who were expecting to become partner.”

What can physicians do?

When employers present changes to them, physicians often feel their hands are tied, Ms. Adler said. In these dangerous times, they are expected to make sacrifices to keep the organization from going out of business.

Even if they wanted to file suits against their employer, “they can’t go to court right now because the courts are closed,” Ms. Adler said. “Employers are banking on doctors not doing anything.”

In most cases, however, doctors don’t have to act right away, she said. “Just because you have not reacted to the new situation does not mean you accepted it,” she said. “You can wait months, even years to file a lawsuit, depending on the state and the cause of action.”

Ms. Adler recommended that doctors make it clear that they don’t agree with the changes. An attorney experienced in physician contracts can review the changes being made and the amended contracts being offered.

Thanks to recent federal changes, employers have to have some ways to continue paying physicians, Ms. Adler said. Medical practices with fewer than 500 employees can get loans from the federal government that would not have to be repaid if they met certain stipulations, such as hiring back all the employees they terminate, she said.

Mr. Claussen said physicians should resist the obvious dangers, such as a shift to a pure production salary, denying bonus payments for work already done, and forcing physicians you use up PTO days.

He also suggested persuading employers to postpone rather than eliminate payments. “Some employers have agreed to postpone payments until a date later in 2020 rather than eliminate them,” he said. “The aim is that the organization will be back on its feet at that time.”

Mr. Claussen said he is trying to limit the contract amendments to 1 or 2 months. Because the situation caused by the pandemic is so fluid, “this allows for flexibility,” he said. “We can revisit the situation and come up with different changes.”

Ms. Adler doubts employers would accept short-term changes with a definite end date because such changes would not be in the employer’s interest. But Mr. Claussen said one employer has agreed to reevaluate its contracts in June.

Both lawyers agreed that many employers are trying to work with their physicians. “In 90% of the cases I have seen, both sides cooperate,” Ms. Adler said. “Because of the situation, people are being much more conciliatory than they would have been.”

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

Employed physicians have had to take large pay cuts, give up bonuses, go on leave, or have even been terminated. In many cases, these actions violate their contract. How can they fight them?
 

Michael D., MD, a colorectal surgeon employed in a large surgical practice in Georgia, is still trying to make sense of a late-night directive from the practice, received in late March.

The practice had just started seeing a steep decline in appointments because of the COVID-19 pandemic. In a hastily arranged group phone call at 11:00 p.m., the CEO told the group what would have to be done.

They would be taking a 50% reduction in salaries, their bonuses for work already done were being withheld, and they would have to use their paid time off (PTO) in order to get their full March salary.

“It’s been over 2 weeks now, and still we’ve seen nothing formalized in writing,” said Dr. D., who asked that his name not be used because he was told that, under no circumstances, should anyone talk to the media.

“They have not told us anything more since then,” he said. “There’s just been a lot of hearsay and speculation.”

Dr. D. has been in touch with employed physicians at other practices, and their experiences run the gamut. One doctor at a large multispecialty group said his salary hadn’t been reduced at all, but a cardiologist was just told he will be laid off in 60 days.

Asking for big sacrifices

As the pandemic has intensified, employed physicians have started to see massive changes in their payment arrangements. They have had to take large pay cuts, give up bonuses, go on leave, and have even been terminated.

“In my 11 years of work on physician contracts, I have never seen changes as drastic as these,” said Kyle Claussen, a physician contract attorney and CEO of Resolve, a company that advises physicians on their careers. The company is based in Columbia, Mo.

He has heard from more than 100 doctors about these proposed changes in their contracts and related matters. Even graduating residents, he said, are being told that the start dates for their new jobs will be delayed.

In many cases, these actions violate the employed physicians’ contracts, said Ericka Adler, a physician contract attorney at Roetzel & Andress in Chicago.

“Some employers are acting out of desperation and are not making legally sound decisions,” Ms. Adler said. “It’s especially upsetting when they do not try to even talk to or work with the doctor first.”

Employers making unfounded unilateral changes

Ms. Adler said some employers are simply issuing a letter to all doctors. “It goes something like, ‘Just to let you know, we are cutting compensation effective immediately,’ and this may apply across the board to all doctors,” she said.

“But the problem with letters is that this is a contractual matter,” she said. “The employer needs to renegotiate each doctor’s contract.”

Employers might insist that the unilateral changes are based on terms in the contract, but this is usually unfounded, both lawyers said. A “force majeure” clause in contracts would allow the employer to set aside terms under certain specified emergencies, and the pandemic might be one of them. But Mr. Claussen said force majeure clauses are rare in physician contracts, and Ms. Adler said she has never seen one.

Lacking a force majeure clause, employers may try to turn to a common law doctrine that allows employers to set aside a contract when it is impossible to perform its terms, owing, for example, to “an unexpected intervening event.” But this tactic is also questionable, says Ms. Adler, who also represents the employer’s side of the contract. “This is a very high standard and unlikely to be satisfied,” she said.

 

 

Employers are desperate to amend contracts

Lacking a cause to take unilateral action, many employers are desperately trying to amend their physician contracts – the subject of the plaintive emails that employed physicians started receiving in mid-March.

“Doctors are trying to decide how they will react to these documents,” Mr. Claussen said. “If they don’t sign, they run the risk of being terminated.” He is expecting termination letters for some of these doctors to start coming in 2-3 weeks.

In response to these amendments, “doctors want to reach out to their employers and see if something can be negotiated,” he said. “Some employers have been amenable, but others have so far not been.”

Ms. Adler said the amendments typically offer open-ended arrangements favoring the employer. “The document might call for a temporary pay cut until the employer thinks they can restore the old salary, but it is up to the employer to decide when that would be,” she said.

Also, when the employer owes the physician for services already performed, the amendments don’t promise to pay them the full amount owed, she said.

Ms. Adler advises doctors to ask for a provision that restoration of their original salary will occur at a definite point in time, such as 30 days after the organization is back at previous volume. And if the doctor is owed money, the doctor should ask for full payment – and to sweeten that offer, allow the employer to pay the doctor back over a period, she says.

Just in the past month, employers have been pushing for several specific changes in doctors’ employment status. Here are some changes that Mr. Claussen and Ms. Adler have been seeing.
 

Withholding quarterly bonuses

In March, just before quarterly bonus payments were due, employed physicians started getting notices that they would not get the bonus, Mr. Claussen said. This covered work already done, and it amounted to a lot of money because practices were busy then.

“Not paying bonuses is a very big deal because they can make up to 50% of a physician’s total compensation,” Mr. Claussen said. He added that unilaterally withholding those funds, without a change in the contract, is legally questionable.

In addition to these changes on past bonuses, he said employers are now trying to temporarily end bonuses going forward through the contract amendments. “It’s not a good idea to sign this,” he said.
 

Doctors paid on pure production are left in the lurch

As volume falls, some hospitals and practices are shutting down doctors’ offices for all but emergencies, leaving their employed doctors with practically nothing to do. Doctors paid purely on their productivity are devastated by this change because their income virtually goes to zero, Mr. Claussen said.

He said office shutdowns are particularly common for specialists because hospitals have been stopping elective procedures during the pandemic, but they can also happen in primary care, which has seen steep declines in patient volume, too.

Having doctors on pure production means that employers can keep doctors hired without having to pay them, Mr. Claussen said. He has seen some employers try to shift more doctors into pure production through the amended contracts.

But Ms. Adler said having doctors on pure production is actually disadvantageous for employers in the current climate. The employer may end up being owed money because of advance payments they have already made to these doctors, she said.

In any case, both lawyers agreed that doctors on a pure production model are in an untenable situation right now. Ms. Adler said they are not earning money but are still technically at work, so they cannot collect unemployment compensation, which would give them some income.

 

 

Forcing doctors to use paid time off

To provide some pay for doctors who have no volume, many employers are forcing these doctors to use up their PTO days, which typically amount to about 4 weeks, Mr. Claussen said. “These doctors have no choice in the matter,” he said.

Furthermore, while on PTO, they are being required to take call. Employers are still obligated to cover call, and there may not be enough doctors still working to fill the call schedule. But making doctors do this work on their time off may be a violation of the contract, Mr. Claussen said.

Terminating physicians

Doctors who have little to do are often put on furlough. This means they don’t get paid but they keep their benefits, Ms. Adler said. The next step, she said, is to lay them off, with the stated intention of rehiring them.

Once laid off, she said, they can get unemployment payments. “Unemployment payments may not be anywhere near what they were earning before, but they are better than not earning anything,” Ms. Adler said.

In some cases, employers are just terminating them and are offering no prospect of rehiring them, she said. Ms. Adler said terminations can be a big problem for doctors. Physicians might have to repay a signing bonus or they might lose their malpractice coverage, forcing them to buy a tail. They could also be subject to a noncompete clause, which would not allow them to practice in the area, she said.

Terminating without cause typically requires 60-90 days’ notice, which both sides might use to negotiate some changes in the contract. But Ms. Adler said some employers are firing doctors with cause, and are using legally questionable reasons to do so.

“In most cases, these employers are grasping at straws,” she said. As a result, she expects many fired doctors will file wrongful termination lawsuits. She thinks employers are better advised to negotiate with the physicians.
 

Delaying start dates for new physicians

Typically, graduating residents and fellows signed with their new employers months ago and are ready to start working on July 1. But some employers are pushing back the start date for several months, Mr. Claussen said.

Mr. Claussen has been helping several clients in this situation. He said these delays are often a clear violation of the employment contract. Most contracts require an amendment to change the start date, he said.

Mr. Claussen said some employers have agreed to a new start date in an amended contract, giving the new physicians a solid date to work with. Not having work can be a real problem for graduating residents, who typically have to start paying off loans.

Now physicians won’t become a new partner

Mr. Claussen said physicians who are up for becoming partner are now being told that the deal is off. With less money coming in, existing partners are not willing to share it with a new partner, and there is no work for a new partner.

“The promise to make them partner is usually a verbal promise, so it is much less likely to be a breach of contract,” he said. “It is frustrating for physicians who were expecting to become partner.”

What can physicians do?

When employers present changes to them, physicians often feel their hands are tied, Ms. Adler said. In these dangerous times, they are expected to make sacrifices to keep the organization from going out of business.

Even if they wanted to file suits against their employer, “they can’t go to court right now because the courts are closed,” Ms. Adler said. “Employers are banking on doctors not doing anything.”

In most cases, however, doctors don’t have to act right away, she said. “Just because you have not reacted to the new situation does not mean you accepted it,” she said. “You can wait months, even years to file a lawsuit, depending on the state and the cause of action.”

Ms. Adler recommended that doctors make it clear that they don’t agree with the changes. An attorney experienced in physician contracts can review the changes being made and the amended contracts being offered.

Thanks to recent federal changes, employers have to have some ways to continue paying physicians, Ms. Adler said. Medical practices with fewer than 500 employees can get loans from the federal government that would not have to be repaid if they met certain stipulations, such as hiring back all the employees they terminate, she said.

Mr. Claussen said physicians should resist the obvious dangers, such as a shift to a pure production salary, denying bonus payments for work already done, and forcing physicians you use up PTO days.

He also suggested persuading employers to postpone rather than eliminate payments. “Some employers have agreed to postpone payments until a date later in 2020 rather than eliminate them,” he said. “The aim is that the organization will be back on its feet at that time.”

Mr. Claussen said he is trying to limit the contract amendments to 1 or 2 months. Because the situation caused by the pandemic is so fluid, “this allows for flexibility,” he said. “We can revisit the situation and come up with different changes.”

Ms. Adler doubts employers would accept short-term changes with a definite end date because such changes would not be in the employer’s interest. But Mr. Claussen said one employer has agreed to reevaluate its contracts in June.

Both lawyers agreed that many employers are trying to work with their physicians. “In 90% of the cases I have seen, both sides cooperate,” Ms. Adler said. “Because of the situation, people are being much more conciliatory than they would have been.”

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap

Sleep quality may affect COPD risk in African American smokers

Article Type
Changed
Mon, 05/18/2020 - 16:03

African American smokers who logged more total sleep time and greater sleep efficacy performed better on a functional walk test than did those with poorer sleep, based on data from 209 adults.

beichh4046/Getty Images

African American smokers tend to develop COPD sooner and also report more sleep problems, compared with white smokers, wrote Andrew J. Gangemi, MD, of Temple University Hospital, Philadelphia, and colleagues.

In addition, African Americans tend to develop COPD at a younger age and with lower levels of smoking than do non-Hispanic whites, they said. “Sleep health may be a contributing factor to the lung and cardiovascular health disparity experienced by AA smokers,” in part because data suggest that insufficient sleep may be associated with increased risk of COPD exacerbation in smokers in general, they said.

In a study published in Chest, the researchers reviewed data from 209 African American adults aged 40-65 years who had smoked at least one cigarette in the past month. The average age of the participants was 55 years, 59% were women, and the average smoking habit was nine cigarettes per day.

The researchers measured functional exercise capacity of the participants using the 6-minute walk test (6MWT). Total sleep time (TST) and sleep efficacy (SE) were measured by way of a finger-based device.

Smokers of at least 10 cigarettes per day gained an additional 0.05-0.58 meters in distance covered on the 6MWT for every added minute of total sleep time in a multivariable regression analysis. Similarly, smokers of at least 10 cigarettes per day gained an additional 0.84-6.17–meter increase in distance covered on the 6MWT for every added percentage of sleep efficacy.

The reasons for the impact of SE and TST on functional exercise capacity in smokers remain unclear, the researchers said. “Heavier smokers have higher levels of autonomic imbalance, including higher resting heart rate and heart rate variability, impaired 24-hour cardiovascular sympathetic tone, and blunted cerebrovascular autonomic regulation and baroreflex response to hypercapnia,” they said.

Also unclear is the reason for the large magnitude of the association between SE and smoking vs. the lesser association between TST and smoking on 6MWT results, the researchers wrote. “Poor sleep efficiency, outside of traditional OSA scoring, is predictive of myocardial infarction, stroke, and cardiovascular-related mortality risk. Moreover, deficits in sleep efficiency have been consistently demonstrated in smokers versus nonsmokers,” they said.

The study findings were limited by several factors including inability to extrapolate data to other demographic groups and the cross-sectional design, the researchers noted. In addition, they did not address how TST and SE may relate to lung function.

However, the results “extend current knowledge about the potential role of improved sleep health to functional exercise capacity in AA smokers,” and set the stage for future studies of how changes in sleep health may affect lung and functional exercise capacity in smokers over time, as well as effects on inflammation and autonomic imbalance, the researchers concluded.

The study was supported by the National Institute on Minority Health and Health Disparities and by the National Institute of General Medical Sciences, both part of the National Institutes Health. The researchers had no financial conflicts to disclose.

SOURCE: Gangemi A et al. Chest 2020 Apr 23. doi: 10.1016/j.chest.2020.03.070.

Publications
Topics
Sections

African American smokers who logged more total sleep time and greater sleep efficacy performed better on a functional walk test than did those with poorer sleep, based on data from 209 adults.

beichh4046/Getty Images

African American smokers tend to develop COPD sooner and also report more sleep problems, compared with white smokers, wrote Andrew J. Gangemi, MD, of Temple University Hospital, Philadelphia, and colleagues.

In addition, African Americans tend to develop COPD at a younger age and with lower levels of smoking than do non-Hispanic whites, they said. “Sleep health may be a contributing factor to the lung and cardiovascular health disparity experienced by AA smokers,” in part because data suggest that insufficient sleep may be associated with increased risk of COPD exacerbation in smokers in general, they said.

In a study published in Chest, the researchers reviewed data from 209 African American adults aged 40-65 years who had smoked at least one cigarette in the past month. The average age of the participants was 55 years, 59% were women, and the average smoking habit was nine cigarettes per day.

The researchers measured functional exercise capacity of the participants using the 6-minute walk test (6MWT). Total sleep time (TST) and sleep efficacy (SE) were measured by way of a finger-based device.

Smokers of at least 10 cigarettes per day gained an additional 0.05-0.58 meters in distance covered on the 6MWT for every added minute of total sleep time in a multivariable regression analysis. Similarly, smokers of at least 10 cigarettes per day gained an additional 0.84-6.17–meter increase in distance covered on the 6MWT for every added percentage of sleep efficacy.

The reasons for the impact of SE and TST on functional exercise capacity in smokers remain unclear, the researchers said. “Heavier smokers have higher levels of autonomic imbalance, including higher resting heart rate and heart rate variability, impaired 24-hour cardiovascular sympathetic tone, and blunted cerebrovascular autonomic regulation and baroreflex response to hypercapnia,” they said.

Also unclear is the reason for the large magnitude of the association between SE and smoking vs. the lesser association between TST and smoking on 6MWT results, the researchers wrote. “Poor sleep efficiency, outside of traditional OSA scoring, is predictive of myocardial infarction, stroke, and cardiovascular-related mortality risk. Moreover, deficits in sleep efficiency have been consistently demonstrated in smokers versus nonsmokers,” they said.

The study findings were limited by several factors including inability to extrapolate data to other demographic groups and the cross-sectional design, the researchers noted. In addition, they did not address how TST and SE may relate to lung function.

However, the results “extend current knowledge about the potential role of improved sleep health to functional exercise capacity in AA smokers,” and set the stage for future studies of how changes in sleep health may affect lung and functional exercise capacity in smokers over time, as well as effects on inflammation and autonomic imbalance, the researchers concluded.

The study was supported by the National Institute on Minority Health and Health Disparities and by the National Institute of General Medical Sciences, both part of the National Institutes Health. The researchers had no financial conflicts to disclose.

SOURCE: Gangemi A et al. Chest 2020 Apr 23. doi: 10.1016/j.chest.2020.03.070.

African American smokers who logged more total sleep time and greater sleep efficacy performed better on a functional walk test than did those with poorer sleep, based on data from 209 adults.

beichh4046/Getty Images

African American smokers tend to develop COPD sooner and also report more sleep problems, compared with white smokers, wrote Andrew J. Gangemi, MD, of Temple University Hospital, Philadelphia, and colleagues.

In addition, African Americans tend to develop COPD at a younger age and with lower levels of smoking than do non-Hispanic whites, they said. “Sleep health may be a contributing factor to the lung and cardiovascular health disparity experienced by AA smokers,” in part because data suggest that insufficient sleep may be associated with increased risk of COPD exacerbation in smokers in general, they said.

In a study published in Chest, the researchers reviewed data from 209 African American adults aged 40-65 years who had smoked at least one cigarette in the past month. The average age of the participants was 55 years, 59% were women, and the average smoking habit was nine cigarettes per day.

The researchers measured functional exercise capacity of the participants using the 6-minute walk test (6MWT). Total sleep time (TST) and sleep efficacy (SE) were measured by way of a finger-based device.

Smokers of at least 10 cigarettes per day gained an additional 0.05-0.58 meters in distance covered on the 6MWT for every added minute of total sleep time in a multivariable regression analysis. Similarly, smokers of at least 10 cigarettes per day gained an additional 0.84-6.17–meter increase in distance covered on the 6MWT for every added percentage of sleep efficacy.

The reasons for the impact of SE and TST on functional exercise capacity in smokers remain unclear, the researchers said. “Heavier smokers have higher levels of autonomic imbalance, including higher resting heart rate and heart rate variability, impaired 24-hour cardiovascular sympathetic tone, and blunted cerebrovascular autonomic regulation and baroreflex response to hypercapnia,” they said.

Also unclear is the reason for the large magnitude of the association between SE and smoking vs. the lesser association between TST and smoking on 6MWT results, the researchers wrote. “Poor sleep efficiency, outside of traditional OSA scoring, is predictive of myocardial infarction, stroke, and cardiovascular-related mortality risk. Moreover, deficits in sleep efficiency have been consistently demonstrated in smokers versus nonsmokers,” they said.

The study findings were limited by several factors including inability to extrapolate data to other demographic groups and the cross-sectional design, the researchers noted. In addition, they did not address how TST and SE may relate to lung function.

However, the results “extend current knowledge about the potential role of improved sleep health to functional exercise capacity in AA smokers,” and set the stage for future studies of how changes in sleep health may affect lung and functional exercise capacity in smokers over time, as well as effects on inflammation and autonomic imbalance, the researchers concluded.

The study was supported by the National Institute on Minority Health and Health Disparities and by the National Institute of General Medical Sciences, both part of the National Institutes Health. The researchers had no financial conflicts to disclose.

SOURCE: Gangemi A et al. Chest 2020 Apr 23. doi: 10.1016/j.chest.2020.03.070.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM CHEST

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap

Hospitals update hydroxychloroquine protocols after FDA warning

Article Type
Changed
Thu, 08/26/2021 - 16:10

Across the country, hospitals are incorporating Friday’s warning from the US Food and Drug Administration (FDA) about the risks of prescribing hydroxychloroquine and chloroquine for COVID-19 into their treatment protocols.

For some hospitals, the message affirmed the cautious approach they were already taking with hydroxychloroquine. “From a New York state or Northwell perspective, there is no major change,” said Onisis Stefas, PharmD, vice president of pharmacy at Northwell Health in New York. “We were not prescribing it out in the community very early on because of the concerns associated with the heart arrhythmias.”

Brigham and Women’s Hospital in Boston, Massachusetts, is currently in the process of updating its publicly available COVID-19 protocols website “to incorporate the FDA’s updated safety assessment and ongoing clinical trials,” a hospital spokesperson told Medscape Medical News. Prior to the updates, the treatment protocols indicated that hydroxychloroquine should only be considered after weighing the risks and benefits for patients who are not candidates for other clinical trials and meet a specific set of health criteria.

The warning is a timely and important synthesis of what physicians know about the drugs so far and how cautiously clinicians across the country should be using them, said Rajesh T. Gandhi, MD, infectious diseases physician at Massachusetts General Hospital (MGH), Boston, professor of medicine at Harvard Medical School, member of the Infectious Diseases Society of America (IDSA), and chair-elect of the HIV Medicine Association.

“I think to be honest it’s a really important message to the public and clinicians across the country,” said Gandhi. “Because we all know there is just a ton of discussion around this drug ... and it came out fairly and said what we know right now.”

The two antimalarial drugs have been at the center of much political debate and scientific scrutiny in recent weeks, following President Trump’s endorsement and the FDA’s emergency use authorization for the two medications in March. Hospitals across the country had incorporated hydroxychloroquine and chloroquine into their constantly evolving treatment protocols for patients with COVID-19.

But the evidence that these drugs actually help treat COVID-19 remains scant. Some small studies suggest the therapies help patients with COVID-19, while others conclude the drugs have no effect or even harm patients. In the United States, medical societies including the American Heart Association have also warned about the serious cardiac issues that can accompany these drugs for some patients.

In the new warning, the FDA said it “cautions against use of hydroxychloroquine or chloroquine for COVID-19 patients outside of the hospital setting or a clinical trial” and urged “close supervision” of patients treated with these therapies, citing cardiac side effects.

The FDA also said it is aware that the outpatient prescription of these medications has increased since its March authorization, but the drugs still have not been shown to be safe or effective in treating or preventing COVID-19.

The FDA announcement is consistent with protocols established by the National Institutes of Health and IDSA earlier this month that recommend against using hydroxychloroquine or chloroquine, except when these drugs are administered as part of a clinical trial.



“We agree wholeheartedly with the FDA and have been hoping that the FDA would in fact issue that kind of clarification,” said Samuel Brown, MD, study committee cochair of the ORCHID clinical trial, a multicenter, blinded study investigating the safety and efficacy of hydroxychloroquine. These medications need to be tested in clinical trials that are able to focus closely on safety monitoring, he said. Experts at Vanderbilt University, one of the medical centers participating in the ORCHID clinical trial, decided before Tennessee had any cases of COVID-19 that unproven therapies like hydroxychloroquine would only be available through clinical trials, said Wesley Self, MD, associate professor of emergency medicine at Vanderbilt University, Nashville, Tennessee, and chair of the ORCHID study committee.

Northwell Health, like other hospitals in New York, has been following a March executive order issued by Governor Andrew Cuomo limiting the use of these drugs for COVID-19 outside of clinical trials, said Stefas. At Northwell Health, patients with COVID-19 only receive hydroxychloroquine or chloroquine when treated in hospital, where they can be closely monitored, or as part of a clinical trial. The hospital system’s protocols currently do not recommend pairing hydroxychloroquine with azithromycin, said Stefas. The new FDA announcement is “very similar” to New York’s existing executive order, he said. “Reading through this reinforces a lot of what we originally thought.”

At MGH in Boston, the FDA safety warning is in line with and “solidifies” the hospital’s evolving protocols, said Gandhi. Clinicians at MGH have been steadily moving away from prescribing hydroxychloroquine outside of clinical trials as the efficacy has remained murky, the serious side effects have become more evident, and clinical trials to assess the drug have gotten underway in recent weeks, he said. Given the conflicting evidence, Gandhi feels the use of these drugs needs to be focused in clinical trials, where scientists can truly evaluate how much they help or harm.

“We know fundamentally that’s the way to do this,” Gandhi said. “We also don’t know that it doesn’t work, so it is ethical and incumbent upon us to do a study,” Gandhi said.

Other hospitals are already heeding the FDA’s warning. At UW Medicine in Washington state, for example, hydroxychloroquine was considered a possible treatment for COVID-19 prior to the FDA’s recent announcement. “Based on FDA guidance, hydroxychloroquine is no longer recommended as therapy for COVID-19 unless done through a clinical trial,” said Tim Dellit, MD, chief medical officer for UW Medicine.

Michigan Medicine stopped using hydroxychloroquine and azithromycin (both separately and in combination) about a month ago, said Daniel Kaul, MD, a professor of infectious disease at the University of Michigan. “When we reviewed the data that was available in more detail, we realized that it was essentially uninterpretable,” he said. As of Monday, the only patients receiving this drug at Michigan Medicine are those enrolled in the ORCHID clinical trial.

But that does not seem to be the case everywhere. Most patients transferred to Michigan Medicine from other hospitals have received these drugs, indicating they are still being widely used, said Kaul. “I think this FDA guidance is appropriate and may reduce usage of this drug and make people more aware of the potential side effects both in inpatient and outpatient settings.”

Hopefully, the FDA guidance will help slow the use of these drugs outside the appropriate clinical trial setting, said Kaul. “I think that the kind of politicization of this drug, which is pretty much unprecedented in my experience, created a really harmful environment where calm decision making and assessment of the relative risks and benefits became somewhat impossible,” said Kaul.

This article first appeared on Medscape.com.

Publications
Topics
Sections

Across the country, hospitals are incorporating Friday’s warning from the US Food and Drug Administration (FDA) about the risks of prescribing hydroxychloroquine and chloroquine for COVID-19 into their treatment protocols.

For some hospitals, the message affirmed the cautious approach they were already taking with hydroxychloroquine. “From a New York state or Northwell perspective, there is no major change,” said Onisis Stefas, PharmD, vice president of pharmacy at Northwell Health in New York. “We were not prescribing it out in the community very early on because of the concerns associated with the heart arrhythmias.”

Brigham and Women’s Hospital in Boston, Massachusetts, is currently in the process of updating its publicly available COVID-19 protocols website “to incorporate the FDA’s updated safety assessment and ongoing clinical trials,” a hospital spokesperson told Medscape Medical News. Prior to the updates, the treatment protocols indicated that hydroxychloroquine should only be considered after weighing the risks and benefits for patients who are not candidates for other clinical trials and meet a specific set of health criteria.

The warning is a timely and important synthesis of what physicians know about the drugs so far and how cautiously clinicians across the country should be using them, said Rajesh T. Gandhi, MD, infectious diseases physician at Massachusetts General Hospital (MGH), Boston, professor of medicine at Harvard Medical School, member of the Infectious Diseases Society of America (IDSA), and chair-elect of the HIV Medicine Association.

“I think to be honest it’s a really important message to the public and clinicians across the country,” said Gandhi. “Because we all know there is just a ton of discussion around this drug ... and it came out fairly and said what we know right now.”

The two antimalarial drugs have been at the center of much political debate and scientific scrutiny in recent weeks, following President Trump’s endorsement and the FDA’s emergency use authorization for the two medications in March. Hospitals across the country had incorporated hydroxychloroquine and chloroquine into their constantly evolving treatment protocols for patients with COVID-19.

But the evidence that these drugs actually help treat COVID-19 remains scant. Some small studies suggest the therapies help patients with COVID-19, while others conclude the drugs have no effect or even harm patients. In the United States, medical societies including the American Heart Association have also warned about the serious cardiac issues that can accompany these drugs for some patients.

In the new warning, the FDA said it “cautions against use of hydroxychloroquine or chloroquine for COVID-19 patients outside of the hospital setting or a clinical trial” and urged “close supervision” of patients treated with these therapies, citing cardiac side effects.

The FDA also said it is aware that the outpatient prescription of these medications has increased since its March authorization, but the drugs still have not been shown to be safe or effective in treating or preventing COVID-19.

The FDA announcement is consistent with protocols established by the National Institutes of Health and IDSA earlier this month that recommend against using hydroxychloroquine or chloroquine, except when these drugs are administered as part of a clinical trial.



“We agree wholeheartedly with the FDA and have been hoping that the FDA would in fact issue that kind of clarification,” said Samuel Brown, MD, study committee cochair of the ORCHID clinical trial, a multicenter, blinded study investigating the safety and efficacy of hydroxychloroquine. These medications need to be tested in clinical trials that are able to focus closely on safety monitoring, he said. Experts at Vanderbilt University, one of the medical centers participating in the ORCHID clinical trial, decided before Tennessee had any cases of COVID-19 that unproven therapies like hydroxychloroquine would only be available through clinical trials, said Wesley Self, MD, associate professor of emergency medicine at Vanderbilt University, Nashville, Tennessee, and chair of the ORCHID study committee.

Northwell Health, like other hospitals in New York, has been following a March executive order issued by Governor Andrew Cuomo limiting the use of these drugs for COVID-19 outside of clinical trials, said Stefas. At Northwell Health, patients with COVID-19 only receive hydroxychloroquine or chloroquine when treated in hospital, where they can be closely monitored, or as part of a clinical trial. The hospital system’s protocols currently do not recommend pairing hydroxychloroquine with azithromycin, said Stefas. The new FDA announcement is “very similar” to New York’s existing executive order, he said. “Reading through this reinforces a lot of what we originally thought.”

At MGH in Boston, the FDA safety warning is in line with and “solidifies” the hospital’s evolving protocols, said Gandhi. Clinicians at MGH have been steadily moving away from prescribing hydroxychloroquine outside of clinical trials as the efficacy has remained murky, the serious side effects have become more evident, and clinical trials to assess the drug have gotten underway in recent weeks, he said. Given the conflicting evidence, Gandhi feels the use of these drugs needs to be focused in clinical trials, where scientists can truly evaluate how much they help or harm.

“We know fundamentally that’s the way to do this,” Gandhi said. “We also don’t know that it doesn’t work, so it is ethical and incumbent upon us to do a study,” Gandhi said.

Other hospitals are already heeding the FDA’s warning. At UW Medicine in Washington state, for example, hydroxychloroquine was considered a possible treatment for COVID-19 prior to the FDA’s recent announcement. “Based on FDA guidance, hydroxychloroquine is no longer recommended as therapy for COVID-19 unless done through a clinical trial,” said Tim Dellit, MD, chief medical officer for UW Medicine.

Michigan Medicine stopped using hydroxychloroquine and azithromycin (both separately and in combination) about a month ago, said Daniel Kaul, MD, a professor of infectious disease at the University of Michigan. “When we reviewed the data that was available in more detail, we realized that it was essentially uninterpretable,” he said. As of Monday, the only patients receiving this drug at Michigan Medicine are those enrolled in the ORCHID clinical trial.

But that does not seem to be the case everywhere. Most patients transferred to Michigan Medicine from other hospitals have received these drugs, indicating they are still being widely used, said Kaul. “I think this FDA guidance is appropriate and may reduce usage of this drug and make people more aware of the potential side effects both in inpatient and outpatient settings.”

Hopefully, the FDA guidance will help slow the use of these drugs outside the appropriate clinical trial setting, said Kaul. “I think that the kind of politicization of this drug, which is pretty much unprecedented in my experience, created a really harmful environment where calm decision making and assessment of the relative risks and benefits became somewhat impossible,” said Kaul.

This article first appeared on Medscape.com.

Across the country, hospitals are incorporating Friday’s warning from the US Food and Drug Administration (FDA) about the risks of prescribing hydroxychloroquine and chloroquine for COVID-19 into their treatment protocols.

For some hospitals, the message affirmed the cautious approach they were already taking with hydroxychloroquine. “From a New York state or Northwell perspective, there is no major change,” said Onisis Stefas, PharmD, vice president of pharmacy at Northwell Health in New York. “We were not prescribing it out in the community very early on because of the concerns associated with the heart arrhythmias.”

Brigham and Women’s Hospital in Boston, Massachusetts, is currently in the process of updating its publicly available COVID-19 protocols website “to incorporate the FDA’s updated safety assessment and ongoing clinical trials,” a hospital spokesperson told Medscape Medical News. Prior to the updates, the treatment protocols indicated that hydroxychloroquine should only be considered after weighing the risks and benefits for patients who are not candidates for other clinical trials and meet a specific set of health criteria.

The warning is a timely and important synthesis of what physicians know about the drugs so far and how cautiously clinicians across the country should be using them, said Rajesh T. Gandhi, MD, infectious diseases physician at Massachusetts General Hospital (MGH), Boston, professor of medicine at Harvard Medical School, member of the Infectious Diseases Society of America (IDSA), and chair-elect of the HIV Medicine Association.

“I think to be honest it’s a really important message to the public and clinicians across the country,” said Gandhi. “Because we all know there is just a ton of discussion around this drug ... and it came out fairly and said what we know right now.”

The two antimalarial drugs have been at the center of much political debate and scientific scrutiny in recent weeks, following President Trump’s endorsement and the FDA’s emergency use authorization for the two medications in March. Hospitals across the country had incorporated hydroxychloroquine and chloroquine into their constantly evolving treatment protocols for patients with COVID-19.

But the evidence that these drugs actually help treat COVID-19 remains scant. Some small studies suggest the therapies help patients with COVID-19, while others conclude the drugs have no effect or even harm patients. In the United States, medical societies including the American Heart Association have also warned about the serious cardiac issues that can accompany these drugs for some patients.

In the new warning, the FDA said it “cautions against use of hydroxychloroquine or chloroquine for COVID-19 patients outside of the hospital setting or a clinical trial” and urged “close supervision” of patients treated with these therapies, citing cardiac side effects.

The FDA also said it is aware that the outpatient prescription of these medications has increased since its March authorization, but the drugs still have not been shown to be safe or effective in treating or preventing COVID-19.

The FDA announcement is consistent with protocols established by the National Institutes of Health and IDSA earlier this month that recommend against using hydroxychloroquine or chloroquine, except when these drugs are administered as part of a clinical trial.



“We agree wholeheartedly with the FDA and have been hoping that the FDA would in fact issue that kind of clarification,” said Samuel Brown, MD, study committee cochair of the ORCHID clinical trial, a multicenter, blinded study investigating the safety and efficacy of hydroxychloroquine. These medications need to be tested in clinical trials that are able to focus closely on safety monitoring, he said. Experts at Vanderbilt University, one of the medical centers participating in the ORCHID clinical trial, decided before Tennessee had any cases of COVID-19 that unproven therapies like hydroxychloroquine would only be available through clinical trials, said Wesley Self, MD, associate professor of emergency medicine at Vanderbilt University, Nashville, Tennessee, and chair of the ORCHID study committee.

Northwell Health, like other hospitals in New York, has been following a March executive order issued by Governor Andrew Cuomo limiting the use of these drugs for COVID-19 outside of clinical trials, said Stefas. At Northwell Health, patients with COVID-19 only receive hydroxychloroquine or chloroquine when treated in hospital, where they can be closely monitored, or as part of a clinical trial. The hospital system’s protocols currently do not recommend pairing hydroxychloroquine with azithromycin, said Stefas. The new FDA announcement is “very similar” to New York’s existing executive order, he said. “Reading through this reinforces a lot of what we originally thought.”

At MGH in Boston, the FDA safety warning is in line with and “solidifies” the hospital’s evolving protocols, said Gandhi. Clinicians at MGH have been steadily moving away from prescribing hydroxychloroquine outside of clinical trials as the efficacy has remained murky, the serious side effects have become more evident, and clinical trials to assess the drug have gotten underway in recent weeks, he said. Given the conflicting evidence, Gandhi feels the use of these drugs needs to be focused in clinical trials, where scientists can truly evaluate how much they help or harm.

“We know fundamentally that’s the way to do this,” Gandhi said. “We also don’t know that it doesn’t work, so it is ethical and incumbent upon us to do a study,” Gandhi said.

Other hospitals are already heeding the FDA’s warning. At UW Medicine in Washington state, for example, hydroxychloroquine was considered a possible treatment for COVID-19 prior to the FDA’s recent announcement. “Based on FDA guidance, hydroxychloroquine is no longer recommended as therapy for COVID-19 unless done through a clinical trial,” said Tim Dellit, MD, chief medical officer for UW Medicine.

Michigan Medicine stopped using hydroxychloroquine and azithromycin (both separately and in combination) about a month ago, said Daniel Kaul, MD, a professor of infectious disease at the University of Michigan. “When we reviewed the data that was available in more detail, we realized that it was essentially uninterpretable,” he said. As of Monday, the only patients receiving this drug at Michigan Medicine are those enrolled in the ORCHID clinical trial.

But that does not seem to be the case everywhere. Most patients transferred to Michigan Medicine from other hospitals have received these drugs, indicating they are still being widely used, said Kaul. “I think this FDA guidance is appropriate and may reduce usage of this drug and make people more aware of the potential side effects both in inpatient and outpatient settings.”

Hopefully, the FDA guidance will help slow the use of these drugs outside the appropriate clinical trial setting, said Kaul. “I think that the kind of politicization of this drug, which is pretty much unprecedented in my experience, created a really harmful environment where calm decision making and assessment of the relative risks and benefits became somewhat impossible,” said Kaul.

This article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Medscape Article

Contact tracing, isolation have impact, study shows

Article Type
Changed
Thu, 08/26/2021 - 16:10

A far-reaching surveillance initiative was implemented in Shenzhen, China, to isolate and contact trace people suspected of having the COVID-19 coronavirus. This initiative led to faster confirmation of new cases and reduced the window of time during which people were infectious in the community. This potentially reduced the number of new infections that arose from each case, according to a study of patients and contacts over 4 weeks (Lancet Infect Dis. 2020 Apr 27. doi: 10.1016/S1473-3099[20]30287-5).

CDC/John Hierholzer, MD

“The experience of COVID-19 in the city of Shenzhen may demonstrate the huge scale of testing and contact tracing that’s needed to reduce the virus spreading,” said study coauthor Ting Ma, PhD, of Harbin Institute of Technology at Shenzhen.

Dr. Ma acknowledged that some of the measures the program used, such as isolating people outside their homes, may be difficult to impose in other countries, “but we urge governments to consider our findings in the global response to COVID-19.”

The study followed 391 coronavirus cases and 1,286 close contacts identified by the Shenzhen Center for Disease Control and Prevention from Jan. 14 to Feb. 12 this year. The study showed that contact tracing led to confirming new diagnoses within 3.2 days on average vs. 5.5 for symptom-based surveillance, and reduced the time it took to isolate newly infected people by 2 days, from an average of 4.6 to 2.7 days. Eighty-seven people were diagnosed with COVID-19 after they were contact traced and tested. Twenty percent of them had no symptoms, and 29% had no fever. Three deaths occurred in the group during the study period.

The surveillance program was comprehensive and intense. On Jan. 8, the Shenzhen CDC started monitoring travelers from Hubei province, of which Wuhan is the capital, for symptoms of COVID-19. Shenzhen is a city of about 12.5 million people in southeastern China, near Hong Kong, and is about 560 miles south of Wuhan. Over the next 2 weeks, the Shenzhen CDC expanded that surveillance program to all travelers from Hubei regardless of symptoms, along with local hospital patients and people detected by fever screenings at area clinics.

Suspected cases and close contacts underwent nasal-swab testing at 40 different locations in the city. The program identified close contacts through contact tracing, and included anyone who lived in the same dwelling, shared a meal, traveled, or had a social interaction with an index 2 days before symptoms appeared. Casual contacts and some close contacts, such as clinic nurses, who wore masks during the encounters were excluded.

“To achieve similar results, other countries might be able to combine near-universal testing and intensive contact tracing with social distancing and partial lockdowns,” said Dr. Ma. “Although no lockdown measures were introduced in Shenzhen until the end of our study period, Wuhan’s lockdown could have significantly restricted the spread of coronavirus to Shenzhen.”

The researchers noted that children are as susceptible to the virus as are adults, even though their symptoms are not as severe as those of adults. The rate of infection in children 10 and younger was similar to the overall infection rate, 7.4% vs. 6.6%, so the researchers noted that surveillance measures should target them as well.

“This study to me confirms a lot of what we’ve already known,” Aaron E. Glatt, MD, chairman of medicine and an epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “It’s an elegant study, but at the same time it sends us a message that we’re at a critical point of time for us to intervene and prevent cases at the very beginning.”

He acknowledged that the Shenzhen effort was intense. “It’s always a resource-intense requirement to do such extensive contact tracing, but that doesn’t mean it shouldn’t be done to the best of your ability to do so,” he said. He was struck by the low relative rate of infection among contacts in the study – around 7%. “There are differences obviously in infection rates in every outbreak,” he said. “Every individual has their own particular infection rate. While we can take ranges and statistical guesses for every individual patient, it could be very high or very low, and that’s most critical to nip it in the bud.”

Lead author Qifang Bi and study coauthors had no financial relationships to disclose.

SOURCE: Bi Q et al. Lancet Infect Dis. 2020 Apr 27. doi: 10.1016/S1473-3099(20)30287-5.

Publications
Topics
Sections

A far-reaching surveillance initiative was implemented in Shenzhen, China, to isolate and contact trace people suspected of having the COVID-19 coronavirus. This initiative led to faster confirmation of new cases and reduced the window of time during which people were infectious in the community. This potentially reduced the number of new infections that arose from each case, according to a study of patients and contacts over 4 weeks (Lancet Infect Dis. 2020 Apr 27. doi: 10.1016/S1473-3099[20]30287-5).

CDC/John Hierholzer, MD

“The experience of COVID-19 in the city of Shenzhen may demonstrate the huge scale of testing and contact tracing that’s needed to reduce the virus spreading,” said study coauthor Ting Ma, PhD, of Harbin Institute of Technology at Shenzhen.

Dr. Ma acknowledged that some of the measures the program used, such as isolating people outside their homes, may be difficult to impose in other countries, “but we urge governments to consider our findings in the global response to COVID-19.”

The study followed 391 coronavirus cases and 1,286 close contacts identified by the Shenzhen Center for Disease Control and Prevention from Jan. 14 to Feb. 12 this year. The study showed that contact tracing led to confirming new diagnoses within 3.2 days on average vs. 5.5 for symptom-based surveillance, and reduced the time it took to isolate newly infected people by 2 days, from an average of 4.6 to 2.7 days. Eighty-seven people were diagnosed with COVID-19 after they were contact traced and tested. Twenty percent of them had no symptoms, and 29% had no fever. Three deaths occurred in the group during the study period.

The surveillance program was comprehensive and intense. On Jan. 8, the Shenzhen CDC started monitoring travelers from Hubei province, of which Wuhan is the capital, for symptoms of COVID-19. Shenzhen is a city of about 12.5 million people in southeastern China, near Hong Kong, and is about 560 miles south of Wuhan. Over the next 2 weeks, the Shenzhen CDC expanded that surveillance program to all travelers from Hubei regardless of symptoms, along with local hospital patients and people detected by fever screenings at area clinics.

Suspected cases and close contacts underwent nasal-swab testing at 40 different locations in the city. The program identified close contacts through contact tracing, and included anyone who lived in the same dwelling, shared a meal, traveled, or had a social interaction with an index 2 days before symptoms appeared. Casual contacts and some close contacts, such as clinic nurses, who wore masks during the encounters were excluded.

“To achieve similar results, other countries might be able to combine near-universal testing and intensive contact tracing with social distancing and partial lockdowns,” said Dr. Ma. “Although no lockdown measures were introduced in Shenzhen until the end of our study period, Wuhan’s lockdown could have significantly restricted the spread of coronavirus to Shenzhen.”

The researchers noted that children are as susceptible to the virus as are adults, even though their symptoms are not as severe as those of adults. The rate of infection in children 10 and younger was similar to the overall infection rate, 7.4% vs. 6.6%, so the researchers noted that surveillance measures should target them as well.

“This study to me confirms a lot of what we’ve already known,” Aaron E. Glatt, MD, chairman of medicine and an epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “It’s an elegant study, but at the same time it sends us a message that we’re at a critical point of time for us to intervene and prevent cases at the very beginning.”

He acknowledged that the Shenzhen effort was intense. “It’s always a resource-intense requirement to do such extensive contact tracing, but that doesn’t mean it shouldn’t be done to the best of your ability to do so,” he said. He was struck by the low relative rate of infection among contacts in the study – around 7%. “There are differences obviously in infection rates in every outbreak,” he said. “Every individual has their own particular infection rate. While we can take ranges and statistical guesses for every individual patient, it could be very high or very low, and that’s most critical to nip it in the bud.”

Lead author Qifang Bi and study coauthors had no financial relationships to disclose.

SOURCE: Bi Q et al. Lancet Infect Dis. 2020 Apr 27. doi: 10.1016/S1473-3099(20)30287-5.

A far-reaching surveillance initiative was implemented in Shenzhen, China, to isolate and contact trace people suspected of having the COVID-19 coronavirus. This initiative led to faster confirmation of new cases and reduced the window of time during which people were infectious in the community. This potentially reduced the number of new infections that arose from each case, according to a study of patients and contacts over 4 weeks (Lancet Infect Dis. 2020 Apr 27. doi: 10.1016/S1473-3099[20]30287-5).

CDC/John Hierholzer, MD

“The experience of COVID-19 in the city of Shenzhen may demonstrate the huge scale of testing and contact tracing that’s needed to reduce the virus spreading,” said study coauthor Ting Ma, PhD, of Harbin Institute of Technology at Shenzhen.

Dr. Ma acknowledged that some of the measures the program used, such as isolating people outside their homes, may be difficult to impose in other countries, “but we urge governments to consider our findings in the global response to COVID-19.”

The study followed 391 coronavirus cases and 1,286 close contacts identified by the Shenzhen Center for Disease Control and Prevention from Jan. 14 to Feb. 12 this year. The study showed that contact tracing led to confirming new diagnoses within 3.2 days on average vs. 5.5 for symptom-based surveillance, and reduced the time it took to isolate newly infected people by 2 days, from an average of 4.6 to 2.7 days. Eighty-seven people were diagnosed with COVID-19 after they were contact traced and tested. Twenty percent of them had no symptoms, and 29% had no fever. Three deaths occurred in the group during the study period.

The surveillance program was comprehensive and intense. On Jan. 8, the Shenzhen CDC started monitoring travelers from Hubei province, of which Wuhan is the capital, for symptoms of COVID-19. Shenzhen is a city of about 12.5 million people in southeastern China, near Hong Kong, and is about 560 miles south of Wuhan. Over the next 2 weeks, the Shenzhen CDC expanded that surveillance program to all travelers from Hubei regardless of symptoms, along with local hospital patients and people detected by fever screenings at area clinics.

Suspected cases and close contacts underwent nasal-swab testing at 40 different locations in the city. The program identified close contacts through contact tracing, and included anyone who lived in the same dwelling, shared a meal, traveled, or had a social interaction with an index 2 days before symptoms appeared. Casual contacts and some close contacts, such as clinic nurses, who wore masks during the encounters were excluded.

“To achieve similar results, other countries might be able to combine near-universal testing and intensive contact tracing with social distancing and partial lockdowns,” said Dr. Ma. “Although no lockdown measures were introduced in Shenzhen until the end of our study period, Wuhan’s lockdown could have significantly restricted the spread of coronavirus to Shenzhen.”

The researchers noted that children are as susceptible to the virus as are adults, even though their symptoms are not as severe as those of adults. The rate of infection in children 10 and younger was similar to the overall infection rate, 7.4% vs. 6.6%, so the researchers noted that surveillance measures should target them as well.

“This study to me confirms a lot of what we’ve already known,” Aaron E. Glatt, MD, chairman of medicine and an epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “It’s an elegant study, but at the same time it sends us a message that we’re at a critical point of time for us to intervene and prevent cases at the very beginning.”

He acknowledged that the Shenzhen effort was intense. “It’s always a resource-intense requirement to do such extensive contact tracing, but that doesn’t mean it shouldn’t be done to the best of your ability to do so,” he said. He was struck by the low relative rate of infection among contacts in the study – around 7%. “There are differences obviously in infection rates in every outbreak,” he said. “Every individual has their own particular infection rate. While we can take ranges and statistical guesses for every individual patient, it could be very high or very low, and that’s most critical to nip it in the bud.”

Lead author Qifang Bi and study coauthors had no financial relationships to disclose.

SOURCE: Bi Q et al. Lancet Infect Dis. 2020 Apr 27. doi: 10.1016/S1473-3099(20)30287-5.

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

FROM LANCET INFECTIOUS DISEASE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

Supreme Court: Government owes more than $12 billion to health plans

Article Type
Changed
Wed, 04/29/2020 - 11:17

The federal government owes billions of dollars to health insurers under an Affordable Care Act provision intended to help insurers mitigate risk, the U.S. Supreme Court has ruled.

gavel
copyright/Kuzma/iStockphoto

In an 8-to-1 vote announced April 27, justices sided with the plaintiff health plans in Maine Community Health Options v. United States, ruling that the risk corridors statute created a government obligation to pay insurers the full amount originally calculated and that appropriation measures later passed by Congress did not repeal this obligation.

“In establishing the temporary risk corridors program, Congress created a rare money-mandating obligation requiring the federal government to make payments under [Section 1342 of the Affordable Care Act’s] formula,” Associate Justice Sonia Sotomayor wrote in the majority opinion. “Lacking other statutory paths to relief ... petitioners may seek to collect payment through a damages action in the Court of Federal Claims.”

Maine Community Health Options v. United States, which consolidates several lawsuits against the government, centers on the ACA’s risk corridor program, which required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged by more than $12 billion all together.

The U.S. Department of Justice countered that the government is not required to pay the plans because of measures passed by Congress in 2014 and later years that limited the funding available to compensate insurers for their losses.

The U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

The U.S. Supreme Court disagreed. Justices noted that even after Congress enacted the first rider, HHS and the Centers for Medicare & Medicaid Services reiterated that the ACA requires the Secretary to make full payments to issuers and that “HHS [would] record risk corridors payments due as an obligation of the United States government for which full payment is required,” according to the Supreme Court opinion.

“They understood that profitable insurers’ payments to the government would not dispel the Secretary’s obligation to pay unprofitable insurers, even ‘in the event of a shortfall,’ ” Justice Sotomayor wrote in the majority opinion.

Associate Justice Samuel Alito Jr. however, took issue with his fellow justices’ decision. In his dissenting opinion, Justice Alito wrote that under the ruling, billions of taxpayer dollars will be turned over to insurance companies that bet unsuccessfully on the success of the program in question.

“This money will have to be paid even though Congress has pointedly declined to appropriate money for that purpose,” he wrote. “Not only will today’s decision have a massive immediate impact, its potential consequences go much further.”

The high court remanded the consolidated cases to the lower court for further proceedings on details of the disbursement.

Publications
Topics
Sections

The federal government owes billions of dollars to health insurers under an Affordable Care Act provision intended to help insurers mitigate risk, the U.S. Supreme Court has ruled.

gavel
copyright/Kuzma/iStockphoto

In an 8-to-1 vote announced April 27, justices sided with the plaintiff health plans in Maine Community Health Options v. United States, ruling that the risk corridors statute created a government obligation to pay insurers the full amount originally calculated and that appropriation measures later passed by Congress did not repeal this obligation.

“In establishing the temporary risk corridors program, Congress created a rare money-mandating obligation requiring the federal government to make payments under [Section 1342 of the Affordable Care Act’s] formula,” Associate Justice Sonia Sotomayor wrote in the majority opinion. “Lacking other statutory paths to relief ... petitioners may seek to collect payment through a damages action in the Court of Federal Claims.”

Maine Community Health Options v. United States, which consolidates several lawsuits against the government, centers on the ACA’s risk corridor program, which required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged by more than $12 billion all together.

The U.S. Department of Justice countered that the government is not required to pay the plans because of measures passed by Congress in 2014 and later years that limited the funding available to compensate insurers for their losses.

The U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

The U.S. Supreme Court disagreed. Justices noted that even after Congress enacted the first rider, HHS and the Centers for Medicare & Medicaid Services reiterated that the ACA requires the Secretary to make full payments to issuers and that “HHS [would] record risk corridors payments due as an obligation of the United States government for which full payment is required,” according to the Supreme Court opinion.

“They understood that profitable insurers’ payments to the government would not dispel the Secretary’s obligation to pay unprofitable insurers, even ‘in the event of a shortfall,’ ” Justice Sotomayor wrote in the majority opinion.

Associate Justice Samuel Alito Jr. however, took issue with his fellow justices’ decision. In his dissenting opinion, Justice Alito wrote that under the ruling, billions of taxpayer dollars will be turned over to insurance companies that bet unsuccessfully on the success of the program in question.

“This money will have to be paid even though Congress has pointedly declined to appropriate money for that purpose,” he wrote. “Not only will today’s decision have a massive immediate impact, its potential consequences go much further.”

The high court remanded the consolidated cases to the lower court for further proceedings on details of the disbursement.

The federal government owes billions of dollars to health insurers under an Affordable Care Act provision intended to help insurers mitigate risk, the U.S. Supreme Court has ruled.

gavel
copyright/Kuzma/iStockphoto

In an 8-to-1 vote announced April 27, justices sided with the plaintiff health plans in Maine Community Health Options v. United States, ruling that the risk corridors statute created a government obligation to pay insurers the full amount originally calculated and that appropriation measures later passed by Congress did not repeal this obligation.

“In establishing the temporary risk corridors program, Congress created a rare money-mandating obligation requiring the federal government to make payments under [Section 1342 of the Affordable Care Act’s] formula,” Associate Justice Sonia Sotomayor wrote in the majority opinion. “Lacking other statutory paths to relief ... petitioners may seek to collect payment through a damages action in the Court of Federal Claims.”

Maine Community Health Options v. United States, which consolidates several lawsuits against the government, centers on the ACA’s risk corridor program, which required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged by more than $12 billion all together.

The U.S. Department of Justice countered that the government is not required to pay the plans because of measures passed by Congress in 2014 and later years that limited the funding available to compensate insurers for their losses.

The U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

The U.S. Supreme Court disagreed. Justices noted that even after Congress enacted the first rider, HHS and the Centers for Medicare & Medicaid Services reiterated that the ACA requires the Secretary to make full payments to issuers and that “HHS [would] record risk corridors payments due as an obligation of the United States government for which full payment is required,” according to the Supreme Court opinion.

“They understood that profitable insurers’ payments to the government would not dispel the Secretary’s obligation to pay unprofitable insurers, even ‘in the event of a shortfall,’ ” Justice Sotomayor wrote in the majority opinion.

Associate Justice Samuel Alito Jr. however, took issue with his fellow justices’ decision. In his dissenting opinion, Justice Alito wrote that under the ruling, billions of taxpayer dollars will be turned over to insurance companies that bet unsuccessfully on the success of the program in question.

“This money will have to be paid even though Congress has pointedly declined to appropriate money for that purpose,” he wrote. “Not only will today’s decision have a massive immediate impact, its potential consequences go much further.”

The high court remanded the consolidated cases to the lower court for further proceedings on details of the disbursement.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

More doctors used digital tools in 2019

Article Type
Changed
Wed, 04/29/2020 - 10:57

 

The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

Publications
Topics
Sections

 

The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

 

The use of digital tools among physicians has markedly risen since 2016, with telehealth visits and remote patient monitoring making the greatest strides in usage, an American Medical Association report shows.

In 2019, 28% of physicians used televisits/virtual visits, up from 14% in 2016, while remote monitoring and management for improved care rose to 22% in 2019, an increase from 13% in 2016, according to the AMA report, released in February 2020. The report, which surveyed 1,359 doctors, includes responses from 672 primary care physicians and 687 specialists.

Remote monitoring for efficiency, meanwhile, grew to 16% in 2019 from 12% in 2016. Remote monitoring for efficiency pertains to smart versions of common clinical devices such as thermometers, blood pressure cuffs, and scales that automatically enter readings in the record. Remote monitoring for improved care refers to mobile applications and devices used for daily measurement of vital signs such as weight, blood pressure, blood glucose.

Adoption of other digital tools by physicians have also grown, including clinical decision support, which climbed to 37% in 2019 from 28% in 2016 and patient engagement tools, which rose to 33% in 2019, up from 26% in 2016. Clinical decision support tools pertain to modules used in conjunction with the electronic health record (EHR), or mobile applications integrated with an EHR that can signify changes in patient data, such as weight gain/loss, or change in blood chemistry. Patient engagement tools, meanwhile, refer to solutions that promote patient wellness and active patient participation in their care.

Tools that encompass use of point of care/workflow enhancement increased to 47% in 2019, from 42% in 2016. This area includes communication and sharing of electronic clinical data to consult with specialists, make referrals and/or transitions of care. Tools that address consumer access to their clinical data, meanwhile, rose to 58% in 2019 from 53% in 2016, the highest adoption rate among the digital health tool categories.

Overall, more physicians see an advantage to digital health solutions than did 3 years ago. More primary care physicians and specialists in 2019 reported a “definite advantage” to digital tools enhancing care of patients than in 2016. Doctors who see no advantage to such tools are trending downward and are concentrated to those age 50 and older, according to the report.

Solo-practice physicians are slowly increasing their use of digital health tools. In 2016, solo physicians reported using an average of 1.5 digital tools, which in 2019 increased to an average of 2.2 digital tools. Small practices with between one and three doctors used an average of 1.4 tools in 2016, which rose to an average of 2.2 tools in 2019, the report found. PCPs used slightly more digital tools, compared with specialists, in both 2016 and 2019.

Female doctors are slightly ahead of their male counterparts when it comes to digital health tools. In 2019, female physicians used an average of 2.6 digital tools, up from 1.9 in 2016. Male doctors used an average of 2.4 tools in 2019, compared with 1.9 tools in 2016.

For the physicians surveyed, the most important factor associated with usage was that digital tools were covered by malpractice insurance, followed by the importance of data privacy/security ensured by the EHR vendor, and that the tools were well integrated with the EHR. Other important factors included that data security was ensured by the practice or hospital, that doctors were reimbursed for their time spent using digital tools, and that the tools were supported by the EHR vendor.

Regarding the top motivator for doctors to use digital tools, 51% of physicians in 2019 said improved efficiency was “very important,” up from 48% in 2016. Other top motivators included that digital tools increased safety, improved diagnostic ability, and addressed physician burnout.

In 2019, the demonstration of safety and efficacy in peer-reviewed publications as it relates to digital tools also grew in importance. Of the physicians surveyed, 36% reported that safety and efficacy demonstrated in peer-reviewed publications was “very important,” an increase from 32% in 2016. Other “very important” factors for physicians are that digital tools used are proven to be as good/superior to traditional care, that they are intuitive/require no special training, that they align with the standard of care, and that their safety and efficacy is validated by the Food and Drug Administration.

“The rise of the digital-native physician will have a profound impact on health care and patient outcomes, and will place digital health technologies under pressure to perform according to higher expectations,” AMA board chair Jesse M. Ehrenfeld, MD, PhD, said in a statement. “The AMA survey provides deep insight into the emerging requirements that physicians expect from digital technologies and sets an industry guidepost for understanding what a growing number of physicians require to adopt new technology.”

The survey was derived from the same physician panel used in 2016, provided by WebMD. For the 2019 survey, the basic 2016 survey was followed in wording and question order, with a few variations to remove some questions no longer relevant. The 2019 sample used careful quotas to ensure a sample composition similar to that of 2016, according to the report.

SOURCE: AMA Digital Health Research: Physicians’ motivations and requirements for adopting digital health – Adoption and attitudinal shifts from 2016 to 2019. American Medical Association. February 2020.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

SGLT2 inhibitor ertugliflozin shows no CV death or renal benefit

Article Type
Changed
Tue, 05/03/2022 - 15:10

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.



These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

Publications
Topics
Sections

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.



These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

The sodium-glucose transporter 2 (SGLT-2) inhibitor ertugliflozin broke ranks with the other drugs in its class and failed to produce statistically significant drops in the both the combined incidence of cardiovascular (CV) death or heart failure hospitalization, and the rate of adverse renal outcomes, in the mandated CV outcomes trial run for ertugliflozin with more than 8,200 patients with type 2 diabetes and established CV disease.

Merck, one of the companies that markets the drug, announced the topline results in a quarterly financial report released on April 28, 2020.

According to the report, the results from the ertugliflozin cardiovascular outcomes trial “achieved its primary endpoint of noninferiority for major adverse CV events (MACE), compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease,” but “the key secondary endpoints of superiority” of ertugliflozin, compared with placebo, “for time to the composite of CV death or hospitalization for heart failure, CV death alone, and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met.”

However, the report added that, “while not a prespecified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed” with ertugliflozin treatment, and the report further said that the drug’s safety profile in the trial “was consistent with that reported in previous studies.” The statement closed by saying that detailed results from the trial are scheduled to be presented on June 16, 2020, at the virtual American Diabetes Association’s 80th Scientific Sessions.



These results came from the VERTIS CV (Evaluation of Ertugliflozin EffIcacy and Safety Cardiovascular Outcomes) trial, which researchers said in 2018 had administered at least one investigational dose to 8,238 randomized patients at centers in any of 34 countries during two enrollment periods in 2013-2015 and 2016-2017 (Am Heart J. 2018 Dec;206:11-23). The tested agent, ertugliflozin (Steglatro) received Food and Drug Administration marketing approval late in 2017 for the indication of improving glycemic control in patients with type 2 diabetes.

The FDA mandated cardiovascular outcomes trials for new glycemic control drugs in guidance the agency issued in 2008 (the FDA released in March 2020 a draft of updated guidance on this topic).

Other FDA-approved agents from the SGLT2 inhibitor class include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance), and all three showed evidence for a statistically significant effect on reducing the incidence of CV disease death and heart failure hospitalizations, as well as renal complications (Can J Diabetes. 2020 Feb;44[1]:61-7). The evidence showing that several SGLT2 drugs have important and consistent effects on endpoints like CV death, heart failure hospitalizations, and renal complications has helped propel this class of agents to the forefront of glycemic control treatments. More recently, one agent from this group, dapagliflozin, also significantly cut the rate of heart failure worsening or CV disease death in patients with heart failure with reduced ejection fraction but without diabetes (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). Based on this evidence, the FDA is currently considering adding a new indication for dapagliflozin that would also label it for use in patients with heart failure with reduced ejection fraction but without diabetes.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.

COVID-19 spurs telemedicine, furloughs, retirement

Article Type
Changed
Thu, 08/26/2021 - 16:10

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

Publications
Topics
Sections

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

The broad use of telemedicine has been a bright spot in the COVID-19 response, but the pandemic is also creating significant disruption as some physicians are furloughed and others consider practice changes.

verbaska_studio/Getty Images

A recent survey of physicians conducted by Merritt Hawkins and The Physicians Foundation examined how physicians are being affected by and responding to the pandemic. The findings are based on completed surveys from 842 physicians. About one-third of respondents are primary care physicians, while two-thirds are surgical, medical, and diagnostic specialists and subspecialists.

The survey shines a light on the rapid adoption of telemedicine, with 48% of physicians respondents reporting that they are now treating patients through telemedicine.

“I think that is purely explainable on the situation that COVID has led to with the desire to see patients remotely, still take care of them, and the fact that at the federal level this was recognized and doctors are being compensated for seeing patients remotely,” Gary Price, MD, a plastic surgeon and president of The Physicians Foundation, said in an interview.

“The Foundation does a study of the nation’s physicians every other year and in 2018, when we asked the same question, only 18% of physicians were using some form of telemedicine,” he added.

And Dr. Price said he thinks the shift to telemedicine is here to stay.

“I think that will be a lasting effect of the pandemic,” he said. “More physicians and more patients will be using telemedicine approaches, I think, from here on out. We will see a shift that persists. I think that’s a good thing. Physicians like it. Patients like it. It won’t replace all in-person visits, certainly, but there are a number of health care visits that could be taken care of quite well with a virtual visit and it saves the patients travel time, time away from work, and I think it can make the physicians’ practice more efficient as well.”

The key to sustainability, he said, will be that private insurers and the Centers for Medicare & Medicaid Services continue to pay for it.

“I think we will have had a good demonstration, not only that it can work, but that it does work and that it can be accomplished without any diminishment in the quality of care that’s delivered,” he said.

But the recent survey also identified a number of employment issues that have arisen during the COVID-19 pandemic. Overall, 18% of respondents who were treating COVID-19 patients and 30% of those not treating COVID-19 patients reported that they had been furloughed or experienced a pay cut. Among respondents, just 38.5% reported that they are seeing COVID-19 patients.

“It is unprecedented to my knowledge in the physician employment sphere,” Dr. Price said. “That was the most surprising thing to me. I think you might be able to explain that by the increasing number of physicians who are employees now of larger health systems and the fact that a big portion of those health systems too, in normal times, involves care that right now no one is able to get to or even wants to be seen for because of the risk, of course, of COVID-19.”

The survey also revealed that some respondents had or were planning a change in practice because of COVID-19: 14% said they had or would seek a different practice, 6% reported they had or would find a job without patient care, 7% said they had or would close their practice temporarily, 5% reported that they had or would retire, and 4% said they had or would leave private practice and seek employment at a hospital.

“The survey represents how they are feeling at the time and it doesn’t mean they will necessarily do that, but if even a portion of doctors did that all at once, we would really aggravate an access problem and what we know is a worsening physician shortage in the country,” he said. “So we are very concerned about that.”

Dr. Price also predicted there would be increased consolidation within the health care system as more smaller, independent practices feel the financial stress of the pandemic.

“I hope that I am wrong about that,” he said. “I think smaller practices offer a very cost-effective solution for high-quality care, and their competition in the marketplace for health care is a good and healthy thing.”

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.