Ob.Gyn. News

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.

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.

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.

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.

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.

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.

A novel combination has boosted responses in women with high-risk, HER2-negative breast cancer.

The new combo comprises the immune checkpoint inhibitor durvalumab (Imfinzi, AstraZeneca) and the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza, AstraZeneca).

When this combo was added to standard neoadjuvant chemotherapy, it yielded a significantly higher pathologic complete response (pCR) rate at the time of surgery than was seen with chemotherapy alone.

The superior pCR rate was seen across all HER2-negative breast cancer subtypes, including HER2-negative, estrogen receptor–positive tumors (Mammaprint high risk), and in women with triple-negative breast cancer (TNBC), reported lead investigator Lajos Pusztai, MD, DPhil, from Yale Cancer Center in New Haven, Connecticut.

“These results provide further evidence for the clinical value of immunotherapy in early-stage breast cancer and suggest new avenues for how to exploit these drugs in hormone receptor [HR]–positive breast cancers,” said Pusztai.

He presented the results at the American Association for Cancer Research (AACR) virtual annual meeting, which took place online, owing to the COVID-19 pandemic.
 

Toxicities, including financial

“The benefits from immunotherapy are clearly emerging in early and metastatic triple-negative breast cancer, likely with PD-L1 expression. However, there’s much more uncertainty in patients with hormone-sensitive tumors whether there is benefit and who will benefit from immunotherapy,” commented Pamela N. Munster, MD, from the University of California, San Francisco, who was the invited discussant.

“The signal of a better pCR rate among patients in the ultra-high Mammaprint group may allow selection of patients with HR-positive disease who may benefit from immunotherapeutic agents and/or PARP inhibitors,” she said.

Munster noted that the approximately 10% higher rate of immune-related adverse events of grade 3 or greater that was seen with the combination appears similar to that seen in other studies, but anemia and fatigue appeared to be less frequent with durvalumab/olaparaib and paclitaxel in comparison with paclitaxel alone.

“In the absence of a clear delineation of the contribution of olaparib, some weight should be given to the financial burden of adding both durvalumab and olaparib to a preoperative regimen,” she said.

The additional cost of durvalumab is approximately $34,000, and adding olaparib boosts that by about $22,000 more, Munster said.
 

Ongoing platform trial

The new results come from one arm of the ongoing Investigation of Serial Studies to Predict Your Therapeutic Response Through Imaging and Molecular Analysis 2 (I-SPY-2) trial. This is an ongoing platform trial that is exploring the use of new drugs in combination with a standard neoadjuvant therapy backbone for the treatment of high-risk cancers.

In this trial, women with stage II or III breast cancer with tumors 2.5 cm or larger are assessed for one of eight biomarker subtypes according to HER2 status, HR status, and genetic risk factors, as determined on the basis of a 70-gene assay. The patients within each biomarker subtype are randomly assigned to receive standard therapy either with or without an investigational agent.

For each subtrial, a primary endpoint is an improvement in pCR in comparison with the standard of care.

Changes in tumor volume on MRI are used to predict whether patients will achieve a pCR. Those who are considered to have a high Bayesian predictive probability of success are eligible for moving on to phase 3 trials.

The I-SPY-2 trial was described in detail by principal investigator Laura J. Esserman, MD, MBA, from the Helen Diller Comprehensive Cancer Center at the University of California, San Francisco, in a 2017 interview from the annual meeting of the American Society of Clinical Oncology.

As previously reported, the first drugs to “graduate” from the trial were the HER2/HER4 inhibitor neratinib (Nerlynx, Puma Biotechnology) and the investigational PARP inhibitor veliparib (AbbVie).
 

Study details

The I-SPY-2 results that Pusztai reported at the AACR meeting were based on an analysis of 73 HER2-negative patients, including 21 patients with TNBC and 52 with HR-positive tumors with Mammaprint high-risk features. These patients underwent treatment with durvalumab 1500 mg every 4 weeks for three cycles, olaparib 100 mg twice daily for weeks 1 through 11, and paclitaxel 80 mg/m2 weekly for 12 weeks, followed by AC chemotherapy (doxorubicin and cyclophosphamide) for four cycles.

The 299 patients in the control arm received paclitaxel and chemotherapy only.

In all three biomarker subsets studied, durvalumab and olaparib increased pCR rates compared with controls, as shown in the table.

The probability that the combination was superior to control in each subgroup approached 100%, Pusztai noted.

Adverse events with the combination were consistent with known side effects of the drugs, he commented. Immune-related grade 3 adverse events occurred in 19% of patients in the combination therapy arm, compared with 1.6% in the control arm.

Higher pCR rates were seen in the subset of immune-rich tumors among all cancer subtypes and in both study arms.

“Exploratory analysis suggests several potential predictive markers of durvalumab/olaparib benefit over chemotherapy alone,” Pusztai reported.

These markers included Mammaprint MP2 (ultra high) versus MP1 in HR+/HER2– tumors, and low CD3/CD8 gene signature ratio, high macrophage/Tc-class 2 gene signature ratio, and high proliferation signature, all of which were associated with higher pCR rates in the experimental arm among patients with TNBC.

The trial was supported by the William K. Bowes Jr Foundation, Foundation for the NIH, Give Breast Cancer the Boot, UCSF, the Biomarkers Consortium, IQVIA, the Breast Cancer Research Foundation, Safeway, California Breast Cancer Research Program, Breast Cancer Research–Atwater Trust, and Stand Up to Cancer. Pusztai has received honoraria and consulting fees from AstraZeneca and other companies. Munster has received research and travel support from and has served on the scientific advisory boards of AstraZeneca and other companies.

This article first appeared on Medscape.com.

A novel combination has boosted responses in women with high-risk, HER2-negative breast cancer.

The new combo comprises the immune checkpoint inhibitor durvalumab (Imfinzi, AstraZeneca) and the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza, AstraZeneca).

When this combo was added to standard neoadjuvant chemotherapy, it yielded a significantly higher pathologic complete response (pCR) rate at the time of surgery than was seen with chemotherapy alone.

The superior pCR rate was seen across all HER2-negative breast cancer subtypes, including HER2-negative, estrogen receptor–positive tumors (Mammaprint high risk), and in women with triple-negative breast cancer (TNBC), reported lead investigator Lajos Pusztai, MD, DPhil, from Yale Cancer Center in New Haven, Connecticut.

“These results provide further evidence for the clinical value of immunotherapy in early-stage breast cancer and suggest new avenues for how to exploit these drugs in hormone receptor [HR]–positive breast cancers,” said Pusztai.

He presented the results at the American Association for Cancer Research (AACR) virtual annual meeting, which took place online, owing to the COVID-19 pandemic.
 

Toxicities, including financial

“The benefits from immunotherapy are clearly emerging in early and metastatic triple-negative breast cancer, likely with PD-L1 expression. However, there’s much more uncertainty in patients with hormone-sensitive tumors whether there is benefit and who will benefit from immunotherapy,” commented Pamela N. Munster, MD, from the University of California, San Francisco, who was the invited discussant.

“The signal of a better pCR rate among patients in the ultra-high Mammaprint group may allow selection of patients with HR-positive disease who may benefit from immunotherapeutic agents and/or PARP inhibitors,” she said.

Munster noted that the approximately 10% higher rate of immune-related adverse events of grade 3 or greater that was seen with the combination appears similar to that seen in other studies, but anemia and fatigue appeared to be less frequent with durvalumab/olaparaib and paclitaxel in comparison with paclitaxel alone.

“In the absence of a clear delineation of the contribution of olaparib, some weight should be given to the financial burden of adding both durvalumab and olaparib to a preoperative regimen,” she said.

The additional cost of durvalumab is approximately $34,000, and adding olaparib boosts that by about $22,000 more, Munster said.
 

Ongoing platform trial

The new results come from one arm of the ongoing Investigation of Serial Studies to Predict Your Therapeutic Response Through Imaging and Molecular Analysis 2 (I-SPY-2) trial. This is an ongoing platform trial that is exploring the use of new drugs in combination with a standard neoadjuvant therapy backbone for the treatment of high-risk cancers.

In this trial, women with stage II or III breast cancer with tumors 2.5 cm or larger are assessed for one of eight biomarker subtypes according to HER2 status, HR status, and genetic risk factors, as determined on the basis of a 70-gene assay. The patients within each biomarker subtype are randomly assigned to receive standard therapy either with or without an investigational agent.

For each subtrial, a primary endpoint is an improvement in pCR in comparison with the standard of care.

Changes in tumor volume on MRI are used to predict whether patients will achieve a pCR. Those who are considered to have a high Bayesian predictive probability of success are eligible for moving on to phase 3 trials.

The I-SPY-2 trial was described in detail by principal investigator Laura J. Esserman, MD, MBA, from the Helen Diller Comprehensive Cancer Center at the University of California, San Francisco, in a 2017 interview from the annual meeting of the American Society of Clinical Oncology.

As previously reported, the first drugs to “graduate” from the trial were the HER2/HER4 inhibitor neratinib (Nerlynx, Puma Biotechnology) and the investigational PARP inhibitor veliparib (AbbVie).
 

Study details

The I-SPY-2 results that Pusztai reported at the AACR meeting were based on an analysis of 73 HER2-negative patients, including 21 patients with TNBC and 52 with HR-positive tumors with Mammaprint high-risk features. These patients underwent treatment with durvalumab 1500 mg every 4 weeks for three cycles, olaparib 100 mg twice daily for weeks 1 through 11, and paclitaxel 80 mg/m2 weekly for 12 weeks, followed by AC chemotherapy (doxorubicin and cyclophosphamide) for four cycles.

The 299 patients in the control arm received paclitaxel and chemotherapy only.

In all three biomarker subsets studied, durvalumab and olaparib increased pCR rates compared with controls, as shown in the table.

The probability that the combination was superior to control in each subgroup approached 100%, Pusztai noted.

Adverse events with the combination were consistent with known side effects of the drugs, he commented. Immune-related grade 3 adverse events occurred in 19% of patients in the combination therapy arm, compared with 1.6% in the control arm.

Higher pCR rates were seen in the subset of immune-rich tumors among all cancer subtypes and in both study arms.

“Exploratory analysis suggests several potential predictive markers of durvalumab/olaparib benefit over chemotherapy alone,” Pusztai reported.

These markers included Mammaprint MP2 (ultra high) versus MP1 in HR+/HER2– tumors, and low CD3/CD8 gene signature ratio, high macrophage/Tc-class 2 gene signature ratio, and high proliferation signature, all of which were associated with higher pCR rates in the experimental arm among patients with TNBC.

The trial was supported by the William K. Bowes Jr Foundation, Foundation for the NIH, Give Breast Cancer the Boot, UCSF, the Biomarkers Consortium, IQVIA, the Breast Cancer Research Foundation, Safeway, California Breast Cancer Research Program, Breast Cancer Research–Atwater Trust, and Stand Up to Cancer. Pusztai has received honoraria and consulting fees from AstraZeneca and other companies. Munster has received research and travel support from and has served on the scientific advisory boards of AstraZeneca and other companies.

This article first appeared on Medscape.com.

A novel combination has boosted responses in women with high-risk, HER2-negative breast cancer.

The new combo comprises the immune checkpoint inhibitor durvalumab (Imfinzi, AstraZeneca) and the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza, AstraZeneca).

When this combo was added to standard neoadjuvant chemotherapy, it yielded a significantly higher pathologic complete response (pCR) rate at the time of surgery than was seen with chemotherapy alone.

The superior pCR rate was seen across all HER2-negative breast cancer subtypes, including HER2-negative, estrogen receptor–positive tumors (Mammaprint high risk), and in women with triple-negative breast cancer (TNBC), reported lead investigator Lajos Pusztai, MD, DPhil, from Yale Cancer Center in New Haven, Connecticut.

“These results provide further evidence for the clinical value of immunotherapy in early-stage breast cancer and suggest new avenues for how to exploit these drugs in hormone receptor [HR]–positive breast cancers,” said Pusztai.

He presented the results at the American Association for Cancer Research (AACR) virtual annual meeting, which took place online, owing to the COVID-19 pandemic.
 

Toxicities, including financial

“The benefits from immunotherapy are clearly emerging in early and metastatic triple-negative breast cancer, likely with PD-L1 expression. However, there’s much more uncertainty in patients with hormone-sensitive tumors whether there is benefit and who will benefit from immunotherapy,” commented Pamela N. Munster, MD, from the University of California, San Francisco, who was the invited discussant.

“The signal of a better pCR rate among patients in the ultra-high Mammaprint group may allow selection of patients with HR-positive disease who may benefit from immunotherapeutic agents and/or PARP inhibitors,” she said.

Munster noted that the approximately 10% higher rate of immune-related adverse events of grade 3 or greater that was seen with the combination appears similar to that seen in other studies, but anemia and fatigue appeared to be less frequent with durvalumab/olaparaib and paclitaxel in comparison with paclitaxel alone.

“In the absence of a clear delineation of the contribution of olaparib, some weight should be given to the financial burden of adding both durvalumab and olaparib to a preoperative regimen,” she said.

The additional cost of durvalumab is approximately $34,000, and adding olaparib boosts that by about $22,000 more, Munster said.
 

Ongoing platform trial

The new results come from one arm of the ongoing Investigation of Serial Studies to Predict Your Therapeutic Response Through Imaging and Molecular Analysis 2 (I-SPY-2) trial. This is an ongoing platform trial that is exploring the use of new drugs in combination with a standard neoadjuvant therapy backbone for the treatment of high-risk cancers.

In this trial, women with stage II or III breast cancer with tumors 2.5 cm or larger are assessed for one of eight biomarker subtypes according to HER2 status, HR status, and genetic risk factors, as determined on the basis of a 70-gene assay. The patients within each biomarker subtype are randomly assigned to receive standard therapy either with or without an investigational agent.

For each subtrial, a primary endpoint is an improvement in pCR in comparison with the standard of care.

Changes in tumor volume on MRI are used to predict whether patients will achieve a pCR. Those who are considered to have a high Bayesian predictive probability of success are eligible for moving on to phase 3 trials.

The I-SPY-2 trial was described in detail by principal investigator Laura J. Esserman, MD, MBA, from the Helen Diller Comprehensive Cancer Center at the University of California, San Francisco, in a 2017 interview from the annual meeting of the American Society of Clinical Oncology.

As previously reported, the first drugs to “graduate” from the trial were the HER2/HER4 inhibitor neratinib (Nerlynx, Puma Biotechnology) and the investigational PARP inhibitor veliparib (AbbVie).
 

Study details

The I-SPY-2 results that Pusztai reported at the AACR meeting were based on an analysis of 73 HER2-negative patients, including 21 patients with TNBC and 52 with HR-positive tumors with Mammaprint high-risk features. These patients underwent treatment with durvalumab 1500 mg every 4 weeks for three cycles, olaparib 100 mg twice daily for weeks 1 through 11, and paclitaxel 80 mg/m2 weekly for 12 weeks, followed by AC chemotherapy (doxorubicin and cyclophosphamide) for four cycles.

The 299 patients in the control arm received paclitaxel and chemotherapy only.

In all three biomarker subsets studied, durvalumab and olaparib increased pCR rates compared with controls, as shown in the table.

The probability that the combination was superior to control in each subgroup approached 100%, Pusztai noted.

Adverse events with the combination were consistent with known side effects of the drugs, he commented. Immune-related grade 3 adverse events occurred in 19% of patients in the combination therapy arm, compared with 1.6% in the control arm.

Higher pCR rates were seen in the subset of immune-rich tumors among all cancer subtypes and in both study arms.

“Exploratory analysis suggests several potential predictive markers of durvalumab/olaparib benefit over chemotherapy alone,” Pusztai reported.

These markers included Mammaprint MP2 (ultra high) versus MP1 in HR+/HER2– tumors, and low CD3/CD8 gene signature ratio, high macrophage/Tc-class 2 gene signature ratio, and high proliferation signature, all of which were associated with higher pCR rates in the experimental arm among patients with TNBC.

The trial was supported by the William K. Bowes Jr Foundation, Foundation for the NIH, Give Breast Cancer the Boot, UCSF, the Biomarkers Consortium, IQVIA, the Breast Cancer Research Foundation, Safeway, California Breast Cancer Research Program, Breast Cancer Research–Atwater Trust, and Stand Up to Cancer. Pusztai has received honoraria and consulting fees from AstraZeneca and other companies. Munster has received research and travel support from and has served on the scientific advisory boards of AstraZeneca and other companies.

This article first appeared on Medscape.com.

When last I wrote this column, I was preparing for travel to professional meetings in the spring, planning a presentation for an upcoming grand rounds, and readying to host a scientific advisory board meeting as part of a large scientific project we conduct in Center for Women’s Mental Health. We were also awaiting the relocation of several junior faculty and research staff to Boston this spring and summer as we build our team.

JarekJoepera/iStock/Getty Images

It is now obvious that the COVID-19 pandemic is not a passing squall, but rather a persistent gale that has placed our collective sails in the water. It has not capsized the boat, however, thanks in part to the actions of courageous frontline caregivers and first responders who have mobilized in the wake of this recent public health crisis. From doctors, nurses, and hospital staff to grocery store clerks, home health aides, and neighbors checking in on the elderly – to name just a few – a whole crew of members across society have helped buoy our collective ship. Resilience also is required by all of us who are managing the array of feelings brought about by the day-in, day-out challenges of living life with restricted movement and freedom to engage in pre-COVID-19 activities we took for granted. What seemed like a temporary workaround is now becoming the “new normal” for an unknown amount of time looking forward.

For over 3 decades, my colleagues and I have worked with women who suffer from serious psychiatric disorders and whose treatment has required psychiatric medications such as antidepressants, mood stabilizers, and anxiolytics. The challenge of our work with women who are pregnant or planning pregnancy has been the configuration of the safest ways to navigate treatment on an individual basis for these women across pregnancy and post partum, with continual assessments of how to minimize the risk to fetus from in utero exposure to medications that have been instrumental in the treatment of psychiatric disorders on one hand versus the risks of untreated psychiatric disorder on the other. This work has been the essence of the clinical mission and the cornerstone of the research conducted at the Center for Women’s Mental Health since its inception.

While I have worked shoulder to shoulder with obstetricians for years, my respect for these colleagues during these past weeks has only grown as they have instituted the swiftest protocols to mitigate risk associated with COVID-19 for our pregnant patients, some of whom have tested positive for COVID-19, all in an effort to keep both mother, fetus, and newborn as safe as possible.

For those of us providing mental health services to pregnant women during this time, certain clinical situations have arisen in the context of the COVID-19 pandemic which require particular attention and discussion.
 

Planned pregnancy and contraception during the COVID-19 pandemic

Half of the pregnancies in this country are unplanned. Now more than ever, it is critical that decisions about moving forward with a plan to conceive be deliberate. These considerations range from the existential to the most concrete. For example, during these last weeks, we have consulted on cases where couples on the cusp of attempts to conceive face concerns about COVID-19, hence making more complicated their timeline with respect to actual plans to get pregnant. These are complicated decisions, particularly for women who may be slightly older and at the reproductive age where delaying pregnancy may have an adverse effect on fertility.

A concrete example of how the pandemic has affected fertility is evident as we encounter situations where women may defer starting a prescription oral contraceptive or lapse in its use because they have had difficulty coordinating visits with health care providers and may fear picking up prescriptions from pharmacies. We also have seen that procedures such as IUD placements have been deferred or canceled, or that some patients decline trips to the hospital or clinic to receive this type of service. These new barriers to access of contraception may require more planning at this time so that decisions about family planning are by design and not default during a time as complicated as the current public health crisis.
 

Telemedicine: telepsychiatry and obstetrics virtual visits

While wide-scale use of telemedicine platforms was not the standard day-to-day practice in either obstetrics or psychiatry prior to the pandemic, telepsychiatry has come up to speed within a short number of weeks. At our institution, 85% of outpatient visits are being conducted remotely, with in-person visits being reserved for only urgent or emergent visits. Our inpatient psychiatry service remains a setting where psychiatric patients, regardless of their COVID-19 status, can receive necessary care.

The use of telemedicine and specifically telepsychiatry is critical to mitigate the likelihood of exposure to SARS-CoV-2. On our reproductive psychiatry service, it has actually been an opportunity to engage with patients for comprehensive initial consults about reproductive safety of psychiatric medications currently being taken, or for ongoing consultation and direct patient care during follow-up visits during pregnancy to see that patients are sustaining emotional well-being or have changes for treatment implemented if they are not well. An increased frequency of visits allows us more opportunity to capture any signs of early clinical worsening of symptoms that might have been missed previously using the more traditional in-person setting.

Telepsychiatry and “virtual visits” have allowed us to do real-time, nimble modifications of treatment regimens with both pharmacologic and nonpharmacologic interventions to keep women well and to keep them out of the hospital for psychiatric care as often as possible. It also has facilitated a closer collaboration with our colleagues in obstetrics. In a way, the team of providers, including psychiatrists, obstetrical providers, social workers, and therapists can more easily communicate virtually than has sometimes been the case previously, when day-to-day use of telemedicine and virtual team meetings was less common.
 

Recognition and treatment of anxiety in perinatal patients

Even pregnant women without preexisting anxiety disorders may have heightened anxiety during usual times, and women and their partners cope with this typically in numerous ways including participation in peer-support opportunities, wellness and self-care activities, leveraging support from care providers, and engaging with family. But the previously “typical pregnancy experience” has shifted in the context of COVID-19. Specifically, added concerns of pregnant women about becoming infected, of potential separation from family if they do become ill, or of separation from partners or support systems during labor and delivery (an issue that has been largely resolved in many hospitals), as well as the possibility that a neonate might become ill with exposure to the coronavirus are obviously understandable and real. Such contingencies are unsettling, even for the most settled of our patients. Labor and delivery plans, and plans for outside help from family or others with the baby and older children in the postpartum period, have been upended for many patients.

These are anxious times. The number of nonpharmacologic virtual interventions available to mitigate anxiety are filling email inboxes daily. Curating these options can be a challenge, although several resources are worth noting, such as our department’s page on mental health resources.

During these past weeks, we have seen growing numbers of women for whom the normative anxiety of pregnancy is increasing to the point of causing distress to the level of functional impairment. Many patients for the first time meet criteria for frank anxiety disorders. These patients deserve prompt evaluation by mental health professionals and treatment with evidence-based therapies for anxiety disorders whether nonpharmacologic or pharmacologic so as to mitigate the risk of untreated anxiety on maternal and fetal well-being and also to limit risk for postpartum depression and postpartum anxiety disorders.

Miscarriage and infertility

A 36-year-old patient came to see me in clinic in late January following a miscarriage. She had a history of a previous miscarriage a year before and had an episode of major depression to follow for which she received treatment with an antidepressant and cognitive-behavioral therapy; she also attended a perinatal loss support group. She saw me in early March, anxious to try to conceive but extremely concerned about the risks associated with becoming pregnant at this point in time. Following a lengthy discussion with me and her obstetrician, the patient decided to wait until “the curve flattened” in Boston in terms of new cases of COVID-19, and then start trying to conceive. The case of another patient with a very similar history was presented at our rounds a few weeks ago; she also elected to defer attempts to conceive until life is more settled.

Perhaps one of the most dramatic examples of the impact of COVID-19 on fertility has been for those women with plans to pursue treatment with one of the assisted reproductive technologies. They have been told that professional societies have made recommendations regarding use of assisted reproductive technologies that are not entirely consistent across the country, but where in many places such interventions have been suspended during the COVID-19 pandemic. For many women near the end of their reproductive years, delays in trying to conceive either with or without the aid of fertility treatments may indelibly shape their plans to have children.
 

Sustaining emotional well-being across pregnancy

Because most psychiatric disorders are chronic in course, it is often the situation where women are treated to wellness for serious psychiatric disorders, with the goal of maintaining wellness across pregnancy and the post partum. One of the most critical takeaway points from 30 years of working with psychiatrically ill pregnant women is the maxim that keeping women well during pregnancy is simply imperative. Maternal psychiatric well-being during pregnancy is a strong predictor of obstetrical and neonatal outcomes, postpartum mental health, and longer-term neurobehavioral outcomes in children. Critically, in the context of the pandemic, keeping women out of psychiatric crises mitigates the necessity of visits to urgent clinical settings such as EDs and psychiatric inpatient units, which can increase the likelihood of exposure to the coronavirus.

Preservation of sleep

Disruption in sleep (duration and quality) can be seen in well over half of women during pregnancy with and without psychiatric disorders, and our experience has been that this has been exacerbated for many women during the COVID-19 crisis. Yet there are very rich data showing that sleep deprivation or sleep dysregulation in women, for example, who suffer from bipolar disorder or major depression can be a strong trigger for psychiatric relapse of underlying illness during pregnancy and the postpartum period.

During a time when normal rhythms of day-to-day life have been shifted – if not frankly disrupted – by swift transitions to remote work, cancellation of school and associated school activities across the country, complaints of insomnia and non-restorative sleep have been exceedingly common. Relevant to all but particularly for pregnant women with histories of psychiatric disorder, attention to sleep hygiene, moderation of caffeine use (if any), and use of any number of biobehavioral interventions to enhance relaxation and modulate stress may be of great value.

Cognitive-behavioral therapy for insomnia (CBT-I) has been demonstrated to be effective in pregnant women. Fortunately, there are user-friendly options on digital platforms that can be used during the pandemic that may play an important role in sustaining emotional well-being for pregnant women who have frank symptoms of insomnia.
 

Maintenance of ongoing antidepressant treatment during pregnancy among women with histories of mood disorder

Over a decade ago, my colleagues and I wrote about the comparison of outcomes for women with histories of recurrent major depression, demonstrating the value of maintenance treatment with antidepressants, compared with discontinuation of these medications during pregnancy (JAMA. 2006 Feb 1;295[5]:499-507). Recently, I was asked if maintenance antidepressant use in women with histories of recurrent depression was still our clinical recommendation. Over the last decade, we have noted that nearly half of women treated with antidepressants, regardless of illness severity, will discontinue their use of these medications prior to or early on in pregnancy given concerns about potential unknown effects of fetal exposure to medications, even medications for which there are robust data supporting reproductive safety regarding risk of congenital malformations. Routine discontinuation of antidepressants prior to or during pregnancy continues, despite the fact that we showed nearly 70% of those women with past histories of depression on maintenance antidepressant treatment relapsed shortly after discontinuing medication.

While we do not dictate the decisions women make about antidepressant use before, during, or after pregnancy, women with the same severity of illness will frequently make different decisions (a good thing) but we are now having very frank discussions about the particular need during a pandemic to avoid the relapse of serious psychiatric disorders. We typically endorse maintenance medication use with all but a very few number of psychotropic medications for which benefit may not outweigh risk to the fetus. However, for women who have decided nonetheless to discontinue antidepressants or other psychotropics during pregnancy despite the known risk of relapse, we strongly advise that they initiate treatment with evidence-based nonpharmacologic intervention such as CBT or mindfulness-based cognitive therapy (MBCT).

As in other areas of medicine, the pandemic is prompting we professionals in psychiatry, and specifically in perinatal psychiatry, to use all of our tools to keep pregnant and postpartum women well. The availability of digital tools to deliver MBCT and CBT has made the use of such interventions particularly viable at a time of social distancing. That being said, for patients with highly recurrent affective disorder with histories of previous recurrence when they stop their antidepressants, we are more strongly recommending serious consideration of maintenance medication treatment.
 

Virtual rounds in reproductive psychiatry and women’s mental health

The use of virtual platforms to connect with both patients and colleagues also has provided new opportunities for interaction with the reproductive psychiatry community as a whole. Peer teaching and peer support has been a critical part of our mission, and we decided 1 month ago to establish Virtual Rounds at the Center for Women’s Mental Health. This is a free digital platform, held on a weekly basis with our colleagues from across the country, where we discuss cases that come up in our own clinical rounds and also questions that get put forth by our colleagues in the area of reproductive psychiatry as they manage patients during the pandemic.

Changes in the postpartum experience

The last decade has brought a growing appreciation of postpartum depression and the need to screen and treat postpartum psychiatric disorders, such as postpartum mood and anxiety disorders. Yet in the era of this pandemic, the postpartum experience is itself is changing. Changes in carefully configured plans for the postpartum period – from family coming and going to mobilizing extra support at home and to now having new moms having to manage families and their other children at home – has been an enormous stressor for many women. Plans to have more elderly parents visit during the acute postpartum period, and the increased concerns about people traveling to and from a home where there is a newborn and the need to quarantine, has made the transition to motherhood much more complicated for all postpartum women, let alone for those postpartum women who have histories of psychiatric disorder.

There is a risk of social isolation for postpartum women even under normal circumstances, and this is profoundly more likely during this pandemic. We are actively working with our postpartum patients and optimizing treatment, brainstorming options in terms of using both virtual and real-time support to the extent that it is safe in order to keep women healthy during such a stressful and critical time.

I am heartened by the efforts on the part of organizations such as Postpartum Support International to make available virtually their resources with respect to community-based support and education for women who feel increasingly isolated during the postpartum period, a time where connectedness is so critical.

Summarily, these have been challenging times, but also times of opportunity. The COVID-19 pandemic has prompted us to get even more creative as we configure ways to optimize the emotional well-being of our patients who are planning to get pregnant, who are pregnant, or who are post partum.

The current time, while challenging in so many ways and a time of great pain, loss, and grief for far too many, has also provided an opportunity to work even more collaboratively with our colleagues, coming up with new paradigms of treatments as we weather this historic challenge.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email him at [email protected].

When last I wrote this column, I was preparing for travel to professional meetings in the spring, planning a presentation for an upcoming grand rounds, and readying to host a scientific advisory board meeting as part of a large scientific project we conduct in Center for Women’s Mental Health. We were also awaiting the relocation of several junior faculty and research staff to Boston this spring and summer as we build our team.

JarekJoepera/iStock/Getty Images

It is now obvious that the COVID-19 pandemic is not a passing squall, but rather a persistent gale that has placed our collective sails in the water. It has not capsized the boat, however, thanks in part to the actions of courageous frontline caregivers and first responders who have mobilized in the wake of this recent public health crisis. From doctors, nurses, and hospital staff to grocery store clerks, home health aides, and neighbors checking in on the elderly – to name just a few – a whole crew of members across society have helped buoy our collective ship. Resilience also is required by all of us who are managing the array of feelings brought about by the day-in, day-out challenges of living life with restricted movement and freedom to engage in pre-COVID-19 activities we took for granted. What seemed like a temporary workaround is now becoming the “new normal” for an unknown amount of time looking forward.

For over 3 decades, my colleagues and I have worked with women who suffer from serious psychiatric disorders and whose treatment has required psychiatric medications such as antidepressants, mood stabilizers, and anxiolytics. The challenge of our work with women who are pregnant or planning pregnancy has been the configuration of the safest ways to navigate treatment on an individual basis for these women across pregnancy and post partum, with continual assessments of how to minimize the risk to fetus from in utero exposure to medications that have been instrumental in the treatment of psychiatric disorders on one hand versus the risks of untreated psychiatric disorder on the other. This work has been the essence of the clinical mission and the cornerstone of the research conducted at the Center for Women’s Mental Health since its inception.

While I have worked shoulder to shoulder with obstetricians for years, my respect for these colleagues during these past weeks has only grown as they have instituted the swiftest protocols to mitigate risk associated with COVID-19 for our pregnant patients, some of whom have tested positive for COVID-19, all in an effort to keep both mother, fetus, and newborn as safe as possible.

For those of us providing mental health services to pregnant women during this time, certain clinical situations have arisen in the context of the COVID-19 pandemic which require particular attention and discussion.
 

Planned pregnancy and contraception during the COVID-19 pandemic

Half of the pregnancies in this country are unplanned. Now more than ever, it is critical that decisions about moving forward with a plan to conceive be deliberate. These considerations range from the existential to the most concrete. For example, during these last weeks, we have consulted on cases where couples on the cusp of attempts to conceive face concerns about COVID-19, hence making more complicated their timeline with respect to actual plans to get pregnant. These are complicated decisions, particularly for women who may be slightly older and at the reproductive age where delaying pregnancy may have an adverse effect on fertility.

A concrete example of how the pandemic has affected fertility is evident as we encounter situations where women may defer starting a prescription oral contraceptive or lapse in its use because they have had difficulty coordinating visits with health care providers and may fear picking up prescriptions from pharmacies. We also have seen that procedures such as IUD placements have been deferred or canceled, or that some patients decline trips to the hospital or clinic to receive this type of service. These new barriers to access of contraception may require more planning at this time so that decisions about family planning are by design and not default during a time as complicated as the current public health crisis.
 

Telemedicine: telepsychiatry and obstetrics virtual visits

While wide-scale use of telemedicine platforms was not the standard day-to-day practice in either obstetrics or psychiatry prior to the pandemic, telepsychiatry has come up to speed within a short number of weeks. At our institution, 85% of outpatient visits are being conducted remotely, with in-person visits being reserved for only urgent or emergent visits. Our inpatient psychiatry service remains a setting where psychiatric patients, regardless of their COVID-19 status, can receive necessary care.

The use of telemedicine and specifically telepsychiatry is critical to mitigate the likelihood of exposure to SARS-CoV-2. On our reproductive psychiatry service, it has actually been an opportunity to engage with patients for comprehensive initial consults about reproductive safety of psychiatric medications currently being taken, or for ongoing consultation and direct patient care during follow-up visits during pregnancy to see that patients are sustaining emotional well-being or have changes for treatment implemented if they are not well. An increased frequency of visits allows us more opportunity to capture any signs of early clinical worsening of symptoms that might have been missed previously using the more traditional in-person setting.

Telepsychiatry and “virtual visits” have allowed us to do real-time, nimble modifications of treatment regimens with both pharmacologic and nonpharmacologic interventions to keep women well and to keep them out of the hospital for psychiatric care as often as possible. It also has facilitated a closer collaboration with our colleagues in obstetrics. In a way, the team of providers, including psychiatrists, obstetrical providers, social workers, and therapists can more easily communicate virtually than has sometimes been the case previously, when day-to-day use of telemedicine and virtual team meetings was less common.
 

Recognition and treatment of anxiety in perinatal patients

Even pregnant women without preexisting anxiety disorders may have heightened anxiety during usual times, and women and their partners cope with this typically in numerous ways including participation in peer-support opportunities, wellness and self-care activities, leveraging support from care providers, and engaging with family. But the previously “typical pregnancy experience” has shifted in the context of COVID-19. Specifically, added concerns of pregnant women about becoming infected, of potential separation from family if they do become ill, or of separation from partners or support systems during labor and delivery (an issue that has been largely resolved in many hospitals), as well as the possibility that a neonate might become ill with exposure to the coronavirus are obviously understandable and real. Such contingencies are unsettling, even for the most settled of our patients. Labor and delivery plans, and plans for outside help from family or others with the baby and older children in the postpartum period, have been upended for many patients.

These are anxious times. The number of nonpharmacologic virtual interventions available to mitigate anxiety are filling email inboxes daily. Curating these options can be a challenge, although several resources are worth noting, such as our department’s page on mental health resources.

During these past weeks, we have seen growing numbers of women for whom the normative anxiety of pregnancy is increasing to the point of causing distress to the level of functional impairment. Many patients for the first time meet criteria for frank anxiety disorders. These patients deserve prompt evaluation by mental health professionals and treatment with evidence-based therapies for anxiety disorders whether nonpharmacologic or pharmacologic so as to mitigate the risk of untreated anxiety on maternal and fetal well-being and also to limit risk for postpartum depression and postpartum anxiety disorders.

Miscarriage and infertility

A 36-year-old patient came to see me in clinic in late January following a miscarriage. She had a history of a previous miscarriage a year before and had an episode of major depression to follow for which she received treatment with an antidepressant and cognitive-behavioral therapy; she also attended a perinatal loss support group. She saw me in early March, anxious to try to conceive but extremely concerned about the risks associated with becoming pregnant at this point in time. Following a lengthy discussion with me and her obstetrician, the patient decided to wait until “the curve flattened” in Boston in terms of new cases of COVID-19, and then start trying to conceive. The case of another patient with a very similar history was presented at our rounds a few weeks ago; she also elected to defer attempts to conceive until life is more settled.

Perhaps one of the most dramatic examples of the impact of COVID-19 on fertility has been for those women with plans to pursue treatment with one of the assisted reproductive technologies. They have been told that professional societies have made recommendations regarding use of assisted reproductive technologies that are not entirely consistent across the country, but where in many places such interventions have been suspended during the COVID-19 pandemic. For many women near the end of their reproductive years, delays in trying to conceive either with or without the aid of fertility treatments may indelibly shape their plans to have children.
 

Sustaining emotional well-being across pregnancy

Because most psychiatric disorders are chronic in course, it is often the situation where women are treated to wellness for serious psychiatric disorders, with the goal of maintaining wellness across pregnancy and the post partum. One of the most critical takeaway points from 30 years of working with psychiatrically ill pregnant women is the maxim that keeping women well during pregnancy is simply imperative. Maternal psychiatric well-being during pregnancy is a strong predictor of obstetrical and neonatal outcomes, postpartum mental health, and longer-term neurobehavioral outcomes in children. Critically, in the context of the pandemic, keeping women out of psychiatric crises mitigates the necessity of visits to urgent clinical settings such as EDs and psychiatric inpatient units, which can increase the likelihood of exposure to the coronavirus.

Preservation of sleep

Disruption in sleep (duration and quality) can be seen in well over half of women during pregnancy with and without psychiatric disorders, and our experience has been that this has been exacerbated for many women during the COVID-19 crisis. Yet there are very rich data showing that sleep deprivation or sleep dysregulation in women, for example, who suffer from bipolar disorder or major depression can be a strong trigger for psychiatric relapse of underlying illness during pregnancy and the postpartum period.

During a time when normal rhythms of day-to-day life have been shifted – if not frankly disrupted – by swift transitions to remote work, cancellation of school and associated school activities across the country, complaints of insomnia and non-restorative sleep have been exceedingly common. Relevant to all but particularly for pregnant women with histories of psychiatric disorder, attention to sleep hygiene, moderation of caffeine use (if any), and use of any number of biobehavioral interventions to enhance relaxation and modulate stress may be of great value.

Cognitive-behavioral therapy for insomnia (CBT-I) has been demonstrated to be effective in pregnant women. Fortunately, there are user-friendly options on digital platforms that can be used during the pandemic that may play an important role in sustaining emotional well-being for pregnant women who have frank symptoms of insomnia.
 

Maintenance of ongoing antidepressant treatment during pregnancy among women with histories of mood disorder

Over a decade ago, my colleagues and I wrote about the comparison of outcomes for women with histories of recurrent major depression, demonstrating the value of maintenance treatment with antidepressants, compared with discontinuation of these medications during pregnancy (JAMA. 2006 Feb 1;295[5]:499-507). Recently, I was asked if maintenance antidepressant use in women with histories of recurrent depression was still our clinical recommendation. Over the last decade, we have noted that nearly half of women treated with antidepressants, regardless of illness severity, will discontinue their use of these medications prior to or early on in pregnancy given concerns about potential unknown effects of fetal exposure to medications, even medications for which there are robust data supporting reproductive safety regarding risk of congenital malformations. Routine discontinuation of antidepressants prior to or during pregnancy continues, despite the fact that we showed nearly 70% of those women with past histories of depression on maintenance antidepressant treatment relapsed shortly after discontinuing medication.

While we do not dictate the decisions women make about antidepressant use before, during, or after pregnancy, women with the same severity of illness will frequently make different decisions (a good thing) but we are now having very frank discussions about the particular need during a pandemic to avoid the relapse of serious psychiatric disorders. We typically endorse maintenance medication use with all but a very few number of psychotropic medications for which benefit may not outweigh risk to the fetus. However, for women who have decided nonetheless to discontinue antidepressants or other psychotropics during pregnancy despite the known risk of relapse, we strongly advise that they initiate treatment with evidence-based nonpharmacologic intervention such as CBT or mindfulness-based cognitive therapy (MBCT).

As in other areas of medicine, the pandemic is prompting we professionals in psychiatry, and specifically in perinatal psychiatry, to use all of our tools to keep pregnant and postpartum women well. The availability of digital tools to deliver MBCT and CBT has made the use of such interventions particularly viable at a time of social distancing. That being said, for patients with highly recurrent affective disorder with histories of previous recurrence when they stop their antidepressants, we are more strongly recommending serious consideration of maintenance medication treatment.
 

Virtual rounds in reproductive psychiatry and women’s mental health

The use of virtual platforms to connect with both patients and colleagues also has provided new opportunities for interaction with the reproductive psychiatry community as a whole. Peer teaching and peer support has been a critical part of our mission, and we decided 1 month ago to establish Virtual Rounds at the Center for Women’s Mental Health. This is a free digital platform, held on a weekly basis with our colleagues from across the country, where we discuss cases that come up in our own clinical rounds and also questions that get put forth by our colleagues in the area of reproductive psychiatry as they manage patients during the pandemic.

Changes in the postpartum experience

The last decade has brought a growing appreciation of postpartum depression and the need to screen and treat postpartum psychiatric disorders, such as postpartum mood and anxiety disorders. Yet in the era of this pandemic, the postpartum experience is itself is changing. Changes in carefully configured plans for the postpartum period – from family coming and going to mobilizing extra support at home and to now having new moms having to manage families and their other children at home – has been an enormous stressor for many women. Plans to have more elderly parents visit during the acute postpartum period, and the increased concerns about people traveling to and from a home where there is a newborn and the need to quarantine, has made the transition to motherhood much more complicated for all postpartum women, let alone for those postpartum women who have histories of psychiatric disorder.

There is a risk of social isolation for postpartum women even under normal circumstances, and this is profoundly more likely during this pandemic. We are actively working with our postpartum patients and optimizing treatment, brainstorming options in terms of using both virtual and real-time support to the extent that it is safe in order to keep women healthy during such a stressful and critical time.

I am heartened by the efforts on the part of organizations such as Postpartum Support International to make available virtually their resources with respect to community-based support and education for women who feel increasingly isolated during the postpartum period, a time where connectedness is so critical.

Summarily, these have been challenging times, but also times of opportunity. The COVID-19 pandemic has prompted us to get even more creative as we configure ways to optimize the emotional well-being of our patients who are planning to get pregnant, who are pregnant, or who are post partum.

The current time, while challenging in so many ways and a time of great pain, loss, and grief for far too many, has also provided an opportunity to work even more collaboratively with our colleagues, coming up with new paradigms of treatments as we weather this historic challenge.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email him at [email protected].

When last I wrote this column, I was preparing for travel to professional meetings in the spring, planning a presentation for an upcoming grand rounds, and readying to host a scientific advisory board meeting as part of a large scientific project we conduct in Center for Women’s Mental Health. We were also awaiting the relocation of several junior faculty and research staff to Boston this spring and summer as we build our team.

JarekJoepera/iStock/Getty Images

It is now obvious that the COVID-19 pandemic is not a passing squall, but rather a persistent gale that has placed our collective sails in the water. It has not capsized the boat, however, thanks in part to the actions of courageous frontline caregivers and first responders who have mobilized in the wake of this recent public health crisis. From doctors, nurses, and hospital staff to grocery store clerks, home health aides, and neighbors checking in on the elderly – to name just a few – a whole crew of members across society have helped buoy our collective ship. Resilience also is required by all of us who are managing the array of feelings brought about by the day-in, day-out challenges of living life with restricted movement and freedom to engage in pre-COVID-19 activities we took for granted. What seemed like a temporary workaround is now becoming the “new normal” for an unknown amount of time looking forward.

For over 3 decades, my colleagues and I have worked with women who suffer from serious psychiatric disorders and whose treatment has required psychiatric medications such as antidepressants, mood stabilizers, and anxiolytics. The challenge of our work with women who are pregnant or planning pregnancy has been the configuration of the safest ways to navigate treatment on an individual basis for these women across pregnancy and post partum, with continual assessments of how to minimize the risk to fetus from in utero exposure to medications that have been instrumental in the treatment of psychiatric disorders on one hand versus the risks of untreated psychiatric disorder on the other. This work has been the essence of the clinical mission and the cornerstone of the research conducted at the Center for Women’s Mental Health since its inception.

While I have worked shoulder to shoulder with obstetricians for years, my respect for these colleagues during these past weeks has only grown as they have instituted the swiftest protocols to mitigate risk associated with COVID-19 for our pregnant patients, some of whom have tested positive for COVID-19, all in an effort to keep both mother, fetus, and newborn as safe as possible.

For those of us providing mental health services to pregnant women during this time, certain clinical situations have arisen in the context of the COVID-19 pandemic which require particular attention and discussion.
 

Planned pregnancy and contraception during the COVID-19 pandemic

Half of the pregnancies in this country are unplanned. Now more than ever, it is critical that decisions about moving forward with a plan to conceive be deliberate. These considerations range from the existential to the most concrete. For example, during these last weeks, we have consulted on cases where couples on the cusp of attempts to conceive face concerns about COVID-19, hence making more complicated their timeline with respect to actual plans to get pregnant. These are complicated decisions, particularly for women who may be slightly older and at the reproductive age where delaying pregnancy may have an adverse effect on fertility.

A concrete example of how the pandemic has affected fertility is evident as we encounter situations where women may defer starting a prescription oral contraceptive or lapse in its use because they have had difficulty coordinating visits with health care providers and may fear picking up prescriptions from pharmacies. We also have seen that procedures such as IUD placements have been deferred or canceled, or that some patients decline trips to the hospital or clinic to receive this type of service. These new barriers to access of contraception may require more planning at this time so that decisions about family planning are by design and not default during a time as complicated as the current public health crisis.
 

Telemedicine: telepsychiatry and obstetrics virtual visits

While wide-scale use of telemedicine platforms was not the standard day-to-day practice in either obstetrics or psychiatry prior to the pandemic, telepsychiatry has come up to speed within a short number of weeks. At our institution, 85% of outpatient visits are being conducted remotely, with in-person visits being reserved for only urgent or emergent visits. Our inpatient psychiatry service remains a setting where psychiatric patients, regardless of their COVID-19 status, can receive necessary care.

The use of telemedicine and specifically telepsychiatry is critical to mitigate the likelihood of exposure to SARS-CoV-2. On our reproductive psychiatry service, it has actually been an opportunity to engage with patients for comprehensive initial consults about reproductive safety of psychiatric medications currently being taken, or for ongoing consultation and direct patient care during follow-up visits during pregnancy to see that patients are sustaining emotional well-being or have changes for treatment implemented if they are not well. An increased frequency of visits allows us more opportunity to capture any signs of early clinical worsening of symptoms that might have been missed previously using the more traditional in-person setting.

Telepsychiatry and “virtual visits” have allowed us to do real-time, nimble modifications of treatment regimens with both pharmacologic and nonpharmacologic interventions to keep women well and to keep them out of the hospital for psychiatric care as often as possible. It also has facilitated a closer collaboration with our colleagues in obstetrics. In a way, the team of providers, including psychiatrists, obstetrical providers, social workers, and therapists can more easily communicate virtually than has sometimes been the case previously, when day-to-day use of telemedicine and virtual team meetings was less common.
 

Recognition and treatment of anxiety in perinatal patients

Even pregnant women without preexisting anxiety disorders may have heightened anxiety during usual times, and women and their partners cope with this typically in numerous ways including participation in peer-support opportunities, wellness and self-care activities, leveraging support from care providers, and engaging with family. But the previously “typical pregnancy experience” has shifted in the context of COVID-19. Specifically, added concerns of pregnant women about becoming infected, of potential separation from family if they do become ill, or of separation from partners or support systems during labor and delivery (an issue that has been largely resolved in many hospitals), as well as the possibility that a neonate might become ill with exposure to the coronavirus are obviously understandable and real. Such contingencies are unsettling, even for the most settled of our patients. Labor and delivery plans, and plans for outside help from family or others with the baby and older children in the postpartum period, have been upended for many patients.

These are anxious times. The number of nonpharmacologic virtual interventions available to mitigate anxiety are filling email inboxes daily. Curating these options can be a challenge, although several resources are worth noting, such as our department’s page on mental health resources.

During these past weeks, we have seen growing numbers of women for whom the normative anxiety of pregnancy is increasing to the point of causing distress to the level of functional impairment. Many patients for the first time meet criteria for frank anxiety disorders. These patients deserve prompt evaluation by mental health professionals and treatment with evidence-based therapies for anxiety disorders whether nonpharmacologic or pharmacologic so as to mitigate the risk of untreated anxiety on maternal and fetal well-being and also to limit risk for postpartum depression and postpartum anxiety disorders.

Miscarriage and infertility

A 36-year-old patient came to see me in clinic in late January following a miscarriage. She had a history of a previous miscarriage a year before and had an episode of major depression to follow for which she received treatment with an antidepressant and cognitive-behavioral therapy; she also attended a perinatal loss support group. She saw me in early March, anxious to try to conceive but extremely concerned about the risks associated with becoming pregnant at this point in time. Following a lengthy discussion with me and her obstetrician, the patient decided to wait until “the curve flattened” in Boston in terms of new cases of COVID-19, and then start trying to conceive. The case of another patient with a very similar history was presented at our rounds a few weeks ago; she also elected to defer attempts to conceive until life is more settled.

Perhaps one of the most dramatic examples of the impact of COVID-19 on fertility has been for those women with plans to pursue treatment with one of the assisted reproductive technologies. They have been told that professional societies have made recommendations regarding use of assisted reproductive technologies that are not entirely consistent across the country, but where in many places such interventions have been suspended during the COVID-19 pandemic. For many women near the end of their reproductive years, delays in trying to conceive either with or without the aid of fertility treatments may indelibly shape their plans to have children.
 

Sustaining emotional well-being across pregnancy

Because most psychiatric disorders are chronic in course, it is often the situation where women are treated to wellness for serious psychiatric disorders, with the goal of maintaining wellness across pregnancy and the post partum. One of the most critical takeaway points from 30 years of working with psychiatrically ill pregnant women is the maxim that keeping women well during pregnancy is simply imperative. Maternal psychiatric well-being during pregnancy is a strong predictor of obstetrical and neonatal outcomes, postpartum mental health, and longer-term neurobehavioral outcomes in children. Critically, in the context of the pandemic, keeping women out of psychiatric crises mitigates the necessity of visits to urgent clinical settings such as EDs and psychiatric inpatient units, which can increase the likelihood of exposure to the coronavirus.

Preservation of sleep

Disruption in sleep (duration and quality) can be seen in well over half of women during pregnancy with and without psychiatric disorders, and our experience has been that this has been exacerbated for many women during the COVID-19 crisis. Yet there are very rich data showing that sleep deprivation or sleep dysregulation in women, for example, who suffer from bipolar disorder or major depression can be a strong trigger for psychiatric relapse of underlying illness during pregnancy and the postpartum period.

During a time when normal rhythms of day-to-day life have been shifted – if not frankly disrupted – by swift transitions to remote work, cancellation of school and associated school activities across the country, complaints of insomnia and non-restorative sleep have been exceedingly common. Relevant to all but particularly for pregnant women with histories of psychiatric disorder, attention to sleep hygiene, moderation of caffeine use (if any), and use of any number of biobehavioral interventions to enhance relaxation and modulate stress may be of great value.

Cognitive-behavioral therapy for insomnia (CBT-I) has been demonstrated to be effective in pregnant women. Fortunately, there are user-friendly options on digital platforms that can be used during the pandemic that may play an important role in sustaining emotional well-being for pregnant women who have frank symptoms of insomnia.
 

Maintenance of ongoing antidepressant treatment during pregnancy among women with histories of mood disorder

Over a decade ago, my colleagues and I wrote about the comparison of outcomes for women with histories of recurrent major depression, demonstrating the value of maintenance treatment with antidepressants, compared with discontinuation of these medications during pregnancy (JAMA. 2006 Feb 1;295[5]:499-507). Recently, I was asked if maintenance antidepressant use in women with histories of recurrent depression was still our clinical recommendation. Over the last decade, we have noted that nearly half of women treated with antidepressants, regardless of illness severity, will discontinue their use of these medications prior to or early on in pregnancy given concerns about potential unknown effects of fetal exposure to medications, even medications for which there are robust data supporting reproductive safety regarding risk of congenital malformations. Routine discontinuation of antidepressants prior to or during pregnancy continues, despite the fact that we showed nearly 70% of those women with past histories of depression on maintenance antidepressant treatment relapsed shortly after discontinuing medication.

While we do not dictate the decisions women make about antidepressant use before, during, or after pregnancy, women with the same severity of illness will frequently make different decisions (a good thing) but we are now having very frank discussions about the particular need during a pandemic to avoid the relapse of serious psychiatric disorders. We typically endorse maintenance medication use with all but a very few number of psychotropic medications for which benefit may not outweigh risk to the fetus. However, for women who have decided nonetheless to discontinue antidepressants or other psychotropics during pregnancy despite the known risk of relapse, we strongly advise that they initiate treatment with evidence-based nonpharmacologic intervention such as CBT or mindfulness-based cognitive therapy (MBCT).

As in other areas of medicine, the pandemic is prompting we professionals in psychiatry, and specifically in perinatal psychiatry, to use all of our tools to keep pregnant and postpartum women well. The availability of digital tools to deliver MBCT and CBT has made the use of such interventions particularly viable at a time of social distancing. That being said, for patients with highly recurrent affective disorder with histories of previous recurrence when they stop their antidepressants, we are more strongly recommending serious consideration of maintenance medication treatment.
 

Virtual rounds in reproductive psychiatry and women’s mental health

The use of virtual platforms to connect with both patients and colleagues also has provided new opportunities for interaction with the reproductive psychiatry community as a whole. Peer teaching and peer support has been a critical part of our mission, and we decided 1 month ago to establish Virtual Rounds at the Center for Women’s Mental Health. This is a free digital platform, held on a weekly basis with our colleagues from across the country, where we discuss cases that come up in our own clinical rounds and also questions that get put forth by our colleagues in the area of reproductive psychiatry as they manage patients during the pandemic.

Changes in the postpartum experience

The last decade has brought a growing appreciation of postpartum depression and the need to screen and treat postpartum psychiatric disorders, such as postpartum mood and anxiety disorders. Yet in the era of this pandemic, the postpartum experience is itself is changing. Changes in carefully configured plans for the postpartum period – from family coming and going to mobilizing extra support at home and to now having new moms having to manage families and their other children at home – has been an enormous stressor for many women. Plans to have more elderly parents visit during the acute postpartum period, and the increased concerns about people traveling to and from a home where there is a newborn and the need to quarantine, has made the transition to motherhood much more complicated for all postpartum women, let alone for those postpartum women who have histories of psychiatric disorder.

There is a risk of social isolation for postpartum women even under normal circumstances, and this is profoundly more likely during this pandemic. We are actively working with our postpartum patients and optimizing treatment, brainstorming options in terms of using both virtual and real-time support to the extent that it is safe in order to keep women healthy during such a stressful and critical time.

I am heartened by the efforts on the part of organizations such as Postpartum Support International to make available virtually their resources with respect to community-based support and education for women who feel increasingly isolated during the postpartum period, a time where connectedness is so critical.

Summarily, these have been challenging times, but also times of opportunity. The COVID-19 pandemic has prompted us to get even more creative as we configure ways to optimize the emotional well-being of our patients who are planning to get pregnant, who are pregnant, or who are post partum.

The current time, while challenging in so many ways and a time of great pain, loss, and grief for far too many, has also provided an opportunity to work even more collaboratively with our colleagues, coming up with new paradigms of treatments as we weather this historic challenge.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email him at [email protected].

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.

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.

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.

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.

[email protected]

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.

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.

[email protected]

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.

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.

[email protected]