Physicians react: Doctors worry about patients reading their clinical notes

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Thu, 12/15/2022 - 14:39

Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.

As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.

The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
 

Potentially more legal woes for physicians?

A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.

“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.

She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.

Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?

As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”

The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.

“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”

One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”

Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.

One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
 

 

 

Will Open Notes erode patient communication?

One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.

“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
 

Some physicians envision positive developments

Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.

A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.

“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.

“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”

One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.

Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”

Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”

“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”

“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”

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

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Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.

As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.

The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
 

Potentially more legal woes for physicians?

A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.

“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.

She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.

Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?

As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”

The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.

“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”

One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”

Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.

One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
 

 

 

Will Open Notes erode patient communication?

One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.

“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
 

Some physicians envision positive developments

Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.

A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.

“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.

“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”

One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.

Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”

Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”

“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”

“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”

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

Patients will soon be able to read the notes that physicians make during an episode of care, as well as information about diagnostic testing and imaging results, tests for STDs, fetal ultrasounds, and cancer biopsies. This open access is raising concerns among physicians.

As part of the 21st Century Cures Act, patients have the right to see their medical notes. Known as Open Notes, the policy will go into effect on April 5, 2021. The Department of Health & Human Services recently changed the original start date, which was to be Nov. 2, 2020.

The mandate has some physicians worrying about potential legal risks and possible violation of doctor-patient confidentiality. When asked to share their views on the new Open Notes mandate, many physicians expressed their concerns but also cited some of the positive effects that could come from this.
 

Potentially more legal woes for physicians?

A key concern raised by one physician commenter is that patients could misunderstand legitimate medical terminology or even put a physician in legal crosshairs. For example, a medical term such as “spontaneous abortion” could be misconstrued by patients. A physician might write notes with the idea that a patient is reading them and thus might alter those notes in a way that creates legal trouble.

“This layers another level of censorship and legal liability onto physicians, who in attempting to be [politically correct], may omit critical information or have to use euphemisms in order to avoid conflict,” one physician said.

She also questioned whether notes might now have to be run through legal counsel before being posted to avoid potential liability.

Another doctor questioned how physicians would be able to document patients suspected of faking injuries for pain medication, for example. Could such documentation lead to lawsuits for the doctor?

As one physician noted, some patients “are drug seekers. Some refuse to aid in their own care. Some are malingerers. Not documenting that is bad medicine.”

The possibility of violating doctor-patient confidentiality laws, particularly for teenagers, could be another negative effect of Open Notes, said one physician.

“Won’t this violate the statutes that teenagers have the right to confidential evaluations?” the commenter mused. “If charts are to be immediately available, then STDs and pregnancies they weren’t ready to talk about will now be suddenly known by their parents.”

One doctor has already faced this issue. “I already ran into this problem once,” he noted. “Now I warn those on their parents’ insurance before I start the visit. I have literally had a patient state, ‘well then we are done,’ and leave without being seen due to it.”

Another physician questioned the possibility of having to write notes differently than they do now, especially if the patients have lower reading comprehension abilities.

One physician who uses Open Notes said he receives patient requests for changes that have little to do with the actual diagnosis and relate to ancillary issues. He highlighted patients who “don’t want psych diagnosis in their chart or are concerned a diagnosis will raise their insurance premium, so they ask me to delete it.”
 

 

 

Will Open Notes erode patient communication?

One physician questioned whether it would lead to patients being less open and forthcoming about their medical concerns with doctors.

“The main problem I see is the patient not telling me the whole story, or worse, telling me the story, and then asking me not to document it (as many have done in the past) because they don’t want their spouse, family, etc. to read the notes and they have already given their permission for them to do so, for a variety of reasons,” he commented. “This includes topics of STDs, infidelity, depression, suicidal thoughts, and other symptoms the patient doesn’t want their family to read about.”
 

Some physicians envision positive developments

Many physicians are unconcerned by the new mandate. “I see some potential good in this, such as improving doctor-patient communication and more scrupulous charting,” one physician said.

A doctor working in the U.S. federal health care system noted that open access has been a part of that system for decades.

“Since health care providers work in this unveiled setting for their entire career, they usually know how to write appropriate clinical notes and what information needs to be included in them,” he wrote. “Now it’s time for the rest of the medical community to catch up to a reality that we have worked within for decades now.

“The world did not end, malpractice complaints did not increase, and physician/patient relationships were not damaged. Living in the information age, archaic practices like private notes were surely going to end at some point.”

One doctor who has been using Open Notes has had experiences in which the patient noted an error in the medical chart that needed correcting. “I have had one patient correct me on a timeline in the HPI which was helpful and I made the requested correction in that instance,” he said.

Another physician agreed. “I’ve had patients add or correct valuable information I’ve missed. Good probably outweighs the bad if we set limits on behaviors expressed by the personality disordered group. The majority of people don’t seem to care and still ask me ‘what would you do’ or ‘tell me what to do.’ It’s all about patient/physician trust.”

Another talked about how Open Notes should have little or no impact. “Here’s a novel concept – talking to our patients,” he commented. “There is nothing in every one of my chart notes that has not already been discussed with my patients and I dictate (speech to text) my findings and plan in front of them. So, if they are reviewing my office notes, it will only serve to reinforce what we have already discussed.”

“I don’t intend to change anything,” he added. “Chances are if they were to see a test result before I have a chance to discuss it with them, they will have already ‘Googled’ its meaning and we can have more meaningful interaction if they have a basic understanding of the test.”

“I understand that this is anxiety provoking, but in general I think it is appropriate for patients to have access to their notes,” said another physician. “If physicians write lousy notes that say they did things they didn’t do, that fail to actually state a diagnosis and a plan (and they often do), that is the doc’s problem, not the patient’s.”

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

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AGS issues pandemic resource allocation recommendations amid ageism concerns

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Changed
Thu, 08/26/2021 - 16:07

The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

Farrell_Timothy_W_UT_web.jpg
Dr. Timothy W. Farrell

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

Angelos_Peter_IL_web.jpg
Dr. Peter Angelos

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.

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The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

Farrell_Timothy_W_UT_web.jpg
Dr. Timothy W. Farrell

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

Angelos_Peter_IL_web.jpg
Dr. Peter Angelos

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.

The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

Farrell_Timothy_W_UT_web.jpg
Dr. Timothy W. Farrell

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

Angelos_Peter_IL_web.jpg
Dr. Peter Angelos

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.

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U.S. is poised to produce a COVID-19 vaccine, but don’t expect it soon

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Thu, 08/26/2021 - 16:08

Manufacturers will begin producing COVID-19 vaccine doses in anticipation of approval so that if a product gets the okay for usage, distribution can begin quickly, according to Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

vaccine_bottles_web.jpg

“We will be producing vaccine at risk, which means we’ll be [investing] considerable resources in developing doses even before we know any given candidate or candidates work,” he testified during a May 12, 2020, hearing of the Senate Health, Education, Labor, and Pensions Committee.

During the hearing, Dr. Fauci did not elaborate on how the production at risk would be undertaken, what criteria would be in place for selecting which candidates would be in the pipeline, or how much would be spent on the advanced production of these vaccines.

And while Dr. Fauci, a member of the White House coronavirus task force, remained optimistic that one or more vaccine candidates would ultimately be viable, he cautioned that there remain many unknowns that could slow the development of a vaccine for COVID-19.

“I must warn that there’s also the possibility of negative consequences that certain vaccines can actually enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will it be present or absent and how durable will it be?”

It’s unlikely that either a vaccine or an effective treatment will be available in the next 3 months, Dr. Fauci told the committee.

Sen. Lamar Alexander (R-Tenn.), the committee chairman, asked Dr. Fauci what he would say to college, primary, and secondary school administrators about how the availability of treatments and vaccines could influence the ability to reopen campuses to students. Dr. Fauci replied that the idea of having treatments or a vaccine available to facilitate the reentry of students in the fall term would be “a bit of a bridge too far.”

The emphasis in the coming months should be on testing, contact tracing, and isolation of those infected with the virus, Dr. Fauci said.

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Manufacturers will begin producing COVID-19 vaccine doses in anticipation of approval so that if a product gets the okay for usage, distribution can begin quickly, according to Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

vaccine_bottles_web.jpg

“We will be producing vaccine at risk, which means we’ll be [investing] considerable resources in developing doses even before we know any given candidate or candidates work,” he testified during a May 12, 2020, hearing of the Senate Health, Education, Labor, and Pensions Committee.

During the hearing, Dr. Fauci did not elaborate on how the production at risk would be undertaken, what criteria would be in place for selecting which candidates would be in the pipeline, or how much would be spent on the advanced production of these vaccines.

And while Dr. Fauci, a member of the White House coronavirus task force, remained optimistic that one or more vaccine candidates would ultimately be viable, he cautioned that there remain many unknowns that could slow the development of a vaccine for COVID-19.

“I must warn that there’s also the possibility of negative consequences that certain vaccines can actually enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will it be present or absent and how durable will it be?”

It’s unlikely that either a vaccine or an effective treatment will be available in the next 3 months, Dr. Fauci told the committee.

Sen. Lamar Alexander (R-Tenn.), the committee chairman, asked Dr. Fauci what he would say to college, primary, and secondary school administrators about how the availability of treatments and vaccines could influence the ability to reopen campuses to students. Dr. Fauci replied that the idea of having treatments or a vaccine available to facilitate the reentry of students in the fall term would be “a bit of a bridge too far.”

The emphasis in the coming months should be on testing, contact tracing, and isolation of those infected with the virus, Dr. Fauci said.

Manufacturers will begin producing COVID-19 vaccine doses in anticipation of approval so that if a product gets the okay for usage, distribution can begin quickly, according to Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

vaccine_bottles_web.jpg

“We will be producing vaccine at risk, which means we’ll be [investing] considerable resources in developing doses even before we know any given candidate or candidates work,” he testified during a May 12, 2020, hearing of the Senate Health, Education, Labor, and Pensions Committee.

During the hearing, Dr. Fauci did not elaborate on how the production at risk would be undertaken, what criteria would be in place for selecting which candidates would be in the pipeline, or how much would be spent on the advanced production of these vaccines.

And while Dr. Fauci, a member of the White House coronavirus task force, remained optimistic that one or more vaccine candidates would ultimately be viable, he cautioned that there remain many unknowns that could slow the development of a vaccine for COVID-19.

“I must warn that there’s also the possibility of negative consequences that certain vaccines can actually enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will it be present or absent and how durable will it be?”

It’s unlikely that either a vaccine or an effective treatment will be available in the next 3 months, Dr. Fauci told the committee.

Sen. Lamar Alexander (R-Tenn.), the committee chairman, asked Dr. Fauci what he would say to college, primary, and secondary school administrators about how the availability of treatments and vaccines could influence the ability to reopen campuses to students. Dr. Fauci replied that the idea of having treatments or a vaccine available to facilitate the reentry of students in the fall term would be “a bit of a bridge too far.”

The emphasis in the coming months should be on testing, contact tracing, and isolation of those infected with the virus, Dr. Fauci said.

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CMS hikes telephone visit payments during pandemic

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Thu, 08/26/2021 - 16:09

 

Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.

On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.

Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.

The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.

“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”

CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.

“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”

Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”

Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*

“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”

Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.

“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”

The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.

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Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.

On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.

Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.

The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.

“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”

CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.

“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”

Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”

Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*

“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”

Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.

“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”

The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.

 

Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.

On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.

Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.

The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.

“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”

CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.

“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”

Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”

Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*

“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”

Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.

“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”

The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.

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COVID-19 spurs telemedicine, furloughs, retirement

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Thu, 08/26/2021 - 16:10

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

Telemedicine_dr_patient_web.jpg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Telemedicine_dr_patient_web.jpg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Telemedicine_dr_patient_web.jpg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Infectious disease experts say testing is key to reopening

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Thu, 08/26/2021 - 16:13

 

The key to opening up the American economy rests on the ability to conduct mass testing, according to the Infectious Diseases Society of America (IDSA).

As policymakers weigh how to safely reopen parts of the United States, the IDSA, along with its HIV Medicine Association, issued a set of recommendations outlining the steps that would be necessary in order to begin easing physical distancing measures.

“A stepwise approach to reopening should reflect early diagnosis and enhanced surveillance for COVID-19 cases, linkage of cases to appropriate levels of care, isolation and/or quarantine, contact tracing, and data processing capabilities for state and local public health departments,” according to the recommendation document.

Some of the recommended steps include the following:
 

  • Widespread testing and surveillance, including use of validated nucleic acid amplification assays and anti–SARS-CoV-2 antibody detection.
  • The ability to diagnose, treat, and isolate individuals with COVID-19.
  • Scaling up of health care capacity and supplies to manage recurrent episodic outbreaks.
  • Maintaining a degree of physical distancing to prevent recurrent outbreaks, including use of masks, limiting gatherings, and continued distancing for susceptible adults.

“The recommendations stress that physical distancing policy changes must be based on relevant data and adequate public health resources and capacities and calls for a rolling and incremental approach to lifting these restrictions, ” Thomas File Jr., MD, IDSA president and a professor at Northeastern Ohio Universities, Rootstown, said during an April 17 press briefing.

The rolling approach “must reflect state and regional capacities for diagnosing, isolating, and treating people with the virus, tracing their contacts, protecting health care workers, and addressing the needs of populations disproportionately affected by COVID-19,” he continued.

In order to fully lift physical distancing restrictions, there would need to be effective treatments for COVID-19 and a protective vaccine that can be deployed to key at-risk populations, according to the recommendations.

During the call, Tina Q. Tan, MD, professor of pediatrics at Northwestern University, Chicago, and a member of the IDSA board of directors, said that easing social distancing requirements requires comprehensive data and that “one of the major missing data points” is the number of people who are currently infected or have been infected. She warned that easing restrictions too soon could have “disastrous consequences,” including an increase in spread of infection, hospitalization, and death rates, as well as overwhelming health care facilities.

“In order to reopen, we have to have the ability to safely, successfully, and rapidly diagnose and treat, as well as isolate, individuals with COVID-19, as well as track their contacts,” she said.

The implementation of more widespread, comprehensive testing would better enable targeting of resources, such as personal protective equipment, ICU beds, and ventilators, Dr. Tan said. “This is needed in order to ensure that, if there is an outbreak and it does occur again, the health care system and the first responders are ready for this,” she said.

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The key to opening up the American economy rests on the ability to conduct mass testing, according to the Infectious Diseases Society of America (IDSA).

As policymakers weigh how to safely reopen parts of the United States, the IDSA, along with its HIV Medicine Association, issued a set of recommendations outlining the steps that would be necessary in order to begin easing physical distancing measures.

“A stepwise approach to reopening should reflect early diagnosis and enhanced surveillance for COVID-19 cases, linkage of cases to appropriate levels of care, isolation and/or quarantine, contact tracing, and data processing capabilities for state and local public health departments,” according to the recommendation document.

Some of the recommended steps include the following:
 

  • Widespread testing and surveillance, including use of validated nucleic acid amplification assays and anti–SARS-CoV-2 antibody detection.
  • The ability to diagnose, treat, and isolate individuals with COVID-19.
  • Scaling up of health care capacity and supplies to manage recurrent episodic outbreaks.
  • Maintaining a degree of physical distancing to prevent recurrent outbreaks, including use of masks, limiting gatherings, and continued distancing for susceptible adults.

“The recommendations stress that physical distancing policy changes must be based on relevant data and adequate public health resources and capacities and calls for a rolling and incremental approach to lifting these restrictions, ” Thomas File Jr., MD, IDSA president and a professor at Northeastern Ohio Universities, Rootstown, said during an April 17 press briefing.

The rolling approach “must reflect state and regional capacities for diagnosing, isolating, and treating people with the virus, tracing their contacts, protecting health care workers, and addressing the needs of populations disproportionately affected by COVID-19,” he continued.

In order to fully lift physical distancing restrictions, there would need to be effective treatments for COVID-19 and a protective vaccine that can be deployed to key at-risk populations, according to the recommendations.

During the call, Tina Q. Tan, MD, professor of pediatrics at Northwestern University, Chicago, and a member of the IDSA board of directors, said that easing social distancing requirements requires comprehensive data and that “one of the major missing data points” is the number of people who are currently infected or have been infected. She warned that easing restrictions too soon could have “disastrous consequences,” including an increase in spread of infection, hospitalization, and death rates, as well as overwhelming health care facilities.

“In order to reopen, we have to have the ability to safely, successfully, and rapidly diagnose and treat, as well as isolate, individuals with COVID-19, as well as track their contacts,” she said.

The implementation of more widespread, comprehensive testing would better enable targeting of resources, such as personal protective equipment, ICU beds, and ventilators, Dr. Tan said. “This is needed in order to ensure that, if there is an outbreak and it does occur again, the health care system and the first responders are ready for this,” she said.

 

The key to opening up the American economy rests on the ability to conduct mass testing, according to the Infectious Diseases Society of America (IDSA).

As policymakers weigh how to safely reopen parts of the United States, the IDSA, along with its HIV Medicine Association, issued a set of recommendations outlining the steps that would be necessary in order to begin easing physical distancing measures.

“A stepwise approach to reopening should reflect early diagnosis and enhanced surveillance for COVID-19 cases, linkage of cases to appropriate levels of care, isolation and/or quarantine, contact tracing, and data processing capabilities for state and local public health departments,” according to the recommendation document.

Some of the recommended steps include the following:
 

  • Widespread testing and surveillance, including use of validated nucleic acid amplification assays and anti–SARS-CoV-2 antibody detection.
  • The ability to diagnose, treat, and isolate individuals with COVID-19.
  • Scaling up of health care capacity and supplies to manage recurrent episodic outbreaks.
  • Maintaining a degree of physical distancing to prevent recurrent outbreaks, including use of masks, limiting gatherings, and continued distancing for susceptible adults.

“The recommendations stress that physical distancing policy changes must be based on relevant data and adequate public health resources and capacities and calls for a rolling and incremental approach to lifting these restrictions, ” Thomas File Jr., MD, IDSA president and a professor at Northeastern Ohio Universities, Rootstown, said during an April 17 press briefing.

The rolling approach “must reflect state and regional capacities for diagnosing, isolating, and treating people with the virus, tracing their contacts, protecting health care workers, and addressing the needs of populations disproportionately affected by COVID-19,” he continued.

In order to fully lift physical distancing restrictions, there would need to be effective treatments for COVID-19 and a protective vaccine that can be deployed to key at-risk populations, according to the recommendations.

During the call, Tina Q. Tan, MD, professor of pediatrics at Northwestern University, Chicago, and a member of the IDSA board of directors, said that easing social distancing requirements requires comprehensive data and that “one of the major missing data points” is the number of people who are currently infected or have been infected. She warned that easing restrictions too soon could have “disastrous consequences,” including an increase in spread of infection, hospitalization, and death rates, as well as overwhelming health care facilities.

“In order to reopen, we have to have the ability to safely, successfully, and rapidly diagnose and treat, as well as isolate, individuals with COVID-19, as well as track their contacts,” she said.

The implementation of more widespread, comprehensive testing would better enable targeting of resources, such as personal protective equipment, ICU beds, and ventilators, Dr. Tan said. “This is needed in order to ensure that, if there is an outbreak and it does occur again, the health care system and the first responders are ready for this,” she said.

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Senate Dems call for nationwide COVID-19 testing strategy, more funding

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Thu, 08/26/2021 - 16:13

Senate Democrats are calling on the Trump Administration to develop a comprehensive strategy for nationwide COVID-19 testing.

Lawmakers released a “roadmap document with the goal of including its provisions in the next legislative aid package for COVID-19. Sen. Patty Murray (D-Wash.), the ranking member of the Health, Education, Labor & Pensions committee, noted during an April 15 press conference call that testing in the United States is actually slowing because of shortages and glitches.

“At our current pace, getting 100 million tests done would already take far too long,” she said. “We absolutely cannot afford any backsliding.”

The components of the roadmap include requiring the federal government to develop and communicate a detailed strategic plan to rapidly scale and optimize COVID-19 testing, Sen. Murray said. “This is a national crisis. We need a federally coordinated, whole-of-society response, not one that leaves each state to fend for itself.”

The strategic plan called for in the roadmap would need to establish a high-functioning supply chain with a sufficient amount of available testing materials and supplies; assess potential bottlenecks in the supply chain and communicate them to all stakeholders; and develop and validate accurate and reliable tests for COVID-19, with an emphasis on tests that can deliver rapid results.

Legislation would be used to bolster the supply chain enhancements, according to the roadmap, and would include incentives for domestic manufacturing of testing supplies and compel the sharing of intellectual property and guarantees on the purchase of testing materials.

Testing would be available to patients at no cost sharing under this proposal. The plan also calls for strengthening the price gouging policy in the CARES (Coronavirus Aid, Relief, and Economic Security) Act to ensure that health care professionals are fairly reimbursed by insurers.

The roadmap calls for $30 billion in new emergency funding to enable faster scaling of testing and development of different types of test, with an emphasis on rapid response tests. The funding would also be used to address supply chain issues, according to the roadmap document.

Sen. Lamar Alexander (R.-Tenn.), who chairs the Senate Health, Education, Labor & Pensions committee, echoed the need for more testing to be done, but suggested that the funding that has already been approved by Congress should be exhausted before more is allocated.

“In the last month, Congress has given federal agencies up to $38 billion to develop tests, treatments, and vaccines. Nothing is more important than finding a new diagnostic technology that will make it possible to test tens of millions of Americans, something our country has never tried to do before,” he said in a statement issued after the roadmap’s release. “We should start by using the money Congress has already provided, put politics aside, and work together on more tests with quick results.”

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Senate Democrats are calling on the Trump Administration to develop a comprehensive strategy for nationwide COVID-19 testing.

Lawmakers released a “roadmap document with the goal of including its provisions in the next legislative aid package for COVID-19. Sen. Patty Murray (D-Wash.), the ranking member of the Health, Education, Labor & Pensions committee, noted during an April 15 press conference call that testing in the United States is actually slowing because of shortages and glitches.

“At our current pace, getting 100 million tests done would already take far too long,” she said. “We absolutely cannot afford any backsliding.”

The components of the roadmap include requiring the federal government to develop and communicate a detailed strategic plan to rapidly scale and optimize COVID-19 testing, Sen. Murray said. “This is a national crisis. We need a federally coordinated, whole-of-society response, not one that leaves each state to fend for itself.”

The strategic plan called for in the roadmap would need to establish a high-functioning supply chain with a sufficient amount of available testing materials and supplies; assess potential bottlenecks in the supply chain and communicate them to all stakeholders; and develop and validate accurate and reliable tests for COVID-19, with an emphasis on tests that can deliver rapid results.

Legislation would be used to bolster the supply chain enhancements, according to the roadmap, and would include incentives for domestic manufacturing of testing supplies and compel the sharing of intellectual property and guarantees on the purchase of testing materials.

Testing would be available to patients at no cost sharing under this proposal. The plan also calls for strengthening the price gouging policy in the CARES (Coronavirus Aid, Relief, and Economic Security) Act to ensure that health care professionals are fairly reimbursed by insurers.

The roadmap calls for $30 billion in new emergency funding to enable faster scaling of testing and development of different types of test, with an emphasis on rapid response tests. The funding would also be used to address supply chain issues, according to the roadmap document.

Sen. Lamar Alexander (R.-Tenn.), who chairs the Senate Health, Education, Labor & Pensions committee, echoed the need for more testing to be done, but suggested that the funding that has already been approved by Congress should be exhausted before more is allocated.

“In the last month, Congress has given federal agencies up to $38 billion to develop tests, treatments, and vaccines. Nothing is more important than finding a new diagnostic technology that will make it possible to test tens of millions of Americans, something our country has never tried to do before,” he said in a statement issued after the roadmap’s release. “We should start by using the money Congress has already provided, put politics aside, and work together on more tests with quick results.”

Senate Democrats are calling on the Trump Administration to develop a comprehensive strategy for nationwide COVID-19 testing.

Lawmakers released a “roadmap document with the goal of including its provisions in the next legislative aid package for COVID-19. Sen. Patty Murray (D-Wash.), the ranking member of the Health, Education, Labor & Pensions committee, noted during an April 15 press conference call that testing in the United States is actually slowing because of shortages and glitches.

“At our current pace, getting 100 million tests done would already take far too long,” she said. “We absolutely cannot afford any backsliding.”

The components of the roadmap include requiring the federal government to develop and communicate a detailed strategic plan to rapidly scale and optimize COVID-19 testing, Sen. Murray said. “This is a national crisis. We need a federally coordinated, whole-of-society response, not one that leaves each state to fend for itself.”

The strategic plan called for in the roadmap would need to establish a high-functioning supply chain with a sufficient amount of available testing materials and supplies; assess potential bottlenecks in the supply chain and communicate them to all stakeholders; and develop and validate accurate and reliable tests for COVID-19, with an emphasis on tests that can deliver rapid results.

Legislation would be used to bolster the supply chain enhancements, according to the roadmap, and would include incentives for domestic manufacturing of testing supplies and compel the sharing of intellectual property and guarantees on the purchase of testing materials.

Testing would be available to patients at no cost sharing under this proposal. The plan also calls for strengthening the price gouging policy in the CARES (Coronavirus Aid, Relief, and Economic Security) Act to ensure that health care professionals are fairly reimbursed by insurers.

The roadmap calls for $30 billion in new emergency funding to enable faster scaling of testing and development of different types of test, with an emphasis on rapid response tests. The funding would also be used to address supply chain issues, according to the roadmap document.

Sen. Lamar Alexander (R.-Tenn.), who chairs the Senate Health, Education, Labor & Pensions committee, echoed the need for more testing to be done, but suggested that the funding that has already been approved by Congress should be exhausted before more is allocated.

“In the last month, Congress has given federal agencies up to $38 billion to develop tests, treatments, and vaccines. Nothing is more important than finding a new diagnostic technology that will make it possible to test tens of millions of Americans, something our country has never tried to do before,” he said in a statement issued after the roadmap’s release. “We should start by using the money Congress has already provided, put politics aside, and work together on more tests with quick results.”

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Pandemic strains blood supply for COVID-19 and noninfected patients

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Thu, 08/26/2021 - 16:13

The COVID-19 pandemic is putting a strain on the blood supply and could be putting people – including those who normally get transfusions, such as patients with sickle cell disease and cancer – at risk.

Osunkwo_Ifeyinwa_Ify NC_web.jpg
Dr. Ifeyinwa (Ify) Osunkwo

“Around the beginning of March, the hematology community got wind of what was going on because the blood banks were saying think about your patients and begin to restrict blood usage because we are expecting an increase in usage for COVID-positive ICU patients,” Ifeyinwa (Ify) Osunkwo, MD, a specialist in hematology and sickle cell disease at Levine Cancer Institute in Charlotte, N.C., said in an interview.

“I think that was the first call to arms around hematology ... you don’t want to shortchange somebody who is well and who is being sustained by life-giving transfusions and cut out their transfusion therapy because you are hoping to use the blood for people who are coming in with COVID-19,” she continued. “That is an ethical dilemma that no doctor wants to have to go through. But the reality is we have to do something to make it work for everybody.”

And the timing of the social restrictions due to the pandemic has added additional strain on the blood supply.

“Over the winter, traditionally, blood drives slow down because of the flu and different viruses,” she noted. “The spring and the summer are when we see the biggest recruitment and uptake of blood donation. COVID-19 hit [and] a lot of the blood drives that were traditionally scheduled to supply blood for the country have been canceled because of the new guidance for social distancing.”

Another big source of blood are health care professionals themselves and they may not be able to donate because of the extra hours being worked because of the pandemic.

In speaking about the needs for traditional patients such as those who are dealing with cancer or leukemia or sickle cell diseases as well as those who are being treated for COVID-19 in North Carolina, “we are not at the critical point, but I am a little bit nervous that we may get there because they are not going to up the usual blood drives anytime this summer. We project [sometime] in the fall, but maybe not even then. So there needs to be a significant call-out for people to make every effort to donate blood,” said Dr. Osunkwo. She added that in places such as New York City that are hot spots for the COVID-19 outbreak, the need is likely a lot greater.

She recalled a recent incident at a New York hospital that highlighted how those managing blood supplies are being restrictive and how this could be harming patients.

“A sickle cell patient came in with COVID-19 and the treatment recommendation was do a red blood cell exchange but the blood bank was nervous about getting enough blood to supply for that exchange transfusion,” she said, noting that the doctor still went to bat for that patient to get the needed treatment. “We gave her the supporting evidence that when you are on treatment for sickle cell disease, you tend to do better if you get COVID-19 or any other viral infection. The symptoms of COVID-19 in sickle cell disease is acute chest syndrome, for which the treatment is red blood cell exchange. Not doing that for [these patients] is really not giving them the optimal way of managing their disease, and managing their disease in the setting of COVID-19.”

To that end, Dr. Osunkwo stressed that doctors need to be doing all they can to get the word out that blood is needed and that the American Red Cross and other donation organizations are making it safe for people to donate. She has been using social media to highlight when her fellow doctors and others make donations as a way to motivate individuals.

“Everybody can do something during this pandemic,” she said. “Don’t feel like you are not working, that you are not a frontline worker, that you have nothing to contribute. You can donate blood. Your cousin can donate blood. You can tell your friends, your neighbors, your relatives, your enemies to go donate. We will take every kind of blood we can get because people are needing it more now. Even though we canceled elective surgeries, my patients when they get COVID-19, they need more blood ... than they usually do during their regular sickle cell admission. It is going to be the same for people who have other blood disorders like cancer and leukemia. We can’t stop life-saving treatments just because we have the COVID pandemic.”

Dr. Osunkwo also praised recent actions taken by the Food and Drug Administration to lessen some of the deferral periods for when an individual can donate.

The FDA on April 2 issued three sets of revised recommendations aimed at getting more people eligible to donate blood. All of the revised recommendations will remain in effect after the COVID-19 health emergency is declared over.

The first revised recommendation makes changes to December 2015 guidance.

For male blood donors who would have been deferred for having sex with another male partner, the deferral period has been reduced from 12 months to 3 months. That deferral period change also applies to female donors who had sex with a man who had sex with another man as well as for those with recent tattoos and piercings.

The second recommendation revises guidance from August 2013 and relates to the risk of transfusion-transmitted malaria.

Under the new recommendations, for those who traveled to malaria-endemic areas (and are residents of malaria non-endemic countries), the FDA is lowering the recommended deferral period from 12 months to 3 months, and also provides notices of an alternate procedure that permits donations without a deferral period provided the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The third recommendation finalizes draft guidance from January that eliminates the referral period for donors who spent time in certain European countries or were on military bases in Europe and were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.

Dr. Osunkwo reports consultancy and being on the speakers bureau and participating in the advisory board for Novartis, and relationships with a variety of other pharmaceutical companies. She is the editor-in-chief for Hematology News.

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The COVID-19 pandemic is putting a strain on the blood supply and could be putting people – including those who normally get transfusions, such as patients with sickle cell disease and cancer – at risk.

Osunkwo_Ifeyinwa_Ify NC_web.jpg
Dr. Ifeyinwa (Ify) Osunkwo

“Around the beginning of March, the hematology community got wind of what was going on because the blood banks were saying think about your patients and begin to restrict blood usage because we are expecting an increase in usage for COVID-positive ICU patients,” Ifeyinwa (Ify) Osunkwo, MD, a specialist in hematology and sickle cell disease at Levine Cancer Institute in Charlotte, N.C., said in an interview.

“I think that was the first call to arms around hematology ... you don’t want to shortchange somebody who is well and who is being sustained by life-giving transfusions and cut out their transfusion therapy because you are hoping to use the blood for people who are coming in with COVID-19,” she continued. “That is an ethical dilemma that no doctor wants to have to go through. But the reality is we have to do something to make it work for everybody.”

And the timing of the social restrictions due to the pandemic has added additional strain on the blood supply.

“Over the winter, traditionally, blood drives slow down because of the flu and different viruses,” she noted. “The spring and the summer are when we see the biggest recruitment and uptake of blood donation. COVID-19 hit [and] a lot of the blood drives that were traditionally scheduled to supply blood for the country have been canceled because of the new guidance for social distancing.”

Another big source of blood are health care professionals themselves and they may not be able to donate because of the extra hours being worked because of the pandemic.

In speaking about the needs for traditional patients such as those who are dealing with cancer or leukemia or sickle cell diseases as well as those who are being treated for COVID-19 in North Carolina, “we are not at the critical point, but I am a little bit nervous that we may get there because they are not going to up the usual blood drives anytime this summer. We project [sometime] in the fall, but maybe not even then. So there needs to be a significant call-out for people to make every effort to donate blood,” said Dr. Osunkwo. She added that in places such as New York City that are hot spots for the COVID-19 outbreak, the need is likely a lot greater.

She recalled a recent incident at a New York hospital that highlighted how those managing blood supplies are being restrictive and how this could be harming patients.

“A sickle cell patient came in with COVID-19 and the treatment recommendation was do a red blood cell exchange but the blood bank was nervous about getting enough blood to supply for that exchange transfusion,” she said, noting that the doctor still went to bat for that patient to get the needed treatment. “We gave her the supporting evidence that when you are on treatment for sickle cell disease, you tend to do better if you get COVID-19 or any other viral infection. The symptoms of COVID-19 in sickle cell disease is acute chest syndrome, for which the treatment is red blood cell exchange. Not doing that for [these patients] is really not giving them the optimal way of managing their disease, and managing their disease in the setting of COVID-19.”

To that end, Dr. Osunkwo stressed that doctors need to be doing all they can to get the word out that blood is needed and that the American Red Cross and other donation organizations are making it safe for people to donate. She has been using social media to highlight when her fellow doctors and others make donations as a way to motivate individuals.

“Everybody can do something during this pandemic,” she said. “Don’t feel like you are not working, that you are not a frontline worker, that you have nothing to contribute. You can donate blood. Your cousin can donate blood. You can tell your friends, your neighbors, your relatives, your enemies to go donate. We will take every kind of blood we can get because people are needing it more now. Even though we canceled elective surgeries, my patients when they get COVID-19, they need more blood ... than they usually do during their regular sickle cell admission. It is going to be the same for people who have other blood disorders like cancer and leukemia. We can’t stop life-saving treatments just because we have the COVID pandemic.”

Dr. Osunkwo also praised recent actions taken by the Food and Drug Administration to lessen some of the deferral periods for when an individual can donate.

The FDA on April 2 issued three sets of revised recommendations aimed at getting more people eligible to donate blood. All of the revised recommendations will remain in effect after the COVID-19 health emergency is declared over.

The first revised recommendation makes changes to December 2015 guidance.

For male blood donors who would have been deferred for having sex with another male partner, the deferral period has been reduced from 12 months to 3 months. That deferral period change also applies to female donors who had sex with a man who had sex with another man as well as for those with recent tattoos and piercings.

The second recommendation revises guidance from August 2013 and relates to the risk of transfusion-transmitted malaria.

Under the new recommendations, for those who traveled to malaria-endemic areas (and are residents of malaria non-endemic countries), the FDA is lowering the recommended deferral period from 12 months to 3 months, and also provides notices of an alternate procedure that permits donations without a deferral period provided the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The third recommendation finalizes draft guidance from January that eliminates the referral period for donors who spent time in certain European countries or were on military bases in Europe and were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.

Dr. Osunkwo reports consultancy and being on the speakers bureau and participating in the advisory board for Novartis, and relationships with a variety of other pharmaceutical companies. She is the editor-in-chief for Hematology News.

The COVID-19 pandemic is putting a strain on the blood supply and could be putting people – including those who normally get transfusions, such as patients with sickle cell disease and cancer – at risk.

Osunkwo_Ifeyinwa_Ify NC_web.jpg
Dr. Ifeyinwa (Ify) Osunkwo

“Around the beginning of March, the hematology community got wind of what was going on because the blood banks were saying think about your patients and begin to restrict blood usage because we are expecting an increase in usage for COVID-positive ICU patients,” Ifeyinwa (Ify) Osunkwo, MD, a specialist in hematology and sickle cell disease at Levine Cancer Institute in Charlotte, N.C., said in an interview.

“I think that was the first call to arms around hematology ... you don’t want to shortchange somebody who is well and who is being sustained by life-giving transfusions and cut out their transfusion therapy because you are hoping to use the blood for people who are coming in with COVID-19,” she continued. “That is an ethical dilemma that no doctor wants to have to go through. But the reality is we have to do something to make it work for everybody.”

And the timing of the social restrictions due to the pandemic has added additional strain on the blood supply.

“Over the winter, traditionally, blood drives slow down because of the flu and different viruses,” she noted. “The spring and the summer are when we see the biggest recruitment and uptake of blood donation. COVID-19 hit [and] a lot of the blood drives that were traditionally scheduled to supply blood for the country have been canceled because of the new guidance for social distancing.”

Another big source of blood are health care professionals themselves and they may not be able to donate because of the extra hours being worked because of the pandemic.

In speaking about the needs for traditional patients such as those who are dealing with cancer or leukemia or sickle cell diseases as well as those who are being treated for COVID-19 in North Carolina, “we are not at the critical point, but I am a little bit nervous that we may get there because they are not going to up the usual blood drives anytime this summer. We project [sometime] in the fall, but maybe not even then. So there needs to be a significant call-out for people to make every effort to donate blood,” said Dr. Osunkwo. She added that in places such as New York City that are hot spots for the COVID-19 outbreak, the need is likely a lot greater.

She recalled a recent incident at a New York hospital that highlighted how those managing blood supplies are being restrictive and how this could be harming patients.

“A sickle cell patient came in with COVID-19 and the treatment recommendation was do a red blood cell exchange but the blood bank was nervous about getting enough blood to supply for that exchange transfusion,” she said, noting that the doctor still went to bat for that patient to get the needed treatment. “We gave her the supporting evidence that when you are on treatment for sickle cell disease, you tend to do better if you get COVID-19 or any other viral infection. The symptoms of COVID-19 in sickle cell disease is acute chest syndrome, for which the treatment is red blood cell exchange. Not doing that for [these patients] is really not giving them the optimal way of managing their disease, and managing their disease in the setting of COVID-19.”

To that end, Dr. Osunkwo stressed that doctors need to be doing all they can to get the word out that blood is needed and that the American Red Cross and other donation organizations are making it safe for people to donate. She has been using social media to highlight when her fellow doctors and others make donations as a way to motivate individuals.

“Everybody can do something during this pandemic,” she said. “Don’t feel like you are not working, that you are not a frontline worker, that you have nothing to contribute. You can donate blood. Your cousin can donate blood. You can tell your friends, your neighbors, your relatives, your enemies to go donate. We will take every kind of blood we can get because people are needing it more now. Even though we canceled elective surgeries, my patients when they get COVID-19, they need more blood ... than they usually do during their regular sickle cell admission. It is going to be the same for people who have other blood disorders like cancer and leukemia. We can’t stop life-saving treatments just because we have the COVID pandemic.”

Dr. Osunkwo also praised recent actions taken by the Food and Drug Administration to lessen some of the deferral periods for when an individual can donate.

The FDA on April 2 issued three sets of revised recommendations aimed at getting more people eligible to donate blood. All of the revised recommendations will remain in effect after the COVID-19 health emergency is declared over.

The first revised recommendation makes changes to December 2015 guidance.

For male blood donors who would have been deferred for having sex with another male partner, the deferral period has been reduced from 12 months to 3 months. That deferral period change also applies to female donors who had sex with a man who had sex with another man as well as for those with recent tattoos and piercings.

The second recommendation revises guidance from August 2013 and relates to the risk of transfusion-transmitted malaria.

Under the new recommendations, for those who traveled to malaria-endemic areas (and are residents of malaria non-endemic countries), the FDA is lowering the recommended deferral period from 12 months to 3 months, and also provides notices of an alternate procedure that permits donations without a deferral period provided the blood components are pathogen-reduced using an FDA-approved pathogen reduction device.

The third recommendation finalizes draft guidance from January that eliminates the referral period for donors who spent time in certain European countries or were on military bases in Europe and were previously considered to have been exposed to a potential risk of transmission of Creutzfeldt-Jakob Disease or Variant Creutzfeldt-Jakob Disease.

Dr. Osunkwo reports consultancy and being on the speakers bureau and participating in the advisory board for Novartis, and relationships with a variety of other pharmaceutical companies. She is the editor-in-chief for Hematology News.

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CMS implements temporary regulatory changes to aid COVID-19 response

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Thu, 08/26/2021 - 16:15

 

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

Verma_Seema_web.3.jpg
Seema Verma

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” the CMS stated in a fact sheet highlighting the regulatory changes.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

For Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

In addition, CMS is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet. Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements and allowing greater use of verbal orders so that clinicians can spend more time on direct patient care.

Another change announced deals with the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Clinicians affected by the pandemic can request reweighting of the MIPS performance categories for the 2019 performance year, which will allow clinicians who are unable to submit MIPS data in the current submission period to request reweighting and receive a neutral payment adjustment in the 2021 payment year.

CMS also added an option for calendar year 2020 in the improvement activity category. Clinicians will receive credit if they are participating in a clinical trial that uses a drug or biological product to treat a COVID-19 patient and they report the findings to a clinical trial repository or registry.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including ED visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

CMS noted that providers can report telehealth for new and established patients, even if the billing code is specific for established patients only. CMS also has removed requirements regarding documentation of medical history and/or physical examination in the medical records during the COVID-19 crisis to help facilitate the use of telehealth for evaluation and management visits.

To help practices financially, providers who participate in Medicare fee-for-service will be able to request up to a 100% advance on their Medicare payments for a 3-month period. Repayment begins 120 days after the advance payment is received and must be paid within 210 days of the payment. Repayment will be automatically deducted from claims processed.

The agency also included new exceptions to the Stark Law. Some examples include the ability for hospitals to pay above or below fair market value to rent equipment or receive services from physicians and the allowance of health care providers to provide financial assistance to each other to ensure continuity of operations.

*This story was updated on 4/17/2020.

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The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

Verma_Seema_web.3.jpg
Seema Verma

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” the CMS stated in a fact sheet highlighting the regulatory changes.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

For Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

In addition, CMS is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet. Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements and allowing greater use of verbal orders so that clinicians can spend more time on direct patient care.

Another change announced deals with the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Clinicians affected by the pandemic can request reweighting of the MIPS performance categories for the 2019 performance year, which will allow clinicians who are unable to submit MIPS data in the current submission period to request reweighting and receive a neutral payment adjustment in the 2021 payment year.

CMS also added an option for calendar year 2020 in the improvement activity category. Clinicians will receive credit if they are participating in a clinical trial that uses a drug or biological product to treat a COVID-19 patient and they report the findings to a clinical trial repository or registry.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including ED visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

CMS noted that providers can report telehealth for new and established patients, even if the billing code is specific for established patients only. CMS also has removed requirements regarding documentation of medical history and/or physical examination in the medical records during the COVID-19 crisis to help facilitate the use of telehealth for evaluation and management visits.

To help practices financially, providers who participate in Medicare fee-for-service will be able to request up to a 100% advance on their Medicare payments for a 3-month period. Repayment begins 120 days after the advance payment is received and must be paid within 210 days of the payment. Repayment will be automatically deducted from claims processed.

The agency also included new exceptions to the Stark Law. Some examples include the ability for hospitals to pay above or below fair market value to rent equipment or receive services from physicians and the allowance of health care providers to provide financial assistance to each other to ensure continuity of operations.

*This story was updated on 4/17/2020.

 

The Centers for Medicare & Medicaid Services has announced a wide range of temporary regulatory moves aimed at helping hospitals and health systems handle the surge of COVID-19 patients.

Verma_Seema_web.3.jpg
Seema Verma

“We are waiving a wide and unprecedented range of regulatory requirements to equip the American health care system with maximum flexibility to deal with an influx of cases,” CMS Administrator Seema Verma said during a March 30 conference call with reporters. “Many health care systems may not need these waivers and they shouldn’t use them if the situation doesn’t warrant it. But the flexibilities are there if it does. At a time of crisis, no regulatory barriers should stand in the way of patient care.”

Among the changes is an expansion of the venues in which health care systems and hospitals can provide services.

Federal regulations call for hospitals to provide services within their own buildings, raising concerns as to whether there will be enough capacity to handle the anticipated COVID-19 caseload.

“Under CMS’s temporary new rules, hospitals will be able to transfer patients to outside facilities, such as ambulatory surgery centers, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving hospital payments under Medicare,” the CMS stated in a fact sheet highlighting the regulatory changes.

Ambulatory surgery centers will have the option to contract with local health care systems to provide hospital services or they can enroll and bill as hospitals during the emergency, the fact sheet noted. They will be able to perform hospital services such as cancer procedures, trauma surgeries, and other essential surgeries.

CMS also is waiving the limit on the number of beds a doctor-owned hospital can have.

For Medicare patients who may be homebound, CMS will now pay for a laboratory technician to make a home visit to collect a specimen for COVID-19 testing, and hospitals will be able to conduct testing in homes or other community-based settings under certain circumstances.

In addition, CMS is taking actions aimed at expanding the health care workforce.

For instance, the agency is issuing a “blanket waiver” that allows hospitals to provide benefits to medical staff, including multiple daily meals, laundry service for personal clothing, or child care services while the staff is at the hospital providing patient care, according to the fact sheet. Teaching hospitals will also receive more flexibility in using residents to provide health care services under the virtual direction of a teaching physician, who may be available through audio/video technology.

CMS also is temporarily eliminating paperwork requirements and allowing greater use of verbal orders so that clinicians can spend more time on direct patient care.

Another change announced deals with the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Clinicians affected by the pandemic can request reweighting of the MIPS performance categories for the 2019 performance year, which will allow clinicians who are unable to submit MIPS data in the current submission period to request reweighting and receive a neutral payment adjustment in the 2021 payment year.

CMS also added an option for calendar year 2020 in the improvement activity category. Clinicians will receive credit if they are participating in a clinical trial that uses a drug or biological product to treat a COVID-19 patient and they report the findings to a clinical trial repository or registry.

On the device/equipment side, Medicare will cover respiratory-related devices and equipment “for any medical reason determined by clinicians,” according to the fact sheet, rather than only under certain circumstances.

And on the telehealth side, CMS is expanding the number of services that it will pay for via telehealth by more than 80, including ED visits, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth. CMS will allow the use of commonly available interactive apps with audio and video, as well as audio-only phones.

CMS noted that providers can report telehealth for new and established patients, even if the billing code is specific for established patients only. CMS also has removed requirements regarding documentation of medical history and/or physical examination in the medical records during the COVID-19 crisis to help facilitate the use of telehealth for evaluation and management visits.

To help practices financially, providers who participate in Medicare fee-for-service will be able to request up to a 100% advance on their Medicare payments for a 3-month period. Repayment begins 120 days after the advance payment is received and must be paid within 210 days of the payment. Repayment will be automatically deducted from claims processed.

The agency also included new exceptions to the Stark Law. Some examples include the ability for hospitals to pay above or below fair market value to rent equipment or receive services from physicians and the allowance of health care providers to provide financial assistance to each other to ensure continuity of operations.

*This story was updated on 4/17/2020.

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ABIM grants MOC extension

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Thu, 08/26/2021 - 16:15

 

Physicians will not lose their certification if they are unable to complete maintenance of certification requirements in 2020, the American Board of Internal Medicine announced.

“Any physician who is currently certified and has a Maintenance of Certification requirement due in 2020 – including an assessment, point requirement or attestation – will now have until the end of 2021 to complete it,” ABIM President Richard Baron, MD, said in a letter sent to all diplomates.

Additionally, physicians “currently in their grace year will also be afforded an additional grace year in 2021,” the letter continued.

ABIM noted that many assessments were planned for the fall of 2020 and the organization will continue to offer them as planned for physicians who are able to take them. It added that more assessment dates for 2020 and 2021 will be sent out later this year.

“The next few weeks and months will challenge our health care system and country like never before,” Dr. Baron stated. “Our many internal medicine colleagues – and the clinical teams that support them – have been heroic in their response, often selflessly putting their own personal safety at risk while using their superb skills to provide care for others. They have inspired all of us.”

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Physicians will not lose their certification if they are unable to complete maintenance of certification requirements in 2020, the American Board of Internal Medicine announced.

“Any physician who is currently certified and has a Maintenance of Certification requirement due in 2020 – including an assessment, point requirement or attestation – will now have until the end of 2021 to complete it,” ABIM President Richard Baron, MD, said in a letter sent to all diplomates.

Additionally, physicians “currently in their grace year will also be afforded an additional grace year in 2021,” the letter continued.

ABIM noted that many assessments were planned for the fall of 2020 and the organization will continue to offer them as planned for physicians who are able to take them. It added that more assessment dates for 2020 and 2021 will be sent out later this year.

“The next few weeks and months will challenge our health care system and country like never before,” Dr. Baron stated. “Our many internal medicine colleagues – and the clinical teams that support them – have been heroic in their response, often selflessly putting their own personal safety at risk while using their superb skills to provide care for others. They have inspired all of us.”

 

Physicians will not lose their certification if they are unable to complete maintenance of certification requirements in 2020, the American Board of Internal Medicine announced.

“Any physician who is currently certified and has a Maintenance of Certification requirement due in 2020 – including an assessment, point requirement or attestation – will now have until the end of 2021 to complete it,” ABIM President Richard Baron, MD, said in a letter sent to all diplomates.

Additionally, physicians “currently in their grace year will also be afforded an additional grace year in 2021,” the letter continued.

ABIM noted that many assessments were planned for the fall of 2020 and the organization will continue to offer them as planned for physicians who are able to take them. It added that more assessment dates for 2020 and 2021 will be sent out later this year.

“The next few weeks and months will challenge our health care system and country like never before,” Dr. Baron stated. “Our many internal medicine colleagues – and the clinical teams that support them – have been heroic in their response, often selflessly putting their own personal safety at risk while using their superb skills to provide care for others. They have inspired all of us.”

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