Mixed Topics

A simple blood test, claimed to detect more than 50 types of cancer, will be used in a pilot trial by National Health Service England in a bid to increase rates of early-stage diagnosis, in particular for cancers that are currently difficult to diagnose.

“Early detection, particularly for hard-to-treat conditions like ovarian and pancreatic cancer, has the potential to save many lives,” said NHS Chief Executive Sir Simon Stevens in a statement.

The pilot trial will use the Galleri blood test, developed by Grail. Sir Stevens described the blood test as “promising” and said it could “be a game changer in cancer care, helping thousands more people to get successful treatment.”

However, some clinicians have expressed concerns over the potential for false-positive results with the test.

Results of a study of the Galleri blood test, published earlier this year, showed that the test detected 50 types of cancer with a specificity of 99.3% and a false positive rate of 0.7%.

It also correctly identified the originating tissue in 90% of cases. However, the sensitivity was lower, at 67%, for the 12 most common cancers, as reported at the time.

The senior author of that study, Michael Seiden, MD, PhD, president of the U.S. Oncology Network, The Woodlands, Tex., noted that it was not a screening study: the test had been used in patients with cancer and in healthy volunteers. He said the test “is intended to be complementary to, and not replace, existing guideline-recommended screening tests and might provide new avenues of investigation for cancers that don’t currently have screening tests.”

The Galleri test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating cell-free DNA in a blood sample.

Several other blood tests for cancer are under development, including the CancerSEEK test, which has been reported to be able to identify eight common cancers. It measures circulating tumor DNA from 16 genes and eight protein biomarkers and then uses machine learning to analyze the data.
 

Improving early detection rates

The pilot trial of the blood test is due to start in mid-2021 and will involve 165,000 people.

The trial will include 140,000 individuals aged 50-79 years who were identified through their health records and who have no cancer symptoms. They will undergo blood tests annually for 3 years and will be referred for investigation if a test result is positive.

A second group will include 25,000 people with potential cancer symptoms. These patients will be offered the blood test to speed up their diagnosis after referral to a hospital via the normal channels.

The results of the pilot are expected in 2023. If successful, the test will be rolled out to 1 million individuals from 2024 to 2025.

The pilot trial is part of the NHS Long Term Plan, which aims to increase early detection of cancer. At present, around half of cancers in England are diagnosed in stage I or II; the NHS aims to increase this to 75% by 2028.

“The NHS has set itself an ambitious target,” commented Peter Johnson, MD, PhD, national clinical director for cancer at NHS England and Improvement.

“Tests like this may help us get there far faster, and I am excited to see how this cutting-edge technology will work out as we test it in clinics across the NHS,” he added.

Lord David Prior, chair of NHS England, noted that almost 200,000 people die from cancer in the United Kingdom every year and that “many of these people are diagnosed too late for treatment to be effective.

“This collaboration between the NHS and Grail offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer,” he said.

However, some clinicians raised potential concerns.

Stephen Duffy, PhD, Center for Cancer Prevention, Queen Mary University of London, described the pilot as “very exciting,” but cautioned: “We will need to find out just how early the test detects cancers and whether it can it be used in a way which minimizes anxiety from false positives.”

Yong-Jie Lu, MD, PhD, also at Queen Mary University of London, said: “It is not clear how early it aims to catch cancer. For a cancer screen test, it needs very high specificity (>99%), otherwise it may end up in a similar situation as the PSA [prostate-specific antigen] test for prostate cancer, or even worse.”

Mangesh Thorat, MD, Cancer Prevention Trials Unit, King’s College London, warned: “It is likely that for every testing round ... there will be about 1,000 false-positive results, and the test may not be able to pinpoint the location of cancer in 3%-4% of those with a true positive result, necessitating a range of imaging and other investigations in these participants.”

No funding for the study has been declared. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A simple blood test, claimed to detect more than 50 types of cancer, will be used in a pilot trial by National Health Service England in a bid to increase rates of early-stage diagnosis, in particular for cancers that are currently difficult to diagnose.

“Early detection, particularly for hard-to-treat conditions like ovarian and pancreatic cancer, has the potential to save many lives,” said NHS Chief Executive Sir Simon Stevens in a statement.

The pilot trial will use the Galleri blood test, developed by Grail. Sir Stevens described the blood test as “promising” and said it could “be a game changer in cancer care, helping thousands more people to get successful treatment.”

However, some clinicians have expressed concerns over the potential for false-positive results with the test.

Results of a study of the Galleri blood test, published earlier this year, showed that the test detected 50 types of cancer with a specificity of 99.3% and a false positive rate of 0.7%.

It also correctly identified the originating tissue in 90% of cases. However, the sensitivity was lower, at 67%, for the 12 most common cancers, as reported at the time.

The senior author of that study, Michael Seiden, MD, PhD, president of the U.S. Oncology Network, The Woodlands, Tex., noted that it was not a screening study: the test had been used in patients with cancer and in healthy volunteers. He said the test “is intended to be complementary to, and not replace, existing guideline-recommended screening tests and might provide new avenues of investigation for cancers that don’t currently have screening tests.”

The Galleri test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating cell-free DNA in a blood sample.

Several other blood tests for cancer are under development, including the CancerSEEK test, which has been reported to be able to identify eight common cancers. It measures circulating tumor DNA from 16 genes and eight protein biomarkers and then uses machine learning to analyze the data.
 

Improving early detection rates

The pilot trial of the blood test is due to start in mid-2021 and will involve 165,000 people.

The trial will include 140,000 individuals aged 50-79 years who were identified through their health records and who have no cancer symptoms. They will undergo blood tests annually for 3 years and will be referred for investigation if a test result is positive.

A second group will include 25,000 people with potential cancer symptoms. These patients will be offered the blood test to speed up their diagnosis after referral to a hospital via the normal channels.

The results of the pilot are expected in 2023. If successful, the test will be rolled out to 1 million individuals from 2024 to 2025.

The pilot trial is part of the NHS Long Term Plan, which aims to increase early detection of cancer. At present, around half of cancers in England are diagnosed in stage I or II; the NHS aims to increase this to 75% by 2028.

“The NHS has set itself an ambitious target,” commented Peter Johnson, MD, PhD, national clinical director for cancer at NHS England and Improvement.

“Tests like this may help us get there far faster, and I am excited to see how this cutting-edge technology will work out as we test it in clinics across the NHS,” he added.

Lord David Prior, chair of NHS England, noted that almost 200,000 people die from cancer in the United Kingdom every year and that “many of these people are diagnosed too late for treatment to be effective.

“This collaboration between the NHS and Grail offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer,” he said.

However, some clinicians raised potential concerns.

Stephen Duffy, PhD, Center for Cancer Prevention, Queen Mary University of London, described the pilot as “very exciting,” but cautioned: “We will need to find out just how early the test detects cancers and whether it can it be used in a way which minimizes anxiety from false positives.”

Yong-Jie Lu, MD, PhD, also at Queen Mary University of London, said: “It is not clear how early it aims to catch cancer. For a cancer screen test, it needs very high specificity (>99%), otherwise it may end up in a similar situation as the PSA [prostate-specific antigen] test for prostate cancer, or even worse.”

Mangesh Thorat, MD, Cancer Prevention Trials Unit, King’s College London, warned: “It is likely that for every testing round ... there will be about 1,000 false-positive results, and the test may not be able to pinpoint the location of cancer in 3%-4% of those with a true positive result, necessitating a range of imaging and other investigations in these participants.”

No funding for the study has been declared. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A simple blood test, claimed to detect more than 50 types of cancer, will be used in a pilot trial by National Health Service England in a bid to increase rates of early-stage diagnosis, in particular for cancers that are currently difficult to diagnose.

“Early detection, particularly for hard-to-treat conditions like ovarian and pancreatic cancer, has the potential to save many lives,” said NHS Chief Executive Sir Simon Stevens in a statement.

The pilot trial will use the Galleri blood test, developed by Grail. Sir Stevens described the blood test as “promising” and said it could “be a game changer in cancer care, helping thousands more people to get successful treatment.”

However, some clinicians have expressed concerns over the potential for false-positive results with the test.

Results of a study of the Galleri blood test, published earlier this year, showed that the test detected 50 types of cancer with a specificity of 99.3% and a false positive rate of 0.7%.

It also correctly identified the originating tissue in 90% of cases. However, the sensitivity was lower, at 67%, for the 12 most common cancers, as reported at the time.

The senior author of that study, Michael Seiden, MD, PhD, president of the U.S. Oncology Network, The Woodlands, Tex., noted that it was not a screening study: the test had been used in patients with cancer and in healthy volunteers. He said the test “is intended to be complementary to, and not replace, existing guideline-recommended screening tests and might provide new avenues of investigation for cancers that don’t currently have screening tests.”

The Galleri test uses next-generation sequencing to analyze the arrangement of methyl groups on circulating cell-free DNA in a blood sample.

Several other blood tests for cancer are under development, including the CancerSEEK test, which has been reported to be able to identify eight common cancers. It measures circulating tumor DNA from 16 genes and eight protein biomarkers and then uses machine learning to analyze the data.
 

Improving early detection rates

The pilot trial of the blood test is due to start in mid-2021 and will involve 165,000 people.

The trial will include 140,000 individuals aged 50-79 years who were identified through their health records and who have no cancer symptoms. They will undergo blood tests annually for 3 years and will be referred for investigation if a test result is positive.

A second group will include 25,000 people with potential cancer symptoms. These patients will be offered the blood test to speed up their diagnosis after referral to a hospital via the normal channels.

The results of the pilot are expected in 2023. If successful, the test will be rolled out to 1 million individuals from 2024 to 2025.

The pilot trial is part of the NHS Long Term Plan, which aims to increase early detection of cancer. At present, around half of cancers in England are diagnosed in stage I or II; the NHS aims to increase this to 75% by 2028.

“The NHS has set itself an ambitious target,” commented Peter Johnson, MD, PhD, national clinical director for cancer at NHS England and Improvement.

“Tests like this may help us get there far faster, and I am excited to see how this cutting-edge technology will work out as we test it in clinics across the NHS,” he added.

Lord David Prior, chair of NHS England, noted that almost 200,000 people die from cancer in the United Kingdom every year and that “many of these people are diagnosed too late for treatment to be effective.

“This collaboration between the NHS and Grail offers the chance for a wide range of cancers to be diagnosed much earlier and could fundamentally change the outlook for people with cancer,” he said.

However, some clinicians raised potential concerns.

Stephen Duffy, PhD, Center for Cancer Prevention, Queen Mary University of London, described the pilot as “very exciting,” but cautioned: “We will need to find out just how early the test detects cancers and whether it can it be used in a way which minimizes anxiety from false positives.”

Yong-Jie Lu, MD, PhD, also at Queen Mary University of London, said: “It is not clear how early it aims to catch cancer. For a cancer screen test, it needs very high specificity (>99%), otherwise it may end up in a similar situation as the PSA [prostate-specific antigen] test for prostate cancer, or even worse.”

Mangesh Thorat, MD, Cancer Prevention Trials Unit, King’s College London, warned: “It is likely that for every testing round ... there will be about 1,000 false-positive results, and the test may not be able to pinpoint the location of cancer in 3%-4% of those with a true positive result, necessitating a range of imaging and other investigations in these participants.”

No funding for the study has been declared. The investigators have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A few years ago, I was asked to give a talk on impostor syndrome at a national conference. My initial thought was “I am not even remotely qualified to give this talk.” Upon reflection, I think that was the first time I acknowledged that I, too, suffer from this syndrome.

There are many definitions and designations (e.g., impostor phenomenon or fraud syndrome), but the one I use most often is high-achieving individuals who are marked by an inability to internalize their accomplishments and a persistent fear of being exposed as a fraud. People with high expressions of this syndrome believe that any success they achieve is due more to luck or error than to personal skill or accomplishment. They live in fear that their incompetence will be exposed and they will be revealed as a fraud both intellectually and within their job or role. First described by Clance and Imes in 1978,¹ the original authors observed that many highly respected and accomplished women did not experience an internal sense of success despite their education and evidence of academic achievement. Based in part on previous observations regarding the differential attribution of success in men and women,² the authors suggested that two general principles were found to be at the heart of this syndrome. The first was that an unexpected performance outcome will be attributed to a temporary cause. The second was that an expected performance outcome will be attributed to a stable cause. As such, the authors originally suggested that women tended to explain failure with lack of ability, whereas men attributed failure to luck or task difficulty. Furthermore, the authors emphasized environmental factors – such as mentorship, competition, and isolation – as the primary influence in the development of these tendencies.

Although originally described in women, this phenomenon can also affect men, as well as a wide variety of people from different occupations and cultures.^3-6 Furthermore, although environmental factors were originally linked as the primary driver of these tendencies, further research has suggested that personality factors play a larger role, and that up to 70% of people may experience this phenomenon in their lifetime.⁷ Personality traits such as perfectionism and neuroticism may be linked to the development of this phenomenon.^3,8

There are several online screening questionnaires that can be used to gauge whether individuals experience some or most of these traits. On one such questionnaire, the Clance IP Scale,⁹ poses such questions as: “I have often succeeded on a test or task even though I was afraid that I would not do well before I undertook the task” and “I am afraid people important to me may find out that I am not as capable as they think I am.” There are 20 questions scored from 1 to 5 and a score of 40 or below suggests few impostor tendencies, while a score of 80 or above suggests the respondent often has intense IP experiences. The higher the score, the more frequently and seriously the impostor syndrome interferes in a person’s life. What is unclear is whether this worsens, improves, or stays the same throughout one’s career. Of interest is that my personal score at this time is 43; however, it would have been 89 had I taken the test during college and medical school. What is unclear to me from the literature is what factors may play a role in a person’s perception of their abilities and their personal confidence over time.

Why is this important? Given that we are all professionals, impostor tendencies appear to have significant impact in the context of our work. This may have impact on us both as employers and as employees.¹⁰ Individuals with impostor syndrome tendencies often characterize themselves negatively and perform poorly on self-appraisals.¹¹ In a study of 201 Belgian white-collar workers, Vergauwe and colleagues found that impostor syndrome tendencies were negatively related to job satisfaction and organizational citizenship behavior; both of which could be influenced by a high degree of social support.¹⁰ Individuals with impostor syndrome tendencies do less career planning, explore career options less frequently, and are less inclined to lead.^12,13 These tendencies can be detrimental as the most qualified people for a position or opportunity may not step forward for consideration. Employers may tend to overlook these individuals for promotions or for pay raises which could negatively influence future earnings. Furthermore, a person may experience increased burnout as they continuously try to overcompensate for what they perceive as their shortcomings. They may feel concerned they are letting others down or not performing to standards. They may derive less enjoyment from life because of the constant focus on feelings of inadequacy.¹⁴ Research along these lines suggest impostor syndrome tendencies can have adverse personal and health-related consequences and may increase social anxiety, depression, and overall psychological distress.^15,16

What do I suggest? It is clear this affects a significant percentage of physicians, health care professionals, and professionals in general. Harboring these tendencies can have a negative impact on health, professional achievement, income, and happiness. It is important to self-reflect, identify if you are at risk, and if so, take the opportunity to explore solutions. My recommendations are:

• Name it: Take the test and see how you score.
• Be mindful: Self-reflection will help you identify the behaviors that are interfering with your happiness and success.
• Write it down: Be strategic and document your plan for success to reinforce your accomplishments.
• Create a feedback group: Friends and colleagues can help to mitigate the negative effects of impostor syndrome tendencies.
• Speak up: Ask for help; coaching has been documented to reduce impostor syndrome scores and help lessen the burden of these tendencies.
• Step out of your comfort zone: Develop a mantra, break bigger challenges into smaller pieces, and acknowledge little wins along the way.

In conclusion, impostor syndrome appears to be highly prevalent in professionals including those of us in medicine. The experience can adversely affect our careers and ability to secure key leadership positions. As managers, we also must keep in mind our role in mentoring others and recognizing the potential impact of impostor syndrome on those who report to us. Recognition of this phenomenon – and understanding of the effects on oneself – is the first step in overcoming the negative effects and moving toward realization of one’s potential.
 

Dr. Brown is a professor of medicine at Wayne State University, division chief of gastroenterology and hepatology at Henry Ford Hospital, and associate medical director at the Henry Ford Hospital Transplant Institute, all in Detroit.

References

1. Clance PR, Imes S. Psychother Theory Res Pract. 1978 Fall;15(3):1-7.

2. Deaux D. In J.H.Harvey, W.J.Ickes and R.F. Kidd (Eds). New directions in attribution research. Vol. 1. New York: Halsted Press Division, Wiley. 1976; p 335-42.

3. Bernard NS et al. J Pers Assess. 2002;78(2):321-33.

4. Topping ME et al. Acad Psychol Bull. 1985;(7):213-26.

5. Langford J et al. Psychotherapy. 1993;30(3):495-501.

6. Chae JH et al. J Pers Assess. 1995;65(3):468-85.

7. Harvey JC et al. If I’m successful, why do I feel like a fake? New York: Random House, 1985.

8. Ross SR et al. Pers Individ Diff. 2001;31:1347-55.

9. Clance PR. The impostor phenomenon: When success makes you feel like a fake. Toronto: Bantam Books, 1985; p 20-2.

10. Vergauwe J et al. J Bus Psychol. 2015;30:565-81.

11. Leary MR et al. J Pers. 2000;68(4):725-56.

12. Neureiter M et al. Front Psychol. 2016;7:48.

13. Neureiter M et al. J Vocat Behav. 2017;98:56-69.

14. Duhigg C. The power of habit: Why we do what we do in life and business. New York: Random House, 2012.

15. Henning K et al. Med Educ. 1998 Sep;32(5):456-64.

16. Oriel K et al. Fam Med. 2004 Apr;36(4):248-52.

17. Zanchetta M et al. Front Psychol. 2020 May 15;11:405.

A few years ago, I was asked to give a talk on impostor syndrome at a national conference. My initial thought was “I am not even remotely qualified to give this talk.” Upon reflection, I think that was the first time I acknowledged that I, too, suffer from this syndrome.

There are many definitions and designations (e.g., impostor phenomenon or fraud syndrome), but the one I use most often is high-achieving individuals who are marked by an inability to internalize their accomplishments and a persistent fear of being exposed as a fraud. People with high expressions of this syndrome believe that any success they achieve is due more to luck or error than to personal skill or accomplishment. They live in fear that their incompetence will be exposed and they will be revealed as a fraud both intellectually and within their job or role. First described by Clance and Imes in 1978,¹ the original authors observed that many highly respected and accomplished women did not experience an internal sense of success despite their education and evidence of academic achievement. Based in part on previous observations regarding the differential attribution of success in men and women,² the authors suggested that two general principles were found to be at the heart of this syndrome. The first was that an unexpected performance outcome will be attributed to a temporary cause. The second was that an expected performance outcome will be attributed to a stable cause. As such, the authors originally suggested that women tended to explain failure with lack of ability, whereas men attributed failure to luck or task difficulty. Furthermore, the authors emphasized environmental factors – such as mentorship, competition, and isolation – as the primary influence in the development of these tendencies.

Although originally described in women, this phenomenon can also affect men, as well as a wide variety of people from different occupations and cultures.^3-6 Furthermore, although environmental factors were originally linked as the primary driver of these tendencies, further research has suggested that personality factors play a larger role, and that up to 70% of people may experience this phenomenon in their lifetime.⁷ Personality traits such as perfectionism and neuroticism may be linked to the development of this phenomenon.^3,8

There are several online screening questionnaires that can be used to gauge whether individuals experience some or most of these traits. On one such questionnaire, the Clance IP Scale,⁹ poses such questions as: “I have often succeeded on a test or task even though I was afraid that I would not do well before I undertook the task” and “I am afraid people important to me may find out that I am not as capable as they think I am.” There are 20 questions scored from 1 to 5 and a score of 40 or below suggests few impostor tendencies, while a score of 80 or above suggests the respondent often has intense IP experiences. The higher the score, the more frequently and seriously the impostor syndrome interferes in a person’s life. What is unclear is whether this worsens, improves, or stays the same throughout one’s career. Of interest is that my personal score at this time is 43; however, it would have been 89 had I taken the test during college and medical school. What is unclear to me from the literature is what factors may play a role in a person’s perception of their abilities and their personal confidence over time.

Why is this important? Given that we are all professionals, impostor tendencies appear to have significant impact in the context of our work. This may have impact on us both as employers and as employees.¹⁰ Individuals with impostor syndrome tendencies often characterize themselves negatively and perform poorly on self-appraisals.¹¹ In a study of 201 Belgian white-collar workers, Vergauwe and colleagues found that impostor syndrome tendencies were negatively related to job satisfaction and organizational citizenship behavior; both of which could be influenced by a high degree of social support.¹⁰ Individuals with impostor syndrome tendencies do less career planning, explore career options less frequently, and are less inclined to lead.^12,13 These tendencies can be detrimental as the most qualified people for a position or opportunity may not step forward for consideration. Employers may tend to overlook these individuals for promotions or for pay raises which could negatively influence future earnings. Furthermore, a person may experience increased burnout as they continuously try to overcompensate for what they perceive as their shortcomings. They may feel concerned they are letting others down or not performing to standards. They may derive less enjoyment from life because of the constant focus on feelings of inadequacy.¹⁴ Research along these lines suggest impostor syndrome tendencies can have adverse personal and health-related consequences and may increase social anxiety, depression, and overall psychological distress.^15,16

What do I suggest? It is clear this affects a significant percentage of physicians, health care professionals, and professionals in general. Harboring these tendencies can have a negative impact on health, professional achievement, income, and happiness. It is important to self-reflect, identify if you are at risk, and if so, take the opportunity to explore solutions. My recommendations are:

• Name it: Take the test and see how you score.
• Be mindful: Self-reflection will help you identify the behaviors that are interfering with your happiness and success.
• Write it down: Be strategic and document your plan for success to reinforce your accomplishments.
• Create a feedback group: Friends and colleagues can help to mitigate the negative effects of impostor syndrome tendencies.
• Speak up: Ask for help; coaching has been documented to reduce impostor syndrome scores and help lessen the burden of these tendencies.
• Step out of your comfort zone: Develop a mantra, break bigger challenges into smaller pieces, and acknowledge little wins along the way.

In conclusion, impostor syndrome appears to be highly prevalent in professionals including those of us in medicine. The experience can adversely affect our careers and ability to secure key leadership positions. As managers, we also must keep in mind our role in mentoring others and recognizing the potential impact of impostor syndrome on those who report to us. Recognition of this phenomenon – and understanding of the effects on oneself – is the first step in overcoming the negative effects and moving toward realization of one’s potential.
 

Dr. Brown is a professor of medicine at Wayne State University, division chief of gastroenterology and hepatology at Henry Ford Hospital, and associate medical director at the Henry Ford Hospital Transplant Institute, all in Detroit.

References

1. Clance PR, Imes S. Psychother Theory Res Pract. 1978 Fall;15(3):1-7.

2. Deaux D. In J.H.Harvey, W.J.Ickes and R.F. Kidd (Eds). New directions in attribution research. Vol. 1. New York: Halsted Press Division, Wiley. 1976; p 335-42.

3. Bernard NS et al. J Pers Assess. 2002;78(2):321-33.

4. Topping ME et al. Acad Psychol Bull. 1985;(7):213-26.

5. Langford J et al. Psychotherapy. 1993;30(3):495-501.

6. Chae JH et al. J Pers Assess. 1995;65(3):468-85.

7. Harvey JC et al. If I’m successful, why do I feel like a fake? New York: Random House, 1985.

8. Ross SR et al. Pers Individ Diff. 2001;31:1347-55.

9. Clance PR. The impostor phenomenon: When success makes you feel like a fake. Toronto: Bantam Books, 1985; p 20-2.

10. Vergauwe J et al. J Bus Psychol. 2015;30:565-81.

11. Leary MR et al. J Pers. 2000;68(4):725-56.

12. Neureiter M et al. Front Psychol. 2016;7:48.

13. Neureiter M et al. J Vocat Behav. 2017;98:56-69.

14. Duhigg C. The power of habit: Why we do what we do in life and business. New York: Random House, 2012.

15. Henning K et al. Med Educ. 1998 Sep;32(5):456-64.

16. Oriel K et al. Fam Med. 2004 Apr;36(4):248-52.

17. Zanchetta M et al. Front Psychol. 2020 May 15;11:405.

A few years ago, I was asked to give a talk on impostor syndrome at a national conference. My initial thought was “I am not even remotely qualified to give this talk.” Upon reflection, I think that was the first time I acknowledged that I, too, suffer from this syndrome.

There are many definitions and designations (e.g., impostor phenomenon or fraud syndrome), but the one I use most often is high-achieving individuals who are marked by an inability to internalize their accomplishments and a persistent fear of being exposed as a fraud. People with high expressions of this syndrome believe that any success they achieve is due more to luck or error than to personal skill or accomplishment. They live in fear that their incompetence will be exposed and they will be revealed as a fraud both intellectually and within their job or role. First described by Clance and Imes in 1978,¹ the original authors observed that many highly respected and accomplished women did not experience an internal sense of success despite their education and evidence of academic achievement. Based in part on previous observations regarding the differential attribution of success in men and women,² the authors suggested that two general principles were found to be at the heart of this syndrome. The first was that an unexpected performance outcome will be attributed to a temporary cause. The second was that an expected performance outcome will be attributed to a stable cause. As such, the authors originally suggested that women tended to explain failure with lack of ability, whereas men attributed failure to luck or task difficulty. Furthermore, the authors emphasized environmental factors – such as mentorship, competition, and isolation – as the primary influence in the development of these tendencies.

Although originally described in women, this phenomenon can also affect men, as well as a wide variety of people from different occupations and cultures.^3-6 Furthermore, although environmental factors were originally linked as the primary driver of these tendencies, further research has suggested that personality factors play a larger role, and that up to 70% of people may experience this phenomenon in their lifetime.⁷ Personality traits such as perfectionism and neuroticism may be linked to the development of this phenomenon.^3,8

There are several online screening questionnaires that can be used to gauge whether individuals experience some or most of these traits. On one such questionnaire, the Clance IP Scale,⁹ poses such questions as: “I have often succeeded on a test or task even though I was afraid that I would not do well before I undertook the task” and “I am afraid people important to me may find out that I am not as capable as they think I am.” There are 20 questions scored from 1 to 5 and a score of 40 or below suggests few impostor tendencies, while a score of 80 or above suggests the respondent often has intense IP experiences. The higher the score, the more frequently and seriously the impostor syndrome interferes in a person’s life. What is unclear is whether this worsens, improves, or stays the same throughout one’s career. Of interest is that my personal score at this time is 43; however, it would have been 89 had I taken the test during college and medical school. What is unclear to me from the literature is what factors may play a role in a person’s perception of their abilities and their personal confidence over time.

Why is this important? Given that we are all professionals, impostor tendencies appear to have significant impact in the context of our work. This may have impact on us both as employers and as employees.¹⁰ Individuals with impostor syndrome tendencies often characterize themselves negatively and perform poorly on self-appraisals.¹¹ In a study of 201 Belgian white-collar workers, Vergauwe and colleagues found that impostor syndrome tendencies were negatively related to job satisfaction and organizational citizenship behavior; both of which could be influenced by a high degree of social support.¹⁰ Individuals with impostor syndrome tendencies do less career planning, explore career options less frequently, and are less inclined to lead.^12,13 These tendencies can be detrimental as the most qualified people for a position or opportunity may not step forward for consideration. Employers may tend to overlook these individuals for promotions or for pay raises which could negatively influence future earnings. Furthermore, a person may experience increased burnout as they continuously try to overcompensate for what they perceive as their shortcomings. They may feel concerned they are letting others down or not performing to standards. They may derive less enjoyment from life because of the constant focus on feelings of inadequacy.¹⁴ Research along these lines suggest impostor syndrome tendencies can have adverse personal and health-related consequences and may increase social anxiety, depression, and overall psychological distress.^15,16

What do I suggest? It is clear this affects a significant percentage of physicians, health care professionals, and professionals in general. Harboring these tendencies can have a negative impact on health, professional achievement, income, and happiness. It is important to self-reflect, identify if you are at risk, and if so, take the opportunity to explore solutions. My recommendations are:

• Name it: Take the test and see how you score.
• Be mindful: Self-reflection will help you identify the behaviors that are interfering with your happiness and success.
• Write it down: Be strategic and document your plan for success to reinforce your accomplishments.
• Create a feedback group: Friends and colleagues can help to mitigate the negative effects of impostor syndrome tendencies.
• Speak up: Ask for help; coaching has been documented to reduce impostor syndrome scores and help lessen the burden of these tendencies.
• Step out of your comfort zone: Develop a mantra, break bigger challenges into smaller pieces, and acknowledge little wins along the way.

In conclusion, impostor syndrome appears to be highly prevalent in professionals including those of us in medicine. The experience can adversely affect our careers and ability to secure key leadership positions. As managers, we also must keep in mind our role in mentoring others and recognizing the potential impact of impostor syndrome on those who report to us. Recognition of this phenomenon – and understanding of the effects on oneself – is the first step in overcoming the negative effects and moving toward realization of one’s potential.
 

Dr. Brown is a professor of medicine at Wayne State University, division chief of gastroenterology and hepatology at Henry Ford Hospital, and associate medical director at the Henry Ford Hospital Transplant Institute, all in Detroit.

References

1. Clance PR, Imes S. Psychother Theory Res Pract. 1978 Fall;15(3):1-7.

2. Deaux D. In J.H.Harvey, W.J.Ickes and R.F. Kidd (Eds). New directions in attribution research. Vol. 1. New York: Halsted Press Division, Wiley. 1976; p 335-42.

3. Bernard NS et al. J Pers Assess. 2002;78(2):321-33.

4. Topping ME et al. Acad Psychol Bull. 1985;(7):213-26.

5. Langford J et al. Psychotherapy. 1993;30(3):495-501.

6. Chae JH et al. J Pers Assess. 1995;65(3):468-85.

7. Harvey JC et al. If I’m successful, why do I feel like a fake? New York: Random House, 1985.

8. Ross SR et al. Pers Individ Diff. 2001;31:1347-55.

9. Clance PR. The impostor phenomenon: When success makes you feel like a fake. Toronto: Bantam Books, 1985; p 20-2.

10. Vergauwe J et al. J Bus Psychol. 2015;30:565-81.

11. Leary MR et al. J Pers. 2000;68(4):725-56.

12. Neureiter M et al. Front Psychol. 2016;7:48.

13. Neureiter M et al. J Vocat Behav. 2017;98:56-69.

14. Duhigg C. The power of habit: Why we do what we do in life and business. New York: Random House, 2012.

15. Henning K et al. Med Educ. 1998 Sep;32(5):456-64.

16. Oriel K et al. Fam Med. 2004 Apr;36(4):248-52.

17. Zanchetta M et al. Front Psychol. 2020 May 15;11:405.

Some who read Federal Practitioner regularly may recall that since 2017, I have been dedicating the December and January editorials to a more substantive version of the popular best and worst awards that appear in the media this time of year. Everything from the most comfortable slippers to the weirdest lawsuits is scored annually. In an effort to elevate the ranking routine, this column has reviewed and evaluated ethical and unethical events and decisions in the 3 federal health care systems Federal Practitioner primarily serves. In previous years it was a challenge requiring research and deliberation to select the most inspiring and troubling occurrences in the world of federal health care. This year neither great effort or prolonged study was required as the choice was immediate and obvious—the year itself. A year in which our individual identities as health care professionals serving in the US Department of Defense, US Department of Veterans Affairs (VA), and US Public Health Service is subsumed in our realities as citizens of a nation in crisis.

The opening lines of A Tale of Two Cities have become such a literary platitude taken out of the context of the novel that the terror and fascination with which Dickens wrote these oft-quoted lines has been diluted and dulled.¹ In citing the entire paragraph as the epigraph, I hope to recapture the moral seriousness of its message, which is so relevant in 2020. While protesting the widespread injustice that fueled the progress of London’s industrial revolution, Dickens also feared such discontent would ignite a bloody uprising as it had done in Paris.¹ This passage is a classic example of the literary device of parallelism that so perfectly expressed Dickens’ reflections on the trajectory of the unprecedented historical impact of the French Revolution. A parallelism that also aptly captures the contemporary contrasts and comparisons of the best and worst of 2020.

It is estimated that at least 66% of those eligible to vote did so on November 3, 2020, the highest turnout in more than a century, demonstrating the strength of the United States as a representative democracy.² It is not about partisan politics, it is that more than 150 million citizens braved the winter, the virus, and potential intimidation to cast a ballot for their values.³ Still, America has never been more divided, and Dickens’ fear of political upheaval has never been more real in our country, or at least since the Civil War.

As I write this editorial, manufacturers for 2 vaccines have submitted phase 3 trial data to the US Food and Drug Administration for Emergency Use Authorizations and a third consortium may follow suit soon. Scientists report that the 2 vaccines, which were developed in less than a year, have high efficacy rates (> 90%) with only modest adverse effects.⁴ It is an unparalleled, really unimaginable, scientific feat. Americans’ characteristic gift for logistical efficiency and scientific innovation faces daunting administrative and technical barriers to achieve a similar viral victory, yet we may have faced even more formidable odds in World War II.

As of December 4, 2020, Johns Hopkins University reports that more than 275,000 Americans have died of coronavirus.⁵ The United States is on track to reach 200,000 cases a day with the signature holiday season of family festivities brutally morphed into gatherings of contagion.⁶ Hospitals across the country are running out of intensive care beds and nurses and doctors to staff them. Unlike the Spring surge in the Northeast, cases are rising in 49 states, and there is nowhere in the land from which respite and reinforcements can come.⁷

Thousands of health care professionals are exhausted, many with COVID-19 or recovering from it, morally distressed, and emotionally spent. Masks and social distancing are no longer public health essentials but elements of a culture war. Those same nurses, doctors, and public health officers still show up day after night for what is much closer to war than work. They struggle to prevent patients from going on ventilators they may never come off and use the few available therapies to keep as many patients alive as possible—whether those patients believe in COVID-19, wore a mask, no matter who they voted for—because that is what it means to practice health care according to a code of ethics.

In March 2020, I pledged to devote every editorial to COVID-19 for as long as the pandemic lasted, as one small candle for all those who have died of COVID-19, who are suffering as survivors of it, and who take risks and labor to deliver essential services from groceries to intensive care. Prudent public health officials wisely advise that the vaccine(s) are not a miracle cure to revive a depleted country, in part because it may undermine life-saving public health measures.⁸ And so the columns will continue in 2021 to illuminate the ethical issues of the pandemic as they affect all of us as federal health care professionals and Americans.

The Tale of Two Cities chapter that begins with the “best of times, and the worst of times” is entitled “Recalled to Life.” Let that be our hope and prayer for the coming year.

Some who read Federal Practitioner regularly may recall that since 2017, I have been dedicating the December and January editorials to a more substantive version of the popular best and worst awards that appear in the media this time of year. Everything from the most comfortable slippers to the weirdest lawsuits is scored annually. In an effort to elevate the ranking routine, this column has reviewed and evaluated ethical and unethical events and decisions in the 3 federal health care systems Federal Practitioner primarily serves. In previous years it was a challenge requiring research and deliberation to select the most inspiring and troubling occurrences in the world of federal health care. This year neither great effort or prolonged study was required as the choice was immediate and obvious—the year itself. A year in which our individual identities as health care professionals serving in the US Department of Defense, US Department of Veterans Affairs (VA), and US Public Health Service is subsumed in our realities as citizens of a nation in crisis.

The opening lines of A Tale of Two Cities have become such a literary platitude taken out of the context of the novel that the terror and fascination with which Dickens wrote these oft-quoted lines has been diluted and dulled.¹ In citing the entire paragraph as the epigraph, I hope to recapture the moral seriousness of its message, which is so relevant in 2020. While protesting the widespread injustice that fueled the progress of London’s industrial revolution, Dickens also feared such discontent would ignite a bloody uprising as it had done in Paris.¹ This passage is a classic example of the literary device of parallelism that so perfectly expressed Dickens’ reflections on the trajectory of the unprecedented historical impact of the French Revolution. A parallelism that also aptly captures the contemporary contrasts and comparisons of the best and worst of 2020.

It is estimated that at least 66% of those eligible to vote did so on November 3, 2020, the highest turnout in more than a century, demonstrating the strength of the United States as a representative democracy.² It is not about partisan politics, it is that more than 150 million citizens braved the winter, the virus, and potential intimidation to cast a ballot for their values.³ Still, America has never been more divided, and Dickens’ fear of political upheaval has never been more real in our country, or at least since the Civil War.

As I write this editorial, manufacturers for 2 vaccines have submitted phase 3 trial data to the US Food and Drug Administration for Emergency Use Authorizations and a third consortium may follow suit soon. Scientists report that the 2 vaccines, which were developed in less than a year, have high efficacy rates (> 90%) with only modest adverse effects.⁴ It is an unparalleled, really unimaginable, scientific feat. Americans’ characteristic gift for logistical efficiency and scientific innovation faces daunting administrative and technical barriers to achieve a similar viral victory, yet we may have faced even more formidable odds in World War II.

As of December 4, 2020, Johns Hopkins University reports that more than 275,000 Americans have died of coronavirus.⁵ The United States is on track to reach 200,000 cases a day with the signature holiday season of family festivities brutally morphed into gatherings of contagion.⁶ Hospitals across the country are running out of intensive care beds and nurses and doctors to staff them. Unlike the Spring surge in the Northeast, cases are rising in 49 states, and there is nowhere in the land from which respite and reinforcements can come.⁷

Thousands of health care professionals are exhausted, many with COVID-19 or recovering from it, morally distressed, and emotionally spent. Masks and social distancing are no longer public health essentials but elements of a culture war. Those same nurses, doctors, and public health officers still show up day after night for what is much closer to war than work. They struggle to prevent patients from going on ventilators they may never come off and use the few available therapies to keep as many patients alive as possible—whether those patients believe in COVID-19, wore a mask, no matter who they voted for—because that is what it means to practice health care according to a code of ethics.

In March 2020, I pledged to devote every editorial to COVID-19 for as long as the pandemic lasted, as one small candle for all those who have died of COVID-19, who are suffering as survivors of it, and who take risks and labor to deliver essential services from groceries to intensive care. Prudent public health officials wisely advise that the vaccine(s) are not a miracle cure to revive a depleted country, in part because it may undermine life-saving public health measures.⁸ And so the columns will continue in 2021 to illuminate the ethical issues of the pandemic as they affect all of us as federal health care professionals and Americans.

The Tale of Two Cities chapter that begins with the “best of times, and the worst of times” is entitled “Recalled to Life.” Let that be our hope and prayer for the coming year.

Some who read Federal Practitioner regularly may recall that since 2017, I have been dedicating the December and January editorials to a more substantive version of the popular best and worst awards that appear in the media this time of year. Everything from the most comfortable slippers to the weirdest lawsuits is scored annually. In an effort to elevate the ranking routine, this column has reviewed and evaluated ethical and unethical events and decisions in the 3 federal health care systems Federal Practitioner primarily serves. In previous years it was a challenge requiring research and deliberation to select the most inspiring and troubling occurrences in the world of federal health care. This year neither great effort or prolonged study was required as the choice was immediate and obvious—the year itself. A year in which our individual identities as health care professionals serving in the US Department of Defense, US Department of Veterans Affairs (VA), and US Public Health Service is subsumed in our realities as citizens of a nation in crisis.

The opening lines of A Tale of Two Cities have become such a literary platitude taken out of the context of the novel that the terror and fascination with which Dickens wrote these oft-quoted lines has been diluted and dulled.¹ In citing the entire paragraph as the epigraph, I hope to recapture the moral seriousness of its message, which is so relevant in 2020. While protesting the widespread injustice that fueled the progress of London’s industrial revolution, Dickens also feared such discontent would ignite a bloody uprising as it had done in Paris.¹ This passage is a classic example of the literary device of parallelism that so perfectly expressed Dickens’ reflections on the trajectory of the unprecedented historical impact of the French Revolution. A parallelism that also aptly captures the contemporary contrasts and comparisons of the best and worst of 2020.

It is estimated that at least 66% of those eligible to vote did so on November 3, 2020, the highest turnout in more than a century, demonstrating the strength of the United States as a representative democracy.² It is not about partisan politics, it is that more than 150 million citizens braved the winter, the virus, and potential intimidation to cast a ballot for their values.³ Still, America has never been more divided, and Dickens’ fear of political upheaval has never been more real in our country, or at least since the Civil War.

As I write this editorial, manufacturers for 2 vaccines have submitted phase 3 trial data to the US Food and Drug Administration for Emergency Use Authorizations and a third consortium may follow suit soon. Scientists report that the 2 vaccines, which were developed in less than a year, have high efficacy rates (> 90%) with only modest adverse effects.⁴ It is an unparalleled, really unimaginable, scientific feat. Americans’ characteristic gift for logistical efficiency and scientific innovation faces daunting administrative and technical barriers to achieve a similar viral victory, yet we may have faced even more formidable odds in World War II.

As of December 4, 2020, Johns Hopkins University reports that more than 275,000 Americans have died of coronavirus.⁵ The United States is on track to reach 200,000 cases a day with the signature holiday season of family festivities brutally morphed into gatherings of contagion.⁶ Hospitals across the country are running out of intensive care beds and nurses and doctors to staff them. Unlike the Spring surge in the Northeast, cases are rising in 49 states, and there is nowhere in the land from which respite and reinforcements can come.⁷

Thousands of health care professionals are exhausted, many with COVID-19 or recovering from it, morally distressed, and emotionally spent. Masks and social distancing are no longer public health essentials but elements of a culture war. Those same nurses, doctors, and public health officers still show up day after night for what is much closer to war than work. They struggle to prevent patients from going on ventilators they may never come off and use the few available therapies to keep as many patients alive as possible—whether those patients believe in COVID-19, wore a mask, no matter who they voted for—because that is what it means to practice health care according to a code of ethics.

In March 2020, I pledged to devote every editorial to COVID-19 for as long as the pandemic lasted, as one small candle for all those who have died of COVID-19, who are suffering as survivors of it, and who take risks and labor to deliver essential services from groceries to intensive care. Prudent public health officials wisely advise that the vaccine(s) are not a miracle cure to revive a depleted country, in part because it may undermine life-saving public health measures.⁸ And so the columns will continue in 2021 to illuminate the ethical issues of the pandemic as they affect all of us as federal health care professionals and Americans.

The Tale of Two Cities chapter that begins with the “best of times, and the worst of times” is entitled “Recalled to Life.” Let that be our hope and prayer for the coming year.

Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.

Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.

Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.

“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”

He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”

The research was published online Nov. 22 in Clinical Endocrinology.
 

Real-world data will inform clinical practice

Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”

The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.

And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.

“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
 

Don’t discount older patients

The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.

Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”

And “older people may feel that hospital-based obesity services are not for them,” he noted.

To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.

Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).

The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m² (P < .05).

The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.

There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.

Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).

Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.

And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”

The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.

Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”

No funding or relevant financial relationships were declared.

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

Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.

Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.

Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.

“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”

He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”

The research was published online Nov. 22 in Clinical Endocrinology.
 

Real-world data will inform clinical practice

Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”

The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.

And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.

“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
 

Don’t discount older patients

The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.

Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”

And “older people may feel that hospital-based obesity services are not for them,” he noted.

To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.

Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).

The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m² (P < .05).

The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.

There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.

Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).

Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.

And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”

The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.

Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”

No funding or relevant financial relationships were declared.

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

Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.

Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.

Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.

“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”

He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”

The research was published online Nov. 22 in Clinical Endocrinology.
 

Real-world data will inform clinical practice

Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”

The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.

And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.

“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
 

Don’t discount older patients

The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.

Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”

And “older people may feel that hospital-based obesity services are not for them,” he noted.

To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.

Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).

The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m² (P < .05).

The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.

There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.

Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).

Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.

And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”

The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.

Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”

No funding or relevant financial relationships were declared.

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

On Dec. 1, the Centers for Medicare & Medicaid Services (CMS) released the 2021 Medicare Physician Fee Schedule, which finalized proposed changes to Medicare reimbursement rates, including a significant negative budget neutrality adjustment. For hospitalists, the Society of Hospital Medicine estimates that the adjustment will amount to an estimated 8% reduction in Medicare reimbursement rates, which will go into effect on Jan. 1, 2021.

“These cuts are coming at the exact wrong time. During the chaos of 2020, when hospitalists have been essential to responding to the COVID-19 pandemic, they should not be met with a significant pay reduction in 2021,” said Eric E. Howell, MD, MHM, chief executive officer of the Society of Hospital Medicine. “While we at SHM support increasing pay for outpatient primary care, which is driving these cuts, we do not believe now is the right time to make significant adjustments to the Medicare Physician Fee Schedule. We now call on Congress to do the right thing for hospitalists and other frontline providers who have otherwise been lauded as heroes.”

SHM will continue to fight for hospitalists and to advocate to reverse these cuts. To send a message of support to your representatives, visit SHM’s Legislative Action Center and click on “Support the Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020.” To learn more about and become involved with SHM’s advocacy efforts, visit hospitalmedicine.org/advocacy.

On Dec. 1, the Centers for Medicare & Medicaid Services (CMS) released the 2021 Medicare Physician Fee Schedule, which finalized proposed changes to Medicare reimbursement rates, including a significant negative budget neutrality adjustment. For hospitalists, the Society of Hospital Medicine estimates that the adjustment will amount to an estimated 8% reduction in Medicare reimbursement rates, which will go into effect on Jan. 1, 2021.

“These cuts are coming at the exact wrong time. During the chaos of 2020, when hospitalists have been essential to responding to the COVID-19 pandemic, they should not be met with a significant pay reduction in 2021,” said Eric E. Howell, MD, MHM, chief executive officer of the Society of Hospital Medicine. “While we at SHM support increasing pay for outpatient primary care, which is driving these cuts, we do not believe now is the right time to make significant adjustments to the Medicare Physician Fee Schedule. We now call on Congress to do the right thing for hospitalists and other frontline providers who have otherwise been lauded as heroes.”

SHM will continue to fight for hospitalists and to advocate to reverse these cuts. To send a message of support to your representatives, visit SHM’s Legislative Action Center and click on “Support the Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020.” To learn more about and become involved with SHM’s advocacy efforts, visit hospitalmedicine.org/advocacy.

On Dec. 1, the Centers for Medicare & Medicaid Services (CMS) released the 2021 Medicare Physician Fee Schedule, which finalized proposed changes to Medicare reimbursement rates, including a significant negative budget neutrality adjustment. For hospitalists, the Society of Hospital Medicine estimates that the adjustment will amount to an estimated 8% reduction in Medicare reimbursement rates, which will go into effect on Jan. 1, 2021.

“These cuts are coming at the exact wrong time. During the chaos of 2020, when hospitalists have been essential to responding to the COVID-19 pandemic, they should not be met with a significant pay reduction in 2021,” said Eric E. Howell, MD, MHM, chief executive officer of the Society of Hospital Medicine. “While we at SHM support increasing pay for outpatient primary care, which is driving these cuts, we do not believe now is the right time to make significant adjustments to the Medicare Physician Fee Schedule. We now call on Congress to do the right thing for hospitalists and other frontline providers who have otherwise been lauded as heroes.”

SHM will continue to fight for hospitalists and to advocate to reverse these cuts. To send a message of support to your representatives, visit SHM’s Legislative Action Center and click on “Support the Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020.” To learn more about and become involved with SHM’s advocacy efforts, visit hospitalmedicine.org/advocacy.

The coronavirus pandemic has impacted all facets of the education and training of this country’s future hospitalists, including their medical school coursework, elective rotations, clerkships, and residency training – although with variations between settings and localities.

The COVID-19 crisis demanded immediate changes in traditional approaches to medical education. Training programs responded quickly to institute those changes. As hospitals geared up for potential surges in COVID cases starting in mid-March, many onsite training activities for medical students were shut down in order to reserve personal protective equipment for essential personnel and not put learners at risk of catching the virus. A variety of events related to their education were canceled. Didactic presentations and meetings were converted to virtual gatherings on internet platforms such as Zoom. Many of these changes were adopted even in settings with few actual COVID cases.

Medical students on clinical rotations were provided with virtual didactics when in-person clinical experiences were put on hold. In some cases, academic years ended early and fourth-year students graduated early so they might potentially join the hospital work force. Residents’ assignments were also changed, perhaps seeing patients on non–COVID-19 units only or taking different shifts, assignments, or rotations. Public health or research projects replaced elective placements. New electives were created, along with journal clubs, online care conferences, and technology-facilitated, self-directed learning.

But every advancing medical student needs to rotate through an experience of taking care of real patients, said Amy Guiot, MD, MEd, a hospitalist and associate director of medical student education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. “The Liaison Committee of Medical Education, jointly sponsored by the Association of American Medical Colleges and the American Medical Association, will not let you graduate a medical student without actual hands-on encounters with patients,” she explained.

For future doctors, especially those pursuing internal medicine – many of whom will practice as hospitalists – their training can’t duplicate “in the hospital” experiences except in the hospital, said Dr. Guiot, who is involved in pediatric training for medical students from the University of Cincinnati and residents.

For third- and fourth-year medical students, getting that personal contact with patients has been the hardest part, she added. But from March to May 2020, that experience was completely shut down at CCHMC, as at many medical schools, because of precautions aimed at preventing exposure to the novel coronavirus for both students and patients. That meant hospitals had to get creative, reshuffling schedules and the order of learning experiences; converting everything possible to virtual encounters on platforms such as Zoom; and reducing the length of rotations, the total number of in-person encounters, and the number of learners participating in an activity.

“We needed to use shift work for medical students, which hadn’t been done before,” Dr. Guiot said. Having students on different shifts, including nights, created more opportunities to fit clinical experiences into the schedule. The use of standardized patients – actors following a script who are examined by a student as part of learning how to do a physical exam – was also put on hold.

“Now we’re starting to get it back, but maybe not as often,” she said. “The actor wears a mask. The student wears a mask and shield. But it’s been harder for us to find actors – who tend to be older adults who may fear coming to the medical center – to perform their role, teaching medical students the art of examining a patient.”

Back to basics

The COVID-19 pandemic forced medical schools to get back to basics, figuring out the key competencies students needed to learn, said Alison Whelan, MD, AAMC’s chief medical education officer. Both medical schools and residency programs needed to respond quickly and in new ways, including with course content that would teach students about the virus and its management and treatment.

Schools have faced crises before, responding in real time to SARS (severe acute respiratory syndrome), Ebola, HIV, and natural disasters, Dr. Whelan said. “But there was a nimbleness and rapidity of adapting to COVID – with a lot of sharing of curriculums among medical colleges.” Back in late March, AAMC put out guidelines that recommended removing students from direct patient contact – not just for the student’s protection but for the community’s. A subsequent guidance, released Aug. 14, emphasized the need for medical schools to continue medical education – with appropriate attention to safety and local conditions while working closely with clinical partners.

Dr. Guiot, with her colleague Leslie Farrell, MD, and four very creative medical students, developed an online fourth-year elective course for University of Cincinnati medical students, offered asynchronously. It aimed to transmit a comprehensive understanding of COVID-19, its virology, transmission, clinical prevention, diagnosis and treatment, as well as examining national and international responses to the pandemic and their consequences and related issues of race, ethnicity, socioeconomic status, and health disparities. “We used several articles from the Journal of Hospital Medicine for students to read and discuss,” Dr. Guiot said.

Yale School of Medicine/Anthony DeCarlo

Christopher Sankey, MD, SFHM, associate program director of the traditional internal medicine residency program and associate professor of medicine at Yale University, New Haven, Conn., oversees the inpatient educational experience for internal medicine residents at Yale. “As with most programs, there was a lot of trepidation as we made the transition from in-person to virtual education,” he said.

The two principal, non–ward-based educational opportunities for the Yale residents are morning report, which involves a case-based discussion of various medical issues, usually led by a chief resident, and noon conference, which is more didactic and content based. Both made the transition to virtual meetings for residents.

“We wondered, could these still be well-attended, well-liked, and successful learning experiences if offered virtually? What I found when I surveyed our residents was that the virtual conferences were not only well received, but actually preferred,” Dr. Sankey said. “We have a large campus with lots of internal medicine services, so it’s hard to assemble everyone for meetings. There were also situations in which there were so many residents that they couldn’t all fit into the same room.” Zoom, the virtual platform of choice, has actually increased attendance.

Marc Miller, MD, a pediatric hospitalist at the Cleveland Clinic, helped his team develop a virtual curriculum in pediatrics presented to third-year medical students during the month of May, when medical students were being taken off the wards. “Some third-year students still needed to get their pediatric clerkships done. We had to balance clinical exposure with a lot of other things,” he explained.

The curriculum included a focus on interprofessional aspects of interdisciplinary, family-centered bedside rounds; a COVID literature review; and a lot of case-based scenarios. “Most challenging was how to remake family rounds. We tried to incorporate students into table rounds, but that didn’t feel as valuable,” Dr. Miller said. “Because pediatrics is so family centered, talking to patients and families at the bedside is highly valued. So we had virtual sessions talking about how to do that, with videos to illustrate it put out by Cincinnati Children’s Hospital.”

The most interactive sessions got the best feedback, but all the sessions went over very well, Dr. Miller said. “Larger lessons from COVID include things we already knew, but now with extra importance, such as the need to encourage interactivity to get students to buy in and take part in these conversations – whatever the structure.”

Vineet Arora, MD, MHM, an academic hospitalist and chief medical officer for the clinical learning environment at the University of Chicago, said that the changes wrought by COVID have also produced unexpected gains for medical education. “We’ve also had to think differently and more creatively about how to get the same information across in this new environment,” she explained. “In some cases, we saw that it was easier for learners to attend conferences and meetings online, with increased attendance for our events.” That includes participation on quality improvement committees, and attending online medical conferences presented locally and regionally.

“Another question: How do we teach interdisciplinary rounds and how to work with other members of the team without having face-to-face interactions?” Dr. Arora said. “Our old interdisciplinary rounding model had to change. It forced us to rethink how to create that kind of learning. We can’t have as many people in the patient’s room at one time. Can there be a physically distanced ‘touch-base’ with the nurse outside the patient’s room after a doctor has gone in to meet the patient?”

Transformational change

In a recent JAMA Viewpoint column, Catherine R. Lucey, MD, and S. Claiborne Johnston, MD, PhD,¹ called the impact of COVID-19 “transformational,” in line with changes in medical curriculums recommended by the 2010 Global Independent Commission on Education of Health Professionals for the 21st Century,² which asserted that the purpose of professional education is to improve the health of communities.

The authors stated that COVID-19 brought clarity and urgency to this purpose, and will someday be viewed as a catalyst for the needed transformation of medical education as medical schools embarked on curriculum redesign to embrace new competencies for current health challenges.

They suggested that medical students not only continued to learn during the COVID crisis “but in many circumstances, accelerated their attainment of the types of competencies that 21^st century physicians must master.” Emerging competencies identified by Dr. Lucey and Dr. Johnston include:

• Being able to address population and public health issues
• Designing and continuously improving of the health care system
• Incorporating data and technology in service to patient care, research, and education
• Eliminating health care disparities and discrimination in medicine
• Adapting the curriculum to current issues in real-time
• Engaging in crisis communication and active change leadership

How is the curriculum changing? It’s still a work in progress. “After the disruptions of the spring and summer, schools are now trying to figure which of the changes should stay,” said Dr. Whelan. “The virus has also highlighted other crises, with social determinants of health and racial disparities becoming more front and center. In terms of content, medical educators are rethinking a lot of things – in a good way.”

Another important trend cast in sharper relief by the pandemic is a gradual evolution toward competency-based education and how to assess when someone is ready to be a doctor, Dr. Whelan said. “There’s been an accelerated consideration of how to be sure each student is competent to practice medicine.”³

Many practicing physicians and students were redeployed in the crisis, she said. Pediatric physicians were asked to take care of adult patients, and internists were drafted to work in the ICU. Hospitals quickly developed refresher courses and competency-based assessments to facilitate these redeployments. What can be learned from such on-the-fly assessments? What was needed to make a pediatrician, under the supervision of an internist, able to take good care of adult patients?

And does competency-based assessment point toward some kind of time-variable graduate medical education of the future – with graduation when the competencies are achieved, rather than just tethered to time- and case volume–based requirements? It seems Canada is moving in this direction, and COVID might catalyze a similar transformation in the United States.³

Changing the curriculum

Does the content of the curriculum for preparing future hospitalists need to change significantly? “My honest answer is yes and no,” Dr. Sankey said. “One thing we found in our training program is that it’s possible to become consumed by this pandemic. We need to educate residents about it, but future doctors still need to learn a lot of other things. Heart failure has not gone away.

“It’s okay to stick to the general curriculum, but with a wider variety of learning opportunities. Adding content sessions on population health, social determinants of health, race and bias, and equity is a start, but it’s by no means sufficient to give these topics the importance they deserve. We need to interpolate these subjects into sessions we’re already doing,” he said. “It is not enough to do a couple of lectures on diversity. We need to weave these concepts into the education we provide for residents every day.

“I think the pandemic has posed an opportunity to critically consider what’s the ideal teaching and learning environment. How can we make it better? Societal events around race have demonstrated essential areas for curricular development, and the pandemic had us primed and already thinking about how we educate future doctors – both in terms of medium and content,” he said.

Some medical schools started their new academic year in July; others put it off until September. Patient care at CCHMC is nearly back to where it used to be before COVID-19 began, Dr. Guiot said in a September interview, “but in masks and goggles.” As a result, hospitals are having to get creative all over again to accommodate medical students.

“I am amazed at the camaraderie of hospitals and medical schools, trying to support our learners in the midst of the pandemic,” she said. “I learned that we can be more adaptive than I ever imagined. We were all nervous about the risks, but we learned how to support each other and still provide excellent care in the midst of the pandemic. We’re forever changed. We also learned how to present didactics on Zoom, but that was the easy part.”
 

References

1. Lucey CR, Johnston SC. The transformational effects of COVID-19 on medical education. JAMA. 2020;324(11):1033-4.

2. Bhutta ZA et al. Education of health professionals for the 21st century: A global independent Commission. Lancet. 2010 Apr 3;375(9721):1137-8.

3. Goldhamer MEJ et al. Can COVID catalyze an educational transformation? Competency-based advancement in a crisis. N Engl J Med. 2020;383:1003-5.

The coronavirus pandemic has impacted all facets of the education and training of this country’s future hospitalists, including their medical school coursework, elective rotations, clerkships, and residency training – although with variations between settings and localities.

The COVID-19 crisis demanded immediate changes in traditional approaches to medical education. Training programs responded quickly to institute those changes. As hospitals geared up for potential surges in COVID cases starting in mid-March, many onsite training activities for medical students were shut down in order to reserve personal protective equipment for essential personnel and not put learners at risk of catching the virus. A variety of events related to their education were canceled. Didactic presentations and meetings were converted to virtual gatherings on internet platforms such as Zoom. Many of these changes were adopted even in settings with few actual COVID cases.

Medical students on clinical rotations were provided with virtual didactics when in-person clinical experiences were put on hold. In some cases, academic years ended early and fourth-year students graduated early so they might potentially join the hospital work force. Residents’ assignments were also changed, perhaps seeing patients on non–COVID-19 units only or taking different shifts, assignments, or rotations. Public health or research projects replaced elective placements. New electives were created, along with journal clubs, online care conferences, and technology-facilitated, self-directed learning.

But every advancing medical student needs to rotate through an experience of taking care of real patients, said Amy Guiot, MD, MEd, a hospitalist and associate director of medical student education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. “The Liaison Committee of Medical Education, jointly sponsored by the Association of American Medical Colleges and the American Medical Association, will not let you graduate a medical student without actual hands-on encounters with patients,” she explained.

For future doctors, especially those pursuing internal medicine – many of whom will practice as hospitalists – their training can’t duplicate “in the hospital” experiences except in the hospital, said Dr. Guiot, who is involved in pediatric training for medical students from the University of Cincinnati and residents.

For third- and fourth-year medical students, getting that personal contact with patients has been the hardest part, she added. But from March to May 2020, that experience was completely shut down at CCHMC, as at many medical schools, because of precautions aimed at preventing exposure to the novel coronavirus for both students and patients. That meant hospitals had to get creative, reshuffling schedules and the order of learning experiences; converting everything possible to virtual encounters on platforms such as Zoom; and reducing the length of rotations, the total number of in-person encounters, and the number of learners participating in an activity.

“We needed to use shift work for medical students, which hadn’t been done before,” Dr. Guiot said. Having students on different shifts, including nights, created more opportunities to fit clinical experiences into the schedule. The use of standardized patients – actors following a script who are examined by a student as part of learning how to do a physical exam – was also put on hold.

“Now we’re starting to get it back, but maybe not as often,” she said. “The actor wears a mask. The student wears a mask and shield. But it’s been harder for us to find actors – who tend to be older adults who may fear coming to the medical center – to perform their role, teaching medical students the art of examining a patient.”

Back to basics

The COVID-19 pandemic forced medical schools to get back to basics, figuring out the key competencies students needed to learn, said Alison Whelan, MD, AAMC’s chief medical education officer. Both medical schools and residency programs needed to respond quickly and in new ways, including with course content that would teach students about the virus and its management and treatment.

Schools have faced crises before, responding in real time to SARS (severe acute respiratory syndrome), Ebola, HIV, and natural disasters, Dr. Whelan said. “But there was a nimbleness and rapidity of adapting to COVID – with a lot of sharing of curriculums among medical colleges.” Back in late March, AAMC put out guidelines that recommended removing students from direct patient contact – not just for the student’s protection but for the community’s. A subsequent guidance, released Aug. 14, emphasized the need for medical schools to continue medical education – with appropriate attention to safety and local conditions while working closely with clinical partners.

Dr. Guiot, with her colleague Leslie Farrell, MD, and four very creative medical students, developed an online fourth-year elective course for University of Cincinnati medical students, offered asynchronously. It aimed to transmit a comprehensive understanding of COVID-19, its virology, transmission, clinical prevention, diagnosis and treatment, as well as examining national and international responses to the pandemic and their consequences and related issues of race, ethnicity, socioeconomic status, and health disparities. “We used several articles from the Journal of Hospital Medicine for students to read and discuss,” Dr. Guiot said.

Yale School of Medicine/Anthony DeCarlo

Christopher Sankey, MD, SFHM, associate program director of the traditional internal medicine residency program and associate professor of medicine at Yale University, New Haven, Conn., oversees the inpatient educational experience for internal medicine residents at Yale. “As with most programs, there was a lot of trepidation as we made the transition from in-person to virtual education,” he said.

The two principal, non–ward-based educational opportunities for the Yale residents are morning report, which involves a case-based discussion of various medical issues, usually led by a chief resident, and noon conference, which is more didactic and content based. Both made the transition to virtual meetings for residents.

“We wondered, could these still be well-attended, well-liked, and successful learning experiences if offered virtually? What I found when I surveyed our residents was that the virtual conferences were not only well received, but actually preferred,” Dr. Sankey said. “We have a large campus with lots of internal medicine services, so it’s hard to assemble everyone for meetings. There were also situations in which there were so many residents that they couldn’t all fit into the same room.” Zoom, the virtual platform of choice, has actually increased attendance.

Marc Miller, MD, a pediatric hospitalist at the Cleveland Clinic, helped his team develop a virtual curriculum in pediatrics presented to third-year medical students during the month of May, when medical students were being taken off the wards. “Some third-year students still needed to get their pediatric clerkships done. We had to balance clinical exposure with a lot of other things,” he explained.

The curriculum included a focus on interprofessional aspects of interdisciplinary, family-centered bedside rounds; a COVID literature review; and a lot of case-based scenarios. “Most challenging was how to remake family rounds. We tried to incorporate students into table rounds, but that didn’t feel as valuable,” Dr. Miller said. “Because pediatrics is so family centered, talking to patients and families at the bedside is highly valued. So we had virtual sessions talking about how to do that, with videos to illustrate it put out by Cincinnati Children’s Hospital.”

The most interactive sessions got the best feedback, but all the sessions went over very well, Dr. Miller said. “Larger lessons from COVID include things we already knew, but now with extra importance, such as the need to encourage interactivity to get students to buy in and take part in these conversations – whatever the structure.”

Vineet Arora, MD, MHM, an academic hospitalist and chief medical officer for the clinical learning environment at the University of Chicago, said that the changes wrought by COVID have also produced unexpected gains for medical education. “We’ve also had to think differently and more creatively about how to get the same information across in this new environment,” she explained. “In some cases, we saw that it was easier for learners to attend conferences and meetings online, with increased attendance for our events.” That includes participation on quality improvement committees, and attending online medical conferences presented locally and regionally.

“Another question: How do we teach interdisciplinary rounds and how to work with other members of the team without having face-to-face interactions?” Dr. Arora said. “Our old interdisciplinary rounding model had to change. It forced us to rethink how to create that kind of learning. We can’t have as many people in the patient’s room at one time. Can there be a physically distanced ‘touch-base’ with the nurse outside the patient’s room after a doctor has gone in to meet the patient?”

Transformational change

In a recent JAMA Viewpoint column, Catherine R. Lucey, MD, and S. Claiborne Johnston, MD, PhD,¹ called the impact of COVID-19 “transformational,” in line with changes in medical curriculums recommended by the 2010 Global Independent Commission on Education of Health Professionals for the 21st Century,² which asserted that the purpose of professional education is to improve the health of communities.

The authors stated that COVID-19 brought clarity and urgency to this purpose, and will someday be viewed as a catalyst for the needed transformation of medical education as medical schools embarked on curriculum redesign to embrace new competencies for current health challenges.

They suggested that medical students not only continued to learn during the COVID crisis “but in many circumstances, accelerated their attainment of the types of competencies that 21^st century physicians must master.” Emerging competencies identified by Dr. Lucey and Dr. Johnston include:

• Being able to address population and public health issues
• Designing and continuously improving of the health care system
• Incorporating data and technology in service to patient care, research, and education
• Eliminating health care disparities and discrimination in medicine
• Adapting the curriculum to current issues in real-time
• Engaging in crisis communication and active change leadership

How is the curriculum changing? It’s still a work in progress. “After the disruptions of the spring and summer, schools are now trying to figure which of the changes should stay,” said Dr. Whelan. “The virus has also highlighted other crises, with social determinants of health and racial disparities becoming more front and center. In terms of content, medical educators are rethinking a lot of things – in a good way.”

Another important trend cast in sharper relief by the pandemic is a gradual evolution toward competency-based education and how to assess when someone is ready to be a doctor, Dr. Whelan said. “There’s been an accelerated consideration of how to be sure each student is competent to practice medicine.”³

Many practicing physicians and students were redeployed in the crisis, she said. Pediatric physicians were asked to take care of adult patients, and internists were drafted to work in the ICU. Hospitals quickly developed refresher courses and competency-based assessments to facilitate these redeployments. What can be learned from such on-the-fly assessments? What was needed to make a pediatrician, under the supervision of an internist, able to take good care of adult patients?

And does competency-based assessment point toward some kind of time-variable graduate medical education of the future – with graduation when the competencies are achieved, rather than just tethered to time- and case volume–based requirements? It seems Canada is moving in this direction, and COVID might catalyze a similar transformation in the United States.³

Changing the curriculum

Does the content of the curriculum for preparing future hospitalists need to change significantly? “My honest answer is yes and no,” Dr. Sankey said. “One thing we found in our training program is that it’s possible to become consumed by this pandemic. We need to educate residents about it, but future doctors still need to learn a lot of other things. Heart failure has not gone away.

“It’s okay to stick to the general curriculum, but with a wider variety of learning opportunities. Adding content sessions on population health, social determinants of health, race and bias, and equity is a start, but it’s by no means sufficient to give these topics the importance they deserve. We need to interpolate these subjects into sessions we’re already doing,” he said. “It is not enough to do a couple of lectures on diversity. We need to weave these concepts into the education we provide for residents every day.

“I think the pandemic has posed an opportunity to critically consider what’s the ideal teaching and learning environment. How can we make it better? Societal events around race have demonstrated essential areas for curricular development, and the pandemic had us primed and already thinking about how we educate future doctors – both in terms of medium and content,” he said.

Some medical schools started their new academic year in July; others put it off until September. Patient care at CCHMC is nearly back to where it used to be before COVID-19 began, Dr. Guiot said in a September interview, “but in masks and goggles.” As a result, hospitals are having to get creative all over again to accommodate medical students.

“I am amazed at the camaraderie of hospitals and medical schools, trying to support our learners in the midst of the pandemic,” she said. “I learned that we can be more adaptive than I ever imagined. We were all nervous about the risks, but we learned how to support each other and still provide excellent care in the midst of the pandemic. We’re forever changed. We also learned how to present didactics on Zoom, but that was the easy part.”
 

References

1. Lucey CR, Johnston SC. The transformational effects of COVID-19 on medical education. JAMA. 2020;324(11):1033-4.

2. Bhutta ZA et al. Education of health professionals for the 21st century: A global independent Commission. Lancet. 2010 Apr 3;375(9721):1137-8.

3. Goldhamer MEJ et al. Can COVID catalyze an educational transformation? Competency-based advancement in a crisis. N Engl J Med. 2020;383:1003-5.

The coronavirus pandemic has impacted all facets of the education and training of this country’s future hospitalists, including their medical school coursework, elective rotations, clerkships, and residency training – although with variations between settings and localities.

The COVID-19 crisis demanded immediate changes in traditional approaches to medical education. Training programs responded quickly to institute those changes. As hospitals geared up for potential surges in COVID cases starting in mid-March, many onsite training activities for medical students were shut down in order to reserve personal protective equipment for essential personnel and not put learners at risk of catching the virus. A variety of events related to their education were canceled. Didactic presentations and meetings were converted to virtual gatherings on internet platforms such as Zoom. Many of these changes were adopted even in settings with few actual COVID cases.

Medical students on clinical rotations were provided with virtual didactics when in-person clinical experiences were put on hold. In some cases, academic years ended early and fourth-year students graduated early so they might potentially join the hospital work force. Residents’ assignments were also changed, perhaps seeing patients on non–COVID-19 units only or taking different shifts, assignments, or rotations. Public health or research projects replaced elective placements. New electives were created, along with journal clubs, online care conferences, and technology-facilitated, self-directed learning.

But every advancing medical student needs to rotate through an experience of taking care of real patients, said Amy Guiot, MD, MEd, a hospitalist and associate director of medical student education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center. “The Liaison Committee of Medical Education, jointly sponsored by the Association of American Medical Colleges and the American Medical Association, will not let you graduate a medical student without actual hands-on encounters with patients,” she explained.

For future doctors, especially those pursuing internal medicine – many of whom will practice as hospitalists – their training can’t duplicate “in the hospital” experiences except in the hospital, said Dr. Guiot, who is involved in pediatric training for medical students from the University of Cincinnati and residents.

For third- and fourth-year medical students, getting that personal contact with patients has been the hardest part, she added. But from March to May 2020, that experience was completely shut down at CCHMC, as at many medical schools, because of precautions aimed at preventing exposure to the novel coronavirus for both students and patients. That meant hospitals had to get creative, reshuffling schedules and the order of learning experiences; converting everything possible to virtual encounters on platforms such as Zoom; and reducing the length of rotations, the total number of in-person encounters, and the number of learners participating in an activity.

“We needed to use shift work for medical students, which hadn’t been done before,” Dr. Guiot said. Having students on different shifts, including nights, created more opportunities to fit clinical experiences into the schedule. The use of standardized patients – actors following a script who are examined by a student as part of learning how to do a physical exam – was also put on hold.

“Now we’re starting to get it back, but maybe not as often,” she said. “The actor wears a mask. The student wears a mask and shield. But it’s been harder for us to find actors – who tend to be older adults who may fear coming to the medical center – to perform their role, teaching medical students the art of examining a patient.”

Back to basics

The COVID-19 pandemic forced medical schools to get back to basics, figuring out the key competencies students needed to learn, said Alison Whelan, MD, AAMC’s chief medical education officer. Both medical schools and residency programs needed to respond quickly and in new ways, including with course content that would teach students about the virus and its management and treatment.

Schools have faced crises before, responding in real time to SARS (severe acute respiratory syndrome), Ebola, HIV, and natural disasters, Dr. Whelan said. “But there was a nimbleness and rapidity of adapting to COVID – with a lot of sharing of curriculums among medical colleges.” Back in late March, AAMC put out guidelines that recommended removing students from direct patient contact – not just for the student’s protection but for the community’s. A subsequent guidance, released Aug. 14, emphasized the need for medical schools to continue medical education – with appropriate attention to safety and local conditions while working closely with clinical partners.

Dr. Guiot, with her colleague Leslie Farrell, MD, and four very creative medical students, developed an online fourth-year elective course for University of Cincinnati medical students, offered asynchronously. It aimed to transmit a comprehensive understanding of COVID-19, its virology, transmission, clinical prevention, diagnosis and treatment, as well as examining national and international responses to the pandemic and their consequences and related issues of race, ethnicity, socioeconomic status, and health disparities. “We used several articles from the Journal of Hospital Medicine for students to read and discuss,” Dr. Guiot said.

Yale School of Medicine/Anthony DeCarlo

Christopher Sankey, MD, SFHM, associate program director of the traditional internal medicine residency program and associate professor of medicine at Yale University, New Haven, Conn., oversees the inpatient educational experience for internal medicine residents at Yale. “As with most programs, there was a lot of trepidation as we made the transition from in-person to virtual education,” he said.

The two principal, non–ward-based educational opportunities for the Yale residents are morning report, which involves a case-based discussion of various medical issues, usually led by a chief resident, and noon conference, which is more didactic and content based. Both made the transition to virtual meetings for residents.

“We wondered, could these still be well-attended, well-liked, and successful learning experiences if offered virtually? What I found when I surveyed our residents was that the virtual conferences were not only well received, but actually preferred,” Dr. Sankey said. “We have a large campus with lots of internal medicine services, so it’s hard to assemble everyone for meetings. There were also situations in which there were so many residents that they couldn’t all fit into the same room.” Zoom, the virtual platform of choice, has actually increased attendance.

Marc Miller, MD, a pediatric hospitalist at the Cleveland Clinic, helped his team develop a virtual curriculum in pediatrics presented to third-year medical students during the month of May, when medical students were being taken off the wards. “Some third-year students still needed to get their pediatric clerkships done. We had to balance clinical exposure with a lot of other things,” he explained.

The curriculum included a focus on interprofessional aspects of interdisciplinary, family-centered bedside rounds; a COVID literature review; and a lot of case-based scenarios. “Most challenging was how to remake family rounds. We tried to incorporate students into table rounds, but that didn’t feel as valuable,” Dr. Miller said. “Because pediatrics is so family centered, talking to patients and families at the bedside is highly valued. So we had virtual sessions talking about how to do that, with videos to illustrate it put out by Cincinnati Children’s Hospital.”

The most interactive sessions got the best feedback, but all the sessions went over very well, Dr. Miller said. “Larger lessons from COVID include things we already knew, but now with extra importance, such as the need to encourage interactivity to get students to buy in and take part in these conversations – whatever the structure.”

Vineet Arora, MD, MHM, an academic hospitalist and chief medical officer for the clinical learning environment at the University of Chicago, said that the changes wrought by COVID have also produced unexpected gains for medical education. “We’ve also had to think differently and more creatively about how to get the same information across in this new environment,” she explained. “In some cases, we saw that it was easier for learners to attend conferences and meetings online, with increased attendance for our events.” That includes participation on quality improvement committees, and attending online medical conferences presented locally and regionally.

“Another question: How do we teach interdisciplinary rounds and how to work with other members of the team without having face-to-face interactions?” Dr. Arora said. “Our old interdisciplinary rounding model had to change. It forced us to rethink how to create that kind of learning. We can’t have as many people in the patient’s room at one time. Can there be a physically distanced ‘touch-base’ with the nurse outside the patient’s room after a doctor has gone in to meet the patient?”

Transformational change

In a recent JAMA Viewpoint column, Catherine R. Lucey, MD, and S. Claiborne Johnston, MD, PhD,¹ called the impact of COVID-19 “transformational,” in line with changes in medical curriculums recommended by the 2010 Global Independent Commission on Education of Health Professionals for the 21st Century,² which asserted that the purpose of professional education is to improve the health of communities.

The authors stated that COVID-19 brought clarity and urgency to this purpose, and will someday be viewed as a catalyst for the needed transformation of medical education as medical schools embarked on curriculum redesign to embrace new competencies for current health challenges.

They suggested that medical students not only continued to learn during the COVID crisis “but in many circumstances, accelerated their attainment of the types of competencies that 21^st century physicians must master.” Emerging competencies identified by Dr. Lucey and Dr. Johnston include:

• Being able to address population and public health issues
• Designing and continuously improving of the health care system
• Incorporating data and technology in service to patient care, research, and education
• Eliminating health care disparities and discrimination in medicine
• Adapting the curriculum to current issues in real-time
• Engaging in crisis communication and active change leadership

How is the curriculum changing? It’s still a work in progress. “After the disruptions of the spring and summer, schools are now trying to figure which of the changes should stay,” said Dr. Whelan. “The virus has also highlighted other crises, with social determinants of health and racial disparities becoming more front and center. In terms of content, medical educators are rethinking a lot of things – in a good way.”

Another important trend cast in sharper relief by the pandemic is a gradual evolution toward competency-based education and how to assess when someone is ready to be a doctor, Dr. Whelan said. “There’s been an accelerated consideration of how to be sure each student is competent to practice medicine.”³

Many practicing physicians and students were redeployed in the crisis, she said. Pediatric physicians were asked to take care of adult patients, and internists were drafted to work in the ICU. Hospitals quickly developed refresher courses and competency-based assessments to facilitate these redeployments. What can be learned from such on-the-fly assessments? What was needed to make a pediatrician, under the supervision of an internist, able to take good care of adult patients?

And does competency-based assessment point toward some kind of time-variable graduate medical education of the future – with graduation when the competencies are achieved, rather than just tethered to time- and case volume–based requirements? It seems Canada is moving in this direction, and COVID might catalyze a similar transformation in the United States.³

Changing the curriculum

Does the content of the curriculum for preparing future hospitalists need to change significantly? “My honest answer is yes and no,” Dr. Sankey said. “One thing we found in our training program is that it’s possible to become consumed by this pandemic. We need to educate residents about it, but future doctors still need to learn a lot of other things. Heart failure has not gone away.

“It’s okay to stick to the general curriculum, but with a wider variety of learning opportunities. Adding content sessions on population health, social determinants of health, race and bias, and equity is a start, but it’s by no means sufficient to give these topics the importance they deserve. We need to interpolate these subjects into sessions we’re already doing,” he said. “It is not enough to do a couple of lectures on diversity. We need to weave these concepts into the education we provide for residents every day.

“I think the pandemic has posed an opportunity to critically consider what’s the ideal teaching and learning environment. How can we make it better? Societal events around race have demonstrated essential areas for curricular development, and the pandemic had us primed and already thinking about how we educate future doctors – both in terms of medium and content,” he said.

Some medical schools started their new academic year in July; others put it off until September. Patient care at CCHMC is nearly back to where it used to be before COVID-19 began, Dr. Guiot said in a September interview, “but in masks and goggles.” As a result, hospitals are having to get creative all over again to accommodate medical students.

“I am amazed at the camaraderie of hospitals and medical schools, trying to support our learners in the midst of the pandemic,” she said. “I learned that we can be more adaptive than I ever imagined. We were all nervous about the risks, but we learned how to support each other and still provide excellent care in the midst of the pandemic. We’re forever changed. We also learned how to present didactics on Zoom, but that was the easy part.”
 

References

1. Lucey CR, Johnston SC. The transformational effects of COVID-19 on medical education. JAMA. 2020;324(11):1033-4.

2. Bhutta ZA et al. Education of health professionals for the 21st century: A global independent Commission. Lancet. 2010 Apr 3;375(9721):1137-8.

3. Goldhamer MEJ et al. Can COVID catalyze an educational transformation? Competency-based advancement in a crisis. N Engl J Med. 2020;383:1003-5.

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

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

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

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

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule will take effect within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%).

CMS had initially set these changes in 2021 pay in motion in the 2020 physician fee schedule. The agency subsequently faced significant opposition to its plans. Many physician groups sought to waive a “budget-neutral” approach to the E/M overhaul, which makes the offsetting of cuts necessary. They argued this would allow increased compensation for clinicians whose practices focus on office visits without requiring offsetting cuts from other fields of medicine.

The American Medical Association is among those urging Congress to prevent or postpone the payment reductions resulting from Medicare’s budget neutrality requirement as applied to the E/M overhaul.

In a Tuesday statement, AMA President Susan R. Bailey, MD, noted that many physicians are facing “substantial economic hardships due to COVID-19.”

By AMA’s calculations, CMS’ planned 2021 E/M overhaul could result in “a shocking reduction of 10.2% to Medicare payment rates,” according to Bailey’s statement. The AMA strongly supports other aspects of the E/M changes CMS finalized, which Bailey said will result in “simpler and more flexible” coding and documentation.

The Surgical Care Coalition, which represents about a dozen medical specialty associations, is asking members of Congress to block the full implementation of the E/M overhaul.

In a Dec. 1 statement, the coalition urged the passage of a bill (HR 8702) that has been introduced in the House by a bipartisan duo of physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Larry Bucshon, MD (R-Ind.). Their bill would effectively block the cuts from going into effect on January 1, 2021. It would provide an additional Medicare payment for certain services in 2021 and 2022 if the otherwise applicable payment is less than it would have been in 2020.

The Medicare E/M overhaul “was a dangerous policy even before the pandemic, and enacting it during the worst health care crisis in a century is unconscionable. If Congress fails to act, it will further strain a health care system that’s already been pushed to the brink due to the COVID-19 pandemic and undermine patient care,” said John A. Wilson, MD, president of the American Association of Neurological Surgeons, in a statement.

Also backing the Bera-Bucshon bill is the American College of Emergency Physicians. In a statement on Tuesday, ACEP President Mark Rosenberg, DO, MBA, urged Congress to act on this measure.

“Emergency physicians and other health care providers battling on the front lines of the ongoing pandemic are already under unprecedented financial strain as they continue to bear the brunt of COVID-19,” Dr. Rosenberg said. “These cuts would have a devastating impact for the future of emergency medicine and could seriously impede patients’ access to emergency care when they need it most.”
 

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a Tuesday tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a November 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

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

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Changes in hormones, body composition, lipids, and vascular health during the menopause transition can increase a woman’s chance of developing cardiovascular disease (CVD) after menopause, the American Heart Association said in a scientific statement.

“This statement aims to raise awareness of both healthcare providers and women about the menopause transition as a time of increasing heart disease risk,” Samar R. El Khoudary, PhD, MPH, who chaired the writing group, said in an interview.

“As such, it emphasizes the importance of monitoring women’s health during midlife and targeting this stage as a critical window for applying early intervention strategies that aim to maintain a healthy heart and reduce the risk of heart disease,” said Dr. El Khoudary, of the University of Pittsburgh.

The statement was published online Nov. 30 in Circulation.
 

Evolution in knowledge

During the past 20 years, knowledge of how menopause might contribute to CVD has evolved “dramatically,” Dr. El Khoudary noted. The accumulated data consistently point to the menopause transition as a time of change in heart health.

“Importantly,” she said, the latest AHA guidelines for CVD prevention in women, published in 2011, do not include data now available on the menopause transition as a time of increased CVD risk.

“As such, there is a compelling need to discuss the implications of the accumulating body of literature on this topic,” said Dr. El Khoudary.

The statement provides a contemporary synthesis of the existing data on menopause and how it relates to CVD, the leading cause of death of U.S. women.

Earlier age at natural menopause has generally been found to be a marker of greater CVD risk. Iatrogenically induced menopause (bilateral oophorectomy) during the premenopausal period is also associated with higher CVD risk, the data suggest.

Vasomotor symptoms are associated with worse levels of CVD risk factors and measures of subclinical atherosclerosis. Sleep disturbance has also been linked to greater risk for subclinical CVD and worse CV health indexes in women during midlife.

Increases in central/visceral fat and decreases in lean muscle mass are more pronounced during the menopause transition. This increased central adiposity is associated with increased risk for mortality, even among those with normal body mass index, the writing group found.

Increases in lipid levels (LDL cholesterol and apolipoprotein B), metabolic syndrome risk, and vascular remodeling at midlife are driven by the menopause transition more than aging, whereas increases in blood pressure, insulin level, and glucose level are likely more influenced by chronological aging, they reported.
 

Lifestyle interventions

The writing group noted that, because of the increase in overall life expectancy in the United States, a significant proportion of women will spend up to 40% of their lives after menopause.

Yet data suggest that only 7.2% of women transitioning to menopause are meeting physical activity guidelines and that fewer than 20% of those women are consistently maintaining a healthy diet.

Limited data from randomized, controlled trials suggest that a multidimensional lifestyle intervention during the menopause transition can prevent weight gain and reduce blood pressure and levels of triglycerides, blood glucose, and insulin and reduce the incidence of subclinical carotid atherosclerosis, they pointed out.

“Novel data” indicate a reversal in the associations of HDL cholesterol with CVD risk over the menopause transition, suggesting that higher HDL cholesterol levels may not consistently reflect good cardiovascular health in middle-aged women, the group noted.

There are also data suggesting that starting menopause hormone therapy when younger than 60 years or within 10 years of menopause is associated with reduced CVD risk.

The group said further research is needed into the cardiometabolic effects of menopause hormone therapy, including effects associated with form, route, and duration of administration, in women traversing menopause.

They also noted that data for the primary and secondary prevention of atherosclerotic CVD and improved survival with lipid-lowering interventions “remain elusive” for women and that further study is needed to develop evidence-based recommendations tailored specifically to women.

The research had no commercial funding. Dr. El Khoudary has disclosed no relevant financial relationships.

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

Instead of flying out to San Diego in California and soaking up a bit of sunshine in between listening to new research presentations, hematologists from around the world will be glued to their computer screens next weekend, tuning into the 62nd American Society of Hematology annual meeting.  

Like many other conferences this year, the ASH meeting will be virtual because of the continuing COVID-19 pandemic, although the dates remain the same: Dec. 5-8.  

This is the premier hematology event of the year, and the largest hematology conference in the world, with around 3,500 abstracts presented this year, commented Aaron T. Gerds, MD, chair of ASH’s Committee on Communications.
 

Ruxolitinib in chronic GvHD

“One of the things that people come to ASH for is to hear about practice-changing clinical trials, and this year is no exception,” said ASH secretary Robert Brodsky, MD.

In a preview webinar, he highlighted four abstracts that offer opportunities to change practice and revamp the current standards of care.

One clinical trial that is “almost certainly a practice changer,” he said, is the REACH 3 study (abstract 77) of the JAK inhibitor ruxolitinib (Jakafi, Incyte) in patients with chronic graft-versus-host disease (GvHD) after a stem cell transplant.

“This has been really hard to treat in patients undergoing allogeneic bone marrow transplants,” said Brodsky. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement, and even steroids don’t work that well.”

There is currently no approved second-line therapy for chronic forms of GvHD, he emphasized. The main endpoint of the trial was overall response rate, which was doubled with ruxolitinib compared to the best available therapy (50% vs 25%).

“This is the first successful phase 3 trial for chronic GvHD,” Brodsky commented.  
 

Transplants for older patients with MDS

Transplant offers the only curative option for myelodysplastic syndromes (MDS), but typically this option is offered to younger patients because benefits for older adults have not been well-defined, Brodsky noted.

New data from a clinical trial conducted in patients with advanced MDS aged 50-75 years (abstract 75) offers the most definitive evidence to date that allogeneic hematopoietic cell transplantation (AHCT) can significantly improve outcomes for older adults.  

It’s clear that transplant is the standard of care in younger patients, Brodsky commented, and although there is a trend of offering it to older patients, some are not getting referred and instead are being offered palliative care. “The thinking is that bone marrow transplant would be too toxic in this age group,” he said. “But what is very clear here is that, in an intent-to-treat analysis, there was a significant survival advantage – 48% versus 27% at 3 years for transplantation – and it was seen across all subgroups.”
 

Subcutaneous daratumumab

New data on a subcutaneous formulation of daratumumab (Darzalex, Janssen), which is usually given by intravenous infusion, will be presented from the APOLLO trial (abstract 412) in patients with relapsed/refractory multiple myeloma.

Patients who received subcutaneous daratumumab combined with pomalidomide and dexamethasone had a 37% reduction in disease progression or death compared to those who received pomalidomide and dexamethasone alone.

“From previous years we’ve learned that daratumumab has had a major impact on outcomes in multiple myeloma,” said Brodsky. “The nice thing about the subcutaneous formulation is that it can be administered quickly and in an outpatient setting, which is especially important in the COVID era.”  
 

Negative data with tranexamic acid

The fourth abstract highlighted by Brodsky is a negative study, but its findings can help guide clinical practice, he said. The a-TREAT study (abstract 2) showed that, despite being routinely used in the clinical setting, tranexamic acid does not prevent bleeding when administered prophylactically to severely thrombocytopenic patients undergoing treatment for hematologic malignancies.

“They found absolutely no difference in bleeding or need for transfusion,” said Brodsky. “What they did find was more catheter-associated blood clots in the tranexamic acid group. This is a practice changer in that it probably should not be given prophylactically to patients with thrombocytopenia.”
 

‘Very exciting’ news about gene therapy

Brodsky also highlighted several late-breaking abstract that will be presented at the meeting.

In particular, the first data on a gene therapy for hemophilia B (abstract LBA-6) are “very, very exciting,” he said. The HOPE-B trial showed a 96% response rate among patients with hemophilia B who were treated with etranacogene dezaparvovec, an investigational gene therapy composed of an adeno-associated virus serotype 5 (AAV5) vector containing a codon-optimized Padua variant human factor IX.

Brodsky pointed out that this was a large trial with 54 patients, but importantly, it included patients with pre-existing anti-AAV5 neutralizing antibodies. “About 40% of patients have naturally occurring antibodies to AAV5, and they have been excluded from previous trials because it was thought they wouldn’t take the vector,” said Brodsky. “But only one patient didn’t get a response.”

Following a single dose of etranacogene dezaparvovec, Factor IX activity increased into the mild to normal range without the need for prophylactic immunosuppression. Treated patients were able to discontinue prophylaxis and bleeding was controlled in most of the cohort.

“This is a big advance and we are getting very close to the point where gene therapy is going to be standard of care for some forms of hemophilia,” said Brodsky. However, he added that “we will still need to see more patients and have longer follow-up.”

He added that, with time, the technology behind gene therapy will probably become less expensive and more accessible to more patients, which will help become a standard of care.

This is also the hope for the technology behind chimeric antigen receptor T-cell (CAR-T) therapy, he added. At present, this cellular therapy is manufactured individually for each patient and is very expensive, but work on “off-the-shelf” products is underway. This topic will be explored during the presidential symposium, entitled, “Universal Donor Solutions in Hematology.”

New data on one of the currently available CAR-T cell products will be presented at the meeting. The phase 2 ZUMA-5 trial showed that axicabtagene ciloleucel (Axi-Cel) may be a viable option for some patients with high-risk non-Hodgkin lymphoma who have not responded to standard treatments (abstract 700).

At a median follow-up of almost 18 months, 92% of participants achieved an objective response, and 78% achieved a complete response to the treatment. By 12 months, 72% were still in response, and at 17.5 months, 64% were still in response.

“We were very impressed with the magnitude of the responses, and also the durability,” said senior study author Caron Jacobson, MD, of the Dana-Farber Cancer Institute, Boston, in a press release. “I was also struck early on by how favorable the safety profile was compared to what we’ve been seeing in the fast-growing lymphomas, such as large B cell lymphoma.”
 

Race and bloods cancers

ASH president Stephanie Lee, MD, MPH, highlighted several abstracts on disparities that will be presented at the meeting. One of these, which is to be presented during the plenary session, is an analysis of patient survival in acute myeloid leukemia (AML) (abstract 6).

It found that “self-reported race was the best indicator of survival,” noted Lee.

Overall survival at 3 years was 41% in White patients versus 32% in Black patients, a difference that was highly significant, she noted.

Part of the study also evaluated patients who were all on the same chemotherapy protocol, “so there was no effect of different treatment since they were on therapy determined by the trial,” said Lee.

Black patients were less likely to have normal cytogenetics compared with White patients (38% vs 51%; P = .01) and had a lower frequency of prognostically favorable NPM1 mutations (25% vs 38%; P = .04), but higher frequencies of spliceosome gene mutations (24% vs 12%; P = .009). Therefore, the results showed race was an independent prognosticator of poor survival in AML, aside from established molecular markers.

A special scientific session on race will be held on Dec. 5, Lee noted. While other abstracts consider race from the patient side, this session will focus on the scientist’s side, she explained, and address questions such as: “What are the implications of diversity and racism? And how does that impact scientists who are from underrepresented minorities?” 
 

COVID-19 and blood disorders

Lee also highlighted a study (abstract 215) that analyzed emerging data from the ASH Research Collaborative COVID-19 Registry for Hematology, which was developed to look at outcomes of COVID-19 infection in patients with underlying blood disorders.

An analysis of data from 250 patients at 74 sites around the world found that overall mortality was 28%. “This supports the emerging consensus that patients with hematologic malignancies experience significant morbidity and mortality from COVID-19 infection,” say the authors.

“We do need real-world data to see how SARS-CoV-2 is affecting our patients with hematologic diseases or those who don’t have a hematologic disease but who are then infected with the coronavirus and develop a hematologic problem like blood clots,” said Lee.

“More data will be coming in, but this is a good example of trying to harness real-world information to learn things until we have more controlled trials.”
 

‘Fireside chat’ with Fauci

COVID-19 will be on the agenda for a special session billed as a “fireside chat” with Anthony Fauci, MD, of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“This will be kicking off our meeting on Saturday morning,” said Lee.

This article first appeared on Medscape.com.

Instead of flying out to San Diego in California and soaking up a bit of sunshine in between listening to new research presentations, hematologists from around the world will be glued to their computer screens next weekend, tuning into the 62nd American Society of Hematology annual meeting.  

Like many other conferences this year, the ASH meeting will be virtual because of the continuing COVID-19 pandemic, although the dates remain the same: Dec. 5-8.  

This is the premier hematology event of the year, and the largest hematology conference in the world, with around 3,500 abstracts presented this year, commented Aaron T. Gerds, MD, chair of ASH’s Committee on Communications.
 

Ruxolitinib in chronic GvHD

“One of the things that people come to ASH for is to hear about practice-changing clinical trials, and this year is no exception,” said ASH secretary Robert Brodsky, MD.

In a preview webinar, he highlighted four abstracts that offer opportunities to change practice and revamp the current standards of care.

One clinical trial that is “almost certainly a practice changer,” he said, is the REACH 3 study (abstract 77) of the JAK inhibitor ruxolitinib (Jakafi, Incyte) in patients with chronic graft-versus-host disease (GvHD) after a stem cell transplant.

“This has been really hard to treat in patients undergoing allogeneic bone marrow transplants,” said Brodsky. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement, and even steroids don’t work that well.”

There is currently no approved second-line therapy for chronic forms of GvHD, he emphasized. The main endpoint of the trial was overall response rate, which was doubled with ruxolitinib compared to the best available therapy (50% vs 25%).

“This is the first successful phase 3 trial for chronic GvHD,” Brodsky commented.  
 

Transplants for older patients with MDS

Transplant offers the only curative option for myelodysplastic syndromes (MDS), but typically this option is offered to younger patients because benefits for older adults have not been well-defined, Brodsky noted.

New data from a clinical trial conducted in patients with advanced MDS aged 50-75 years (abstract 75) offers the most definitive evidence to date that allogeneic hematopoietic cell transplantation (AHCT) can significantly improve outcomes for older adults.  

It’s clear that transplant is the standard of care in younger patients, Brodsky commented, and although there is a trend of offering it to older patients, some are not getting referred and instead are being offered palliative care. “The thinking is that bone marrow transplant would be too toxic in this age group,” he said. “But what is very clear here is that, in an intent-to-treat analysis, there was a significant survival advantage – 48% versus 27% at 3 years for transplantation – and it was seen across all subgroups.”
 

Subcutaneous daratumumab

New data on a subcutaneous formulation of daratumumab (Darzalex, Janssen), which is usually given by intravenous infusion, will be presented from the APOLLO trial (abstract 412) in patients with relapsed/refractory multiple myeloma.

Patients who received subcutaneous daratumumab combined with pomalidomide and dexamethasone had a 37% reduction in disease progression or death compared to those who received pomalidomide and dexamethasone alone.

“From previous years we’ve learned that daratumumab has had a major impact on outcomes in multiple myeloma,” said Brodsky. “The nice thing about the subcutaneous formulation is that it can be administered quickly and in an outpatient setting, which is especially important in the COVID era.”  
 

Negative data with tranexamic acid

The fourth abstract highlighted by Brodsky is a negative study, but its findings can help guide clinical practice, he said. The a-TREAT study (abstract 2) showed that, despite being routinely used in the clinical setting, tranexamic acid does not prevent bleeding when administered prophylactically to severely thrombocytopenic patients undergoing treatment for hematologic malignancies.

“They found absolutely no difference in bleeding or need for transfusion,” said Brodsky. “What they did find was more catheter-associated blood clots in the tranexamic acid group. This is a practice changer in that it probably should not be given prophylactically to patients with thrombocytopenia.”
 

‘Very exciting’ news about gene therapy

Brodsky also highlighted several late-breaking abstract that will be presented at the meeting.

In particular, the first data on a gene therapy for hemophilia B (abstract LBA-6) are “very, very exciting,” he said. The HOPE-B trial showed a 96% response rate among patients with hemophilia B who were treated with etranacogene dezaparvovec, an investigational gene therapy composed of an adeno-associated virus serotype 5 (AAV5) vector containing a codon-optimized Padua variant human factor IX.

Brodsky pointed out that this was a large trial with 54 patients, but importantly, it included patients with pre-existing anti-AAV5 neutralizing antibodies. “About 40% of patients have naturally occurring antibodies to AAV5, and they have been excluded from previous trials because it was thought they wouldn’t take the vector,” said Brodsky. “But only one patient didn’t get a response.”

Following a single dose of etranacogene dezaparvovec, Factor IX activity increased into the mild to normal range without the need for prophylactic immunosuppression. Treated patients were able to discontinue prophylaxis and bleeding was controlled in most of the cohort.

“This is a big advance and we are getting very close to the point where gene therapy is going to be standard of care for some forms of hemophilia,” said Brodsky. However, he added that “we will still need to see more patients and have longer follow-up.”

He added that, with time, the technology behind gene therapy will probably become less expensive and more accessible to more patients, which will help become a standard of care.

This is also the hope for the technology behind chimeric antigen receptor T-cell (CAR-T) therapy, he added. At present, this cellular therapy is manufactured individually for each patient and is very expensive, but work on “off-the-shelf” products is underway. This topic will be explored during the presidential symposium, entitled, “Universal Donor Solutions in Hematology.”

New data on one of the currently available CAR-T cell products will be presented at the meeting. The phase 2 ZUMA-5 trial showed that axicabtagene ciloleucel (Axi-Cel) may be a viable option for some patients with high-risk non-Hodgkin lymphoma who have not responded to standard treatments (abstract 700).

At a median follow-up of almost 18 months, 92% of participants achieved an objective response, and 78% achieved a complete response to the treatment. By 12 months, 72% were still in response, and at 17.5 months, 64% were still in response.

“We were very impressed with the magnitude of the responses, and also the durability,” said senior study author Caron Jacobson, MD, of the Dana-Farber Cancer Institute, Boston, in a press release. “I was also struck early on by how favorable the safety profile was compared to what we’ve been seeing in the fast-growing lymphomas, such as large B cell lymphoma.”
 

Race and bloods cancers

ASH president Stephanie Lee, MD, MPH, highlighted several abstracts on disparities that will be presented at the meeting. One of these, which is to be presented during the plenary session, is an analysis of patient survival in acute myeloid leukemia (AML) (abstract 6).

It found that “self-reported race was the best indicator of survival,” noted Lee.

Overall survival at 3 years was 41% in White patients versus 32% in Black patients, a difference that was highly significant, she noted.

Part of the study also evaluated patients who were all on the same chemotherapy protocol, “so there was no effect of different treatment since they were on therapy determined by the trial,” said Lee.

Black patients were less likely to have normal cytogenetics compared with White patients (38% vs 51%; P = .01) and had a lower frequency of prognostically favorable NPM1 mutations (25% vs 38%; P = .04), but higher frequencies of spliceosome gene mutations (24% vs 12%; P = .009). Therefore, the results showed race was an independent prognosticator of poor survival in AML, aside from established molecular markers.

A special scientific session on race will be held on Dec. 5, Lee noted. While other abstracts consider race from the patient side, this session will focus on the scientist’s side, she explained, and address questions such as: “What are the implications of diversity and racism? And how does that impact scientists who are from underrepresented minorities?” 
 

COVID-19 and blood disorders

Lee also highlighted a study (abstract 215) that analyzed emerging data from the ASH Research Collaborative COVID-19 Registry for Hematology, which was developed to look at outcomes of COVID-19 infection in patients with underlying blood disorders.

An analysis of data from 250 patients at 74 sites around the world found that overall mortality was 28%. “This supports the emerging consensus that patients with hematologic malignancies experience significant morbidity and mortality from COVID-19 infection,” say the authors.

“We do need real-world data to see how SARS-CoV-2 is affecting our patients with hematologic diseases or those who don’t have a hematologic disease but who are then infected with the coronavirus and develop a hematologic problem like blood clots,” said Lee.

“More data will be coming in, but this is a good example of trying to harness real-world information to learn things until we have more controlled trials.”
 

‘Fireside chat’ with Fauci

COVID-19 will be on the agenda for a special session billed as a “fireside chat” with Anthony Fauci, MD, of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“This will be kicking off our meeting on Saturday morning,” said Lee.

This article first appeared on Medscape.com.

Instead of flying out to San Diego in California and soaking up a bit of sunshine in between listening to new research presentations, hematologists from around the world will be glued to their computer screens next weekend, tuning into the 62nd American Society of Hematology annual meeting.  

Like many other conferences this year, the ASH meeting will be virtual because of the continuing COVID-19 pandemic, although the dates remain the same: Dec. 5-8.  

This is the premier hematology event of the year, and the largest hematology conference in the world, with around 3,500 abstracts presented this year, commented Aaron T. Gerds, MD, chair of ASH’s Committee on Communications.
 

Ruxolitinib in chronic GvHD

“One of the things that people come to ASH for is to hear about practice-changing clinical trials, and this year is no exception,” said ASH secretary Robert Brodsky, MD.

In a preview webinar, he highlighted four abstracts that offer opportunities to change practice and revamp the current standards of care.

One clinical trial that is “almost certainly a practice changer,” he said, is the REACH 3 study (abstract 77) of the JAK inhibitor ruxolitinib (Jakafi, Incyte) in patients with chronic graft-versus-host disease (GvHD) after a stem cell transplant.

“This has been really hard to treat in patients undergoing allogeneic bone marrow transplants,” said Brodsky. “Steroids are the first-line treatment, but after that, nothing else has shown any improvement, and even steroids don’t work that well.”

There is currently no approved second-line therapy for chronic forms of GvHD, he emphasized. The main endpoint of the trial was overall response rate, which was doubled with ruxolitinib compared to the best available therapy (50% vs 25%).

“This is the first successful phase 3 trial for chronic GvHD,” Brodsky commented.  
 

Transplants for older patients with MDS

Transplant offers the only curative option for myelodysplastic syndromes (MDS), but typically this option is offered to younger patients because benefits for older adults have not been well-defined, Brodsky noted.

New data from a clinical trial conducted in patients with advanced MDS aged 50-75 years (abstract 75) offers the most definitive evidence to date that allogeneic hematopoietic cell transplantation (AHCT) can significantly improve outcomes for older adults.  

It’s clear that transplant is the standard of care in younger patients, Brodsky commented, and although there is a trend of offering it to older patients, some are not getting referred and instead are being offered palliative care. “The thinking is that bone marrow transplant would be too toxic in this age group,” he said. “But what is very clear here is that, in an intent-to-treat analysis, there was a significant survival advantage – 48% versus 27% at 3 years for transplantation – and it was seen across all subgroups.”
 

Subcutaneous daratumumab

New data on a subcutaneous formulation of daratumumab (Darzalex, Janssen), which is usually given by intravenous infusion, will be presented from the APOLLO trial (abstract 412) in patients with relapsed/refractory multiple myeloma.

Patients who received subcutaneous daratumumab combined with pomalidomide and dexamethasone had a 37% reduction in disease progression or death compared to those who received pomalidomide and dexamethasone alone.

“From previous years we’ve learned that daratumumab has had a major impact on outcomes in multiple myeloma,” said Brodsky. “The nice thing about the subcutaneous formulation is that it can be administered quickly and in an outpatient setting, which is especially important in the COVID era.”  
 

Negative data with tranexamic acid

The fourth abstract highlighted by Brodsky is a negative study, but its findings can help guide clinical practice, he said. The a-TREAT study (abstract 2) showed that, despite being routinely used in the clinical setting, tranexamic acid does not prevent bleeding when administered prophylactically to severely thrombocytopenic patients undergoing treatment for hematologic malignancies.

“They found absolutely no difference in bleeding or need for transfusion,” said Brodsky. “What they did find was more catheter-associated blood clots in the tranexamic acid group. This is a practice changer in that it probably should not be given prophylactically to patients with thrombocytopenia.”
 

‘Very exciting’ news about gene therapy

Brodsky also highlighted several late-breaking abstract that will be presented at the meeting.

In particular, the first data on a gene therapy for hemophilia B (abstract LBA-6) are “very, very exciting,” he said. The HOPE-B trial showed a 96% response rate among patients with hemophilia B who were treated with etranacogene dezaparvovec, an investigational gene therapy composed of an adeno-associated virus serotype 5 (AAV5) vector containing a codon-optimized Padua variant human factor IX.

Brodsky pointed out that this was a large trial with 54 patients, but importantly, it included patients with pre-existing anti-AAV5 neutralizing antibodies. “About 40% of patients have naturally occurring antibodies to AAV5, and they have been excluded from previous trials because it was thought they wouldn’t take the vector,” said Brodsky. “But only one patient didn’t get a response.”

Following a single dose of etranacogene dezaparvovec, Factor IX activity increased into the mild to normal range without the need for prophylactic immunosuppression. Treated patients were able to discontinue prophylaxis and bleeding was controlled in most of the cohort.

“This is a big advance and we are getting very close to the point where gene therapy is going to be standard of care for some forms of hemophilia,” said Brodsky. However, he added that “we will still need to see more patients and have longer follow-up.”

He added that, with time, the technology behind gene therapy will probably become less expensive and more accessible to more patients, which will help become a standard of care.

This is also the hope for the technology behind chimeric antigen receptor T-cell (CAR-T) therapy, he added. At present, this cellular therapy is manufactured individually for each patient and is very expensive, but work on “off-the-shelf” products is underway. This topic will be explored during the presidential symposium, entitled, “Universal Donor Solutions in Hematology.”

New data on one of the currently available CAR-T cell products will be presented at the meeting. The phase 2 ZUMA-5 trial showed that axicabtagene ciloleucel (Axi-Cel) may be a viable option for some patients with high-risk non-Hodgkin lymphoma who have not responded to standard treatments (abstract 700).

At a median follow-up of almost 18 months, 92% of participants achieved an objective response, and 78% achieved a complete response to the treatment. By 12 months, 72% were still in response, and at 17.5 months, 64% were still in response.

“We were very impressed with the magnitude of the responses, and also the durability,” said senior study author Caron Jacobson, MD, of the Dana-Farber Cancer Institute, Boston, in a press release. “I was also struck early on by how favorable the safety profile was compared to what we’ve been seeing in the fast-growing lymphomas, such as large B cell lymphoma.”
 

Race and bloods cancers

ASH president Stephanie Lee, MD, MPH, highlighted several abstracts on disparities that will be presented at the meeting. One of these, which is to be presented during the plenary session, is an analysis of patient survival in acute myeloid leukemia (AML) (abstract 6).

It found that “self-reported race was the best indicator of survival,” noted Lee.

Overall survival at 3 years was 41% in White patients versus 32% in Black patients, a difference that was highly significant, she noted.

Part of the study also evaluated patients who were all on the same chemotherapy protocol, “so there was no effect of different treatment since they were on therapy determined by the trial,” said Lee.

Black patients were less likely to have normal cytogenetics compared with White patients (38% vs 51%; P = .01) and had a lower frequency of prognostically favorable NPM1 mutations (25% vs 38%; P = .04), but higher frequencies of spliceosome gene mutations (24% vs 12%; P = .009). Therefore, the results showed race was an independent prognosticator of poor survival in AML, aside from established molecular markers.

A special scientific session on race will be held on Dec. 5, Lee noted. While other abstracts consider race from the patient side, this session will focus on the scientist’s side, she explained, and address questions such as: “What are the implications of diversity and racism? And how does that impact scientists who are from underrepresented minorities?” 
 

COVID-19 and blood disorders

Lee also highlighted a study (abstract 215) that analyzed emerging data from the ASH Research Collaborative COVID-19 Registry for Hematology, which was developed to look at outcomes of COVID-19 infection in patients with underlying blood disorders.

An analysis of data from 250 patients at 74 sites around the world found that overall mortality was 28%. “This supports the emerging consensus that patients with hematologic malignancies experience significant morbidity and mortality from COVID-19 infection,” say the authors.

“We do need real-world data to see how SARS-CoV-2 is affecting our patients with hematologic diseases or those who don’t have a hematologic disease but who are then infected with the coronavirus and develop a hematologic problem like blood clots,” said Lee.

“More data will be coming in, but this is a good example of trying to harness real-world information to learn things until we have more controlled trials.”
 

‘Fireside chat’ with Fauci

COVID-19 will be on the agenda for a special session billed as a “fireside chat” with Anthony Fauci, MD, of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“This will be kicking off our meeting on Saturday morning,” said Lee.

This article first appeared on Medscape.com.

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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

As an increasing number of health systems implement “hospital-at-home” (HaH) programs to increase their traditional hospital capacity, the Centers for Medicare & Medicaid Services has given the movement a boost by changing its regulations to allow acute care to be provided in a patient’s home under certain conditions.

The CMS announced Nov. 25 that it was launching its Acute Hospital Care at Home program “to increase the capacity of the American health care system” during the COVID-19 pandemic.

At the same time, the agency announced it was giving more flexibility to ambulatory surgery centers (ASCs) to provide hospital-level care.

The CMS said its new HaH program is an expansion of the Hospitals Without Walls initiative that was unveiled last March. Hospitals Without Walls is a set of “temporary new rules” that provide flexibility for hospitals to provide acute care outside of inpatient settings. Under those rules, hospitals are able to transfer patients to outside facilities, such as ASCs, inpatient rehabilitation hospitals, hotels, and dormitories, while still receiving Medicare hospital payments.

Under CMS’ new Acute Hospital Care at Home, which is not described as temporary, patients can be transferred from emergency departments or inpatient wards to hospital-level care at home. The CMS said the HaH program is designed for people with conditions such as the acute phases of asthma, heart failure, pneumonia, and chronic obstructive pulmonary disease. Altogether, the agency said, more than 60 acute conditions can be treated safely at home.

However, the agency didn’t say that facilities can’t admit COVID-19 patients to the hospital at home. Rami Karjian, MBA, cofounder and CEO of Medically Home, a firm that supplies health systems with technical services and software for HaH programs, said in an interview that several Medically Home clients plan to treat both COVID-19 and non-COVID-19 patients at home when they begin to participate in the CMS program in the near future.

The CMS said it consulted extensively with academic and private industry leaders in building its HaH program. Before rolling out the initiative, the agency noted, it conducted successful pilot programs in leading hospitals and health systems. The results of some of these pilots have been reported in academic journals.

Participating hospitals will be required to have specified screening protocols in place before beginning acute care at home, the CMS announced. An in-person physician evaluation will be required before starting care at home. A nurse will evaluate each patient once daily in person or remotely, and either nurses or paramedics will visit the patient in person twice a day.

In contrast, Medicare regulations require nursing staff to be available around the clock in traditional hospitals. So the CMS has to grant waivers to hospitals for HaH programs.

While not going into detail on the telemonitoring capabilities that will be required in the acute hospital care at home, the release said, “Today’s announcement builds upon the critical work by CMS to expand telehealth coverage to keep beneficiaries safe and prevent the spread of COVID-19.”
 

More flexibility for ASCs

The agency is also giving ASCs the flexibility to provide 24-hour nursing services only when one or more patients are receiving care on site. This flexibility will be available to any of the 5,700 ASCs that wish to participate, and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, the CMS said.

The new ASC regulations, the CMS said, are aimed at allowing communities “to maintain surgical capacity and other life-saving non-COVID-19 [care], like cancer surgeries.” Patients who need such procedures will be able to receive them in ASCs without being exposed to known COVID-19 cases.

Similarly, the CMS said patients and families not diagnosed with COVID-19 may prefer to receive acute care at home if local hospitals are full of COVID-19 patients. In addition, the CMS said it anticipates patients may value the ability to be treated at home without the visitation restrictions of hospitals.
 

Early HaH participants

Six health systems with extensive experience in providing acute hospital care at home have been approved for the new HaH waivers from Medicare rules. They include Brigham and Women’s Hospital (Massachusetts); Huntsman Cancer Institute (Utah); Massachusetts General Hospital (Massachusetts); Mount Sinai Health System (New York City); Presbyterian Healthcare Services (New Mexico); and UnityPoint Health (Iowa).

The CMS said that it’s in discussions with other health care systems and expects new applications to be submitted soon.

To support these efforts, the CMS has launched an online portal to streamline the waiver request process. The agency said it will closely monitor the program to safeguard beneficiaries and will require participating hospitals to report quality and safety data on a regular basis.
 

Support from hospitals

The first health systems participating in the CMS HaH appear to be supportive of the program, with some hospital leaders submitting comments to the CMS about their view of the initiative.

“The CMS has taken an extraordinary step today, facilitating the rapid expansion of Hospitalization at Home, an innovative care model with proven results,” said Kenneth L. Davis, MD, president and CEO of the Mount Sinai Health System in New York City. “This important and timely move will enable hospitals across the country to use effective tools to safely care for patients during this pandemic.”

David Levine, MD, assistant professor of medicine and medical director of strategy and innovation for Brigham Health Home Hospital in Boston, was similarly laudatory: “Our research at Brigham Health Home has shown that we can deliver hospital-level care in our patients’ homes with lower readmission rates, more physical mobility, and a positive patient experience,” he said. “During these challenging times, a focus on the home is critical. We are so encouraged that CMS is taking this important step, which will allow hospitals across the country to increase their capacity while delivering the care all patients deserve.”
 

Scaling up quickly

If other hospitals and health systems recognize the value of HaH, how long might it take them to develop and implement these programs in the midst of a pandemic?

Atrium Health, a large health system in the Southeast, ramped up a hospital-at-home initiative last spring for its 10 hospitals in the Charlotte, N.C., area, in just 2 weeks. However, it had been working on the project for some time before the pandemic struck. Focusing mostly on COVID-19 patients, the initiative reduced the COVID-19 patient load by 20%-25% in Atrium’s hospitals.

Medically Home, the HaH infrastructure company, said in a news release that it “enables health systems to establish new hospital-at-home services in as little as 30 days.” Medically Home has partnered in this venture with Huron Consulting Group, which has about 200 HaH-trained consultants, and Cardinal Health, a large global medical supplies distributor.

Mr. Karjian said in an interview that he expects private insurers to follow CMS’ example, as they often do. “We think this decision will cause not only CMS but private insurers to cover hospital at home after the pandemic, if it becomes the standard of care, because patients have better outcomes when treated at home,” he said.

Asked for his view on why the CMS specified that patients could be admitted to an HaH only from emergency departments or inpatient settings, Mr. Karjian said that the CMS wants to make sure that patients have access to brick-and-mortar hospital care if that’s what they need. Also, he noted, this model is new to most hospitals, so the CMS wants to make sure it starts “with all the safety guardrails” in place.

Overall, Mr. Karjian said, “This is an exciting development for patients across the country. What CMS has done is terrific in terms of letting patients get the care they want, where they want it, and get the benefit of better outcomes while the nation is going through this capacity crunch for hospital beds.”

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