Pediatric News

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com

We are in the midst of an epidemic and possibly pandemic of anxiety and distress. The worry that folks have about themselves, families, finances, and work is overwhelming for millions.

I speak with people who report periods of racing thoughts jumping back in time and thinking of roads not taken. They also talk about their thoughts jumping forward with life plans of what they’ll do to change their lives in the future – if they survive COVID-19.

Consider what this uncertainty is doing to people who have an underlying emotional problem that is well-controlled with care (and even without care). Those people are suffering even more. Meanwhile, people with obsessive-compulsive disorder that had been under control appear to have worsened with the added stress.

Social distancing has disrupted our everyday routines. For many, there is no work, no spending time with people we care about, no going to movies or shows, no doing discretionary shopping, no going to school. Parents with children at home report frustration about balancing working from home with completing home-schooling packets. Physicians on the front lines of this unprecedented time report not having the proper protective equipment and worrying about the possibility of exposing their families to SARS-CoV-2.

We hear stories about the illness and even deaths of some young and middle-aged people with no underlying conditions, not to mention the loss of older adults. People are bursting into tears, and becoming easily frustrated and angry. Add in nightmares, ongoing anxiety states, insomnia, and decreased concentration.

We are seeing news reports of people stocking up on guns and ammunition and a case of one taking – and dying from – nonpharmaceutical grade chloroquine in an effort to prevent COVID-19.

I spoke with Juliana Tseng, PsyD, a clinical psychologist based in New York, and she said that the hype, half-truths, and false information from some outlets in the popular media are making things worse. Dr. Tseng added that the lack of coordination among local, state, and federal governments also is increasing fear and alienation.

As I see this period in time, my first thoughts are that we are witnessing a national epidemic of trauma. Specifically, what we have here is a clinical picture of PTSD.

PTSD is defined clearly as a traumatic disorder with a real or perceived fracture with life. Isolation (which we are creating as a way to “flatten the curve” or slow the spread of COVID-19), although that strategy is in our best personal and public health interests, is both painful and stressful. Frustration, flashbacks of past life experiences plus flashbacks of being ill are reported in people I’ve spoken with. Avoidance, even though it is planned in this instance, is part of the PTSD complex.

What can we as mental health professionals do to help alleviate this suffering?

First, of course, we must listen to the scientific experts and the data – and tell people to do the same. Most experts will say that COVID-19 is a mild or moderate illness for the vast majority of people. We also must encourage people to observe precautions outlined by the Centers for Disease Control and Prevention, such as distancing from people, hand washing, and avoiding those who are ill. Explain to people that, currently, there is no vaccine to prevent COVID-19. Treatment is mainly supportive, and some medication trials are being explored. However, we can empower people by helping them to develop skills aimed at increasing the ability to relax and focus on more positive aspects of life to break the chain of the stress and tension of anxiety as well as control the PTSD.

For more than 40 years, I have helped people master relaxation techniques and guided imagery. When taught properly, people are able to use these techniques on their own.

To begin, I teach people how to relax, using a simple three-point method:

• Get comfortable in a nice chair, and slowly count from one to three. At the count of one, do one thing: “roll your eyes up to the top of your head.”
• At the count of two, do two things, “close your lids on your eyes and take a deep breath.”
• At three, exhale slowly, relax your eyes, and concentrate on a restful feeling of floating.
• Do this for about 30 seconds to a minute.
• Count backward, from three to two to one and open your eyes.

The person will notice how nice and restful they will feel.

After that exercise, get the person to move to the graduate level and go beyond just relaxation. In the following exercise, people can go into a relaxed state by imagining a movie screen. Tell the person to do two things:

1. Look at the imagined movie screen and project on it any pleasant scene you wish; this is your screen. You will feel yourself becoming more and more relaxed. The person can do this one, two, three or whatever times a day. The exercise can last 1 minute or 5.

2. Incorporate the 1, 2, 3 relaxation described earlier, allowing yourself to float into this restful state and go to your movie screen. Now, on the screen, imagine a thick line down the center, and on the left side, project your worries and anxieties and fears. The idea is to see but not experience them. Then shift to the ride side of the screen, and again, visualize any pleasant scene you wish. Again, do this for 1 minute or 5 minutes, whatever works.

You will notice that the pleasant scene on the right will overcome the anxiety scene on the left, in that pleasantness, in most instances, overcomes anxiety. For many, these techniques have proved very useful – whether the problem is anxiety or fear – or both. In my experience, these techniques are a good beginning for controlling PTSD and successfully treating it.

We are in the midst of what could be the biggest public health crisis that America has faced since the 1918 pandemic, also known as the Spanish flu. The lockdowns, quarantines, and the myriad of other disruptions can lead to alienation. In fact, it would be strange for us not to experience strong emotions under these extreme conditions. Life will get better! In the meantime, let’s encourage people to hope, pray, and use relaxation techniques and guided imagery approaches to help control anxiety, worry, stress, and issues related to PTSD. These approaches can give our minds and bodies periods of relaxation and recovery, and ultimately, they can calm our minds.
 

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

We are in the midst of an epidemic and possibly pandemic of anxiety and distress. The worry that folks have about themselves, families, finances, and work is overwhelming for millions.

I speak with people who report periods of racing thoughts jumping back in time and thinking of roads not taken. They also talk about their thoughts jumping forward with life plans of what they’ll do to change their lives in the future – if they survive COVID-19.

Consider what this uncertainty is doing to people who have an underlying emotional problem that is well-controlled with care (and even without care). Those people are suffering even more. Meanwhile, people with obsessive-compulsive disorder that had been under control appear to have worsened with the added stress.

Social distancing has disrupted our everyday routines. For many, there is no work, no spending time with people we care about, no going to movies or shows, no doing discretionary shopping, no going to school. Parents with children at home report frustration about balancing working from home with completing home-schooling packets. Physicians on the front lines of this unprecedented time report not having the proper protective equipment and worrying about the possibility of exposing their families to SARS-CoV-2.

We hear stories about the illness and even deaths of some young and middle-aged people with no underlying conditions, not to mention the loss of older adults. People are bursting into tears, and becoming easily frustrated and angry. Add in nightmares, ongoing anxiety states, insomnia, and decreased concentration.

We are seeing news reports of people stocking up on guns and ammunition and a case of one taking – and dying from – nonpharmaceutical grade chloroquine in an effort to prevent COVID-19.

I spoke with Juliana Tseng, PsyD, a clinical psychologist based in New York, and she said that the hype, half-truths, and false information from some outlets in the popular media are making things worse. Dr. Tseng added that the lack of coordination among local, state, and federal governments also is increasing fear and alienation.

As I see this period in time, my first thoughts are that we are witnessing a national epidemic of trauma. Specifically, what we have here is a clinical picture of PTSD.

PTSD is defined clearly as a traumatic disorder with a real or perceived fracture with life. Isolation (which we are creating as a way to “flatten the curve” or slow the spread of COVID-19), although that strategy is in our best personal and public health interests, is both painful and stressful. Frustration, flashbacks of past life experiences plus flashbacks of being ill are reported in people I’ve spoken with. Avoidance, even though it is planned in this instance, is part of the PTSD complex.

What can we as mental health professionals do to help alleviate this suffering?

First, of course, we must listen to the scientific experts and the data – and tell people to do the same. Most experts will say that COVID-19 is a mild or moderate illness for the vast majority of people. We also must encourage people to observe precautions outlined by the Centers for Disease Control and Prevention, such as distancing from people, hand washing, and avoiding those who are ill. Explain to people that, currently, there is no vaccine to prevent COVID-19. Treatment is mainly supportive, and some medication trials are being explored. However, we can empower people by helping them to develop skills aimed at increasing the ability to relax and focus on more positive aspects of life to break the chain of the stress and tension of anxiety as well as control the PTSD.

For more than 40 years, I have helped people master relaxation techniques and guided imagery. When taught properly, people are able to use these techniques on their own.

To begin, I teach people how to relax, using a simple three-point method:

• Get comfortable in a nice chair, and slowly count from one to three. At the count of one, do one thing: “roll your eyes up to the top of your head.”
• At the count of two, do two things, “close your lids on your eyes and take a deep breath.”
• At three, exhale slowly, relax your eyes, and concentrate on a restful feeling of floating.
• Do this for about 30 seconds to a minute.
• Count backward, from three to two to one and open your eyes.

The person will notice how nice and restful they will feel.

After that exercise, get the person to move to the graduate level and go beyond just relaxation. In the following exercise, people can go into a relaxed state by imagining a movie screen. Tell the person to do two things:

1. Look at the imagined movie screen and project on it any pleasant scene you wish; this is your screen. You will feel yourself becoming more and more relaxed. The person can do this one, two, three or whatever times a day. The exercise can last 1 minute or 5.

2. Incorporate the 1, 2, 3 relaxation described earlier, allowing yourself to float into this restful state and go to your movie screen. Now, on the screen, imagine a thick line down the center, and on the left side, project your worries and anxieties and fears. The idea is to see but not experience them. Then shift to the ride side of the screen, and again, visualize any pleasant scene you wish. Again, do this for 1 minute or 5 minutes, whatever works.

You will notice that the pleasant scene on the right will overcome the anxiety scene on the left, in that pleasantness, in most instances, overcomes anxiety. For many, these techniques have proved very useful – whether the problem is anxiety or fear – or both. In my experience, these techniques are a good beginning for controlling PTSD and successfully treating it.

We are in the midst of what could be the biggest public health crisis that America has faced since the 1918 pandemic, also known as the Spanish flu. The lockdowns, quarantines, and the myriad of other disruptions can lead to alienation. In fact, it would be strange for us not to experience strong emotions under these extreme conditions. Life will get better! In the meantime, let’s encourage people to hope, pray, and use relaxation techniques and guided imagery approaches to help control anxiety, worry, stress, and issues related to PTSD. These approaches can give our minds and bodies periods of relaxation and recovery, and ultimately, they can calm our minds.
 

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

We are in the midst of an epidemic and possibly pandemic of anxiety and distress. The worry that folks have about themselves, families, finances, and work is overwhelming for millions.

I speak with people who report periods of racing thoughts jumping back in time and thinking of roads not taken. They also talk about their thoughts jumping forward with life plans of what they’ll do to change their lives in the future – if they survive COVID-19.

Consider what this uncertainty is doing to people who have an underlying emotional problem that is well-controlled with care (and even without care). Those people are suffering even more. Meanwhile, people with obsessive-compulsive disorder that had been under control appear to have worsened with the added stress.

Social distancing has disrupted our everyday routines. For many, there is no work, no spending time with people we care about, no going to movies or shows, no doing discretionary shopping, no going to school. Parents with children at home report frustration about balancing working from home with completing home-schooling packets. Physicians on the front lines of this unprecedented time report not having the proper protective equipment and worrying about the possibility of exposing their families to SARS-CoV-2.

We hear stories about the illness and even deaths of some young and middle-aged people with no underlying conditions, not to mention the loss of older adults. People are bursting into tears, and becoming easily frustrated and angry. Add in nightmares, ongoing anxiety states, insomnia, and decreased concentration.

We are seeing news reports of people stocking up on guns and ammunition and a case of one taking – and dying from – nonpharmaceutical grade chloroquine in an effort to prevent COVID-19.

I spoke with Juliana Tseng, PsyD, a clinical psychologist based in New York, and she said that the hype, half-truths, and false information from some outlets in the popular media are making things worse. Dr. Tseng added that the lack of coordination among local, state, and federal governments also is increasing fear and alienation.

As I see this period in time, my first thoughts are that we are witnessing a national epidemic of trauma. Specifically, what we have here is a clinical picture of PTSD.

PTSD is defined clearly as a traumatic disorder with a real or perceived fracture with life. Isolation (which we are creating as a way to “flatten the curve” or slow the spread of COVID-19), although that strategy is in our best personal and public health interests, is both painful and stressful. Frustration, flashbacks of past life experiences plus flashbacks of being ill are reported in people I’ve spoken with. Avoidance, even though it is planned in this instance, is part of the PTSD complex.

What can we as mental health professionals do to help alleviate this suffering?

First, of course, we must listen to the scientific experts and the data – and tell people to do the same. Most experts will say that COVID-19 is a mild or moderate illness for the vast majority of people. We also must encourage people to observe precautions outlined by the Centers for Disease Control and Prevention, such as distancing from people, hand washing, and avoiding those who are ill. Explain to people that, currently, there is no vaccine to prevent COVID-19. Treatment is mainly supportive, and some medication trials are being explored. However, we can empower people by helping them to develop skills aimed at increasing the ability to relax and focus on more positive aspects of life to break the chain of the stress and tension of anxiety as well as control the PTSD.

For more than 40 years, I have helped people master relaxation techniques and guided imagery. When taught properly, people are able to use these techniques on their own.

To begin, I teach people how to relax, using a simple three-point method:

• Get comfortable in a nice chair, and slowly count from one to three. At the count of one, do one thing: “roll your eyes up to the top of your head.”
• At the count of two, do two things, “close your lids on your eyes and take a deep breath.”
• At three, exhale slowly, relax your eyes, and concentrate on a restful feeling of floating.
• Do this for about 30 seconds to a minute.
• Count backward, from three to two to one and open your eyes.

The person will notice how nice and restful they will feel.

After that exercise, get the person to move to the graduate level and go beyond just relaxation. In the following exercise, people can go into a relaxed state by imagining a movie screen. Tell the person to do two things:

1. Look at the imagined movie screen and project on it any pleasant scene you wish; this is your screen. You will feel yourself becoming more and more relaxed. The person can do this one, two, three or whatever times a day. The exercise can last 1 minute or 5.

2. Incorporate the 1, 2, 3 relaxation described earlier, allowing yourself to float into this restful state and go to your movie screen. Now, on the screen, imagine a thick line down the center, and on the left side, project your worries and anxieties and fears. The idea is to see but not experience them. Then shift to the ride side of the screen, and again, visualize any pleasant scene you wish. Again, do this for 1 minute or 5 minutes, whatever works.

You will notice that the pleasant scene on the right will overcome the anxiety scene on the left, in that pleasantness, in most instances, overcomes anxiety. For many, these techniques have proved very useful – whether the problem is anxiety or fear – or both. In my experience, these techniques are a good beginning for controlling PTSD and successfully treating it.

We are in the midst of what could be the biggest public health crisis that America has faced since the 1918 pandemic, also known as the Spanish flu. The lockdowns, quarantines, and the myriad of other disruptions can lead to alienation. In fact, it would be strange for us not to experience strong emotions under these extreme conditions. Life will get better! In the meantime, let’s encourage people to hope, pray, and use relaxation techniques and guided imagery approaches to help control anxiety, worry, stress, and issues related to PTSD. These approaches can give our minds and bodies periods of relaxation and recovery, and ultimately, they can calm our minds.
 

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

As we are all facing uncertainties in caring for our patients amid the COVID-19 pandemic, I wanted to share some thoughts I have had and some of my own experiences treating patients during this unsettling time. I practice at the University of Washington, Seattle, in an area that initially had the highest prevalence of COVID-19 cases in the United States.

I have never felt better about being a part of the medical profession because of the altruism, compassion, and deep caring I have seen displayed by my colleagues, our nurses, our staff, and our students. I am proud to have worked with all of them while trying to figure out how to practice in this environment.

These times are really difficult and challenging as we face new problems every day. Last week, we had to send our students home, and we switched to phone and telehealth visits to keep our patients and staff safer.

I have had some unanticipated electronic messages from patients during this time. Two of my patients with major medical problems and very dependent on their medications were stranded internationally and running out of medications. I had the family of an incarcerated patient contact me for a letter because that patient was moved to a part of a jail where all patients with upper respiratory infection symptoms were being housed. My patient has severe immunosuppression, and they were requesting an exception for him.

Another of my patients, who has sarcoidosis and is immunosuppressed, informed me that her daughter who lives with her was diagnosed with COVID-19. After 3 days, this patient told me she had become febrile and short of breath. I instructed her patient to go to a hospital, where she was also diagnosed with COVID-19 and was admitted. This patient was discharged within 24 hours, because the utilization review department did not feel she should be in the hospital.

The lack of beds is forcing physicians to frequently make tough decisions like the one made for this patient. This unfortunate reality raises the question of: “How do you manage a patient you are worried about from his or her home?”

In this particular case, I sent my patient an oxygen saturation monitor. We touched base frequently, and I felt okay as long as her saturations on room air were above 90%. So far, she has done okay.

More recently, I received a message from a patient recently diagnosed with Mycobacterium avium complex. I learned that this patient and her disabled husband’s caregiver refused to continue to provide care to them, because my patient had a cough, which began 2 months prior. In this case, a COVID-19 test was done for the explicit purpose of getting the caregiver to return to work.

So how do we face this?

Burnout had been high before this difficult time. But now physicians are being called to care for more and sicker patients without the necessary personal protective gear. Our physicians have demonstrated strength and commitment to patients in their response to this challenge, but they need help from others, including regulators.

I think a first step that needs to be taken is to decrease the volume of documentation physicians are required to make in this time where we are forced to triage to what is most important and drop what isn’t. How is spending so much time documenting instead of seeing the high volumes of patients who need to be seen a good thing? Documentation to the level that Medicare has required isn’t going to work. In fact, it has never been a good thing and is a big driver of burnout.

Our health care system was broken and badly injured before this crisis, and I think now might be a time when positive changes for the future occur. In fact, COVID-19 has resulted in some temporary changes in medicine that I would like to see outlast this outbreak. The telehealth option is now available, for example, and this kind of care is covered much more broadly by Medicare under the 1135 waiver – this has been needed for years. Being able to conduct regular clinic visits via telehealth without the marked restrictions that were previously in place is a big advance. It is currently in place for this emergency only, but this is the time to start pushing hard to make sure this option will be permanent.

I invite you to help me fight for long-term change. Write a letter to the editor of your local newspaper or blog, share your thoughts on social media, and tweet. (I suggest using #documentationordoctors or, although a bit long, #excessivedocumentationcostslives.) This is an unprecedented time in modern medicine. Traumatic times are when the greatest changes occur. Let’s hope for the better.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He frequently contributes Pearl of the Month and Myth of the Month columns to MDedge, and he serves on the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at imnews@mdedge.com.

As we are all facing uncertainties in caring for our patients amid the COVID-19 pandemic, I wanted to share some thoughts I have had and some of my own experiences treating patients during this unsettling time. I practice at the University of Washington, Seattle, in an area that initially had the highest prevalence of COVID-19 cases in the United States.

I have never felt better about being a part of the medical profession because of the altruism, compassion, and deep caring I have seen displayed by my colleagues, our nurses, our staff, and our students. I am proud to have worked with all of them while trying to figure out how to practice in this environment.

These times are really difficult and challenging as we face new problems every day. Last week, we had to send our students home, and we switched to phone and telehealth visits to keep our patients and staff safer.

I have had some unanticipated electronic messages from patients during this time. Two of my patients with major medical problems and very dependent on their medications were stranded internationally and running out of medications. I had the family of an incarcerated patient contact me for a letter because that patient was moved to a part of a jail where all patients with upper respiratory infection symptoms were being housed. My patient has severe immunosuppression, and they were requesting an exception for him.

Another of my patients, who has sarcoidosis and is immunosuppressed, informed me that her daughter who lives with her was diagnosed with COVID-19. After 3 days, this patient told me she had become febrile and short of breath. I instructed her patient to go to a hospital, where she was also diagnosed with COVID-19 and was admitted. This patient was discharged within 24 hours, because the utilization review department did not feel she should be in the hospital.

The lack of beds is forcing physicians to frequently make tough decisions like the one made for this patient. This unfortunate reality raises the question of: “How do you manage a patient you are worried about from his or her home?”

In this particular case, I sent my patient an oxygen saturation monitor. We touched base frequently, and I felt okay as long as her saturations on room air were above 90%. So far, she has done okay.

More recently, I received a message from a patient recently diagnosed with Mycobacterium avium complex. I learned that this patient and her disabled husband’s caregiver refused to continue to provide care to them, because my patient had a cough, which began 2 months prior. In this case, a COVID-19 test was done for the explicit purpose of getting the caregiver to return to work.

So how do we face this?

Burnout had been high before this difficult time. But now physicians are being called to care for more and sicker patients without the necessary personal protective gear. Our physicians have demonstrated strength and commitment to patients in their response to this challenge, but they need help from others, including regulators.

I think a first step that needs to be taken is to decrease the volume of documentation physicians are required to make in this time where we are forced to triage to what is most important and drop what isn’t. How is spending so much time documenting instead of seeing the high volumes of patients who need to be seen a good thing? Documentation to the level that Medicare has required isn’t going to work. In fact, it has never been a good thing and is a big driver of burnout.

Our health care system was broken and badly injured before this crisis, and I think now might be a time when positive changes for the future occur. In fact, COVID-19 has resulted in some temporary changes in medicine that I would like to see outlast this outbreak. The telehealth option is now available, for example, and this kind of care is covered much more broadly by Medicare under the 1135 waiver – this has been needed for years. Being able to conduct regular clinic visits via telehealth without the marked restrictions that were previously in place is a big advance. It is currently in place for this emergency only, but this is the time to start pushing hard to make sure this option will be permanent.

I invite you to help me fight for long-term change. Write a letter to the editor of your local newspaper or blog, share your thoughts on social media, and tweet. (I suggest using #documentationordoctors or, although a bit long, #excessivedocumentationcostslives.) This is an unprecedented time in modern medicine. Traumatic times are when the greatest changes occur. Let’s hope for the better.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He frequently contributes Pearl of the Month and Myth of the Month columns to MDedge, and he serves on the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at imnews@mdedge.com.

As we are all facing uncertainties in caring for our patients amid the COVID-19 pandemic, I wanted to share some thoughts I have had and some of my own experiences treating patients during this unsettling time. I practice at the University of Washington, Seattle, in an area that initially had the highest prevalence of COVID-19 cases in the United States.

I have never felt better about being a part of the medical profession because of the altruism, compassion, and deep caring I have seen displayed by my colleagues, our nurses, our staff, and our students. I am proud to have worked with all of them while trying to figure out how to practice in this environment.

These times are really difficult and challenging as we face new problems every day. Last week, we had to send our students home, and we switched to phone and telehealth visits to keep our patients and staff safer.

I have had some unanticipated electronic messages from patients during this time. Two of my patients with major medical problems and very dependent on their medications were stranded internationally and running out of medications. I had the family of an incarcerated patient contact me for a letter because that patient was moved to a part of a jail where all patients with upper respiratory infection symptoms were being housed. My patient has severe immunosuppression, and they were requesting an exception for him.

Another of my patients, who has sarcoidosis and is immunosuppressed, informed me that her daughter who lives with her was diagnosed with COVID-19. After 3 days, this patient told me she had become febrile and short of breath. I instructed her patient to go to a hospital, where she was also diagnosed with COVID-19 and was admitted. This patient was discharged within 24 hours, because the utilization review department did not feel she should be in the hospital.

The lack of beds is forcing physicians to frequently make tough decisions like the one made for this patient. This unfortunate reality raises the question of: “How do you manage a patient you are worried about from his or her home?”

In this particular case, I sent my patient an oxygen saturation monitor. We touched base frequently, and I felt okay as long as her saturations on room air were above 90%. So far, she has done okay.

More recently, I received a message from a patient recently diagnosed with Mycobacterium avium complex. I learned that this patient and her disabled husband’s caregiver refused to continue to provide care to them, because my patient had a cough, which began 2 months prior. In this case, a COVID-19 test was done for the explicit purpose of getting the caregiver to return to work.

So how do we face this?

Burnout had been high before this difficult time. But now physicians are being called to care for more and sicker patients without the necessary personal protective gear. Our physicians have demonstrated strength and commitment to patients in their response to this challenge, but they need help from others, including regulators.

I think a first step that needs to be taken is to decrease the volume of documentation physicians are required to make in this time where we are forced to triage to what is most important and drop what isn’t. How is spending so much time documenting instead of seeing the high volumes of patients who need to be seen a good thing? Documentation to the level that Medicare has required isn’t going to work. In fact, it has never been a good thing and is a big driver of burnout.

Our health care system was broken and badly injured before this crisis, and I think now might be a time when positive changes for the future occur. In fact, COVID-19 has resulted in some temporary changes in medicine that I would like to see outlast this outbreak. The telehealth option is now available, for example, and this kind of care is covered much more broadly by Medicare under the 1135 waiver – this has been needed for years. Being able to conduct regular clinic visits via telehealth without the marked restrictions that were previously in place is a big advance. It is currently in place for this emergency only, but this is the time to start pushing hard to make sure this option will be permanent.

I invite you to help me fight for long-term change. Write a letter to the editor of your local newspaper or blog, share your thoughts on social media, and tweet. (I suggest using #documentationordoctors or, although a bit long, #excessivedocumentationcostslives.) This is an unprecedented time in modern medicine. Traumatic times are when the greatest changes occur. Let’s hope for the better.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He frequently contributes Pearl of the Month and Myth of the Month columns to MDedge, and he serves on the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact Dr. Paauw at imnews@mdedge.com.

In the face of the COVID-19 pandemic, the American Academy of Neurology (AAN) is calling on the federal government to do more to expand telehealth services beyond Medicare.

On March 17, the Trump administration announced an expansion of telehealth benefits to help stop the spread of COVID-19 and allow more Medicare patients to receive virtual care without having to visit a healthcare center or physician office.

Under the expansion, Medicare will pay for office, hospital, and other visits furnished via telehealth across the country and including in the patient’s home, delivered by a range of providers, such as physicians, nurse practitioners, clinical psychologists, and licensed clinical social workers.

Prior to this waiver, Medicare would only pay for telehealth on a limited basis, such as when the patient receiving the service was in a designated rural area.

However, in a letter to Alex Azar, secretary of the U.S. Department of Health & Human Services (HHS), the AAN says the easing of restrictions on telehealth should be extended beyond Medicare fee-for-service to both Medicare Advantage and Medicaid patients.
 

Practice changing?

“It is very heartening that the government is stepping up to the plate” and lifting many telemedicine restrictions, Neil Busis, MD, member of the AAN Health Policy Subcommittee, said in an interview.

Dr. Busis, who leads the telemedicine program for the department of neurology at NYU Langone Health in New York, said the global pandemic has “heightened, focused, and sharpened” attention to the need for telehealth services, particularly for neurology.

“By definition, a lot of neurology patients have mobility problems, traveling is a burden, making it difficult to see a neurologist,” he said.

Dr. Busis hopes these waivers in telehealth, made on a temporary and emergency basis, will become permanent once the COVID-19 pandemic has passed.

“What we hope is that the usefulness of various virtual technologies tested in the crucible of this pandemic will stimulate people to think about it once the pandemic is over and not rescind these loosening of restrictions, and that this will be the beginning of a new era for telemedicine,” he said.

The COVID-19 pandemic may be a “catalyst to accelerate the incorporation of non-face-to-face care into our armamentarium,” he added.

“What we have discovered in recent years is non-face-to-face care with enabling communication technologies is as effective in many clinical situations as face-to-face care. Now is the time to really focus on making the virtual experience as good as possible and to make it as available to as many people as possible,” said Dr. Busis.
 

Reduce regulatory burdens

The AAN also calls on the federal government to urge states to take action to ensure access to telehealth services and allow telehealth companies to provide telehealth technology and education free of charge to providers who don’t currently use telehealth in their practices.

“The AAN notes that doing so may implicate provisions of the Anti-Kickback Statute. We believe during the current emergency that HHS should issue guidance making it clear to providers that accepting free access to telehealth platforms and education does not put them at risk of violating fraud and abuse laws,” the letter, signed by AAN President James Stevens, MD, stated.

The AAN also wants the government to reduce regulatory burdens during this public health emergency to allow physicians more time to focus on patient care. “This is especially true for providers that are self-quarantining or are in a practice that is experiencing staffing shortages due to self-quarantines,” he wrote.

Specifically, the AAN asked the Centers for Medicare & Medicaid Services to extend the March 31 deadline for physicians to submit their data for the Merit-based Incentive Payment System program for calendar year 2019 (and other compliance deadlines) by at least 30 days.

The AAN also calls on the CMS to delay implementation of the Appropriate Use Criteria program by 1 year, saying that many providers will not have the capacity to “meaningfully” participate in the current testing year for the program.

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

In the face of the COVID-19 pandemic, the American Academy of Neurology (AAN) is calling on the federal government to do more to expand telehealth services beyond Medicare.

On March 17, the Trump administration announced an expansion of telehealth benefits to help stop the spread of COVID-19 and allow more Medicare patients to receive virtual care without having to visit a healthcare center or physician office.

Under the expansion, Medicare will pay for office, hospital, and other visits furnished via telehealth across the country and including in the patient’s home, delivered by a range of providers, such as physicians, nurse practitioners, clinical psychologists, and licensed clinical social workers.

Prior to this waiver, Medicare would only pay for telehealth on a limited basis, such as when the patient receiving the service was in a designated rural area.

However, in a letter to Alex Azar, secretary of the U.S. Department of Health & Human Services (HHS), the AAN says the easing of restrictions on telehealth should be extended beyond Medicare fee-for-service to both Medicare Advantage and Medicaid patients.
 

Practice changing?

“It is very heartening that the government is stepping up to the plate” and lifting many telemedicine restrictions, Neil Busis, MD, member of the AAN Health Policy Subcommittee, said in an interview.

Dr. Busis, who leads the telemedicine program for the department of neurology at NYU Langone Health in New York, said the global pandemic has “heightened, focused, and sharpened” attention to the need for telehealth services, particularly for neurology.

“By definition, a lot of neurology patients have mobility problems, traveling is a burden, making it difficult to see a neurologist,” he said.

Dr. Busis hopes these waivers in telehealth, made on a temporary and emergency basis, will become permanent once the COVID-19 pandemic has passed.

“What we hope is that the usefulness of various virtual technologies tested in the crucible of this pandemic will stimulate people to think about it once the pandemic is over and not rescind these loosening of restrictions, and that this will be the beginning of a new era for telemedicine,” he said.

The COVID-19 pandemic may be a “catalyst to accelerate the incorporation of non-face-to-face care into our armamentarium,” he added.

“What we have discovered in recent years is non-face-to-face care with enabling communication technologies is as effective in many clinical situations as face-to-face care. Now is the time to really focus on making the virtual experience as good as possible and to make it as available to as many people as possible,” said Dr. Busis.
 

Reduce regulatory burdens

The AAN also calls on the federal government to urge states to take action to ensure access to telehealth services and allow telehealth companies to provide telehealth technology and education free of charge to providers who don’t currently use telehealth in their practices.

“The AAN notes that doing so may implicate provisions of the Anti-Kickback Statute. We believe during the current emergency that HHS should issue guidance making it clear to providers that accepting free access to telehealth platforms and education does not put them at risk of violating fraud and abuse laws,” the letter, signed by AAN President James Stevens, MD, stated.

The AAN also wants the government to reduce regulatory burdens during this public health emergency to allow physicians more time to focus on patient care. “This is especially true for providers that are self-quarantining or are in a practice that is experiencing staffing shortages due to self-quarantines,” he wrote.

Specifically, the AAN asked the Centers for Medicare & Medicaid Services to extend the March 31 deadline for physicians to submit their data for the Merit-based Incentive Payment System program for calendar year 2019 (and other compliance deadlines) by at least 30 days.

The AAN also calls on the CMS to delay implementation of the Appropriate Use Criteria program by 1 year, saying that many providers will not have the capacity to “meaningfully” participate in the current testing year for the program.

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

In the face of the COVID-19 pandemic, the American Academy of Neurology (AAN) is calling on the federal government to do more to expand telehealth services beyond Medicare.

On March 17, the Trump administration announced an expansion of telehealth benefits to help stop the spread of COVID-19 and allow more Medicare patients to receive virtual care without having to visit a healthcare center or physician office.

Under the expansion, Medicare will pay for office, hospital, and other visits furnished via telehealth across the country and including in the patient’s home, delivered by a range of providers, such as physicians, nurse practitioners, clinical psychologists, and licensed clinical social workers.

Prior to this waiver, Medicare would only pay for telehealth on a limited basis, such as when the patient receiving the service was in a designated rural area.

However, in a letter to Alex Azar, secretary of the U.S. Department of Health & Human Services (HHS), the AAN says the easing of restrictions on telehealth should be extended beyond Medicare fee-for-service to both Medicare Advantage and Medicaid patients.
 

Practice changing?

“It is very heartening that the government is stepping up to the plate” and lifting many telemedicine restrictions, Neil Busis, MD, member of the AAN Health Policy Subcommittee, said in an interview.

Dr. Busis, who leads the telemedicine program for the department of neurology at NYU Langone Health in New York, said the global pandemic has “heightened, focused, and sharpened” attention to the need for telehealth services, particularly for neurology.

“By definition, a lot of neurology patients have mobility problems, traveling is a burden, making it difficult to see a neurologist,” he said.

Dr. Busis hopes these waivers in telehealth, made on a temporary and emergency basis, will become permanent once the COVID-19 pandemic has passed.

“What we hope is that the usefulness of various virtual technologies tested in the crucible of this pandemic will stimulate people to think about it once the pandemic is over and not rescind these loosening of restrictions, and that this will be the beginning of a new era for telemedicine,” he said.

The COVID-19 pandemic may be a “catalyst to accelerate the incorporation of non-face-to-face care into our armamentarium,” he added.

“What we have discovered in recent years is non-face-to-face care with enabling communication technologies is as effective in many clinical situations as face-to-face care. Now is the time to really focus on making the virtual experience as good as possible and to make it as available to as many people as possible,” said Dr. Busis.
 

Reduce regulatory burdens

The AAN also calls on the federal government to urge states to take action to ensure access to telehealth services and allow telehealth companies to provide telehealth technology and education free of charge to providers who don’t currently use telehealth in their practices.

“The AAN notes that doing so may implicate provisions of the Anti-Kickback Statute. We believe during the current emergency that HHS should issue guidance making it clear to providers that accepting free access to telehealth platforms and education does not put them at risk of violating fraud and abuse laws,” the letter, signed by AAN President James Stevens, MD, stated.

The AAN also wants the government to reduce regulatory burdens during this public health emergency to allow physicians more time to focus on patient care. “This is especially true for providers that are self-quarantining or are in a practice that is experiencing staffing shortages due to self-quarantines,” he wrote.

Specifically, the AAN asked the Centers for Medicare & Medicaid Services to extend the March 31 deadline for physicians to submit their data for the Merit-based Incentive Payment System program for calendar year 2019 (and other compliance deadlines) by at least 30 days.

The AAN also calls on the CMS to delay implementation of the Appropriate Use Criteria program by 1 year, saying that many providers will not have the capacity to “meaningfully” participate in the current testing year for the program.

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

Stephen M. Schwartz, MD, PhD, a pioneer in the field of vascular biology and a longtime professor of pathology at the University of Washington, Seattle, died March 17, 2020, after being hospitalized with COVID-19. He was 78.

“This has become all too real,” UW president Ana Mari Cauce said on Facebook, where she described Dr. Schwartz as “larger than life,” and superimposed a photo of him in front of Mount Rainier, according to a report in the Seattle Times.

Dr. Schwartz is “rightfully considered a giant among investigators of the biology of smooth muscle cells and the structure of blood vessels,” Paul Ramsey, MD, CEO of UW Medicine, said in a statement. He will be remembered for his “vigorous advocacy for research and for the field of vascular biology as well as for his many trainees who have gone on to great success as independent investigators in the field of vascular pathobiology,” Dr. Ramsey said.

Dr. Schwartz received a BA in biology from Harvard University in 1963 and an MD from Boston University in 1967. Dr. Schwartz started a residency in the UW department of pathology in 1967 and received his PhD from the institution in 1973. From 1974 to 1979, he was an assistant professor of pathology and became a full professor in 1984.

Dr. Schwartz was also an adjunct professor in the UW departments of bioengineering and medicine, “reflective of his many collaborative relationships with faculty in other departments in our medical school and in the world,” Dr. Ramsey said.

“Dr. Schwartz left a lasting imprint on the UW School of Medicine and the broader scientific community. He will be greatly missed,” he added.
 

‘A great loss’

Dr. Schwartz chaired numerous national and international meetings in the field of vascular biology. He was the founding chair of the Gordon Research Conference on Vascular Biology and a cofounder and second president of the North American Vascular Biology Organization (NAVBO). He created NAVBO’s flagship summer course, Vasculata.

“The NAVBO community has suffered a great loss,” Bernadette Englert, executive officer for the organization, said in a statement. He will be “sorely missed by generations of vascular biologists and pathologists.”

News of Dr. Schwartz’s passing lit up Twitter. Here are just a few comments:

UW lost to COVID-19 “beloved professor Stephen Schwartz, a pioneer in vascular biology and a larger-than-life scientist. Steve, you will be missed!” Rong Tian, MD, PhD, with the bioengineering department, wrote in a tweet.

“Stephen Schwartz was a giant in vascular biology and a mentor to countless faculty and trainees, including myself. He will be deeply missed,” said Kelly Stevens, PhD, also from the bioengineering department.

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

Stephen M. Schwartz, MD, PhD, a pioneer in the field of vascular biology and a longtime professor of pathology at the University of Washington, Seattle, died March 17, 2020, after being hospitalized with COVID-19. He was 78.

“This has become all too real,” UW president Ana Mari Cauce said on Facebook, where she described Dr. Schwartz as “larger than life,” and superimposed a photo of him in front of Mount Rainier, according to a report in the Seattle Times.

Dr. Schwartz is “rightfully considered a giant among investigators of the biology of smooth muscle cells and the structure of blood vessels,” Paul Ramsey, MD, CEO of UW Medicine, said in a statement. He will be remembered for his “vigorous advocacy for research and for the field of vascular biology as well as for his many trainees who have gone on to great success as independent investigators in the field of vascular pathobiology,” Dr. Ramsey said.

Dr. Schwartz received a BA in biology from Harvard University in 1963 and an MD from Boston University in 1967. Dr. Schwartz started a residency in the UW department of pathology in 1967 and received his PhD from the institution in 1973. From 1974 to 1979, he was an assistant professor of pathology and became a full professor in 1984.

Dr. Schwartz was also an adjunct professor in the UW departments of bioengineering and medicine, “reflective of his many collaborative relationships with faculty in other departments in our medical school and in the world,” Dr. Ramsey said.

“Dr. Schwartz left a lasting imprint on the UW School of Medicine and the broader scientific community. He will be greatly missed,” he added.
 

‘A great loss’

Dr. Schwartz chaired numerous national and international meetings in the field of vascular biology. He was the founding chair of the Gordon Research Conference on Vascular Biology and a cofounder and second president of the North American Vascular Biology Organization (NAVBO). He created NAVBO’s flagship summer course, Vasculata.

“The NAVBO community has suffered a great loss,” Bernadette Englert, executive officer for the organization, said in a statement. He will be “sorely missed by generations of vascular biologists and pathologists.”

News of Dr. Schwartz’s passing lit up Twitter. Here are just a few comments:

UW lost to COVID-19 “beloved professor Stephen Schwartz, a pioneer in vascular biology and a larger-than-life scientist. Steve, you will be missed!” Rong Tian, MD, PhD, with the bioengineering department, wrote in a tweet.

“Stephen Schwartz was a giant in vascular biology and a mentor to countless faculty and trainees, including myself. He will be deeply missed,” said Kelly Stevens, PhD, also from the bioengineering department.

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

Stephen M. Schwartz, MD, PhD, a pioneer in the field of vascular biology and a longtime professor of pathology at the University of Washington, Seattle, died March 17, 2020, after being hospitalized with COVID-19. He was 78.

“This has become all too real,” UW president Ana Mari Cauce said on Facebook, where she described Dr. Schwartz as “larger than life,” and superimposed a photo of him in front of Mount Rainier, according to a report in the Seattle Times.

Dr. Schwartz is “rightfully considered a giant among investigators of the biology of smooth muscle cells and the structure of blood vessels,” Paul Ramsey, MD, CEO of UW Medicine, said in a statement. He will be remembered for his “vigorous advocacy for research and for the field of vascular biology as well as for his many trainees who have gone on to great success as independent investigators in the field of vascular pathobiology,” Dr. Ramsey said.

Dr. Schwartz received a BA in biology from Harvard University in 1963 and an MD from Boston University in 1967. Dr. Schwartz started a residency in the UW department of pathology in 1967 and received his PhD from the institution in 1973. From 1974 to 1979, he was an assistant professor of pathology and became a full professor in 1984.

Dr. Schwartz was also an adjunct professor in the UW departments of bioengineering and medicine, “reflective of his many collaborative relationships with faculty in other departments in our medical school and in the world,” Dr. Ramsey said.

“Dr. Schwartz left a lasting imprint on the UW School of Medicine and the broader scientific community. He will be greatly missed,” he added.
 

‘A great loss’

Dr. Schwartz chaired numerous national and international meetings in the field of vascular biology. He was the founding chair of the Gordon Research Conference on Vascular Biology and a cofounder and second president of the North American Vascular Biology Organization (NAVBO). He created NAVBO’s flagship summer course, Vasculata.

“The NAVBO community has suffered a great loss,” Bernadette Englert, executive officer for the organization, said in a statement. He will be “sorely missed by generations of vascular biologists and pathologists.”

News of Dr. Schwartz’s passing lit up Twitter. Here are just a few comments:

UW lost to COVID-19 “beloved professor Stephen Schwartz, a pioneer in vascular biology and a larger-than-life scientist. Steve, you will be missed!” Rong Tian, MD, PhD, with the bioengineering department, wrote in a tweet.

“Stephen Schwartz was a giant in vascular biology and a mentor to countless faculty and trainees, including myself. He will be deeply missed,” said Kelly Stevens, PhD, also from the bioengineering department.

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

Stay alert to subtle signs of abusive head trauma in children, the American Academy of Pediatrics said in an updated policy statement.

Alona Siniehina/iStock/Getty Images

Abusive head trauma (AHT) is fatal in approximately one-quarter of cases in infants during the first year of life, and less-obvious clinical signs such as vomiting and fussiness often are missed, wrote Sandeep K. Narang, MD, JD, of Northwestern University, Chicago, and colleagues on the AAP Council on Child Abuse and Neglect.

In a policy statement published in Pediatrics, the AAP cautioned physicians to remain vigilant for signs that are common in AHT cases. In particular, bruising on the torso, ears, and neck in children aged younger than 4 years, or any bruising in infants younger than 4 months should be a red flag. In addition, the most recent data indicate that apnea and retinal hemorrhages are more common in cases of abuse than in accidental injuries. The AAP also recommends a skeletal survey in suspected AHT for children younger than 2 years to identify occult fractures.

“Oral injuries in infants, such as frenulum tears, may also accompany or precede AHT,” Dr. Narang and associates said.

In addition, secondary brain injury as a result of AHT can lead to poor outcomes that may be observed. “Almost 70% of survivors of AHT have some degree of lasting neurologic impairment, including static encephalopathy, intellectual disability, cerebral palsy, cortical blindness, seizure disorders, behavior problems, and learning disabilities,” according to the statement.

Endocrine dysfunction also is common in children with a history of AHT, but might not present until years later, the authors noted.

When AHT is suspected in a patient, the policy statement recommends that a subspecialist in child abuse pediatrics or in related areas including radiology, ophthalmology, neurosurgery, neurology, and general pediatric surgery “should also be consulted when necessary to ensure a complete and accurate evaluation.”

Although falls from a height of 1.5 m or 5 feet often are used as an explanation for AHT injuries, “numerous lines of clinical research have clarified the extreme rarity of short falls as a cause of severe neurologic injury or death in young infants,” Dr. Narang and associates wrote.

Other recommendations in the updated policy encourage use of the term “abusive head trauma” in medical communications, as well as encourage caregivers to serve as a medical home for survivors of AHT or refer them to medical homes for rehabilitation and monitoring. Parents and caregivers may need to be educated about the dangers of shaking or striking an infant, shown safe ways to manage a crying baby, and given tools to manage their own stress and frustration.

Physicians are legally required to report suspected cases of child abuse or neglect, and should be prepared to educate stakeholders if you are called on to work with legal and child protective services about the science behind AHT.

“The role of the pediatric practitioner is not to apportion blame or investigate potential criminal activity but to identify the medical problem, evaluate and treat the child’s injuries, and offer honest medical information to parents, families, investigators, and attorneys and/or judges,” Dr. Narang and associates wrote.

This policy statement updates the previous policy statement issued in 2009 and affirmed in 2013. The policy had no external funding, and the authors had no financial conflicts to disclose. Dr. Narang, Amanda Fingarson, DO, and James Lukefahr, MD, have served as paid expert witnesses/consultants in cases of abusive head trauma in infants and children.

SOURCE: Narang SK et al. Pediatrics. 2020 Mar 23. doi: 10.1542/peds.2020-0203.

Stay alert to subtle signs of abusive head trauma in children, the American Academy of Pediatrics said in an updated policy statement.

Alona Siniehina/iStock/Getty Images

Abusive head trauma (AHT) is fatal in approximately one-quarter of cases in infants during the first year of life, and less-obvious clinical signs such as vomiting and fussiness often are missed, wrote Sandeep K. Narang, MD, JD, of Northwestern University, Chicago, and colleagues on the AAP Council on Child Abuse and Neglect.

In a policy statement published in Pediatrics, the AAP cautioned physicians to remain vigilant for signs that are common in AHT cases. In particular, bruising on the torso, ears, and neck in children aged younger than 4 years, or any bruising in infants younger than 4 months should be a red flag. In addition, the most recent data indicate that apnea and retinal hemorrhages are more common in cases of abuse than in accidental injuries. The AAP also recommends a skeletal survey in suspected AHT for children younger than 2 years to identify occult fractures.

“Oral injuries in infants, such as frenulum tears, may also accompany or precede AHT,” Dr. Narang and associates said.

In addition, secondary brain injury as a result of AHT can lead to poor outcomes that may be observed. “Almost 70% of survivors of AHT have some degree of lasting neurologic impairment, including static encephalopathy, intellectual disability, cerebral palsy, cortical blindness, seizure disorders, behavior problems, and learning disabilities,” according to the statement.

Endocrine dysfunction also is common in children with a history of AHT, but might not present until years later, the authors noted.

When AHT is suspected in a patient, the policy statement recommends that a subspecialist in child abuse pediatrics or in related areas including radiology, ophthalmology, neurosurgery, neurology, and general pediatric surgery “should also be consulted when necessary to ensure a complete and accurate evaluation.”

Although falls from a height of 1.5 m or 5 feet often are used as an explanation for AHT injuries, “numerous lines of clinical research have clarified the extreme rarity of short falls as a cause of severe neurologic injury or death in young infants,” Dr. Narang and associates wrote.

Other recommendations in the updated policy encourage use of the term “abusive head trauma” in medical communications, as well as encourage caregivers to serve as a medical home for survivors of AHT or refer them to medical homes for rehabilitation and monitoring. Parents and caregivers may need to be educated about the dangers of shaking or striking an infant, shown safe ways to manage a crying baby, and given tools to manage their own stress and frustration.

Physicians are legally required to report suspected cases of child abuse or neglect, and should be prepared to educate stakeholders if you are called on to work with legal and child protective services about the science behind AHT.

“The role of the pediatric practitioner is not to apportion blame or investigate potential criminal activity but to identify the medical problem, evaluate and treat the child’s injuries, and offer honest medical information to parents, families, investigators, and attorneys and/or judges,” Dr. Narang and associates wrote.

This policy statement updates the previous policy statement issued in 2009 and affirmed in 2013. The policy had no external funding, and the authors had no financial conflicts to disclose. Dr. Narang, Amanda Fingarson, DO, and James Lukefahr, MD, have served as paid expert witnesses/consultants in cases of abusive head trauma in infants and children.

SOURCE: Narang SK et al. Pediatrics. 2020 Mar 23. doi: 10.1542/peds.2020-0203.

Stay alert to subtle signs of abusive head trauma in children, the American Academy of Pediatrics said in an updated policy statement.

Alona Siniehina/iStock/Getty Images

Abusive head trauma (AHT) is fatal in approximately one-quarter of cases in infants during the first year of life, and less-obvious clinical signs such as vomiting and fussiness often are missed, wrote Sandeep K. Narang, MD, JD, of Northwestern University, Chicago, and colleagues on the AAP Council on Child Abuse and Neglect.

In a policy statement published in Pediatrics, the AAP cautioned physicians to remain vigilant for signs that are common in AHT cases. In particular, bruising on the torso, ears, and neck in children aged younger than 4 years, or any bruising in infants younger than 4 months should be a red flag. In addition, the most recent data indicate that apnea and retinal hemorrhages are more common in cases of abuse than in accidental injuries. The AAP also recommends a skeletal survey in suspected AHT for children younger than 2 years to identify occult fractures.

“Oral injuries in infants, such as frenulum tears, may also accompany or precede AHT,” Dr. Narang and associates said.

In addition, secondary brain injury as a result of AHT can lead to poor outcomes that may be observed. “Almost 70% of survivors of AHT have some degree of lasting neurologic impairment, including static encephalopathy, intellectual disability, cerebral palsy, cortical blindness, seizure disorders, behavior problems, and learning disabilities,” according to the statement.

Endocrine dysfunction also is common in children with a history of AHT, but might not present until years later, the authors noted.

When AHT is suspected in a patient, the policy statement recommends that a subspecialist in child abuse pediatrics or in related areas including radiology, ophthalmology, neurosurgery, neurology, and general pediatric surgery “should also be consulted when necessary to ensure a complete and accurate evaluation.”

Although falls from a height of 1.5 m or 5 feet often are used as an explanation for AHT injuries, “numerous lines of clinical research have clarified the extreme rarity of short falls as a cause of severe neurologic injury or death in young infants,” Dr. Narang and associates wrote.

Other recommendations in the updated policy encourage use of the term “abusive head trauma” in medical communications, as well as encourage caregivers to serve as a medical home for survivors of AHT or refer them to medical homes for rehabilitation and monitoring. Parents and caregivers may need to be educated about the dangers of shaking or striking an infant, shown safe ways to manage a crying baby, and given tools to manage their own stress and frustration.

Physicians are legally required to report suspected cases of child abuse or neglect, and should be prepared to educate stakeholders if you are called on to work with legal and child protective services about the science behind AHT.

“The role of the pediatric practitioner is not to apportion blame or investigate potential criminal activity but to identify the medical problem, evaluate and treat the child’s injuries, and offer honest medical information to parents, families, investigators, and attorneys and/or judges,” Dr. Narang and associates wrote.

This policy statement updates the previous policy statement issued in 2009 and affirmed in 2013. The policy had no external funding, and the authors had no financial conflicts to disclose. Dr. Narang, Amanda Fingarson, DO, and James Lukefahr, MD, have served as paid expert witnesses/consultants in cases of abusive head trauma in infants and children.

SOURCE: Narang SK et al. Pediatrics. 2020 Mar 23. doi: 10.1542/peds.2020-0203.

The Food and Drug Administration identified a number of medical devices that can be used to help treat patients suffering from COVID-19 if ventilators are not available. “Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.

“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.

FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.

“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”

The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.

The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.

FDA is also allowing for products to be used past their indicated shelf life.

gtwatchtman@mdege.com

The Food and Drug Administration identified a number of medical devices that can be used to help treat patients suffering from COVID-19 if ventilators are not available. “Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.

“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.

FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.

“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”

The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.

The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.

FDA is also allowing for products to be used past their indicated shelf life.

gtwatchtman@mdege.com

The Food and Drug Administration identified a number of medical devices that can be used to help treat patients suffering from COVID-19 if ventilators are not available. “Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.

“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.

FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.

“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”

The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.

The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.

FDA is also allowing for products to be used past their indicated shelf life.

gtwatchtman@mdege.com

The Food and Drug Administration has issued a Safety Alert warning of the potential for SARS-CoV-2 transmission through fecal microbiota transplantation and that additional safety procedures may be required.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.

Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.

• Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
• Testing donors and/or donor stool for SARS-CoV-2, as feasible.
• Development of criteria for exclusion of donors and donor stool based on screening and testing.
• Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.

“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.

lfranki@mdedge.com

The Food and Drug Administration has issued a Safety Alert warning of the potential for SARS-CoV-2 transmission through fecal microbiota transplantation and that additional safety procedures may be required.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.

Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.

• Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
• Testing donors and/or donor stool for SARS-CoV-2, as feasible.
• Development of criteria for exclusion of donors and donor stool based on screening and testing.
• Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.

“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.

lfranki@mdedge.com

The Food and Drug Administration has issued a Safety Alert warning of the potential for SARS-CoV-2 transmission through fecal microbiota transplantation and that additional safety procedures may be required.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.

Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.

• Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
• Testing donors and/or donor stool for SARS-CoV-2, as feasible.
• Development of criteria for exclusion of donors and donor stool based on screening and testing.
• Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.

“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.

lfranki@mdedge.com

The Society of Critical Care Medicine released its first set of guidelines for managing critically ill patients with novel coronavirus disease (COVID-19) on March 20, 2020.

The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.

The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.

Useful guide nonspecialists

Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).

“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”

“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.

He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”

One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.

“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.

Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.

mzoler@mdedge.com

The Society of Critical Care Medicine released its first set of guidelines for managing critically ill patients with novel coronavirus disease (COVID-19) on March 20, 2020.

The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.

The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.

Useful guide nonspecialists

Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).

“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”

“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.

He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”

One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.

“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.

Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.

mzoler@mdedge.com

The Society of Critical Care Medicine released its first set of guidelines for managing critically ill patients with novel coronavirus disease (COVID-19) on March 20, 2020.

The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.

The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.

Useful guide nonspecialists

Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).

“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”

“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.

He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”

One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.

“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.

Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.

mzoler@mdedge.com

The Food and Drug Administration has issued Emergency Use Authorizations for three products offering rapid, point-of-care diagnostic tests for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.

The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.

The company plans to roll out the test by March 30, according to the FDA.

Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.

FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.

The test was developed with funding from the U.S. Department of Defense.

“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.

Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.

The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”

Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.

“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”

In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe

that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.

gtwachtman@mdedge.com

The Food and Drug Administration has issued Emergency Use Authorizations for three products offering rapid, point-of-care diagnostic tests for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.

The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.

The company plans to roll out the test by March 30, according to the FDA.

Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.

FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.

The test was developed with funding from the U.S. Department of Defense.

“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.

Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.

The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”

Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.

“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”

In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe

that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.

gtwachtman@mdedge.com

The Food and Drug Administration has issued Emergency Use Authorizations for three products offering rapid, point-of-care diagnostic tests for COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.

The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.

The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.

The company plans to roll out the test by March 30, according to the FDA.

Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.

FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.

The test was developed with funding from the U.S. Department of Defense.

“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.

Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.

The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”

Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.

“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”

In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe

that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.

gtwachtman@mdedge.com