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FDA proposes new rule for over-the-counter hearing aids
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
Survey spotlights double-edged sword for minority cardiologists
Survey results paint a stark picture of discrimination among racial minorities in the cardiology workforce but also a strong sense of belonging.
Among respondents to the 2015 American College of Cardiology (ACC) Professional Life Survey, which is the most recent survey, over half (52.3%) of underrepresented racial and ethnic minorities (URMs) and 45.5% of Asian or Pacific Islanders reported experiencing discrimination compared with 36.4% of Whites (both P < .01).
Nevertheless, 91.2% of URMs reported being satisfied with their career, as did 90% of Asians or Pacific Islanders and 89.1% of Whites.
Satisfaction with financial compensation also did not differ between groups, and most cardiologists believed their opportunities for advancement were similar to those of their peers.
One possible explanation is that the respondents may simply be people who’ve had better experiences, lead author Kevin L. Thomas, MD, Duke Clinical Research Institute, Durham, N.C., and colleagues told this news organization. A second hypothesis looks more to sheer determination, or grit.
“Perhaps along the sometimes circuitous pathway to being a cardiologist – which is a lot of training, a lot of standardized testing, a lot of applications – that maybe you sub-select a group of individuals who are simply more resilient based on their life experiences and things that they’ve overcome to get where they are,” he said.
Interestingly, rates of burnout were lower among URMs (22.4%) and Asians/Pacific Islanders (20.1%) than Whites (30.3%; P = .02 and P < .01, respectively). The finding is unexpected but in line with a recent report of more than 4,400 U.S. physicians finding lower odds of burnout among Asian, Hispanic/Latinx, and Black physicians.
The new study, published October 18 in the Journal of the American College of Cardiology, however, affirms that women of all racial and ethnic groups face significant headwinds in the White, male-dominated cardiology workforce.
Just 13.9% of White men reported experiencing discrimination, compared with 44.6% of URM men and 36.2% of Asians/Pacific Islander men. In comparison, 69.2% of White women reported discrimination, as did 62.7% of URM women and 57% of Asian/Pacific Islander women (both P <.01).
“When you look specifically at White men versus White women, there is a large discrepancy there, and it just shows us, I think, for a lot of different groups, we still have a long way to go in terms of trying to achieve equity and to try to be inclusive in the workplace,” Dr. Thomas said.
Men were more likely to experience race- and religion-based discrimination in the workplace, whereas nearly all women reported sex discrimination, with parenting an important second. Approximately 85% of cardiologists reported being satisfied with their family lives, although unpublished data suggest URMs were less likely to be married and to have fewer children, Dr. Thomas said.
During job negotiations, URM cardiologists were less likely to prioritize salary, benefits, and work hours for their first job (13.6%, 10.9% 19.3%) than White cardiologists (20.6%, 23.3%, 31.3%; P < .02 for all).
In subsequent negotiations, URMs placed more emphasis on salary, benefits, and work hours than Whites, whereas both URMs and Asians/Pacific Islanders placed a greater importance on travel benefits, diversity, mentoring, workspace, time to promotion, academic rank, and roles with community, institutional, or national recognition, which the authors say, “might indicate a greater need to overcome systemic barriers.”
Three-fourths of all cardiologist respondents had a mentor during training, which can take many shapes, Dr. Thomas noted. “Within my own section as an electrophysiologist, which is a very subspecialized category, we have four Black electrophysiologists, and I think it was because many of us mentored each other as we came along, and it inspired us.”
URMs are more likely to experience the so-called “minority tax” of being tapped for added responsibilities in the name of inclusivity efforts, he said, and called on individuals from the dominant culture to mentor or sponsor cardiologists from other racial groups and to carve out leadership pathways for women and minorities so they “can use their gifts to benefit the profession at large,” leading clinical trials or steering committees and serving in high-profile roles.
Although the events of 2020 sharpened attention on the issue of diversity in America, Dr. Thomas and colleagues say that more work needs to be done defining the problem and that professional organizations and health systems also should systematically collect sex, racial, and ethnic identifies of members using classifications similar to the 2020 U.S. Census.
The study was based on 2,245 respondents to the 2015 Professional Life Survey, which was not specifically designed to assess racial/ethnic diversity topics and had a response rate of 21%, which limited representatives of each group.
In all, 197 were from URMs (80 Blacks, 113 Hispanics, 4 Native Americans), 564 were Asians/Pacific Islanders, 1,447 were Whites, and 37 listed multiracial/other. More than half (58%) were men, and most were adult cardiologists (83% to 85%), followed by pediatric cardiology (6% to 10%) and cardiovascular surgery (1% to 2%).
“Further research is needed to understand these findings and their significance, because ongoing efforts within ACC and other organizations to increase diversity will fail unless this is successfully addressed,” the authors conclude.
To that end, Dr. Thomas said they are looking to develop a new survey that taps other groups like the Association of Black Cardiologists and members of the LGBTQ community.
“I’m really excited about the opportunity to develop a survey that specifically has the objective of trying to understand the experiences of systematically disadvantaged, historically marginalized groups to see if we can see the same information, but maybe through a clear lens, and then be able to develop strategies to mitigate some of the challenges that we see” he said. “So we can increase the numbers and also have a workforce that is reflective of the populations that we take care of and the nation as a whole.”
The study was funded by the American College of Cardiology. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Survey results paint a stark picture of discrimination among racial minorities in the cardiology workforce but also a strong sense of belonging.
Among respondents to the 2015 American College of Cardiology (ACC) Professional Life Survey, which is the most recent survey, over half (52.3%) of underrepresented racial and ethnic minorities (URMs) and 45.5% of Asian or Pacific Islanders reported experiencing discrimination compared with 36.4% of Whites (both P < .01).
Nevertheless, 91.2% of URMs reported being satisfied with their career, as did 90% of Asians or Pacific Islanders and 89.1% of Whites.
Satisfaction with financial compensation also did not differ between groups, and most cardiologists believed their opportunities for advancement were similar to those of their peers.
One possible explanation is that the respondents may simply be people who’ve had better experiences, lead author Kevin L. Thomas, MD, Duke Clinical Research Institute, Durham, N.C., and colleagues told this news organization. A second hypothesis looks more to sheer determination, or grit.
“Perhaps along the sometimes circuitous pathway to being a cardiologist – which is a lot of training, a lot of standardized testing, a lot of applications – that maybe you sub-select a group of individuals who are simply more resilient based on their life experiences and things that they’ve overcome to get where they are,” he said.
Interestingly, rates of burnout were lower among URMs (22.4%) and Asians/Pacific Islanders (20.1%) than Whites (30.3%; P = .02 and P < .01, respectively). The finding is unexpected but in line with a recent report of more than 4,400 U.S. physicians finding lower odds of burnout among Asian, Hispanic/Latinx, and Black physicians.
The new study, published October 18 in the Journal of the American College of Cardiology, however, affirms that women of all racial and ethnic groups face significant headwinds in the White, male-dominated cardiology workforce.
Just 13.9% of White men reported experiencing discrimination, compared with 44.6% of URM men and 36.2% of Asians/Pacific Islander men. In comparison, 69.2% of White women reported discrimination, as did 62.7% of URM women and 57% of Asian/Pacific Islander women (both P <.01).
“When you look specifically at White men versus White women, there is a large discrepancy there, and it just shows us, I think, for a lot of different groups, we still have a long way to go in terms of trying to achieve equity and to try to be inclusive in the workplace,” Dr. Thomas said.
Men were more likely to experience race- and religion-based discrimination in the workplace, whereas nearly all women reported sex discrimination, with parenting an important second. Approximately 85% of cardiologists reported being satisfied with their family lives, although unpublished data suggest URMs were less likely to be married and to have fewer children, Dr. Thomas said.
During job negotiations, URM cardiologists were less likely to prioritize salary, benefits, and work hours for their first job (13.6%, 10.9% 19.3%) than White cardiologists (20.6%, 23.3%, 31.3%; P < .02 for all).
In subsequent negotiations, URMs placed more emphasis on salary, benefits, and work hours than Whites, whereas both URMs and Asians/Pacific Islanders placed a greater importance on travel benefits, diversity, mentoring, workspace, time to promotion, academic rank, and roles with community, institutional, or national recognition, which the authors say, “might indicate a greater need to overcome systemic barriers.”
Three-fourths of all cardiologist respondents had a mentor during training, which can take many shapes, Dr. Thomas noted. “Within my own section as an electrophysiologist, which is a very subspecialized category, we have four Black electrophysiologists, and I think it was because many of us mentored each other as we came along, and it inspired us.”
URMs are more likely to experience the so-called “minority tax” of being tapped for added responsibilities in the name of inclusivity efforts, he said, and called on individuals from the dominant culture to mentor or sponsor cardiologists from other racial groups and to carve out leadership pathways for women and minorities so they “can use their gifts to benefit the profession at large,” leading clinical trials or steering committees and serving in high-profile roles.
Although the events of 2020 sharpened attention on the issue of diversity in America, Dr. Thomas and colleagues say that more work needs to be done defining the problem and that professional organizations and health systems also should systematically collect sex, racial, and ethnic identifies of members using classifications similar to the 2020 U.S. Census.
The study was based on 2,245 respondents to the 2015 Professional Life Survey, which was not specifically designed to assess racial/ethnic diversity topics and had a response rate of 21%, which limited representatives of each group.
In all, 197 were from URMs (80 Blacks, 113 Hispanics, 4 Native Americans), 564 were Asians/Pacific Islanders, 1,447 were Whites, and 37 listed multiracial/other. More than half (58%) were men, and most were adult cardiologists (83% to 85%), followed by pediatric cardiology (6% to 10%) and cardiovascular surgery (1% to 2%).
“Further research is needed to understand these findings and their significance, because ongoing efforts within ACC and other organizations to increase diversity will fail unless this is successfully addressed,” the authors conclude.
To that end, Dr. Thomas said they are looking to develop a new survey that taps other groups like the Association of Black Cardiologists and members of the LGBTQ community.
“I’m really excited about the opportunity to develop a survey that specifically has the objective of trying to understand the experiences of systematically disadvantaged, historically marginalized groups to see if we can see the same information, but maybe through a clear lens, and then be able to develop strategies to mitigate some of the challenges that we see” he said. “So we can increase the numbers and also have a workforce that is reflective of the populations that we take care of and the nation as a whole.”
The study was funded by the American College of Cardiology. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Survey results paint a stark picture of discrimination among racial minorities in the cardiology workforce but also a strong sense of belonging.
Among respondents to the 2015 American College of Cardiology (ACC) Professional Life Survey, which is the most recent survey, over half (52.3%) of underrepresented racial and ethnic minorities (URMs) and 45.5% of Asian or Pacific Islanders reported experiencing discrimination compared with 36.4% of Whites (both P < .01).
Nevertheless, 91.2% of URMs reported being satisfied with their career, as did 90% of Asians or Pacific Islanders and 89.1% of Whites.
Satisfaction with financial compensation also did not differ between groups, and most cardiologists believed their opportunities for advancement were similar to those of their peers.
One possible explanation is that the respondents may simply be people who’ve had better experiences, lead author Kevin L. Thomas, MD, Duke Clinical Research Institute, Durham, N.C., and colleagues told this news organization. A second hypothesis looks more to sheer determination, or grit.
“Perhaps along the sometimes circuitous pathway to being a cardiologist – which is a lot of training, a lot of standardized testing, a lot of applications – that maybe you sub-select a group of individuals who are simply more resilient based on their life experiences and things that they’ve overcome to get where they are,” he said.
Interestingly, rates of burnout were lower among URMs (22.4%) and Asians/Pacific Islanders (20.1%) than Whites (30.3%; P = .02 and P < .01, respectively). The finding is unexpected but in line with a recent report of more than 4,400 U.S. physicians finding lower odds of burnout among Asian, Hispanic/Latinx, and Black physicians.
The new study, published October 18 in the Journal of the American College of Cardiology, however, affirms that women of all racial and ethnic groups face significant headwinds in the White, male-dominated cardiology workforce.
Just 13.9% of White men reported experiencing discrimination, compared with 44.6% of URM men and 36.2% of Asians/Pacific Islander men. In comparison, 69.2% of White women reported discrimination, as did 62.7% of URM women and 57% of Asian/Pacific Islander women (both P <.01).
“When you look specifically at White men versus White women, there is a large discrepancy there, and it just shows us, I think, for a lot of different groups, we still have a long way to go in terms of trying to achieve equity and to try to be inclusive in the workplace,” Dr. Thomas said.
Men were more likely to experience race- and religion-based discrimination in the workplace, whereas nearly all women reported sex discrimination, with parenting an important second. Approximately 85% of cardiologists reported being satisfied with their family lives, although unpublished data suggest URMs were less likely to be married and to have fewer children, Dr. Thomas said.
During job negotiations, URM cardiologists were less likely to prioritize salary, benefits, and work hours for their first job (13.6%, 10.9% 19.3%) than White cardiologists (20.6%, 23.3%, 31.3%; P < .02 for all).
In subsequent negotiations, URMs placed more emphasis on salary, benefits, and work hours than Whites, whereas both URMs and Asians/Pacific Islanders placed a greater importance on travel benefits, diversity, mentoring, workspace, time to promotion, academic rank, and roles with community, institutional, or national recognition, which the authors say, “might indicate a greater need to overcome systemic barriers.”
Three-fourths of all cardiologist respondents had a mentor during training, which can take many shapes, Dr. Thomas noted. “Within my own section as an electrophysiologist, which is a very subspecialized category, we have four Black electrophysiologists, and I think it was because many of us mentored each other as we came along, and it inspired us.”
URMs are more likely to experience the so-called “minority tax” of being tapped for added responsibilities in the name of inclusivity efforts, he said, and called on individuals from the dominant culture to mentor or sponsor cardiologists from other racial groups and to carve out leadership pathways for women and minorities so they “can use their gifts to benefit the profession at large,” leading clinical trials or steering committees and serving in high-profile roles.
Although the events of 2020 sharpened attention on the issue of diversity in America, Dr. Thomas and colleagues say that more work needs to be done defining the problem and that professional organizations and health systems also should systematically collect sex, racial, and ethnic identifies of members using classifications similar to the 2020 U.S. Census.
The study was based on 2,245 respondents to the 2015 Professional Life Survey, which was not specifically designed to assess racial/ethnic diversity topics and had a response rate of 21%, which limited representatives of each group.
In all, 197 were from URMs (80 Blacks, 113 Hispanics, 4 Native Americans), 564 were Asians/Pacific Islanders, 1,447 were Whites, and 37 listed multiracial/other. More than half (58%) were men, and most were adult cardiologists (83% to 85%), followed by pediatric cardiology (6% to 10%) and cardiovascular surgery (1% to 2%).
“Further research is needed to understand these findings and their significance, because ongoing efforts within ACC and other organizations to increase diversity will fail unless this is successfully addressed,” the authors conclude.
To that end, Dr. Thomas said they are looking to develop a new survey that taps other groups like the Association of Black Cardiologists and members of the LGBTQ community.
“I’m really excited about the opportunity to develop a survey that specifically has the objective of trying to understand the experiences of systematically disadvantaged, historically marginalized groups to see if we can see the same information, but maybe through a clear lens, and then be able to develop strategies to mitigate some of the challenges that we see” he said. “So we can increase the numbers and also have a workforce that is reflective of the populations that we take care of and the nation as a whole.”
The study was funded by the American College of Cardiology. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Expensive insulins, pen devices dominate U.S. diabetes care
Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.
The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.
The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.
Few studies indicate analog insulins better than human insulins
“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.
“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.
“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.
However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.
Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”
The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.
Analogs prevailed, while biosimilar use rose
The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.
Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.
Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.
On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.
Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.
The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.
Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.
“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.
“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”
By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.
Use of pen devices also increased
The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.
“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.
The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.
“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.
Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.
A version of this article first appeared on Medscape.com.
Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.
The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.
The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.
Few studies indicate analog insulins better than human insulins
“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.
“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.
“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.
However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.
Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”
The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.
Analogs prevailed, while biosimilar use rose
The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.
Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.
Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.
On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.
Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.
The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.
Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.
“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.
“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”
By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.
Use of pen devices also increased
The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.
“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.
The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.
“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.
Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.
A version of this article first appeared on Medscape.com.
Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.
The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.
The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.
Few studies indicate analog insulins better than human insulins
“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.
“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.
“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.
However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.
Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”
The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.
Analogs prevailed, while biosimilar use rose
The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.
Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.
Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.
On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.
Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.
The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.
Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.
“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.
“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”
By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.
Use of pen devices also increased
The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.
“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.
The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.
“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.
Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.
A version of this article first appeared on Medscape.com.
What I will and won’t miss
Someday I plan to retire.
Hopefully it’s not coming up anytime soon, but I’m sure it’s sooner than I realize. I’ve been in practice for 23 years, so I’m well past the halfway point of an average medical career.
I will miss a lot. There will be many things I won’t miss, but the job has far more good than bad, even today.
I’ve spent a lot of time at this huge desk, which my dad bought for his solo law practice in 1967. Although I won’t miss the lack of sleep, I will miss the silence of getting to the office before first light, making tea, and getting started for the day. It’s a peaceful daily start in a less-then-predictable job.
I’ll miss my patients. Not all of them, but most. The majority are decent people, and it’s an honor to be able to help them. Doing that has been the driving force that started me on this path a long time ago and still keeps me moving forward.
In some respects I’ll feel bad about retiring and leaving them. Some have been with me since residency. It will bother me that they’ll have to start over with a new neurologist. Hopefully that person will give them care as good, if not better, than I have.
I’ll really miss my staff. I’ve been lucky. They’re awesome, and have stayed with me for this crazy ride. My MA has been here since 1999, my secretary since 2004. At work they’re my family. Away from work they’re a part of my family. The three of us have survived my hospital call, good economic times, bad economic times, moving the office, my MA moving to the boondocks, the antics and events of our kids, and, as of now, a pandemic. They make the day fun. I’ll feel bad that they’ll need to change jobs if they’re still working then.
What I won’t miss are more concrete things – the endless forms, time spent on the phone and online to get medications and tests approved, the difficult (personality wise) patients who think being nasty and mean is going to get them better care, and having to practice CYA defensive medicine.
It’s good to look back after 23 years, and still have, overall, no regrets about choosing this ride.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Someday I plan to retire.
Hopefully it’s not coming up anytime soon, but I’m sure it’s sooner than I realize. I’ve been in practice for 23 years, so I’m well past the halfway point of an average medical career.
I will miss a lot. There will be many things I won’t miss, but the job has far more good than bad, even today.
I’ve spent a lot of time at this huge desk, which my dad bought for his solo law practice in 1967. Although I won’t miss the lack of sleep, I will miss the silence of getting to the office before first light, making tea, and getting started for the day. It’s a peaceful daily start in a less-then-predictable job.
I’ll miss my patients. Not all of them, but most. The majority are decent people, and it’s an honor to be able to help them. Doing that has been the driving force that started me on this path a long time ago and still keeps me moving forward.
In some respects I’ll feel bad about retiring and leaving them. Some have been with me since residency. It will bother me that they’ll have to start over with a new neurologist. Hopefully that person will give them care as good, if not better, than I have.
I’ll really miss my staff. I’ve been lucky. They’re awesome, and have stayed with me for this crazy ride. My MA has been here since 1999, my secretary since 2004. At work they’re my family. Away from work they’re a part of my family. The three of us have survived my hospital call, good economic times, bad economic times, moving the office, my MA moving to the boondocks, the antics and events of our kids, and, as of now, a pandemic. They make the day fun. I’ll feel bad that they’ll need to change jobs if they’re still working then.
What I won’t miss are more concrete things – the endless forms, time spent on the phone and online to get medications and tests approved, the difficult (personality wise) patients who think being nasty and mean is going to get them better care, and having to practice CYA defensive medicine.
It’s good to look back after 23 years, and still have, overall, no regrets about choosing this ride.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Someday I plan to retire.
Hopefully it’s not coming up anytime soon, but I’m sure it’s sooner than I realize. I’ve been in practice for 23 years, so I’m well past the halfway point of an average medical career.
I will miss a lot. There will be many things I won’t miss, but the job has far more good than bad, even today.
I’ve spent a lot of time at this huge desk, which my dad bought for his solo law practice in 1967. Although I won’t miss the lack of sleep, I will miss the silence of getting to the office before first light, making tea, and getting started for the day. It’s a peaceful daily start in a less-then-predictable job.
I’ll miss my patients. Not all of them, but most. The majority are decent people, and it’s an honor to be able to help them. Doing that has been the driving force that started me on this path a long time ago and still keeps me moving forward.
In some respects I’ll feel bad about retiring and leaving them. Some have been with me since residency. It will bother me that they’ll have to start over with a new neurologist. Hopefully that person will give them care as good, if not better, than I have.
I’ll really miss my staff. I’ve been lucky. They’re awesome, and have stayed with me for this crazy ride. My MA has been here since 1999, my secretary since 2004. At work they’re my family. Away from work they’re a part of my family. The three of us have survived my hospital call, good economic times, bad economic times, moving the office, my MA moving to the boondocks, the antics and events of our kids, and, as of now, a pandemic. They make the day fun. I’ll feel bad that they’ll need to change jobs if they’re still working then.
What I won’t miss are more concrete things – the endless forms, time spent on the phone and online to get medications and tests approved, the difficult (personality wise) patients who think being nasty and mean is going to get them better care, and having to practice CYA defensive medicine.
It’s good to look back after 23 years, and still have, overall, no regrets about choosing this ride.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Timeless stories
Let me tell you a story. In 5 billion years the sun will run out of hydrogen, the fuel it is currently burning to power my solar panels amongst other things. At that time, the sun will no longer be able to keep its core contracted and will expand into a fiery, red giant, engulfing earth and obliterating any sign that we ever existed. No buildings. No blog posts. No mausoleums. No stories. Nothing of us will remain.
Well, here for a moment anyway, I’ve gotten you to think about something other than COVID. You’re welcome.
Fascinatingly, the image in your mind’s eye right now of a barren scorched landscape was put there by me. Simply by placing a few words together I have caused new thoughts in your head. You might even share this story with someone else – I would have actually changed your behavior through the power of language. This miraculous phenomenon seems to be unique to us humans; we are the only ones who can create whole worlds in another individual’s head just by making a few sounds. We in medicine have the privilege of experiencing this miracle every day.
Last week, a 97-year-old pale, frail, white man saw me for a basal cell carcinoma on his cheek. While performing a simple electrodesiccation and curettage, I asked if he remembers getting a lot of sunburns when he was young. He certainly remembered one. On a blustery sunny day, he fell asleep for hours on the deck of the USS West Virginia while in the Philippines. As a radio man, he was exhausted from days of conflict and he recalled how warm breezes lulled him asleep. He was so sunburned that for days he forgot how afraid he was of the Japanese.
After listening to his story, I had an image in my mind of palm trees swaying in the tropical winds while hundreds of hulking gray castles sat hidden in the vast surrounding oceans awaiting one of the greatest naval conflicts in history. I got to hear it from surely one of the last remaining people in existence to be able to tell that story. Listening to a patient’s tales is one of the benefits of being a physician. Not only do they help bond us with our patients, but also help lessen our burden of having to make diagnosis after diagnosis and write note after note for hours on end. Somehow performing yet another biopsy that day is made just a bit easier if I’m also learning about what it was like at the Battle of Leyte Gulf.
Encouraging patients to talk more can be risky. No physician, not even allergists, can afford to be waylaid by a retiree with nothing else to do today. But meaningful encounters can not only be a vaccine against burnout, they also lead to better patient adherence and satisfaction. Sometimes, there is simply not time. But often there is a little window during a procedure or when you’re reasonably caught up and don’t expect delays ahead. And like every story, they literally transform us, the listener. In a true physical sense, their stories live on in me, and now that I’ve shared this one in writing, also with you for perpetuity. That is at least for the next 5 billion years when it, too, will be swallowed by the sun, leaving only a crispy, smoking rock where we once existed.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
Let me tell you a story. In 5 billion years the sun will run out of hydrogen, the fuel it is currently burning to power my solar panels amongst other things. At that time, the sun will no longer be able to keep its core contracted and will expand into a fiery, red giant, engulfing earth and obliterating any sign that we ever existed. No buildings. No blog posts. No mausoleums. No stories. Nothing of us will remain.
Well, here for a moment anyway, I’ve gotten you to think about something other than COVID. You’re welcome.
Fascinatingly, the image in your mind’s eye right now of a barren scorched landscape was put there by me. Simply by placing a few words together I have caused new thoughts in your head. You might even share this story with someone else – I would have actually changed your behavior through the power of language. This miraculous phenomenon seems to be unique to us humans; we are the only ones who can create whole worlds in another individual’s head just by making a few sounds. We in medicine have the privilege of experiencing this miracle every day.
Last week, a 97-year-old pale, frail, white man saw me for a basal cell carcinoma on his cheek. While performing a simple electrodesiccation and curettage, I asked if he remembers getting a lot of sunburns when he was young. He certainly remembered one. On a blustery sunny day, he fell asleep for hours on the deck of the USS West Virginia while in the Philippines. As a radio man, he was exhausted from days of conflict and he recalled how warm breezes lulled him asleep. He was so sunburned that for days he forgot how afraid he was of the Japanese.
After listening to his story, I had an image in my mind of palm trees swaying in the tropical winds while hundreds of hulking gray castles sat hidden in the vast surrounding oceans awaiting one of the greatest naval conflicts in history. I got to hear it from surely one of the last remaining people in existence to be able to tell that story. Listening to a patient’s tales is one of the benefits of being a physician. Not only do they help bond us with our patients, but also help lessen our burden of having to make diagnosis after diagnosis and write note after note for hours on end. Somehow performing yet another biopsy that day is made just a bit easier if I’m also learning about what it was like at the Battle of Leyte Gulf.
Encouraging patients to talk more can be risky. No physician, not even allergists, can afford to be waylaid by a retiree with nothing else to do today. But meaningful encounters can not only be a vaccine against burnout, they also lead to better patient adherence and satisfaction. Sometimes, there is simply not time. But often there is a little window during a procedure or when you’re reasonably caught up and don’t expect delays ahead. And like every story, they literally transform us, the listener. In a true physical sense, their stories live on in me, and now that I’ve shared this one in writing, also with you for perpetuity. That is at least for the next 5 billion years when it, too, will be swallowed by the sun, leaving only a crispy, smoking rock where we once existed.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
Let me tell you a story. In 5 billion years the sun will run out of hydrogen, the fuel it is currently burning to power my solar panels amongst other things. At that time, the sun will no longer be able to keep its core contracted and will expand into a fiery, red giant, engulfing earth and obliterating any sign that we ever existed. No buildings. No blog posts. No mausoleums. No stories. Nothing of us will remain.
Well, here for a moment anyway, I’ve gotten you to think about something other than COVID. You’re welcome.
Fascinatingly, the image in your mind’s eye right now of a barren scorched landscape was put there by me. Simply by placing a few words together I have caused new thoughts in your head. You might even share this story with someone else – I would have actually changed your behavior through the power of language. This miraculous phenomenon seems to be unique to us humans; we are the only ones who can create whole worlds in another individual’s head just by making a few sounds. We in medicine have the privilege of experiencing this miracle every day.
Last week, a 97-year-old pale, frail, white man saw me for a basal cell carcinoma on his cheek. While performing a simple electrodesiccation and curettage, I asked if he remembers getting a lot of sunburns when he was young. He certainly remembered one. On a blustery sunny day, he fell asleep for hours on the deck of the USS West Virginia while in the Philippines. As a radio man, he was exhausted from days of conflict and he recalled how warm breezes lulled him asleep. He was so sunburned that for days he forgot how afraid he was of the Japanese.
After listening to his story, I had an image in my mind of palm trees swaying in the tropical winds while hundreds of hulking gray castles sat hidden in the vast surrounding oceans awaiting one of the greatest naval conflicts in history. I got to hear it from surely one of the last remaining people in existence to be able to tell that story. Listening to a patient’s tales is one of the benefits of being a physician. Not only do they help bond us with our patients, but also help lessen our burden of having to make diagnosis after diagnosis and write note after note for hours on end. Somehow performing yet another biopsy that day is made just a bit easier if I’m also learning about what it was like at the Battle of Leyte Gulf.
Encouraging patients to talk more can be risky. No physician, not even allergists, can afford to be waylaid by a retiree with nothing else to do today. But meaningful encounters can not only be a vaccine against burnout, they also lead to better patient adherence and satisfaction. Sometimes, there is simply not time. But often there is a little window during a procedure or when you’re reasonably caught up and don’t expect delays ahead. And like every story, they literally transform us, the listener. In a true physical sense, their stories live on in me, and now that I’ve shared this one in writing, also with you for perpetuity. That is at least for the next 5 billion years when it, too, will be swallowed by the sun, leaving only a crispy, smoking rock where we once existed.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.
PA defends against license suspension for COVID treatment
The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.
“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”
Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”
Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.
“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.
Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”
In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.
Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.
A version of this article first appeared on Medscape.com.
The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.
“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”
Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”
Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.
“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.
Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”
In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.
Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.
A version of this article first appeared on Medscape.com.
The suspension stemmed from allegations against Scott C. Miller, PA-C, by at least six COVID patients, including some who weren’t his patients or whom he never examined and a few who later died from the virus, according to the Washington Medical Commission.
“Miller’s treatment of COVID-19 patients fell below the standard of care,” the suspension report states. “Miller began a public campaign promoting ivermectin as a curative for COVID-19, and prescribing it without adequate examination to at least one person, with no reliable clinical studies that establish its efficacy in preventing or treating COVID-19.”
Mr. Miller has until early November to respond to the allegations. On his clinic’s website, Mr. Miller stated, “In response to the charges, I want to reassure all of you that the initial attacks against me have been brought on by a small handful of people that have no ties to our medical practice, and by pharmacies and hospitals that have a zero tolerance policy on family members asking that I help them advocate for loved ones that have been admitted and written off in our current system of dismissiveness and neglect.”
Mr. Miller also expressed gratitude for the support he has received recently. A GoFundMe campaign to raise money for Mr. Miller’s legal fund had raised more than $59,000 at press time. His GoFundMe page had been shared 2,400 times. He has more than 550 followers and more than 400 donors.
“I don’t know that I have the words to adequately describe the deep sense of love and connection I have received from you, the families I serve, and those that have reached out to me in this deeply challenging time,” he wrote on the clinic website.
Mr. Miller has spoken publicly about his anti-mask views and his support for ivermectin, according to the commission report. As part of the suspension, he was charged with making “misleading representations regarding the efficacy of non-FDA approved treatment and mask use.”
In one case that was cited in the report, a 39-year-old patient contacted the pediatric clinic, and Mr. Miller spoke with the patient by phone. The patient reported that he had tested positive for COVID. Mr. Miller advised the patient to take supplements, including vitamin D and C, zinc, and melatonin, and he prescribed ivermectin, dexamethasone, and azithromycin. He did not perform an exam, verify the information that the patient had provided, advise the patient regarding interactions, or order follow-up testing, the report states.
Other charges against Mr. Miller include harassing hospital staff by making threatening statements about hospitals and doctors who treat COVID-19 patients and misrepresenting his original 2013 license application. He denied on the application that he was being investigated by another licensing board. At the time, the California Physician Assistant Board was investigating him for providing medical care and prescribing without a supervising doctor’s authorization and without conducting physical exams, among other charges.
A version of this article first appeared on Medscape.com.
AHA: Quality of STEMI care has stalled, needs improvement
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
FROM CIRCULATION
COVID-19: Can doctors refuse to see unvaccinated patients?
In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.
“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”
Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”
Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”
Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.
Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.
“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”
The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”
In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.
“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”
Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”
Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”
Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.
Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.
“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”
The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”
In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.
“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”
Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”
Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”
Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.
Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.
“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”
The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”
In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
Midwife-assisted community births post low adverse outcomes
Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.
Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.
“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.
In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.
Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.
Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.
Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.
“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.
The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.
Birth location should be an informed decision
The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.
“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.
“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.
“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.
Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
Patient selection is key to successful community birth
The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.
“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.
Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.
“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.
“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.
“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.
The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.
Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.
Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.
“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.
In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.
Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.
Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.
Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.
“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.
The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.
Birth location should be an informed decision
The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.
“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.
“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.
“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.
Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
Patient selection is key to successful community birth
The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.
“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.
Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.
“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.
“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.
“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.
The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.
Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.
Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.
“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.
In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.
Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.
Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.
Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.
“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.
The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.
Birth location should be an informed decision
The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.
“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.
“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.
“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.
Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
Patient selection is key to successful community birth
The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.
“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.
Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.
“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.
“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.
“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.
The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.
FROM OBSTETRICS & GYNECOLOGY
New land mines in your next (and even current) employment contract
Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.
Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.
Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
You could be immediately terminated without notice
One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.
“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”
What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.
The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
No protections if you’re let go through no fault of your own
You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.
In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.
What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”
Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.
In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
Employer could unilaterally alter your compensation
Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.
Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.
What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”
“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
Accelerating notice for without-cause terminations
Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.
Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.
“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.
Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.
What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
You could be assigned to far-off locations
As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.
Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.
What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.
You could end up working too many off-hours
“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”
What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.
If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
You wouldn’t be able to work nearby if you left the job
Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.
“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”
Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.
For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.
What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
You might end up with too much call
Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.
Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.
But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.
Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.
What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
Physician must pay for reimbursement claw-backs by payers
When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?
In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.
What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
Some work may be outside of your subspecialty
In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.
For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.
What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.
What the employer promised isn’t in the contract
“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”
Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.
For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.
What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
Contract is simply accepted as is
“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.
But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.
The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”
Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.
“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”
A version of this article first appeared on Medscape.com.
Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.
Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.
Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
You could be immediately terminated without notice
One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.
“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”
What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.
The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
No protections if you’re let go through no fault of your own
You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.
In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.
What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”
Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.
In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
Employer could unilaterally alter your compensation
Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.
Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.
What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”
“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
Accelerating notice for without-cause terminations
Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.
Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.
“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.
Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.
What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
You could be assigned to far-off locations
As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.
Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.
What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.
You could end up working too many off-hours
“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”
What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.
If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
You wouldn’t be able to work nearby if you left the job
Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.
“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”
Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.
For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.
What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
You might end up with too much call
Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.
Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.
But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.
Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.
What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
Physician must pay for reimbursement claw-backs by payers
When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?
In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.
What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
Some work may be outside of your subspecialty
In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.
For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.
What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.
What the employer promised isn’t in the contract
“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”
Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.
For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.
What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
Contract is simply accepted as is
“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.
But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.
The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”
Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.
“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”
A version of this article first appeared on Medscape.com.
Physician employment contracts include some new dangers. This includes physicians taking a new job, but it also includes already-employed doctors who are being asked to resign a new contract that contains new conditions. A number of these new clauses have arisen because of COVID-19. When the pandemic dramatically reduced patient flow, many employers didn’t have enough money to pay doctors and didn’t always have physicians in the right location or practice setting.
Vowing this would never happen again, some employers have rewritten their physician contracts to make it easier to reassign and terminate physicians.
Here are 12 potential land mines in a physician employment contract, some of which were added as a result of the pandemic.
You could be immediately terminated without notice
One outcome of the pandemic is the growing use of “force majeure” clauses, which give the employer the right to reduce your compensation or even terminate you due to a natural disaster, which could include COVID.
“COVID made employers aware of the potential impact of disasters on their operations,” said Dan Shay, a health law attorney at Alice Gosfield & Associates in Philadelphia. “Therefore, even as the threat of COVID abates in many places, employers are continuing to put this provision in the contract.”
What can you do? “One way to get some protection is to rule out a termination without cause in the first year,” said Michael A. Cassidy, a physician contract attorney at Tucker Arensberg in Pittsburgh.
The force majeure clause is less likely to affect salary, but could impact bonus and incentive tied to performance. It’s wise to try to specifically limit how much the force majeure could reduce pay tied to performance, and to be prepared to negotiate that aspect of your contract.
No protections if you’re let go through no fault of your own
You could lose your job if your employer could not generate enough business and has to let some doctors go. This happened quite often in the early days of the COVID pandemic.
In these situations, the doctor has not done anything wrong to prompt the termination, but the restrictive covenant may still apply, meaning that the doctor would have to leave the area to find work.
What can you do? You’re in a good position to get this changed, said Christopher L. Nuland, a solo physician contract attorney in Jacksonville, Fla. “Many employers recognize that it would be draconian to require a restrictive covenant in this case, and they will agree to modify this provision.”
Similarly, the employer may not cover your tail insurance even if you were let go from your work through no fault of your own. Most malpractice policies for employer physicians require buying an extra policy, called a tail, if you leave. In some cases, the employer won’t provide a tail and will make the departing doctor buy it.
In these cases, “try for a compromise, such as stipulating that the party that caused the termination should pay for the tail,” Mr. Nuland said. “The employer may not agree to anything more than that because they want to set up a disincentive against you leaving.”
Employer could unilaterally alter your compensation
Many recent contracts give the employer the option to unilaterally modify compensation, such as changing the base salary or raising the target required for meeting the productivity bonus, said Ericka L. Adler, a physician contract attorney at Roetzel & Andress in Chicago.
Ms. Adler thought this change could have been prompted by employers’ financial problems during the pandemic. In the early months of COVID, many physicians were not making much money for the employer but still had to be paid. So employers added a clause saying they could reduce compensation at any time, she said.
What can you do? Harsh provisions like this often come up in contracts with private equity firms, Mr. Cassidy said. “The contract might say the employer can adjust compensation or even terminate physicians based on productivity or their profitability. And it may say that if they reassign you to a new location and you refuse, they can terminate you.”
“If you can’t get these clauses removed, try to reduce the impact of a termination by providing longer notice periods or by inserting a severance agreement,” Mr. Cassidy said.
Accelerating notice for without-cause terminations
Physicians who are convicted of a felony or other moral issue can usually be terminated immediately. But if you are terminated for other reasons – that is, “without cause” – you are given notice at a certain number of days before you have to leave (typically 60-90 days), so that you have time to find a new job.
Some recent contracts, however, allow for very little notice in without-cause terminations, which allows the employer to fire you in as little as 0 days after providing notice, Ms. Adler said.
“This means that, even if 90 days’ notice is provided in the contract, the employer can decide that your last day will be an earlier date,” she said.
Why is this happening? Ms. Adler said employers want to begin reallocating resources and patients as soon as possible. The problem came to employers’ attention during the COVID pandemic, when they were contractually forced to pay doctors for doing little or nothing during the notice period.
What can you do? Possibly not much, other than attempt to negotiate. “Large employers typically don’t want to drop this provision, but at the least, the doctor needs to understand the risk it creates for them,” she said.
You could be assigned to far-off locations
As patient care needs changed dramatically during the pandemic, employers needed to reassign doctors to new locations.
Some new contracts allow employers to simply inform the doctor that they are changing the work location. However, “you don’t want to be assigned to a new work location that is 50 miles away,” Mr. Nuland said.
What can you do? Mr. Nuland recommended adding new language saying that, if the new assignment is more than 20 miles away, both parties would have to approve it.
You could end up working too many off-hours
“Most employers won’t issue a specific work schedule,” Mr. Nuland said. “They want the flexibility to assign evening or weekend work, and it would be difficult for a young doctor to change this.”
What can you do? Mr. Nuland recommended trying to set some limits. “You can try to limit off-hours work to two times a month or something like that,” she said. And if you need to have a special schedule, such as not working on Fridays, Adler advises that this should be put into the contract.
If you can’t get anything changed in the contract, Mr. Nuland said the next-best thing is to ask employers to tell you specifically what they plan to do with you. “Most employers will give you an informal idea of what’s expected – maybe not an exact schedule, but it’s quite likely they will honor it.”
You wouldn’t be able to work nearby if you left the job
Most contracts have a noncompete clause, also known as a “restrictive covenant,” which prevents employed physicians from working in the area if they left the job.
“Almost every doctor I represent has told me that they’re not concerned about the noncompete clause because, they believe, it is not enforceable anyway,” Ms. Adler said. “This is incorrect.”
Mr. Nuland said the faster pace of job-changing during the pandemic makes it all the more likely that doctors have to deal with a restrictive covenant. At the same time, some employers have been expanding the restriction – either by enlarging the radius where the restriction applies or by making the restriction apply to each of their sites, so that each one has a restricted radius around it.
For example, one contract Mr. Nuland is currently reviewing has a 20-mile radius that in effect becomes a 120-mile radius because the employer is counting four offices.
What can you do? Mr. Nuland advised trying to reduce the impact of the noncompete – for instance, making it apply only to the offices where you worked, or trading more time for less distance. “If you have a 2-year, 20-mile restriction, ask for a 3-year, 10-mile restriction, where the radius could be easier to deal with,” he said.
You might end up with too much call
Contracts rarely detail your call schedule because employers want flexibility to expand call as patient care needs change, but you can try adding some specificity, said Sanja Ord, a physician contract attorney at Greensfelder, Hemker & Gale in St. Louis.
Contracts often use wide-open language to describe call, such as simply making it “subject to the house call policies,” Mr. Cassidy said. Language that is more beneficial to the physician would say that call must be “equal” among “similarly situated” physicians.
But Ms. Ord said even provisions for equal call can turn out to be onerous if there are too few doctors in the call roster, so it’s a good idea to find out just how many doctors will be participating in call.
Still, Adler said even that strategy can’t remove all risk. What happens, she asked, if several physicians participating in call decide to leave? Then you might end up with call every other night.
What can you do? Mr. Cassidy recommends specifying a maximum amount of call – for example, no more frequent than one in four nights.
Physician must pay for reimbursement claw-backs by payers
When auditors for Medicare or other payers find overpayments after the fact, called a ‘claw-back,’ the provider must pay them back. But which provider has to do that – you or your employer?
In many cases, your employer’s billing office may have introduced the error, but there may be a clause in the contract stating that the physician is solely responsible for all claw-backs. That could be costly.
What can you do? Mr. Shay said the clause should state that you have to pay only when it is the result of your own error or omission, and also not when it was made at the direction of the employer.
Some work may be outside of your subspecialty
In some cases, the employer may assign subspecialized doctors to work outside their subspecialty, Mr. Nuland said.
For example, he said he represented an endocrinologist who expected to see only diabetes patients but was assigned to some general internal medicine work as well, and an otolaryngologist client of his who completed a fellowship on facial plastic surgery was expected to do liposuction in a cosmetic surgery group.
What can you do? To prevent this from happening, Mr. Nuland recommends a clause stating that your work will be restricted to your subspecialty.
What the employer promised isn’t in the contract
“Beware of promises that are not in the contract,” Mr. Shay said. “You might feel you can really trust your new boss and what he tells you, but what if that person resigns, or the organization gets a new owner who doesn’t honor unwritten agreements?”
Many contracts have an integration clause, which specifies that the contract constitutes the complete agreement between the two parties, and it nullifies any other oral or written promises made to the physician.
For example, the employer might have promised a relocation bonus and a sign-on bonus, but for some reason it didn’t get into the contract, Ms. Ord said. In those cases, the employer is under no obligation to honor the promise.
What can you do? Mr. Cassidy said it is possible to hold the employer to a commitment made outside the contract. The alternative document, such as an offer letter, has to specifically state that the commitment is protected from the integration clause in the contract, he said, adding: “It is still better to have the commitment put into the contract.”
Contract is simply accepted as is
“Generally, the bigger the employer, the less likely they will alter an agreement just to make you happy,” Mr. Shay said.
But even in these contracts, he said there is still opportunity to fix errors and ambiguities that could harm you later – or even alter a provision if you can’t remove it outright.
The back-and-forth is important, Ms. Adler said. “Negotiation means trying to have some control over your job and your life.”
Mr. Cassidy said a big part of contract review is facing up to the possibility that you may have to resign or be let go.
“Many physicians don’t like to think about leaving when they’re just starting a job, but they need to,” he said. “You need to begin with the end in mind. Think about what would happen if this job didn’t work out.”
A version of this article first appeared on Medscape.com.