Residents

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.

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.

Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.com.

Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.com.

Recommendations to help clinicians triage surgical procedures during the COVID-19 pandemic, developed quickly by a team of urology experts from around the world and shared last week, are already out of date.

“I would change some things we said a week ago,” said David Canes, MD, from Lahey Hospital and Medical Center in Burlington, Massachusetts, and Derry, New Hampshire, who was one of those experts.

“We now know it’s not possible to create a cookbook in the face of a rapidly evolving pandemic,” he told Medscape Medical News.

“It’s heartening that we could do it so fast, but now it’s a snapshot in time, a starting point. People have to have conversations locally, in their community, taking into account where they are in relation to a surge of COVID patients, to make good decisions,” Canes said.

Long-thought-out guidance can no longer come from societies. “As the pace of information changes so rapidly,” Canes said he has changed the way he disseminates information and searches for guidance. “I’m even looking to nontraditional channels, like Twitter.”

As the COVID-19 pandemic evolves, informal discussions on social media are helping specialists make decisions. “Threads about various cancers and how people are handling them are helpful,” he said.

He described, for example, a thoughtful discussion on the use of androgen-deprivation therapy, a hormone therapy that can block the effects of androgens and can slow the growth of prostate cancer. “This is not a standard-of-care treatment,” he said, but now it’s being discussed very seriously to treat patients whose care might get delayed.

A multiple-choice survey was posted on Twitter by Ashish Kamat, MD, MBBS, from the MD Anderson Cancer Center in Houston, asking respondents what they would do for a patient with stage T2 high-grade muscle invasive bladder cancer and normal glomerular filtration during the pandemic.

In less than 20 hours, his post received 290 votes in response.

And when Badar Mian, MD, from the Albany Medical Center in New York, asked 23 urologists whether they would recommend radiotherapy (20 fractions) without any chemotherapy, he quickly got two responses: one yes and one no, with explanations.

People are responding to posts quickly. “With the COVID pandemic, we can’t wait for consensus guidelines from the American Urology Association or European Association of Urology,” Canes said.
 

One Week Changed Everything

When Canes and his coauthors said last week that prostatectomies should be delayed, they didn’t know the extent to which surgery was going to be halted. “When we wrote this statement, most facilities were still allowing elective surgeries or were just on the cusp of shutting down.”

Today, if you’re in an area where elective surgeries are still allowed or it is early in the crisis, “you might still take a patient with a Gleason 9 and a PSA of 25 and judiciously get the surgery done.”

As of March 23, however, surgery in New York City is entirely off the table. “No cancer surgery is happening anymore,” Canes reported.

The recommendations suggested using “shared decision-making” to guide radiation therapy choices. “But now, bringing a patient in for daily radiation treatment may not even be feasible, with the effort it takes to clean, the consumption of PPEs, etc,” he added.

When the dust settles, there will be a lot of assessment of current decision-making. “We’ll see if there are blips in mortality according to decisions being made,” Canes said.

The bottom line is that “we’re running on a 24-hour news cycle,” he pointed out. “It’s humbling to see how quickly decision-making changes and how nimble we have to be in making these very difficult decisions that we’ve never had to make before.”

For his own patients, Canes said he is doing consultations by phone or video at this point. “My patients have been very gracious; everyone has a general feeling we’re all in this together.”

And so far, “I haven’t had a situation where I thought the patient wasn’t going to survive,” he added.

This article first appeared on Medscape.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 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

Several days ago, Rodney Bordeaux, president of the Rosebud Sioux Tribe in South Dakota, sent a strongly worded SOS to the directors of the World Health Organization and the Pan American Health Organization about COVID-19, saying, “We have approximately 30,000 tribal members living in south central South Dakota with access to fewer than 200 beds within our reservation.”

Not only were beds woefully inadequate to the needs of potential COVID-19 victims, but tests to find out who might need the beds also were lacking. “We believe that some kits have been sent to the states,” Bordeaux wrote, “but it is the states that have been determining who gets a test and who does not.”

In Michigan, Aaron Payment, chair of the Sault Ste. Marie Tribe of Chippewa Indians, told the Native America Calling radio show, “We’re the largest tribe east of the Mississippi, and we have two test kits.”

The “chronically underfunded” Indian Health Service (IHS) was underprepared for handling virus response, Melissa Riley, PhD, executive director of Indigenous Women Rising, charged in a March 24 opinion piece in Rewire News. “If IHS can barely keep up with broken bones and preventive care,” she wrote, “what makes our people across the country think IHS can handle the outbreak of COVID-19?”  

The Centers for Disease Control and Prevention (CDC) does not break down data on cases according to race or ethnicity, but according to the IHS website, 42 people in the agency’s jurisdiction had tested positive for COVID-19 as of Mar. 24. Of those, 29 were in Navajo Country. By the evening of that day, according to Native News Online, the number of Navajos testing positive had risen to 49. Given the often-invisible spread of the virus, many more are likely to be infected.

The IHS website directs visitors to visit CDC pages for more information. However, these pages do not provide information “in a culturally literate and responsive manner,” Riley says, that explain ways to stay indoors, nor do they offer contacts for indigenous people—despite the fact, she adds, that on the West Coast they were among the first to contract the virus and to reach out with questions.

For its part, the IHS has said it “continues to work closely with our tribal partners to coordinate a comprehensive public health response to COVID-19,” holding weekly conference calls with tribal and urban Indian health organization leaders to “provide updates, answer questions, and hear concerns.” It also is in constant contact with the White House and the CDC, IHS says. IHS facilities “generally” have access to testing for individuals who may have COVID-19, the website says: However, “there are nationwide shortages of materials that may temporarily affect the availability of COVID-19 testing at a particular location.” Tribes, the website recommends, should first follow their usual process for ordering supplies. If they can’t access supplies, they should contact their IHS Area Office, which can access supplies through the IH National Supply Service Center.

Bordeaux, Payment, and Riley are not alone in their criticisms and concerns. Native Americans and Alaska Natives were hit disproportionately during the 2009 H1N1 influenza pandemic: The death rate was 4 times higher than in all other racial and ethnic groups combined. The NIH says AI/ANs are particularly vulnerable to epidemic infections, due to poverty, underlying chronic illnesses (including asthma), and delayed access to care.

Tribes began taking steps early on to protect their members, even before the federal and state governments began requiring such measures. Lummi Nation leaders, in the Pacific Northwest, for instance, began preparing when the virus first appeared in Wuhan in late 2019, according to an article in The Guardian, and declared a state of emergency on March 3—10 days before President Trump did.

The tribe has been “beefing up” emergency plans, reorganizing services, and gathering medical supplies. It also approved $1 million for emergency response, including repurposing a community fitness center into a field hospital. “We quickly recognized the need to make sacrifices for the greater good, in order to protect our people and the wider community,” Dr. Dakotah Lane, medical director of the tribal health service, said in the Guardian interview.

On March 17, the Navajo Nation shut down its 4 casinos after an Arizona tribe member was diagnosed with the virus. President Jonathan Nez says the tribe stands to lose $3 million to $5 million in revenue. But “[t]he health and well-being of our Navajo people is of utmost importance and not just profit,” Nez said in a Navajo Times interview.

In the meantime, bending to pressure from Rep. Deb Haaland (D-NM) and “a handful” of other lawmakers, according to an article in The Guardian, Congress designated $40 million for tribal health and Urban Indian Health organizations as part of the emergency federal relief legislation.

While the states received the emergency funds immediately, the CDC disburses the money to tribes, who have yet to receive any. Haaland, the first Native American woman elected to Congress, says the tribes needed the money “yesterday.”

Several days ago, Rodney Bordeaux, president of the Rosebud Sioux Tribe in South Dakota, sent a strongly worded SOS to the directors of the World Health Organization and the Pan American Health Organization about COVID-19, saying, “We have approximately 30,000 tribal members living in south central South Dakota with access to fewer than 200 beds within our reservation.”

Not only were beds woefully inadequate to the needs of potential COVID-19 victims, but tests to find out who might need the beds also were lacking. “We believe that some kits have been sent to the states,” Bordeaux wrote, “but it is the states that have been determining who gets a test and who does not.”

In Michigan, Aaron Payment, chair of the Sault Ste. Marie Tribe of Chippewa Indians, told the Native America Calling radio show, “We’re the largest tribe east of the Mississippi, and we have two test kits.”

The “chronically underfunded” Indian Health Service (IHS) was underprepared for handling virus response, Melissa Riley, PhD, executive director of Indigenous Women Rising, charged in a March 24 opinion piece in Rewire News. “If IHS can barely keep up with broken bones and preventive care,” she wrote, “what makes our people across the country think IHS can handle the outbreak of COVID-19?”  

The Centers for Disease Control and Prevention (CDC) does not break down data on cases according to race or ethnicity, but according to the IHS website, 42 people in the agency’s jurisdiction had tested positive for COVID-19 as of Mar. 24. Of those, 29 were in Navajo Country. By the evening of that day, according to Native News Online, the number of Navajos testing positive had risen to 49. Given the often-invisible spread of the virus, many more are likely to be infected.

The IHS website directs visitors to visit CDC pages for more information. However, these pages do not provide information “in a culturally literate and responsive manner,” Riley says, that explain ways to stay indoors, nor do they offer contacts for indigenous people—despite the fact, she adds, that on the West Coast they were among the first to contract the virus and to reach out with questions.

For its part, the IHS has said it “continues to work closely with our tribal partners to coordinate a comprehensive public health response to COVID-19,” holding weekly conference calls with tribal and urban Indian health organization leaders to “provide updates, answer questions, and hear concerns.” It also is in constant contact with the White House and the CDC, IHS says. IHS facilities “generally” have access to testing for individuals who may have COVID-19, the website says: However, “there are nationwide shortages of materials that may temporarily affect the availability of COVID-19 testing at a particular location.” Tribes, the website recommends, should first follow their usual process for ordering supplies. If they can’t access supplies, they should contact their IHS Area Office, which can access supplies through the IH National Supply Service Center.

Bordeaux, Payment, and Riley are not alone in their criticisms and concerns. Native Americans and Alaska Natives were hit disproportionately during the 2009 H1N1 influenza pandemic: The death rate was 4 times higher than in all other racial and ethnic groups combined. The NIH says AI/ANs are particularly vulnerable to epidemic infections, due to poverty, underlying chronic illnesses (including asthma), and delayed access to care.

Tribes began taking steps early on to protect their members, even before the federal and state governments began requiring such measures. Lummi Nation leaders, in the Pacific Northwest, for instance, began preparing when the virus first appeared in Wuhan in late 2019, according to an article in The Guardian, and declared a state of emergency on March 3—10 days before President Trump did.

The tribe has been “beefing up” emergency plans, reorganizing services, and gathering medical supplies. It also approved $1 million for emergency response, including repurposing a community fitness center into a field hospital. “We quickly recognized the need to make sacrifices for the greater good, in order to protect our people and the wider community,” Dr. Dakotah Lane, medical director of the tribal health service, said in the Guardian interview.

On March 17, the Navajo Nation shut down its 4 casinos after an Arizona tribe member was diagnosed with the virus. President Jonathan Nez says the tribe stands to lose $3 million to $5 million in revenue. But “[t]he health and well-being of our Navajo people is of utmost importance and not just profit,” Nez said in a Navajo Times interview.

In the meantime, bending to pressure from Rep. Deb Haaland (D-NM) and “a handful” of other lawmakers, according to an article in The Guardian, Congress designated $40 million for tribal health and Urban Indian Health organizations as part of the emergency federal relief legislation.

While the states received the emergency funds immediately, the CDC disburses the money to tribes, who have yet to receive any. Haaland, the first Native American woman elected to Congress, says the tribes needed the money “yesterday.”

Several days ago, Rodney Bordeaux, president of the Rosebud Sioux Tribe in South Dakota, sent a strongly worded SOS to the directors of the World Health Organization and the Pan American Health Organization about COVID-19, saying, “We have approximately 30,000 tribal members living in south central South Dakota with access to fewer than 200 beds within our reservation.”

Not only were beds woefully inadequate to the needs of potential COVID-19 victims, but tests to find out who might need the beds also were lacking. “We believe that some kits have been sent to the states,” Bordeaux wrote, “but it is the states that have been determining who gets a test and who does not.”

In Michigan, Aaron Payment, chair of the Sault Ste. Marie Tribe of Chippewa Indians, told the Native America Calling radio show, “We’re the largest tribe east of the Mississippi, and we have two test kits.”

The “chronically underfunded” Indian Health Service (IHS) was underprepared for handling virus response, Melissa Riley, PhD, executive director of Indigenous Women Rising, charged in a March 24 opinion piece in Rewire News. “If IHS can barely keep up with broken bones and preventive care,” she wrote, “what makes our people across the country think IHS can handle the outbreak of COVID-19?”  

The Centers for Disease Control and Prevention (CDC) does not break down data on cases according to race or ethnicity, but according to the IHS website, 42 people in the agency’s jurisdiction had tested positive for COVID-19 as of Mar. 24. Of those, 29 were in Navajo Country. By the evening of that day, according to Native News Online, the number of Navajos testing positive had risen to 49. Given the often-invisible spread of the virus, many more are likely to be infected.

The IHS website directs visitors to visit CDC pages for more information. However, these pages do not provide information “in a culturally literate and responsive manner,” Riley says, that explain ways to stay indoors, nor do they offer contacts for indigenous people—despite the fact, she adds, that on the West Coast they were among the first to contract the virus and to reach out with questions.

For its part, the IHS has said it “continues to work closely with our tribal partners to coordinate a comprehensive public health response to COVID-19,” holding weekly conference calls with tribal and urban Indian health organization leaders to “provide updates, answer questions, and hear concerns.” It also is in constant contact with the White House and the CDC, IHS says. IHS facilities “generally” have access to testing for individuals who may have COVID-19, the website says: However, “there are nationwide shortages of materials that may temporarily affect the availability of COVID-19 testing at a particular location.” Tribes, the website recommends, should first follow their usual process for ordering supplies. If they can’t access supplies, they should contact their IHS Area Office, which can access supplies through the IH National Supply Service Center.

Bordeaux, Payment, and Riley are not alone in their criticisms and concerns. Native Americans and Alaska Natives were hit disproportionately during the 2009 H1N1 influenza pandemic: The death rate was 4 times higher than in all other racial and ethnic groups combined. The NIH says AI/ANs are particularly vulnerable to epidemic infections, due to poverty, underlying chronic illnesses (including asthma), and delayed access to care.

Tribes began taking steps early on to protect their members, even before the federal and state governments began requiring such measures. Lummi Nation leaders, in the Pacific Northwest, for instance, began preparing when the virus first appeared in Wuhan in late 2019, according to an article in The Guardian, and declared a state of emergency on March 3—10 days before President Trump did.

The tribe has been “beefing up” emergency plans, reorganizing services, and gathering medical supplies. It also approved $1 million for emergency response, including repurposing a community fitness center into a field hospital. “We quickly recognized the need to make sacrifices for the greater good, in order to protect our people and the wider community,” Dr. Dakotah Lane, medical director of the tribal health service, said in the Guardian interview.

On March 17, the Navajo Nation shut down its 4 casinos after an Arizona tribe member was diagnosed with the virus. President Jonathan Nez says the tribe stands to lose $3 million to $5 million in revenue. But “[t]he health and well-being of our Navajo people is of utmost importance and not just profit,” Nez said in a Navajo Times interview.

In the meantime, bending to pressure from Rep. Deb Haaland (D-NM) and “a handful” of other lawmakers, according to an article in The Guardian, Congress designated $40 million for tribal health and Urban Indian Health organizations as part of the emergency federal relief legislation.

While the states received the emergency funds immediately, the CDC disburses the money to tribes, who have yet to receive any. Haaland, the first Native American woman elected to Congress, says the tribes needed the money “yesterday.”

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

The American Medical Association is offering on its website various published resources to assist physicians on the front lines of the COVID-19 pandemic.

The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.

“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.

The COVID-19 physician and practice resources released by the AMA include:

• A Physicians Guide to COVID-19 .
• An AMA COVID-19 online resource center and a COVID-19 FAQ.
• A Quick Guide to Telemedicine in Practice.
• Ethical guidance for physicians .
• Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
• CME for physicians through the JAMA Network’s JN Learning website.

klennon@mdedge.com

The American Medical Association is offering on its website various published resources to assist physicians on the front lines of the COVID-19 pandemic.

The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.

“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.

The COVID-19 physician and practice resources released by the AMA include:

• A Physicians Guide to COVID-19 .
• An AMA COVID-19 online resource center and a COVID-19 FAQ.
• A Quick Guide to Telemedicine in Practice.
• Ethical guidance for physicians .
• Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
• CME for physicians through the JAMA Network’s JN Learning website.

klennon@mdedge.com

The American Medical Association is offering on its website various published resources to assist physicians on the front lines of the COVID-19 pandemic.

The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.

“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.

The COVID-19 physician and practice resources released by the AMA include:

• A Physicians Guide to COVID-19 .
• An AMA COVID-19 online resource center and a COVID-19 FAQ.
• A Quick Guide to Telemedicine in Practice.
• Ethical guidance for physicians .
• Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
• CME for physicians through the JAMA Network’s JN Learning website.

klennon@mdedge.com

Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.

Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.

“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.

“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.

Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.

Create “Incident Command Structure”

In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.

Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”

Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.

First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.

“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”

Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.

“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.

“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”

Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.

In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.

Outpatient Care

Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.

To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.

One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.

Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.

Treatment Decisions

Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.

Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.

Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.

Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”

Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.

The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.

Inpatient Care

For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.

Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.

In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.

The Future

The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”

Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”

Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.

Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.

“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.

“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.

Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.

Create “Incident Command Structure”

In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.

Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”

Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.

First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.

“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”

Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.

“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.

“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”

Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.

In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.

Outpatient Care

Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.

To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.

One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.

Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.

Treatment Decisions

Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.

Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.

Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.

Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”

Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.

The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.

Inpatient Care

For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.

Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.

In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.

The Future

The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”

Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”

Two months after the first patient with COVID-19 was identified in China, the first case was reported in the United States in the Seattle, Washington, metropolitan area.

Seattle rapidly became the first US epicenter for COVID-19, and local experts are now offering their expertise and advice on how to provide optimal cancer care during the pandemic in a special feature published online March 20 in the Journal of the National Comprehensive Cancer Network.

“We began implementing measures in early March, including infection control and screening of visitors, staff, and patients at the door,” said lead author Masumi Ueda, MD, who holds positions at the Seattle Cancer Care Alliance, the University of Washington, and the Fred Hutchinson Research Center.

“A lot of changes have been implemented, and it changes on a daily basis. We are responding to the growing rate of COVID-19 infection in the community,” she told Medscape Medical News.

Ueda notes that as a result of the quick implementation of new procedures, so far, very few cancer patients at their facilities have been infected by the virus. “It has not hit our cancer population hard, which is a good thing,” she said.

Create “Incident Command Structure”

In sharing their experience, the authors emphasize the importance of keeping channels of communication open between all stakeholders ― administrators and staff, patients, caregivers, and the general public. They also recommend that each facility create an “incident command structure” that can provide early coordination of institution-wide efforts and that can rapidly respond to changing information.

Ueda noted that their command structure was set up very early on, “so we could get communication set up and start building an infrastructure for response.”

Several areas of care that required new strategies were addressed, both to protect patients and to work around staff shortages caused by possible exposure and/or school closings, as well as projected shortages of supplies and hospital resources.

First and foremost was to identify patients and visitors who had respiratory symptoms and to provide them with masks. Although this is always routine practice during the respiratory virus season, screening has now been initiated at entry points throughout the system.

“We were lucky in Seattle and Washington state in that the University of Washington virology lab developed PCR [polymerase chain reaction] testing early on for COVID-19, which subsequently got FDA approval,” said Ueda. “So we were able to have local testing and didn’t have to rely on the state lab. Testing has also been rapidly scaled up.”

Initiating a comprehensive policy for testing staff, tracking results and exposures for persons under investigation, and defining when it is possible to return to work are essential elements for maintaining a stable workforce. In addition, reinforcing a strict “stay at home when ill” policy and providing access to testing for symptomatic staff have been key to limiting exposures.

“What is unique to our region is that we had testing early on, and we are turning it around in 24 hours,” she pointed out. “This is important for staff to be able to return to work.” Currently, staff, patients, and visitors are being tested only if they show the cardinal symptoms associated with COVID-19: fever, shortness of breath, and cough, although muscle aches have recently been added to their testing protocol.

“I think if we had unlimited capacity, we might consider testing people who are asymptomatic,” Ueda noted, “although if you don’t have symptoms, you may not have the viral load needed for an accurate test.”

Educational materials explaining infection control were also needed for patients and families, along with signs and a website to provide COVID-19 education. These were quickly developed.

In addition, a telephone triage line was established for patients with mild symptoms in order to minimize exposures in clinics and to lessen the number of patients presenting at emergency departments.

Outpatient Care

Because theirs is a referral center, many cancer patients come from out of town, and so there is concern about exposing nonlocal patients to COVID-19 as the virus spreads in the Seattle area. In addition, staffing shortages due to factors such as illness, exposure, and school closures are anticipated.

To address these problems, an initial priority was to establish a “multilayer” coverage system for the clinics in the event that practitioners had to be quarantined on short notice, the authors explain.

One decision was to reschedule all wellness visits for current patients or to use telemedicine. Capacity for that option expanded quickly, which was greatly helped by the recent decision by the Centers for Medicare & Medicaid Services to lift Medicare restrictions on the use of certain telemedicine services.

Another approach is to defer all consultations for second opinions for patients who were already undergoing treatment and to increase clinic hours of operations and capabilities for acute evaluations. This helps reserve emergency departments and hospital resources for patients who require higher-level care, the authors comment.

Treatment Decisions

Treatment decisions were more challenging to make, the authors note. One decision was that, despite the risk for COVID-19 for patients with solid tumors, adjuvant therapy with curative intent should proceed, they note. Similarly, patients with metastatic disease might lose the window of opportunity for treatment if it is delayed.

Treatment for aggressive hematologic malignancies is usually urgent, and stem cell transplant and cellular immunotherapies that provide curative treatments cannot be delayed in many cases.

Enrollment in clinical trials will most likely be limited to those trials that are most likely to benefit the patient.

Ueda noted that, because their patients come from all over the country, they are now conducting consultations for stem cell transplant by telephone so that nonlocal patients do not have to travel to Seattle. “If there is some way we can delay the treatment, we have taken that approach,” Ueda told Medscape Medical News. “If we can divert a patient to an area that is not as heavily affected, that’s another option we are taking.”

Although cancer surgery is not considered elective, surgical intervention needs to be prioritized, the authors comment. In the Seattle system, there is currently a 2-week ban on elective surgery in the healthcare system, owing to limited availability of personal protective equipment (PPE), staffing, and beds.

The oncology teams are currently reviewing treatment regimens to determine which treatments might lessen immunosuppression and which treatment options can be moved from the inpatient to the outpatient setting or can be delayed.

Inpatient Care

For hospitalized patients, several issues are being addressed. The priority is to prepare for an upcoming shortage of beds and resources because of the surge of patients with COVID-19 that is predicted. For both clinic and hospitalized patients, shortages of blood products have necessitated stricter adherence to thresholds for transfusion, and consideration is being given to lowering those thresholds.

Another important problem is the need to conserve PPE, which includes masks, gowns, gloves, and other products. The Seattle teams have implemented solutions such as favoring handwashing with soap and water over the use of hand gel for standard-precaution rooms, limiting the number of personnel entering patient rooms (so as to use less PPE), and reducing nursing procedures that require PPE, such as measuring urine output, unless they are necessary.

In addition, a no-visitor policy has been adopted in inpatient units to conserve PPE, with the exception of end-of-life situations.

The Future

The future trajectory of the COVID-19 pandemic is uncertain, Ueda commented. She emphasized that “we must continue to prepare for its widespread impact. The unknown is what we are looking at. We are expecting it to evolve, and the number of infections cannot go down.”

Ueda and coauthors end their article on a positive note. “To many of us, this has become the health care challenge of our generation, one that modern cancer therapy has never had to face. We will prevail, and when the pandemic ends, we will all be proud of what we did for our patients and each other in this critical moment for humanity.”