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Doctors as trusted messengers
On a recent Friday, oncologist Christine Berg, MD, devoted 3 hours to a webinar about electrification of heavy- and medium-duty trucks in Maryland.
It’s not the way most cancer specialists choose to spend their time. But Dr. Berg, who is board certified in medical oncology, radiation oncology, and internal medicine, has made air pollution her current focus. Through organizations such as the Public Employees for Environmental Responsibility, she is working to raise awareness of the huge impact it can have on cancer.
“I think oncologists can make a difference,” she said.
That’s why Dr. Berg took a keen interest in a recent study by ProPublica, the nonprofit journalism organization, that identified previously ignored “hot spots of cancer-causing air.” While the ProPublica report gives an incomplete picture of airborne carcinogens, it puts an important spotlight on industrial air pollution, Dr. Berg and other experts say.
Relying on data from the Environmental Protection Agency’s Risk-Screening Environmental Indicators (RSEI), ProPublica researchers estimated the effects of industrial air pollution around the country and found problems the EPA overlooked, they reported. “The EPA collects data on each individual facility, but it doesn’t consider the excess cancer risk from all of the facilities’ combined emissions,” reporter Lylla Younes and colleagues wrote. “ProPublica did.”
The ProPublica team produced a map of cancer-causing industrial air pollution hot spots. They estimated that 256,000 people in the United States live in areas where incidences of cancer caused by air pollution exceed the EPA’s upper limit of acceptable risk.
While some of the spots are scattered around the country, they are concentrated along the Gulf Coast of Texas and Louisiana. For example, near the Equistar Chemicals Bayport Chemical Plant in Pasadena, Texas, ProPublica calculated the increased risk of cancer at 1 in 220, “46 times the EPA’s acceptable risk.” (The agency defines an acceptable risk as less than a 1 in 10,000 chance of developing cancer.)
Almost all the hot spots with the highest level of risk are in southern United States “known for having weaker environmental regulations,” the report said.
The researchers also identified race as a risk factor. In predominantly Black census tracts, they estimated the risk from toxic air pollution is more than double the risk in predominantly White census tracts. It attributed this pattern to deliberate policies of redlining that segregated neighborhoods and to zoning ordinances that encouraged industry in communities of color.
Measuring risk not straightforward
In response to a query from this news organization, an EPA spokesperson provided a statement saying the RSEI data are not intended for the purpose used by ProPublica. “RSEI does not provide a risk assessment (e.g., excess cancer case estimates),” the statement said. The RSEI data are poorly suited to this purpose because they use “worst-case assumptions about toxicity and potential exposure where data are lacking, and also use simplifying assumptions to reduce the complexity of the calculations,” the statement said.
Instead, the data are meant as a kind of index to compare one place to another, or show changes over time, the agency said. In this way, it can prompt regulators to investigate further. “A more refined assessment is required before any conclusions about health impacts can be drawn.” The agency is working on just such a refined approach, per the EPA statement.
That’s not just bureaucratic stonewalling, said Stan Meiberg, PhD, MA, a former EPA official and director of graduate studies in sustainability at Wake Forest University in Winston-Salem, N.C. “To say that you can speak with great precision, that the risk of individuals getting cancer is 1 in 100, may be a little overstating the date on which that statement is based.”
Risk estimates are improving as citizens gain access to more sophisticated monitoring devices, he said. And the primary point of the ProPublica report, that the EPA has underestimated risk by looking at individual sources of pollution rather than combining them, is not an original one, Dr. Meiberg said. “This is an issue that’s been kicking around for quite some time.”
Still, it’s one that demands attention. EPA regulations have succeeded in reducing the overall risk from industrial air pollution over the past few decades. “But there remain areas of particular geographic concentrations,” he said. “And the ProPublica article hit two of them, which have been the subject of discussion for many years, the Houston Ship Channel area and the Baton Rouge to New Orleans industrial corridor where you have a significant proportion of all the chemical petrochemical industry in the United States.”
Improvements in containment of the pollutants, and changes to the industrial processes that produce them, can also help reduce exposure. These changes should occur in the context of dialogue within the communities exposed to the pollution, Dr. Meiberg said.
The role of cancer-causing airborne particulate matter
But even if measures are perfectly implemented, Joan Schiller, MD, will not breathe easy. An adjunct professor of oncology at the University of Virginia in Charlottesville, Dr. Schiller has researched the role of airborne particulate matter in causing cancer, a correlation barely mentioned in the ProPublica analysis, she pointed out.
Particulate matter contains a wide range of toxic substances, she said. Researchers have focused on particles 2.5 microns in diameter, or PM 2.5. Some studies have indicated that it’s responsible for one in seven deaths from lung cancer, Dr. Schiller said. “Air pollution also causes lung cancer in never smokers, people who’ve never smoked, not just in smokers.”
Power plants and automobile traffic may be more significant sources of PM 2.5 than industry, and wildfires have recently emerged as increasingly important source, a result of climate change and poor forest management, she said.
PM 2.5 doesn’t affect just lung cancer, said Alexandra White, PhD, an investigator at the National Institute of Environmental Health Sciences in Research Triangle Park, N.C. “My work, as well as work of others, is increasingly suggesting that air pollution is also related to breast cancer risk, in particular, air pollution that is arising from traffic related forces.” And more research is needed on other cancers, she said. “I think that the lack of findings of other cancer sites reflects a lack of study.”
Other pollutants not analyzed in the ProPublica report are also correlated to cancer risk. In a recent meta-analysis, researcher Stephan Gabet, PhD, PharmD, and colleagues at the University of Grenoble, France, estimated that 3.15% of new breast cancer cases in that country could be attributed to nitrogen dioxide and 2.15% to PM 10.
Sources of nitrogen dioxide, PM 2.5, and PM 10 in France include automobile traffic, inefficient wood-burning stoves, and coal-burning power plants in neighboring countries, Dr. Gabet said.
A good approach to reducing pollution from road traffic is the implementation of low-emission zones that prohibit the most polluting vehicles, he said. But a 2019 United Kingdom government study found that brake wear, tire wear, and road surface wear account for 72% of the PM 10 and 60% of the PM 2.5 pollution from road traffic, suggesting that a transition to electric vehicles won’t fix the problem. Better yet, is “the promotion of active modes like walking, cycling, etc., because like this, you can bring additional health gains due to the increase in physical activity,” he said.
Oncologists can help their patients reduce their exposure to air pollution, Dr. Schiller said. “If you have lung cancer, air pollution will hasten your demise. It makes you sicker. Oncologists should be telling their patients about this and advising them to move away from air pollution if possible, and also making sure they know to monitor the health of the air.”
On days when air pollution is high, patients may want to avoid exercising outdoors, or stay indoors altogether, Dr. Berg said. Air purifiers and N95 masks may also help.
And physicians can make a difference by speaking out in their communities, Dr. Schiller said. She is inviting oncologists to join a new group, Oncologists Understanding for Climate and Health. Through this group or on their own, oncologists can speak to their local legislatures or city councils in support of measures to reduce pollution, she said. “Doctors are trusted messengers.”
Dr. Berg disclosed affiliations with Grail, Mercy BioAnalytics and Lucid Diagnostics.
On a recent Friday, oncologist Christine Berg, MD, devoted 3 hours to a webinar about electrification of heavy- and medium-duty trucks in Maryland.
It’s not the way most cancer specialists choose to spend their time. But Dr. Berg, who is board certified in medical oncology, radiation oncology, and internal medicine, has made air pollution her current focus. Through organizations such as the Public Employees for Environmental Responsibility, she is working to raise awareness of the huge impact it can have on cancer.
“I think oncologists can make a difference,” she said.
That’s why Dr. Berg took a keen interest in a recent study by ProPublica, the nonprofit journalism organization, that identified previously ignored “hot spots of cancer-causing air.” While the ProPublica report gives an incomplete picture of airborne carcinogens, it puts an important spotlight on industrial air pollution, Dr. Berg and other experts say.
Relying on data from the Environmental Protection Agency’s Risk-Screening Environmental Indicators (RSEI), ProPublica researchers estimated the effects of industrial air pollution around the country and found problems the EPA overlooked, they reported. “The EPA collects data on each individual facility, but it doesn’t consider the excess cancer risk from all of the facilities’ combined emissions,” reporter Lylla Younes and colleagues wrote. “ProPublica did.”
The ProPublica team produced a map of cancer-causing industrial air pollution hot spots. They estimated that 256,000 people in the United States live in areas where incidences of cancer caused by air pollution exceed the EPA’s upper limit of acceptable risk.
While some of the spots are scattered around the country, they are concentrated along the Gulf Coast of Texas and Louisiana. For example, near the Equistar Chemicals Bayport Chemical Plant in Pasadena, Texas, ProPublica calculated the increased risk of cancer at 1 in 220, “46 times the EPA’s acceptable risk.” (The agency defines an acceptable risk as less than a 1 in 10,000 chance of developing cancer.)
Almost all the hot spots with the highest level of risk are in southern United States “known for having weaker environmental regulations,” the report said.
The researchers also identified race as a risk factor. In predominantly Black census tracts, they estimated the risk from toxic air pollution is more than double the risk in predominantly White census tracts. It attributed this pattern to deliberate policies of redlining that segregated neighborhoods and to zoning ordinances that encouraged industry in communities of color.
Measuring risk not straightforward
In response to a query from this news organization, an EPA spokesperson provided a statement saying the RSEI data are not intended for the purpose used by ProPublica. “RSEI does not provide a risk assessment (e.g., excess cancer case estimates),” the statement said. The RSEI data are poorly suited to this purpose because they use “worst-case assumptions about toxicity and potential exposure where data are lacking, and also use simplifying assumptions to reduce the complexity of the calculations,” the statement said.
Instead, the data are meant as a kind of index to compare one place to another, or show changes over time, the agency said. In this way, it can prompt regulators to investigate further. “A more refined assessment is required before any conclusions about health impacts can be drawn.” The agency is working on just such a refined approach, per the EPA statement.
That’s not just bureaucratic stonewalling, said Stan Meiberg, PhD, MA, a former EPA official and director of graduate studies in sustainability at Wake Forest University in Winston-Salem, N.C. “To say that you can speak with great precision, that the risk of individuals getting cancer is 1 in 100, may be a little overstating the date on which that statement is based.”
Risk estimates are improving as citizens gain access to more sophisticated monitoring devices, he said. And the primary point of the ProPublica report, that the EPA has underestimated risk by looking at individual sources of pollution rather than combining them, is not an original one, Dr. Meiberg said. “This is an issue that’s been kicking around for quite some time.”
Still, it’s one that demands attention. EPA regulations have succeeded in reducing the overall risk from industrial air pollution over the past few decades. “But there remain areas of particular geographic concentrations,” he said. “And the ProPublica article hit two of them, which have been the subject of discussion for many years, the Houston Ship Channel area and the Baton Rouge to New Orleans industrial corridor where you have a significant proportion of all the chemical petrochemical industry in the United States.”
Improvements in containment of the pollutants, and changes to the industrial processes that produce them, can also help reduce exposure. These changes should occur in the context of dialogue within the communities exposed to the pollution, Dr. Meiberg said.
The role of cancer-causing airborne particulate matter
But even if measures are perfectly implemented, Joan Schiller, MD, will not breathe easy. An adjunct professor of oncology at the University of Virginia in Charlottesville, Dr. Schiller has researched the role of airborne particulate matter in causing cancer, a correlation barely mentioned in the ProPublica analysis, she pointed out.
Particulate matter contains a wide range of toxic substances, she said. Researchers have focused on particles 2.5 microns in diameter, or PM 2.5. Some studies have indicated that it’s responsible for one in seven deaths from lung cancer, Dr. Schiller said. “Air pollution also causes lung cancer in never smokers, people who’ve never smoked, not just in smokers.”
Power plants and automobile traffic may be more significant sources of PM 2.5 than industry, and wildfires have recently emerged as increasingly important source, a result of climate change and poor forest management, she said.
PM 2.5 doesn’t affect just lung cancer, said Alexandra White, PhD, an investigator at the National Institute of Environmental Health Sciences in Research Triangle Park, N.C. “My work, as well as work of others, is increasingly suggesting that air pollution is also related to breast cancer risk, in particular, air pollution that is arising from traffic related forces.” And more research is needed on other cancers, she said. “I think that the lack of findings of other cancer sites reflects a lack of study.”
Other pollutants not analyzed in the ProPublica report are also correlated to cancer risk. In a recent meta-analysis, researcher Stephan Gabet, PhD, PharmD, and colleagues at the University of Grenoble, France, estimated that 3.15% of new breast cancer cases in that country could be attributed to nitrogen dioxide and 2.15% to PM 10.
Sources of nitrogen dioxide, PM 2.5, and PM 10 in France include automobile traffic, inefficient wood-burning stoves, and coal-burning power plants in neighboring countries, Dr. Gabet said.
A good approach to reducing pollution from road traffic is the implementation of low-emission zones that prohibit the most polluting vehicles, he said. But a 2019 United Kingdom government study found that brake wear, tire wear, and road surface wear account for 72% of the PM 10 and 60% of the PM 2.5 pollution from road traffic, suggesting that a transition to electric vehicles won’t fix the problem. Better yet, is “the promotion of active modes like walking, cycling, etc., because like this, you can bring additional health gains due to the increase in physical activity,” he said.
Oncologists can help their patients reduce their exposure to air pollution, Dr. Schiller said. “If you have lung cancer, air pollution will hasten your demise. It makes you sicker. Oncologists should be telling their patients about this and advising them to move away from air pollution if possible, and also making sure they know to monitor the health of the air.”
On days when air pollution is high, patients may want to avoid exercising outdoors, or stay indoors altogether, Dr. Berg said. Air purifiers and N95 masks may also help.
And physicians can make a difference by speaking out in their communities, Dr. Schiller said. She is inviting oncologists to join a new group, Oncologists Understanding for Climate and Health. Through this group or on their own, oncologists can speak to their local legislatures or city councils in support of measures to reduce pollution, she said. “Doctors are trusted messengers.”
Dr. Berg disclosed affiliations with Grail, Mercy BioAnalytics and Lucid Diagnostics.
On a recent Friday, oncologist Christine Berg, MD, devoted 3 hours to a webinar about electrification of heavy- and medium-duty trucks in Maryland.
It’s not the way most cancer specialists choose to spend their time. But Dr. Berg, who is board certified in medical oncology, radiation oncology, and internal medicine, has made air pollution her current focus. Through organizations such as the Public Employees for Environmental Responsibility, she is working to raise awareness of the huge impact it can have on cancer.
“I think oncologists can make a difference,” she said.
That’s why Dr. Berg took a keen interest in a recent study by ProPublica, the nonprofit journalism organization, that identified previously ignored “hot spots of cancer-causing air.” While the ProPublica report gives an incomplete picture of airborne carcinogens, it puts an important spotlight on industrial air pollution, Dr. Berg and other experts say.
Relying on data from the Environmental Protection Agency’s Risk-Screening Environmental Indicators (RSEI), ProPublica researchers estimated the effects of industrial air pollution around the country and found problems the EPA overlooked, they reported. “The EPA collects data on each individual facility, but it doesn’t consider the excess cancer risk from all of the facilities’ combined emissions,” reporter Lylla Younes and colleagues wrote. “ProPublica did.”
The ProPublica team produced a map of cancer-causing industrial air pollution hot spots. They estimated that 256,000 people in the United States live in areas where incidences of cancer caused by air pollution exceed the EPA’s upper limit of acceptable risk.
While some of the spots are scattered around the country, they are concentrated along the Gulf Coast of Texas and Louisiana. For example, near the Equistar Chemicals Bayport Chemical Plant in Pasadena, Texas, ProPublica calculated the increased risk of cancer at 1 in 220, “46 times the EPA’s acceptable risk.” (The agency defines an acceptable risk as less than a 1 in 10,000 chance of developing cancer.)
Almost all the hot spots with the highest level of risk are in southern United States “known for having weaker environmental regulations,” the report said.
The researchers also identified race as a risk factor. In predominantly Black census tracts, they estimated the risk from toxic air pollution is more than double the risk in predominantly White census tracts. It attributed this pattern to deliberate policies of redlining that segregated neighborhoods and to zoning ordinances that encouraged industry in communities of color.
Measuring risk not straightforward
In response to a query from this news organization, an EPA spokesperson provided a statement saying the RSEI data are not intended for the purpose used by ProPublica. “RSEI does not provide a risk assessment (e.g., excess cancer case estimates),” the statement said. The RSEI data are poorly suited to this purpose because they use “worst-case assumptions about toxicity and potential exposure where data are lacking, and also use simplifying assumptions to reduce the complexity of the calculations,” the statement said.
Instead, the data are meant as a kind of index to compare one place to another, or show changes over time, the agency said. In this way, it can prompt regulators to investigate further. “A more refined assessment is required before any conclusions about health impacts can be drawn.” The agency is working on just such a refined approach, per the EPA statement.
That’s not just bureaucratic stonewalling, said Stan Meiberg, PhD, MA, a former EPA official and director of graduate studies in sustainability at Wake Forest University in Winston-Salem, N.C. “To say that you can speak with great precision, that the risk of individuals getting cancer is 1 in 100, may be a little overstating the date on which that statement is based.”
Risk estimates are improving as citizens gain access to more sophisticated monitoring devices, he said. And the primary point of the ProPublica report, that the EPA has underestimated risk by looking at individual sources of pollution rather than combining them, is not an original one, Dr. Meiberg said. “This is an issue that’s been kicking around for quite some time.”
Still, it’s one that demands attention. EPA regulations have succeeded in reducing the overall risk from industrial air pollution over the past few decades. “But there remain areas of particular geographic concentrations,” he said. “And the ProPublica article hit two of them, which have been the subject of discussion for many years, the Houston Ship Channel area and the Baton Rouge to New Orleans industrial corridor where you have a significant proportion of all the chemical petrochemical industry in the United States.”
Improvements in containment of the pollutants, and changes to the industrial processes that produce them, can also help reduce exposure. These changes should occur in the context of dialogue within the communities exposed to the pollution, Dr. Meiberg said.
The role of cancer-causing airborne particulate matter
But even if measures are perfectly implemented, Joan Schiller, MD, will not breathe easy. An adjunct professor of oncology at the University of Virginia in Charlottesville, Dr. Schiller has researched the role of airborne particulate matter in causing cancer, a correlation barely mentioned in the ProPublica analysis, she pointed out.
Particulate matter contains a wide range of toxic substances, she said. Researchers have focused on particles 2.5 microns in diameter, or PM 2.5. Some studies have indicated that it’s responsible for one in seven deaths from lung cancer, Dr. Schiller said. “Air pollution also causes lung cancer in never smokers, people who’ve never smoked, not just in smokers.”
Power plants and automobile traffic may be more significant sources of PM 2.5 than industry, and wildfires have recently emerged as increasingly important source, a result of climate change and poor forest management, she said.
PM 2.5 doesn’t affect just lung cancer, said Alexandra White, PhD, an investigator at the National Institute of Environmental Health Sciences in Research Triangle Park, N.C. “My work, as well as work of others, is increasingly suggesting that air pollution is also related to breast cancer risk, in particular, air pollution that is arising from traffic related forces.” And more research is needed on other cancers, she said. “I think that the lack of findings of other cancer sites reflects a lack of study.”
Other pollutants not analyzed in the ProPublica report are also correlated to cancer risk. In a recent meta-analysis, researcher Stephan Gabet, PhD, PharmD, and colleagues at the University of Grenoble, France, estimated that 3.15% of new breast cancer cases in that country could be attributed to nitrogen dioxide and 2.15% to PM 10.
Sources of nitrogen dioxide, PM 2.5, and PM 10 in France include automobile traffic, inefficient wood-burning stoves, and coal-burning power plants in neighboring countries, Dr. Gabet said.
A good approach to reducing pollution from road traffic is the implementation of low-emission zones that prohibit the most polluting vehicles, he said. But a 2019 United Kingdom government study found that brake wear, tire wear, and road surface wear account for 72% of the PM 10 and 60% of the PM 2.5 pollution from road traffic, suggesting that a transition to electric vehicles won’t fix the problem. Better yet, is “the promotion of active modes like walking, cycling, etc., because like this, you can bring additional health gains due to the increase in physical activity,” he said.
Oncologists can help their patients reduce their exposure to air pollution, Dr. Schiller said. “If you have lung cancer, air pollution will hasten your demise. It makes you sicker. Oncologists should be telling their patients about this and advising them to move away from air pollution if possible, and also making sure they know to monitor the health of the air.”
On days when air pollution is high, patients may want to avoid exercising outdoors, or stay indoors altogether, Dr. Berg said. Air purifiers and N95 masks may also help.
And physicians can make a difference by speaking out in their communities, Dr. Schiller said. She is inviting oncologists to join a new group, Oncologists Understanding for Climate and Health. Through this group or on their own, oncologists can speak to their local legislatures or city councils in support of measures to reduce pollution, she said. “Doctors are trusted messengers.”
Dr. Berg disclosed affiliations with Grail, Mercy BioAnalytics and Lucid Diagnostics.
A pandemic silver lining? Dramatic drop in teen drug use
Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.
The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.
“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release.
“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.
The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.
This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.
Compared with 2020, the percentage of students reporting any illicit drug use (other than marijuana) in 2021 decreased significantly for 8th graders (down 5.4%), 10th graders (down 11.7%), and 12th graders (down 4.8%).
For alcohol, about 47% of 12th graders and 29% of 10th graders said they drank alcohol in 2021, down significantly from 55% and 41%, respectively, in 2020. The percentage of 8th graders who said they drank alcohol remained stable (17% in 2021 and 20% in 2020).
For teen vaping, about 27% of 12th graders and 20% of 10th graders said they had vaped nicotine in 2021, down significantly from nearly 35% and 31%, respectively, in 2020. Fewer 8th graders also vaped nicotine in 2021 compared with 2020 (12% vs. 17%).
For marijuana, use dropped significantly for all three grades in 2021 compared with 2020. About 31% of 12th graders and 17% of 10th graders said they used marijuana in 2021, down from 35% and 28% in 2020. Among 8th graders, 7% used marijuana in 2021, down from 11% in 2020.
The latest survey also shows significant declines in use of a range of other drugs for many of the age cohorts, including cocaine, hallucinogens, and nonmedical use of amphetamines, tranquilizers, and prescription opioids.
“We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people, and in the coming years, we will find out whether those impacts are long-lasting as we continue tracking the drug use patterns of these unique cohorts of adolescents,” Richard A. Miech, PhD, who heads the Monitoring the Future study at the University of Michigan, said in the news release.
“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts,” Dr. Volkow added.
In 2021, students across all age groups reported moderate increases in feelings of boredom, anxiety, depression, loneliness, worry, difficulty sleeping, and other negative mental health indicators since the beginning of the pandemic.
A version of this article first appeared on Medscape.com.
Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.
The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.
“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release.
“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.
The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.
This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.
Compared with 2020, the percentage of students reporting any illicit drug use (other than marijuana) in 2021 decreased significantly for 8th graders (down 5.4%), 10th graders (down 11.7%), and 12th graders (down 4.8%).
For alcohol, about 47% of 12th graders and 29% of 10th graders said they drank alcohol in 2021, down significantly from 55% and 41%, respectively, in 2020. The percentage of 8th graders who said they drank alcohol remained stable (17% in 2021 and 20% in 2020).
For teen vaping, about 27% of 12th graders and 20% of 10th graders said they had vaped nicotine in 2021, down significantly from nearly 35% and 31%, respectively, in 2020. Fewer 8th graders also vaped nicotine in 2021 compared with 2020 (12% vs. 17%).
For marijuana, use dropped significantly for all three grades in 2021 compared with 2020. About 31% of 12th graders and 17% of 10th graders said they used marijuana in 2021, down from 35% and 28% in 2020. Among 8th graders, 7% used marijuana in 2021, down from 11% in 2020.
The latest survey also shows significant declines in use of a range of other drugs for many of the age cohorts, including cocaine, hallucinogens, and nonmedical use of amphetamines, tranquilizers, and prescription opioids.
“We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people, and in the coming years, we will find out whether those impacts are long-lasting as we continue tracking the drug use patterns of these unique cohorts of adolescents,” Richard A. Miech, PhD, who heads the Monitoring the Future study at the University of Michigan, said in the news release.
“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts,” Dr. Volkow added.
In 2021, students across all age groups reported moderate increases in feelings of boredom, anxiety, depression, loneliness, worry, difficulty sleeping, and other negative mental health indicators since the beginning of the pandemic.
A version of this article first appeared on Medscape.com.
Illicit drug use among U.S. teenagers dropped sharply in 2021, likely because of stay-at-home orders and other restrictions on social activities due to the COVID-19 pandemic.
The latest findings, from the Monitoring the Future survey, represent the largest 1-year decrease in overall illicit drug use reported since the survey began in 1975.
“We have never seen such dramatic decreases in drug use among teens in just a 1-year period,” Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), said in a news release.
“These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Dr. Volkow.
The annual Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA, to assess drug and alcohol use and related attitudes among adolescent students across the United States.
This year’s self-reported survey included 32,260 students in grades 8, 10, and 12 across 319 public and private schools.
Compared with 2020, the percentage of students reporting any illicit drug use (other than marijuana) in 2021 decreased significantly for 8th graders (down 5.4%), 10th graders (down 11.7%), and 12th graders (down 4.8%).
For alcohol, about 47% of 12th graders and 29% of 10th graders said they drank alcohol in 2021, down significantly from 55% and 41%, respectively, in 2020. The percentage of 8th graders who said they drank alcohol remained stable (17% in 2021 and 20% in 2020).
For teen vaping, about 27% of 12th graders and 20% of 10th graders said they had vaped nicotine in 2021, down significantly from nearly 35% and 31%, respectively, in 2020. Fewer 8th graders also vaped nicotine in 2021 compared with 2020 (12% vs. 17%).
For marijuana, use dropped significantly for all three grades in 2021 compared with 2020. About 31% of 12th graders and 17% of 10th graders said they used marijuana in 2021, down from 35% and 28% in 2020. Among 8th graders, 7% used marijuana in 2021, down from 11% in 2020.
The latest survey also shows significant declines in use of a range of other drugs for many of the age cohorts, including cocaine, hallucinogens, and nonmedical use of amphetamines, tranquilizers, and prescription opioids.
“We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people, and in the coming years, we will find out whether those impacts are long-lasting as we continue tracking the drug use patterns of these unique cohorts of adolescents,” Richard A. Miech, PhD, who heads the Monitoring the Future study at the University of Michigan, said in the news release.
“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts,” Dr. Volkow added.
In 2021, students across all age groups reported moderate increases in feelings of boredom, anxiety, depression, loneliness, worry, difficulty sleeping, and other negative mental health indicators since the beginning of the pandemic.
A version of this article first appeared on Medscape.com.
Medicare insulin negotiations seen saving $17 billion
Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.
On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.
Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.
“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.
House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.
It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.
That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.
Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.
“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”
The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.
“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
Better deals for military, medicaid programs
Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.
Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing.
For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.
In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.
The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.
The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.
The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.
But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
Insulin still of interest, 100 years after its discovery
The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.
Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.
Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.
Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.
Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.
Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.
“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.
Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern.
GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).
Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.
In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”
“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.
$35 a month for insulin?
Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.
“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.
“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”
Indianapolis-based Lilly offered a similar response in a statement to this news organization.
“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”
Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”
In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35.
The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.
“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.
People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.
A version of this article first appeared on Medscape.com.
Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.
On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.
Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.
“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.
House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.
It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.
That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.
Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.
“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”
The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.
“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
Better deals for military, medicaid programs
Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.
Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing.
For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.
In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.
The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.
The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.
The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.
But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
Insulin still of interest, 100 years after its discovery
The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.
Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.
Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.
Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.
Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.
Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.
“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.
Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern.
GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).
Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.
In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”
“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.
$35 a month for insulin?
Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.
“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.
“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”
Indianapolis-based Lilly offered a similar response in a statement to this news organization.
“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”
Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”
In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35.
The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.
“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.
People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.
A version of this article first appeared on Medscape.com.
Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.
On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.
Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.
“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.
House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.
It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.
That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.
Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.
“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”
The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.
“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
Better deals for military, medicaid programs
Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.
Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing.
For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.
In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.
The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.
The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.
The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.
But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
Insulin still of interest, 100 years after its discovery
The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.
Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.
Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.
Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.
Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.
Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.
“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.
Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern.
GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).
Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.
In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”
“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.
$35 a month for insulin?
Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.
“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.
“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”
Indianapolis-based Lilly offered a similar response in a statement to this news organization.
“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”
Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”
In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35.
The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.
“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.
People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.
A version of this article first appeared on Medscape.com.
More Americans skipping medical care because of cost, survey says
That’s the highest reported number since the pandemic began and a tripling from March to October.
Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.
“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.
“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.
As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.
What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.
The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.
About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.
“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”
A version of this article first appeared on WebMD.com.
That’s the highest reported number since the pandemic began and a tripling from March to October.
Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.
“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.
“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.
As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.
What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.
The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.
About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.
“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”
A version of this article first appeared on WebMD.com.
That’s the highest reported number since the pandemic began and a tripling from March to October.
Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.
“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.
“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.
As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.
What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.
The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.
About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.
“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”
A version of this article first appeared on WebMD.com.
Fixing the maternal health problem in the U.S.: Signs of hope?
In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. And another 60,000 have pregnancy-related or childbirth-related health issues.
Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.
In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.
“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”
“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.
As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:
U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.
At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.
A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.
President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.
Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
Best hospitals for maternity
For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.
To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.
Of those, 237 were identified as best for maternity.
As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.
On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.
The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
A call to action: Expand coverage
Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”
Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.
“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.
“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.
A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.
The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.
According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
Congressional actions
Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.
“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.
Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
Explaining and fixing the disparities
No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.
Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.
According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
When statistics hit home
Many who work to improve maternal health have gone through issues themselves or had loved ones who did.
Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.
For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.
“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”
She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.
“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.
Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.
U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.
Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.
In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.
The child’s question is understandable and heartbreaking: She wants to know where her mommy is.
“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”
A version of this article first appeared on WebMD.com.
In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. And another 60,000 have pregnancy-related or childbirth-related health issues.
Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.
In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.
“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”
“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.
As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:
U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.
At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.
A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.
President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.
Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
Best hospitals for maternity
For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.
To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.
Of those, 237 were identified as best for maternity.
As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.
On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.
The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
A call to action: Expand coverage
Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”
Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.
“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.
“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.
A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.
The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.
According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
Congressional actions
Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.
“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.
Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
Explaining and fixing the disparities
No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.
Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.
According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
When statistics hit home
Many who work to improve maternal health have gone through issues themselves or had loved ones who did.
Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.
For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.
“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”
She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.
“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.
Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.
U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.
Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.
In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.
The child’s question is understandable and heartbreaking: She wants to know where her mommy is.
“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”
A version of this article first appeared on WebMD.com.
In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. And another 60,000 have pregnancy-related or childbirth-related health issues.
Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.
In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.
“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”
“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.
As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:
U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.
At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.
A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.
President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.
Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
Best hospitals for maternity
For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.
To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.
Of those, 237 were identified as best for maternity.
As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.
On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.
The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
A call to action: Expand coverage
Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”
Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.
“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.
“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.
A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.
The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.
According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
Congressional actions
Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.
“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.
Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
Explaining and fixing the disparities
No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.
Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.
According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
When statistics hit home
Many who work to improve maternal health have gone through issues themselves or had loved ones who did.
Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.
For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.
“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”
She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.
“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.
Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.
U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.
Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.
In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.
The child’s question is understandable and heartbreaking: She wants to know where her mommy is.
“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”
A version of this article first appeared on WebMD.com.
Delays in cancer referral, diagnosis linked with morbidities
These findings are based on a retrospective study of data from 11,716 cancer patients from the United Kingdom’s National Cancer Diagnosis Audit – an initiative that aimed to better understand the journey of cancer patients from primary care to diagnosis. Three-quarters of the study participants had at least one morbidity in their primary care record, according to the authors of the new research, which was published in Family Practice (2021 Nov 30. doi: 10.1093/fampra/cmab139).
In their analysis of all of the patient data, Minjoung M. Koo and colleagues found that the median time between first presenting to a primary care physician with cancer symptoms and being referred to a specialist was 5 days. For all patients studied, the median time to receiving a cancer diagnosis was 42 days, the investigators wrote.
Patients with multiple morbidities were 26% more likely to have their cancer diagnosed at least 60 days after the initial primary care consultation than were those without morbidities (95% confidence interval, 1.10-1.45). This was true after adjustment for confounders, including morbidity, sex, age, and cancer. Similarly, those with a Charlson score of 3 or above – signifying more severe comorbidities – had a 19% greater odds of being diagnosed more than 60 days after presenting to primary care (95% CI, 1.01-1.40)
Older adults ‘less likely to be screen-detected’
Dr. Fran Boyle, professor of medical oncology at the University of Sydney, Australia, said it wasn’t clear from the study whether people with multiple comorbidities may have symptoms that cloud the diagnostic process, or whether short primary care consultations may not allow for enough time to manage multiple issues.
“Older adults typically have more comorbidities, and they are less likely to be screen-detected; for example, breast cancer screening and bowel cancer screening typically stop after 75,” said Dr. Boyle, director of Patricia Ritchie Centre for Cancer Care and Research at Sydney’s Mater Hospital.
Dr. Boyle pointed to a recent systematic review in Australian rural oncology that suggested that patients with more comorbidities tend to be offered less intense treatment, and have higher operative mortality and morbidity, which can contribute to less effective therapy.
Referral delays seen in multiple patient groups
Ms. Koo, from the University College London and the National Disease Registration Service in the United Kingdom, and coauthors noted a nonsignificant trend toward increased intervals between primary care consultation and referral or diagnosis even in patients with one or more comorbidities.
A higher burden of comorbidities also meant patients were more likely to have more than one primary care consultation before being referred to a specialist. Those with three or more comorbidities were 21% more likely to have at least three consultations before referral, compared with patients with no comorbidities (95% CI, 1.05-1.40, P = .010).
Overall, 60% of the participants in the study experienced at least one investigation into whether they had cancer by a primary care clinician before being referred to a specialist.
Morbidities linked with emergency referral
The study also saw an association between morbidities and the likelihood of receiving an emergency referral. Those with three or more morbidities were 60% more likely to have an emergency referral than were those with no comorbidities. Those with a Charlson score of three or above were 61% more likely to be referred to an emergency department.
“The greater likelihood of clinical complexity or acute deterioration among individuals with multiple or severe chronic conditions means that an emergency referral may be clinically appropriate,” the authors wrote.
Commenting on the findings, Dr. Diane M. Harper, professor of family medicine at the University of Michigan, Ann Arbor, said primary care patients often have multiple chronic illnesses, and the relationship between the physician and patients determines how quickly symptoms of cancer are explored.
“What this work cannot explore is the quality of discussions between the physician and the patient, nor can it explore how the decision to go to the ED was made,” said Dr. Harper, president of the North American Primary Care Research Group. “Exploring these data would provide important information to the physician-patient dyad.”
Diagnostic difficulty might have been at play, according to authors
The investigators didn’t find any evidence of an interaction between cancer site, number of morbidities, and referral or diagnostic time, except in cases of colorectal cancer, where patients with multiple morbidities were more likely to experience a longer wait between primary care consultation and diagnosis.
The authors observed that diagnostic difficulty of the cancer might have been at play here, given that colorectal cancer can have a broad symptom signature.
“This was less often observed among patients diagnosed with a cancer that had a narrow symptom signature (“easy” diagnostic difficulty, e.g. breast cancer) or a broad symptom signature of mostly low PPVs (“hard” diagnostic difficulty, e.g. brain cancer),” they wrote.
The authors concluded that “it is reasonable to suggest that both improvement efforts and future research in this field should target patients with multiple or severe morbidity, and explore the reasons for prolonged diagnostic intervals in specialist care.”
The study was supported by Cancer Research UK. The authors and experts interviewed for this piece did not declare having any conflicts of interest.
These findings are based on a retrospective study of data from 11,716 cancer patients from the United Kingdom’s National Cancer Diagnosis Audit – an initiative that aimed to better understand the journey of cancer patients from primary care to diagnosis. Three-quarters of the study participants had at least one morbidity in their primary care record, according to the authors of the new research, which was published in Family Practice (2021 Nov 30. doi: 10.1093/fampra/cmab139).
In their analysis of all of the patient data, Minjoung M. Koo and colleagues found that the median time between first presenting to a primary care physician with cancer symptoms and being referred to a specialist was 5 days. For all patients studied, the median time to receiving a cancer diagnosis was 42 days, the investigators wrote.
Patients with multiple morbidities were 26% more likely to have their cancer diagnosed at least 60 days after the initial primary care consultation than were those without morbidities (95% confidence interval, 1.10-1.45). This was true after adjustment for confounders, including morbidity, sex, age, and cancer. Similarly, those with a Charlson score of 3 or above – signifying more severe comorbidities – had a 19% greater odds of being diagnosed more than 60 days after presenting to primary care (95% CI, 1.01-1.40)
Older adults ‘less likely to be screen-detected’
Dr. Fran Boyle, professor of medical oncology at the University of Sydney, Australia, said it wasn’t clear from the study whether people with multiple comorbidities may have symptoms that cloud the diagnostic process, or whether short primary care consultations may not allow for enough time to manage multiple issues.
“Older adults typically have more comorbidities, and they are less likely to be screen-detected; for example, breast cancer screening and bowel cancer screening typically stop after 75,” said Dr. Boyle, director of Patricia Ritchie Centre for Cancer Care and Research at Sydney’s Mater Hospital.
Dr. Boyle pointed to a recent systematic review in Australian rural oncology that suggested that patients with more comorbidities tend to be offered less intense treatment, and have higher operative mortality and morbidity, which can contribute to less effective therapy.
Referral delays seen in multiple patient groups
Ms. Koo, from the University College London and the National Disease Registration Service in the United Kingdom, and coauthors noted a nonsignificant trend toward increased intervals between primary care consultation and referral or diagnosis even in patients with one or more comorbidities.
A higher burden of comorbidities also meant patients were more likely to have more than one primary care consultation before being referred to a specialist. Those with three or more comorbidities were 21% more likely to have at least three consultations before referral, compared with patients with no comorbidities (95% CI, 1.05-1.40, P = .010).
Overall, 60% of the participants in the study experienced at least one investigation into whether they had cancer by a primary care clinician before being referred to a specialist.
Morbidities linked with emergency referral
The study also saw an association between morbidities and the likelihood of receiving an emergency referral. Those with three or more morbidities were 60% more likely to have an emergency referral than were those with no comorbidities. Those with a Charlson score of three or above were 61% more likely to be referred to an emergency department.
“The greater likelihood of clinical complexity or acute deterioration among individuals with multiple or severe chronic conditions means that an emergency referral may be clinically appropriate,” the authors wrote.
Commenting on the findings, Dr. Diane M. Harper, professor of family medicine at the University of Michigan, Ann Arbor, said primary care patients often have multiple chronic illnesses, and the relationship between the physician and patients determines how quickly symptoms of cancer are explored.
“What this work cannot explore is the quality of discussions between the physician and the patient, nor can it explore how the decision to go to the ED was made,” said Dr. Harper, president of the North American Primary Care Research Group. “Exploring these data would provide important information to the physician-patient dyad.”
Diagnostic difficulty might have been at play, according to authors
The investigators didn’t find any evidence of an interaction between cancer site, number of morbidities, and referral or diagnostic time, except in cases of colorectal cancer, where patients with multiple morbidities were more likely to experience a longer wait between primary care consultation and diagnosis.
The authors observed that diagnostic difficulty of the cancer might have been at play here, given that colorectal cancer can have a broad symptom signature.
“This was less often observed among patients diagnosed with a cancer that had a narrow symptom signature (“easy” diagnostic difficulty, e.g. breast cancer) or a broad symptom signature of mostly low PPVs (“hard” diagnostic difficulty, e.g. brain cancer),” they wrote.
The authors concluded that “it is reasonable to suggest that both improvement efforts and future research in this field should target patients with multiple or severe morbidity, and explore the reasons for prolonged diagnostic intervals in specialist care.”
The study was supported by Cancer Research UK. The authors and experts interviewed for this piece did not declare having any conflicts of interest.
These findings are based on a retrospective study of data from 11,716 cancer patients from the United Kingdom’s National Cancer Diagnosis Audit – an initiative that aimed to better understand the journey of cancer patients from primary care to diagnosis. Three-quarters of the study participants had at least one morbidity in their primary care record, according to the authors of the new research, which was published in Family Practice (2021 Nov 30. doi: 10.1093/fampra/cmab139).
In their analysis of all of the patient data, Minjoung M. Koo and colleagues found that the median time between first presenting to a primary care physician with cancer symptoms and being referred to a specialist was 5 days. For all patients studied, the median time to receiving a cancer diagnosis was 42 days, the investigators wrote.
Patients with multiple morbidities were 26% more likely to have their cancer diagnosed at least 60 days after the initial primary care consultation than were those without morbidities (95% confidence interval, 1.10-1.45). This was true after adjustment for confounders, including morbidity, sex, age, and cancer. Similarly, those with a Charlson score of 3 or above – signifying more severe comorbidities – had a 19% greater odds of being diagnosed more than 60 days after presenting to primary care (95% CI, 1.01-1.40)
Older adults ‘less likely to be screen-detected’
Dr. Fran Boyle, professor of medical oncology at the University of Sydney, Australia, said it wasn’t clear from the study whether people with multiple comorbidities may have symptoms that cloud the diagnostic process, or whether short primary care consultations may not allow for enough time to manage multiple issues.
“Older adults typically have more comorbidities, and they are less likely to be screen-detected; for example, breast cancer screening and bowel cancer screening typically stop after 75,” said Dr. Boyle, director of Patricia Ritchie Centre for Cancer Care and Research at Sydney’s Mater Hospital.
Dr. Boyle pointed to a recent systematic review in Australian rural oncology that suggested that patients with more comorbidities tend to be offered less intense treatment, and have higher operative mortality and morbidity, which can contribute to less effective therapy.
Referral delays seen in multiple patient groups
Ms. Koo, from the University College London and the National Disease Registration Service in the United Kingdom, and coauthors noted a nonsignificant trend toward increased intervals between primary care consultation and referral or diagnosis even in patients with one or more comorbidities.
A higher burden of comorbidities also meant patients were more likely to have more than one primary care consultation before being referred to a specialist. Those with three or more comorbidities were 21% more likely to have at least three consultations before referral, compared with patients with no comorbidities (95% CI, 1.05-1.40, P = .010).
Overall, 60% of the participants in the study experienced at least one investigation into whether they had cancer by a primary care clinician before being referred to a specialist.
Morbidities linked with emergency referral
The study also saw an association between morbidities and the likelihood of receiving an emergency referral. Those with three or more morbidities were 60% more likely to have an emergency referral than were those with no comorbidities. Those with a Charlson score of three or above were 61% more likely to be referred to an emergency department.
“The greater likelihood of clinical complexity or acute deterioration among individuals with multiple or severe chronic conditions means that an emergency referral may be clinically appropriate,” the authors wrote.
Commenting on the findings, Dr. Diane M. Harper, professor of family medicine at the University of Michigan, Ann Arbor, said primary care patients often have multiple chronic illnesses, and the relationship between the physician and patients determines how quickly symptoms of cancer are explored.
“What this work cannot explore is the quality of discussions between the physician and the patient, nor can it explore how the decision to go to the ED was made,” said Dr. Harper, president of the North American Primary Care Research Group. “Exploring these data would provide important information to the physician-patient dyad.”
Diagnostic difficulty might have been at play, according to authors
The investigators didn’t find any evidence of an interaction between cancer site, number of morbidities, and referral or diagnostic time, except in cases of colorectal cancer, where patients with multiple morbidities were more likely to experience a longer wait between primary care consultation and diagnosis.
The authors observed that diagnostic difficulty of the cancer might have been at play here, given that colorectal cancer can have a broad symptom signature.
“This was less often observed among patients diagnosed with a cancer that had a narrow symptom signature (“easy” diagnostic difficulty, e.g. breast cancer) or a broad symptom signature of mostly low PPVs (“hard” diagnostic difficulty, e.g. brain cancer),” they wrote.
The authors concluded that “it is reasonable to suggest that both improvement efforts and future research in this field should target patients with multiple or severe morbidity, and explore the reasons for prolonged diagnostic intervals in specialist care.”
The study was supported by Cancer Research UK. The authors and experts interviewed for this piece did not declare having any conflicts of interest.
FROM FAMILY PRACTICE
Case report: ECT for delirious mania
Delirious mania is a diagnostic term used in variety of settings, including the emergency department and inpatient psychiatry, but it does not have formal criteria established in the DSM-5. Delirious mania was first described in the 1800s and was referred to as “Bell’s Mania.”
As the late Max Fink, MD, wrote in the journal Bipolar Disorders (2002 Feb 23. doi: 10.1034/j.1399-561.1999.10112.x), delirious mania is considered to be a syndrome of the acute onset of the excitement, grandiosity, emotional lability, delusions, and insomnia characteristic of mania, and the disorientation and altered consciousness characteristic of delirium.
Such patients can be considered as having a component of bipolar I disorder, comprising mania with psychotic features. Delirious mania is associated with higher rates of morbidity and mortality, and demonstrates limited response to conventional treatment guidelines. Therefore, early detection and decisive treatment are imperative. The concurrence of delirium and mania is not unusual, yet currently there are no universal accepted treatment guidelines for delirious mania (BMC Psychiatry. 2012 Jun 21. doi: 10.1186/1471-244X-12-65). The purpose of this case report is to inspire and support community psychiatric clinicians in managing such complex cases and to improve behavioral health care outcomes. To protect our patient’s identity, we changed several key identifiers.
The treatment plan emerges
This case is of a middle-aged man with an established diagnosis of bipolar disorder. He was referred to the ED because of worsening manic symptoms marked by mood lability, pressured speech, grandiose delusions, tangential thought processes, poor insight, and impaired sleep.
Laboratory studies in the ED revealed hyponatremia and serum sodium of 126meq/l (ref. range: 135-146). The patient’s toxicology screen was positive for benzodiazepines. He was stabilized on the medical floor and then transitioned to inpatient psychiatry.
Before his admission to psychiatry, the patient’s medications were alprazolam 1 mg at bed time, bupropion 100 mg twice daily, loxapine 25 mg morning and 50 mg at bed time, olanzapine 20 mg at bedtime and 5 mg twice daily, risperidone 2 mg twice daily and oxcarbazepine 900 mg twice daily.
The bupropion was discontinued because of manic behavior, and the patient’s dose of oxcarbazepine was lowered from 900 mg twice daily to 450 mg twice daily because of hyponatremia. Our team continued to administer risperidone, olanzapine, loxapine, and alprazolam to the patient. However, he was agitated and disorganized on the psychiatry floor. In addition, we noticed that the patient exhibited confusion, disorientation, an inability to connect with reality, and periods of profound agitation.
The patient was frequently restrained physically, and medications were administered to him for safety and containment. The use of benzodiazepines and anticholinergics was minimized. However, we noticed that the patient acted paranoid, disinhibited, and combative, and he became difficult to restrain. He seemed to have a high pain tolerance, responded to internal stimuli, and began hallucinating and displaying aggressive behavior toward staff persons.
It became apparent that the patient’s circadian rhythm had been altered. He slept for only a couple of hours during the day. During the course of treatment, in one incidence, the patient became agitated and charged at a nurse. Subsequently, the patient hit his head on a wall and fell – suffering a head strike and lacerations.
The team conducted investigations, including labs and neuroimaging, to make sure that the patient was OK. His CT head scan proved unremarkable. Liver function tests revealed mild transaminitis. His TSH, folate, B12, and B1 levels were normal.
We then placed the patient in a single room with continuous behavior monitoring. His recovery seemed to take a long time with trials of different antipsychotic medications, including olanzapine, loxapine, risperidone, and paliperidone. Because of his poor response to medications, the team considered using electroconvulsive therapy (ECT).
However, the patient was unable to give informed consent for ECT because of his impaired mental status. At this point, our team submitted a substitute treatment plan that included ECT to the court for approval, and the court approved our plan.
After receiving approximately four bilateral ECT procedures three times a week, the patient’s condition started to improve gradually. He received total of 11 procedures.
Our patient became alert to time, place, and person, and his circadian rhythm normalized. Soon, his delirium cleared, and he demonstrated marked improvement in both insight into his illness and behavioral control. His grandiose delusions were still present, but he was easily redirectable. In addition, our patient demonstrated improved reality testing. He was able to be discharged home following medication adjustments and with community supports within a few short weeks of receiving ECT.
As Bo-Shyan Lee, MD, and associates reported (BMC Psychiatry. 2012 Jun 21;12:65. doi: 10.1186/1471-244X-12-65), delirious mania is closely related to catatonia. Although there are different definitions for delirium and catatonia, even the most lethal form of catatonia meets the criteria for delirium. ECT is a well established first-line treatment for catatonia. This tool has been shown to be highly effective in the treatment of delirious mania. Delirious mania can be life-threatening and should be managed aggressively. The most common causes of death are heart failure from arrhythmias, cardiac arrest, and respiratory failure. ECT is a safe treatment, and, as Dr. Fink argued, the mortality rate is even less than that associated with normal pregnancies (World J Biol Psychiatry. 2001 Jan;2[1]:1-8). In light of the safety and effectiveness of ECT, we think the tool should be considered not only in university hospital settings but as an early intervention in community settings. This case warrants further research in exploring hyperactive delirium and delirious mania.
Dr. Lamba is BR-2 unit medical director at BayRidge Hospital in Lynn, Mass. Ms. Kennedy is an attending clinician at BayRidge. Dr. Vu is medical director at BayRidge. He also serves as associate chief of psychiatry at Beverly (Mass.) Hospital and at Addison Gilbert Hospital in Gloucester, Mass. Dr. Lamba, Ms. Kennedy, and Dr. Vu have no disclosures.
Delirious mania is a diagnostic term used in variety of settings, including the emergency department and inpatient psychiatry, but it does not have formal criteria established in the DSM-5. Delirious mania was first described in the 1800s and was referred to as “Bell’s Mania.”
As the late Max Fink, MD, wrote in the journal Bipolar Disorders (2002 Feb 23. doi: 10.1034/j.1399-561.1999.10112.x), delirious mania is considered to be a syndrome of the acute onset of the excitement, grandiosity, emotional lability, delusions, and insomnia characteristic of mania, and the disorientation and altered consciousness characteristic of delirium.
Such patients can be considered as having a component of bipolar I disorder, comprising mania with psychotic features. Delirious mania is associated with higher rates of morbidity and mortality, and demonstrates limited response to conventional treatment guidelines. Therefore, early detection and decisive treatment are imperative. The concurrence of delirium and mania is not unusual, yet currently there are no universal accepted treatment guidelines for delirious mania (BMC Psychiatry. 2012 Jun 21. doi: 10.1186/1471-244X-12-65). The purpose of this case report is to inspire and support community psychiatric clinicians in managing such complex cases and to improve behavioral health care outcomes. To protect our patient’s identity, we changed several key identifiers.
The treatment plan emerges
This case is of a middle-aged man with an established diagnosis of bipolar disorder. He was referred to the ED because of worsening manic symptoms marked by mood lability, pressured speech, grandiose delusions, tangential thought processes, poor insight, and impaired sleep.
Laboratory studies in the ED revealed hyponatremia and serum sodium of 126meq/l (ref. range: 135-146). The patient’s toxicology screen was positive for benzodiazepines. He was stabilized on the medical floor and then transitioned to inpatient psychiatry.
Before his admission to psychiatry, the patient’s medications were alprazolam 1 mg at bed time, bupropion 100 mg twice daily, loxapine 25 mg morning and 50 mg at bed time, olanzapine 20 mg at bedtime and 5 mg twice daily, risperidone 2 mg twice daily and oxcarbazepine 900 mg twice daily.
The bupropion was discontinued because of manic behavior, and the patient’s dose of oxcarbazepine was lowered from 900 mg twice daily to 450 mg twice daily because of hyponatremia. Our team continued to administer risperidone, olanzapine, loxapine, and alprazolam to the patient. However, he was agitated and disorganized on the psychiatry floor. In addition, we noticed that the patient exhibited confusion, disorientation, an inability to connect with reality, and periods of profound agitation.
The patient was frequently restrained physically, and medications were administered to him for safety and containment. The use of benzodiazepines and anticholinergics was minimized. However, we noticed that the patient acted paranoid, disinhibited, and combative, and he became difficult to restrain. He seemed to have a high pain tolerance, responded to internal stimuli, and began hallucinating and displaying aggressive behavior toward staff persons.
It became apparent that the patient’s circadian rhythm had been altered. He slept for only a couple of hours during the day. During the course of treatment, in one incidence, the patient became agitated and charged at a nurse. Subsequently, the patient hit his head on a wall and fell – suffering a head strike and lacerations.
The team conducted investigations, including labs and neuroimaging, to make sure that the patient was OK. His CT head scan proved unremarkable. Liver function tests revealed mild transaminitis. His TSH, folate, B12, and B1 levels were normal.
We then placed the patient in a single room with continuous behavior monitoring. His recovery seemed to take a long time with trials of different antipsychotic medications, including olanzapine, loxapine, risperidone, and paliperidone. Because of his poor response to medications, the team considered using electroconvulsive therapy (ECT).
However, the patient was unable to give informed consent for ECT because of his impaired mental status. At this point, our team submitted a substitute treatment plan that included ECT to the court for approval, and the court approved our plan.
After receiving approximately four bilateral ECT procedures three times a week, the patient’s condition started to improve gradually. He received total of 11 procedures.
Our patient became alert to time, place, and person, and his circadian rhythm normalized. Soon, his delirium cleared, and he demonstrated marked improvement in both insight into his illness and behavioral control. His grandiose delusions were still present, but he was easily redirectable. In addition, our patient demonstrated improved reality testing. He was able to be discharged home following medication adjustments and with community supports within a few short weeks of receiving ECT.
As Bo-Shyan Lee, MD, and associates reported (BMC Psychiatry. 2012 Jun 21;12:65. doi: 10.1186/1471-244X-12-65), delirious mania is closely related to catatonia. Although there are different definitions for delirium and catatonia, even the most lethal form of catatonia meets the criteria for delirium. ECT is a well established first-line treatment for catatonia. This tool has been shown to be highly effective in the treatment of delirious mania. Delirious mania can be life-threatening and should be managed aggressively. The most common causes of death are heart failure from arrhythmias, cardiac arrest, and respiratory failure. ECT is a safe treatment, and, as Dr. Fink argued, the mortality rate is even less than that associated with normal pregnancies (World J Biol Psychiatry. 2001 Jan;2[1]:1-8). In light of the safety and effectiveness of ECT, we think the tool should be considered not only in university hospital settings but as an early intervention in community settings. This case warrants further research in exploring hyperactive delirium and delirious mania.
Dr. Lamba is BR-2 unit medical director at BayRidge Hospital in Lynn, Mass. Ms. Kennedy is an attending clinician at BayRidge. Dr. Vu is medical director at BayRidge. He also serves as associate chief of psychiatry at Beverly (Mass.) Hospital and at Addison Gilbert Hospital in Gloucester, Mass. Dr. Lamba, Ms. Kennedy, and Dr. Vu have no disclosures.
Delirious mania is a diagnostic term used in variety of settings, including the emergency department and inpatient psychiatry, but it does not have formal criteria established in the DSM-5. Delirious mania was first described in the 1800s and was referred to as “Bell’s Mania.”
As the late Max Fink, MD, wrote in the journal Bipolar Disorders (2002 Feb 23. doi: 10.1034/j.1399-561.1999.10112.x), delirious mania is considered to be a syndrome of the acute onset of the excitement, grandiosity, emotional lability, delusions, and insomnia characteristic of mania, and the disorientation and altered consciousness characteristic of delirium.
Such patients can be considered as having a component of bipolar I disorder, comprising mania with psychotic features. Delirious mania is associated with higher rates of morbidity and mortality, and demonstrates limited response to conventional treatment guidelines. Therefore, early detection and decisive treatment are imperative. The concurrence of delirium and mania is not unusual, yet currently there are no universal accepted treatment guidelines for delirious mania (BMC Psychiatry. 2012 Jun 21. doi: 10.1186/1471-244X-12-65). The purpose of this case report is to inspire and support community psychiatric clinicians in managing such complex cases and to improve behavioral health care outcomes. To protect our patient’s identity, we changed several key identifiers.
The treatment plan emerges
This case is of a middle-aged man with an established diagnosis of bipolar disorder. He was referred to the ED because of worsening manic symptoms marked by mood lability, pressured speech, grandiose delusions, tangential thought processes, poor insight, and impaired sleep.
Laboratory studies in the ED revealed hyponatremia and serum sodium of 126meq/l (ref. range: 135-146). The patient’s toxicology screen was positive for benzodiazepines. He was stabilized on the medical floor and then transitioned to inpatient psychiatry.
Before his admission to psychiatry, the patient’s medications were alprazolam 1 mg at bed time, bupropion 100 mg twice daily, loxapine 25 mg morning and 50 mg at bed time, olanzapine 20 mg at bedtime and 5 mg twice daily, risperidone 2 mg twice daily and oxcarbazepine 900 mg twice daily.
The bupropion was discontinued because of manic behavior, and the patient’s dose of oxcarbazepine was lowered from 900 mg twice daily to 450 mg twice daily because of hyponatremia. Our team continued to administer risperidone, olanzapine, loxapine, and alprazolam to the patient. However, he was agitated and disorganized on the psychiatry floor. In addition, we noticed that the patient exhibited confusion, disorientation, an inability to connect with reality, and periods of profound agitation.
The patient was frequently restrained physically, and medications were administered to him for safety and containment. The use of benzodiazepines and anticholinergics was minimized. However, we noticed that the patient acted paranoid, disinhibited, and combative, and he became difficult to restrain. He seemed to have a high pain tolerance, responded to internal stimuli, and began hallucinating and displaying aggressive behavior toward staff persons.
It became apparent that the patient’s circadian rhythm had been altered. He slept for only a couple of hours during the day. During the course of treatment, in one incidence, the patient became agitated and charged at a nurse. Subsequently, the patient hit his head on a wall and fell – suffering a head strike and lacerations.
The team conducted investigations, including labs and neuroimaging, to make sure that the patient was OK. His CT head scan proved unremarkable. Liver function tests revealed mild transaminitis. His TSH, folate, B12, and B1 levels were normal.
We then placed the patient in a single room with continuous behavior monitoring. His recovery seemed to take a long time with trials of different antipsychotic medications, including olanzapine, loxapine, risperidone, and paliperidone. Because of his poor response to medications, the team considered using electroconvulsive therapy (ECT).
However, the patient was unable to give informed consent for ECT because of his impaired mental status. At this point, our team submitted a substitute treatment plan that included ECT to the court for approval, and the court approved our plan.
After receiving approximately four bilateral ECT procedures three times a week, the patient’s condition started to improve gradually. He received total of 11 procedures.
Our patient became alert to time, place, and person, and his circadian rhythm normalized. Soon, his delirium cleared, and he demonstrated marked improvement in both insight into his illness and behavioral control. His grandiose delusions were still present, but he was easily redirectable. In addition, our patient demonstrated improved reality testing. He was able to be discharged home following medication adjustments and with community supports within a few short weeks of receiving ECT.
As Bo-Shyan Lee, MD, and associates reported (BMC Psychiatry. 2012 Jun 21;12:65. doi: 10.1186/1471-244X-12-65), delirious mania is closely related to catatonia. Although there are different definitions for delirium and catatonia, even the most lethal form of catatonia meets the criteria for delirium. ECT is a well established first-line treatment for catatonia. This tool has been shown to be highly effective in the treatment of delirious mania. Delirious mania can be life-threatening and should be managed aggressively. The most common causes of death are heart failure from arrhythmias, cardiac arrest, and respiratory failure. ECT is a safe treatment, and, as Dr. Fink argued, the mortality rate is even less than that associated with normal pregnancies (World J Biol Psychiatry. 2001 Jan;2[1]:1-8). In light of the safety and effectiveness of ECT, we think the tool should be considered not only in university hospital settings but as an early intervention in community settings. This case warrants further research in exploring hyperactive delirium and delirious mania.
Dr. Lamba is BR-2 unit medical director at BayRidge Hospital in Lynn, Mass. Ms. Kennedy is an attending clinician at BayRidge. Dr. Vu is medical director at BayRidge. He also serves as associate chief of psychiatry at Beverly (Mass.) Hospital and at Addison Gilbert Hospital in Gloucester, Mass. Dr. Lamba, Ms. Kennedy, and Dr. Vu have no disclosures.
Alternative rheumatology practice models aim to avoid traditional limitations
Elizabeth Ortiz, MD, knew she needed a change. Working at an academic county clinic, she was often worn down and pulled in different directions. “When I thought about what I really liked about my job, it was patient care and spending time with my patients, which I wasn’t able to do,” Dr. Ortiz said during the annual meeting of the American College of Rheumatology.
She’d heard of direct or concierge care but wasn’t sure if it was a good fit for her. COVID-19 offered a catalyst of sorts for a move to a new care model.
Ten weeks after she moved to Dallas, the pandemic hit full force. Seeing how telehealth was taking off, Dr. Ortiz began crafting a new model of care, a hybrid of telemedicine and house calls that offered multiple venues to connect with patients. The practice is just a year old, and “it’s working and it’s a constant experiment,” said Dr. Ortiz, who offers membership plans and prepaid appointments. She also does “a la carte” visits where established patients can see her at a one-off price. Her goal is to achieve 100% membership.
Although she operates through a direct pay and cash-only model, only recently has she become comfortable with the word “concierge.” There’s a preconceived notion of what that word means, she said.
Direct care: A definition
Following the trend of some primary care practices, more rheumatologists who are dissatisfied with the status quo are embracing these models of care.
Direct and concierge care are often mentioned in tandem, but there are nuanced differences. Direct specialty care removes third-party payers to protect the best interests of patients, according to Diana Girnita, MD, founder and CEO of Rheumatologist OnCall, a direct care practice. Her patient base hails from rural and urban areas in least 10 states. She also created a Facebook group for specialists in direct care and is the cofounder of the Direct Specialty Care Alliance.
Direct care offers a membership fee and additional fees for “as needed” services. “As the physician, I do not have to be contracted to an insurance company to see patients. I contract directly with patients. It is the patient’s choice to contract with an insurance and use the insurance for ancillary services and medication,” Dr. Girnita said. Patients with out-of-network benefits can claim the insurance to cover part of the consultation cost, she added.
In concierge or retainer medicine, a patient pays an annual or monthly fee or retainer to get access to the physician practice. In addition to this fee, the practice can bill the patient’s insurance for consultations or other services. “The concierge model does not eliminate the sub payer. You still contract with the patient’s insurance,” explained Dr. Girnita.
Physicians who establish these models sometimes do a hybrid of cash only and insurance. Micah Yu, MD, who practices rheumatology in Newport Beach, Calif., only takes Medicare. “Otherwise, patients are private pay. I am mainly fee for service, so patients are paying me for my time,” he said.
By tailoring their patient base and services, adopters find they have more time to spend with patients. “In my model, I spend 30 minutes for follow-up and 1 hour for new patients,” Dr. Yu said.
Limitations of traditional care
Carrying insurance doesn’t guarantee you the right care, Dr. Girnita said. Wait times to see a rheumatologist range from 4 to 6 months. For physicians who contract with insurance companies, reimbursement for services isn’t always paid promptly and decreases every year. A new cut in reimbursement is expected for rheumatology services in 2022.
Patients in direct care “pay a small amount for memberships that cover the cost of their visits and the time physicians spend in coordinating their additional care between the visits. The cost of the visits is always transparent,” Dr. Girnita said.
Irene Kazmers, MD, a solo private rheumatology practitioner in northern Michigan, was seeing 20-plus patients a day before she made the leap to a concierge model. “The paperwork and administrative burdens of practicing rheumatology as a solo [physician] have mushroomed in the last 10 years,” she said during the ACR meeting. She and staff were spending an inordinate amount of time on prior authorizations, step therapy requirements, electronic health record documentation, and other administrative burdens.
Reimbursements from payers have progressively declined as administrative challenges have necessitated more staff. “I was struggling to maintain an ample financial margin,” she said.
Improved communication, unlimited visits
Dr. Kazmers attests that the transition to the concierge model has enabled and fostered a higher level of communication and specialty care for her patients.
Patients who enroll in the practice pay an annual membership fee and get access to her personal cell phone number and email address. “If they need an urgent appointment, it is typically arranged the same or next day,” she said in an interview. “Visits are not as rushed as in the traditional model, conducive to incorporating beneficial integrative medicine modalities such as dietary, exercise, and mind-body approaches as appropriate, in addition to state-of-the-art treatment.”
She also has more time to coordinate care with her patients’ primary care providers and other care team professionals and to give patients feedback on lab and study results.
Dr. Girnita has ramped down from 28 to 15 patients a day. She’s able to spend 60 minutes for new patients and 30 minutes for follow-ups. Like Dr. Kazmers, she feels she has more time to address patient needs and listen to their concerns.
She’s kept her hospital affiliations but finds that she doesn’t have to go to the hospital as much as she used to. Direct care “reduces hospital visits because physicians significantly have much more time to spend with the patient and address the needs of the patient.” A patient with a gout flare, for example, may end up in the hospital under traditional care because there’s no room in the physician’s schedule to address the patient’s needs.
Dr. Girnita recalled when she assisted a patient who had developed inflammatory arthritis and was desperate to see a doctor. The patient had good insurance, but appointments in her area weren’t available for at least 6 months. “Her primary care physician called me. I saw her and provided her with the appropriate care. A couple of months later she is doing great.”
What insurance does and doesn’t cover
Many patients who seek out direct or concierge models retain their insurance. At least 90% of Dr. Girnita’s patients have insurance with high deductibles. The other 10% have other types of insurance or no insurance.
Ellen McKnight, MD, who has a hybrid rheumatology practice in Pensacola, Fla., still accepts commercial insurance, but has opted out of Medicare. Her patients mostly come from rural areas in Florida, and their insurance situations vary widely. “In my practice, I estimate that 65% have insurance and 35% do not. Most of my patients have commercial insurance, and a substantial portion, about 40%, are just paying cash. My cash pay patients have Medicare, HMOs, and others are uninsured,” she said in an interview.
Direct care practices may continue to bill traditional insurance for items like visits, injections, and ultrasound.
Dr. Girnita’s patients have the option of submitting a “superbill” or invoice to insurance companies for patients to be reimbursed by their insurance for the cost of the visit. It contains the CPT code for the visit along with the ICD-10 codes for diagnoses. “I use a company called Reimbursify to help patients submit their invoice to their insurance company,” Dr. Girnita said.
Dr. Ortiz takes a different approach, offering superbills for consults and individual appointments, but not for patients enrolled in her membership program.
Some in the payer industry contend that direct care arrangements increase costs and distort risk pools. If most direct care patients already have a comprehensive health insurance policy, it’s likely they’re being billed twice for services, said David Allen, spokesperson for America’s Health Insurance Plans.
“Duplicative payments inflate the cost of care at a convenience to the providers and increase the cost of insurance premiums when insurers receive bills for those same services from providers. In other words, patients are being double billed,” Mr. Allen said.
These providers are assuming risk without state insurance oversight or regulations to ensure patient protections and safeguards are in place, he continued. “If utilization of services outpaces capacity, the provider may ultimately be unable to provide the amount of care expected by the patient because their practice agreed to unlimited visits and services with little or no restrictions.”
Eliminating ‘surprise’ bills
Adopters of direct care/concierge services counter that it’s the insurance and pharmaceutical companies driving up costs. Patients – especially those who have high-deductible plans – save money through these models. “In the direct care model, doctors have worked out advocacy for patients that are unsurpassed. Insurance companies don’t do that,” Dr. McKnight said.
Consumers know up front what the price is for other services. When you go to a restaurant, you always look on the menu to see what the price is for a bottle of wine or steak, Dr. Girnita said. “Only in the medical field you don’t know anything. And you’re shocked about the price you must pay.” Not many practices list their prices on their website, although federal rules seek to further increase price transparency in hospitals and among insurers.
Patients will sometimes get a “surprise” bill for their visit, laboratory, or imaging tests. According to Dr. Girnita, “that doesn’t happen in my practice. I discuss all prices with them before they get to the lab or MRI. I don’t charge copayments or anything extra.” Without a copayment – usually $50-$75 for specialist services – or a surprise bill, patients are always paying less, she said.
Costs through insurance are oftentimes higher, she continued. For routine lab work, a patient in a direct care practice pays about $30-$40. If they request this work through a lab, they’re likely to pay $150. “Think about an MRI. Through a direct care practice like mine, you pay $450-$700. In a hospital setting, you pay at least $5,000.”
Patients with high-deductible insurance plans often pay thousands of dollars before meeting their deductible, Dr. Girnita and others noted. A patient with this type of plan may pay $250 for a vitamin D lab if they haven’t met their deductible, Dr. McKnight explained. “With direct care, you’ll be paying $12.50.”
Dr. Girnita said her members get excellent discounts for labs and imaging. In the direct care models, physicians can help with this by contracting directly with labs, imaging centers, and independent pharmacies, giving patients access to affordable and transparent prices for their medical care.
What patients pay for services
In direct and concierge care membership models, coverage for services and fees vary widely from practice to practice.
Dr. Girnita offers several membership options. One package, which is $199 a month, is for patients with stable symptoms that guarantee continuity of care. It includes four visits a year and immediate access to the practice in case of emergency (including two additional urgent visits). “This works for a lot of patients. They consider that affordable, and they have all the benefits of a concierge practice. They can have direct communication with me, and they have guaranteed continuity of care,” Dr. Girnita said.
The other model, which is $299 per month, is for patients who need monthly contact with the rheumatologist for visits, telephone and email communications, urgent appointments, integrative medicine consultations, and many other benefits. For 1-hour consultations, Dr. Girnita charges $399.
Dr. Ortiz, who offers a direct pay model, charges $899 for an initial consult, which covers 3.5 hours of her time. “We do an hour of telemedicine, and we do a house call, which is 1.5-2 hours.” She follows up with a telehealth visit. Labs and x-rays are not included and go through the patient’s insurance.
Once the consult takes place, she assesses what a patient needs and offers them either a 6- or 12-month membership, which includes unlimited visits.
Patients can also buy a prepaid, six-appointment package with a 12% discount. Dr. Ortiz prices her telehealth visits at $350 and house calls at $550.
Dr. McKnight’s cash-only model for established patients offers four visits a year, reducing the fee for each visit. For example, a patient will pay $95 for the first visit, then $90, $85, and $80 for subsequent visits.
Accessing medications through direct care
One challenge with this model is finding affordable medications for patients outside of insurance.
Insurance dictates what’s covered, leaving fewer options for patients, Dr. McKnight said. “You have to jump through hoops, and there’s prior authorizations.” For a condition like severe osteoporosis, treatment should start sequentially with the true bone builders first, then move on to a medication like alendronate (Fosamax).
“Insurers will make you go to Fosamax first and then fail it,” she said. This results in the patient potentially developing worsening bone loss or possibly even sustaining a fracture.
Prior authorization requirements demand excessive staff time and effort, Dr. Kazmers said. This can translate to more than $90,000 a year in human resource costs for rheumatologists, who often deal with many specialty drug authorizations. “Every practice needs to hire staff to handle prior authorizations. We receive no compensation for this from the pharmaceutical companies and middlemen who ultimately profit from this cumbersome process,” she added.
Among the two big classes for rheumatology patients, conventional synthetic disease-modifying antirheumatic drugs (DMARDs) are the most widely available. Pharmacies can offer DMARDs for cash, although some are limited in terms of where they can ship, Dr. Girnita said.
The other class, biologic DMARDs, are the most expensive medications rheumatologists use for conditions such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
With biologics, it’s more difficult, as they’re very expensive, typically $6,000 a month or more, sources told this news organization.
“Unfortunately, we can’t partner at this time with pharmaceutical companies that produce biologics or independent pharmacies,” Dr. Girnita said. Physicians can’t control biologic prices either. “Insurance companies and pharmacy benefit managers have the control on these prices.”
Physicians can direct patients to multiple resources where they can find assistance.
Biologics companies that offer patient assistance programs can sometimes offer medications for free, while others offer savings cards or copay cards, “which helps a lot,” Dr. Girnita said. She assists her patients by filing some of the paperwork necessary to qualify for these programs, and the patients submit the rest.
“For these companies to help the patient, they need the patient’s financial information,” she said. “But I do most of that work; I complete the forms and send to the company and justify need for the medication.”
What’s ahead for direct specialty care
While some patients have benefited, others have had to seek alternatives as their doctors transition to alternative models.
Not everyone can afford the concierge retainer fee, said Dr. Kazmers, who practices in a rural area of Michigan, where rheumatologists are scarce. Enrollment in her concierge practice filled months before the switchover from her traditional practice took place. There are 70 patients on a waiting list.
Patients who elect not to enroll in the concierge practice need to find another source of rheumatology care. This is a downside to the practice transition, she acknowledged. “The closest rheumatologist taking new patients is a 3- to 4-hour drive away, which simply reflects the shortage of medical school graduates choosing to go into rheumatology in the United States,” Dr. Kazmers added.
One physician caring for thousands of chronically ill, complicated patients within systems that don’t allow them the time to really care for their patients threatens to make the access problem worse, Dr. Ortiz said. The direct care/concierge model offers an alternative for the provider “and is a way to keep providers in the workforce, who may otherwise consider leaving.”
Direct care/concierge medicine isn’t for all doctors. But for Dr. Kazmers, it’s the best option for her at this point in her career. “I’ve been practicing for 45 years in various models, including academic positions and private practice employment. I have worked for years in settings accepting Medicaid. I understand that if every rheumatologist went concierge tomorrow, this would constrict access to needed specialty care. But in my case, it provided a viable alternative to closing the practice’s doors altogether.”
Ultimately, the U.S. medical system needs more rheumatologists and other specialists. “If you really want to increase the service, then Medicare or other sources should support opening more residency and fellowship spots for medical graduates to pursue,” Dr. Girnita said.
Other solutions call for more systemic and institutional changes, such as expanding rheumatology divisions and faculties at institutions that train fellows and addressing medical school debt, Dr. Ortiz said.
Some practices see themselves branching out from individual patient care and partnering with local businesses to provide care for employees. That’s the future for direct specialty care, said Dr. Girnita, who’s been in discussions with a few employers to make such arrangements.
The direct primary care community has already started to contract with employers. “Their employees get care they need for just a fraction of the cost. These discussions are arising more and more,” she said.
A version of this article first appeared on Medscape.com.
Elizabeth Ortiz, MD, knew she needed a change. Working at an academic county clinic, she was often worn down and pulled in different directions. “When I thought about what I really liked about my job, it was patient care and spending time with my patients, which I wasn’t able to do,” Dr. Ortiz said during the annual meeting of the American College of Rheumatology.
She’d heard of direct or concierge care but wasn’t sure if it was a good fit for her. COVID-19 offered a catalyst of sorts for a move to a new care model.
Ten weeks after she moved to Dallas, the pandemic hit full force. Seeing how telehealth was taking off, Dr. Ortiz began crafting a new model of care, a hybrid of telemedicine and house calls that offered multiple venues to connect with patients. The practice is just a year old, and “it’s working and it’s a constant experiment,” said Dr. Ortiz, who offers membership plans and prepaid appointments. She also does “a la carte” visits where established patients can see her at a one-off price. Her goal is to achieve 100% membership.
Although she operates through a direct pay and cash-only model, only recently has she become comfortable with the word “concierge.” There’s a preconceived notion of what that word means, she said.
Direct care: A definition
Following the trend of some primary care practices, more rheumatologists who are dissatisfied with the status quo are embracing these models of care.
Direct and concierge care are often mentioned in tandem, but there are nuanced differences. Direct specialty care removes third-party payers to protect the best interests of patients, according to Diana Girnita, MD, founder and CEO of Rheumatologist OnCall, a direct care practice. Her patient base hails from rural and urban areas in least 10 states. She also created a Facebook group for specialists in direct care and is the cofounder of the Direct Specialty Care Alliance.
Direct care offers a membership fee and additional fees for “as needed” services. “As the physician, I do not have to be contracted to an insurance company to see patients. I contract directly with patients. It is the patient’s choice to contract with an insurance and use the insurance for ancillary services and medication,” Dr. Girnita said. Patients with out-of-network benefits can claim the insurance to cover part of the consultation cost, she added.
In concierge or retainer medicine, a patient pays an annual or monthly fee or retainer to get access to the physician practice. In addition to this fee, the practice can bill the patient’s insurance for consultations or other services. “The concierge model does not eliminate the sub payer. You still contract with the patient’s insurance,” explained Dr. Girnita.
Physicians who establish these models sometimes do a hybrid of cash only and insurance. Micah Yu, MD, who practices rheumatology in Newport Beach, Calif., only takes Medicare. “Otherwise, patients are private pay. I am mainly fee for service, so patients are paying me for my time,” he said.
By tailoring their patient base and services, adopters find they have more time to spend with patients. “In my model, I spend 30 minutes for follow-up and 1 hour for new patients,” Dr. Yu said.
Limitations of traditional care
Carrying insurance doesn’t guarantee you the right care, Dr. Girnita said. Wait times to see a rheumatologist range from 4 to 6 months. For physicians who contract with insurance companies, reimbursement for services isn’t always paid promptly and decreases every year. A new cut in reimbursement is expected for rheumatology services in 2022.
Patients in direct care “pay a small amount for memberships that cover the cost of their visits and the time physicians spend in coordinating their additional care between the visits. The cost of the visits is always transparent,” Dr. Girnita said.
Irene Kazmers, MD, a solo private rheumatology practitioner in northern Michigan, was seeing 20-plus patients a day before she made the leap to a concierge model. “The paperwork and administrative burdens of practicing rheumatology as a solo [physician] have mushroomed in the last 10 years,” she said during the ACR meeting. She and staff were spending an inordinate amount of time on prior authorizations, step therapy requirements, electronic health record documentation, and other administrative burdens.
Reimbursements from payers have progressively declined as administrative challenges have necessitated more staff. “I was struggling to maintain an ample financial margin,” she said.
Improved communication, unlimited visits
Dr. Kazmers attests that the transition to the concierge model has enabled and fostered a higher level of communication and specialty care for her patients.
Patients who enroll in the practice pay an annual membership fee and get access to her personal cell phone number and email address. “If they need an urgent appointment, it is typically arranged the same or next day,” she said in an interview. “Visits are not as rushed as in the traditional model, conducive to incorporating beneficial integrative medicine modalities such as dietary, exercise, and mind-body approaches as appropriate, in addition to state-of-the-art treatment.”
She also has more time to coordinate care with her patients’ primary care providers and other care team professionals and to give patients feedback on lab and study results.
Dr. Girnita has ramped down from 28 to 15 patients a day. She’s able to spend 60 minutes for new patients and 30 minutes for follow-ups. Like Dr. Kazmers, she feels she has more time to address patient needs and listen to their concerns.
She’s kept her hospital affiliations but finds that she doesn’t have to go to the hospital as much as she used to. Direct care “reduces hospital visits because physicians significantly have much more time to spend with the patient and address the needs of the patient.” A patient with a gout flare, for example, may end up in the hospital under traditional care because there’s no room in the physician’s schedule to address the patient’s needs.
Dr. Girnita recalled when she assisted a patient who had developed inflammatory arthritis and was desperate to see a doctor. The patient had good insurance, but appointments in her area weren’t available for at least 6 months. “Her primary care physician called me. I saw her and provided her with the appropriate care. A couple of months later she is doing great.”
What insurance does and doesn’t cover
Many patients who seek out direct or concierge models retain their insurance. At least 90% of Dr. Girnita’s patients have insurance with high deductibles. The other 10% have other types of insurance or no insurance.
Ellen McKnight, MD, who has a hybrid rheumatology practice in Pensacola, Fla., still accepts commercial insurance, but has opted out of Medicare. Her patients mostly come from rural areas in Florida, and their insurance situations vary widely. “In my practice, I estimate that 65% have insurance and 35% do not. Most of my patients have commercial insurance, and a substantial portion, about 40%, are just paying cash. My cash pay patients have Medicare, HMOs, and others are uninsured,” she said in an interview.
Direct care practices may continue to bill traditional insurance for items like visits, injections, and ultrasound.
Dr. Girnita’s patients have the option of submitting a “superbill” or invoice to insurance companies for patients to be reimbursed by their insurance for the cost of the visit. It contains the CPT code for the visit along with the ICD-10 codes for diagnoses. “I use a company called Reimbursify to help patients submit their invoice to their insurance company,” Dr. Girnita said.
Dr. Ortiz takes a different approach, offering superbills for consults and individual appointments, but not for patients enrolled in her membership program.
Some in the payer industry contend that direct care arrangements increase costs and distort risk pools. If most direct care patients already have a comprehensive health insurance policy, it’s likely they’re being billed twice for services, said David Allen, spokesperson for America’s Health Insurance Plans.
“Duplicative payments inflate the cost of care at a convenience to the providers and increase the cost of insurance premiums when insurers receive bills for those same services from providers. In other words, patients are being double billed,” Mr. Allen said.
These providers are assuming risk without state insurance oversight or regulations to ensure patient protections and safeguards are in place, he continued. “If utilization of services outpaces capacity, the provider may ultimately be unable to provide the amount of care expected by the patient because their practice agreed to unlimited visits and services with little or no restrictions.”
Eliminating ‘surprise’ bills
Adopters of direct care/concierge services counter that it’s the insurance and pharmaceutical companies driving up costs. Patients – especially those who have high-deductible plans – save money through these models. “In the direct care model, doctors have worked out advocacy for patients that are unsurpassed. Insurance companies don’t do that,” Dr. McKnight said.
Consumers know up front what the price is for other services. When you go to a restaurant, you always look on the menu to see what the price is for a bottle of wine or steak, Dr. Girnita said. “Only in the medical field you don’t know anything. And you’re shocked about the price you must pay.” Not many practices list their prices on their website, although federal rules seek to further increase price transparency in hospitals and among insurers.
Patients will sometimes get a “surprise” bill for their visit, laboratory, or imaging tests. According to Dr. Girnita, “that doesn’t happen in my practice. I discuss all prices with them before they get to the lab or MRI. I don’t charge copayments or anything extra.” Without a copayment – usually $50-$75 for specialist services – or a surprise bill, patients are always paying less, she said.
Costs through insurance are oftentimes higher, she continued. For routine lab work, a patient in a direct care practice pays about $30-$40. If they request this work through a lab, they’re likely to pay $150. “Think about an MRI. Through a direct care practice like mine, you pay $450-$700. In a hospital setting, you pay at least $5,000.”
Patients with high-deductible insurance plans often pay thousands of dollars before meeting their deductible, Dr. Girnita and others noted. A patient with this type of plan may pay $250 for a vitamin D lab if they haven’t met their deductible, Dr. McKnight explained. “With direct care, you’ll be paying $12.50.”
Dr. Girnita said her members get excellent discounts for labs and imaging. In the direct care models, physicians can help with this by contracting directly with labs, imaging centers, and independent pharmacies, giving patients access to affordable and transparent prices for their medical care.
What patients pay for services
In direct and concierge care membership models, coverage for services and fees vary widely from practice to practice.
Dr. Girnita offers several membership options. One package, which is $199 a month, is for patients with stable symptoms that guarantee continuity of care. It includes four visits a year and immediate access to the practice in case of emergency (including two additional urgent visits). “This works for a lot of patients. They consider that affordable, and they have all the benefits of a concierge practice. They can have direct communication with me, and they have guaranteed continuity of care,” Dr. Girnita said.
The other model, which is $299 per month, is for patients who need monthly contact with the rheumatologist for visits, telephone and email communications, urgent appointments, integrative medicine consultations, and many other benefits. For 1-hour consultations, Dr. Girnita charges $399.
Dr. Ortiz, who offers a direct pay model, charges $899 for an initial consult, which covers 3.5 hours of her time. “We do an hour of telemedicine, and we do a house call, which is 1.5-2 hours.” She follows up with a telehealth visit. Labs and x-rays are not included and go through the patient’s insurance.
Once the consult takes place, she assesses what a patient needs and offers them either a 6- or 12-month membership, which includes unlimited visits.
Patients can also buy a prepaid, six-appointment package with a 12% discount. Dr. Ortiz prices her telehealth visits at $350 and house calls at $550.
Dr. McKnight’s cash-only model for established patients offers four visits a year, reducing the fee for each visit. For example, a patient will pay $95 for the first visit, then $90, $85, and $80 for subsequent visits.
Accessing medications through direct care
One challenge with this model is finding affordable medications for patients outside of insurance.
Insurance dictates what’s covered, leaving fewer options for patients, Dr. McKnight said. “You have to jump through hoops, and there’s prior authorizations.” For a condition like severe osteoporosis, treatment should start sequentially with the true bone builders first, then move on to a medication like alendronate (Fosamax).
“Insurers will make you go to Fosamax first and then fail it,” she said. This results in the patient potentially developing worsening bone loss or possibly even sustaining a fracture.
Prior authorization requirements demand excessive staff time and effort, Dr. Kazmers said. This can translate to more than $90,000 a year in human resource costs for rheumatologists, who often deal with many specialty drug authorizations. “Every practice needs to hire staff to handle prior authorizations. We receive no compensation for this from the pharmaceutical companies and middlemen who ultimately profit from this cumbersome process,” she added.
Among the two big classes for rheumatology patients, conventional synthetic disease-modifying antirheumatic drugs (DMARDs) are the most widely available. Pharmacies can offer DMARDs for cash, although some are limited in terms of where they can ship, Dr. Girnita said.
The other class, biologic DMARDs, are the most expensive medications rheumatologists use for conditions such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
With biologics, it’s more difficult, as they’re very expensive, typically $6,000 a month or more, sources told this news organization.
“Unfortunately, we can’t partner at this time with pharmaceutical companies that produce biologics or independent pharmacies,” Dr. Girnita said. Physicians can’t control biologic prices either. “Insurance companies and pharmacy benefit managers have the control on these prices.”
Physicians can direct patients to multiple resources where they can find assistance.
Biologics companies that offer patient assistance programs can sometimes offer medications for free, while others offer savings cards or copay cards, “which helps a lot,” Dr. Girnita said. She assists her patients by filing some of the paperwork necessary to qualify for these programs, and the patients submit the rest.
“For these companies to help the patient, they need the patient’s financial information,” she said. “But I do most of that work; I complete the forms and send to the company and justify need for the medication.”
What’s ahead for direct specialty care
While some patients have benefited, others have had to seek alternatives as their doctors transition to alternative models.
Not everyone can afford the concierge retainer fee, said Dr. Kazmers, who practices in a rural area of Michigan, where rheumatologists are scarce. Enrollment in her concierge practice filled months before the switchover from her traditional practice took place. There are 70 patients on a waiting list.
Patients who elect not to enroll in the concierge practice need to find another source of rheumatology care. This is a downside to the practice transition, she acknowledged. “The closest rheumatologist taking new patients is a 3- to 4-hour drive away, which simply reflects the shortage of medical school graduates choosing to go into rheumatology in the United States,” Dr. Kazmers added.
One physician caring for thousands of chronically ill, complicated patients within systems that don’t allow them the time to really care for their patients threatens to make the access problem worse, Dr. Ortiz said. The direct care/concierge model offers an alternative for the provider “and is a way to keep providers in the workforce, who may otherwise consider leaving.”
Direct care/concierge medicine isn’t for all doctors. But for Dr. Kazmers, it’s the best option for her at this point in her career. “I’ve been practicing for 45 years in various models, including academic positions and private practice employment. I have worked for years in settings accepting Medicaid. I understand that if every rheumatologist went concierge tomorrow, this would constrict access to needed specialty care. But in my case, it provided a viable alternative to closing the practice’s doors altogether.”
Ultimately, the U.S. medical system needs more rheumatologists and other specialists. “If you really want to increase the service, then Medicare or other sources should support opening more residency and fellowship spots for medical graduates to pursue,” Dr. Girnita said.
Other solutions call for more systemic and institutional changes, such as expanding rheumatology divisions and faculties at institutions that train fellows and addressing medical school debt, Dr. Ortiz said.
Some practices see themselves branching out from individual patient care and partnering with local businesses to provide care for employees. That’s the future for direct specialty care, said Dr. Girnita, who’s been in discussions with a few employers to make such arrangements.
The direct primary care community has already started to contract with employers. “Their employees get care they need for just a fraction of the cost. These discussions are arising more and more,” she said.
A version of this article first appeared on Medscape.com.
Elizabeth Ortiz, MD, knew she needed a change. Working at an academic county clinic, she was often worn down and pulled in different directions. “When I thought about what I really liked about my job, it was patient care and spending time with my patients, which I wasn’t able to do,” Dr. Ortiz said during the annual meeting of the American College of Rheumatology.
She’d heard of direct or concierge care but wasn’t sure if it was a good fit for her. COVID-19 offered a catalyst of sorts for a move to a new care model.
Ten weeks after she moved to Dallas, the pandemic hit full force. Seeing how telehealth was taking off, Dr. Ortiz began crafting a new model of care, a hybrid of telemedicine and house calls that offered multiple venues to connect with patients. The practice is just a year old, and “it’s working and it’s a constant experiment,” said Dr. Ortiz, who offers membership plans and prepaid appointments. She also does “a la carte” visits where established patients can see her at a one-off price. Her goal is to achieve 100% membership.
Although she operates through a direct pay and cash-only model, only recently has she become comfortable with the word “concierge.” There’s a preconceived notion of what that word means, she said.
Direct care: A definition
Following the trend of some primary care practices, more rheumatologists who are dissatisfied with the status quo are embracing these models of care.
Direct and concierge care are often mentioned in tandem, but there are nuanced differences. Direct specialty care removes third-party payers to protect the best interests of patients, according to Diana Girnita, MD, founder and CEO of Rheumatologist OnCall, a direct care practice. Her patient base hails from rural and urban areas in least 10 states. She also created a Facebook group for specialists in direct care and is the cofounder of the Direct Specialty Care Alliance.
Direct care offers a membership fee and additional fees for “as needed” services. “As the physician, I do not have to be contracted to an insurance company to see patients. I contract directly with patients. It is the patient’s choice to contract with an insurance and use the insurance for ancillary services and medication,” Dr. Girnita said. Patients with out-of-network benefits can claim the insurance to cover part of the consultation cost, she added.
In concierge or retainer medicine, a patient pays an annual or monthly fee or retainer to get access to the physician practice. In addition to this fee, the practice can bill the patient’s insurance for consultations or other services. “The concierge model does not eliminate the sub payer. You still contract with the patient’s insurance,” explained Dr. Girnita.
Physicians who establish these models sometimes do a hybrid of cash only and insurance. Micah Yu, MD, who practices rheumatology in Newport Beach, Calif., only takes Medicare. “Otherwise, patients are private pay. I am mainly fee for service, so patients are paying me for my time,” he said.
By tailoring their patient base and services, adopters find they have more time to spend with patients. “In my model, I spend 30 minutes for follow-up and 1 hour for new patients,” Dr. Yu said.
Limitations of traditional care
Carrying insurance doesn’t guarantee you the right care, Dr. Girnita said. Wait times to see a rheumatologist range from 4 to 6 months. For physicians who contract with insurance companies, reimbursement for services isn’t always paid promptly and decreases every year. A new cut in reimbursement is expected for rheumatology services in 2022.
Patients in direct care “pay a small amount for memberships that cover the cost of their visits and the time physicians spend in coordinating their additional care between the visits. The cost of the visits is always transparent,” Dr. Girnita said.
Irene Kazmers, MD, a solo private rheumatology practitioner in northern Michigan, was seeing 20-plus patients a day before she made the leap to a concierge model. “The paperwork and administrative burdens of practicing rheumatology as a solo [physician] have mushroomed in the last 10 years,” she said during the ACR meeting. She and staff were spending an inordinate amount of time on prior authorizations, step therapy requirements, electronic health record documentation, and other administrative burdens.
Reimbursements from payers have progressively declined as administrative challenges have necessitated more staff. “I was struggling to maintain an ample financial margin,” she said.
Improved communication, unlimited visits
Dr. Kazmers attests that the transition to the concierge model has enabled and fostered a higher level of communication and specialty care for her patients.
Patients who enroll in the practice pay an annual membership fee and get access to her personal cell phone number and email address. “If they need an urgent appointment, it is typically arranged the same or next day,” she said in an interview. “Visits are not as rushed as in the traditional model, conducive to incorporating beneficial integrative medicine modalities such as dietary, exercise, and mind-body approaches as appropriate, in addition to state-of-the-art treatment.”
She also has more time to coordinate care with her patients’ primary care providers and other care team professionals and to give patients feedback on lab and study results.
Dr. Girnita has ramped down from 28 to 15 patients a day. She’s able to spend 60 minutes for new patients and 30 minutes for follow-ups. Like Dr. Kazmers, she feels she has more time to address patient needs and listen to their concerns.
She’s kept her hospital affiliations but finds that she doesn’t have to go to the hospital as much as she used to. Direct care “reduces hospital visits because physicians significantly have much more time to spend with the patient and address the needs of the patient.” A patient with a gout flare, for example, may end up in the hospital under traditional care because there’s no room in the physician’s schedule to address the patient’s needs.
Dr. Girnita recalled when she assisted a patient who had developed inflammatory arthritis and was desperate to see a doctor. The patient had good insurance, but appointments in her area weren’t available for at least 6 months. “Her primary care physician called me. I saw her and provided her with the appropriate care. A couple of months later she is doing great.”
What insurance does and doesn’t cover
Many patients who seek out direct or concierge models retain their insurance. At least 90% of Dr. Girnita’s patients have insurance with high deductibles. The other 10% have other types of insurance or no insurance.
Ellen McKnight, MD, who has a hybrid rheumatology practice in Pensacola, Fla., still accepts commercial insurance, but has opted out of Medicare. Her patients mostly come from rural areas in Florida, and their insurance situations vary widely. “In my practice, I estimate that 65% have insurance and 35% do not. Most of my patients have commercial insurance, and a substantial portion, about 40%, are just paying cash. My cash pay patients have Medicare, HMOs, and others are uninsured,” she said in an interview.
Direct care practices may continue to bill traditional insurance for items like visits, injections, and ultrasound.
Dr. Girnita’s patients have the option of submitting a “superbill” or invoice to insurance companies for patients to be reimbursed by their insurance for the cost of the visit. It contains the CPT code for the visit along with the ICD-10 codes for diagnoses. “I use a company called Reimbursify to help patients submit their invoice to their insurance company,” Dr. Girnita said.
Dr. Ortiz takes a different approach, offering superbills for consults and individual appointments, but not for patients enrolled in her membership program.
Some in the payer industry contend that direct care arrangements increase costs and distort risk pools. If most direct care patients already have a comprehensive health insurance policy, it’s likely they’re being billed twice for services, said David Allen, spokesperson for America’s Health Insurance Plans.
“Duplicative payments inflate the cost of care at a convenience to the providers and increase the cost of insurance premiums when insurers receive bills for those same services from providers. In other words, patients are being double billed,” Mr. Allen said.
These providers are assuming risk without state insurance oversight or regulations to ensure patient protections and safeguards are in place, he continued. “If utilization of services outpaces capacity, the provider may ultimately be unable to provide the amount of care expected by the patient because their practice agreed to unlimited visits and services with little or no restrictions.”
Eliminating ‘surprise’ bills
Adopters of direct care/concierge services counter that it’s the insurance and pharmaceutical companies driving up costs. Patients – especially those who have high-deductible plans – save money through these models. “In the direct care model, doctors have worked out advocacy for patients that are unsurpassed. Insurance companies don’t do that,” Dr. McKnight said.
Consumers know up front what the price is for other services. When you go to a restaurant, you always look on the menu to see what the price is for a bottle of wine or steak, Dr. Girnita said. “Only in the medical field you don’t know anything. And you’re shocked about the price you must pay.” Not many practices list their prices on their website, although federal rules seek to further increase price transparency in hospitals and among insurers.
Patients will sometimes get a “surprise” bill for their visit, laboratory, or imaging tests. According to Dr. Girnita, “that doesn’t happen in my practice. I discuss all prices with them before they get to the lab or MRI. I don’t charge copayments or anything extra.” Without a copayment – usually $50-$75 for specialist services – or a surprise bill, patients are always paying less, she said.
Costs through insurance are oftentimes higher, she continued. For routine lab work, a patient in a direct care practice pays about $30-$40. If they request this work through a lab, they’re likely to pay $150. “Think about an MRI. Through a direct care practice like mine, you pay $450-$700. In a hospital setting, you pay at least $5,000.”
Patients with high-deductible insurance plans often pay thousands of dollars before meeting their deductible, Dr. Girnita and others noted. A patient with this type of plan may pay $250 for a vitamin D lab if they haven’t met their deductible, Dr. McKnight explained. “With direct care, you’ll be paying $12.50.”
Dr. Girnita said her members get excellent discounts for labs and imaging. In the direct care models, physicians can help with this by contracting directly with labs, imaging centers, and independent pharmacies, giving patients access to affordable and transparent prices for their medical care.
What patients pay for services
In direct and concierge care membership models, coverage for services and fees vary widely from practice to practice.
Dr. Girnita offers several membership options. One package, which is $199 a month, is for patients with stable symptoms that guarantee continuity of care. It includes four visits a year and immediate access to the practice in case of emergency (including two additional urgent visits). “This works for a lot of patients. They consider that affordable, and they have all the benefits of a concierge practice. They can have direct communication with me, and they have guaranteed continuity of care,” Dr. Girnita said.
The other model, which is $299 per month, is for patients who need monthly contact with the rheumatologist for visits, telephone and email communications, urgent appointments, integrative medicine consultations, and many other benefits. For 1-hour consultations, Dr. Girnita charges $399.
Dr. Ortiz, who offers a direct pay model, charges $899 for an initial consult, which covers 3.5 hours of her time. “We do an hour of telemedicine, and we do a house call, which is 1.5-2 hours.” She follows up with a telehealth visit. Labs and x-rays are not included and go through the patient’s insurance.
Once the consult takes place, she assesses what a patient needs and offers them either a 6- or 12-month membership, which includes unlimited visits.
Patients can also buy a prepaid, six-appointment package with a 12% discount. Dr. Ortiz prices her telehealth visits at $350 and house calls at $550.
Dr. McKnight’s cash-only model for established patients offers four visits a year, reducing the fee for each visit. For example, a patient will pay $95 for the first visit, then $90, $85, and $80 for subsequent visits.
Accessing medications through direct care
One challenge with this model is finding affordable medications for patients outside of insurance.
Insurance dictates what’s covered, leaving fewer options for patients, Dr. McKnight said. “You have to jump through hoops, and there’s prior authorizations.” For a condition like severe osteoporosis, treatment should start sequentially with the true bone builders first, then move on to a medication like alendronate (Fosamax).
“Insurers will make you go to Fosamax first and then fail it,” she said. This results in the patient potentially developing worsening bone loss or possibly even sustaining a fracture.
Prior authorization requirements demand excessive staff time and effort, Dr. Kazmers said. This can translate to more than $90,000 a year in human resource costs for rheumatologists, who often deal with many specialty drug authorizations. “Every practice needs to hire staff to handle prior authorizations. We receive no compensation for this from the pharmaceutical companies and middlemen who ultimately profit from this cumbersome process,” she added.
Among the two big classes for rheumatology patients, conventional synthetic disease-modifying antirheumatic drugs (DMARDs) are the most widely available. Pharmacies can offer DMARDs for cash, although some are limited in terms of where they can ship, Dr. Girnita said.
The other class, biologic DMARDs, are the most expensive medications rheumatologists use for conditions such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
With biologics, it’s more difficult, as they’re very expensive, typically $6,000 a month or more, sources told this news organization.
“Unfortunately, we can’t partner at this time with pharmaceutical companies that produce biologics or independent pharmacies,” Dr. Girnita said. Physicians can’t control biologic prices either. “Insurance companies and pharmacy benefit managers have the control on these prices.”
Physicians can direct patients to multiple resources where they can find assistance.
Biologics companies that offer patient assistance programs can sometimes offer medications for free, while others offer savings cards or copay cards, “which helps a lot,” Dr. Girnita said. She assists her patients by filing some of the paperwork necessary to qualify for these programs, and the patients submit the rest.
“For these companies to help the patient, they need the patient’s financial information,” she said. “But I do most of that work; I complete the forms and send to the company and justify need for the medication.”
What’s ahead for direct specialty care
While some patients have benefited, others have had to seek alternatives as their doctors transition to alternative models.
Not everyone can afford the concierge retainer fee, said Dr. Kazmers, who practices in a rural area of Michigan, where rheumatologists are scarce. Enrollment in her concierge practice filled months before the switchover from her traditional practice took place. There are 70 patients on a waiting list.
Patients who elect not to enroll in the concierge practice need to find another source of rheumatology care. This is a downside to the practice transition, she acknowledged. “The closest rheumatologist taking new patients is a 3- to 4-hour drive away, which simply reflects the shortage of medical school graduates choosing to go into rheumatology in the United States,” Dr. Kazmers added.
One physician caring for thousands of chronically ill, complicated patients within systems that don’t allow them the time to really care for their patients threatens to make the access problem worse, Dr. Ortiz said. The direct care/concierge model offers an alternative for the provider “and is a way to keep providers in the workforce, who may otherwise consider leaving.”
Direct care/concierge medicine isn’t for all doctors. But for Dr. Kazmers, it’s the best option for her at this point in her career. “I’ve been practicing for 45 years in various models, including academic positions and private practice employment. I have worked for years in settings accepting Medicaid. I understand that if every rheumatologist went concierge tomorrow, this would constrict access to needed specialty care. But in my case, it provided a viable alternative to closing the practice’s doors altogether.”
Ultimately, the U.S. medical system needs more rheumatologists and other specialists. “If you really want to increase the service, then Medicare or other sources should support opening more residency and fellowship spots for medical graduates to pursue,” Dr. Girnita said.
Other solutions call for more systemic and institutional changes, such as expanding rheumatology divisions and faculties at institutions that train fellows and addressing medical school debt, Dr. Ortiz said.
Some practices see themselves branching out from individual patient care and partnering with local businesses to provide care for employees. That’s the future for direct specialty care, said Dr. Girnita, who’s been in discussions with a few employers to make such arrangements.
The direct primary care community has already started to contract with employers. “Their employees get care they need for just a fraction of the cost. These discussions are arising more and more,” she said.
A version of this article first appeared on Medscape.com.
Electrocuted by 11,000 volts, now a triple amputee ... and an MD
Bruce “BJ” Miller Jr., a 19-year-old Princeton (N.J.) University sophomore, was horsing around with friends near a train track in 1990 when they spotted a parked commuter train. They decided to climb over the train, and Mr. Miller was first up the ladder.
An explosion ripped through the air, and Mr. Miller was thrown on top of the train, his body smoking. His petrified friends called for an ambulance.
Clinging to life, Mr. Miller was airlifted to the burn unit at Saint Barnabas Medical Center in Livingston, N.J..
Physicians saved Mr. Miller’s life, but they had to amputate both of his legs below the knees and his left arm below the elbow.
“With electricity, you burn from the inside out,” said Mr. Miller, now 50. “The voltage enters your body – in my case, the wrist – and runs around internally until it finds a way out. That is often the lower extremities as the ground tends to ground the current, but not always. In my case, the current tried to come through my chest – which is also burned and required skin grafting – but not enough to spare my legs. I think I had a half-dozen or so surgeries over the first month or 2 at the hospital.”
Waking up to a new body
Mr. Miller doesn’t remember much about the accident, but he recalls waking up a few days later in the ICU and feeling the need to use the bathroom. Disoriented, Mr. Miller pulled off his ventilator, climbed out of bed, and tried to walk forward, unaware of his injuries. His feet and legs had not yet been amputated. When the catheter line ran out of slack, he collapsed.
“Eventually, a nurse came rushing in, responding to the ventilator alarm bells going off,” Mr. Miller said. “My dad wasn’t far behind. It became clear to me then that this was not a dream and [I realized] what had happened and why I was in the hospital.”
For months, Mr. Miller lived in the burn unit, undergoing countless skin grafts and surgeries. Because viable and nonviable tissue take time to be revealed after burns, surgeons take the minimum amount of tissue during each operation to give damaged tissue a chance to heal, he explained. In Mr. Miller’s case, his feet were amputated first, and later, his legs.
“In those early days from the hospital bed, my mind turned to issues related to identity,” he said. “What do I do with myself?
Mr. Miller eventually moved to the Rehabilitation Institute of Chicago (now called The Shirley Ryan AbilityLab), where he started the grueling process of rebuilding his strength and learning to walk on prosthetic legs.
“Any one day was filled with a mix of optimism and good fight and 5 minutes later, exasperation, frustration, tons of pain, and insecurity about my body,” he said. “My family and friends held the gate for me in a way, but a lot of the work was up to me. I had to believe that I deserved this love, that I wanted to be alive, and that there was still something here for me.”
Mr. Miller didn’t have to look far for inspiration. His mom had lived with polio for most of her life and acquired post-polio syndrome as she grew older, he said. When he was a child, his mom walked with crutches, and she became wheelchair-dependent by the time he was a teenager.
After the first surgery to amputate his feet, Mr. Miller and his mom shared a deep discussion about his joining the ranks of “the disabled,” and how their connection was now even stronger.
“In this way, the injuries unlocked even more experiences to share between us, and more love to feel, and therefore some early sense of gain to complement all the losses happening,” he said. “She had taught me so much about living with disability and had given me all the tools I needed to refashion my sense of self.”
From burn patient to medical student
After returning to Princeton University and finishing his undergraduate degree, Mr. Miller decided to go into medicine. He wanted to use his experience to help patients and find ways to improve weaknesses in the health care system, he said. But he made a deal with himself that he wouldn’t become a doctor for the sake of becoming one; he would enter the vocation only if he could do the work and enjoy the job.
“I wasn’t sure if I could do it,” he said. “There weren’t a lot of triple amputees to point to, to say whether this was even mechanically possible, to get through the training. The medical institutions I spoke with knew they had some obligation by law to protect me, but there’s also an obligation that I need to be able to fulfill the competencies. This was uncharted water.”
Because his greatest physical challenge was standing for long periods, instructors at the University of California, San Francisco, made accommodations to alleviate the strain. His clinical rotations for example, were organized near his home to limit the need for travel. On surgical rotations, he was allowed to sit on a stool.
Medical training progressed smoothly until Mr. Miller completed a rotation in his chosen specialty, rehabilitation medicine. He didn’t enjoy it. The passion and meaning he hoped to find was missing. Disillusioned, and with his final year in medical school coming to an end, Mr. Miller dropped out of the Match program. Around the same time, his sister, Lisa, died by suicide.
“My whole family life was in shambles,” he said. “I felt like, ‘I can’t even help my sister, how am I going to help other people?’ ”
Mr. Miller earned his MD and moved to his parents’ home in Milwaukee after his sister’s death. He was close to giving up on medicine, but his deans convinced him to do a post-doc internship. It was as an intern at the Medical College of Wisconsin, Milwaukee, that he completed an elective in palliative care.
“I fell immediately in love with it the first day,” he said. “This was a field devoted to working with things you can’t change and dealing with a lack of control, what it’s like to live with these diagnoses. This was a place where I could dig into my experience and share that with patients and families. This was a place where my life story had something to offer.”
Creating a new form of palliative care
Dr. Miller went on to complete a fellowship at Harvard Medical School, Boston, in hospice and palliative medicine. He became a palliative care physician at UCSF Health, and later directed the Zen Hospice Project, a nonprofit dedicated to teaching mindfulness-based caregiving for professionals, family members, and caregivers.
Gayle Kojimoto, a program manager who worked with Dr. Miller at UCSF’s outpatient palliative care clinic for cancer patients, said Miller was a favorite among patients because of his authenticity and his ability to make them feel understood.
“Patients love him because he is 100% present with them,” said Ms. Kojimoto. “They feel like he can understand their suffering better than other docs. He’s open to hearing about their suffering, when others may not be, and he doesn’t judge them. Many patients have said that seeing him is better than seeing a therapist.”
In 2020, Dr. Miller cofounded Mettle Health, a first-of-its-kind company that aims to reframe the way people think about their well-being as it relates to chronic and serious illness. Mettle Health’s care team provides consultations on a range of topics, including practical, emotional, and existential issues. No physician referrals are needed.
When the pandemic started, Dr. Miller said he and his colleagues felt the moment was ripe for bringing palliative care online to increase access, while decreasing caregiver and clinician burnout.
“We set up Mettle Health as an online palliative care counseling and coaching business and we pulled it out of the healthcare system so that whether you’re a patient or a caregiver you don’t need to satisfy some insurance need to get this kind of care,” he said. “We also realized there are enough people writing prescriptions. The medical piece is relatively well tended to; it’s the psychosocial and spiritual issues, and the existential issues, that are so underdeveloped. We are a social service, not a medical service, and this allows us to complement existing structures of care rather than compete with them.”
Having Dr. Miller as a leader for Mettle Health is a huge driver for why people seek out the company, said Sonya Dolan, director of operations and cofounder of Mettle Health.
“His approach to working with patients, caregivers, and clinicians is something I think sets us apart and makes us special,” she said. “His way of thinking about serious illness and death and dying is incredibly unique and he has a way of talking about and humanizing something that’s scary for a lot of us.”
‘Surprised by how much I can still do’
Since the accident, Dr. Miller has come a long way in navigating his physical limitations. In the early years, Dr. Miller said he was determined to do as many activities as he still could. He skied, biked, and pushed himself to stand for long periods on his prosthetic legs.
“For years, I would force myself to do these things just to prove I could, but not really enjoy them,” he said. “I’d get out on the dance floor or put myself out in vulnerable social situations where I might fall. It was kind of brutal and difficult. But at about year 5 or so, I became much more at ease with myself and more at peace with myself.”
Today, Dr. Miller’s prosthetics make nearly all ambulatory activities possible, but he concentrates on the activities that bring him joy.
“Probably the thing I can still do that surprises people most, including myself, is riding a motorcycle,” he said. “As for my upper body, I’m thoroughly used to living with only one hand and I continue to be surprised at how much I can still do. With enough time and experimentation, I can usually find a way to do what I need/want to do. It took me awhile to figure out how to clap! Now I just pound my chest for the same effect!”
Dr. Miller is an animal-lover and said his pets and nature are a large part of his self-care. His dog Maysie travels nearly everywhere with him and his cats, the Muffin Man and Darkness, enjoy making guest appearances on his Zoom calls. The physician frequently visits the desert in southern Utah and said he loves the arts, architecture, and design.
Dr. Miller’s advice for others who are disabled and want to go into medicine? Live out loud with your truths and be open about your disabilities. Too often, disabled individuals hide their disabilities, lie about them, or shield the world from their story, he said.
“These are rich, ripe experiences that are incredibly valuable to someone who wants to go out and be of service in the world,” he said. “We should be proud of our experiences as disabled people. The creativity we’ve had to exercise, the workarounds we’ve had to employ, these should not be points of embarrassment, but points of pride. Anyone who wants to pursue clinical training of any kind should use these experiences explicitly. These are sources of strength, not something to be forgiven or tolerated or accommodated.”
The same goes for physicians who do not have disabilities but who have lived through hardship, pain, struggle, or adversity, he emphasized.
“Find a way to learn from them, find a way to own them,” he said. “Use them as a source of strength and the rest of the world will respond to you differently.”
A version of this article first appeared on Medscape.com.
Bruce “BJ” Miller Jr., a 19-year-old Princeton (N.J.) University sophomore, was horsing around with friends near a train track in 1990 when they spotted a parked commuter train. They decided to climb over the train, and Mr. Miller was first up the ladder.
An explosion ripped through the air, and Mr. Miller was thrown on top of the train, his body smoking. His petrified friends called for an ambulance.
Clinging to life, Mr. Miller was airlifted to the burn unit at Saint Barnabas Medical Center in Livingston, N.J..
Physicians saved Mr. Miller’s life, but they had to amputate both of his legs below the knees and his left arm below the elbow.
“With electricity, you burn from the inside out,” said Mr. Miller, now 50. “The voltage enters your body – in my case, the wrist – and runs around internally until it finds a way out. That is often the lower extremities as the ground tends to ground the current, but not always. In my case, the current tried to come through my chest – which is also burned and required skin grafting – but not enough to spare my legs. I think I had a half-dozen or so surgeries over the first month or 2 at the hospital.”
Waking up to a new body
Mr. Miller doesn’t remember much about the accident, but he recalls waking up a few days later in the ICU and feeling the need to use the bathroom. Disoriented, Mr. Miller pulled off his ventilator, climbed out of bed, and tried to walk forward, unaware of his injuries. His feet and legs had not yet been amputated. When the catheter line ran out of slack, he collapsed.
“Eventually, a nurse came rushing in, responding to the ventilator alarm bells going off,” Mr. Miller said. “My dad wasn’t far behind. It became clear to me then that this was not a dream and [I realized] what had happened and why I was in the hospital.”
For months, Mr. Miller lived in the burn unit, undergoing countless skin grafts and surgeries. Because viable and nonviable tissue take time to be revealed after burns, surgeons take the minimum amount of tissue during each operation to give damaged tissue a chance to heal, he explained. In Mr. Miller’s case, his feet were amputated first, and later, his legs.
“In those early days from the hospital bed, my mind turned to issues related to identity,” he said. “What do I do with myself?
Mr. Miller eventually moved to the Rehabilitation Institute of Chicago (now called The Shirley Ryan AbilityLab), where he started the grueling process of rebuilding his strength and learning to walk on prosthetic legs.
“Any one day was filled with a mix of optimism and good fight and 5 minutes later, exasperation, frustration, tons of pain, and insecurity about my body,” he said. “My family and friends held the gate for me in a way, but a lot of the work was up to me. I had to believe that I deserved this love, that I wanted to be alive, and that there was still something here for me.”
Mr. Miller didn’t have to look far for inspiration. His mom had lived with polio for most of her life and acquired post-polio syndrome as she grew older, he said. When he was a child, his mom walked with crutches, and she became wheelchair-dependent by the time he was a teenager.
After the first surgery to amputate his feet, Mr. Miller and his mom shared a deep discussion about his joining the ranks of “the disabled,” and how their connection was now even stronger.
“In this way, the injuries unlocked even more experiences to share between us, and more love to feel, and therefore some early sense of gain to complement all the losses happening,” he said. “She had taught me so much about living with disability and had given me all the tools I needed to refashion my sense of self.”
From burn patient to medical student
After returning to Princeton University and finishing his undergraduate degree, Mr. Miller decided to go into medicine. He wanted to use his experience to help patients and find ways to improve weaknesses in the health care system, he said. But he made a deal with himself that he wouldn’t become a doctor for the sake of becoming one; he would enter the vocation only if he could do the work and enjoy the job.
“I wasn’t sure if I could do it,” he said. “There weren’t a lot of triple amputees to point to, to say whether this was even mechanically possible, to get through the training. The medical institutions I spoke with knew they had some obligation by law to protect me, but there’s also an obligation that I need to be able to fulfill the competencies. This was uncharted water.”
Because his greatest physical challenge was standing for long periods, instructors at the University of California, San Francisco, made accommodations to alleviate the strain. His clinical rotations for example, were organized near his home to limit the need for travel. On surgical rotations, he was allowed to sit on a stool.
Medical training progressed smoothly until Mr. Miller completed a rotation in his chosen specialty, rehabilitation medicine. He didn’t enjoy it. The passion and meaning he hoped to find was missing. Disillusioned, and with his final year in medical school coming to an end, Mr. Miller dropped out of the Match program. Around the same time, his sister, Lisa, died by suicide.
“My whole family life was in shambles,” he said. “I felt like, ‘I can’t even help my sister, how am I going to help other people?’ ”
Mr. Miller earned his MD and moved to his parents’ home in Milwaukee after his sister’s death. He was close to giving up on medicine, but his deans convinced him to do a post-doc internship. It was as an intern at the Medical College of Wisconsin, Milwaukee, that he completed an elective in palliative care.
“I fell immediately in love with it the first day,” he said. “This was a field devoted to working with things you can’t change and dealing with a lack of control, what it’s like to live with these diagnoses. This was a place where I could dig into my experience and share that with patients and families. This was a place where my life story had something to offer.”
Creating a new form of palliative care
Dr. Miller went on to complete a fellowship at Harvard Medical School, Boston, in hospice and palliative medicine. He became a palliative care physician at UCSF Health, and later directed the Zen Hospice Project, a nonprofit dedicated to teaching mindfulness-based caregiving for professionals, family members, and caregivers.
Gayle Kojimoto, a program manager who worked with Dr. Miller at UCSF’s outpatient palliative care clinic for cancer patients, said Miller was a favorite among patients because of his authenticity and his ability to make them feel understood.
“Patients love him because he is 100% present with them,” said Ms. Kojimoto. “They feel like he can understand their suffering better than other docs. He’s open to hearing about their suffering, when others may not be, and he doesn’t judge them. Many patients have said that seeing him is better than seeing a therapist.”
In 2020, Dr. Miller cofounded Mettle Health, a first-of-its-kind company that aims to reframe the way people think about their well-being as it relates to chronic and serious illness. Mettle Health’s care team provides consultations on a range of topics, including practical, emotional, and existential issues. No physician referrals are needed.
When the pandemic started, Dr. Miller said he and his colleagues felt the moment was ripe for bringing palliative care online to increase access, while decreasing caregiver and clinician burnout.
“We set up Mettle Health as an online palliative care counseling and coaching business and we pulled it out of the healthcare system so that whether you’re a patient or a caregiver you don’t need to satisfy some insurance need to get this kind of care,” he said. “We also realized there are enough people writing prescriptions. The medical piece is relatively well tended to; it’s the psychosocial and spiritual issues, and the existential issues, that are so underdeveloped. We are a social service, not a medical service, and this allows us to complement existing structures of care rather than compete with them.”
Having Dr. Miller as a leader for Mettle Health is a huge driver for why people seek out the company, said Sonya Dolan, director of operations and cofounder of Mettle Health.
“His approach to working with patients, caregivers, and clinicians is something I think sets us apart and makes us special,” she said. “His way of thinking about serious illness and death and dying is incredibly unique and he has a way of talking about and humanizing something that’s scary for a lot of us.”
‘Surprised by how much I can still do’
Since the accident, Dr. Miller has come a long way in navigating his physical limitations. In the early years, Dr. Miller said he was determined to do as many activities as he still could. He skied, biked, and pushed himself to stand for long periods on his prosthetic legs.
“For years, I would force myself to do these things just to prove I could, but not really enjoy them,” he said. “I’d get out on the dance floor or put myself out in vulnerable social situations where I might fall. It was kind of brutal and difficult. But at about year 5 or so, I became much more at ease with myself and more at peace with myself.”
Today, Dr. Miller’s prosthetics make nearly all ambulatory activities possible, but he concentrates on the activities that bring him joy.
“Probably the thing I can still do that surprises people most, including myself, is riding a motorcycle,” he said. “As for my upper body, I’m thoroughly used to living with only one hand and I continue to be surprised at how much I can still do. With enough time and experimentation, I can usually find a way to do what I need/want to do. It took me awhile to figure out how to clap! Now I just pound my chest for the same effect!”
Dr. Miller is an animal-lover and said his pets and nature are a large part of his self-care. His dog Maysie travels nearly everywhere with him and his cats, the Muffin Man and Darkness, enjoy making guest appearances on his Zoom calls. The physician frequently visits the desert in southern Utah and said he loves the arts, architecture, and design.
Dr. Miller’s advice for others who are disabled and want to go into medicine? Live out loud with your truths and be open about your disabilities. Too often, disabled individuals hide their disabilities, lie about them, or shield the world from their story, he said.
“These are rich, ripe experiences that are incredibly valuable to someone who wants to go out and be of service in the world,” he said. “We should be proud of our experiences as disabled people. The creativity we’ve had to exercise, the workarounds we’ve had to employ, these should not be points of embarrassment, but points of pride. Anyone who wants to pursue clinical training of any kind should use these experiences explicitly. These are sources of strength, not something to be forgiven or tolerated or accommodated.”
The same goes for physicians who do not have disabilities but who have lived through hardship, pain, struggle, or adversity, he emphasized.
“Find a way to learn from them, find a way to own them,” he said. “Use them as a source of strength and the rest of the world will respond to you differently.”
A version of this article first appeared on Medscape.com.
Bruce “BJ” Miller Jr., a 19-year-old Princeton (N.J.) University sophomore, was horsing around with friends near a train track in 1990 when they spotted a parked commuter train. They decided to climb over the train, and Mr. Miller was first up the ladder.
An explosion ripped through the air, and Mr. Miller was thrown on top of the train, his body smoking. His petrified friends called for an ambulance.
Clinging to life, Mr. Miller was airlifted to the burn unit at Saint Barnabas Medical Center in Livingston, N.J..
Physicians saved Mr. Miller’s life, but they had to amputate both of his legs below the knees and his left arm below the elbow.
“With electricity, you burn from the inside out,” said Mr. Miller, now 50. “The voltage enters your body – in my case, the wrist – and runs around internally until it finds a way out. That is often the lower extremities as the ground tends to ground the current, but not always. In my case, the current tried to come through my chest – which is also burned and required skin grafting – but not enough to spare my legs. I think I had a half-dozen or so surgeries over the first month or 2 at the hospital.”
Waking up to a new body
Mr. Miller doesn’t remember much about the accident, but he recalls waking up a few days later in the ICU and feeling the need to use the bathroom. Disoriented, Mr. Miller pulled off his ventilator, climbed out of bed, and tried to walk forward, unaware of his injuries. His feet and legs had not yet been amputated. When the catheter line ran out of slack, he collapsed.
“Eventually, a nurse came rushing in, responding to the ventilator alarm bells going off,” Mr. Miller said. “My dad wasn’t far behind. It became clear to me then that this was not a dream and [I realized] what had happened and why I was in the hospital.”
For months, Mr. Miller lived in the burn unit, undergoing countless skin grafts and surgeries. Because viable and nonviable tissue take time to be revealed after burns, surgeons take the minimum amount of tissue during each operation to give damaged tissue a chance to heal, he explained. In Mr. Miller’s case, his feet were amputated first, and later, his legs.
“In those early days from the hospital bed, my mind turned to issues related to identity,” he said. “What do I do with myself?
Mr. Miller eventually moved to the Rehabilitation Institute of Chicago (now called The Shirley Ryan AbilityLab), where he started the grueling process of rebuilding his strength and learning to walk on prosthetic legs.
“Any one day was filled with a mix of optimism and good fight and 5 minutes later, exasperation, frustration, tons of pain, and insecurity about my body,” he said. “My family and friends held the gate for me in a way, but a lot of the work was up to me. I had to believe that I deserved this love, that I wanted to be alive, and that there was still something here for me.”
Mr. Miller didn’t have to look far for inspiration. His mom had lived with polio for most of her life and acquired post-polio syndrome as she grew older, he said. When he was a child, his mom walked with crutches, and she became wheelchair-dependent by the time he was a teenager.
After the first surgery to amputate his feet, Mr. Miller and his mom shared a deep discussion about his joining the ranks of “the disabled,” and how their connection was now even stronger.
“In this way, the injuries unlocked even more experiences to share between us, and more love to feel, and therefore some early sense of gain to complement all the losses happening,” he said. “She had taught me so much about living with disability and had given me all the tools I needed to refashion my sense of self.”
From burn patient to medical student
After returning to Princeton University and finishing his undergraduate degree, Mr. Miller decided to go into medicine. He wanted to use his experience to help patients and find ways to improve weaknesses in the health care system, he said. But he made a deal with himself that he wouldn’t become a doctor for the sake of becoming one; he would enter the vocation only if he could do the work and enjoy the job.
“I wasn’t sure if I could do it,” he said. “There weren’t a lot of triple amputees to point to, to say whether this was even mechanically possible, to get through the training. The medical institutions I spoke with knew they had some obligation by law to protect me, but there’s also an obligation that I need to be able to fulfill the competencies. This was uncharted water.”
Because his greatest physical challenge was standing for long periods, instructors at the University of California, San Francisco, made accommodations to alleviate the strain. His clinical rotations for example, were organized near his home to limit the need for travel. On surgical rotations, he was allowed to sit on a stool.
Medical training progressed smoothly until Mr. Miller completed a rotation in his chosen specialty, rehabilitation medicine. He didn’t enjoy it. The passion and meaning he hoped to find was missing. Disillusioned, and with his final year in medical school coming to an end, Mr. Miller dropped out of the Match program. Around the same time, his sister, Lisa, died by suicide.
“My whole family life was in shambles,” he said. “I felt like, ‘I can’t even help my sister, how am I going to help other people?’ ”
Mr. Miller earned his MD and moved to his parents’ home in Milwaukee after his sister’s death. He was close to giving up on medicine, but his deans convinced him to do a post-doc internship. It was as an intern at the Medical College of Wisconsin, Milwaukee, that he completed an elective in palliative care.
“I fell immediately in love with it the first day,” he said. “This was a field devoted to working with things you can’t change and dealing with a lack of control, what it’s like to live with these diagnoses. This was a place where I could dig into my experience and share that with patients and families. This was a place where my life story had something to offer.”
Creating a new form of palliative care
Dr. Miller went on to complete a fellowship at Harvard Medical School, Boston, in hospice and palliative medicine. He became a palliative care physician at UCSF Health, and later directed the Zen Hospice Project, a nonprofit dedicated to teaching mindfulness-based caregiving for professionals, family members, and caregivers.
Gayle Kojimoto, a program manager who worked with Dr. Miller at UCSF’s outpatient palliative care clinic for cancer patients, said Miller was a favorite among patients because of his authenticity and his ability to make them feel understood.
“Patients love him because he is 100% present with them,” said Ms. Kojimoto. “They feel like he can understand their suffering better than other docs. He’s open to hearing about their suffering, when others may not be, and he doesn’t judge them. Many patients have said that seeing him is better than seeing a therapist.”
In 2020, Dr. Miller cofounded Mettle Health, a first-of-its-kind company that aims to reframe the way people think about their well-being as it relates to chronic and serious illness. Mettle Health’s care team provides consultations on a range of topics, including practical, emotional, and existential issues. No physician referrals are needed.
When the pandemic started, Dr. Miller said he and his colleagues felt the moment was ripe for bringing palliative care online to increase access, while decreasing caregiver and clinician burnout.
“We set up Mettle Health as an online palliative care counseling and coaching business and we pulled it out of the healthcare system so that whether you’re a patient or a caregiver you don’t need to satisfy some insurance need to get this kind of care,” he said. “We also realized there are enough people writing prescriptions. The medical piece is relatively well tended to; it’s the psychosocial and spiritual issues, and the existential issues, that are so underdeveloped. We are a social service, not a medical service, and this allows us to complement existing structures of care rather than compete with them.”
Having Dr. Miller as a leader for Mettle Health is a huge driver for why people seek out the company, said Sonya Dolan, director of operations and cofounder of Mettle Health.
“His approach to working with patients, caregivers, and clinicians is something I think sets us apart and makes us special,” she said. “His way of thinking about serious illness and death and dying is incredibly unique and he has a way of talking about and humanizing something that’s scary for a lot of us.”
‘Surprised by how much I can still do’
Since the accident, Dr. Miller has come a long way in navigating his physical limitations. In the early years, Dr. Miller said he was determined to do as many activities as he still could. He skied, biked, and pushed himself to stand for long periods on his prosthetic legs.
“For years, I would force myself to do these things just to prove I could, but not really enjoy them,” he said. “I’d get out on the dance floor or put myself out in vulnerable social situations where I might fall. It was kind of brutal and difficult. But at about year 5 or so, I became much more at ease with myself and more at peace with myself.”
Today, Dr. Miller’s prosthetics make nearly all ambulatory activities possible, but he concentrates on the activities that bring him joy.
“Probably the thing I can still do that surprises people most, including myself, is riding a motorcycle,” he said. “As for my upper body, I’m thoroughly used to living with only one hand and I continue to be surprised at how much I can still do. With enough time and experimentation, I can usually find a way to do what I need/want to do. It took me awhile to figure out how to clap! Now I just pound my chest for the same effect!”
Dr. Miller is an animal-lover and said his pets and nature are a large part of his self-care. His dog Maysie travels nearly everywhere with him and his cats, the Muffin Man and Darkness, enjoy making guest appearances on his Zoom calls. The physician frequently visits the desert in southern Utah and said he loves the arts, architecture, and design.
Dr. Miller’s advice for others who are disabled and want to go into medicine? Live out loud with your truths and be open about your disabilities. Too often, disabled individuals hide their disabilities, lie about them, or shield the world from their story, he said.
“These are rich, ripe experiences that are incredibly valuable to someone who wants to go out and be of service in the world,” he said. “We should be proud of our experiences as disabled people. The creativity we’ve had to exercise, the workarounds we’ve had to employ, these should not be points of embarrassment, but points of pride. Anyone who wants to pursue clinical training of any kind should use these experiences explicitly. These are sources of strength, not something to be forgiven or tolerated or accommodated.”
The same goes for physicians who do not have disabilities but who have lived through hardship, pain, struggle, or adversity, he emphasized.
“Find a way to learn from them, find a way to own them,” he said. “Use them as a source of strength and the rest of the world will respond to you differently.”
A version of this article first appeared on Medscape.com.
D-dimer thresholds rule out PE in meta-analysis
In a patient suspected to have a PE, “diagnosis is made radiographically, usually with CT pulmonary angiogram, or V/Q scan,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview.
“Validated clinical decision tools such as Wells’ score or Geneva score may be used to identify patients at low pretest probability of PE who may initially get a D-dimer level check, followed by imaging only if D-dimer level is elevated,” explained Dr. Pal, who was not involved with the new research, which was published in the Annals of Internal Medicine.
According to the authors of the new paper, while current diagnostic strategies in patients with suspected PE include use of a validated clinical decision rule (CDR) and D-dimer testing to rule out PE without imaging tests, the effectiveness of D-dimer tests in older patients, inpatients, cancer patients, and other high-risk groups has not been well-studied.
Lead author of the paper, Milou A.M. Stals, MD, and colleagues said their goal was to evaluate the safety and efficiency of the Wells rule and revised Geneva score in combination with D-dimer tests, and also the YEARS algorithm for D-dimer thresholds, in their paper.
Dr. Stals, of Leiden (the Netherlands) University Medical Center, and the coinvestigators conducted an international systemic review and individual patient data meta-analysis that included 16 studies and 20,553 patients, with all studies having been published between Jan. 1, 1995, and Jan. 1, 2021. Their primary outcomes were the safety and efficiency of each of these three strategies.
In the review, the researchers defined safety as the 3-month incidence of venous thromboembolism after PE was ruled out without imaging at baseline. They defined efficiency as the proportion patients for whom PE was ruled out based on D-dimer thresholds without imaging.
Overall, efficiency was highest in the subset of patients aged younger than 40 years, ranging from 47% to 68% in this group. Efficiency was lowest in patients aged 80 years and older (6.0%-23%), and in patients with cancer (9.6%-26%).
The efficiency was higher when D-dimer thresholds based on pretest probability were used, compared with when fixed or age-adjusted D-dimer thresholds were used.
The key finding was the significant variability in performance of the diagnostic strategies, the researchers said.
“The predicted failure rate was generally highest for strategies incorporating adapted D-dimer thresholds. However, at the same time, predicted overall efficiency was substantially higher with these strategies versus strategies with a fixed D-dimer threshold as well,” they said. Given that the benefits of each of the three diagnostic strategies depends on their correct application, the researchers recommended that an individual hospitalist choose one strategy for their institution.
“Whether clinicians should rely on the Wells rule, the YEARS algorithm, or the revised Geneva score becomes a matter of local preference and experience,” Dr. Stals and colleagues wrote.
The study findings were limited by several factors including between-study differences in scoring predictors and D-dimer assays. Another limitation was that differential verification biases for classifying fatal events and PE may have contributed to overestimation of failure rates of the adapted D-dimer thresholds.
Strengths of the study included its large sample size and original data on pretest probability, and that data support the use of any of the three strategies for ruling out PE in the identified subgroups without the need for imaging tests, the authors wrote.
“Pending the results of ongoing diagnostic randomized trials, physicians and guideline committees should balance the interlink between safety and efficiency of available diagnostic strategies,” they concluded.
Adapted D-dimer benefits some patients
“Clearly, increasing the D-dimer cutoff will lower the number of patients who require radiographic imaging (improved specificity), but this comes with a risk for missing PE (lower sensitivity). Is this risk worth taking?” Daniel J. Brotman, MD, of Johns Hopkins University, Baltimore, asked in an editorial accompanying the new study.
Dr. Brotman was not surprised by the study findings.
“Conditions that predispose to thrombosis through activated hemostasis – such as advanced age, cancer, inflammation, prolonged hospitalization, and trauma – drive D-dimer levels higher independent of the presence or absence of radiographically apparent thrombosis,” he said. However, these patients are unlikely to have normal D-dimer levels regardless of the cutoff used.
Adapted D-dimer cutoffs may benefit some patients, including those with contraindications or limited access to imaging, said Dr. Brotman. D-dimer may be used for risk stratification regardless of PE, since patients with marginally elevated D-dimers have better prognoses than those with higher D-dimer elevations, even if a small PE is missed.
Dr. Brotman wrote that increasing D-dimer cutoffs for high-risk patients in the subgroups analyzed may spare some patients radiographic testing, but doing so carries an increased risk for diagnostic failure. Overall, “the important work by Stals and colleagues offers reassurance that modifying D-dimer thresholds according to age or pretest probability is safe enough for widespread practice, even in high-risk groups.”
Focus on single strategy ‘based on local needs’
“Several validated clinical decision tools, along with age or pretest probability adjusted D-dimer threshold are currently in use as diagnostic strategies for ruling out pulmonary embolism,” Dr. Pal said in an interview.
The current study is important because of limited data on the performance of these strategies in specific subgroups of patients whose risk of PE may differ from the overall patient population, he noted.
“Different diagnostic strategies for PE have a variable performance in patients with differences of age, active cancer, and history of VTE,” said Dr. Pal. “However, in this study, no clear preference for one strategy over others could be established for these subgroups, and clinicians should continue to follow institution-specific guidance.
“A single strategy should be adopted at each institution based on local needs and used as the standard of care until further data are available,” he said.
“The use of D-dimer to rule out PE, either with fixed threshold or age-adjusted thresholds, can be confounded in clinical settings by other comorbid conditions such as sepsis, recent surgery, and more recently, COVID-19,” he said.
“Since the findings of this study do not show a clear benefit of one diagnostic strategy over others in the analyzed subgroups of patients, further prospective head-to-head comparison among the subgroups of interest would be helpful to guide clinical decision making,” Dr. Pal added.
YEARS-specific study supports D-dimer safety and value
A recent paper published in JAMA supported the results of the meta-analysis. In that study, Yonathan Freund, MD, of Sorbonne Université, Paris, and colleagues focused on the YEARS strategy combined with age-adjusted D-dimer thresholds as a way to rule out PE in PERC-positive ED patients.
The authors of this paper randomized 18 EDs to either a protocol of intervention followed by control, or control followed by intervention. The study population included 726 patients in the intervention group and 688 in the control group.
The intervention strategy to rule out PE consisted of assessing the YEARS criteria and D-dimer testing. PE was ruled out in patients with no YEARS criteria and a D-dimer level below 1,000 ng/mL and in patients with one or more YEARS criteria and D-dimers below an age-adjusted threshold (defined as age times 10 ng/mL in patients aged 50 years and older).
The control strategy consisted of D-dimer testing for all patients with the threshold at age-adjusted levels; D-dimers about these levels prompted chest imaging.
Overall, the risk of a missed VTE at 3 months was noninferior between the groups (0.15% in the intervention group and 0.80% in the controls).
“The intervention was associated with a statistically significant reduction in chest imaging use,” the researchers wrote.
This study’s findings were limited by randomization at the center level, rather than the patient level, and the use of imaging on some patients despite negative D-dimer tests, the researchers wrote. However, their findings support those of previous studies and especially support the safety of the intervention, in an emergency medicine setting, as no PEs occurred in patients with a YEARS score of zero who underwent the intervention.
Downsides to applying algorithms to every patient explained
In an editorial accompanying the JAMA study, Marcel Levi, MD, and Nick van Es, MD, of Amsterdam University Medical Center, emphasized the challenges of diagnosing PE given that many patients present with nonspecific clinical manifestations and without typical signs and symptoms. High-resolution CT pulmonary angiography allows for a fast and easy diagnosis in an emergency setting. However, efforts are ongoing to develop alternative strategies that avoid unnecessary scanning for potential PE patients, many of whom have alternative diagnoses such as pulmonary infections, cardiac conditions, pleural disease, or musculoskeletal problems.
On review of the JAMA study using the YEARS rule with adjusted D-dimer thresholds, the editorialists noted that the data were robust and indicated a 10% reduction in chest imaging. They also emphasized the potential to overwhelm busy clinicians with more algorithms.
“Blindly applying algorithms to every patient may be less appropriate or even undesirable in specific situations in which deviation from the rules on clinical grounds is indicated,” but a complex imaging approach may be time consuming and challenging in the acute setting, and a simple algorithm may be safe and efficient in many cases, they wrote. “From a patient perspective, a negative diagnostic algorithm for pulmonary embolism does not diminish the physician’s obligation to consider other diagnoses that explain the symptoms, for which chest CT scans may still be needed and helpful.”
The Annals of Internal Medicine study was supported by the Dutch Research Council. The JAMA study was supported by the French Health Ministry. Dr. Stals, Dr. Freund, Dr. Pal, Dr. Levi, and Dr. van Es had no financial conflicts to disclose.
In a patient suspected to have a PE, “diagnosis is made radiographically, usually with CT pulmonary angiogram, or V/Q scan,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview.
“Validated clinical decision tools such as Wells’ score or Geneva score may be used to identify patients at low pretest probability of PE who may initially get a D-dimer level check, followed by imaging only if D-dimer level is elevated,” explained Dr. Pal, who was not involved with the new research, which was published in the Annals of Internal Medicine.
According to the authors of the new paper, while current diagnostic strategies in patients with suspected PE include use of a validated clinical decision rule (CDR) and D-dimer testing to rule out PE without imaging tests, the effectiveness of D-dimer tests in older patients, inpatients, cancer patients, and other high-risk groups has not been well-studied.
Lead author of the paper, Milou A.M. Stals, MD, and colleagues said their goal was to evaluate the safety and efficiency of the Wells rule and revised Geneva score in combination with D-dimer tests, and also the YEARS algorithm for D-dimer thresholds, in their paper.
Dr. Stals, of Leiden (the Netherlands) University Medical Center, and the coinvestigators conducted an international systemic review and individual patient data meta-analysis that included 16 studies and 20,553 patients, with all studies having been published between Jan. 1, 1995, and Jan. 1, 2021. Their primary outcomes were the safety and efficiency of each of these three strategies.
In the review, the researchers defined safety as the 3-month incidence of venous thromboembolism after PE was ruled out without imaging at baseline. They defined efficiency as the proportion patients for whom PE was ruled out based on D-dimer thresholds without imaging.
Overall, efficiency was highest in the subset of patients aged younger than 40 years, ranging from 47% to 68% in this group. Efficiency was lowest in patients aged 80 years and older (6.0%-23%), and in patients with cancer (9.6%-26%).
The efficiency was higher when D-dimer thresholds based on pretest probability were used, compared with when fixed or age-adjusted D-dimer thresholds were used.
The key finding was the significant variability in performance of the diagnostic strategies, the researchers said.
“The predicted failure rate was generally highest for strategies incorporating adapted D-dimer thresholds. However, at the same time, predicted overall efficiency was substantially higher with these strategies versus strategies with a fixed D-dimer threshold as well,” they said. Given that the benefits of each of the three diagnostic strategies depends on their correct application, the researchers recommended that an individual hospitalist choose one strategy for their institution.
“Whether clinicians should rely on the Wells rule, the YEARS algorithm, or the revised Geneva score becomes a matter of local preference and experience,” Dr. Stals and colleagues wrote.
The study findings were limited by several factors including between-study differences in scoring predictors and D-dimer assays. Another limitation was that differential verification biases for classifying fatal events and PE may have contributed to overestimation of failure rates of the adapted D-dimer thresholds.
Strengths of the study included its large sample size and original data on pretest probability, and that data support the use of any of the three strategies for ruling out PE in the identified subgroups without the need for imaging tests, the authors wrote.
“Pending the results of ongoing diagnostic randomized trials, physicians and guideline committees should balance the interlink between safety and efficiency of available diagnostic strategies,” they concluded.
Adapted D-dimer benefits some patients
“Clearly, increasing the D-dimer cutoff will lower the number of patients who require radiographic imaging (improved specificity), but this comes with a risk for missing PE (lower sensitivity). Is this risk worth taking?” Daniel J. Brotman, MD, of Johns Hopkins University, Baltimore, asked in an editorial accompanying the new study.
Dr. Brotman was not surprised by the study findings.
“Conditions that predispose to thrombosis through activated hemostasis – such as advanced age, cancer, inflammation, prolonged hospitalization, and trauma – drive D-dimer levels higher independent of the presence or absence of radiographically apparent thrombosis,” he said. However, these patients are unlikely to have normal D-dimer levels regardless of the cutoff used.
Adapted D-dimer cutoffs may benefit some patients, including those with contraindications or limited access to imaging, said Dr. Brotman. D-dimer may be used for risk stratification regardless of PE, since patients with marginally elevated D-dimers have better prognoses than those with higher D-dimer elevations, even if a small PE is missed.
Dr. Brotman wrote that increasing D-dimer cutoffs for high-risk patients in the subgroups analyzed may spare some patients radiographic testing, but doing so carries an increased risk for diagnostic failure. Overall, “the important work by Stals and colleagues offers reassurance that modifying D-dimer thresholds according to age or pretest probability is safe enough for widespread practice, even in high-risk groups.”
Focus on single strategy ‘based on local needs’
“Several validated clinical decision tools, along with age or pretest probability adjusted D-dimer threshold are currently in use as diagnostic strategies for ruling out pulmonary embolism,” Dr. Pal said in an interview.
The current study is important because of limited data on the performance of these strategies in specific subgroups of patients whose risk of PE may differ from the overall patient population, he noted.
“Different diagnostic strategies for PE have a variable performance in patients with differences of age, active cancer, and history of VTE,” said Dr. Pal. “However, in this study, no clear preference for one strategy over others could be established for these subgroups, and clinicians should continue to follow institution-specific guidance.
“A single strategy should be adopted at each institution based on local needs and used as the standard of care until further data are available,” he said.
“The use of D-dimer to rule out PE, either with fixed threshold or age-adjusted thresholds, can be confounded in clinical settings by other comorbid conditions such as sepsis, recent surgery, and more recently, COVID-19,” he said.
“Since the findings of this study do not show a clear benefit of one diagnostic strategy over others in the analyzed subgroups of patients, further prospective head-to-head comparison among the subgroups of interest would be helpful to guide clinical decision making,” Dr. Pal added.
YEARS-specific study supports D-dimer safety and value
A recent paper published in JAMA supported the results of the meta-analysis. In that study, Yonathan Freund, MD, of Sorbonne Université, Paris, and colleagues focused on the YEARS strategy combined with age-adjusted D-dimer thresholds as a way to rule out PE in PERC-positive ED patients.
The authors of this paper randomized 18 EDs to either a protocol of intervention followed by control, or control followed by intervention. The study population included 726 patients in the intervention group and 688 in the control group.
The intervention strategy to rule out PE consisted of assessing the YEARS criteria and D-dimer testing. PE was ruled out in patients with no YEARS criteria and a D-dimer level below 1,000 ng/mL and in patients with one or more YEARS criteria and D-dimers below an age-adjusted threshold (defined as age times 10 ng/mL in patients aged 50 years and older).
The control strategy consisted of D-dimer testing for all patients with the threshold at age-adjusted levels; D-dimers about these levels prompted chest imaging.
Overall, the risk of a missed VTE at 3 months was noninferior between the groups (0.15% in the intervention group and 0.80% in the controls).
“The intervention was associated with a statistically significant reduction in chest imaging use,” the researchers wrote.
This study’s findings were limited by randomization at the center level, rather than the patient level, and the use of imaging on some patients despite negative D-dimer tests, the researchers wrote. However, their findings support those of previous studies and especially support the safety of the intervention, in an emergency medicine setting, as no PEs occurred in patients with a YEARS score of zero who underwent the intervention.
Downsides to applying algorithms to every patient explained
In an editorial accompanying the JAMA study, Marcel Levi, MD, and Nick van Es, MD, of Amsterdam University Medical Center, emphasized the challenges of diagnosing PE given that many patients present with nonspecific clinical manifestations and without typical signs and symptoms. High-resolution CT pulmonary angiography allows for a fast and easy diagnosis in an emergency setting. However, efforts are ongoing to develop alternative strategies that avoid unnecessary scanning for potential PE patients, many of whom have alternative diagnoses such as pulmonary infections, cardiac conditions, pleural disease, or musculoskeletal problems.
On review of the JAMA study using the YEARS rule with adjusted D-dimer thresholds, the editorialists noted that the data were robust and indicated a 10% reduction in chest imaging. They also emphasized the potential to overwhelm busy clinicians with more algorithms.
“Blindly applying algorithms to every patient may be less appropriate or even undesirable in specific situations in which deviation from the rules on clinical grounds is indicated,” but a complex imaging approach may be time consuming and challenging in the acute setting, and a simple algorithm may be safe and efficient in many cases, they wrote. “From a patient perspective, a negative diagnostic algorithm for pulmonary embolism does not diminish the physician’s obligation to consider other diagnoses that explain the symptoms, for which chest CT scans may still be needed and helpful.”
The Annals of Internal Medicine study was supported by the Dutch Research Council. The JAMA study was supported by the French Health Ministry. Dr. Stals, Dr. Freund, Dr. Pal, Dr. Levi, and Dr. van Es had no financial conflicts to disclose.
In a patient suspected to have a PE, “diagnosis is made radiographically, usually with CT pulmonary angiogram, or V/Q scan,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview.
“Validated clinical decision tools such as Wells’ score or Geneva score may be used to identify patients at low pretest probability of PE who may initially get a D-dimer level check, followed by imaging only if D-dimer level is elevated,” explained Dr. Pal, who was not involved with the new research, which was published in the Annals of Internal Medicine.
According to the authors of the new paper, while current diagnostic strategies in patients with suspected PE include use of a validated clinical decision rule (CDR) and D-dimer testing to rule out PE without imaging tests, the effectiveness of D-dimer tests in older patients, inpatients, cancer patients, and other high-risk groups has not been well-studied.
Lead author of the paper, Milou A.M. Stals, MD, and colleagues said their goal was to evaluate the safety and efficiency of the Wells rule and revised Geneva score in combination with D-dimer tests, and also the YEARS algorithm for D-dimer thresholds, in their paper.
Dr. Stals, of Leiden (the Netherlands) University Medical Center, and the coinvestigators conducted an international systemic review and individual patient data meta-analysis that included 16 studies and 20,553 patients, with all studies having been published between Jan. 1, 1995, and Jan. 1, 2021. Their primary outcomes were the safety and efficiency of each of these three strategies.
In the review, the researchers defined safety as the 3-month incidence of venous thromboembolism after PE was ruled out without imaging at baseline. They defined efficiency as the proportion patients for whom PE was ruled out based on D-dimer thresholds without imaging.
Overall, efficiency was highest in the subset of patients aged younger than 40 years, ranging from 47% to 68% in this group. Efficiency was lowest in patients aged 80 years and older (6.0%-23%), and in patients with cancer (9.6%-26%).
The efficiency was higher when D-dimer thresholds based on pretest probability were used, compared with when fixed or age-adjusted D-dimer thresholds were used.
The key finding was the significant variability in performance of the diagnostic strategies, the researchers said.
“The predicted failure rate was generally highest for strategies incorporating adapted D-dimer thresholds. However, at the same time, predicted overall efficiency was substantially higher with these strategies versus strategies with a fixed D-dimer threshold as well,” they said. Given that the benefits of each of the three diagnostic strategies depends on their correct application, the researchers recommended that an individual hospitalist choose one strategy for their institution.
“Whether clinicians should rely on the Wells rule, the YEARS algorithm, or the revised Geneva score becomes a matter of local preference and experience,” Dr. Stals and colleagues wrote.
The study findings were limited by several factors including between-study differences in scoring predictors and D-dimer assays. Another limitation was that differential verification biases for classifying fatal events and PE may have contributed to overestimation of failure rates of the adapted D-dimer thresholds.
Strengths of the study included its large sample size and original data on pretest probability, and that data support the use of any of the three strategies for ruling out PE in the identified subgroups without the need for imaging tests, the authors wrote.
“Pending the results of ongoing diagnostic randomized trials, physicians and guideline committees should balance the interlink between safety and efficiency of available diagnostic strategies,” they concluded.
Adapted D-dimer benefits some patients
“Clearly, increasing the D-dimer cutoff will lower the number of patients who require radiographic imaging (improved specificity), but this comes with a risk for missing PE (lower sensitivity). Is this risk worth taking?” Daniel J. Brotman, MD, of Johns Hopkins University, Baltimore, asked in an editorial accompanying the new study.
Dr. Brotman was not surprised by the study findings.
“Conditions that predispose to thrombosis through activated hemostasis – such as advanced age, cancer, inflammation, prolonged hospitalization, and trauma – drive D-dimer levels higher independent of the presence or absence of radiographically apparent thrombosis,” he said. However, these patients are unlikely to have normal D-dimer levels regardless of the cutoff used.
Adapted D-dimer cutoffs may benefit some patients, including those with contraindications or limited access to imaging, said Dr. Brotman. D-dimer may be used for risk stratification regardless of PE, since patients with marginally elevated D-dimers have better prognoses than those with higher D-dimer elevations, even if a small PE is missed.
Dr. Brotman wrote that increasing D-dimer cutoffs for high-risk patients in the subgroups analyzed may spare some patients radiographic testing, but doing so carries an increased risk for diagnostic failure. Overall, “the important work by Stals and colleagues offers reassurance that modifying D-dimer thresholds according to age or pretest probability is safe enough for widespread practice, even in high-risk groups.”
Focus on single strategy ‘based on local needs’
“Several validated clinical decision tools, along with age or pretest probability adjusted D-dimer threshold are currently in use as diagnostic strategies for ruling out pulmonary embolism,” Dr. Pal said in an interview.
The current study is important because of limited data on the performance of these strategies in specific subgroups of patients whose risk of PE may differ from the overall patient population, he noted.
“Different diagnostic strategies for PE have a variable performance in patients with differences of age, active cancer, and history of VTE,” said Dr. Pal. “However, in this study, no clear preference for one strategy over others could be established for these subgroups, and clinicians should continue to follow institution-specific guidance.
“A single strategy should be adopted at each institution based on local needs and used as the standard of care until further data are available,” he said.
“The use of D-dimer to rule out PE, either with fixed threshold or age-adjusted thresholds, can be confounded in clinical settings by other comorbid conditions such as sepsis, recent surgery, and more recently, COVID-19,” he said.
“Since the findings of this study do not show a clear benefit of one diagnostic strategy over others in the analyzed subgroups of patients, further prospective head-to-head comparison among the subgroups of interest would be helpful to guide clinical decision making,” Dr. Pal added.
YEARS-specific study supports D-dimer safety and value
A recent paper published in JAMA supported the results of the meta-analysis. In that study, Yonathan Freund, MD, of Sorbonne Université, Paris, and colleagues focused on the YEARS strategy combined with age-adjusted D-dimer thresholds as a way to rule out PE in PERC-positive ED patients.
The authors of this paper randomized 18 EDs to either a protocol of intervention followed by control, or control followed by intervention. The study population included 726 patients in the intervention group and 688 in the control group.
The intervention strategy to rule out PE consisted of assessing the YEARS criteria and D-dimer testing. PE was ruled out in patients with no YEARS criteria and a D-dimer level below 1,000 ng/mL and in patients with one or more YEARS criteria and D-dimers below an age-adjusted threshold (defined as age times 10 ng/mL in patients aged 50 years and older).
The control strategy consisted of D-dimer testing for all patients with the threshold at age-adjusted levels; D-dimers about these levels prompted chest imaging.
Overall, the risk of a missed VTE at 3 months was noninferior between the groups (0.15% in the intervention group and 0.80% in the controls).
“The intervention was associated with a statistically significant reduction in chest imaging use,” the researchers wrote.
This study’s findings were limited by randomization at the center level, rather than the patient level, and the use of imaging on some patients despite negative D-dimer tests, the researchers wrote. However, their findings support those of previous studies and especially support the safety of the intervention, in an emergency medicine setting, as no PEs occurred in patients with a YEARS score of zero who underwent the intervention.
Downsides to applying algorithms to every patient explained
In an editorial accompanying the JAMA study, Marcel Levi, MD, and Nick van Es, MD, of Amsterdam University Medical Center, emphasized the challenges of diagnosing PE given that many patients present with nonspecific clinical manifestations and without typical signs and symptoms. High-resolution CT pulmonary angiography allows for a fast and easy diagnosis in an emergency setting. However, efforts are ongoing to develop alternative strategies that avoid unnecessary scanning for potential PE patients, many of whom have alternative diagnoses such as pulmonary infections, cardiac conditions, pleural disease, or musculoskeletal problems.
On review of the JAMA study using the YEARS rule with adjusted D-dimer thresholds, the editorialists noted that the data were robust and indicated a 10% reduction in chest imaging. They also emphasized the potential to overwhelm busy clinicians with more algorithms.
“Blindly applying algorithms to every patient may be less appropriate or even undesirable in specific situations in which deviation from the rules on clinical grounds is indicated,” but a complex imaging approach may be time consuming and challenging in the acute setting, and a simple algorithm may be safe and efficient in many cases, they wrote. “From a patient perspective, a negative diagnostic algorithm for pulmonary embolism does not diminish the physician’s obligation to consider other diagnoses that explain the symptoms, for which chest CT scans may still be needed and helpful.”
The Annals of Internal Medicine study was supported by the Dutch Research Council. The JAMA study was supported by the French Health Ministry. Dr. Stals, Dr. Freund, Dr. Pal, Dr. Levi, and Dr. van Es had no financial conflicts to disclose.
FROM THE ANNALS OF INTERNAL MEDICINE