MDedge Cardiology

In a stunning verdict against Blue Cross and Blue Shield of Louisiana, a New Orleans jury has awarded $421 million in damages to a surgery center over the insurer’s alleged failure to fully pay out-of-network charges.

Insurance specialists told this news organization that the September 20 verdict is unusual. If upheld on appeal, one said, it could give out-of-network providers more power to decide how much insurers must pay them.

The case, which the St. Charles Surgical Hospital and Center for Restorative Breast Surgery first filed in 2017 in Louisiana state court, will be appealed and could ultimately land in federal court. The center has seen mixed results from a similar case it filed in federal court, legal documents show. Physicians from the center declined comment.

At issue: Did Blue Cross fail to fully pay the surgery center for about 7000 out-of-network procedures that it authorized? 

The lawsuit claimed that the insurer’s online system confirmed that claims would be paid and noted the percentage of patient bills that would be reimbursed.

However, “Blue Cross and Blue Shield of Louisiana either slow-paid, low-paid, or no-paid all their bills over an eight-year period, hoping to pressure the doctors and hospital to either come into the network or fail and close down,” the surgery center’s attorney, James Williams, said in a statement.

Blue Cross denied that it acted fraudulently, “arguing that because the hospital is not a member of its provider network, it had no contractual obligation to pay anything,” the Times-Picayune newspaper reported. Authorization of a procedure doesn’t guarantee payment, the insurer argued in court.

In a statement to the media, Blue Cross said it disagrees with the verdict and will appeal.
 

Out-of-Network Free For All

Paul B. Ginsburg, PhD, professor of the Practice of Health Policy at the Price School of Public Policy, University of Southern California, Los Angeles, said out-of-network care doesn’t come with a contractual relationship.

Without a contract, he said, “providers can charge whatever they want, and the insurers will pay them whatever they want, and then it’s up to the provider to see how much additional balance bill they can collect from the patients.” (Some states and the federal government have laws partly protecting patients from balance billing when doctors and insurers conflict over payment.)

He added that “if insurance companies were on the hook to pay whatever any provider charges, nobody would ever belong to a network, and rates would be sky high. Many fewer people would buy insurance. Providers would [then] charge as much as they think they can get from the patients.”

What about the insurer’s apparent authorization of the out-of-network procedures? “They’re authorizing them because they believe the procedures are medically warranted,” Dr. Ginsburg said. “That’s totally separate from how much they’ll pay.”

Dr. Ginsburg added that juries in the South are known for imposing high penalties against companies. “They often come up with crazy verdicts.”

Mark V. Pauly, PhD, MA, professor emeritus of health care management at the Wharton School of the University of Pennsylvania, Philadelphia, questioned why the clinic kept accepting Blue Cross patients.

“Once it became apparent that Blue Cross wasn’t going to pay them well or would give them a lot of grief,” Dr. Pauly said, “the simplest thing would have been to tell patients that we’re going to go back to the old-fashioned way of doing things: You pay us up front, or assure us that you’re going to pay.”

Lawton Robert Burns, PhD, MBA, professor of health care management at the Wharton School, said the case and the verdict are unusual. He noted that insurer contracts with employers often state that out-of-network care will be covered at a specific rate, such as 70% of “reasonable charges.”

A 2020 analysis found that initial breast reconstruction surgeries in the United States cost a median of $24,600-$38,000 from 2009 to 2016. According to the Times-Picayune, the New Orleans clinic billed Blue Cross for $506.7 million, averaging more than $72,385 per procedure.

Dr. Ginsburg, Dr. Pauly, and Dr. Burns had no disclosures.

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

In a stunning verdict against Blue Cross and Blue Shield of Louisiana, a New Orleans jury has awarded $421 million in damages to a surgery center over the insurer’s alleged failure to fully pay out-of-network charges.

Insurance specialists told this news organization that the September 20 verdict is unusual. If upheld on appeal, one said, it could give out-of-network providers more power to decide how much insurers must pay them.

The case, which the St. Charles Surgical Hospital and Center for Restorative Breast Surgery first filed in 2017 in Louisiana state court, will be appealed and could ultimately land in federal court. The center has seen mixed results from a similar case it filed in federal court, legal documents show. Physicians from the center declined comment.

At issue: Did Blue Cross fail to fully pay the surgery center for about 7000 out-of-network procedures that it authorized? 

The lawsuit claimed that the insurer’s online system confirmed that claims would be paid and noted the percentage of patient bills that would be reimbursed.

However, “Blue Cross and Blue Shield of Louisiana either slow-paid, low-paid, or no-paid all their bills over an eight-year period, hoping to pressure the doctors and hospital to either come into the network or fail and close down,” the surgery center’s attorney, James Williams, said in a statement.

Blue Cross denied that it acted fraudulently, “arguing that because the hospital is not a member of its provider network, it had no contractual obligation to pay anything,” the Times-Picayune newspaper reported. Authorization of a procedure doesn’t guarantee payment, the insurer argued in court.

In a statement to the media, Blue Cross said it disagrees with the verdict and will appeal.
 

Out-of-Network Free For All

Paul B. Ginsburg, PhD, professor of the Practice of Health Policy at the Price School of Public Policy, University of Southern California, Los Angeles, said out-of-network care doesn’t come with a contractual relationship.

Without a contract, he said, “providers can charge whatever they want, and the insurers will pay them whatever they want, and then it’s up to the provider to see how much additional balance bill they can collect from the patients.” (Some states and the federal government have laws partly protecting patients from balance billing when doctors and insurers conflict over payment.)

He added that “if insurance companies were on the hook to pay whatever any provider charges, nobody would ever belong to a network, and rates would be sky high. Many fewer people would buy insurance. Providers would [then] charge as much as they think they can get from the patients.”

What about the insurer’s apparent authorization of the out-of-network procedures? “They’re authorizing them because they believe the procedures are medically warranted,” Dr. Ginsburg said. “That’s totally separate from how much they’ll pay.”

Dr. Ginsburg added that juries in the South are known for imposing high penalties against companies. “They often come up with crazy verdicts.”

Mark V. Pauly, PhD, MA, professor emeritus of health care management at the Wharton School of the University of Pennsylvania, Philadelphia, questioned why the clinic kept accepting Blue Cross patients.

“Once it became apparent that Blue Cross wasn’t going to pay them well or would give them a lot of grief,” Dr. Pauly said, “the simplest thing would have been to tell patients that we’re going to go back to the old-fashioned way of doing things: You pay us up front, or assure us that you’re going to pay.”

Lawton Robert Burns, PhD, MBA, professor of health care management at the Wharton School, said the case and the verdict are unusual. He noted that insurer contracts with employers often state that out-of-network care will be covered at a specific rate, such as 70% of “reasonable charges.”

A 2020 analysis found that initial breast reconstruction surgeries in the United States cost a median of $24,600-$38,000 from 2009 to 2016. According to the Times-Picayune, the New Orleans clinic billed Blue Cross for $506.7 million, averaging more than $72,385 per procedure.

Dr. Ginsburg, Dr. Pauly, and Dr. Burns had no disclosures.

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

In a stunning verdict against Blue Cross and Blue Shield of Louisiana, a New Orleans jury has awarded $421 million in damages to a surgery center over the insurer’s alleged failure to fully pay out-of-network charges.

Insurance specialists told this news organization that the September 20 verdict is unusual. If upheld on appeal, one said, it could give out-of-network providers more power to decide how much insurers must pay them.

The case, which the St. Charles Surgical Hospital and Center for Restorative Breast Surgery first filed in 2017 in Louisiana state court, will be appealed and could ultimately land in federal court. The center has seen mixed results from a similar case it filed in federal court, legal documents show. Physicians from the center declined comment.

At issue: Did Blue Cross fail to fully pay the surgery center for about 7000 out-of-network procedures that it authorized? 

The lawsuit claimed that the insurer’s online system confirmed that claims would be paid and noted the percentage of patient bills that would be reimbursed.

However, “Blue Cross and Blue Shield of Louisiana either slow-paid, low-paid, or no-paid all their bills over an eight-year period, hoping to pressure the doctors and hospital to either come into the network or fail and close down,” the surgery center’s attorney, James Williams, said in a statement.

Blue Cross denied that it acted fraudulently, “arguing that because the hospital is not a member of its provider network, it had no contractual obligation to pay anything,” the Times-Picayune newspaper reported. Authorization of a procedure doesn’t guarantee payment, the insurer argued in court.

In a statement to the media, Blue Cross said it disagrees with the verdict and will appeal.
 

Out-of-Network Free For All

Paul B. Ginsburg, PhD, professor of the Practice of Health Policy at the Price School of Public Policy, University of Southern California, Los Angeles, said out-of-network care doesn’t come with a contractual relationship.

Without a contract, he said, “providers can charge whatever they want, and the insurers will pay them whatever they want, and then it’s up to the provider to see how much additional balance bill they can collect from the patients.” (Some states and the federal government have laws partly protecting patients from balance billing when doctors and insurers conflict over payment.)

He added that “if insurance companies were on the hook to pay whatever any provider charges, nobody would ever belong to a network, and rates would be sky high. Many fewer people would buy insurance. Providers would [then] charge as much as they think they can get from the patients.”

What about the insurer’s apparent authorization of the out-of-network procedures? “They’re authorizing them because they believe the procedures are medically warranted,” Dr. Ginsburg said. “That’s totally separate from how much they’ll pay.”

Dr. Ginsburg added that juries in the South are known for imposing high penalties against companies. “They often come up with crazy verdicts.”

Mark V. Pauly, PhD, MA, professor emeritus of health care management at the Wharton School of the University of Pennsylvania, Philadelphia, questioned why the clinic kept accepting Blue Cross patients.

“Once it became apparent that Blue Cross wasn’t going to pay them well or would give them a lot of grief,” Dr. Pauly said, “the simplest thing would have been to tell patients that we’re going to go back to the old-fashioned way of doing things: You pay us up front, or assure us that you’re going to pay.”

Lawton Robert Burns, PhD, MBA, professor of health care management at the Wharton School, said the case and the verdict are unusual. He noted that insurer contracts with employers often state that out-of-network care will be covered at a specific rate, such as 70% of “reasonable charges.”

A 2020 analysis found that initial breast reconstruction surgeries in the United States cost a median of $24,600-$38,000 from 2009 to 2016. According to the Times-Picayune, the New Orleans clinic billed Blue Cross for $506.7 million, averaging more than $72,385 per procedure.

Dr. Ginsburg, Dr. Pauly, and Dr. Burns had no disclosures.

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

Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.

When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.

All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Lack of access to nutritious food or transportation, a shortage of safe green spaces, unstable housing, and low health literacy are examples of social determinants of health (SDOH) that affect lifestyle choices. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step. 

The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
 

Small Steps to Big Changes

Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients. 

Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.

It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.

For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.

To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.

A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort. 

Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.

Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.

When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.

All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Lack of access to nutritious food or transportation, a shortage of safe green spaces, unstable housing, and low health literacy are examples of social determinants of health (SDOH) that affect lifestyle choices. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step. 

The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
 

Small Steps to Big Changes

Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients. 

Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.

It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.

For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.

To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.

A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort. 

Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.

Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Primary care clinicians understand that addressing lifestyle-related chronic disease health disparities in minority and lower-income communities is a significant opportunity to alleviate unnecessary suffering. Disparate health outcomes associated with underlying comorbidities during the COVID pandemic exposed the urgency of this problem.

When it comes to delivering evidence-based therapeutic lifestyle behavior interventions to these populations, however, there is a misconception that lifestyle medicine is only for the wealthy. Such a misconception needlessly widens the gap in health disparities because the truth is that everyone deserves access to lifestyle medicine. Fortunately, there are numerous successful examples of delivering these services to underresourced patients. We can all contribute to narrowing health inequities by sourcing increasingly abundant lifestyle medicine resources.

All patients’ lived experiences are unique, and there is a wide range of potential challenges to achieving lifestyle behavior change. Lack of access to nutritious food or transportation, a shortage of safe green spaces, unstable housing, and low health literacy are examples of social determinants of health (SDOH) that affect lifestyle choices. Ignoring these obstacles is a disservice to patients and almost certainly results in treatment failure. Requirements to document SDOH have been a tremendous initial step. 

The next step is to have conversations with every patient about the powerful outcomes of even small lifestyle changes. All too often, clinicians forgo conversations on lifestyle change with patients affected by adverse SDOH and assume that social obstacles automatically mean that patients are neither willing nor able to attempt behavior modification. Instead, it is an opportunity for clinicians, particularly those certified in lifestyle medicine, to meet patients where they are, work with them to identify solutions, and provide referrals to community-based organizations with resources to help.
 

Small Steps to Big Changes

Not all lifestyle behavior interventions need to be programmatic or time intensive. Clinicians can guide patients toward simple but specific actions that can make a difference in health outcomes over time. Small steps, like eating one can of beans or two bags of frozen leafy greens each week, are a good start toward adjusted eating patterns. The American College of Lifestyle Medicine offers a whole-food, plant-predominant meal guide to share with patients. 

Individuals can increase their physical activity in their living rooms by doing sit-to-stands or balancing on one leg. Deep breathing and establishing a sleep routine are other lifestyle behavior changes without a price tag.

It is true that early adopters of lifestyle medicine often had difficulty practicing in underresourced communities. Those practitioners were forced to operate on a cash-pay basis, making access to care cost-prohibitive for many patients. However, board certification has been available since 2017, and lifestyle medicine is being integrated into medical schools and residency programs. Many such board-certified clinicians now work in large health systems and bill under the usual methods. There are also frameworks, such as the community-engaged lifestyle medicine model, showing how to treat patients affected by adverse SDOH effectively.

For example, patients at risk for malnutrition because of illnesses like chronic kidney disease, cancer, and heart failure receive medically tailored meals and access to a registered dietitian through a partnership between UC San Diego Health and Mama’s Kitchen. In Pennsylvania’s Lehigh Valley, where 1 in 10 of the approximately 700,000 residents face food insecurity, the Kellyn Foundation delivers fresh food through the Eat Real Food Mobile Market and offers whole-food, plant-predominant cooking classes, interactive elementary school programs focused on healthy lifestyle choices, and therapeutic lifestyle-change programs in community locations. Three months after launching new mobile market sites in Allentown, 1200 households were utilizing $15 weekly food vouchers through the program. Lifestyle medicine clinicians serve inner-city and rural areas in independent practices, large health systems, and community-based practice activities.

To improve access to lifestyle medicine in underresourced communities, more clinicians trained and certified in lifestyle medicine are needed. The Health Equity Achieved through Lifestyle Medicine Initiative supports a diverse lifestyle medicine workforce by offering scholarships to clinicians underrepresented in medicine and is working to train and certify at least one physician within each of the 1400 federally qualified health centers where clinicians are on the front lines of delivering care to the most underserved populations.

A meaningful first step for clinicians to address health disparities is to screen patients for and document SDOH. The American Academy of Family Physicians offers useful tools to screen patients, identify community-based resources, and help patients create action plans to overcome health risks and improve outcomes. In a promising trend to better support addressing SDOH in clinical care, the 2024 Medicare Physician Fee Schedule final rule included new codes to support this effort. 

Not every patient will be ready or willing to begin a lifestyle medicine treatment plan. Still, all of them will be grateful for the opportunity to decide for themselves. If we are invested in narrowing health inequities, lifestyle medicine and behavior change must be a topic in clinical encounters with all our patients.

Dr. Collings, director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM^2.5 is more toxic than general PM^2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM^2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM^2.5, non-fire PM^2.5, and total PM^2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM^2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM^2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM^2.5 were approximately 10 times larger than those calculated using total PM^2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM^2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

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

Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM^2.5 is more toxic than general PM^2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM^2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM^2.5, non-fire PM^2.5, and total PM^2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM^2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM^2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM^2.5 were approximately 10 times larger than those calculated using total PM^2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM^2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

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

Wildfire-related air pollution in Europe kills more than non-wildfire air pollution. As climate change exacerbates the frequency and violence of wildfires, researchers are studying the health implications of mitigation methods such as prescribed fires.

Presenting at the annual congress of the European Respiratory Society (ERS), Cathryn Tonne, PhD, an environmental epidemiologist at the Instituto de Salud Global de Barcelona, Spain, said wildfire-related PM^2.5 is more toxic than general PM^2.5, leading to significantly higher mortality rates.

Prescribed, controlled fires have been employed worldwide to reduce the chance of uncontrolled, catastrophic fires. However, researchers wonder whether the techniques reduce the overall fire-related PM^2.5 or add up to it. “Prescribed fire increases ecosystem resilience and can reduce the risk of catastrophic wildfire,” said Jason Sacks, MPH, an epidemiologist in the Center for Public Health and Environmental Assessment in the Office of Research and Development at the Environmental Protection Agency (EPA), at the congress. “But it also leads to poorer air quality and health impacts, and we still don’t know what this means at a regional scale.”
 

Wildfire Pollution Kills More Than Other Air Pollution

Researchers at the Instituto de Salud Global de Barcelona used a large dataset of daily mortality data from 32 European countries collected through the EARLY-ADAPT project. They utilized the SILAM model to derive daily average concentrations of wildfire-related PM^2.5, non-fire PM^2.5, and total PM^2.5 levels. They also employed GEOSTAT population grids at a 1-km resolution to calculate the attributable number of deaths across different regions, specifically focusing on data from 2006, 2011, and 2018.

The data analysis indicated that the relative risk per unit of PM^2.5 is substantially larger for wildfire-related PM2.5, compared with non-fire PM2.5. “We essentially assume that wildfire smoke PM^2.5 has the same toxicity as total PM2.5, but it’s increasingly clear that’s likely not the case,” Dr. Tonne said, presenting the study.

When employing exposure-response functions (ERFs) specific to wildfire smoke, researchers found that the attributable deaths from all causes of wildfire PM^2.5 were approximately 10 times larger than those calculated using total PM^2.5 exposure estimates. Dr. Tonne explained that this stark difference highlights the critical need for tailored ERFs that accurately reflect the unique health risks posed by wildfire smoke.

“Respiratory mortality usually has the strongest relative risks, and we’re seeing that in this study as well,” Dr. Tonne said. “Wildfire smoke seems to operate through quite immediate mechanisms, likely through inflammation and oxidative stress.”

One significant challenge of the study was the lack of uniform spatial resolution across all countries involved in the analysis. This inconsistency may affect how accurately mortality estimates can be attributed to specific PM^2.5 sources. Additionally, the study had limited statistical power for generating age- and sex-specific mortality estimates, which could obscure important demographic differences in vulnerability to wildfire smoke exposure. The analysis was also constrained to data available only up to 2020, thereby excluding critical wildfire events from subsequent years, such as those in 2022 and 2023, which may have further elucidated the health impacts of wildfire smoke in Europe.
 

Fires Prescription

Prescribed fires or controlled burns are intentional fires set by land managers under carefully managed conditions.

Historically, many forested areas have been subjected to fire suppression practices, which allow combustible materials like dry leaves, twigs, and shrubs to accumulate over time. This buildup leads to a higher likelihood of severe, uncontrollable wildfires. Prescribed fires can reduce these fuel loads and improve the health and resilience of ecosystems.

They release fewer pollutants and emissions than the large-scale, unmanageable wildfires they help prevent because they happen at lower temperatures. But they still introduce pollutants in the air that can negatively affect nearby communities’ health.

People with preexisting respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are particularly vulnerable to smoke, which can trigger health issues like breathing difficulties, coughing, and eye irritation. The cumulative impact of increased burns raises concerns about long-term air quality, especially in densely populated areas. “We need to understand if we’re actually tipping the scale to having less wildfire smoke or just increasing the total amount of smoke.”

Mitigation strategies include accurately picking the right timing and weather conditions to determine when and where to conduct controlled burns and effective and timely communication to inform local communities about upcoming burns, the potential for smoke exposure, and how to protect themselves.

There is a growing need to improve public messaging around prescribed fires, Mr. Sacks said, because often the message communicated is oversimplified, such as “there will be smoke, but don’t worry. But that’s not the message we want to convey, especially for people with asthma or COPD.”

Instead, he said public health agencies should provide clearer, science-based guidance on the risks for smoke exposure and practical steps people can take to reduce their risk.
 

What Can Doctors Do?

Chris Carlsten, MD, director of the Centre for Lung Health and professor and head of the Respiratory Medicine Division at the University of British Columbia, Vancouver, Canada, told this news organization that determining whether an exacerbation of a respiratory condition is caused by fire exposure or other factors, such as viral infections, is complex because both can trigger similar responses and may complement each other. “It’s very difficult for any individual to know whether, when they’re having an exacerbation of asthma or COPD, that’s due to the fire,” he said. Fire smoke also increases infection risks, further complicating diagnosis.

Dr. Carlsten suggested that physicians could recommend preventative use of inhalers for at-risk patients when wildfires occur rather than waiting for symptoms to worsen. “That is a really interesting idea that could be practical.” Still, he advises caution, stressing that patients should consult their providers because not all may react well to increased inhaler use.

He also highlighted a significant shift in the healthcare landscape, noting that traditionally, the focus has been on the cardiovascular impacts of pollution, particularly traffic-related pollution. However, as wildfire smoke becomes a growing issue, the focus is shifting back to respiratory problems, with profound implications for healthcare resources, budgets, and drug approvals based on the burden of respiratory disease. “Fire smoke is becoming more of a problem. This swing back to respiratory has huge implications for healthcare systems and respiratory disease burden.”

Mr. Sacks and Dr. Carlsten reported no relevant financial relationships. The study presented by Dr. Tonne received funding from the European Union’s Horizon Europe research and innovation programme under Grant Agreement No. 101057131.
 

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

Medicare will speed nationwide payment decisions for as many as five promising new medical devices a year, a move that could get some products to patients earlier and spare companies from a bureaucratic slog to secure regional clearances.

The Centers for Medicare & Medicaid Services (CMS) in August finalized a long-awaited plan to accelerate coverage decisions on medical devices that have impressed regulators.

The intent is to create a smoother pathway for some devices that earned a “breakthrough” designation from the US Food and Drug Administration (FDA), a label intended for innovative products that significantly advance treatment for serious illness.

“We’ll see how many they actually take on, but it could make a really big difference on how quickly devices make it through the Medicare coverage gauntlet and get to patients,” Emily P. Zeitler, MD, MHS, a cardiologist and assistant professor of medicine at Dartmouth’s Geisel School of Medicine in Hanover, New Hampshire, told this news organization.

Companies selling “breakthrough” devices face tougher challenges in securing Medicare payment than device makers whose products fit into already established niches. Previous Medicare decisions can serve as a path to coverage for those products.

The new CMS Transitional Coverage for Emerging Technologies (TCET) pathway addresses two causes of delay in securing Medicare coverage for newcomer devices:

• CMS delegates many decisions on new device coverage to Medicare Administrative Contractors (MACs). MACs are businesses owned by, or affiliated with, insurers such as Blue Cross plans. Companies sometimes need to work their way through several regional MACs to gain nationwide coverage of their devices.
• Congress sets different mandates for the FDA and CMS regarding medical products. The FDA needs to know a product is safe and effective enough for US sales. Companies sometimes produce enough evidence to show products can meet the FDA’s standard without generating sufficient data to compel Medicare coverage. Medicare covers about 66.7 million people: 59.1 million aged 65 years or older and 7.6 million with disabilities.

“Medicare beneficiaries are often older, have multiple comorbidities, and are often underrepresented or not represented in many clinical studies,” CMS said in its August notice on the TCET pathway.

“Consequently, a device’s potential benefits and harms for older patients with more comorbidities may not be well understood at the time of FDA market authorization,” the agency added.
 

Coverage With Evidence Development (CED) Experience

TCET is meant to help CMS officials clear coverage of breakthrough devices sooner, and on a nationwide basis, while sometimes continuing to study how well these products work for people enrolled in Medicare.

The TCET pathway builds on Medicare’s experience over two decades with its “CED” program. That program allows coverage of well-regarded new devices or treatments whose effects on older patients were not yet well understood.

In the TCET notice, CMS provided details of its plans for using contractors for evidence reviews and evidence development plans as part of its new coverage pathway.

Securing help from these experts outside of CMS, along with perhaps some new arrangements for in-house staff, would help the agency reach its goals for TCET, Dr. Zeitler said. She has published research on the CED process and has participated in cardiac registries associated with CED as both a researcher and a physician who implants devices.

The poster child for the benefits of the CED approach is the transcatheter aortic valve replacement (TAVR) devices, said Ralph Brindis, MD, MPH, a past president of the American College of Cardiology (ACC) and the senior medical officer for external affairs of the ACC’s National Cardiovascular Data Registry (NCDR).

Through the NCDR, ACC members worked with CMS for years in trying to find ways to gather evidence about the best uses of medical devices.

Brindis said this approach to evidence generation involved more tracking of off-label use and analysis of how TAVR devices performed in routine use through the data obtained through a registry, rather than relying solely on clinical trials requiring a much longer time frame for completion and at an increased cost.

This approach allowed cardiovascular surgeons and cardiologists to steer the course of real-world evidence gathering, he said.

“We were able to expand indications for TAVR without relying on industry to fund randomized clinical trials that they may not have had interest or bandwidth or finances” to do, Dr. Brindis said. “And we already had the data in hand.”

The TCET policy is welcomed, although there remain questions about how well CMS will be able to carry out this program due to funding limitations, Dr. Brindis said. Groups such as the ACC may be able to help CMS by encouraging Congress to provide the agency with more money to carry out the TCET plans, Dr. Brindis said.

“The professional societies will work hand in hand with CMS in trying to achieve these goals” with TCET, he said.

AdvaMed, the trade group for makers of medical devices, also called for beefing up the administrative budget for CMS to speed reviews of innovative devices.

“The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources,” AdvaMed CEO Scott Whitaker said in a statement.

Mr. Whitaker also described CMS’ decision to exclude medical tests from the TCET pathway as a disappointment.

The agency said the majority of coverage decisions on diagnostic tests should stay with MACs. In some cases, there may be a need for CMS to use its long-standing processes for considering a national coverage decision for certain tests, the agency said.

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering,” AdvaMed’s Mr. Whitaker said.

Dr. Brindis said he had no relevant financial disclosures. Dr. Zeitler reported having received consulting and speaking fees, travel payments, and research support from Medtronic, Abbott, Biosense Webster, Sanofi, NIH/NIGMS, Element Science, Edwards, Boston Scientific, Philips, and V-Wave.
 

A version of this article appeared on Medscape.com.

Medicare will speed nationwide payment decisions for as many as five promising new medical devices a year, a move that could get some products to patients earlier and spare companies from a bureaucratic slog to secure regional clearances.

The Centers for Medicare & Medicaid Services (CMS) in August finalized a long-awaited plan to accelerate coverage decisions on medical devices that have impressed regulators.

The intent is to create a smoother pathway for some devices that earned a “breakthrough” designation from the US Food and Drug Administration (FDA), a label intended for innovative products that significantly advance treatment for serious illness.

“We’ll see how many they actually take on, but it could make a really big difference on how quickly devices make it through the Medicare coverage gauntlet and get to patients,” Emily P. Zeitler, MD, MHS, a cardiologist and assistant professor of medicine at Dartmouth’s Geisel School of Medicine in Hanover, New Hampshire, told this news organization.

Companies selling “breakthrough” devices face tougher challenges in securing Medicare payment than device makers whose products fit into already established niches. Previous Medicare decisions can serve as a path to coverage for those products.

The new CMS Transitional Coverage for Emerging Technologies (TCET) pathway addresses two causes of delay in securing Medicare coverage for newcomer devices:

• CMS delegates many decisions on new device coverage to Medicare Administrative Contractors (MACs). MACs are businesses owned by, or affiliated with, insurers such as Blue Cross plans. Companies sometimes need to work their way through several regional MACs to gain nationwide coverage of their devices.
• Congress sets different mandates for the FDA and CMS regarding medical products. The FDA needs to know a product is safe and effective enough for US sales. Companies sometimes produce enough evidence to show products can meet the FDA’s standard without generating sufficient data to compel Medicare coverage. Medicare covers about 66.7 million people: 59.1 million aged 65 years or older and 7.6 million with disabilities.

“Medicare beneficiaries are often older, have multiple comorbidities, and are often underrepresented or not represented in many clinical studies,” CMS said in its August notice on the TCET pathway.

“Consequently, a device’s potential benefits and harms for older patients with more comorbidities may not be well understood at the time of FDA market authorization,” the agency added.
 

Coverage With Evidence Development (CED) Experience

TCET is meant to help CMS officials clear coverage of breakthrough devices sooner, and on a nationwide basis, while sometimes continuing to study how well these products work for people enrolled in Medicare.

The TCET pathway builds on Medicare’s experience over two decades with its “CED” program. That program allows coverage of well-regarded new devices or treatments whose effects on older patients were not yet well understood.

In the TCET notice, CMS provided details of its plans for using contractors for evidence reviews and evidence development plans as part of its new coverage pathway.

Securing help from these experts outside of CMS, along with perhaps some new arrangements for in-house staff, would help the agency reach its goals for TCET, Dr. Zeitler said. She has published research on the CED process and has participated in cardiac registries associated with CED as both a researcher and a physician who implants devices.

The poster child for the benefits of the CED approach is the transcatheter aortic valve replacement (TAVR) devices, said Ralph Brindis, MD, MPH, a past president of the American College of Cardiology (ACC) and the senior medical officer for external affairs of the ACC’s National Cardiovascular Data Registry (NCDR).

Through the NCDR, ACC members worked with CMS for years in trying to find ways to gather evidence about the best uses of medical devices.

Brindis said this approach to evidence generation involved more tracking of off-label use and analysis of how TAVR devices performed in routine use through the data obtained through a registry, rather than relying solely on clinical trials requiring a much longer time frame for completion and at an increased cost.

This approach allowed cardiovascular surgeons and cardiologists to steer the course of real-world evidence gathering, he said.

“We were able to expand indications for TAVR without relying on industry to fund randomized clinical trials that they may not have had interest or bandwidth or finances” to do, Dr. Brindis said. “And we already had the data in hand.”

The TCET policy is welcomed, although there remain questions about how well CMS will be able to carry out this program due to funding limitations, Dr. Brindis said. Groups such as the ACC may be able to help CMS by encouraging Congress to provide the agency with more money to carry out the TCET plans, Dr. Brindis said.

“The professional societies will work hand in hand with CMS in trying to achieve these goals” with TCET, he said.

AdvaMed, the trade group for makers of medical devices, also called for beefing up the administrative budget for CMS to speed reviews of innovative devices.

“The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources,” AdvaMed CEO Scott Whitaker said in a statement.

Mr. Whitaker also described CMS’ decision to exclude medical tests from the TCET pathway as a disappointment.

The agency said the majority of coverage decisions on diagnostic tests should stay with MACs. In some cases, there may be a need for CMS to use its long-standing processes for considering a national coverage decision for certain tests, the agency said.

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering,” AdvaMed’s Mr. Whitaker said.

Dr. Brindis said he had no relevant financial disclosures. Dr. Zeitler reported having received consulting and speaking fees, travel payments, and research support from Medtronic, Abbott, Biosense Webster, Sanofi, NIH/NIGMS, Element Science, Edwards, Boston Scientific, Philips, and V-Wave.
 

A version of this article appeared on Medscape.com.

Medicare will speed nationwide payment decisions for as many as five promising new medical devices a year, a move that could get some products to patients earlier and spare companies from a bureaucratic slog to secure regional clearances.

The Centers for Medicare & Medicaid Services (CMS) in August finalized a long-awaited plan to accelerate coverage decisions on medical devices that have impressed regulators.

The intent is to create a smoother pathway for some devices that earned a “breakthrough” designation from the US Food and Drug Administration (FDA), a label intended for innovative products that significantly advance treatment for serious illness.

“We’ll see how many they actually take on, but it could make a really big difference on how quickly devices make it through the Medicare coverage gauntlet and get to patients,” Emily P. Zeitler, MD, MHS, a cardiologist and assistant professor of medicine at Dartmouth’s Geisel School of Medicine in Hanover, New Hampshire, told this news organization.

Companies selling “breakthrough” devices face tougher challenges in securing Medicare payment than device makers whose products fit into already established niches. Previous Medicare decisions can serve as a path to coverage for those products.

The new CMS Transitional Coverage for Emerging Technologies (TCET) pathway addresses two causes of delay in securing Medicare coverage for newcomer devices:

• CMS delegates many decisions on new device coverage to Medicare Administrative Contractors (MACs). MACs are businesses owned by, or affiliated with, insurers such as Blue Cross plans. Companies sometimes need to work their way through several regional MACs to gain nationwide coverage of their devices.
• Congress sets different mandates for the FDA and CMS regarding medical products. The FDA needs to know a product is safe and effective enough for US sales. Companies sometimes produce enough evidence to show products can meet the FDA’s standard without generating sufficient data to compel Medicare coverage. Medicare covers about 66.7 million people: 59.1 million aged 65 years or older and 7.6 million with disabilities.

“Medicare beneficiaries are often older, have multiple comorbidities, and are often underrepresented or not represented in many clinical studies,” CMS said in its August notice on the TCET pathway.

“Consequently, a device’s potential benefits and harms for older patients with more comorbidities may not be well understood at the time of FDA market authorization,” the agency added.
 

Coverage With Evidence Development (CED) Experience

TCET is meant to help CMS officials clear coverage of breakthrough devices sooner, and on a nationwide basis, while sometimes continuing to study how well these products work for people enrolled in Medicare.

The TCET pathway builds on Medicare’s experience over two decades with its “CED” program. That program allows coverage of well-regarded new devices or treatments whose effects on older patients were not yet well understood.

In the TCET notice, CMS provided details of its plans for using contractors for evidence reviews and evidence development plans as part of its new coverage pathway.

Securing help from these experts outside of CMS, along with perhaps some new arrangements for in-house staff, would help the agency reach its goals for TCET, Dr. Zeitler said. She has published research on the CED process and has participated in cardiac registries associated with CED as both a researcher and a physician who implants devices.

The poster child for the benefits of the CED approach is the transcatheter aortic valve replacement (TAVR) devices, said Ralph Brindis, MD, MPH, a past president of the American College of Cardiology (ACC) and the senior medical officer for external affairs of the ACC’s National Cardiovascular Data Registry (NCDR).

Through the NCDR, ACC members worked with CMS for years in trying to find ways to gather evidence about the best uses of medical devices.

Brindis said this approach to evidence generation involved more tracking of off-label use and analysis of how TAVR devices performed in routine use through the data obtained through a registry, rather than relying solely on clinical trials requiring a much longer time frame for completion and at an increased cost.

This approach allowed cardiovascular surgeons and cardiologists to steer the course of real-world evidence gathering, he said.

“We were able to expand indications for TAVR without relying on industry to fund randomized clinical trials that they may not have had interest or bandwidth or finances” to do, Dr. Brindis said. “And we already had the data in hand.”

The TCET policy is welcomed, although there remain questions about how well CMS will be able to carry out this program due to funding limitations, Dr. Brindis said. Groups such as the ACC may be able to help CMS by encouraging Congress to provide the agency with more money to carry out the TCET plans, Dr. Brindis said.

“The professional societies will work hand in hand with CMS in trying to achieve these goals” with TCET, he said.

AdvaMed, the trade group for makers of medical devices, also called for beefing up the administrative budget for CMS to speed reviews of innovative devices.

“The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources,” AdvaMed CEO Scott Whitaker said in a statement.

Mr. Whitaker also described CMS’ decision to exclude medical tests from the TCET pathway as a disappointment.

The agency said the majority of coverage decisions on diagnostic tests should stay with MACs. In some cases, there may be a need for CMS to use its long-standing processes for considering a national coverage decision for certain tests, the agency said.

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering,” AdvaMed’s Mr. Whitaker said.

Dr. Brindis said he had no relevant financial disclosures. Dr. Zeitler reported having received consulting and speaking fees, travel payments, and research support from Medtronic, Abbott, Biosense Webster, Sanofi, NIH/NIGMS, Element Science, Edwards, Boston Scientific, Philips, and V-Wave.
 

A version of this article appeared on Medscape.com.

In Germany, the activity of acute respiratory diseases is at a higher level than usual for this time of year because of rhinoviruses and SARS-CoV-2, according to the Robert Koch Institute, Germany. If a patient has a fever and cough and feels exhausted, it could be COVID-19. What significance do rapid tests have? And when should doctors advise their patients about them?

When to Test

People at a higher risk for severe COVID-19 benefit from tests. This population includes the following groups:

• Older patients
• Immunocompromised patients
• Patients with respiratory diseases
• Patients with cardiovascular diseases
• Patients with liver and kidney diseases
• Patients with neurological diseases
• Patients with obesity

If doctors detect SARS-CoV-2 infection early, they can prescribe Paxlovid, for example, to reduce morbidity and mortality risks. Conversely, people without specific risks should test themselves if they plan to visit vulnerable individuals.
 

Detecting New Variants

A comprehensive study from the fall of 2022 provides evidence that antigen tests targeting the nucleocapsid (N) protein of SARS-CoV-2 also detect new variants.

The researchers built a library of various versions of the SARS-CoV-2 N protein. Their collection included nearly 8000 individual amino acid substitutions, representing more than 99.5% of all statistically possible mutations of the N protein.

They then examined how these N proteins interacted with 17 antibodies used in 11 commercially available antigen rapid tests.

All antibodies were able to recognize altered N proteins. Since the researchers successfully investigated diagnostic antibodies against nearly all possible N-protein mutations, rapid tests should be able to detect future virus variants. However, sensitivity and specificity may still change.
 

Test Timing

Uncertainty about what time of day to test can be mitigated by performing multiple COVID-19 rapid tests over time. The Food and Drug Administration (FDA) and similar organizations make this recommendation. Studies of symptomatic individuals show that serial tests increase accuracy.

In the early stages of infection, swabs may contain too little virus material because of widespread immunity against SARS-CoV-2. That is, they may contain inadequate levels of the relevant antigen. Especially in asymptomatic individuals or patients in the incubation phase, a single test may therefore yield a false-negative result. Therefore, the FDA recommends conducting at least two additional tests 48 hours apart in case of a negative test result.

 

Costs of Rapid Tests

The days of free tests are long gone. In Germany, the distribution of free preventive coronavirus tests was discontinued on March 1, 2023.

Test kits are still available in pharmacies or drugstores. In packages with 5-10 tests, the individual test costs between €0.90 and €1.50, depending on the provider. If a patient still has old rapid coronavirus tests in his or her medicine cabinet, are they still suitable?
 

Expired Tests

Properly stored tests that have not passed their expiration dates can still be used. But microbiologist and pathologist Daniel Rhoads, MD, from the Cleveland Clinic in Ohio warns against expired rapid tests.

The chemicals may have decomposed, the solvent may have evaporated, or antibodies may have lost their effectiveness, thus making false negative results more likely. “These are proteins that can decompose over time,” said Dr. Rhoads.
 

Ordering PCR Tests

The polymerase chain reaction (PCR) test remains the gold standard for diagnosing COVID-19. It is still available within statutory health insurance coverage. As Germany’s National Association of Statutory Health Insurance Physicians observes, form Muster 10 is used to order the test in that country.

The fee for the swab is included in the insured patient’s basic flat rate. Laboratories bill the PCR test using fee schedule position (GOP) 32816, according to the Uniform Value Scale (EBM).

There is no possibility for billing rapid tests for SARS-CoV-2 in medical practices within the EBM. A laboratory-based SARS-CoV-2 antigen detection test (GOP 32779) can be requested via the Muster 10 form.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

In Germany, the activity of acute respiratory diseases is at a higher level than usual for this time of year because of rhinoviruses and SARS-CoV-2, according to the Robert Koch Institute, Germany. If a patient has a fever and cough and feels exhausted, it could be COVID-19. What significance do rapid tests have? And when should doctors advise their patients about them?

When to Test

People at a higher risk for severe COVID-19 benefit from tests. This population includes the following groups:

• Older patients
• Immunocompromised patients
• Patients with respiratory diseases
• Patients with cardiovascular diseases
• Patients with liver and kidney diseases
• Patients with neurological diseases
• Patients with obesity

If doctors detect SARS-CoV-2 infection early, they can prescribe Paxlovid, for example, to reduce morbidity and mortality risks. Conversely, people without specific risks should test themselves if they plan to visit vulnerable individuals.
 

Detecting New Variants

A comprehensive study from the fall of 2022 provides evidence that antigen tests targeting the nucleocapsid (N) protein of SARS-CoV-2 also detect new variants.

The researchers built a library of various versions of the SARS-CoV-2 N protein. Their collection included nearly 8000 individual amino acid substitutions, representing more than 99.5% of all statistically possible mutations of the N protein.

They then examined how these N proteins interacted with 17 antibodies used in 11 commercially available antigen rapid tests.

All antibodies were able to recognize altered N proteins. Since the researchers successfully investigated diagnostic antibodies against nearly all possible N-protein mutations, rapid tests should be able to detect future virus variants. However, sensitivity and specificity may still change.
 

Test Timing

Uncertainty about what time of day to test can be mitigated by performing multiple COVID-19 rapid tests over time. The Food and Drug Administration (FDA) and similar organizations make this recommendation. Studies of symptomatic individuals show that serial tests increase accuracy.

In the early stages of infection, swabs may contain too little virus material because of widespread immunity against SARS-CoV-2. That is, they may contain inadequate levels of the relevant antigen. Especially in asymptomatic individuals or patients in the incubation phase, a single test may therefore yield a false-negative result. Therefore, the FDA recommends conducting at least two additional tests 48 hours apart in case of a negative test result.

 

Costs of Rapid Tests

The days of free tests are long gone. In Germany, the distribution of free preventive coronavirus tests was discontinued on March 1, 2023.

Test kits are still available in pharmacies or drugstores. In packages with 5-10 tests, the individual test costs between €0.90 and €1.50, depending on the provider. If a patient still has old rapid coronavirus tests in his or her medicine cabinet, are they still suitable?
 

Expired Tests

Properly stored tests that have not passed their expiration dates can still be used. But microbiologist and pathologist Daniel Rhoads, MD, from the Cleveland Clinic in Ohio warns against expired rapid tests.

The chemicals may have decomposed, the solvent may have evaporated, or antibodies may have lost their effectiveness, thus making false negative results more likely. “These are proteins that can decompose over time,” said Dr. Rhoads.
 

Ordering PCR Tests

The polymerase chain reaction (PCR) test remains the gold standard for diagnosing COVID-19. It is still available within statutory health insurance coverage. As Germany’s National Association of Statutory Health Insurance Physicians observes, form Muster 10 is used to order the test in that country.

The fee for the swab is included in the insured patient’s basic flat rate. Laboratories bill the PCR test using fee schedule position (GOP) 32816, according to the Uniform Value Scale (EBM).

There is no possibility for billing rapid tests for SARS-CoV-2 in medical practices within the EBM. A laboratory-based SARS-CoV-2 antigen detection test (GOP 32779) can be requested via the Muster 10 form.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

In Germany, the activity of acute respiratory diseases is at a higher level than usual for this time of year because of rhinoviruses and SARS-CoV-2, according to the Robert Koch Institute, Germany. If a patient has a fever and cough and feels exhausted, it could be COVID-19. What significance do rapid tests have? And when should doctors advise their patients about them?

When to Test

People at a higher risk for severe COVID-19 benefit from tests. This population includes the following groups:

• Older patients
• Immunocompromised patients
• Patients with respiratory diseases
• Patients with cardiovascular diseases
• Patients with liver and kidney diseases
• Patients with neurological diseases
• Patients with obesity

If doctors detect SARS-CoV-2 infection early, they can prescribe Paxlovid, for example, to reduce morbidity and mortality risks. Conversely, people without specific risks should test themselves if they plan to visit vulnerable individuals.
 

Detecting New Variants

A comprehensive study from the fall of 2022 provides evidence that antigen tests targeting the nucleocapsid (N) protein of SARS-CoV-2 also detect new variants.

The researchers built a library of various versions of the SARS-CoV-2 N protein. Their collection included nearly 8000 individual amino acid substitutions, representing more than 99.5% of all statistically possible mutations of the N protein.

They then examined how these N proteins interacted with 17 antibodies used in 11 commercially available antigen rapid tests.

All antibodies were able to recognize altered N proteins. Since the researchers successfully investigated diagnostic antibodies against nearly all possible N-protein mutations, rapid tests should be able to detect future virus variants. However, sensitivity and specificity may still change.
 

Test Timing

Uncertainty about what time of day to test can be mitigated by performing multiple COVID-19 rapid tests over time. The Food and Drug Administration (FDA) and similar organizations make this recommendation. Studies of symptomatic individuals show that serial tests increase accuracy.

In the early stages of infection, swabs may contain too little virus material because of widespread immunity against SARS-CoV-2. That is, they may contain inadequate levels of the relevant antigen. Especially in asymptomatic individuals or patients in the incubation phase, a single test may therefore yield a false-negative result. Therefore, the FDA recommends conducting at least two additional tests 48 hours apart in case of a negative test result.

 

Costs of Rapid Tests

The days of free tests are long gone. In Germany, the distribution of free preventive coronavirus tests was discontinued on March 1, 2023.

Test kits are still available in pharmacies or drugstores. In packages with 5-10 tests, the individual test costs between €0.90 and €1.50, depending on the provider. If a patient still has old rapid coronavirus tests in his or her medicine cabinet, are they still suitable?
 

Expired Tests

Properly stored tests that have not passed their expiration dates can still be used. But microbiologist and pathologist Daniel Rhoads, MD, from the Cleveland Clinic in Ohio warns against expired rapid tests.

The chemicals may have decomposed, the solvent may have evaporated, or antibodies may have lost their effectiveness, thus making false negative results more likely. “These are proteins that can decompose over time,” said Dr. Rhoads.
 

Ordering PCR Tests

The polymerase chain reaction (PCR) test remains the gold standard for diagnosing COVID-19. It is still available within statutory health insurance coverage. As Germany’s National Association of Statutory Health Insurance Physicians observes, form Muster 10 is used to order the test in that country.

The fee for the swab is included in the insured patient’s basic flat rate. Laboratories bill the PCR test using fee schedule position (GOP) 32816, according to the Uniform Value Scale (EBM).

There is no possibility for billing rapid tests for SARS-CoV-2 in medical practices within the EBM. A laboratory-based SARS-CoV-2 antigen detection test (GOP 32779) can be requested via the Muster 10 form.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

A new COVID-19 variant called XEC is on the rise, and it has experts who track variants on alert. 

Each time a new variant makes a grand entrance onto tracker lists, health officials take notice because it may mean there’s an important change in behavior of SARS-CoV-2, the virus that causes COVID.

Countries reporting rising detections of XEC include Germany, the United Kingdom, and the Netherlands, Australian data scientist Mike Honey posted on the platform X this past week.

XEC’s “characteristic mutations” have been detected in at least 25 states, CBS News reported, with New Jersey, California, and Virginia labs reporting 10 or more cases each. New Jersey detections at least in part stem from the CDC’s testing program for international travelers at Newark Liberty International Airport.

Still, XEC hasn’t gained enough traction in Europe, the United States, or any other part of the world for it to be listed as a standalone variant on official watchlists maintained by the CDC, European Union, or World Health Organization.

However, Eric Topol, MD, executive vice president of Scripps Research and editor-at-large for Medscape, believes XEC is the next variant “to get legs.” 

The rate at which a new variant takes the stage doesn’t always predict how severe it will be. Around this time last year, health officials sounded alarms about another Omicron variant called BA.2.86, dubbed Pirola, that ultimately didn’t make major waves.

“CDC is not aware of any specific symptoms associated with XEC or any other co-circulating SARS-CoV-2 lineage,” a CDC spokesperson said in a statement to CBS News.

The current dominant variant in the U.S. is called KP.3.1.1, accounting for an estimated 53% of U.S. COVID cases. Its parent lineages are KP.2 and KP.3, and all of these belong to the Omicron family. The SARS-CoV-2 virus mutates over time, and scientists use the names and labels to identify groups of viral variants based on their similarities and on which strains a mutated descendant came from.
 

A version of this article appeared on WebMD.com.

A new COVID-19 variant called XEC is on the rise, and it has experts who track variants on alert. 

Each time a new variant makes a grand entrance onto tracker lists, health officials take notice because it may mean there’s an important change in behavior of SARS-CoV-2, the virus that causes COVID.

Countries reporting rising detections of XEC include Germany, the United Kingdom, and the Netherlands, Australian data scientist Mike Honey posted on the platform X this past week.

XEC’s “characteristic mutations” have been detected in at least 25 states, CBS News reported, with New Jersey, California, and Virginia labs reporting 10 or more cases each. New Jersey detections at least in part stem from the CDC’s testing program for international travelers at Newark Liberty International Airport.

Still, XEC hasn’t gained enough traction in Europe, the United States, or any other part of the world for it to be listed as a standalone variant on official watchlists maintained by the CDC, European Union, or World Health Organization.

However, Eric Topol, MD, executive vice president of Scripps Research and editor-at-large for Medscape, believes XEC is the next variant “to get legs.” 

The rate at which a new variant takes the stage doesn’t always predict how severe it will be. Around this time last year, health officials sounded alarms about another Omicron variant called BA.2.86, dubbed Pirola, that ultimately didn’t make major waves.

“CDC is not aware of any specific symptoms associated with XEC or any other co-circulating SARS-CoV-2 lineage,” a CDC spokesperson said in a statement to CBS News.

The current dominant variant in the U.S. is called KP.3.1.1, accounting for an estimated 53% of U.S. COVID cases. Its parent lineages are KP.2 and KP.3, and all of these belong to the Omicron family. The SARS-CoV-2 virus mutates over time, and scientists use the names and labels to identify groups of viral variants based on their similarities and on which strains a mutated descendant came from.
 

A version of this article appeared on WebMD.com.

A new COVID-19 variant called XEC is on the rise, and it has experts who track variants on alert. 

Each time a new variant makes a grand entrance onto tracker lists, health officials take notice because it may mean there’s an important change in behavior of SARS-CoV-2, the virus that causes COVID.

Countries reporting rising detections of XEC include Germany, the United Kingdom, and the Netherlands, Australian data scientist Mike Honey posted on the platform X this past week.

XEC’s “characteristic mutations” have been detected in at least 25 states, CBS News reported, with New Jersey, California, and Virginia labs reporting 10 or more cases each. New Jersey detections at least in part stem from the CDC’s testing program for international travelers at Newark Liberty International Airport.

Still, XEC hasn’t gained enough traction in Europe, the United States, or any other part of the world for it to be listed as a standalone variant on official watchlists maintained by the CDC, European Union, or World Health Organization.

However, Eric Topol, MD, executive vice president of Scripps Research and editor-at-large for Medscape, believes XEC is the next variant “to get legs.” 

The rate at which a new variant takes the stage doesn’t always predict how severe it will be. Around this time last year, health officials sounded alarms about another Omicron variant called BA.2.86, dubbed Pirola, that ultimately didn’t make major waves.

“CDC is not aware of any specific symptoms associated with XEC or any other co-circulating SARS-CoV-2 lineage,” a CDC spokesperson said in a statement to CBS News.

The current dominant variant in the U.S. is called KP.3.1.1, accounting for an estimated 53% of U.S. COVID cases. Its parent lineages are KP.2 and KP.3, and all of these belong to the Omicron family. The SARS-CoV-2 virus mutates over time, and scientists use the names and labels to identify groups of viral variants based on their similarities and on which strains a mutated descendant came from.
 

A version of this article appeared on WebMD.com.

More women are enrolling into higher-paid physician specialty fields, especially surgery, but they still have a way to go before reaching parity with their male counterparts, an analysis found.

Rising Interest in Surgical Specialties

Among 490,188 students to “pipeline” specialties from 2008 to 2022 (47.4% women), the proportion of women entering higher-paid specialties grew from 32.7% to 40.8% (P = .003), powered by increased interest in surgical jobs, reported Karina Pereira-Lima, PhD, MSc, of the University of Michigan, Ann Arbor, Michigan, and colleagues in JAMA.

“It was exciting to see the proportion of women entering high-compensation surgical specialties jump from 28.8% in 2008 to 42.4% in 2022,” Dr. Pereira-Lima told this news organization. “At the same time, the proportion of women entering high-compensation nonsurgical specialties didn’t change much over time, and we even saw a decrease in female applicants to those fields.”

The researchers launched the analysis to better understand the career choices of medical students. “We’ve been seeing a national trend where more women are entering the medical profession, with women now making up more than half of medical school students. At the same time, most of the highest compensation specialties have traditionally been dominated by men,” Dr. Pereira-Lima said. “Tracking changes in the proportion of women entering these programs over time can give us insight into whether we’re making progress toward more equitable gender representation in these high-compensation specialties.”
 

Highest vs Lowest Compensated Specialties

The researchers analyzed 2008-2022 data from students and applicants to Accreditation Council for Graduate Medical Education–accredited residency programs in “pipeline” specialties, defined as those that lead to primary board certification.

Specialties defined as having the highest compensation, based on data from Doximity, were the surgical fields of neurosurgery, ophthalmology, orthopedic surgery, otorhinolaryngology, plastic surgery (integrated), surgery (general), thoracic surgery (integrated), urology, and vascular surgery (integrated) and the nonsurgical fields of anesthesiology, dermatology, nuclear medicine, radiation oncology, and radiology (diagnostic).

The lowest-compensated fields were all nonsurgical: Child neurology, emergency medicine, family medicine, internal medicine, internal medicine/pediatrics, medical genetics and genomics, neurology, nuclear medicine, obstetrics and gynecology, pathology, pediatrics, physical medicine and rehabilitation, and psychiatry.

The proportion of women entering lower-compensated specialties stayed steady from 2008 to 2022 (53.0% vs 53.3%, respectively; P = .44), as did the percentage entering nonsurgical specialties (37.6% vs 38.7%, respectively; P = .55).

Meanwhile, the proportion of women applicants to high-compensation nonsurgical specialties fell from 36.8% in 2009 to 34.3% in 2022 (P = .001), whereas the number grew in high-compensation surgical specialties from 28.1% in 2009 to 37.6% in 2022 (P < .001).
 

Implications for Future Representation

The findings suggest that “the issue of women’s underrepresentation isn’t just limited to surgical specialties,” Dr. Pereira-Lima said. “It’s affecting many of the highest-compensated specialties overall. Moving forward, it’ll be important to investigate what’s driving the increase in women entering these highly compensated surgical specialties and see if those same factors can be applied to other fields where women are still underrepresented.”

She added that it will take time for the dominance of women among medical students to translate into more representation in the physician workforce. Also, “studies show that female physicians have higher attrition rates than men. To achieve a more balanced gender representation in medicine, it’s crucial not just to have more women entering the profession, but to focus on addressing the barriers that hinder their career advancement.”

Shikha Jain, MD, University of Illinois College of Medicine, Chicago, an oncologist who’s studied gender representation in medicine, told this news organization that the rise in women entering surgical fields may be due to an increased focus on gender disparity. “It’s nice to see that we’re actually seeing some movement there,” she said, especially in light of findings that female surgeons have better outcomes than male surgeons.

However, research has shown that women in surgical specialties aren’t as highly compensated as men, she said. “Bullying, harassment, micro- and macro-aggressions, and gaslighting are all huge problems that continue to persist in healthcare. They’re a huge part of the reason many women weren’t in these specialties. With the increase in women entering these fields, I hope we see a real concerted effort to address these challenges so we can continue to see these trends moving forward.”

Dr. Pereira-Lima is supported by the National Institutes of Health, and another author is supported by the National Institute of Mental Health. No author disclosures were reported. Dr. Jain had no disclosures.
 

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

More women are enrolling into higher-paid physician specialty fields, especially surgery, but they still have a way to go before reaching parity with their male counterparts, an analysis found.

Rising Interest in Surgical Specialties

Among 490,188 students to “pipeline” specialties from 2008 to 2022 (47.4% women), the proportion of women entering higher-paid specialties grew from 32.7% to 40.8% (P = .003), powered by increased interest in surgical jobs, reported Karina Pereira-Lima, PhD, MSc, of the University of Michigan, Ann Arbor, Michigan, and colleagues in JAMA.

“It was exciting to see the proportion of women entering high-compensation surgical specialties jump from 28.8% in 2008 to 42.4% in 2022,” Dr. Pereira-Lima told this news organization. “At the same time, the proportion of women entering high-compensation nonsurgical specialties didn’t change much over time, and we even saw a decrease in female applicants to those fields.”

The researchers launched the analysis to better understand the career choices of medical students. “We’ve been seeing a national trend where more women are entering the medical profession, with women now making up more than half of medical school students. At the same time, most of the highest compensation specialties have traditionally been dominated by men,” Dr. Pereira-Lima said. “Tracking changes in the proportion of women entering these programs over time can give us insight into whether we’re making progress toward more equitable gender representation in these high-compensation specialties.”
 

Highest vs Lowest Compensated Specialties

The researchers analyzed 2008-2022 data from students and applicants to Accreditation Council for Graduate Medical Education–accredited residency programs in “pipeline” specialties, defined as those that lead to primary board certification.

Specialties defined as having the highest compensation, based on data from Doximity, were the surgical fields of neurosurgery, ophthalmology, orthopedic surgery, otorhinolaryngology, plastic surgery (integrated), surgery (general), thoracic surgery (integrated), urology, and vascular surgery (integrated) and the nonsurgical fields of anesthesiology, dermatology, nuclear medicine, radiation oncology, and radiology (diagnostic).

The lowest-compensated fields were all nonsurgical: Child neurology, emergency medicine, family medicine, internal medicine, internal medicine/pediatrics, medical genetics and genomics, neurology, nuclear medicine, obstetrics and gynecology, pathology, pediatrics, physical medicine and rehabilitation, and psychiatry.

The proportion of women entering lower-compensated specialties stayed steady from 2008 to 2022 (53.0% vs 53.3%, respectively; P = .44), as did the percentage entering nonsurgical specialties (37.6% vs 38.7%, respectively; P = .55).

Meanwhile, the proportion of women applicants to high-compensation nonsurgical specialties fell from 36.8% in 2009 to 34.3% in 2022 (P = .001), whereas the number grew in high-compensation surgical specialties from 28.1% in 2009 to 37.6% in 2022 (P < .001).
 

Implications for Future Representation

The findings suggest that “the issue of women’s underrepresentation isn’t just limited to surgical specialties,” Dr. Pereira-Lima said. “It’s affecting many of the highest-compensated specialties overall. Moving forward, it’ll be important to investigate what’s driving the increase in women entering these highly compensated surgical specialties and see if those same factors can be applied to other fields where women are still underrepresented.”

She added that it will take time for the dominance of women among medical students to translate into more representation in the physician workforce. Also, “studies show that female physicians have higher attrition rates than men. To achieve a more balanced gender representation in medicine, it’s crucial not just to have more women entering the profession, but to focus on addressing the barriers that hinder their career advancement.”

Shikha Jain, MD, University of Illinois College of Medicine, Chicago, an oncologist who’s studied gender representation in medicine, told this news organization that the rise in women entering surgical fields may be due to an increased focus on gender disparity. “It’s nice to see that we’re actually seeing some movement there,” she said, especially in light of findings that female surgeons have better outcomes than male surgeons.

However, research has shown that women in surgical specialties aren’t as highly compensated as men, she said. “Bullying, harassment, micro- and macro-aggressions, and gaslighting are all huge problems that continue to persist in healthcare. They’re a huge part of the reason many women weren’t in these specialties. With the increase in women entering these fields, I hope we see a real concerted effort to address these challenges so we can continue to see these trends moving forward.”

Dr. Pereira-Lima is supported by the National Institutes of Health, and another author is supported by the National Institute of Mental Health. No author disclosures were reported. Dr. Jain had no disclosures.
 

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

More women are enrolling into higher-paid physician specialty fields, especially surgery, but they still have a way to go before reaching parity with their male counterparts, an analysis found.

Rising Interest in Surgical Specialties

Among 490,188 students to “pipeline” specialties from 2008 to 2022 (47.4% women), the proportion of women entering higher-paid specialties grew from 32.7% to 40.8% (P = .003), powered by increased interest in surgical jobs, reported Karina Pereira-Lima, PhD, MSc, of the University of Michigan, Ann Arbor, Michigan, and colleagues in JAMA.

“It was exciting to see the proportion of women entering high-compensation surgical specialties jump from 28.8% in 2008 to 42.4% in 2022,” Dr. Pereira-Lima told this news organization. “At the same time, the proportion of women entering high-compensation nonsurgical specialties didn’t change much over time, and we even saw a decrease in female applicants to those fields.”

The researchers launched the analysis to better understand the career choices of medical students. “We’ve been seeing a national trend where more women are entering the medical profession, with women now making up more than half of medical school students. At the same time, most of the highest compensation specialties have traditionally been dominated by men,” Dr. Pereira-Lima said. “Tracking changes in the proportion of women entering these programs over time can give us insight into whether we’re making progress toward more equitable gender representation in these high-compensation specialties.”
 

Highest vs Lowest Compensated Specialties

The researchers analyzed 2008-2022 data from students and applicants to Accreditation Council for Graduate Medical Education–accredited residency programs in “pipeline” specialties, defined as those that lead to primary board certification.

Specialties defined as having the highest compensation, based on data from Doximity, were the surgical fields of neurosurgery, ophthalmology, orthopedic surgery, otorhinolaryngology, plastic surgery (integrated), surgery (general), thoracic surgery (integrated), urology, and vascular surgery (integrated) and the nonsurgical fields of anesthesiology, dermatology, nuclear medicine, radiation oncology, and radiology (diagnostic).

The lowest-compensated fields were all nonsurgical: Child neurology, emergency medicine, family medicine, internal medicine, internal medicine/pediatrics, medical genetics and genomics, neurology, nuclear medicine, obstetrics and gynecology, pathology, pediatrics, physical medicine and rehabilitation, and psychiatry.

The proportion of women entering lower-compensated specialties stayed steady from 2008 to 2022 (53.0% vs 53.3%, respectively; P = .44), as did the percentage entering nonsurgical specialties (37.6% vs 38.7%, respectively; P = .55).

Meanwhile, the proportion of women applicants to high-compensation nonsurgical specialties fell from 36.8% in 2009 to 34.3% in 2022 (P = .001), whereas the number grew in high-compensation surgical specialties from 28.1% in 2009 to 37.6% in 2022 (P < .001).
 

Implications for Future Representation

The findings suggest that “the issue of women’s underrepresentation isn’t just limited to surgical specialties,” Dr. Pereira-Lima said. “It’s affecting many of the highest-compensated specialties overall. Moving forward, it’ll be important to investigate what’s driving the increase in women entering these highly compensated surgical specialties and see if those same factors can be applied to other fields where women are still underrepresented.”

She added that it will take time for the dominance of women among medical students to translate into more representation in the physician workforce. Also, “studies show that female physicians have higher attrition rates than men. To achieve a more balanced gender representation in medicine, it’s crucial not just to have more women entering the profession, but to focus on addressing the barriers that hinder their career advancement.”

Shikha Jain, MD, University of Illinois College of Medicine, Chicago, an oncologist who’s studied gender representation in medicine, told this news organization that the rise in women entering surgical fields may be due to an increased focus on gender disparity. “It’s nice to see that we’re actually seeing some movement there,” she said, especially in light of findings that female surgeons have better outcomes than male surgeons.

However, research has shown that women in surgical specialties aren’t as highly compensated as men, she said. “Bullying, harassment, micro- and macro-aggressions, and gaslighting are all huge problems that continue to persist in healthcare. They’re a huge part of the reason many women weren’t in these specialties. With the increase in women entering these fields, I hope we see a real concerted effort to address these challenges so we can continue to see these trends moving forward.”

Dr. Pereira-Lima is supported by the National Institutes of Health, and another author is supported by the National Institute of Mental Health. No author disclosures were reported. Dr. Jain had no disclosures.
 

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

Salaries for millennial physicians are slightly increasing, but clinicians still face pay disparities across location, practice type, and gender.

Medscape Medical News reviewed survey data from more than 1200 practicing doctors under age 40 across 29 specialties over a 4-month period starting in October 2023.

The average annual total compensation (including any bonuses) for young clinicians rose from $326,000 to $338,000, about 4%, between 2022 and 2023. Among millennials, primary care physicians saw a 5% increase. But a large pay gap exists between fields: Specialists under age 40 earned an average of $357,000 in 2023, compared with the average primary care clinician salary of $271,000.

“Procedures are reimbursed too high, while very little value is placed on primary care,” one survey respondent complained.

The type of practice plays a major part in compensation. Millennial doctors in office-based, single-specialty group practices earned an average of $358,000 per year, followed by those in office-based multispecialty group practices at 355,000 per year. Those in outpatient clinics earned $278,000 per year.

“I believe the practice situation is a huge portion of compensation,” said Tiffany Di Pietro, DO, a cardiologist and internal medicine physician in Fort Lauderdale, Florida. “Owning your own private practice is generally more lucrative (if you have good business sense), but it is also quite a bit more time-consuming, whereas employed physicians usually make less but have fewer concerns with staffing and overhead.”

Like in previous years, a gender pay gap equated to men outearning women. Female physicians under age 40 of any kind earned about $302,000 per year, 24% less than their male counterparts, on average.

Millennial doctors in the Midwest brought home the biggest earnings, with an average salary of $343,000 vs $332,000 on the West Coast.

Millennial physicians also reported higher levels of dissatisfaction. In the 2022 report, 46% said they were not paid fairly. That figure rose to 49%. Just 68% of millennial doctors would choose medicine again if they could do things over, down from 76% in the 2021 report.

“Doctors go through multiple years of school and then have to act like we are working at Dunkin’ Donuts — like we’re on an assembly line,” one survey respondent said. “We should not have to be paid per patient seen but valued for 8-9 years of training.”

Despite these complaints, close to 7 out of 10 millennial respondents said pay was not a major factor in what area of medicine they chose, with 29% saying it played no role at all in their decision.

Psychiatrists and anesthesiologists were the happiest with their earnings, with 61% of both specialties reporting that they felt fairly paid. They were followed by dermatologists and emergency medicine doctors, both of whom 60% reported fair earnings.

Many millennial doctors are finding ways to make money outside of their practice, with 18% securing other medical-related work, 15% doing medical moonlighting, and 5% taking on non–medical-related work.

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

Salaries for millennial physicians are slightly increasing, but clinicians still face pay disparities across location, practice type, and gender.

Medscape Medical News reviewed survey data from more than 1200 practicing doctors under age 40 across 29 specialties over a 4-month period starting in October 2023.

The average annual total compensation (including any bonuses) for young clinicians rose from $326,000 to $338,000, about 4%, between 2022 and 2023. Among millennials, primary care physicians saw a 5% increase. But a large pay gap exists between fields: Specialists under age 40 earned an average of $357,000 in 2023, compared with the average primary care clinician salary of $271,000.

“Procedures are reimbursed too high, while very little value is placed on primary care,” one survey respondent complained.

The type of practice plays a major part in compensation. Millennial doctors in office-based, single-specialty group practices earned an average of $358,000 per year, followed by those in office-based multispecialty group practices at 355,000 per year. Those in outpatient clinics earned $278,000 per year.

“I believe the practice situation is a huge portion of compensation,” said Tiffany Di Pietro, DO, a cardiologist and internal medicine physician in Fort Lauderdale, Florida. “Owning your own private practice is generally more lucrative (if you have good business sense), but it is also quite a bit more time-consuming, whereas employed physicians usually make less but have fewer concerns with staffing and overhead.”

Like in previous years, a gender pay gap equated to men outearning women. Female physicians under age 40 of any kind earned about $302,000 per year, 24% less than their male counterparts, on average.

Millennial doctors in the Midwest brought home the biggest earnings, with an average salary of $343,000 vs $332,000 on the West Coast.

Millennial physicians also reported higher levels of dissatisfaction. In the 2022 report, 46% said they were not paid fairly. That figure rose to 49%. Just 68% of millennial doctors would choose medicine again if they could do things over, down from 76% in the 2021 report.

“Doctors go through multiple years of school and then have to act like we are working at Dunkin’ Donuts — like we’re on an assembly line,” one survey respondent said. “We should not have to be paid per patient seen but valued for 8-9 years of training.”

Despite these complaints, close to 7 out of 10 millennial respondents said pay was not a major factor in what area of medicine they chose, with 29% saying it played no role at all in their decision.

Psychiatrists and anesthesiologists were the happiest with their earnings, with 61% of both specialties reporting that they felt fairly paid. They were followed by dermatologists and emergency medicine doctors, both of whom 60% reported fair earnings.

Many millennial doctors are finding ways to make money outside of their practice, with 18% securing other medical-related work, 15% doing medical moonlighting, and 5% taking on non–medical-related work.

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

Salaries for millennial physicians are slightly increasing, but clinicians still face pay disparities across location, practice type, and gender.

Medscape Medical News reviewed survey data from more than 1200 practicing doctors under age 40 across 29 specialties over a 4-month period starting in October 2023.

The average annual total compensation (including any bonuses) for young clinicians rose from $326,000 to $338,000, about 4%, between 2022 and 2023. Among millennials, primary care physicians saw a 5% increase. But a large pay gap exists between fields: Specialists under age 40 earned an average of $357,000 in 2023, compared with the average primary care clinician salary of $271,000.

“Procedures are reimbursed too high, while very little value is placed on primary care,” one survey respondent complained.

The type of practice plays a major part in compensation. Millennial doctors in office-based, single-specialty group practices earned an average of $358,000 per year, followed by those in office-based multispecialty group practices at 355,000 per year. Those in outpatient clinics earned $278,000 per year.

“I believe the practice situation is a huge portion of compensation,” said Tiffany Di Pietro, DO, a cardiologist and internal medicine physician in Fort Lauderdale, Florida. “Owning your own private practice is generally more lucrative (if you have good business sense), but it is also quite a bit more time-consuming, whereas employed physicians usually make less but have fewer concerns with staffing and overhead.”

Like in previous years, a gender pay gap equated to men outearning women. Female physicians under age 40 of any kind earned about $302,000 per year, 24% less than their male counterparts, on average.

Millennial doctors in the Midwest brought home the biggest earnings, with an average salary of $343,000 vs $332,000 on the West Coast.

Millennial physicians also reported higher levels of dissatisfaction. In the 2022 report, 46% said they were not paid fairly. That figure rose to 49%. Just 68% of millennial doctors would choose medicine again if they could do things over, down from 76% in the 2021 report.

“Doctors go through multiple years of school and then have to act like we are working at Dunkin’ Donuts — like we’re on an assembly line,” one survey respondent said. “We should not have to be paid per patient seen but valued for 8-9 years of training.”

Despite these complaints, close to 7 out of 10 millennial respondents said pay was not a major factor in what area of medicine they chose, with 29% saying it played no role at all in their decision.

Psychiatrists and anesthesiologists were the happiest with their earnings, with 61% of both specialties reporting that they felt fairly paid. They were followed by dermatologists and emergency medicine doctors, both of whom 60% reported fair earnings.

Many millennial doctors are finding ways to make money outside of their practice, with 18% securing other medical-related work, 15% doing medical moonlighting, and 5% taking on non–medical-related work.

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

There’s a new morning ritual in Pinedale, Wyoming, a town of about 2000, nestled against the Wind River Mountains.

Friends and neighbors in the oil- and gas-rich community “take their morning coffee and pull up” to watch workers building the county’s first hospital, said Kari DeWitt, the project’s public relations director.

“I think it’s just gratitude,” Ms. DeWitt said.

Sublette County is the only one in Wyoming — where counties span thousands of square miles — without a hospital. The 10-bed, 40,000-square-foot hospital, with a similarly sized attached long-term care facility, is slated to open by the summer of 2025.

Ms. DeWitt, who also is executive director of the Sublette County Health Foundation, has an office at the town’s health clinic with a window view of the construction.

Pinedale’s residents have good reason to be excited. New full-service hospitals with inpatient beds are rare in rural America, where declining population has spurred decades of downsizing and closures. Yet, a few communities in Wyoming and others in Kansas and Georgia are defying the trend.

“To be honest with you, it even seems strange to me,” said Wyoming Hospital Association President Eric Boley. Small rural “hospitals are really struggling all across the country,” he said.

There is no official tally of new hospitals being built in rural America, but industry experts such as Mr. Boley said they’re rare. Typically, health-related construction projects in rural areas are for smaller urgent care centers or stand-alone emergency facilities or are replacements for old hospitals.

About half of rural hospitals lost money in the prior year, according to Chartis, a health analytics and consulting firm. And nearly 150 rural hospitals have closed or converted to smaller operations since 2010, according to data collected by the University of North Carolina’s Cecil G. Sheps Center for Health Services Research.

To stem the tide of closures, Congress created a new rural emergency hospital designation that allowed struggling hospitals to close their inpatient units and provide only outpatient and emergency services. Since January 2023, when the program took effect, 32 of the more than 1700 eligible rural hospitals — from Georgia to New Mexico — have joined the program, according to data from the Centers for Medicare & Medicaid Services.

Tony Breitlow is healthcare studio director for EUA, which has extensive experience working for rural health care systems. Mr. Breitlow said his national architecture and engineering firm’s work expands, replaces, or revamps older buildings, many of which were constructed during the middle of the last century.

The work, Mr. Breitlow said, is part of health care “systems figuring out how to remain robust and viable.”

Freeman Health System, based in Joplin, Missouri, announced plans last year to build a new 50-bed hospital across the state line in Kansas. Paula Baker, Freeman’s president and chief executive, said the system is building for patients in the southeastern corner of the state who travel 45 minutes or more to its bigger Joplin facilities for care.

Freeman’s new hospital, with construction on the building expected to begin in the spring, will be less than 10 miles away from an older, 64-bed hospital that has existed for decades. Kansas is one of more than a dozen states with no “certificate of need” law that would require health providers to obtain approval from the state before offering new services or building or expanding facilities.

Ms. Baker also said Freeman plans to operate emergency services and a small 10-bed outpost in Fort Scott, Kansas, opening early next year in a corner of a hospital that closed in late 2018. Residents there “cried, they cheered, they hugged me,” Ms. Baker said, adding that the “level of appreciation and gratitude that they felt and they displayed was overwhelming to me.”

Michael Topchik, executive director of the Chartis Center for Rural Health, said regional healthcare systems in the Upper Midwest have been particularly active in competing for patients by, among other things, building new hospitals.

And while private corporate money can drive construction, many rural hospital projects tap government programs, especially those supported by the US Department of Agriculture, Mr. Topchik said. That, he said, “surprises a lot of people.”

Since 2021, the USDA’s rural Community Facilities Programs have awarded $2.24 billion in loans and grants to 68 rural hospitals for work that was not related to an emergency or disaster, according to data analyzed by KFF Health News and confirmed by the agency. The federal program is funded through what is often known as the farm bill, which faces a September congressional renewal deadline.

Nearly all the projects are replacements or expansions and updates of older facilities.

The USDA confirmed that three new or planned Wyoming hospitals received federal funding. Hospital projects in Riverton and Saratoga received loans of $37.2 million and $18.3 million, respectively. Pinedale’s hospital received a $29.2 million loan from the agency.

Wyoming’s new construction is rare in a state where more than 80% of rural hospitals reported losses in the third quarter of 2023, according to Chartis. The state association’s Mr. Boley said he worries about several hospitals that have less than 10 days’ cash on hand “day and night.”

Pinedale’s project loan was approved after the community submitted a feasibility study to the USDA that included local clinics and a long-term care facility. “It’s pretty remote and right up in the mountains,” Mr. Boley said.

Pinedale’s Ms. DeWitt said the community was missing key services, such as blood transfusions, which are often necessary when there is a trauma like a car crash or if a pregnant woman faces severe complications. Local ambulances drove 94,000 miles last year, she said.

Ms. DeWitt began working to raise support for the new hospital after her own pregnancy-related trauma in 2014. She was bleeding heavily and arrived at the local health clinic believing it operated like a hospital.

“It was shocking to hear, ‘No, we’re not a hospital. We can’t do blood transfusions. We’re just going to have to pray you live for the next 45 minutes,’ ” Ms. DeWitt said.

Ms. DeWitt had to be airlifted to Idaho, where she delivered a few minutes after landing. When the hospital financing went on the ballot in 2020, Ms. DeWitt — fully recovered, with healthy grade-schoolers at home — began making five calls a night to rally support for a county tax increase to help fund the hospital.

“By improving health care, I think we improve everybody’s chances of survival. You know, it’s pretty basic,” Ms. DeWitt said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

There’s a new morning ritual in Pinedale, Wyoming, a town of about 2000, nestled against the Wind River Mountains.

Friends and neighbors in the oil- and gas-rich community “take their morning coffee and pull up” to watch workers building the county’s first hospital, said Kari DeWitt, the project’s public relations director.

“I think it’s just gratitude,” Ms. DeWitt said.

Sublette County is the only one in Wyoming — where counties span thousands of square miles — without a hospital. The 10-bed, 40,000-square-foot hospital, with a similarly sized attached long-term care facility, is slated to open by the summer of 2025.

Ms. DeWitt, who also is executive director of the Sublette County Health Foundation, has an office at the town’s health clinic with a window view of the construction.

Pinedale’s residents have good reason to be excited. New full-service hospitals with inpatient beds are rare in rural America, where declining population has spurred decades of downsizing and closures. Yet, a few communities in Wyoming and others in Kansas and Georgia are defying the trend.

“To be honest with you, it even seems strange to me,” said Wyoming Hospital Association President Eric Boley. Small rural “hospitals are really struggling all across the country,” he said.

There is no official tally of new hospitals being built in rural America, but industry experts such as Mr. Boley said they’re rare. Typically, health-related construction projects in rural areas are for smaller urgent care centers or stand-alone emergency facilities or are replacements for old hospitals.

About half of rural hospitals lost money in the prior year, according to Chartis, a health analytics and consulting firm. And nearly 150 rural hospitals have closed or converted to smaller operations since 2010, according to data collected by the University of North Carolina’s Cecil G. Sheps Center for Health Services Research.

To stem the tide of closures, Congress created a new rural emergency hospital designation that allowed struggling hospitals to close their inpatient units and provide only outpatient and emergency services. Since January 2023, when the program took effect, 32 of the more than 1700 eligible rural hospitals — from Georgia to New Mexico — have joined the program, according to data from the Centers for Medicare & Medicaid Services.

Tony Breitlow is healthcare studio director for EUA, which has extensive experience working for rural health care systems. Mr. Breitlow said his national architecture and engineering firm’s work expands, replaces, or revamps older buildings, many of which were constructed during the middle of the last century.

The work, Mr. Breitlow said, is part of health care “systems figuring out how to remain robust and viable.”

Freeman Health System, based in Joplin, Missouri, announced plans last year to build a new 50-bed hospital across the state line in Kansas. Paula Baker, Freeman’s president and chief executive, said the system is building for patients in the southeastern corner of the state who travel 45 minutes or more to its bigger Joplin facilities for care.

Freeman’s new hospital, with construction on the building expected to begin in the spring, will be less than 10 miles away from an older, 64-bed hospital that has existed for decades. Kansas is one of more than a dozen states with no “certificate of need” law that would require health providers to obtain approval from the state before offering new services or building or expanding facilities.

Ms. Baker also said Freeman plans to operate emergency services and a small 10-bed outpost in Fort Scott, Kansas, opening early next year in a corner of a hospital that closed in late 2018. Residents there “cried, they cheered, they hugged me,” Ms. Baker said, adding that the “level of appreciation and gratitude that they felt and they displayed was overwhelming to me.”

Michael Topchik, executive director of the Chartis Center for Rural Health, said regional healthcare systems in the Upper Midwest have been particularly active in competing for patients by, among other things, building new hospitals.

And while private corporate money can drive construction, many rural hospital projects tap government programs, especially those supported by the US Department of Agriculture, Mr. Topchik said. That, he said, “surprises a lot of people.”

Since 2021, the USDA’s rural Community Facilities Programs have awarded $2.24 billion in loans and grants to 68 rural hospitals for work that was not related to an emergency or disaster, according to data analyzed by KFF Health News and confirmed by the agency. The federal program is funded through what is often known as the farm bill, which faces a September congressional renewal deadline.

Nearly all the projects are replacements or expansions and updates of older facilities.

The USDA confirmed that three new or planned Wyoming hospitals received federal funding. Hospital projects in Riverton and Saratoga received loans of $37.2 million and $18.3 million, respectively. Pinedale’s hospital received a $29.2 million loan from the agency.

Wyoming’s new construction is rare in a state where more than 80% of rural hospitals reported losses in the third quarter of 2023, according to Chartis. The state association’s Mr. Boley said he worries about several hospitals that have less than 10 days’ cash on hand “day and night.”

Pinedale’s project loan was approved after the community submitted a feasibility study to the USDA that included local clinics and a long-term care facility. “It’s pretty remote and right up in the mountains,” Mr. Boley said.

Pinedale’s Ms. DeWitt said the community was missing key services, such as blood transfusions, which are often necessary when there is a trauma like a car crash or if a pregnant woman faces severe complications. Local ambulances drove 94,000 miles last year, she said.

Ms. DeWitt began working to raise support for the new hospital after her own pregnancy-related trauma in 2014. She was bleeding heavily and arrived at the local health clinic believing it operated like a hospital.

“It was shocking to hear, ‘No, we’re not a hospital. We can’t do blood transfusions. We’re just going to have to pray you live for the next 45 minutes,’ ” Ms. DeWitt said.

Ms. DeWitt had to be airlifted to Idaho, where she delivered a few minutes after landing. When the hospital financing went on the ballot in 2020, Ms. DeWitt — fully recovered, with healthy grade-schoolers at home — began making five calls a night to rally support for a county tax increase to help fund the hospital.

“By improving health care, I think we improve everybody’s chances of survival. You know, it’s pretty basic,” Ms. DeWitt said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

There’s a new morning ritual in Pinedale, Wyoming, a town of about 2000, nestled against the Wind River Mountains.

Friends and neighbors in the oil- and gas-rich community “take their morning coffee and pull up” to watch workers building the county’s first hospital, said Kari DeWitt, the project’s public relations director.

“I think it’s just gratitude,” Ms. DeWitt said.

Sublette County is the only one in Wyoming — where counties span thousands of square miles — without a hospital. The 10-bed, 40,000-square-foot hospital, with a similarly sized attached long-term care facility, is slated to open by the summer of 2025.

Ms. DeWitt, who also is executive director of the Sublette County Health Foundation, has an office at the town’s health clinic with a window view of the construction.

Pinedale’s residents have good reason to be excited. New full-service hospitals with inpatient beds are rare in rural America, where declining population has spurred decades of downsizing and closures. Yet, a few communities in Wyoming and others in Kansas and Georgia are defying the trend.

“To be honest with you, it even seems strange to me,” said Wyoming Hospital Association President Eric Boley. Small rural “hospitals are really struggling all across the country,” he said.

There is no official tally of new hospitals being built in rural America, but industry experts such as Mr. Boley said they’re rare. Typically, health-related construction projects in rural areas are for smaller urgent care centers or stand-alone emergency facilities or are replacements for old hospitals.

About half of rural hospitals lost money in the prior year, according to Chartis, a health analytics and consulting firm. And nearly 150 rural hospitals have closed or converted to smaller operations since 2010, according to data collected by the University of North Carolina’s Cecil G. Sheps Center for Health Services Research.

To stem the tide of closures, Congress created a new rural emergency hospital designation that allowed struggling hospitals to close their inpatient units and provide only outpatient and emergency services. Since January 2023, when the program took effect, 32 of the more than 1700 eligible rural hospitals — from Georgia to New Mexico — have joined the program, according to data from the Centers for Medicare & Medicaid Services.

Tony Breitlow is healthcare studio director for EUA, which has extensive experience working for rural health care systems. Mr. Breitlow said his national architecture and engineering firm’s work expands, replaces, or revamps older buildings, many of which were constructed during the middle of the last century.

The work, Mr. Breitlow said, is part of health care “systems figuring out how to remain robust and viable.”

Freeman Health System, based in Joplin, Missouri, announced plans last year to build a new 50-bed hospital across the state line in Kansas. Paula Baker, Freeman’s president and chief executive, said the system is building for patients in the southeastern corner of the state who travel 45 minutes or more to its bigger Joplin facilities for care.

Freeman’s new hospital, with construction on the building expected to begin in the spring, will be less than 10 miles away from an older, 64-bed hospital that has existed for decades. Kansas is one of more than a dozen states with no “certificate of need” law that would require health providers to obtain approval from the state before offering new services or building or expanding facilities.

Ms. Baker also said Freeman plans to operate emergency services and a small 10-bed outpost in Fort Scott, Kansas, opening early next year in a corner of a hospital that closed in late 2018. Residents there “cried, they cheered, they hugged me,” Ms. Baker said, adding that the “level of appreciation and gratitude that they felt and they displayed was overwhelming to me.”

Michael Topchik, executive director of the Chartis Center for Rural Health, said regional healthcare systems in the Upper Midwest have been particularly active in competing for patients by, among other things, building new hospitals.

And while private corporate money can drive construction, many rural hospital projects tap government programs, especially those supported by the US Department of Agriculture, Mr. Topchik said. That, he said, “surprises a lot of people.”

Since 2021, the USDA’s rural Community Facilities Programs have awarded $2.24 billion in loans and grants to 68 rural hospitals for work that was not related to an emergency or disaster, according to data analyzed by KFF Health News and confirmed by the agency. The federal program is funded through what is often known as the farm bill, which faces a September congressional renewal deadline.

Nearly all the projects are replacements or expansions and updates of older facilities.

The USDA confirmed that three new or planned Wyoming hospitals received federal funding. Hospital projects in Riverton and Saratoga received loans of $37.2 million and $18.3 million, respectively. Pinedale’s hospital received a $29.2 million loan from the agency.

Wyoming’s new construction is rare in a state where more than 80% of rural hospitals reported losses in the third quarter of 2023, according to Chartis. The state association’s Mr. Boley said he worries about several hospitals that have less than 10 days’ cash on hand “day and night.”

Pinedale’s project loan was approved after the community submitted a feasibility study to the USDA that included local clinics and a long-term care facility. “It’s pretty remote and right up in the mountains,” Mr. Boley said.

Pinedale’s Ms. DeWitt said the community was missing key services, such as blood transfusions, which are often necessary when there is a trauma like a car crash or if a pregnant woman faces severe complications. Local ambulances drove 94,000 miles last year, she said.

Ms. DeWitt began working to raise support for the new hospital after her own pregnancy-related trauma in 2014. She was bleeding heavily and arrived at the local health clinic believing it operated like a hospital.

“It was shocking to hear, ‘No, we’re not a hospital. We can’t do blood transfusions. We’re just going to have to pray you live for the next 45 minutes,’ ” Ms. DeWitt said.

Ms. DeWitt had to be airlifted to Idaho, where she delivered a few minutes after landing. When the hospital financing went on the ballot in 2020, Ms. DeWitt — fully recovered, with healthy grade-schoolers at home — began making five calls a night to rally support for a county tax increase to help fund the hospital.

“By improving health care, I think we improve everybody’s chances of survival. You know, it’s pretty basic,” Ms. DeWitt said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

LONDON — Single-pill combinations that include three or four antihypertensive medications are the way forward for the management of patients with elevated blood pressure, according to experts evaluating the new approach.

This multidrug strategy — in which ultralow-dose triple combinations can be used as a starting treatment and four full-dose combinations can be used to treat resistant hypertension — has shown an impressive ability to lower blood pressure in several new studies.

But will it catch on as a routine treatment recommendation in current practice?

Studies of treatment strategies that involve an ultralow quarter dose of three drugs that lower blood pressure and then escalation to a half-dose triple combination and then to a full-dose triple combination, all given as a single pill, were presented at the European Society of Cardiology (ESC) Congress 2024. Another strategy presented involves a four-drug full-dose combination in patients with resistant hypertension.
 

Start With Low Doses of Three Drugs

The triple-combination pill contains telmisartan (an angiotensin blocker), amlodipine (a calcium channel blocker), and indapamide (a diuretic). The three medications are used at three doses: Quarter, half, and standard.

“The idea is to start treatment with a little bit of the three main drug classes instead of the full dose of one drug and then to increase the triple-combination doses as required to get to blood pressure goal,” said Anthony Rodgers, PhD, from the team at The George Institute for Global Health, Sydney, Australia, that is developing this triple-combination product.

“Using three different mechanisms right from the beginning covers all the bases and leads to improved blood pressure reduction while just using very small doses of each agent. This represents a completely new approach that could transform the management of hypertension,” he reported.

Single-pill triple-combination antihypertensive formulations exist already, but the component drugs are all at standard doses. Such combinations were designed to improve adherence in patients with hard-to-control blood pressure who need more than two full-dose medications, he explained.

“We are suggesting a completely different concept using much lower doses of the triple combination right from the beginning of treatment,” Dr. Rodgers explained. “Convenience and adherence will be an added advantage, but there’s more to it than that. It’s about combining the different mechanisms of three separate drug classes to get a better antihypertensive effect and being able to do this right from the start of treatment in patients with mildly elevated blood pressure, as well as those with higher levels.”

Proof-of-concept trials of this approach have been conducted, but no commercial low-dose triple-combination product has been available.

The George Institute is now developing such a product — through George Medicines, its commercial arm — with the aim of bringing the triple-combination pill to market in both high- and low-income countries. An approval submission has been filed in the United States.

Dr. Rodgers presented two studies that assessed the triple combination. One showed that the quarter dose reduced blood pressure significantly better than placebo in patients with mildly elevated blood pressure. The second showed that half and standard doses of the three medications were more effective at lowering blood pressure than three dual combinations at the same doses.
 

The VERONICA Trial

The triple combination was also assessed in the VERONICA study, which showed that among Black adults in Nigeria with uncontrolled hypertension, blood pressure was lower and control was better with the low-dose triple-combination pill than with standard care, and tolerability was good.

In VERONICA, recently published in JAMA, 300 patients with a mean baseline blood pressure of 151/97 mm Hg at home and 156/97 mm Hg in the clinic were randomly assigned to receive the triple-combination pill or standard care.

In the triple-combination group, patients started with the quarter-dose pill, then accelerated, as necessary, to the half-dose and standard-dose pills.

In the standard care group, patients started with amlodipine (5 mg), which was stepped up at monthly intervals so patients could achieve a target blood pressure < 140/90 mm Hg as follows: Amlodipine (5 mg) plus losartan (50 mg); then amlodipine (10 mg) plus losartan (100 mg); then amlodipine (10 mg), losartan (100 mg), plus hydrochlorothiazide (25 mg); and finally referral to a specialist if the target blood pressure was still not achieved.

At month 6, mean home systolic blood pressure was, on average, 31 mm Hg lower in the triple-combination group and 26 mm Hg lower in the standard care group (adjusted difference, −5.8 mm Hg; P < .001).

More patients in the triple-combination group than in the standard care group achieved clinic blood pressure control, defined as blood pressure < 140/90 mm Hg (82% vs 72%), and more patients achieved home blood pressure control, defined as blood pressure below 130/80 mm Hg (62% vs 28%).

No participants discontinued treatment due to adverse events, and adverse events of special interest were reported by just 2% and 3% patients in the triple-combination and standard care groups, respectively.

At month 6, however, more participants in the triple-combination group than in the standard care group had serum potassium levels < 3.5 mmol/L (34% vs 18%), although fewer participants in both the groups had potassium levels < 3.0 mmol/L (10% vs 5%).

Hypokalemia may be the consequence of low dietary potassium intake in Africa, and co-administration with potassium-enriched salt substitution should be evaluated, said Dike Ojji, MBBS, PhD, University of Abuja, Nigeria, who was the lead investigator of VERONICA.

“These findings have broad clinical and public health implications, given that improved hypertension control is a priority in Africa and globally. The results underscore the need for combination therapy to be the cornerstone of effective treatment regimens,” Dr. Ojji said.
 

Missed Targets

“It has taken a long time for the penny to drop as to why the existing antihypertensive treatment paradigm does not work so well,” Dr. Rodgers pointed out. “What tends to happen in clinical practice is that people start on one drug and blood pressure falls a bit, then no further action is taken. But this is not usually enough to get to target. With our approach of using three drugs at low doses straight away, we can often get the blood pressure controlled to target much more quickly with one tablet.”

Low doses of the triple-combination pill should also have a favorable adverse-effect profile and fewer drug interactions, as these issues are generally seen much more frequently with higher doses of drugs, he explained.

This low-dose triple-combination approach could help manage the current epidemic of hypertension and cardiometabolic disease, said Pam Taub, MD, director of preventive cardiology at UC San Diego Health System.

“We are in a new era of cardiometabolic disease, and one of the fundamental drivers of atherosclerotic cardiovascular disease is hypertension, which is prevalent in patients with diabetes, in those with obesity, and is a contributor to chronic kidney disease,” she said.

“We really need to be addressing hypertension very early to prevent this end-organ damage, but because hypertension tends to occur alongside multiple other comorbidities, patients are often on many different medications and are overwhelmed by the burden of polypharmacy.”

Dr. Taub described this triple-combination approach as “looking at hypertension treatment through a new lens.”

“We’ve always been taught to maximize the dose of one agent before we go to a new agent,” she said. “These studies are fundamentally challenging that paradigm. From a pathophysiological and mechanistic perspective, we are seeing that lower doses of different medications can really harness some unique synergistic mechanisms, which can be beneficial for patients.”

But not all experts are convinced that this approach will be a popular option in all countries.

Although this approach makes sense, in that the different agents work synergistically to give a better antihypertensive effect, many physicians could be uncomfortable with the idea of giving multiple medications straight off as the first step of treatment, said Eugene Yang, MD, from the University of Washington in Seattle.

If the patient develops a side effect, it will not be clear which medication is causing it, making it difficult to know which one to stop, he pointed out.

“These studies confirm that a low-dose multidrug-combination pill is effective at lowering blood pressure, but we already have previous studies showing this,” he added. “The issue is how we translate this into patient care. It would be great if we could get people to use it, but I think concerns from both clinicians and patients about identifying the source of any side effects may be a stumbling block.”

The approach is more likely to be adopted in low- to middle-income countries, where there is limited access to healthcare and where the population-wide control of blood pressure makes sense, said Dr. Yang.

Most current guidelines now recommend initiating therapy with two agents, ideally, as a single-pill combination product. “We have finally acknowledged that the vast majority of patients need two drugs. That’s a good starting point. This low-dose triple combination could be an interesting new approach,” said Neil Poulter, MD, professor of preventive cardiovascular medicine at Imperial College London, England.

This approach is in line with the idea that single-pill combinations are the way forward for hypertension therapy, he added.

“The triple combination is attractive, in that you are never quite sure which particular mechanism is driving an individual’s elevated blood pressure, so if you can target three different mechanisms at the same time, you’ve got more chance of a good hit,” Dr. Poulter said.

“The VERONICA trial showed a very good result on lowering BP using this low-dose triple combination as a starting point and increasing quickly to single-pill combinations of triple half doses, then triple full doses, as required. But I think we need more evidence on how this compares to current practice than just this one study in Africa to make this an acceptable routine approach on a global level,” he said.
 

QUADRO: Four-Drug Combo in Resistant Hypertension

Another scenario in which single-pill antihypertensive combinations could be particularly useful is at the other end of the spectrum: The treatment of patients with resistant hypertension.

The QUADRO study showed that a single pill containing perindopril, indapamide, amlodipine, and bisoprolol is better at lowering blood pressure than the triple combination of perindopril, indapamide, and amlodipine.

The primary endpoint — office sitting systolic blood pressure at 16 weeks — was 8 mm Hg lower with the quadruple combination than with the triple combination. And mean ambulatory 24-hour systolic blood pressure was 7.5 mm Hg lower with the four-drug combination.

This was the first study of a single-pill quadruple combination in patients with resistant hypertension, which is a “difficult-to-treat condition demanding a high number of pills with not enough safe and practical options,” said Stefano Taddei, MD, from the University of Pisa, Italy, when he presented the study at the ESC meeting.

Using “four well-established drugs in a single-combination pill may improve adherence and should be an innovative solution for resistant and difficult-to-treat hypertensive patients,” he said.

Nonadherence is a big problem in patients with resistant hypertension. “It is really difficult to get patients to take three or four antihypertensive agents along with all the other medications they have for other comorbidities,” Dr. Taub pointed out. “We really need to think about combination formulations that reduce the pill burden for our patients.”

Around 10% patients with hypertension may require a fourth drug, so a four-drug single-pill combination therefore makes good sense, said Dr. Poulter.

But the choice of the fourth drug is the subject of debate. The PATHWAY trial showed spironolactone to be the most effective fourth agent, but it can cause side effects, such as gynecomastia and hyperkalemia.

“The beta-blocker in the four-drug combination product used in the QUADRO study may not be as effective as spironolactone at lowering blood pressure,” Dr. Poulter explained, noting that beta-blockers have known side effects. However, “they are often already recommended for patients with very common comorbidities, such as arrhythmias, history of MI, heart failure, angina. In that regard, it makes sense to have a beta-blocker in there.”

The four-drug combination used in the QUADRO study led to a bigger reduction — by 8 mm Hg — than the three-drug combination. “That’s pretty good. I thought this was a very useful and interesting study,” he said.

There could be a role for a four-drug combination product in resistant hypertension. “Whatever we can do to improve adherence and reduce blood pressure is good thing,” said Dr. Yang.

However, a mineralocorticoid receptor antagonist (such as spironolactone) might be better as the fourth drug; that is what is recommended in the resistant hypertension algorithm.
 

Lower Blood Pressure, Better Outcomes

“What we are seeing in these trials is that across a wide spectrum of patients with hypertension or resistant hypertension, combination pills are superior to standard practice for BP lowering, and that will lead to improved outcomes,” said Dr. Taub.

“For years, such single-pill combinations have been viewed as ‘bad medicine’ in hypertension,” Dr. Poulter added. “That is clearly not the case, as these studies are showing. And single-pill combination therapies are used extensively in practically every other area of medicine. We are starting to accept them now in the blood pressure community, and I think the use of triple and quadruple combinations, as in these studies, has a real logic to it. But for this approach to be useful, these single-pill combinations must be made available, cheaply, across the world, especially in low- and middle-income countries where hypertension rates are a particular problem.”
 

A version of this article appeared on Medscape.com.

LONDON — Single-pill combinations that include three or four antihypertensive medications are the way forward for the management of patients with elevated blood pressure, according to experts evaluating the new approach.

This multidrug strategy — in which ultralow-dose triple combinations can be used as a starting treatment and four full-dose combinations can be used to treat resistant hypertension — has shown an impressive ability to lower blood pressure in several new studies.

But will it catch on as a routine treatment recommendation in current practice?

Studies of treatment strategies that involve an ultralow quarter dose of three drugs that lower blood pressure and then escalation to a half-dose triple combination and then to a full-dose triple combination, all given as a single pill, were presented at the European Society of Cardiology (ESC) Congress 2024. Another strategy presented involves a four-drug full-dose combination in patients with resistant hypertension.
 

Start With Low Doses of Three Drugs

The triple-combination pill contains telmisartan (an angiotensin blocker), amlodipine (a calcium channel blocker), and indapamide (a diuretic). The three medications are used at three doses: Quarter, half, and standard.

“The idea is to start treatment with a little bit of the three main drug classes instead of the full dose of one drug and then to increase the triple-combination doses as required to get to blood pressure goal,” said Anthony Rodgers, PhD, from the team at The George Institute for Global Health, Sydney, Australia, that is developing this triple-combination product.

“Using three different mechanisms right from the beginning covers all the bases and leads to improved blood pressure reduction while just using very small doses of each agent. This represents a completely new approach that could transform the management of hypertension,” he reported.

Single-pill triple-combination antihypertensive formulations exist already, but the component drugs are all at standard doses. Such combinations were designed to improve adherence in patients with hard-to-control blood pressure who need more than two full-dose medications, he explained.

“We are suggesting a completely different concept using much lower doses of the triple combination right from the beginning of treatment,” Dr. Rodgers explained. “Convenience and adherence will be an added advantage, but there’s more to it than that. It’s about combining the different mechanisms of three separate drug classes to get a better antihypertensive effect and being able to do this right from the start of treatment in patients with mildly elevated blood pressure, as well as those with higher levels.”

Proof-of-concept trials of this approach have been conducted, but no commercial low-dose triple-combination product has been available.

The George Institute is now developing such a product — through George Medicines, its commercial arm — with the aim of bringing the triple-combination pill to market in both high- and low-income countries. An approval submission has been filed in the United States.

Dr. Rodgers presented two studies that assessed the triple combination. One showed that the quarter dose reduced blood pressure significantly better than placebo in patients with mildly elevated blood pressure. The second showed that half and standard doses of the three medications were more effective at lowering blood pressure than three dual combinations at the same doses.
 

The VERONICA Trial

The triple combination was also assessed in the VERONICA study, which showed that among Black adults in Nigeria with uncontrolled hypertension, blood pressure was lower and control was better with the low-dose triple-combination pill than with standard care, and tolerability was good.

In VERONICA, recently published in JAMA, 300 patients with a mean baseline blood pressure of 151/97 mm Hg at home and 156/97 mm Hg in the clinic were randomly assigned to receive the triple-combination pill or standard care.

In the triple-combination group, patients started with the quarter-dose pill, then accelerated, as necessary, to the half-dose and standard-dose pills.

In the standard care group, patients started with amlodipine (5 mg), which was stepped up at monthly intervals so patients could achieve a target blood pressure < 140/90 mm Hg as follows: Amlodipine (5 mg) plus losartan (50 mg); then amlodipine (10 mg) plus losartan (100 mg); then amlodipine (10 mg), losartan (100 mg), plus hydrochlorothiazide (25 mg); and finally referral to a specialist if the target blood pressure was still not achieved.

At month 6, mean home systolic blood pressure was, on average, 31 mm Hg lower in the triple-combination group and 26 mm Hg lower in the standard care group (adjusted difference, −5.8 mm Hg; P < .001).

More patients in the triple-combination group than in the standard care group achieved clinic blood pressure control, defined as blood pressure < 140/90 mm Hg (82% vs 72%), and more patients achieved home blood pressure control, defined as blood pressure below 130/80 mm Hg (62% vs 28%).

No participants discontinued treatment due to adverse events, and adverse events of special interest were reported by just 2% and 3% patients in the triple-combination and standard care groups, respectively.

At month 6, however, more participants in the triple-combination group than in the standard care group had serum potassium levels < 3.5 mmol/L (34% vs 18%), although fewer participants in both the groups had potassium levels < 3.0 mmol/L (10% vs 5%).

Hypokalemia may be the consequence of low dietary potassium intake in Africa, and co-administration with potassium-enriched salt substitution should be evaluated, said Dike Ojji, MBBS, PhD, University of Abuja, Nigeria, who was the lead investigator of VERONICA.

“These findings have broad clinical and public health implications, given that improved hypertension control is a priority in Africa and globally. The results underscore the need for combination therapy to be the cornerstone of effective treatment regimens,” Dr. Ojji said.
 

Missed Targets

“It has taken a long time for the penny to drop as to why the existing antihypertensive treatment paradigm does not work so well,” Dr. Rodgers pointed out. “What tends to happen in clinical practice is that people start on one drug and blood pressure falls a bit, then no further action is taken. But this is not usually enough to get to target. With our approach of using three drugs at low doses straight away, we can often get the blood pressure controlled to target much more quickly with one tablet.”

Low doses of the triple-combination pill should also have a favorable adverse-effect profile and fewer drug interactions, as these issues are generally seen much more frequently with higher doses of drugs, he explained.

This low-dose triple-combination approach could help manage the current epidemic of hypertension and cardiometabolic disease, said Pam Taub, MD, director of preventive cardiology at UC San Diego Health System.

“We are in a new era of cardiometabolic disease, and one of the fundamental drivers of atherosclerotic cardiovascular disease is hypertension, which is prevalent in patients with diabetes, in those with obesity, and is a contributor to chronic kidney disease,” she said.

“We really need to be addressing hypertension very early to prevent this end-organ damage, but because hypertension tends to occur alongside multiple other comorbidities, patients are often on many different medications and are overwhelmed by the burden of polypharmacy.”

Dr. Taub described this triple-combination approach as “looking at hypertension treatment through a new lens.”

“We’ve always been taught to maximize the dose of one agent before we go to a new agent,” she said. “These studies are fundamentally challenging that paradigm. From a pathophysiological and mechanistic perspective, we are seeing that lower doses of different medications can really harness some unique synergistic mechanisms, which can be beneficial for patients.”

But not all experts are convinced that this approach will be a popular option in all countries.

Although this approach makes sense, in that the different agents work synergistically to give a better antihypertensive effect, many physicians could be uncomfortable with the idea of giving multiple medications straight off as the first step of treatment, said Eugene Yang, MD, from the University of Washington in Seattle.

If the patient develops a side effect, it will not be clear which medication is causing it, making it difficult to know which one to stop, he pointed out.

“These studies confirm that a low-dose multidrug-combination pill is effective at lowering blood pressure, but we already have previous studies showing this,” he added. “The issue is how we translate this into patient care. It would be great if we could get people to use it, but I think concerns from both clinicians and patients about identifying the source of any side effects may be a stumbling block.”

The approach is more likely to be adopted in low- to middle-income countries, where there is limited access to healthcare and where the population-wide control of blood pressure makes sense, said Dr. Yang.

Most current guidelines now recommend initiating therapy with two agents, ideally, as a single-pill combination product. “We have finally acknowledged that the vast majority of patients need two drugs. That’s a good starting point. This low-dose triple combination could be an interesting new approach,” said Neil Poulter, MD, professor of preventive cardiovascular medicine at Imperial College London, England.

This approach is in line with the idea that single-pill combinations are the way forward for hypertension therapy, he added.

“The triple combination is attractive, in that you are never quite sure which particular mechanism is driving an individual’s elevated blood pressure, so if you can target three different mechanisms at the same time, you’ve got more chance of a good hit,” Dr. Poulter said.

“The VERONICA trial showed a very good result on lowering BP using this low-dose triple combination as a starting point and increasing quickly to single-pill combinations of triple half doses, then triple full doses, as required. But I think we need more evidence on how this compares to current practice than just this one study in Africa to make this an acceptable routine approach on a global level,” he said.
 

QUADRO: Four-Drug Combo in Resistant Hypertension

Another scenario in which single-pill antihypertensive combinations could be particularly useful is at the other end of the spectrum: The treatment of patients with resistant hypertension.

The QUADRO study showed that a single pill containing perindopril, indapamide, amlodipine, and bisoprolol is better at lowering blood pressure than the triple combination of perindopril, indapamide, and amlodipine.

The primary endpoint — office sitting systolic blood pressure at 16 weeks — was 8 mm Hg lower with the quadruple combination than with the triple combination. And mean ambulatory 24-hour systolic blood pressure was 7.5 mm Hg lower with the four-drug combination.

This was the first study of a single-pill quadruple combination in patients with resistant hypertension, which is a “difficult-to-treat condition demanding a high number of pills with not enough safe and practical options,” said Stefano Taddei, MD, from the University of Pisa, Italy, when he presented the study at the ESC meeting.

Using “four well-established drugs in a single-combination pill may improve adherence and should be an innovative solution for resistant and difficult-to-treat hypertensive patients,” he said.

Nonadherence is a big problem in patients with resistant hypertension. “It is really difficult to get patients to take three or four antihypertensive agents along with all the other medications they have for other comorbidities,” Dr. Taub pointed out. “We really need to think about combination formulations that reduce the pill burden for our patients.”

Around 10% patients with hypertension may require a fourth drug, so a four-drug single-pill combination therefore makes good sense, said Dr. Poulter.

But the choice of the fourth drug is the subject of debate. The PATHWAY trial showed spironolactone to be the most effective fourth agent, but it can cause side effects, such as gynecomastia and hyperkalemia.

“The beta-blocker in the four-drug combination product used in the QUADRO study may not be as effective as spironolactone at lowering blood pressure,” Dr. Poulter explained, noting that beta-blockers have known side effects. However, “they are often already recommended for patients with very common comorbidities, such as arrhythmias, history of MI, heart failure, angina. In that regard, it makes sense to have a beta-blocker in there.”

The four-drug combination used in the QUADRO study led to a bigger reduction — by 8 mm Hg — than the three-drug combination. “That’s pretty good. I thought this was a very useful and interesting study,” he said.

There could be a role for a four-drug combination product in resistant hypertension. “Whatever we can do to improve adherence and reduce blood pressure is good thing,” said Dr. Yang.

However, a mineralocorticoid receptor antagonist (such as spironolactone) might be better as the fourth drug; that is what is recommended in the resistant hypertension algorithm.
 

Lower Blood Pressure, Better Outcomes

“What we are seeing in these trials is that across a wide spectrum of patients with hypertension or resistant hypertension, combination pills are superior to standard practice for BP lowering, and that will lead to improved outcomes,” said Dr. Taub.

“For years, such single-pill combinations have been viewed as ‘bad medicine’ in hypertension,” Dr. Poulter added. “That is clearly not the case, as these studies are showing. And single-pill combination therapies are used extensively in practically every other area of medicine. We are starting to accept them now in the blood pressure community, and I think the use of triple and quadruple combinations, as in these studies, has a real logic to it. But for this approach to be useful, these single-pill combinations must be made available, cheaply, across the world, especially in low- and middle-income countries where hypertension rates are a particular problem.”
 

A version of this article appeared on Medscape.com.

LONDON — Single-pill combinations that include three or four antihypertensive medications are the way forward for the management of patients with elevated blood pressure, according to experts evaluating the new approach.

This multidrug strategy — in which ultralow-dose triple combinations can be used as a starting treatment and four full-dose combinations can be used to treat resistant hypertension — has shown an impressive ability to lower blood pressure in several new studies.

But will it catch on as a routine treatment recommendation in current practice?

Studies of treatment strategies that involve an ultralow quarter dose of three drugs that lower blood pressure and then escalation to a half-dose triple combination and then to a full-dose triple combination, all given as a single pill, were presented at the European Society of Cardiology (ESC) Congress 2024. Another strategy presented involves a four-drug full-dose combination in patients with resistant hypertension.
 

Start With Low Doses of Three Drugs

The triple-combination pill contains telmisartan (an angiotensin blocker), amlodipine (a calcium channel blocker), and indapamide (a diuretic). The three medications are used at three doses: Quarter, half, and standard.

“The idea is to start treatment with a little bit of the three main drug classes instead of the full dose of one drug and then to increase the triple-combination doses as required to get to blood pressure goal,” said Anthony Rodgers, PhD, from the team at The George Institute for Global Health, Sydney, Australia, that is developing this triple-combination product.

“Using three different mechanisms right from the beginning covers all the bases and leads to improved blood pressure reduction while just using very small doses of each agent. This represents a completely new approach that could transform the management of hypertension,” he reported.

Single-pill triple-combination antihypertensive formulations exist already, but the component drugs are all at standard doses. Such combinations were designed to improve adherence in patients with hard-to-control blood pressure who need more than two full-dose medications, he explained.

“We are suggesting a completely different concept using much lower doses of the triple combination right from the beginning of treatment,” Dr. Rodgers explained. “Convenience and adherence will be an added advantage, but there’s more to it than that. It’s about combining the different mechanisms of three separate drug classes to get a better antihypertensive effect and being able to do this right from the start of treatment in patients with mildly elevated blood pressure, as well as those with higher levels.”

Proof-of-concept trials of this approach have been conducted, but no commercial low-dose triple-combination product has been available.

The George Institute is now developing such a product — through George Medicines, its commercial arm — with the aim of bringing the triple-combination pill to market in both high- and low-income countries. An approval submission has been filed in the United States.

Dr. Rodgers presented two studies that assessed the triple combination. One showed that the quarter dose reduced blood pressure significantly better than placebo in patients with mildly elevated blood pressure. The second showed that half and standard doses of the three medications were more effective at lowering blood pressure than three dual combinations at the same doses.
 

The VERONICA Trial

The triple combination was also assessed in the VERONICA study, which showed that among Black adults in Nigeria with uncontrolled hypertension, blood pressure was lower and control was better with the low-dose triple-combination pill than with standard care, and tolerability was good.

In VERONICA, recently published in JAMA, 300 patients with a mean baseline blood pressure of 151/97 mm Hg at home and 156/97 mm Hg in the clinic were randomly assigned to receive the triple-combination pill or standard care.

In the triple-combination group, patients started with the quarter-dose pill, then accelerated, as necessary, to the half-dose and standard-dose pills.

In the standard care group, patients started with amlodipine (5 mg), which was stepped up at monthly intervals so patients could achieve a target blood pressure < 140/90 mm Hg as follows: Amlodipine (5 mg) plus losartan (50 mg); then amlodipine (10 mg) plus losartan (100 mg); then amlodipine (10 mg), losartan (100 mg), plus hydrochlorothiazide (25 mg); and finally referral to a specialist if the target blood pressure was still not achieved.

At month 6, mean home systolic blood pressure was, on average, 31 mm Hg lower in the triple-combination group and 26 mm Hg lower in the standard care group (adjusted difference, −5.8 mm Hg; P < .001).

More patients in the triple-combination group than in the standard care group achieved clinic blood pressure control, defined as blood pressure < 140/90 mm Hg (82% vs 72%), and more patients achieved home blood pressure control, defined as blood pressure below 130/80 mm Hg (62% vs 28%).

No participants discontinued treatment due to adverse events, and adverse events of special interest were reported by just 2% and 3% patients in the triple-combination and standard care groups, respectively.

At month 6, however, more participants in the triple-combination group than in the standard care group had serum potassium levels < 3.5 mmol/L (34% vs 18%), although fewer participants in both the groups had potassium levels < 3.0 mmol/L (10% vs 5%).

Hypokalemia may be the consequence of low dietary potassium intake in Africa, and co-administration with potassium-enriched salt substitution should be evaluated, said Dike Ojji, MBBS, PhD, University of Abuja, Nigeria, who was the lead investigator of VERONICA.

“These findings have broad clinical and public health implications, given that improved hypertension control is a priority in Africa and globally. The results underscore the need for combination therapy to be the cornerstone of effective treatment regimens,” Dr. Ojji said.
 

Missed Targets

“It has taken a long time for the penny to drop as to why the existing antihypertensive treatment paradigm does not work so well,” Dr. Rodgers pointed out. “What tends to happen in clinical practice is that people start on one drug and blood pressure falls a bit, then no further action is taken. But this is not usually enough to get to target. With our approach of using three drugs at low doses straight away, we can often get the blood pressure controlled to target much more quickly with one tablet.”

Low doses of the triple-combination pill should also have a favorable adverse-effect profile and fewer drug interactions, as these issues are generally seen much more frequently with higher doses of drugs, he explained.

This low-dose triple-combination approach could help manage the current epidemic of hypertension and cardiometabolic disease, said Pam Taub, MD, director of preventive cardiology at UC San Diego Health System.

“We are in a new era of cardiometabolic disease, and one of the fundamental drivers of atherosclerotic cardiovascular disease is hypertension, which is prevalent in patients with diabetes, in those with obesity, and is a contributor to chronic kidney disease,” she said.

“We really need to be addressing hypertension very early to prevent this end-organ damage, but because hypertension tends to occur alongside multiple other comorbidities, patients are often on many different medications and are overwhelmed by the burden of polypharmacy.”

Dr. Taub described this triple-combination approach as “looking at hypertension treatment through a new lens.”

“We’ve always been taught to maximize the dose of one agent before we go to a new agent,” she said. “These studies are fundamentally challenging that paradigm. From a pathophysiological and mechanistic perspective, we are seeing that lower doses of different medications can really harness some unique synergistic mechanisms, which can be beneficial for patients.”

But not all experts are convinced that this approach will be a popular option in all countries.

Although this approach makes sense, in that the different agents work synergistically to give a better antihypertensive effect, many physicians could be uncomfortable with the idea of giving multiple medications straight off as the first step of treatment, said Eugene Yang, MD, from the University of Washington in Seattle.

If the patient develops a side effect, it will not be clear which medication is causing it, making it difficult to know which one to stop, he pointed out.

“These studies confirm that a low-dose multidrug-combination pill is effective at lowering blood pressure, but we already have previous studies showing this,” he added. “The issue is how we translate this into patient care. It would be great if we could get people to use it, but I think concerns from both clinicians and patients about identifying the source of any side effects may be a stumbling block.”

The approach is more likely to be adopted in low- to middle-income countries, where there is limited access to healthcare and where the population-wide control of blood pressure makes sense, said Dr. Yang.

Most current guidelines now recommend initiating therapy with two agents, ideally, as a single-pill combination product. “We have finally acknowledged that the vast majority of patients need two drugs. That’s a good starting point. This low-dose triple combination could be an interesting new approach,” said Neil Poulter, MD, professor of preventive cardiovascular medicine at Imperial College London, England.

This approach is in line with the idea that single-pill combinations are the way forward for hypertension therapy, he added.

“The triple combination is attractive, in that you are never quite sure which particular mechanism is driving an individual’s elevated blood pressure, so if you can target three different mechanisms at the same time, you’ve got more chance of a good hit,” Dr. Poulter said.

“The VERONICA trial showed a very good result on lowering BP using this low-dose triple combination as a starting point and increasing quickly to single-pill combinations of triple half doses, then triple full doses, as required. But I think we need more evidence on how this compares to current practice than just this one study in Africa to make this an acceptable routine approach on a global level,” he said.
 

QUADRO: Four-Drug Combo in Resistant Hypertension

Another scenario in which single-pill antihypertensive combinations could be particularly useful is at the other end of the spectrum: The treatment of patients with resistant hypertension.

The QUADRO study showed that a single pill containing perindopril, indapamide, amlodipine, and bisoprolol is better at lowering blood pressure than the triple combination of perindopril, indapamide, and amlodipine.

The primary endpoint — office sitting systolic blood pressure at 16 weeks — was 8 mm Hg lower with the quadruple combination than with the triple combination. And mean ambulatory 24-hour systolic blood pressure was 7.5 mm Hg lower with the four-drug combination.

This was the first study of a single-pill quadruple combination in patients with resistant hypertension, which is a “difficult-to-treat condition demanding a high number of pills with not enough safe and practical options,” said Stefano Taddei, MD, from the University of Pisa, Italy, when he presented the study at the ESC meeting.

Using “four well-established drugs in a single-combination pill may improve adherence and should be an innovative solution for resistant and difficult-to-treat hypertensive patients,” he said.

Nonadherence is a big problem in patients with resistant hypertension. “It is really difficult to get patients to take three or four antihypertensive agents along with all the other medications they have for other comorbidities,” Dr. Taub pointed out. “We really need to think about combination formulations that reduce the pill burden for our patients.”

Around 10% patients with hypertension may require a fourth drug, so a four-drug single-pill combination therefore makes good sense, said Dr. Poulter.

But the choice of the fourth drug is the subject of debate. The PATHWAY trial showed spironolactone to be the most effective fourth agent, but it can cause side effects, such as gynecomastia and hyperkalemia.

“The beta-blocker in the four-drug combination product used in the QUADRO study may not be as effective as spironolactone at lowering blood pressure,” Dr. Poulter explained, noting that beta-blockers have known side effects. However, “they are often already recommended for patients with very common comorbidities, such as arrhythmias, history of MI, heart failure, angina. In that regard, it makes sense to have a beta-blocker in there.”

The four-drug combination used in the QUADRO study led to a bigger reduction — by 8 mm Hg — than the three-drug combination. “That’s pretty good. I thought this was a very useful and interesting study,” he said.

There could be a role for a four-drug combination product in resistant hypertension. “Whatever we can do to improve adherence and reduce blood pressure is good thing,” said Dr. Yang.

However, a mineralocorticoid receptor antagonist (such as spironolactone) might be better as the fourth drug; that is what is recommended in the resistant hypertension algorithm.
 

Lower Blood Pressure, Better Outcomes

“What we are seeing in these trials is that across a wide spectrum of patients with hypertension or resistant hypertension, combination pills are superior to standard practice for BP lowering, and that will lead to improved outcomes,” said Dr. Taub.

“For years, such single-pill combinations have been viewed as ‘bad medicine’ in hypertension,” Dr. Poulter added. “That is clearly not the case, as these studies are showing. And single-pill combination therapies are used extensively in practically every other area of medicine. We are starting to accept them now in the blood pressure community, and I think the use of triple and quadruple combinations, as in these studies, has a real logic to it. But for this approach to be useful, these single-pill combinations must be made available, cheaply, across the world, especially in low- and middle-income countries where hypertension rates are a particular problem.”
 

A version of this article appeared on Medscape.com.