Feature

Which conditions are caused by infection? Though it may seem like an amateur concern in the era of advanced microscopy, some culprits evade conventional methods of detection. Large medical databases hold the power to unlock answers. 

A recent study from Sweden and Denmark meticulously traced the lives and medical histories of nearly one million men and women in those countries who had received blood transfusions over nearly five decades. Some of these patients later experienced brain bleeds. The inescapable question: Could a virus found in some donor blood have caused the hemorrhages?

Traditionally, brain bleeds have been thought to strike at random. But the new study, published in JAMA, points toward an infection that causes or, at the very least, is linked to the condition. The researchers used a large databank to make the discovery. 

“As health data becomes more available and easier to analyze, we’ll see all kinds of cases like this,” said Jingcheng Zhao, MD, of the clinical epidemiology division of Sweden’s Karolinska Institutet in Solna and lead author of the study.

Scientists say the field of medical research is on the cusp of a revolution as immense health databases guide discovery and improve clinical care. 

“If you can aggregate data, you have the statistical power to identify associations,” said David R. Crosslin, PhD, professor in the division of biomedical informatics and genomics at Tulane University in New Orleans. “It opens up the world for understanding diseases.”

With access to the large database, Dr. Zhao and his team found that some blood donors later experienced brain bleeds. And it turned out that the recipients of blood from those same donors carried the highest risk of experiencing a brain bleed later in life. Meanwhile, patients whose donors remained bleed-free had the lowest risk.
 

Not so fast in the United States

In Nordic countries, all hospitals, clinics, and pharmacies report data on diagnoses and health care visits to the government, tracking that began with paper and pen in the 1960s. But the United States health care system is too fragmented to replicate such efforts, with several brands of electronic medical records operating across different systems. Data sharing across institutions is minimal. 

Most comparable health data in the United States comes from reimbursement information collected by the Centers for Medicare & Medicaid Services on government-sponsored insurance programs.

“We would need all the health care systems in the country to operate within the same IT system or use the same data model,” said Euan Ashley, MD, PhD, professor of genomics at Stanford (Calif.) University. “It’s an exciting prospect. But I think [the United States] is one of the last countries where it’ll happen.”

States, meanwhile, collect health data on specific areas like sexually transmitted infection cases and rates. Other states have registries, like the Connecticut Tumor Registry, which was established in 1941 and is the oldest population-based cancer registry in the world.

But all of these efforts are ad hoc, and no equivalent exists for heart disease and other conditions.

Health data companies have recently entered the U.S. data industry mainly through partnerships with health systems and insurance companies, using deidentified information from patient charts.

The large databases have yielded important findings that randomized clinical trials simply cannot, according to Dr. Ashley.

For instance, a study found that a heavily-lauded immunotherapy treatment did not provide meaningful outcomes for patients aged 75 years or older, but it did for younger patients.

This sort of analysis might enable clinicians to administer treatments based on how effective they are for patients with particular demographics, according to Cary Gross, MD, professor at Yale University in New Haven, Conn.

“From a bedside standpoint, these large databases can identify who benefits from what,” Dr. Gross said. “Precision medicine is not just about genetic tailoring.” These large datasets also provide insight into genetic and environmental variables that contribute to disease. 

For instance, the UK Biobank has more than 500,000 participants paired with their medical records and scans of their body and brain. Researchers perform cognitive tests on participants and extract DNA from blood samples over their lifetime, allowing examination of interactions between risk factors. 

A similar but much smaller-scale effort underway in the United States, called the All of Us Research Program, has enrolled more than 650,000 people, less than one-third the size of the UK Biobank by relative populations. The goal of the program is to provide insights into prevention and treatment of chronic disease among a diverse set of at least one million participants. The database includes information on sexual orientation, which is a fairly new datapoint collected by researchers in an effort to study health outcomes and inequities among the LGBTQ+ community.

Dr. Crosslin and his colleagues are writing a grant proposal to use the All of Us database to identify genetic risks for preeclampsia. People with certain genetic profiles may be predisposed to the life-threatening condition, and researchers may discover that lifestyle changes could decrease risk, Dr. Crosslin said. 
 

Changes in the United States

The COVID-19 pandemic exposed the lack of centralized data in the United States because a majority of research on the virus has been conducted abroad in countries with national health care systems and these large databases. 

The U.S. gap spurred a group of researchers to create the National Institutes of Health–funded National COVID Cohort Collaborative (N3C), a project that gathers medical records from millions of patients across health systems and provides access to research teams investigating a wide spectrum of topics, such as optimal timing for ventilator use.

But until government or private health systems develop a way to share and regulate health data ethically and efficiently, significant limits will persist on what large-scale databases can do, Dr. Gross said. 

“At the federal level, we need to ensure this health information is made available for public health researchers so we don’t create these private fiefdoms of data,” Dr. Gross said. “Things have to be transparent. I think our country needs to take a step back and think about what we’re doing with our health data and how we can make sure it’s being managed ethically.”

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

Which conditions are caused by infection? Though it may seem like an amateur concern in the era of advanced microscopy, some culprits evade conventional methods of detection. Large medical databases hold the power to unlock answers. 

A recent study from Sweden and Denmark meticulously traced the lives and medical histories of nearly one million men and women in those countries who had received blood transfusions over nearly five decades. Some of these patients later experienced brain bleeds. The inescapable question: Could a virus found in some donor blood have caused the hemorrhages?

Traditionally, brain bleeds have been thought to strike at random. But the new study, published in JAMA, points toward an infection that causes or, at the very least, is linked to the condition. The researchers used a large databank to make the discovery. 

“As health data becomes more available and easier to analyze, we’ll see all kinds of cases like this,” said Jingcheng Zhao, MD, of the clinical epidemiology division of Sweden’s Karolinska Institutet in Solna and lead author of the study.

Scientists say the field of medical research is on the cusp of a revolution as immense health databases guide discovery and improve clinical care. 

“If you can aggregate data, you have the statistical power to identify associations,” said David R. Crosslin, PhD, professor in the division of biomedical informatics and genomics at Tulane University in New Orleans. “It opens up the world for understanding diseases.”

With access to the large database, Dr. Zhao and his team found that some blood donors later experienced brain bleeds. And it turned out that the recipients of blood from those same donors carried the highest risk of experiencing a brain bleed later in life. Meanwhile, patients whose donors remained bleed-free had the lowest risk.
 

Not so fast in the United States

In Nordic countries, all hospitals, clinics, and pharmacies report data on diagnoses and health care visits to the government, tracking that began with paper and pen in the 1960s. But the United States health care system is too fragmented to replicate such efforts, with several brands of electronic medical records operating across different systems. Data sharing across institutions is minimal. 

Most comparable health data in the United States comes from reimbursement information collected by the Centers for Medicare & Medicaid Services on government-sponsored insurance programs.

“We would need all the health care systems in the country to operate within the same IT system or use the same data model,” said Euan Ashley, MD, PhD, professor of genomics at Stanford (Calif.) University. “It’s an exciting prospect. But I think [the United States] is one of the last countries where it’ll happen.”

States, meanwhile, collect health data on specific areas like sexually transmitted infection cases and rates. Other states have registries, like the Connecticut Tumor Registry, which was established in 1941 and is the oldest population-based cancer registry in the world.

But all of these efforts are ad hoc, and no equivalent exists for heart disease and other conditions.

Health data companies have recently entered the U.S. data industry mainly through partnerships with health systems and insurance companies, using deidentified information from patient charts.

The large databases have yielded important findings that randomized clinical trials simply cannot, according to Dr. Ashley.

For instance, a study found that a heavily-lauded immunotherapy treatment did not provide meaningful outcomes for patients aged 75 years or older, but it did for younger patients.

This sort of analysis might enable clinicians to administer treatments based on how effective they are for patients with particular demographics, according to Cary Gross, MD, professor at Yale University in New Haven, Conn.

“From a bedside standpoint, these large databases can identify who benefits from what,” Dr. Gross said. “Precision medicine is not just about genetic tailoring.” These large datasets also provide insight into genetic and environmental variables that contribute to disease. 

For instance, the UK Biobank has more than 500,000 participants paired with their medical records and scans of their body and brain. Researchers perform cognitive tests on participants and extract DNA from blood samples over their lifetime, allowing examination of interactions between risk factors. 

A similar but much smaller-scale effort underway in the United States, called the All of Us Research Program, has enrolled more than 650,000 people, less than one-third the size of the UK Biobank by relative populations. The goal of the program is to provide insights into prevention and treatment of chronic disease among a diverse set of at least one million participants. The database includes information on sexual orientation, which is a fairly new datapoint collected by researchers in an effort to study health outcomes and inequities among the LGBTQ+ community.

Dr. Crosslin and his colleagues are writing a grant proposal to use the All of Us database to identify genetic risks for preeclampsia. People with certain genetic profiles may be predisposed to the life-threatening condition, and researchers may discover that lifestyle changes could decrease risk, Dr. Crosslin said. 
 

Changes in the United States

The COVID-19 pandemic exposed the lack of centralized data in the United States because a majority of research on the virus has been conducted abroad in countries with national health care systems and these large databases. 

The U.S. gap spurred a group of researchers to create the National Institutes of Health–funded National COVID Cohort Collaborative (N3C), a project that gathers medical records from millions of patients across health systems and provides access to research teams investigating a wide spectrum of topics, such as optimal timing for ventilator use.

But until government or private health systems develop a way to share and regulate health data ethically and efficiently, significant limits will persist on what large-scale databases can do, Dr. Gross said. 

“At the federal level, we need to ensure this health information is made available for public health researchers so we don’t create these private fiefdoms of data,” Dr. Gross said. “Things have to be transparent. I think our country needs to take a step back and think about what we’re doing with our health data and how we can make sure it’s being managed ethically.”

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

Which conditions are caused by infection? Though it may seem like an amateur concern in the era of advanced microscopy, some culprits evade conventional methods of detection. Large medical databases hold the power to unlock answers. 

A recent study from Sweden and Denmark meticulously traced the lives and medical histories of nearly one million men and women in those countries who had received blood transfusions over nearly five decades. Some of these patients later experienced brain bleeds. The inescapable question: Could a virus found in some donor blood have caused the hemorrhages?

Traditionally, brain bleeds have been thought to strike at random. But the new study, published in JAMA, points toward an infection that causes or, at the very least, is linked to the condition. The researchers used a large databank to make the discovery. 

“As health data becomes more available and easier to analyze, we’ll see all kinds of cases like this,” said Jingcheng Zhao, MD, of the clinical epidemiology division of Sweden’s Karolinska Institutet in Solna and lead author of the study.

Scientists say the field of medical research is on the cusp of a revolution as immense health databases guide discovery and improve clinical care. 

“If you can aggregate data, you have the statistical power to identify associations,” said David R. Crosslin, PhD, professor in the division of biomedical informatics and genomics at Tulane University in New Orleans. “It opens up the world for understanding diseases.”

With access to the large database, Dr. Zhao and his team found that some blood donors later experienced brain bleeds. And it turned out that the recipients of blood from those same donors carried the highest risk of experiencing a brain bleed later in life. Meanwhile, patients whose donors remained bleed-free had the lowest risk.
 

Not so fast in the United States

In Nordic countries, all hospitals, clinics, and pharmacies report data on diagnoses and health care visits to the government, tracking that began with paper and pen in the 1960s. But the United States health care system is too fragmented to replicate such efforts, with several brands of electronic medical records operating across different systems. Data sharing across institutions is minimal. 

Most comparable health data in the United States comes from reimbursement information collected by the Centers for Medicare & Medicaid Services on government-sponsored insurance programs.

“We would need all the health care systems in the country to operate within the same IT system or use the same data model,” said Euan Ashley, MD, PhD, professor of genomics at Stanford (Calif.) University. “It’s an exciting prospect. But I think [the United States] is one of the last countries where it’ll happen.”

States, meanwhile, collect health data on specific areas like sexually transmitted infection cases and rates. Other states have registries, like the Connecticut Tumor Registry, which was established in 1941 and is the oldest population-based cancer registry in the world.

But all of these efforts are ad hoc, and no equivalent exists for heart disease and other conditions.

Health data companies have recently entered the U.S. data industry mainly through partnerships with health systems and insurance companies, using deidentified information from patient charts.

The large databases have yielded important findings that randomized clinical trials simply cannot, according to Dr. Ashley.

For instance, a study found that a heavily-lauded immunotherapy treatment did not provide meaningful outcomes for patients aged 75 years or older, but it did for younger patients.

This sort of analysis might enable clinicians to administer treatments based on how effective they are for patients with particular demographics, according to Cary Gross, MD, professor at Yale University in New Haven, Conn.

“From a bedside standpoint, these large databases can identify who benefits from what,” Dr. Gross said. “Precision medicine is not just about genetic tailoring.” These large datasets also provide insight into genetic and environmental variables that contribute to disease. 

For instance, the UK Biobank has more than 500,000 participants paired with their medical records and scans of their body and brain. Researchers perform cognitive tests on participants and extract DNA from blood samples over their lifetime, allowing examination of interactions between risk factors. 

A similar but much smaller-scale effort underway in the United States, called the All of Us Research Program, has enrolled more than 650,000 people, less than one-third the size of the UK Biobank by relative populations. The goal of the program is to provide insights into prevention and treatment of chronic disease among a diverse set of at least one million participants. The database includes information on sexual orientation, which is a fairly new datapoint collected by researchers in an effort to study health outcomes and inequities among the LGBTQ+ community.

Dr. Crosslin and his colleagues are writing a grant proposal to use the All of Us database to identify genetic risks for preeclampsia. People with certain genetic profiles may be predisposed to the life-threatening condition, and researchers may discover that lifestyle changes could decrease risk, Dr. Crosslin said. 
 

Changes in the United States

The COVID-19 pandemic exposed the lack of centralized data in the United States because a majority of research on the virus has been conducted abroad in countries with national health care systems and these large databases. 

The U.S. gap spurred a group of researchers to create the National Institutes of Health–funded National COVID Cohort Collaborative (N3C), a project that gathers medical records from millions of patients across health systems and provides access to research teams investigating a wide spectrum of topics, such as optimal timing for ventilator use.

But until government or private health systems develop a way to share and regulate health data ethically and efficiently, significant limits will persist on what large-scale databases can do, Dr. Gross said. 

“At the federal level, we need to ensure this health information is made available for public health researchers so we don’t create these private fiefdoms of data,” Dr. Gross said. “Things have to be transparent. I think our country needs to take a step back and think about what we’re doing with our health data and how we can make sure it’s being managed ethically.”

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

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.

In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.

The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.

“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.

Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.

“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.

As a result, not enough gastroenterologists are giving this topic the attention it needs, some in the industry contend.

One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.

But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
 

Nutrition overlooked in procedure-heavy specialty

In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.

Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.

Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.

GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.

The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.

Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.

Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.

Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.

It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.

Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.

“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.

It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.

GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.

If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
 

Weaving more nutrition into training

To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.

Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.

“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.

GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.

The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.

But it hasn’t been as widely adopted as hoped, he said.

“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
 

Collaboration in practice

Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.

Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.

“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.

In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.

In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.

The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.

It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.

At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.

We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.

At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.

Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.

Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”

“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.

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

Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.

In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.

The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.

“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.

Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.

“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.

As a result, not enough gastroenterologists are giving this topic the attention it needs, some in the industry contend.

One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.

But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
 

Nutrition overlooked in procedure-heavy specialty

In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.

Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.

Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.

GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.

The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.

Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.

Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.

Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.

It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.

Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.

“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.

It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.

GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.

If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
 

Weaving more nutrition into training

To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.

Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.

“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.

GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.

The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.

But it hasn’t been as widely adopted as hoped, he said.

“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
 

Collaboration in practice

Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.

Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.

“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.

In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.

In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.

The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.

It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.

At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.

We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.

At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.

Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.

Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”

“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.

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

Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.

In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.

The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.

“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.

Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.

“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.

As a result, not enough gastroenterologists are giving this topic the attention it needs, some in the industry contend.

One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.

But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
 

Nutrition overlooked in procedure-heavy specialty

In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.

Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.

Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.

GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.

The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.

Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.

Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.

Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.

It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.

Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.

“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.

It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.

GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.

If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
 

Weaving more nutrition into training

To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.

Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.

“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.

GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.

The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.

But it hasn’t been as widely adopted as hoped, he said.

“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
 

Collaboration in practice

Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.

Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.

“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.

In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.

In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.

The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.

It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.

At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.

We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.

At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.

Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.

Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”

“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.

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

WASHINGTON – In psoriatic disease, psoriatic arthritis (PsA) remains one of the greatest unmet needs, with the transition from cutaneous psoriasis poorly understood, diagnosis challenging, and therapeutic accomplishments trailing far behind advances for skin disease. However, leading researchers in rheumatology and dermatology believe that they’re turning the corner toward a day when therapies are phenotype-targeted and diagnosis can be made early and treatment begun well before inflammation worsens and pain and joint damage ensue.

“The challenge right now is that we don’t understand the discrete and overlapping endotypes that underlie the phenotypes or domains” of PsA, said Christopher Ritchlin, MD, MPH, professor of medicine in the division of allergy/immunology and rheumatology and the Center of Musculoskeletal Research at the University of Rochester (N.Y.), who spoke about PsA at the annual research symposium of the National Psoriasis Foundation.

A deep dive into the tissue

Dr. Ritchlin is among those rheumatology clinician-researchers who advocated early on for a “domain” approach to the diagnosis and management of PsA – that is, consideration of the key domains of peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis.

The approach is an especially important part of treatment recommendations from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. But while interventions can be tailored to some extent to these domains, or phenotypes, there are limitations without an understanding of the different pathophysiology and mechanisms driving the heterogeneity in tissue involvement.

Dr. Ritchlin draws inspiration from pulmonology, which subtyped asthma into various phenotypes (for example, eosinophilic, allergic, intrinsic, exercise-induced) and “drilled down” on understanding underlying mechanisms to guide more specific treatment. Similar phenotype-endotype research has been done for chronic obstructive pulmonary disease, he said at the meeting, pointing to a phase 3 randomized controlled trial, published in the New England Journal of Medicine, that found dupilimab (Dupixent) was effective for patients with COPD who had type 2 inflammation as indicated by elevated eosinophil counts.

“It’s a beautiful example of how to define an endotype from a phenotypic biomarker and then use a specific intervention to improve outcomes,” Dr. Ritchlin said. “We need to do this for psoriasis and PsA.”

The ELLIPSS project will utilize the host of -omics tools and technologies (for proteomics, metabolomics, and genomics, for instance) that are making it increasingly possible to dissect the heterogeneity of single diseases and achieve more precision with treatments.

Researchers will collect blood samples and skin and/or synovial tissue biopsies from cohorts of patients with psoriasis and PsA who are treatment naïve as well as patients who are treated with a biologic or DMARD (looking at responders and non-responders). They’ll also study a cohort of psoriasis patients who may be “on a transition pathway” for PsA based on risk factors such as family history, nail psoriasis, scalp psoriasis, and body surface area greater than 5%.

Patients in all cohorts will represent distinct synovio-entheseal domains of PsA and the heterogeneity of psoriasis (for example, plaque, general, pustular, palmoplantar) and will be followed longitudinally.

With regards to PsA, one goal is to “find new pathways in the joint, then find surrogate markers in the blood that we can use to help mark particular subphenotypes [that will be identified through deep phenotyping],” Dr. Ritchlin said in an interview after the meeting. “This will lead us hopefully to a more precision-based approach.”

The ELLIPSS team joins other researchers who have been studying rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) in an earlier iteration of the AIM program, and that will continue this work. Research on RA has thus far elucidated T-cell subsets in the rheumatoid synovium, as well as interactions of mesenchymal cells with the endothelium, for instance, and led to the identification of key molecules such as granzyme A that weren’t previously known to be involved in RA pathogenesis, Dr. Ritchin said in the interview. The current AIM work also includes Sjögren’s disease.
 

Finding biomarkers, diagnostic signatures

The psoriasis-PsA team has the advantage today of being able to utilize a new technology called spatial transcriptomics, which takes transcriptomics (RNA) from the single-cell level to the tissue level, enabling a look at how disease is affecting cellular organization/tissue architecture, gene activity, and cellular signaling within tissues. “It’s a huge advance in technology,” said Dr. Ritchlin. “We can actually see how the cells are interacting in the synovium [and other tissues].”

A paper published in Science Immunology and discussed at the NPF meeting demonstrates the power of special transcriptomics for learning about the skin. Dr. Scher, Dr. Ritchlin, first authors Rochelle L. Castillo, MD, and Ikjot Sidhu, MS, and other co-investigators reported a “dynamic re-organization of the immune milieu and fibroblasts in PsO lesional and non-lesional skin,” the presence of B cells in lesioned skin, and cellular organization/ecosystems that vary occurring according to clinical severity, among other findings.

Dr. Scher is using the tool for his NPF-funded diagnostic test research and as part of his work at NYU Langone for the ELLIPPS project. Among his goals: To “discover new cell populations in the microenvironment and study how they interact with each other, then compare those cells between psoriasis and PsA patients to first understand if they’re any different,” he explained after the meeting. Researchers can then investigate the synovial tissue, comparing cell populations and interactions in both compartments and looking for any shared markers/cytokines/proteins, he said.

Multiomics research, meanwhile, is showing that a test for early PsA detection could potentially combine clinical parameters with integrated multi-omic markers into a “diagnostic signature” of sorts.

At the meeting, Vinod Chandran, MD, PhD, a rheumatologist at the University of Toronto who also has an NPF PsA diagnostic test grant, said that his multi-omics analysis of blood samples from patients with psoriasis and PsA has identified signatures with a “high discriminatory value” and that certain metabolic pathways appear to play “a central role in the development and differentiation of PsA.” (Validation in other cohorts and economic analyses are ongoing, Dr. Chandran said. Low-cost alternatives that can be applied broadly in the clinic will need to be pursued, Dr. Scher said.)

Eyes on combination therapy

“The likelihood that all patients will respond to one biologic is very low in PsA, so we’ve been thinking about combination therapy for some time,” Dr. Ritchlin said at the meeting. “I think [dual inhibition] is coming.”

Safety has been the concern, but a phase 2 trial published this year compared a combination of IL-23 and TNF inhibition (guselkumab [Tremfya] plus golimumab [Simponi]) with monotherapy of both biologics in patients with ulcerative colitis and showed that the combination safely drove synergistic restoration of a normal epithelium and mucosal healing, he said.

A phase 2 trial in PsA, designed by Dr. Ritchlin and Dr. Scher and named AFFINITY, will study the safety and efficacy of the same combination of IL-23 and TNF blockade, compared with guselkumab (IL-23 inhibition) alone. The trial is currently completing enrollment of patients who have failed one or two anti-TNF agents.

In the meantime, combination therapy is being employed in clinics for “PsA patients who’ve been channeled through multiple biologics and are still not responding ... when [physicians] feel they’re forced to, not right away,” Dr. Ritchlin said in an interview after the meeting. “As we get a better understanding [through clinical trials], it might be something you’ll see earlier in the treatment process.”

It is wise, Dr. Ritchlin said, to devote more time to addressing “extra-articular traits” (for example, obesity, diabetes, uveitis, colitis, centralized pain) and treatable lifestyle/behavioral risk factors (for example, smoking, exercise, nutrition, adherence to therapy, social support) that can contribute to PsA and treatment nonresponse. He calls this the “treatable traits” strategy.

In practice, “there’s a big focus on inflammation and immune dysfunction, but the problem is, there are other factors involved in nonresponse, and I think ‘treatable traits’ gets to those,” Dr. Ritchlin said after the meeting. Rheumatologists and dermatologists lack time and alliances to address these issues, but “if we can find ways to do it, I think we’ll have improved outcomes.”

Dr. Ritchlin, Dr. Chandran, and Dr. Liao reported no relevant disclosures. Dr. Scher reported ties to Janssen, Pfizer, Sanofi, UCB, and Bristol-Myers Squibb.

WASHINGTON – In psoriatic disease, psoriatic arthritis (PsA) remains one of the greatest unmet needs, with the transition from cutaneous psoriasis poorly understood, diagnosis challenging, and therapeutic accomplishments trailing far behind advances for skin disease. However, leading researchers in rheumatology and dermatology believe that they’re turning the corner toward a day when therapies are phenotype-targeted and diagnosis can be made early and treatment begun well before inflammation worsens and pain and joint damage ensue.

“The challenge right now is that we don’t understand the discrete and overlapping endotypes that underlie the phenotypes or domains” of PsA, said Christopher Ritchlin, MD, MPH, professor of medicine in the division of allergy/immunology and rheumatology and the Center of Musculoskeletal Research at the University of Rochester (N.Y.), who spoke about PsA at the annual research symposium of the National Psoriasis Foundation.

A deep dive into the tissue

Dr. Ritchlin is among those rheumatology clinician-researchers who advocated early on for a “domain” approach to the diagnosis and management of PsA – that is, consideration of the key domains of peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis.

The approach is an especially important part of treatment recommendations from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. But while interventions can be tailored to some extent to these domains, or phenotypes, there are limitations without an understanding of the different pathophysiology and mechanisms driving the heterogeneity in tissue involvement.

Dr. Ritchlin draws inspiration from pulmonology, which subtyped asthma into various phenotypes (for example, eosinophilic, allergic, intrinsic, exercise-induced) and “drilled down” on understanding underlying mechanisms to guide more specific treatment. Similar phenotype-endotype research has been done for chronic obstructive pulmonary disease, he said at the meeting, pointing to a phase 3 randomized controlled trial, published in the New England Journal of Medicine, that found dupilimab (Dupixent) was effective for patients with COPD who had type 2 inflammation as indicated by elevated eosinophil counts.

“It’s a beautiful example of how to define an endotype from a phenotypic biomarker and then use a specific intervention to improve outcomes,” Dr. Ritchlin said. “We need to do this for psoriasis and PsA.”

The ELLIPSS project will utilize the host of -omics tools and technologies (for proteomics, metabolomics, and genomics, for instance) that are making it increasingly possible to dissect the heterogeneity of single diseases and achieve more precision with treatments.

Researchers will collect blood samples and skin and/or synovial tissue biopsies from cohorts of patients with psoriasis and PsA who are treatment naïve as well as patients who are treated with a biologic or DMARD (looking at responders and non-responders). They’ll also study a cohort of psoriasis patients who may be “on a transition pathway” for PsA based on risk factors such as family history, nail psoriasis, scalp psoriasis, and body surface area greater than 5%.

Patients in all cohorts will represent distinct synovio-entheseal domains of PsA and the heterogeneity of psoriasis (for example, plaque, general, pustular, palmoplantar) and will be followed longitudinally.

With regards to PsA, one goal is to “find new pathways in the joint, then find surrogate markers in the blood that we can use to help mark particular subphenotypes [that will be identified through deep phenotyping],” Dr. Ritchlin said in an interview after the meeting. “This will lead us hopefully to a more precision-based approach.”

The ELLIPSS team joins other researchers who have been studying rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) in an earlier iteration of the AIM program, and that will continue this work. Research on RA has thus far elucidated T-cell subsets in the rheumatoid synovium, as well as interactions of mesenchymal cells with the endothelium, for instance, and led to the identification of key molecules such as granzyme A that weren’t previously known to be involved in RA pathogenesis, Dr. Ritchin said in the interview. The current AIM work also includes Sjögren’s disease.
 

Finding biomarkers, diagnostic signatures

The psoriasis-PsA team has the advantage today of being able to utilize a new technology called spatial transcriptomics, which takes transcriptomics (RNA) from the single-cell level to the tissue level, enabling a look at how disease is affecting cellular organization/tissue architecture, gene activity, and cellular signaling within tissues. “It’s a huge advance in technology,” said Dr. Ritchlin. “We can actually see how the cells are interacting in the synovium [and other tissues].”

A paper published in Science Immunology and discussed at the NPF meeting demonstrates the power of special transcriptomics for learning about the skin. Dr. Scher, Dr. Ritchlin, first authors Rochelle L. Castillo, MD, and Ikjot Sidhu, MS, and other co-investigators reported a “dynamic re-organization of the immune milieu and fibroblasts in PsO lesional and non-lesional skin,” the presence of B cells in lesioned skin, and cellular organization/ecosystems that vary occurring according to clinical severity, among other findings.

Dr. Scher is using the tool for his NPF-funded diagnostic test research and as part of his work at NYU Langone for the ELLIPPS project. Among his goals: To “discover new cell populations in the microenvironment and study how they interact with each other, then compare those cells between psoriasis and PsA patients to first understand if they’re any different,” he explained after the meeting. Researchers can then investigate the synovial tissue, comparing cell populations and interactions in both compartments and looking for any shared markers/cytokines/proteins, he said.

Multiomics research, meanwhile, is showing that a test for early PsA detection could potentially combine clinical parameters with integrated multi-omic markers into a “diagnostic signature” of sorts.

At the meeting, Vinod Chandran, MD, PhD, a rheumatologist at the University of Toronto who also has an NPF PsA diagnostic test grant, said that his multi-omics analysis of blood samples from patients with psoriasis and PsA has identified signatures with a “high discriminatory value” and that certain metabolic pathways appear to play “a central role in the development and differentiation of PsA.” (Validation in other cohorts and economic analyses are ongoing, Dr. Chandran said. Low-cost alternatives that can be applied broadly in the clinic will need to be pursued, Dr. Scher said.)

Eyes on combination therapy

“The likelihood that all patients will respond to one biologic is very low in PsA, so we’ve been thinking about combination therapy for some time,” Dr. Ritchlin said at the meeting. “I think [dual inhibition] is coming.”

Safety has been the concern, but a phase 2 trial published this year compared a combination of IL-23 and TNF inhibition (guselkumab [Tremfya] plus golimumab [Simponi]) with monotherapy of both biologics in patients with ulcerative colitis and showed that the combination safely drove synergistic restoration of a normal epithelium and mucosal healing, he said.

A phase 2 trial in PsA, designed by Dr. Ritchlin and Dr. Scher and named AFFINITY, will study the safety and efficacy of the same combination of IL-23 and TNF blockade, compared with guselkumab (IL-23 inhibition) alone. The trial is currently completing enrollment of patients who have failed one or two anti-TNF agents.

In the meantime, combination therapy is being employed in clinics for “PsA patients who’ve been channeled through multiple biologics and are still not responding ... when [physicians] feel they’re forced to, not right away,” Dr. Ritchlin said in an interview after the meeting. “As we get a better understanding [through clinical trials], it might be something you’ll see earlier in the treatment process.”

It is wise, Dr. Ritchlin said, to devote more time to addressing “extra-articular traits” (for example, obesity, diabetes, uveitis, colitis, centralized pain) and treatable lifestyle/behavioral risk factors (for example, smoking, exercise, nutrition, adherence to therapy, social support) that can contribute to PsA and treatment nonresponse. He calls this the “treatable traits” strategy.

In practice, “there’s a big focus on inflammation and immune dysfunction, but the problem is, there are other factors involved in nonresponse, and I think ‘treatable traits’ gets to those,” Dr. Ritchlin said after the meeting. Rheumatologists and dermatologists lack time and alliances to address these issues, but “if we can find ways to do it, I think we’ll have improved outcomes.”

Dr. Ritchlin, Dr. Chandran, and Dr. Liao reported no relevant disclosures. Dr. Scher reported ties to Janssen, Pfizer, Sanofi, UCB, and Bristol-Myers Squibb.

WASHINGTON – In psoriatic disease, psoriatic arthritis (PsA) remains one of the greatest unmet needs, with the transition from cutaneous psoriasis poorly understood, diagnosis challenging, and therapeutic accomplishments trailing far behind advances for skin disease. However, leading researchers in rheumatology and dermatology believe that they’re turning the corner toward a day when therapies are phenotype-targeted and diagnosis can be made early and treatment begun well before inflammation worsens and pain and joint damage ensue.

“The challenge right now is that we don’t understand the discrete and overlapping endotypes that underlie the phenotypes or domains” of PsA, said Christopher Ritchlin, MD, MPH, professor of medicine in the division of allergy/immunology and rheumatology and the Center of Musculoskeletal Research at the University of Rochester (N.Y.), who spoke about PsA at the annual research symposium of the National Psoriasis Foundation.

A deep dive into the tissue

Dr. Ritchlin is among those rheumatology clinician-researchers who advocated early on for a “domain” approach to the diagnosis and management of PsA – that is, consideration of the key domains of peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis.

The approach is an especially important part of treatment recommendations from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. But while interventions can be tailored to some extent to these domains, or phenotypes, there are limitations without an understanding of the different pathophysiology and mechanisms driving the heterogeneity in tissue involvement.

Dr. Ritchlin draws inspiration from pulmonology, which subtyped asthma into various phenotypes (for example, eosinophilic, allergic, intrinsic, exercise-induced) and “drilled down” on understanding underlying mechanisms to guide more specific treatment. Similar phenotype-endotype research has been done for chronic obstructive pulmonary disease, he said at the meeting, pointing to a phase 3 randomized controlled trial, published in the New England Journal of Medicine, that found dupilimab (Dupixent) was effective for patients with COPD who had type 2 inflammation as indicated by elevated eosinophil counts.

“It’s a beautiful example of how to define an endotype from a phenotypic biomarker and then use a specific intervention to improve outcomes,” Dr. Ritchlin said. “We need to do this for psoriasis and PsA.”

The ELLIPSS project will utilize the host of -omics tools and technologies (for proteomics, metabolomics, and genomics, for instance) that are making it increasingly possible to dissect the heterogeneity of single diseases and achieve more precision with treatments.

Researchers will collect blood samples and skin and/or synovial tissue biopsies from cohorts of patients with psoriasis and PsA who are treatment naïve as well as patients who are treated with a biologic or DMARD (looking at responders and non-responders). They’ll also study a cohort of psoriasis patients who may be “on a transition pathway” for PsA based on risk factors such as family history, nail psoriasis, scalp psoriasis, and body surface area greater than 5%.

Patients in all cohorts will represent distinct synovio-entheseal domains of PsA and the heterogeneity of psoriasis (for example, plaque, general, pustular, palmoplantar) and will be followed longitudinally.

With regards to PsA, one goal is to “find new pathways in the joint, then find surrogate markers in the blood that we can use to help mark particular subphenotypes [that will be identified through deep phenotyping],” Dr. Ritchlin said in an interview after the meeting. “This will lead us hopefully to a more precision-based approach.”

The ELLIPSS team joins other researchers who have been studying rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) in an earlier iteration of the AIM program, and that will continue this work. Research on RA has thus far elucidated T-cell subsets in the rheumatoid synovium, as well as interactions of mesenchymal cells with the endothelium, for instance, and led to the identification of key molecules such as granzyme A that weren’t previously known to be involved in RA pathogenesis, Dr. Ritchin said in the interview. The current AIM work also includes Sjögren’s disease.
 

Finding biomarkers, diagnostic signatures

The psoriasis-PsA team has the advantage today of being able to utilize a new technology called spatial transcriptomics, which takes transcriptomics (RNA) from the single-cell level to the tissue level, enabling a look at how disease is affecting cellular organization/tissue architecture, gene activity, and cellular signaling within tissues. “It’s a huge advance in technology,” said Dr. Ritchlin. “We can actually see how the cells are interacting in the synovium [and other tissues].”

A paper published in Science Immunology and discussed at the NPF meeting demonstrates the power of special transcriptomics for learning about the skin. Dr. Scher, Dr. Ritchlin, first authors Rochelle L. Castillo, MD, and Ikjot Sidhu, MS, and other co-investigators reported a “dynamic re-organization of the immune milieu and fibroblasts in PsO lesional and non-lesional skin,” the presence of B cells in lesioned skin, and cellular organization/ecosystems that vary occurring according to clinical severity, among other findings.

Dr. Scher is using the tool for his NPF-funded diagnostic test research and as part of his work at NYU Langone for the ELLIPPS project. Among his goals: To “discover new cell populations in the microenvironment and study how they interact with each other, then compare those cells between psoriasis and PsA patients to first understand if they’re any different,” he explained after the meeting. Researchers can then investigate the synovial tissue, comparing cell populations and interactions in both compartments and looking for any shared markers/cytokines/proteins, he said.

Multiomics research, meanwhile, is showing that a test for early PsA detection could potentially combine clinical parameters with integrated multi-omic markers into a “diagnostic signature” of sorts.

At the meeting, Vinod Chandran, MD, PhD, a rheumatologist at the University of Toronto who also has an NPF PsA diagnostic test grant, said that his multi-omics analysis of blood samples from patients with psoriasis and PsA has identified signatures with a “high discriminatory value” and that certain metabolic pathways appear to play “a central role in the development and differentiation of PsA.” (Validation in other cohorts and economic analyses are ongoing, Dr. Chandran said. Low-cost alternatives that can be applied broadly in the clinic will need to be pursued, Dr. Scher said.)

Eyes on combination therapy

“The likelihood that all patients will respond to one biologic is very low in PsA, so we’ve been thinking about combination therapy for some time,” Dr. Ritchlin said at the meeting. “I think [dual inhibition] is coming.”

Safety has been the concern, but a phase 2 trial published this year compared a combination of IL-23 and TNF inhibition (guselkumab [Tremfya] plus golimumab [Simponi]) with monotherapy of both biologics in patients with ulcerative colitis and showed that the combination safely drove synergistic restoration of a normal epithelium and mucosal healing, he said.

A phase 2 trial in PsA, designed by Dr. Ritchlin and Dr. Scher and named AFFINITY, will study the safety and efficacy of the same combination of IL-23 and TNF blockade, compared with guselkumab (IL-23 inhibition) alone. The trial is currently completing enrollment of patients who have failed one or two anti-TNF agents.

In the meantime, combination therapy is being employed in clinics for “PsA patients who’ve been channeled through multiple biologics and are still not responding ... when [physicians] feel they’re forced to, not right away,” Dr. Ritchlin said in an interview after the meeting. “As we get a better understanding [through clinical trials], it might be something you’ll see earlier in the treatment process.”

It is wise, Dr. Ritchlin said, to devote more time to addressing “extra-articular traits” (for example, obesity, diabetes, uveitis, colitis, centralized pain) and treatable lifestyle/behavioral risk factors (for example, smoking, exercise, nutrition, adherence to therapy, social support) that can contribute to PsA and treatment nonresponse. He calls this the “treatable traits” strategy.

In practice, “there’s a big focus on inflammation and immune dysfunction, but the problem is, there are other factors involved in nonresponse, and I think ‘treatable traits’ gets to those,” Dr. Ritchlin said after the meeting. Rheumatologists and dermatologists lack time and alliances to address these issues, but “if we can find ways to do it, I think we’ll have improved outcomes.”

Dr. Ritchlin, Dr. Chandran, and Dr. Liao reported no relevant disclosures. Dr. Scher reported ties to Janssen, Pfizer, Sanofi, UCB, and Bristol-Myers Squibb.

Alexandra Kharazi, MD, a California-based cardiothoracic surgeon, previously worked as an employed physician and is now in private practice. Though she appreciates that there are some trade-offs to working with her small group of three surgeons, Dr. Kharazi has no qualms about her choice.

“For me, it’s an issue of autonomy,” she said. “While I have to work a lot of hours, I don’t have to adhere to a strict schedule. I also don’t have to follow specific policies and rules.”

In contrast, Cassandra Boduch, MD, an employed psychiatrist with PsychPlus in Houston, is very satisfied with working as an employee. “I looked into private practice, but no one really prepares you for the complications that come with it,” she said. “There’s a lot more that goes into it than people realize.”

By hanging up her own shingle, Dr. Kharazi may be living a rapidly shrinking dream. According to the American Medical Association, between 2012 and 2022, the share of physicians working in private practice fell from 60% to 47%. The share of physicians working in hospitals as direct employees or contractors increased from about 6% to about 10% during the same time period.

Many factors contribute to these shifting trends, a major factor being economic stress stemming from payment cuts in Medicare. Add in rising practice costs and administrative burdens, and more doctors than ever are seeking employment, according to the AMA.

Though the traditional dream of owning your own practice may be slipping away, are employed physicians less happy than are their self-employed peers? By many measures, the answer is no.

In Medscape’s Employed Physicians Report 2023, doctors weighed in on the pros and cons of their jobs.

When asked what they like most about their jobs, employed physician respondents reported “not having to run a business” as their number-one benefit, followed closely by a stable income. The fact that employers pay for malpractice insurance ranked third, followed by work-life balance.

“We get no business classes in medical school or residency,” said one employed physician. “Having a good salary feels good,” said another. Yet another respondent chimed in: “Running a practice as a small business has become undoable over the past 10-12 years.”

And 50% of employed physicians said that they were “very satisfied/satisfied” with their degree of autonomy.

Still, employed physicians also had plenty to say about the downsides of their jobs.

Many pointed to “feeling like a cog in the machine,” and one doctor pointed to the hassle of dealing with bureaucracy. Others complained about the fact that nonphysicians ran the business and lacked an understanding of what physicians really need from their jobs. When asked whether administrative rules made sense, 63% of physician respondents said that yes, the rules make sense for the business; but, only 52% said that the rules make sense for the doctors themselves.

Other complaints included the requirement to reach high productivity targets and too low an income potential. In the 9 years since Medscape’s 2104 Employed Physicians Report, the share of employed doctors paid on a straight salary has declined from 46% to 31%. Those compensated on a base salary plus productivity targets and other performance metrics rose from 13% in 2014 to 32% now.

“Many doctors go into private practice because of the freedom it brings and the potential financial incentives,” added Dr. Boduch. “I know that many doctors have a dream of working for themselves, and in many cases, that works out great for them.”

Dr. Boduch noted that in her job as chief medical officer at PsychPlus, she still has flexibility plus the perks of working with a bigger practice. In this scenario, Dr. Boduch said, the company can negotiate with insurance companies, allowing her the financial rewards of private practice.
 

What’s right for you?

“I think it might be somewhat generational,” said Cody Futch, senior recruiting executive at AMN Healthcare. “It used to be that fewer hospitals offered employment, so private practice was the way to go. Now, there are fewer privates because hospitals and corporations are buying them up.”

This reality has potentially shaped the way younger generations approach their workplace. Also, Gen Z tends to have less intention to stay with a current employer for the long term than did their parents. “Older physicians were trained to expect they’d run their own business and build it over the years,” said Mr. Futch. “The younger generations look at it as a job, something they may want to switch in a few years. It’s a combination of candidates wanting more options, and also the fact that there are more options to be employed.”

Along those lines, younger generations in general tend to place work-life balance as a higher priority than do older generations, and employed physicians place this equation high on the list as well. In the Employed Physicians Report 2023, 54% said that they are satisfied or better with their work-life balance, up from 51% in the 2022 report.

With that in mind, Dr. Kharazi noted that flexibility is one of the chief reasons why she likes private practice. “If my kid has an event I want to attend, I don’t have to adhere to a strict schedule,” she said.

Satisfaction as an employee vs. employed doctor sometimes changes based on the type of medicine you practice too. With specialties that tend to be primarily outpatient, such as dermatology and allergy, private practice may be the best option regardless. “Hospitals don’t seek out those specialists as much and the specialists can operate successfully without a hospital,” said Mr. Futch.

Hospitals try to incentivize doctors with perks like hefty sign-on bonuses, student loan forgiveness, plenty of vacation time, and more. They also put money into marketing their doctors, a time-consuming and expensive aspect that is tough to shoulder in private practice, especially in the early years. Mr. Futch adds that many doctors view employment as a more stable option. “As the government changes reimbursement policies, the income from private practice fluctuates,” he said. “So many doctors worry that if they buy into a private practice, it is a risky endeavor.”

Hospitals aren’t always a sure bet in that regard, either: They go through tough financial times, lay off staff, or make salary cuts. Historically, however, employment tends to be the safer route, which can make it an attractive option.

Ultimately, the pros and cons of each scenario are individual. It’s up to physicians to do their own math and balance sheet before making a decision.

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

Alexandra Kharazi, MD, a California-based cardiothoracic surgeon, previously worked as an employed physician and is now in private practice. Though she appreciates that there are some trade-offs to working with her small group of three surgeons, Dr. Kharazi has no qualms about her choice.

“For me, it’s an issue of autonomy,” she said. “While I have to work a lot of hours, I don’t have to adhere to a strict schedule. I also don’t have to follow specific policies and rules.”

In contrast, Cassandra Boduch, MD, an employed psychiatrist with PsychPlus in Houston, is very satisfied with working as an employee. “I looked into private practice, but no one really prepares you for the complications that come with it,” she said. “There’s a lot more that goes into it than people realize.”

By hanging up her own shingle, Dr. Kharazi may be living a rapidly shrinking dream. According to the American Medical Association, between 2012 and 2022, the share of physicians working in private practice fell from 60% to 47%. The share of physicians working in hospitals as direct employees or contractors increased from about 6% to about 10% during the same time period.

Many factors contribute to these shifting trends, a major factor being economic stress stemming from payment cuts in Medicare. Add in rising practice costs and administrative burdens, and more doctors than ever are seeking employment, according to the AMA.

Though the traditional dream of owning your own practice may be slipping away, are employed physicians less happy than are their self-employed peers? By many measures, the answer is no.

In Medscape’s Employed Physicians Report 2023, doctors weighed in on the pros and cons of their jobs.

When asked what they like most about their jobs, employed physician respondents reported “not having to run a business” as their number-one benefit, followed closely by a stable income. The fact that employers pay for malpractice insurance ranked third, followed by work-life balance.

“We get no business classes in medical school or residency,” said one employed physician. “Having a good salary feels good,” said another. Yet another respondent chimed in: “Running a practice as a small business has become undoable over the past 10-12 years.”

And 50% of employed physicians said that they were “very satisfied/satisfied” with their degree of autonomy.

Still, employed physicians also had plenty to say about the downsides of their jobs.

Many pointed to “feeling like a cog in the machine,” and one doctor pointed to the hassle of dealing with bureaucracy. Others complained about the fact that nonphysicians ran the business and lacked an understanding of what physicians really need from their jobs. When asked whether administrative rules made sense, 63% of physician respondents said that yes, the rules make sense for the business; but, only 52% said that the rules make sense for the doctors themselves.

Other complaints included the requirement to reach high productivity targets and too low an income potential. In the 9 years since Medscape’s 2104 Employed Physicians Report, the share of employed doctors paid on a straight salary has declined from 46% to 31%. Those compensated on a base salary plus productivity targets and other performance metrics rose from 13% in 2014 to 32% now.

“Many doctors go into private practice because of the freedom it brings and the potential financial incentives,” added Dr. Boduch. “I know that many doctors have a dream of working for themselves, and in many cases, that works out great for them.”

Dr. Boduch noted that in her job as chief medical officer at PsychPlus, she still has flexibility plus the perks of working with a bigger practice. In this scenario, Dr. Boduch said, the company can negotiate with insurance companies, allowing her the financial rewards of private practice.
 

What’s right for you?

“I think it might be somewhat generational,” said Cody Futch, senior recruiting executive at AMN Healthcare. “It used to be that fewer hospitals offered employment, so private practice was the way to go. Now, there are fewer privates because hospitals and corporations are buying them up.”

This reality has potentially shaped the way younger generations approach their workplace. Also, Gen Z tends to have less intention to stay with a current employer for the long term than did their parents. “Older physicians were trained to expect they’d run their own business and build it over the years,” said Mr. Futch. “The younger generations look at it as a job, something they may want to switch in a few years. It’s a combination of candidates wanting more options, and also the fact that there are more options to be employed.”

Along those lines, younger generations in general tend to place work-life balance as a higher priority than do older generations, and employed physicians place this equation high on the list as well. In the Employed Physicians Report 2023, 54% said that they are satisfied or better with their work-life balance, up from 51% in the 2022 report.

With that in mind, Dr. Kharazi noted that flexibility is one of the chief reasons why she likes private practice. “If my kid has an event I want to attend, I don’t have to adhere to a strict schedule,” she said.

Satisfaction as an employee vs. employed doctor sometimes changes based on the type of medicine you practice too. With specialties that tend to be primarily outpatient, such as dermatology and allergy, private practice may be the best option regardless. “Hospitals don’t seek out those specialists as much and the specialists can operate successfully without a hospital,” said Mr. Futch.

Hospitals try to incentivize doctors with perks like hefty sign-on bonuses, student loan forgiveness, plenty of vacation time, and more. They also put money into marketing their doctors, a time-consuming and expensive aspect that is tough to shoulder in private practice, especially in the early years. Mr. Futch adds that many doctors view employment as a more stable option. “As the government changes reimbursement policies, the income from private practice fluctuates,” he said. “So many doctors worry that if they buy into a private practice, it is a risky endeavor.”

Hospitals aren’t always a sure bet in that regard, either: They go through tough financial times, lay off staff, or make salary cuts. Historically, however, employment tends to be the safer route, which can make it an attractive option.

Ultimately, the pros and cons of each scenario are individual. It’s up to physicians to do their own math and balance sheet before making a decision.

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

Alexandra Kharazi, MD, a California-based cardiothoracic surgeon, previously worked as an employed physician and is now in private practice. Though she appreciates that there are some trade-offs to working with her small group of three surgeons, Dr. Kharazi has no qualms about her choice.

“For me, it’s an issue of autonomy,” she said. “While I have to work a lot of hours, I don’t have to adhere to a strict schedule. I also don’t have to follow specific policies and rules.”

In contrast, Cassandra Boduch, MD, an employed psychiatrist with PsychPlus in Houston, is very satisfied with working as an employee. “I looked into private practice, but no one really prepares you for the complications that come with it,” she said. “There’s a lot more that goes into it than people realize.”

By hanging up her own shingle, Dr. Kharazi may be living a rapidly shrinking dream. According to the American Medical Association, between 2012 and 2022, the share of physicians working in private practice fell from 60% to 47%. The share of physicians working in hospitals as direct employees or contractors increased from about 6% to about 10% during the same time period.

Many factors contribute to these shifting trends, a major factor being economic stress stemming from payment cuts in Medicare. Add in rising practice costs and administrative burdens, and more doctors than ever are seeking employment, according to the AMA.

Though the traditional dream of owning your own practice may be slipping away, are employed physicians less happy than are their self-employed peers? By many measures, the answer is no.

In Medscape’s Employed Physicians Report 2023, doctors weighed in on the pros and cons of their jobs.

When asked what they like most about their jobs, employed physician respondents reported “not having to run a business” as their number-one benefit, followed closely by a stable income. The fact that employers pay for malpractice insurance ranked third, followed by work-life balance.

“We get no business classes in medical school or residency,” said one employed physician. “Having a good salary feels good,” said another. Yet another respondent chimed in: “Running a practice as a small business has become undoable over the past 10-12 years.”

And 50% of employed physicians said that they were “very satisfied/satisfied” with their degree of autonomy.

Still, employed physicians also had plenty to say about the downsides of their jobs.

Many pointed to “feeling like a cog in the machine,” and one doctor pointed to the hassle of dealing with bureaucracy. Others complained about the fact that nonphysicians ran the business and lacked an understanding of what physicians really need from their jobs. When asked whether administrative rules made sense, 63% of physician respondents said that yes, the rules make sense for the business; but, only 52% said that the rules make sense for the doctors themselves.

Other complaints included the requirement to reach high productivity targets and too low an income potential. In the 9 years since Medscape’s 2104 Employed Physicians Report, the share of employed doctors paid on a straight salary has declined from 46% to 31%. Those compensated on a base salary plus productivity targets and other performance metrics rose from 13% in 2014 to 32% now.

“Many doctors go into private practice because of the freedom it brings and the potential financial incentives,” added Dr. Boduch. “I know that many doctors have a dream of working for themselves, and in many cases, that works out great for them.”

Dr. Boduch noted that in her job as chief medical officer at PsychPlus, she still has flexibility plus the perks of working with a bigger practice. In this scenario, Dr. Boduch said, the company can negotiate with insurance companies, allowing her the financial rewards of private practice.
 

What’s right for you?

“I think it might be somewhat generational,” said Cody Futch, senior recruiting executive at AMN Healthcare. “It used to be that fewer hospitals offered employment, so private practice was the way to go. Now, there are fewer privates because hospitals and corporations are buying them up.”

This reality has potentially shaped the way younger generations approach their workplace. Also, Gen Z tends to have less intention to stay with a current employer for the long term than did their parents. “Older physicians were trained to expect they’d run their own business and build it over the years,” said Mr. Futch. “The younger generations look at it as a job, something they may want to switch in a few years. It’s a combination of candidates wanting more options, and also the fact that there are more options to be employed.”

Along those lines, younger generations in general tend to place work-life balance as a higher priority than do older generations, and employed physicians place this equation high on the list as well. In the Employed Physicians Report 2023, 54% said that they are satisfied or better with their work-life balance, up from 51% in the 2022 report.

With that in mind, Dr. Kharazi noted that flexibility is one of the chief reasons why she likes private practice. “If my kid has an event I want to attend, I don’t have to adhere to a strict schedule,” she said.

Satisfaction as an employee vs. employed doctor sometimes changes based on the type of medicine you practice too. With specialties that tend to be primarily outpatient, such as dermatology and allergy, private practice may be the best option regardless. “Hospitals don’t seek out those specialists as much and the specialists can operate successfully without a hospital,” said Mr. Futch.

Hospitals try to incentivize doctors with perks like hefty sign-on bonuses, student loan forgiveness, plenty of vacation time, and more. They also put money into marketing their doctors, a time-consuming and expensive aspect that is tough to shoulder in private practice, especially in the early years. Mr. Futch adds that many doctors view employment as a more stable option. “As the government changes reimbursement policies, the income from private practice fluctuates,” he said. “So many doctors worry that if they buy into a private practice, it is a risky endeavor.”

Hospitals aren’t always a sure bet in that regard, either: They go through tough financial times, lay off staff, or make salary cuts. Historically, however, employment tends to be the safer route, which can make it an attractive option.

Ultimately, the pros and cons of each scenario are individual. It’s up to physicians to do their own math and balance sheet before making a decision.

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

As of 2023, most people eligible for Medicare are enrolled in Medicare Advantage plans administered by commercial insurers, rather than traditional Medicare plans sponsored by the federal government. The Kaiser Family Foundation reports that 31 million people are now enrolled in a Medicare Advantage plan, with almost half of them (47%) served by United Healthcare or Humana.

This is 51% of all people eligible for Medicare, compared with 19% in 2007. The Congressional Budget Office projects that 62% of Medicare participants will be in Medicare Advantage plans by 2033.

Given the explosive growth in Medicare Advantage participation, many readers have likely seen patients served by Medicare Advantage or will soon. Below is information about the program’s purpose, strengths, limitations, and effect on physicians.

How does Medicare Advantage differ from traditional Medicare?

A Medicare Advantage plan is approved by the U.S. Centers for Medicare & Medicaid Services and competes for customers by offering lower premiums and/or more benefits. Traditional Medicare plans are unified contracts across the country, with the same fees for the same services paid nationwide.

CMS pays Medicare Advantage plans a per-member rate, which can be increased for people who seem sicker than other plan participants – for example, someone with uncontrolled diabetes and multiple comorbidities. This so-called “risk adjustment” doesn’t exist in traditional Medicare.

CMS also gives incentive payments to Medicare Advantage plans whose members receive better care, measured by such metrics as lower unnecessary hospital admissions. There are some analogues to this in traditional Medicare, such as the Making Care Primary program, but value-based care is a larger component of Medicare Advantage.

“Being paid for outcomes is what we as physicians always thought we went into medicine to do,” said Sarah Candler, MD, an internist in Houston. She most recently worked for One Medical and her experiences with Veterans Affairs and One Medical focused on value-based contracts, including for Medicare Advantage plans.

How do patients benefit from Medicare Advantage?

“Honestly the financial benefits to patients are what’s really driving the rise in Medicare Advantage,” said

Claire Ankuda, MD, MPH, is a geriatrician at the Icahn School of Medicine at Mt. Sinai in New York who has published extensively about Medicare Advantage.

A spokesperson for Highmark Health, which provides Medicare Advantage plans, told us that “Medicare Advantage plans are offered by private health insurers, such as Highmark, and typically offer benefits that support members’ total health, such as low-cost access to doctors and preventive care, and cover things like prescription drugs, vision, and hearing services, dental, and chiropractic care. Medicare Advantage plans also protect members from unforeseen costs like hospitalizations, surgery, or an expensive drug. And unlike traditional Medicare, Medicare Advantage plans can offer set copays for doctor’s visits (rather than coinsurance) to help members budget for their costs.”

Dr. Ankuda said hospitalization costs are sometimes higher for Medicare Advantage but agreed that costs for doctor visits are often lower with Medicare Advantage plans than with traditional Medicare.

So while the overarching goal of Medicare Advantage makes sense, Dr. Candler said, the actual physician experience of working with Medicare Advantage can be challenging.

What challenges might physicians experience when treating patients in a Medicare Advantage plan?

“The plan itself has control over what it will pay for and they’re much more aggressive about it than traditional Medicare,” Dr. Candler said. Medicare Advantage plans are often structured as health maintenance organizations, with narrow provider networks and extensive prior authorization requirements.

Dr. Candler gave an example of a plan that offers transportation to medical appointments – a seemingly great benefit. But what if someone needs to see a cardiologist and the only cardiologist within the plan is 100 miles away? That’s too far for the transportation benefit, it turns out.

Or a Medicare Advantage plan requires a physician to first do a physical exam before ordering an MRI, even though in the physician’s judgment only the MRI will have diagnostic value. Or the plan denies coverage for a service that’s already occurred. These practices aim to weed out unnecessary care but at the cost of patient confusion or physician time in arguing why something should be covered.

“The argument from us as physicians would be, ‘Just trust us to practice good medicine,’” Dr. Candler said.

Beside these concerns at the physician level, the regulations surrounding Medicare Advantage plans may open the door to billing fraud.

How do Medicare Advantage Plans interact with diagnosis codes?

“I just can’t stand when I see fraud in the health care system,” said Nancy Keating, MD, MPH, an internist at Brigham and Women’s Hospital and a health policy professor at Harvard Medical School, both in Boston.

This July, Dr. Keating published a report in the Annals of Internal Medicine about a patient of hers whose health insurer – a Medicare Advantage plan – claimed had diabetes with comorbidities and was morbidly obese. None of this was true. But submitting such diagnoses to CMS would suggest that Dr. Keating’s patient was especially ill, leading to greater reimbursements from CMS for covering her care.

“I’m not averse to paying plans that are taking care of sicker patients more, but we need to figure out who those patients truly are,” Dr. Keating said.

“It is absolutely true and widely proven that Medicare Advantage plans do a lot of clever things” to inflate diagnoses, added Dr. Ankuda. Also, she said that Medicare Advantage plan representatives would say this is legitimate work, as the entire point of Medicare Advantage is to pay more for caring for sicker patients.

“I don’t think anyone here is acting in bad faith. It’s just that [there are] very different incentives,” Dr. Ankuda said.

How can Medicare Advantage be improved?

Dr. Keating believes that CMS should reduce the number of diagnosis codes allowed within Medicare Advantage to thwart the potential for upcoding. Dr. Ankuda thinks the biggest problem is that there is no good way for patients to choose among Medicare Advantage plans.

“I don’t see it as Medicare Advantage is bad or Medicare Advantage is good. MA plans are incredibly diverse,” Dr. Ankuda said. The problem is that it’s very hard for patients to tell which plans are delivering the best care, what their out-of-pocket costs will actually be, or how often a plan denies payment.

Dr. Ankuda argues for much more data transparency around such plan factors.

Dr. Candler and Dr. Ankuda had no relevant conflicts. Dr. Keating is a consultant to the Research Triangle Institute, which advises CMS about Medicare Advantage billing codes.

As of 2023, most people eligible for Medicare are enrolled in Medicare Advantage plans administered by commercial insurers, rather than traditional Medicare plans sponsored by the federal government. The Kaiser Family Foundation reports that 31 million people are now enrolled in a Medicare Advantage plan, with almost half of them (47%) served by United Healthcare or Humana.

This is 51% of all people eligible for Medicare, compared with 19% in 2007. The Congressional Budget Office projects that 62% of Medicare participants will be in Medicare Advantage plans by 2033.

Given the explosive growth in Medicare Advantage participation, many readers have likely seen patients served by Medicare Advantage or will soon. Below is information about the program’s purpose, strengths, limitations, and effect on physicians.

How does Medicare Advantage differ from traditional Medicare?

A Medicare Advantage plan is approved by the U.S. Centers for Medicare & Medicaid Services and competes for customers by offering lower premiums and/or more benefits. Traditional Medicare plans are unified contracts across the country, with the same fees for the same services paid nationwide.

CMS pays Medicare Advantage plans a per-member rate, which can be increased for people who seem sicker than other plan participants – for example, someone with uncontrolled diabetes and multiple comorbidities. This so-called “risk adjustment” doesn’t exist in traditional Medicare.

CMS also gives incentive payments to Medicare Advantage plans whose members receive better care, measured by such metrics as lower unnecessary hospital admissions. There are some analogues to this in traditional Medicare, such as the Making Care Primary program, but value-based care is a larger component of Medicare Advantage.

“Being paid for outcomes is what we as physicians always thought we went into medicine to do,” said Sarah Candler, MD, an internist in Houston. She most recently worked for One Medical and her experiences with Veterans Affairs and One Medical focused on value-based contracts, including for Medicare Advantage plans.

How do patients benefit from Medicare Advantage?

“Honestly the financial benefits to patients are what’s really driving the rise in Medicare Advantage,” said

Claire Ankuda, MD, MPH, is a geriatrician at the Icahn School of Medicine at Mt. Sinai in New York who has published extensively about Medicare Advantage.

A spokesperson for Highmark Health, which provides Medicare Advantage plans, told us that “Medicare Advantage plans are offered by private health insurers, such as Highmark, and typically offer benefits that support members’ total health, such as low-cost access to doctors and preventive care, and cover things like prescription drugs, vision, and hearing services, dental, and chiropractic care. Medicare Advantage plans also protect members from unforeseen costs like hospitalizations, surgery, or an expensive drug. And unlike traditional Medicare, Medicare Advantage plans can offer set copays for doctor’s visits (rather than coinsurance) to help members budget for their costs.”

Dr. Ankuda said hospitalization costs are sometimes higher for Medicare Advantage but agreed that costs for doctor visits are often lower with Medicare Advantage plans than with traditional Medicare.

So while the overarching goal of Medicare Advantage makes sense, Dr. Candler said, the actual physician experience of working with Medicare Advantage can be challenging.

What challenges might physicians experience when treating patients in a Medicare Advantage plan?

“The plan itself has control over what it will pay for and they’re much more aggressive about it than traditional Medicare,” Dr. Candler said. Medicare Advantage plans are often structured as health maintenance organizations, with narrow provider networks and extensive prior authorization requirements.

Dr. Candler gave an example of a plan that offers transportation to medical appointments – a seemingly great benefit. But what if someone needs to see a cardiologist and the only cardiologist within the plan is 100 miles away? That’s too far for the transportation benefit, it turns out.

Or a Medicare Advantage plan requires a physician to first do a physical exam before ordering an MRI, even though in the physician’s judgment only the MRI will have diagnostic value. Or the plan denies coverage for a service that’s already occurred. These practices aim to weed out unnecessary care but at the cost of patient confusion or physician time in arguing why something should be covered.

“The argument from us as physicians would be, ‘Just trust us to practice good medicine,’” Dr. Candler said.

Beside these concerns at the physician level, the regulations surrounding Medicare Advantage plans may open the door to billing fraud.

How do Medicare Advantage Plans interact with diagnosis codes?

“I just can’t stand when I see fraud in the health care system,” said Nancy Keating, MD, MPH, an internist at Brigham and Women’s Hospital and a health policy professor at Harvard Medical School, both in Boston.

This July, Dr. Keating published a report in the Annals of Internal Medicine about a patient of hers whose health insurer – a Medicare Advantage plan – claimed had diabetes with comorbidities and was morbidly obese. None of this was true. But submitting such diagnoses to CMS would suggest that Dr. Keating’s patient was especially ill, leading to greater reimbursements from CMS for covering her care.

“I’m not averse to paying plans that are taking care of sicker patients more, but we need to figure out who those patients truly are,” Dr. Keating said.

“It is absolutely true and widely proven that Medicare Advantage plans do a lot of clever things” to inflate diagnoses, added Dr. Ankuda. Also, she said that Medicare Advantage plan representatives would say this is legitimate work, as the entire point of Medicare Advantage is to pay more for caring for sicker patients.

“I don’t think anyone here is acting in bad faith. It’s just that [there are] very different incentives,” Dr. Ankuda said.

How can Medicare Advantage be improved?

Dr. Keating believes that CMS should reduce the number of diagnosis codes allowed within Medicare Advantage to thwart the potential for upcoding. Dr. Ankuda thinks the biggest problem is that there is no good way for patients to choose among Medicare Advantage plans.

“I don’t see it as Medicare Advantage is bad or Medicare Advantage is good. MA plans are incredibly diverse,” Dr. Ankuda said. The problem is that it’s very hard for patients to tell which plans are delivering the best care, what their out-of-pocket costs will actually be, or how often a plan denies payment.

Dr. Ankuda argues for much more data transparency around such plan factors.

Dr. Candler and Dr. Ankuda had no relevant conflicts. Dr. Keating is a consultant to the Research Triangle Institute, which advises CMS about Medicare Advantage billing codes.

As of 2023, most people eligible for Medicare are enrolled in Medicare Advantage plans administered by commercial insurers, rather than traditional Medicare plans sponsored by the federal government. The Kaiser Family Foundation reports that 31 million people are now enrolled in a Medicare Advantage plan, with almost half of them (47%) served by United Healthcare or Humana.

This is 51% of all people eligible for Medicare, compared with 19% in 2007. The Congressional Budget Office projects that 62% of Medicare participants will be in Medicare Advantage plans by 2033.

Given the explosive growth in Medicare Advantage participation, many readers have likely seen patients served by Medicare Advantage or will soon. Below is information about the program’s purpose, strengths, limitations, and effect on physicians.

How does Medicare Advantage differ from traditional Medicare?

A Medicare Advantage plan is approved by the U.S. Centers for Medicare & Medicaid Services and competes for customers by offering lower premiums and/or more benefits. Traditional Medicare plans are unified contracts across the country, with the same fees for the same services paid nationwide.

CMS pays Medicare Advantage plans a per-member rate, which can be increased for people who seem sicker than other plan participants – for example, someone with uncontrolled diabetes and multiple comorbidities. This so-called “risk adjustment” doesn’t exist in traditional Medicare.

CMS also gives incentive payments to Medicare Advantage plans whose members receive better care, measured by such metrics as lower unnecessary hospital admissions. There are some analogues to this in traditional Medicare, such as the Making Care Primary program, but value-based care is a larger component of Medicare Advantage.

“Being paid for outcomes is what we as physicians always thought we went into medicine to do,” said Sarah Candler, MD, an internist in Houston. She most recently worked for One Medical and her experiences with Veterans Affairs and One Medical focused on value-based contracts, including for Medicare Advantage plans.

How do patients benefit from Medicare Advantage?

“Honestly the financial benefits to patients are what’s really driving the rise in Medicare Advantage,” said

Claire Ankuda, MD, MPH, is a geriatrician at the Icahn School of Medicine at Mt. Sinai in New York who has published extensively about Medicare Advantage.

A spokesperson for Highmark Health, which provides Medicare Advantage plans, told us that “Medicare Advantage plans are offered by private health insurers, such as Highmark, and typically offer benefits that support members’ total health, such as low-cost access to doctors and preventive care, and cover things like prescription drugs, vision, and hearing services, dental, and chiropractic care. Medicare Advantage plans also protect members from unforeseen costs like hospitalizations, surgery, or an expensive drug. And unlike traditional Medicare, Medicare Advantage plans can offer set copays for doctor’s visits (rather than coinsurance) to help members budget for their costs.”

Dr. Ankuda said hospitalization costs are sometimes higher for Medicare Advantage but agreed that costs for doctor visits are often lower with Medicare Advantage plans than with traditional Medicare.

So while the overarching goal of Medicare Advantage makes sense, Dr. Candler said, the actual physician experience of working with Medicare Advantage can be challenging.

What challenges might physicians experience when treating patients in a Medicare Advantage plan?

“The plan itself has control over what it will pay for and they’re much more aggressive about it than traditional Medicare,” Dr. Candler said. Medicare Advantage plans are often structured as health maintenance organizations, with narrow provider networks and extensive prior authorization requirements.

Dr. Candler gave an example of a plan that offers transportation to medical appointments – a seemingly great benefit. But what if someone needs to see a cardiologist and the only cardiologist within the plan is 100 miles away? That’s too far for the transportation benefit, it turns out.

Or a Medicare Advantage plan requires a physician to first do a physical exam before ordering an MRI, even though in the physician’s judgment only the MRI will have diagnostic value. Or the plan denies coverage for a service that’s already occurred. These practices aim to weed out unnecessary care but at the cost of patient confusion or physician time in arguing why something should be covered.

“The argument from us as physicians would be, ‘Just trust us to practice good medicine,’” Dr. Candler said.

Beside these concerns at the physician level, the regulations surrounding Medicare Advantage plans may open the door to billing fraud.

How do Medicare Advantage Plans interact with diagnosis codes?

“I just can’t stand when I see fraud in the health care system,” said Nancy Keating, MD, MPH, an internist at Brigham and Women’s Hospital and a health policy professor at Harvard Medical School, both in Boston.

This July, Dr. Keating published a report in the Annals of Internal Medicine about a patient of hers whose health insurer – a Medicare Advantage plan – claimed had diabetes with comorbidities and was morbidly obese. None of this was true. But submitting such diagnoses to CMS would suggest that Dr. Keating’s patient was especially ill, leading to greater reimbursements from CMS for covering her care.

“I’m not averse to paying plans that are taking care of sicker patients more, but we need to figure out who those patients truly are,” Dr. Keating said.

“It is absolutely true and widely proven that Medicare Advantage plans do a lot of clever things” to inflate diagnoses, added Dr. Ankuda. Also, she said that Medicare Advantage plan representatives would say this is legitimate work, as the entire point of Medicare Advantage is to pay more for caring for sicker patients.

“I don’t think anyone here is acting in bad faith. It’s just that [there are] very different incentives,” Dr. Ankuda said.

How can Medicare Advantage be improved?

Dr. Keating believes that CMS should reduce the number of diagnosis codes allowed within Medicare Advantage to thwart the potential for upcoding. Dr. Ankuda thinks the biggest problem is that there is no good way for patients to choose among Medicare Advantage plans.

“I don’t see it as Medicare Advantage is bad or Medicare Advantage is good. MA plans are incredibly diverse,” Dr. Ankuda said. The problem is that it’s very hard for patients to tell which plans are delivering the best care, what their out-of-pocket costs will actually be, or how often a plan denies payment.

Dr. Ankuda argues for much more data transparency around such plan factors.

Dr. Candler and Dr. Ankuda had no relevant conflicts. Dr. Keating is a consultant to the Research Triangle Institute, which advises CMS about Medicare Advantage billing codes.

The emerging advantages of PET myocardial perfusion imaging (MPI) for coronary artery disease (CAD) diagnosis and assessment of cardiovascular event risk has prompted growing use of this technology as an alternative to the more commonly used single photon–emission CT (SPECT) MPI.

The advantages of PET MPI include better diagnostic performance and shorter acquisition times. The latest position statement from the American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging highlights these advantages and pinpoints additional important properties of PET, including consistent, high-quality images and low radiation exposure. It also allows quantification of myocardial blood flow, and it has “strong prognostic power.”
 

Tracer availability

Despite these advantages, that position paper and subsequent studies note that PET MPI has been underutilized in the United States, largely owing to issues with the available tracers, which have characteristics that limit widespread use in the clinic.

Rubidium, arguably the most commonly used tracer for PET MPI, is not available in unit dosing and so can be expensive for low-volume centers, plus it also requires an on-site generator, Michael Salerno, MD, PhD, a member of the American College of Cardiology’s Imaging Council and section chief of cardiovascular imaging, Stanford (Calif.) University, told this news organization.

N-ammonia, the other U.S. Food and Drug Administration–approved tracer, is available in unit dosing, but its short half-life means that centers need an onsite cyclotron, Dr. Salerno said.

For cardiac perfusion imaging and myocardial blood flow (MBF) quantification, 15O-water is considered the gold standard, although it’s not approved by the FDA. This tracer also requires an on-site cyclotron and “is challenging to use,” Dr. Salerno said. Use has been largely restricted to research purposes, though efforts are underway to widen its availability.

Enter flurpiridaz F-18 (GE Healthcare), a novel PET MPI tracer labeled with fluorine-18. Its longer half-life – similar to that of fluorodeoxyglucose, a tracer used to detect various cancers – could broaden the number of sites that could perform perfusion PET studies, Dr. Salerno said.

“Flurpiridaz also is supposed to have a more linear relationship between flow and tracer uptake, which could improve the ability to perform quantification of perfusion,” he noted. “It also offers the ability to do exercise PET, which is impossible for rubidium and challenging for ammonia, given its 11-minute half-life.”
 

Flurpiridaz status

The FDA requires two phase-3 studies that show safety and sufficient diagnostic performance before it will approve a new tracer. The first required study, published in the Journal of the American College of Cardiology, showed that the tracer’s sensitivity for detection of greater than or equal to 50% stenosis by ICA was significantly higher than SPECT; however, the specificity did not meet the prespecified noninferiority criterion.

The second FDA-required study, published online recently, also in the Journal of the American College of Cardiology, was designed differently from the first in that only patients with suspected – not known – CAD were enrolled. The primary efficacy endpoint was sensitivity and specificity of flurpiridaz PET for overall detection of CAD, rather than comparing it to SPECT MPI (which became a secondary endpoint). PET and SPECT studies were both performed before invasive coronary angiography to minimize referral bias; SPECT studies included cadmium zinc telluride cameras.

In that study, which included 578 patients (mean age, 64; 32.5% women) from 48 centers in the United States, Canada, and Europe, flurpiridaz met the efficacy endpoints: Its sensitivity and specificity were significantly higher than the prespecified threshold value by two of the three readers; its sensitivity was higher than SPECT (80.3% vs. 68.7%); and its specificity was noninferior (63.8% vs. 61.7%).

PET areas under the receiver-operating characteristic curves were higher than SPECT in the overall population and in women and obese patients, at half the radiation dose of SPECT.

“Cardiac PET MPI is positioned to serve as the leading modality for the functional evaluation of suspected and known CAD,” Jamieson M. Bourque, MD, MHS, medical director of nuclear cardiology, echocardiography, and the Stress Laboratory, University of Virginia, Charlottesville, wrote in an editorial accompanying the second study . “18F-flurpiridaz will facilitate this upward progression with beneficial tracer characteristics that will increase access and availability, enable exercise stress, and optimize MBF quantification.”

At this point, FDA approval of flurpiridaz is expected sometime in 2024, said James E. Udelson, MD, principal investigator of the recent study, chief of the division of cardiology, and director of the Nuclear Cardiology Laboratory at Tufts University School of Medicine, Boston.
 

Learning curve

Flurpiridaz comes with “a really interesting and important” learning curve, Dr. Udelson said. “The images are really crisp, and they look very different from what most people are used to. The GE folks are going to have to make sure that the American Society of Nuclear Cardiology and other professional societies are tuned in to help in the education part, because it’s not an easy, automatic switch. Very good image readers can adapt, but it’s not just one day you do one, then switch to the other.”

A “somewhat apt” analogy would be the difference between an echocardiogram and an MRI, he explained. “The MRI is much crisper. You’re seeing edges more crisply. You’re seeing the difference between a thicker and a thinner segment of the wall more crisply, and that’s actually real. You can’t say the thinner segment is abnormal; it’s just that you’re seeing it better. So, with this tracer, normal differences in the thickness of a wall can almost look like a defect if you’re not used to knowing that’s the new normal.”

The expected approval of flurpiridaz “will be a win for cardiac PET, broadening the range of sites that could perform PET,” Dr. Salerno commented. “However, it is worth cautioning that all of the prior data with PET using different agents does not necessarily equate to the same performance with the new agent, given that the performance seems to be lower than that shown in prior PET studies using other agents.”

Dr. Salerno would like to see additional studies comparing flurpiridaz with rubidium or ammonia, as well as studies performing quantification with flurpiridaz, “which theoretically should have some advantages,” he said.

Dr. Udelson noted that MedTrace, a company in Denmark, is working on a radiolabeled water tracer based on 15-O-water that is just starting a pivotal trial. Dr. Udelson is a consultant to the company and is a steering committee member for the pivotal trial.

For now, “the big take-home is that there are a lot of ways these days to test people for CAD,” he said. “As the types of things we can do to test people expand, individuals and centers need to make sure they focus on providing any new service, however they do it, with really superb quality and experience.”

“You don’t just do something new because it’s new,” he added. “It has to be done really well. If you do the new thing badly, you’re not going to get better information.”

Dr. Udelson is a consultant and advisory board member for GE Healthcare, a consultant to MedTrace, and a steering committee member for MedTrace’s pivotal trial. Dr. Bourque has served on a GE Healthcare advisory board for amyloid imaging. Dr. Salerno reports no relevant financial relationships.

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

The emerging advantages of PET myocardial perfusion imaging (MPI) for coronary artery disease (CAD) diagnosis and assessment of cardiovascular event risk has prompted growing use of this technology as an alternative to the more commonly used single photon–emission CT (SPECT) MPI.

The advantages of PET MPI include better diagnostic performance and shorter acquisition times. The latest position statement from the American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging highlights these advantages and pinpoints additional important properties of PET, including consistent, high-quality images and low radiation exposure. It also allows quantification of myocardial blood flow, and it has “strong prognostic power.”
 

Tracer availability

Despite these advantages, that position paper and subsequent studies note that PET MPI has been underutilized in the United States, largely owing to issues with the available tracers, which have characteristics that limit widespread use in the clinic.

Rubidium, arguably the most commonly used tracer for PET MPI, is not available in unit dosing and so can be expensive for low-volume centers, plus it also requires an on-site generator, Michael Salerno, MD, PhD, a member of the American College of Cardiology’s Imaging Council and section chief of cardiovascular imaging, Stanford (Calif.) University, told this news organization.

N-ammonia, the other U.S. Food and Drug Administration–approved tracer, is available in unit dosing, but its short half-life means that centers need an onsite cyclotron, Dr. Salerno said.

For cardiac perfusion imaging and myocardial blood flow (MBF) quantification, 15O-water is considered the gold standard, although it’s not approved by the FDA. This tracer also requires an on-site cyclotron and “is challenging to use,” Dr. Salerno said. Use has been largely restricted to research purposes, though efforts are underway to widen its availability.

Enter flurpiridaz F-18 (GE Healthcare), a novel PET MPI tracer labeled with fluorine-18. Its longer half-life – similar to that of fluorodeoxyglucose, a tracer used to detect various cancers – could broaden the number of sites that could perform perfusion PET studies, Dr. Salerno said.

“Flurpiridaz also is supposed to have a more linear relationship between flow and tracer uptake, which could improve the ability to perform quantification of perfusion,” he noted. “It also offers the ability to do exercise PET, which is impossible for rubidium and challenging for ammonia, given its 11-minute half-life.”
 

Flurpiridaz status

The FDA requires two phase-3 studies that show safety and sufficient diagnostic performance before it will approve a new tracer. The first required study, published in the Journal of the American College of Cardiology, showed that the tracer’s sensitivity for detection of greater than or equal to 50% stenosis by ICA was significantly higher than SPECT; however, the specificity did not meet the prespecified noninferiority criterion.

The second FDA-required study, published online recently, also in the Journal of the American College of Cardiology, was designed differently from the first in that only patients with suspected – not known – CAD were enrolled. The primary efficacy endpoint was sensitivity and specificity of flurpiridaz PET for overall detection of CAD, rather than comparing it to SPECT MPI (which became a secondary endpoint). PET and SPECT studies were both performed before invasive coronary angiography to minimize referral bias; SPECT studies included cadmium zinc telluride cameras.

In that study, which included 578 patients (mean age, 64; 32.5% women) from 48 centers in the United States, Canada, and Europe, flurpiridaz met the efficacy endpoints: Its sensitivity and specificity were significantly higher than the prespecified threshold value by two of the three readers; its sensitivity was higher than SPECT (80.3% vs. 68.7%); and its specificity was noninferior (63.8% vs. 61.7%).

PET areas under the receiver-operating characteristic curves were higher than SPECT in the overall population and in women and obese patients, at half the radiation dose of SPECT.

“Cardiac PET MPI is positioned to serve as the leading modality for the functional evaluation of suspected and known CAD,” Jamieson M. Bourque, MD, MHS, medical director of nuclear cardiology, echocardiography, and the Stress Laboratory, University of Virginia, Charlottesville, wrote in an editorial accompanying the second study . “18F-flurpiridaz will facilitate this upward progression with beneficial tracer characteristics that will increase access and availability, enable exercise stress, and optimize MBF quantification.”

At this point, FDA approval of flurpiridaz is expected sometime in 2024, said James E. Udelson, MD, principal investigator of the recent study, chief of the division of cardiology, and director of the Nuclear Cardiology Laboratory at Tufts University School of Medicine, Boston.
 

Learning curve

Flurpiridaz comes with “a really interesting and important” learning curve, Dr. Udelson said. “The images are really crisp, and they look very different from what most people are used to. The GE folks are going to have to make sure that the American Society of Nuclear Cardiology and other professional societies are tuned in to help in the education part, because it’s not an easy, automatic switch. Very good image readers can adapt, but it’s not just one day you do one, then switch to the other.”

A “somewhat apt” analogy would be the difference between an echocardiogram and an MRI, he explained. “The MRI is much crisper. You’re seeing edges more crisply. You’re seeing the difference between a thicker and a thinner segment of the wall more crisply, and that’s actually real. You can’t say the thinner segment is abnormal; it’s just that you’re seeing it better. So, with this tracer, normal differences in the thickness of a wall can almost look like a defect if you’re not used to knowing that’s the new normal.”

The expected approval of flurpiridaz “will be a win for cardiac PET, broadening the range of sites that could perform PET,” Dr. Salerno commented. “However, it is worth cautioning that all of the prior data with PET using different agents does not necessarily equate to the same performance with the new agent, given that the performance seems to be lower than that shown in prior PET studies using other agents.”

Dr. Salerno would like to see additional studies comparing flurpiridaz with rubidium or ammonia, as well as studies performing quantification with flurpiridaz, “which theoretically should have some advantages,” he said.

Dr. Udelson noted that MedTrace, a company in Denmark, is working on a radiolabeled water tracer based on 15-O-water that is just starting a pivotal trial. Dr. Udelson is a consultant to the company and is a steering committee member for the pivotal trial.

For now, “the big take-home is that there are a lot of ways these days to test people for CAD,” he said. “As the types of things we can do to test people expand, individuals and centers need to make sure they focus on providing any new service, however they do it, with really superb quality and experience.”

“You don’t just do something new because it’s new,” he added. “It has to be done really well. If you do the new thing badly, you’re not going to get better information.”

Dr. Udelson is a consultant and advisory board member for GE Healthcare, a consultant to MedTrace, and a steering committee member for MedTrace’s pivotal trial. Dr. Bourque has served on a GE Healthcare advisory board for amyloid imaging. Dr. Salerno reports no relevant financial relationships.

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

The emerging advantages of PET myocardial perfusion imaging (MPI) for coronary artery disease (CAD) diagnosis and assessment of cardiovascular event risk has prompted growing use of this technology as an alternative to the more commonly used single photon–emission CT (SPECT) MPI.

The advantages of PET MPI include better diagnostic performance and shorter acquisition times. The latest position statement from the American Society of Nuclear Cardiology and Society of Nuclear Medicine and Molecular Imaging highlights these advantages and pinpoints additional important properties of PET, including consistent, high-quality images and low radiation exposure. It also allows quantification of myocardial blood flow, and it has “strong prognostic power.”
 

Tracer availability

Despite these advantages, that position paper and subsequent studies note that PET MPI has been underutilized in the United States, largely owing to issues with the available tracers, which have characteristics that limit widespread use in the clinic.

Rubidium, arguably the most commonly used tracer for PET MPI, is not available in unit dosing and so can be expensive for low-volume centers, plus it also requires an on-site generator, Michael Salerno, MD, PhD, a member of the American College of Cardiology’s Imaging Council and section chief of cardiovascular imaging, Stanford (Calif.) University, told this news organization.

N-ammonia, the other U.S. Food and Drug Administration–approved tracer, is available in unit dosing, but its short half-life means that centers need an onsite cyclotron, Dr. Salerno said.

For cardiac perfusion imaging and myocardial blood flow (MBF) quantification, 15O-water is considered the gold standard, although it’s not approved by the FDA. This tracer also requires an on-site cyclotron and “is challenging to use,” Dr. Salerno said. Use has been largely restricted to research purposes, though efforts are underway to widen its availability.

Enter flurpiridaz F-18 (GE Healthcare), a novel PET MPI tracer labeled with fluorine-18. Its longer half-life – similar to that of fluorodeoxyglucose, a tracer used to detect various cancers – could broaden the number of sites that could perform perfusion PET studies, Dr. Salerno said.

“Flurpiridaz also is supposed to have a more linear relationship between flow and tracer uptake, which could improve the ability to perform quantification of perfusion,” he noted. “It also offers the ability to do exercise PET, which is impossible for rubidium and challenging for ammonia, given its 11-minute half-life.”
 

Flurpiridaz status

The FDA requires two phase-3 studies that show safety and sufficient diagnostic performance before it will approve a new tracer. The first required study, published in the Journal of the American College of Cardiology, showed that the tracer’s sensitivity for detection of greater than or equal to 50% stenosis by ICA was significantly higher than SPECT; however, the specificity did not meet the prespecified noninferiority criterion.

The second FDA-required study, published online recently, also in the Journal of the American College of Cardiology, was designed differently from the first in that only patients with suspected – not known – CAD were enrolled. The primary efficacy endpoint was sensitivity and specificity of flurpiridaz PET for overall detection of CAD, rather than comparing it to SPECT MPI (which became a secondary endpoint). PET and SPECT studies were both performed before invasive coronary angiography to minimize referral bias; SPECT studies included cadmium zinc telluride cameras.

In that study, which included 578 patients (mean age, 64; 32.5% women) from 48 centers in the United States, Canada, and Europe, flurpiridaz met the efficacy endpoints: Its sensitivity and specificity were significantly higher than the prespecified threshold value by two of the three readers; its sensitivity was higher than SPECT (80.3% vs. 68.7%); and its specificity was noninferior (63.8% vs. 61.7%).

PET areas under the receiver-operating characteristic curves were higher than SPECT in the overall population and in women and obese patients, at half the radiation dose of SPECT.

“Cardiac PET MPI is positioned to serve as the leading modality for the functional evaluation of suspected and known CAD,” Jamieson M. Bourque, MD, MHS, medical director of nuclear cardiology, echocardiography, and the Stress Laboratory, University of Virginia, Charlottesville, wrote in an editorial accompanying the second study . “18F-flurpiridaz will facilitate this upward progression with beneficial tracer characteristics that will increase access and availability, enable exercise stress, and optimize MBF quantification.”

At this point, FDA approval of flurpiridaz is expected sometime in 2024, said James E. Udelson, MD, principal investigator of the recent study, chief of the division of cardiology, and director of the Nuclear Cardiology Laboratory at Tufts University School of Medicine, Boston.
 

Learning curve

Flurpiridaz comes with “a really interesting and important” learning curve, Dr. Udelson said. “The images are really crisp, and they look very different from what most people are used to. The GE folks are going to have to make sure that the American Society of Nuclear Cardiology and other professional societies are tuned in to help in the education part, because it’s not an easy, automatic switch. Very good image readers can adapt, but it’s not just one day you do one, then switch to the other.”

A “somewhat apt” analogy would be the difference between an echocardiogram and an MRI, he explained. “The MRI is much crisper. You’re seeing edges more crisply. You’re seeing the difference between a thicker and a thinner segment of the wall more crisply, and that’s actually real. You can’t say the thinner segment is abnormal; it’s just that you’re seeing it better. So, with this tracer, normal differences in the thickness of a wall can almost look like a defect if you’re not used to knowing that’s the new normal.”

The expected approval of flurpiridaz “will be a win for cardiac PET, broadening the range of sites that could perform PET,” Dr. Salerno commented. “However, it is worth cautioning that all of the prior data with PET using different agents does not necessarily equate to the same performance with the new agent, given that the performance seems to be lower than that shown in prior PET studies using other agents.”

Dr. Salerno would like to see additional studies comparing flurpiridaz with rubidium or ammonia, as well as studies performing quantification with flurpiridaz, “which theoretically should have some advantages,” he said.

Dr. Udelson noted that MedTrace, a company in Denmark, is working on a radiolabeled water tracer based on 15-O-water that is just starting a pivotal trial. Dr. Udelson is a consultant to the company and is a steering committee member for the pivotal trial.

For now, “the big take-home is that there are a lot of ways these days to test people for CAD,” he said. “As the types of things we can do to test people expand, individuals and centers need to make sure they focus on providing any new service, however they do it, with really superb quality and experience.”

“You don’t just do something new because it’s new,” he added. “It has to be done really well. If you do the new thing badly, you’re not going to get better information.”

Dr. Udelson is a consultant and advisory board member for GE Healthcare, a consultant to MedTrace, and a steering committee member for MedTrace’s pivotal trial. Dr. Bourque has served on a GE Healthcare advisory board for amyloid imaging. Dr. Salerno reports no relevant financial relationships.

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

Researchers have identified two genes that may contribute to Raynaud’s phenomenon, a condition where blood vessels in the extremities constrict and limit blood flow.

Raynaud’s is a relatively common condition, affecting 2%-5% of the general population. Though Raynaud’s can be an annoyance for some, it can also cause severe pain and can require medication.

Barb Elkin/iStock/Getty Images Plus

These newly identified genes will hopefully lead to new therapeutic options, said Maik Pietzner, PhD, chair in health data modeling at Queen Mary University of London’s Precision Healthcare University Research Institute (PHURI) and group leader in the Computational Medicine Group at the Berlin Institute of Health at Charité – Universitätsmedizin Berlin, Germany.

Berlin Institute of Health at Charité - Universitätsmedizin Berlin

Dr. Pietzner led the research along with Claudia Langenberg, MD, PhD, director of PHURI.

The study was published in Nature Communications.


 

Largest genomic study of Raynaud’s to date

The researchers looked through electronic medical records from the UK Biobank, a large-scale database that contains genetic and health information on half a million participants. They identified more than 5,100 individuals with Raynaud’s, of which 68% had primary Raynaud’s. These participants were compared with more than 439,000 controls who did not have Raynaud’s.

In a secondary analysis, the team also used health records from the Queen Mary University of London Genes & Health Study, which contains health information on individuals of South Asian ancestry.

The researchers identified two genes that are likely involved with Raynaud’s. The first, ADRA2A, encodes for the alpha-2A adrenergic receptor that can cause vasoconstriction of small blood vessels in response to stress hormones. Researchers have long suspected that this type of receptor could be involved with Raynaud’s, but there was debate over which receptor subtype was responsible.

“Our finding of alpha-2A receptors is quite interesting because the focus has always been on alpha-2C receptors,” said Dr. Pietzner. “It’s only a letter, but it’s a massive difference in terms of biology and physiology,” he said, and could be why therapies targeting 2C receptors have been ineffective.

The second strongest association was for the transcription factor IRX1. Less is known about this gene, but the data we do have suggest that it is involved with regulating the dilation of blood vessels, Dr. Pietzner noted.

“There might be balance between the ADRA2A finding being responsible for constriction and the IRX1 finding indirectly linked to the dilation of those vessels following constrictions. Having both may explain why these prolonged episodes of vasoconstriction lead to a loss of oxygen to the tissues,” so they turn white and then blue, he said.

Because the Biobank cohort was European-centric, Dr. Pietzner and colleagues also identified 400 cases of Raynaud’s in British individuals of Bangladeshi and Pakistani ancestry and were able to replicate the association between IRX1 and Raynaud’s. Data on ADRA2A were unavailable.

The genes identified are associated with primary Raynaud’s. Secondary Raynaud’s is a rarer type of the condition that occurs along with autoimmune disorders, such as scleroderma, and is generally more severe.

It’s long been suspected that Raynaud’s had some genetic component, because half of patients with Raynaud’s have another family member with the same condition, said Laura Hummers, MD, who codirects the John Hopkins Scleroderma Center in Baltimore. She was not involved with the study.

Johns Hopkins University

This is “the largest study of this kind that’s been done,” she said, and the first to show a potential mechanism behind this genetic association.

The main gene finding, ADRA2A, “points to a receptor on the cells that regulate the tone of these blood vessels,” she continued. “It suggests maybe there’s too many of these receptors or they’re overly sensitive; something about them is different that makes patients more susceptible to these cold triggers. Knowing that is potentially really important, because it could give you a direct way to intervene, if true.”
 

New therapeutic avenues

The first-line treatment for primary Raynaud’s is behavioral interventions, such as maintaining body and extremity warmth and avoiding certain vasoconstricting drugs, said Kimberly Lakin, MD, a rheumatologist at the Hospital for Special Surgery in New York, who not involved in the research. These drugs could include over-the-counter decongestants and certain medications for attention-deficit/hyperactivity disorder.

Hospital for Special Surgery

If these behavioral interventions are not enough, clinicians most commonly prescribe calcium channel blockers. These medications are vasodilators but can be a concern for people with normal or already low blood pressure, Dr. Lakin said. They can also cause symptoms such as headache, leg swelling, constipation, and other gastrointestinal symptoms.

Other medications, such as fluoxetine, may also be considered as a later-line therapy, “but the effectiveness is fairly limited in Raynaud’s,” she said. “Certainly, other medication options that would be helpful and driven by the mechanisms of Raynaud’s would add to our ability to help patients.”

As it turns out, one of the genes identified in the study, ADRA2A, “is actually one of the most commonly targeted genes by drugs,” said Dr. Pietzner. Because the findings suggest that ADRA2A is overexpressed in Raynaud, a selective inhibitor like the antidepressant mirtazapine could be a promising candidate to repurpose for treating Raynaud’s, he said.
 

Limitations to electronic medical record analyses

Both Dr. Hummers and Dr. Lakin noted that research using diagnostic codes from medical records to identify cases has some limitations. The study may have included patients misdiagnosed with Raynaud’s when perhaps they had another condition. Patients with milder Raynaud’s who have not sought medical attention for the condition would not be represented in the study, Dr. Lakin said.

The UK Biobank includes individuals of mostly European descent, so an analysis confirming these findings in a more diverse population would be helpful, she said.

However, both Dr. Lakin and Dr. Hummers agreed that the study contributes to the understanding of the mechanisms behind Raynaud’s. Although the two identified genes were tied to primary Raynaud’s, the study’s findings could potentially apply to secondary Raynaud’s as well, Dr. Hummers said.

“Anything we learn about primary Raynaud’s may have implication for Raynaud’s more broadly,” she noted.

Dr. Hummers and Dr. Lakin disclosed no relevant financial relationships. Dr. Pietzner has received partnership funding for the MRC Clinical Pharmacology Training Scheme (cofunded by MRC and Roche, UCB, Eli Lilly, and Novartis) and a PhD studentship jointly funded by the UK Engineering and Physical Sciences Research Council and AstraZeneca. Dr. Pietzner also has unrestricted educational grant support for the UK Pharmacogenetics and Stratified Medicine Network from Bristol-Myers Squibb.

A version of this article appeared on Medscape.com.

Researchers have identified two genes that may contribute to Raynaud’s phenomenon, a condition where blood vessels in the extremities constrict and limit blood flow.

Raynaud’s is a relatively common condition, affecting 2%-5% of the general population. Though Raynaud’s can be an annoyance for some, it can also cause severe pain and can require medication.

Barb Elkin/iStock/Getty Images Plus

These newly identified genes will hopefully lead to new therapeutic options, said Maik Pietzner, PhD, chair in health data modeling at Queen Mary University of London’s Precision Healthcare University Research Institute (PHURI) and group leader in the Computational Medicine Group at the Berlin Institute of Health at Charité – Universitätsmedizin Berlin, Germany.

Berlin Institute of Health at Charité - Universitätsmedizin Berlin

Dr. Pietzner led the research along with Claudia Langenberg, MD, PhD, director of PHURI.

The study was published in Nature Communications.


 

Largest genomic study of Raynaud’s to date

The researchers looked through electronic medical records from the UK Biobank, a large-scale database that contains genetic and health information on half a million participants. They identified more than 5,100 individuals with Raynaud’s, of which 68% had primary Raynaud’s. These participants were compared with more than 439,000 controls who did not have Raynaud’s.

In a secondary analysis, the team also used health records from the Queen Mary University of London Genes & Health Study, which contains health information on individuals of South Asian ancestry.

The researchers identified two genes that are likely involved with Raynaud’s. The first, ADRA2A, encodes for the alpha-2A adrenergic receptor that can cause vasoconstriction of small blood vessels in response to stress hormones. Researchers have long suspected that this type of receptor could be involved with Raynaud’s, but there was debate over which receptor subtype was responsible.

“Our finding of alpha-2A receptors is quite interesting because the focus has always been on alpha-2C receptors,” said Dr. Pietzner. “It’s only a letter, but it’s a massive difference in terms of biology and physiology,” he said, and could be why therapies targeting 2C receptors have been ineffective.

The second strongest association was for the transcription factor IRX1. Less is known about this gene, but the data we do have suggest that it is involved with regulating the dilation of blood vessels, Dr. Pietzner noted.

“There might be balance between the ADRA2A finding being responsible for constriction and the IRX1 finding indirectly linked to the dilation of those vessels following constrictions. Having both may explain why these prolonged episodes of vasoconstriction lead to a loss of oxygen to the tissues,” so they turn white and then blue, he said.

Because the Biobank cohort was European-centric, Dr. Pietzner and colleagues also identified 400 cases of Raynaud’s in British individuals of Bangladeshi and Pakistani ancestry and were able to replicate the association between IRX1 and Raynaud’s. Data on ADRA2A were unavailable.

The genes identified are associated with primary Raynaud’s. Secondary Raynaud’s is a rarer type of the condition that occurs along with autoimmune disorders, such as scleroderma, and is generally more severe.

It’s long been suspected that Raynaud’s had some genetic component, because half of patients with Raynaud’s have another family member with the same condition, said Laura Hummers, MD, who codirects the John Hopkins Scleroderma Center in Baltimore. She was not involved with the study.

Johns Hopkins University

This is “the largest study of this kind that’s been done,” she said, and the first to show a potential mechanism behind this genetic association.

The main gene finding, ADRA2A, “points to a receptor on the cells that regulate the tone of these blood vessels,” she continued. “It suggests maybe there’s too many of these receptors or they’re overly sensitive; something about them is different that makes patients more susceptible to these cold triggers. Knowing that is potentially really important, because it could give you a direct way to intervene, if true.”
 

New therapeutic avenues

The first-line treatment for primary Raynaud’s is behavioral interventions, such as maintaining body and extremity warmth and avoiding certain vasoconstricting drugs, said Kimberly Lakin, MD, a rheumatologist at the Hospital for Special Surgery in New York, who not involved in the research. These drugs could include over-the-counter decongestants and certain medications for attention-deficit/hyperactivity disorder.

Hospital for Special Surgery

If these behavioral interventions are not enough, clinicians most commonly prescribe calcium channel blockers. These medications are vasodilators but can be a concern for people with normal or already low blood pressure, Dr. Lakin said. They can also cause symptoms such as headache, leg swelling, constipation, and other gastrointestinal symptoms.

Other medications, such as fluoxetine, may also be considered as a later-line therapy, “but the effectiveness is fairly limited in Raynaud’s,” she said. “Certainly, other medication options that would be helpful and driven by the mechanisms of Raynaud’s would add to our ability to help patients.”

As it turns out, one of the genes identified in the study, ADRA2A, “is actually one of the most commonly targeted genes by drugs,” said Dr. Pietzner. Because the findings suggest that ADRA2A is overexpressed in Raynaud, a selective inhibitor like the antidepressant mirtazapine could be a promising candidate to repurpose for treating Raynaud’s, he said.
 

Limitations to electronic medical record analyses

Both Dr. Hummers and Dr. Lakin noted that research using diagnostic codes from medical records to identify cases has some limitations. The study may have included patients misdiagnosed with Raynaud’s when perhaps they had another condition. Patients with milder Raynaud’s who have not sought medical attention for the condition would not be represented in the study, Dr. Lakin said.

The UK Biobank includes individuals of mostly European descent, so an analysis confirming these findings in a more diverse population would be helpful, she said.

However, both Dr. Lakin and Dr. Hummers agreed that the study contributes to the understanding of the mechanisms behind Raynaud’s. Although the two identified genes were tied to primary Raynaud’s, the study’s findings could potentially apply to secondary Raynaud’s as well, Dr. Hummers said.

“Anything we learn about primary Raynaud’s may have implication for Raynaud’s more broadly,” she noted.

Dr. Hummers and Dr. Lakin disclosed no relevant financial relationships. Dr. Pietzner has received partnership funding for the MRC Clinical Pharmacology Training Scheme (cofunded by MRC and Roche, UCB, Eli Lilly, and Novartis) and a PhD studentship jointly funded by the UK Engineering and Physical Sciences Research Council and AstraZeneca. Dr. Pietzner also has unrestricted educational grant support for the UK Pharmacogenetics and Stratified Medicine Network from Bristol-Myers Squibb.

A version of this article appeared on Medscape.com.

Researchers have identified two genes that may contribute to Raynaud’s phenomenon, a condition where blood vessels in the extremities constrict and limit blood flow.

Raynaud’s is a relatively common condition, affecting 2%-5% of the general population. Though Raynaud’s can be an annoyance for some, it can also cause severe pain and can require medication.

Barb Elkin/iStock/Getty Images Plus

These newly identified genes will hopefully lead to new therapeutic options, said Maik Pietzner, PhD, chair in health data modeling at Queen Mary University of London’s Precision Healthcare University Research Institute (PHURI) and group leader in the Computational Medicine Group at the Berlin Institute of Health at Charité – Universitätsmedizin Berlin, Germany.

Berlin Institute of Health at Charité - Universitätsmedizin Berlin

Dr. Pietzner led the research along with Claudia Langenberg, MD, PhD, director of PHURI.

The study was published in Nature Communications.


 

Largest genomic study of Raynaud’s to date

The researchers looked through electronic medical records from the UK Biobank, a large-scale database that contains genetic and health information on half a million participants. They identified more than 5,100 individuals with Raynaud’s, of which 68% had primary Raynaud’s. These participants were compared with more than 439,000 controls who did not have Raynaud’s.

In a secondary analysis, the team also used health records from the Queen Mary University of London Genes & Health Study, which contains health information on individuals of South Asian ancestry.

The researchers identified two genes that are likely involved with Raynaud’s. The first, ADRA2A, encodes for the alpha-2A adrenergic receptor that can cause vasoconstriction of small blood vessels in response to stress hormones. Researchers have long suspected that this type of receptor could be involved with Raynaud’s, but there was debate over which receptor subtype was responsible.

“Our finding of alpha-2A receptors is quite interesting because the focus has always been on alpha-2C receptors,” said Dr. Pietzner. “It’s only a letter, but it’s a massive difference in terms of biology and physiology,” he said, and could be why therapies targeting 2C receptors have been ineffective.

The second strongest association was for the transcription factor IRX1. Less is known about this gene, but the data we do have suggest that it is involved with regulating the dilation of blood vessels, Dr. Pietzner noted.

“There might be balance between the ADRA2A finding being responsible for constriction and the IRX1 finding indirectly linked to the dilation of those vessels following constrictions. Having both may explain why these prolonged episodes of vasoconstriction lead to a loss of oxygen to the tissues,” so they turn white and then blue, he said.

Because the Biobank cohort was European-centric, Dr. Pietzner and colleagues also identified 400 cases of Raynaud’s in British individuals of Bangladeshi and Pakistani ancestry and were able to replicate the association between IRX1 and Raynaud’s. Data on ADRA2A were unavailable.

The genes identified are associated with primary Raynaud’s. Secondary Raynaud’s is a rarer type of the condition that occurs along with autoimmune disorders, such as scleroderma, and is generally more severe.

It’s long been suspected that Raynaud’s had some genetic component, because half of patients with Raynaud’s have another family member with the same condition, said Laura Hummers, MD, who codirects the John Hopkins Scleroderma Center in Baltimore. She was not involved with the study.

Johns Hopkins University

This is “the largest study of this kind that’s been done,” she said, and the first to show a potential mechanism behind this genetic association.

The main gene finding, ADRA2A, “points to a receptor on the cells that regulate the tone of these blood vessels,” she continued. “It suggests maybe there’s too many of these receptors or they’re overly sensitive; something about them is different that makes patients more susceptible to these cold triggers. Knowing that is potentially really important, because it could give you a direct way to intervene, if true.”
 

New therapeutic avenues

The first-line treatment for primary Raynaud’s is behavioral interventions, such as maintaining body and extremity warmth and avoiding certain vasoconstricting drugs, said Kimberly Lakin, MD, a rheumatologist at the Hospital for Special Surgery in New York, who not involved in the research. These drugs could include over-the-counter decongestants and certain medications for attention-deficit/hyperactivity disorder.

Hospital for Special Surgery

If these behavioral interventions are not enough, clinicians most commonly prescribe calcium channel blockers. These medications are vasodilators but can be a concern for people with normal or already low blood pressure, Dr. Lakin said. They can also cause symptoms such as headache, leg swelling, constipation, and other gastrointestinal symptoms.

Other medications, such as fluoxetine, may also be considered as a later-line therapy, “but the effectiveness is fairly limited in Raynaud’s,” she said. “Certainly, other medication options that would be helpful and driven by the mechanisms of Raynaud’s would add to our ability to help patients.”

As it turns out, one of the genes identified in the study, ADRA2A, “is actually one of the most commonly targeted genes by drugs,” said Dr. Pietzner. Because the findings suggest that ADRA2A is overexpressed in Raynaud, a selective inhibitor like the antidepressant mirtazapine could be a promising candidate to repurpose for treating Raynaud’s, he said.
 

Limitations to electronic medical record analyses

Both Dr. Hummers and Dr. Lakin noted that research using diagnostic codes from medical records to identify cases has some limitations. The study may have included patients misdiagnosed with Raynaud’s when perhaps they had another condition. Patients with milder Raynaud’s who have not sought medical attention for the condition would not be represented in the study, Dr. Lakin said.

The UK Biobank includes individuals of mostly European descent, so an analysis confirming these findings in a more diverse population would be helpful, she said.

However, both Dr. Lakin and Dr. Hummers agreed that the study contributes to the understanding of the mechanisms behind Raynaud’s. Although the two identified genes were tied to primary Raynaud’s, the study’s findings could potentially apply to secondary Raynaud’s as well, Dr. Hummers said.

“Anything we learn about primary Raynaud’s may have implication for Raynaud’s more broadly,” she noted.

Dr. Hummers and Dr. Lakin disclosed no relevant financial relationships. Dr. Pietzner has received partnership funding for the MRC Clinical Pharmacology Training Scheme (cofunded by MRC and Roche, UCB, Eli Lilly, and Novartis) and a PhD studentship jointly funded by the UK Engineering and Physical Sciences Research Council and AstraZeneca. Dr. Pietzner also has unrestricted educational grant support for the UK Pharmacogenetics and Stratified Medicine Network from Bristol-Myers Squibb.

A version of this article appeared on Medscape.com.

New England Baptist Hospital has been grappling with a serious problem facing health care today: insurers demanding prior authorizations for services ordered by physicians. Meeting payers’ requirements eats up time, delays treatment, and can be a costly drain on doctors’ practices. 

To deal with this problem, the Boston orthopedic hospital has opted to automate submission of prior authorization requests on behalf of more than 100 mostly orthopedic surgeons on staff. 

After 5 years using this system, “we can say that automation definitely works,” said Lidiya Hadzhieva, director of patient access at the hospital. The software has reduced write-offs by 30% and staff costs by 25%. Prior authorization gets approved 3 days after scheduling, compared with 11 days previously, she said.

“This software not only saves staff time, but it can also more accurately predict when prior authorization is needed,” she added.

For practices deluged with required prior authorizations by insurers, automation is emerging as a way for practices to make the process less time-consuming and save money. However, the software can be costly and may not be adoptable to many practices, and many physicians are not even aware it exists.

So far, the software is mainly used at large organizations like hospital systems. But as word gets out and the software becomes easier to use, private practices and other smaller entities may join the automation trend.

There is definitely a need to automate prior authorization. The American Medical Association reports that physicians spend 16 hours per week on prior authorizations. In a recent AMA survey, more than 60% of physicians indicated that it’s difficult to know when prior authorization is needed. And 93% of physicians reported care delays while waiting for authorization, the AMA said.  

Experts estimate that 80% of prior authorization work could be automated, but most practices still use the phone or fax, even as numbers of prior authorizations continue to increase.
 

How it works

Automation software connects directly to the practice’s electronic health record (EHR). “When the doctor places an order in the EHR, the process starts automatically,” Ms. Hadzhieva said. “The doctor may not even notice it.” 

In addition to using an EHR connection, many software products can communicate with the payer through its portal or by fax or phone, while still automating other parts of the process.

The software’s first step is to decide whether prior authorization is needed. This requires having an updated list of the rules that each payer uses for prior authorization. Manually keeping track of payer rules is very time-consuming, but automation uses bots to visit each payer site to look for rules changes. One vendor, Infinitus, uses a voice-based bot called Eva that calls up each payer and speaks with a representative.

“Automatically updating payer rules is not a new technology,” said YiDing Yu, MD, chief product officer at Olive, the automation vendor for New England Baptist. “What is new in the last 5 years is extracting the information needed for the prior authorization out of the clinical notes.”

This is challenging because each doctor has different ways to describe each step of clinical work. To identify this shorthand, Dr. Yu said Olive uses natural language processing, which is a form of artificial intelligence that learns how each doctor describes things.

Dr. Yu asserts that Olive is actually better than a practice’s staff at digging out clinical information. She said staff without much clinical training may miss terms that the software can catch, and they don’t have the time to go back many months into the record to find valuable information. But automation can do that.

In some instances, however, the software may not be able to find the information, in which case it alerts staff through a prompt in the EHR and the information is retrieved manually, Dr. Yu said.

Next, the Olive software puts the information it found into the request form and sends it to the payer. After submission, the software constantly checks on the status of each request, again visiting payer sites with a bot.

At New England Baptist, the software is used mainly by physicians in fairly small private practices who are on staff. They are using the software on the hospital’s dime, but it only works inside the hospital, Ms. Hadzhieva said. For their work outside of the hospital, they would have to purchase the Olive software on their own, she said.
 

Automation hasn’t spread to practices yet

Despite the promising outcomes for products like Olive, automation software is still primarily used by large organizations. Vendors say very few private practices have bought it yet. “The technology works, but it is still in the early-adopter phase,” Dr. Yu said.

For one thing, the software can be expensive. Very few vendors reveal their prices, but Dr. Yu did so. She said Olive normally costs about $50,000 a year for even a small organization. She insisted, however, that the savings from avoiding just one denial each month for a hip surgery would justify the expense.

On the other hand, some automation software is free, such as the Surescripts product for prior authorization of prescriptions. But it is unclear whether Surescripts does as much as Olive. Vendors’ descriptions of their products tend to be vague.

Also, Surescripts and Olive have entirely separate functions. Dr. Yu said Olive is limited to procedures, so it benefits specialties like oncology, neurosurgery, colorectal surgery, vascular surgery, and cardiology. Olive does not cover prescriptions, because they operate on a different technology.

Dr. Yu said another hurdle for adopting the software is the kind of EHR systems that doctors use. At this point, only a few EHR systems – such as Epic, Cerner, and Athena – are compatible with Olive. Large organizations tend to use Epic and Cerner, while many practices often use Athena or a variety of other systems, she said.

Despite stunted demand, there is no shortage of companies offering automation software for medical (that is, non-prescription) prior authorization. One compilation lists 25 such vendors, including companies like Myndshft, Rhyme, Infinitus, Infinx, and Waystar. As with any start-up technology, companies occasionally buy each other out.

In addition to issues like cost, specialty, and EHR compatibility, another hurdle is that few doctors even know the technology exists. Vendors say marketing focuses on larger provider organizations, not smaller practices.

Even many tech-savvy doctors, like Adam Bruggeman, MD, an orthopedist and CEO of Texas Spine Care Center in San Antonio, say they know little about the technology. “There is definitely a need to automate prior authorization,” he said. “But I don’t know of any colleagues who use it.” He has only just begun to explore vendors, he said.

Many medical practice consultants also have not yet explored the technology. “Automation makes a lot of sense, because there are a lot of repetitive tasks in prior authorization,” said Jill Arena, CEO of Portland, Ore.–based Health e Practices. “But I haven’t looked into it yet, and none of my clients has even asked about it.”

“I could see how it could be an easier sell for large organizations,” she added. “They have an IT person and a CFO who can explore the issue. Smaller practices usually don’t have that kind of expertise.”
 

Where does automation go from here?

Until now, clinicians who want to fully automate prior authorizations would have to buy two products – one for medical procedures and one for prescriptions. This has to do with incompatible electronic transmission standards, which are used to digitize information, said Susan Lawson-Dawson, content marketing strategist for the vendor Myndshft Health.

Myndshft has long been selling automation software for medical prior authorizations, but now it is introducing a product for prescriptions, Ms. Lawson-Dawson said. She said Myndshft will then be the only vendor to automate both kinds of prior authorizations.

Ms. Lawson-Dawson said Myndshft has 685 customers to date and is looking for more business. Recently the company entered the Google Cloud Marketplace. Google Cloud customers can now direct their committed spend with Google to purchasing Myndshft, meaning they could get it at a discount.

Software like Olive and Myndshft can operate independently of payers, but a vendor called Rhyme depends on payers for its software to function, said Rhyme CEO Joe Anstine. He said more than 300 payers have agreed to install the Rhyme system, and Rhyme has signed up a number of large health systems to use the product. Initially, he said, clinicians paid for the service, but now Rhyme is beginning to find payers to foot the costs and to let clinicians use it for free, which would open Rhyme up to smaller practices.

EHR companies themselves are beginning to offer automation, too. Epic, for example, has created a tool for prior authorization as part of its Epic Payer Platform. Like Rhyme, it requires payer cooperation, because information goes back and forth between clinician and payer in what is called bi-directional exchange.

The Epic product is still in its pilot phase. Epic reported that several large health systems were using its product in conjunction with a specific payer – for instance, Mayo Clinic with Blue Cross and Blue Shield of Minnesota and Ochsner Health with Humana. According to Epic, the arrangement reduced Mayo’s denials due to additional documentation requests by 63% for professional billing.

Automating with just one payer still means the clinician has to deal with manual processes at other payers, but a large clinician could have sufficient volume with that one payer to make the arrangement useful.
 

Will payers automate prior authorization?

Ultimately, payers may take the automation business away from vendors, offering a free product to all clinicians. But don’t hold your breath. Payers first have to rebuild their electronic systems to accommodate an electronic connection with providers. Even then, some payers might hold back from automating, forcing practices to continue manually processing some prior authorizations.

Efforts are underway, however, to mandate payers to support prior authorization automation. For this to happen, payers would have to revamp their data so that it could be easily read by practices’ EHRs. This would mean adopting a specific interoperability standard called Health Level 7 Fast Healthcare Interoperability Resources (FHIR).

Toward this goal, the Centers for Medicare & Medicaid Services proposes to require payers to adopt FHIR by January 2026. (CMS still has to finalize the rule.) Experts say the two-year ramp-up time is needed because it takes extensive work for payers to translate their data into FHIR.

The only payer so far to switch to FHIR for prior authorization is Regence in Washington state. In a pilot project, it has automated prior authorization with just one provider, MultiCare Connected Care, an accountable care organization (ACO), also in Washington state.

Anna Taylor, associate vice president of population health and value-based care at MultiCare, explained how the arrangement works. “Two separate entities are sharing one operational process,” she told this news organization. “That means they can have a digital conversation back and forth, so it is much easier to resolve prior authorization issues.” 

Unlike many vendor products, the Regence service is free. And while the vendors market only to large organizations, most doctors in the MultiCare arrangement are in independent practices. Ms. Taylor said these doctors have been “enthusiastic” about the arrangement.

The results of the pilot are impressive. Ms. Taylor said automation has resulted in a 233% productivity gain for MultiCare clinicians, and 89% of submissions to Regence get an immediate response.

There is a potential downside, however, to working directly with payers. A direct connection to clinicians allows payers to access the doctor’s clinical notes, which could make many doctors uneasy. But Ms. Taylor said Regence only has access to the “discrete data fields” on MultiCare’s EHR dashboard, not to the notes themselves.

The ultimate goal of the Regence-Multicare project is to include more payers and clinicians. Ms. Taylor said two of the 27 other payers that MultiCare works with are “highly interested,” but it would take a lot of work for them to get connected with practices and other clinicians. 

Ultimately, payers could offer automation and third-party vendors might then fade away. However, physicians may resist working directly with payers if the arrangement requires full access to their medical records.

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

New England Baptist Hospital has been grappling with a serious problem facing health care today: insurers demanding prior authorizations for services ordered by physicians. Meeting payers’ requirements eats up time, delays treatment, and can be a costly drain on doctors’ practices. 

To deal with this problem, the Boston orthopedic hospital has opted to automate submission of prior authorization requests on behalf of more than 100 mostly orthopedic surgeons on staff. 

After 5 years using this system, “we can say that automation definitely works,” said Lidiya Hadzhieva, director of patient access at the hospital. The software has reduced write-offs by 30% and staff costs by 25%. Prior authorization gets approved 3 days after scheduling, compared with 11 days previously, she said.

“This software not only saves staff time, but it can also more accurately predict when prior authorization is needed,” she added.

For practices deluged with required prior authorizations by insurers, automation is emerging as a way for practices to make the process less time-consuming and save money. However, the software can be costly and may not be adoptable to many practices, and many physicians are not even aware it exists.

So far, the software is mainly used at large organizations like hospital systems. But as word gets out and the software becomes easier to use, private practices and other smaller entities may join the automation trend.

There is definitely a need to automate prior authorization. The American Medical Association reports that physicians spend 16 hours per week on prior authorizations. In a recent AMA survey, more than 60% of physicians indicated that it’s difficult to know when prior authorization is needed. And 93% of physicians reported care delays while waiting for authorization, the AMA said.  

Experts estimate that 80% of prior authorization work could be automated, but most practices still use the phone or fax, even as numbers of prior authorizations continue to increase.
 

How it works

Automation software connects directly to the practice’s electronic health record (EHR). “When the doctor places an order in the EHR, the process starts automatically,” Ms. Hadzhieva said. “The doctor may not even notice it.” 

In addition to using an EHR connection, many software products can communicate with the payer through its portal or by fax or phone, while still automating other parts of the process.

The software’s first step is to decide whether prior authorization is needed. This requires having an updated list of the rules that each payer uses for prior authorization. Manually keeping track of payer rules is very time-consuming, but automation uses bots to visit each payer site to look for rules changes. One vendor, Infinitus, uses a voice-based bot called Eva that calls up each payer and speaks with a representative.

“Automatically updating payer rules is not a new technology,” said YiDing Yu, MD, chief product officer at Olive, the automation vendor for New England Baptist. “What is new in the last 5 years is extracting the information needed for the prior authorization out of the clinical notes.”

This is challenging because each doctor has different ways to describe each step of clinical work. To identify this shorthand, Dr. Yu said Olive uses natural language processing, which is a form of artificial intelligence that learns how each doctor describes things.

Dr. Yu asserts that Olive is actually better than a practice’s staff at digging out clinical information. She said staff without much clinical training may miss terms that the software can catch, and they don’t have the time to go back many months into the record to find valuable information. But automation can do that.

In some instances, however, the software may not be able to find the information, in which case it alerts staff through a prompt in the EHR and the information is retrieved manually, Dr. Yu said.

Next, the Olive software puts the information it found into the request form and sends it to the payer. After submission, the software constantly checks on the status of each request, again visiting payer sites with a bot.

At New England Baptist, the software is used mainly by physicians in fairly small private practices who are on staff. They are using the software on the hospital’s dime, but it only works inside the hospital, Ms. Hadzhieva said. For their work outside of the hospital, they would have to purchase the Olive software on their own, she said.
 

Automation hasn’t spread to practices yet

Despite the promising outcomes for products like Olive, automation software is still primarily used by large organizations. Vendors say very few private practices have bought it yet. “The technology works, but it is still in the early-adopter phase,” Dr. Yu said.

For one thing, the software can be expensive. Very few vendors reveal their prices, but Dr. Yu did so. She said Olive normally costs about $50,000 a year for even a small organization. She insisted, however, that the savings from avoiding just one denial each month for a hip surgery would justify the expense.

On the other hand, some automation software is free, such as the Surescripts product for prior authorization of prescriptions. But it is unclear whether Surescripts does as much as Olive. Vendors’ descriptions of their products tend to be vague.

Also, Surescripts and Olive have entirely separate functions. Dr. Yu said Olive is limited to procedures, so it benefits specialties like oncology, neurosurgery, colorectal surgery, vascular surgery, and cardiology. Olive does not cover prescriptions, because they operate on a different technology.

Dr. Yu said another hurdle for adopting the software is the kind of EHR systems that doctors use. At this point, only a few EHR systems – such as Epic, Cerner, and Athena – are compatible with Olive. Large organizations tend to use Epic and Cerner, while many practices often use Athena or a variety of other systems, she said.

Despite stunted demand, there is no shortage of companies offering automation software for medical (that is, non-prescription) prior authorization. One compilation lists 25 such vendors, including companies like Myndshft, Rhyme, Infinitus, Infinx, and Waystar. As with any start-up technology, companies occasionally buy each other out.

In addition to issues like cost, specialty, and EHR compatibility, another hurdle is that few doctors even know the technology exists. Vendors say marketing focuses on larger provider organizations, not smaller practices.

Even many tech-savvy doctors, like Adam Bruggeman, MD, an orthopedist and CEO of Texas Spine Care Center in San Antonio, say they know little about the technology. “There is definitely a need to automate prior authorization,” he said. “But I don’t know of any colleagues who use it.” He has only just begun to explore vendors, he said.

Many medical practice consultants also have not yet explored the technology. “Automation makes a lot of sense, because there are a lot of repetitive tasks in prior authorization,” said Jill Arena, CEO of Portland, Ore.–based Health e Practices. “But I haven’t looked into it yet, and none of my clients has even asked about it.”

“I could see how it could be an easier sell for large organizations,” she added. “They have an IT person and a CFO who can explore the issue. Smaller practices usually don’t have that kind of expertise.”
 

Where does automation go from here?

Until now, clinicians who want to fully automate prior authorizations would have to buy two products – one for medical procedures and one for prescriptions. This has to do with incompatible electronic transmission standards, which are used to digitize information, said Susan Lawson-Dawson, content marketing strategist for the vendor Myndshft Health.

Myndshft has long been selling automation software for medical prior authorizations, but now it is introducing a product for prescriptions, Ms. Lawson-Dawson said. She said Myndshft will then be the only vendor to automate both kinds of prior authorizations.

Ms. Lawson-Dawson said Myndshft has 685 customers to date and is looking for more business. Recently the company entered the Google Cloud Marketplace. Google Cloud customers can now direct their committed spend with Google to purchasing Myndshft, meaning they could get it at a discount.

Software like Olive and Myndshft can operate independently of payers, but a vendor called Rhyme depends on payers for its software to function, said Rhyme CEO Joe Anstine. He said more than 300 payers have agreed to install the Rhyme system, and Rhyme has signed up a number of large health systems to use the product. Initially, he said, clinicians paid for the service, but now Rhyme is beginning to find payers to foot the costs and to let clinicians use it for free, which would open Rhyme up to smaller practices.

EHR companies themselves are beginning to offer automation, too. Epic, for example, has created a tool for prior authorization as part of its Epic Payer Platform. Like Rhyme, it requires payer cooperation, because information goes back and forth between clinician and payer in what is called bi-directional exchange.

The Epic product is still in its pilot phase. Epic reported that several large health systems were using its product in conjunction with a specific payer – for instance, Mayo Clinic with Blue Cross and Blue Shield of Minnesota and Ochsner Health with Humana. According to Epic, the arrangement reduced Mayo’s denials due to additional documentation requests by 63% for professional billing.

Automating with just one payer still means the clinician has to deal with manual processes at other payers, but a large clinician could have sufficient volume with that one payer to make the arrangement useful.
 

Will payers automate prior authorization?

Ultimately, payers may take the automation business away from vendors, offering a free product to all clinicians. But don’t hold your breath. Payers first have to rebuild their electronic systems to accommodate an electronic connection with providers. Even then, some payers might hold back from automating, forcing practices to continue manually processing some prior authorizations.

Efforts are underway, however, to mandate payers to support prior authorization automation. For this to happen, payers would have to revamp their data so that it could be easily read by practices’ EHRs. This would mean adopting a specific interoperability standard called Health Level 7 Fast Healthcare Interoperability Resources (FHIR).

Toward this goal, the Centers for Medicare & Medicaid Services proposes to require payers to adopt FHIR by January 2026. (CMS still has to finalize the rule.) Experts say the two-year ramp-up time is needed because it takes extensive work for payers to translate their data into FHIR.

The only payer so far to switch to FHIR for prior authorization is Regence in Washington state. In a pilot project, it has automated prior authorization with just one provider, MultiCare Connected Care, an accountable care organization (ACO), also in Washington state.

Anna Taylor, associate vice president of population health and value-based care at MultiCare, explained how the arrangement works. “Two separate entities are sharing one operational process,” she told this news organization. “That means they can have a digital conversation back and forth, so it is much easier to resolve prior authorization issues.” 

Unlike many vendor products, the Regence service is free. And while the vendors market only to large organizations, most doctors in the MultiCare arrangement are in independent practices. Ms. Taylor said these doctors have been “enthusiastic” about the arrangement.

The results of the pilot are impressive. Ms. Taylor said automation has resulted in a 233% productivity gain for MultiCare clinicians, and 89% of submissions to Regence get an immediate response.

There is a potential downside, however, to working directly with payers. A direct connection to clinicians allows payers to access the doctor’s clinical notes, which could make many doctors uneasy. But Ms. Taylor said Regence only has access to the “discrete data fields” on MultiCare’s EHR dashboard, not to the notes themselves.

The ultimate goal of the Regence-Multicare project is to include more payers and clinicians. Ms. Taylor said two of the 27 other payers that MultiCare works with are “highly interested,” but it would take a lot of work for them to get connected with practices and other clinicians. 

Ultimately, payers could offer automation and third-party vendors might then fade away. However, physicians may resist working directly with payers if the arrangement requires full access to their medical records.

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

New England Baptist Hospital has been grappling with a serious problem facing health care today: insurers demanding prior authorizations for services ordered by physicians. Meeting payers’ requirements eats up time, delays treatment, and can be a costly drain on doctors’ practices. 

To deal with this problem, the Boston orthopedic hospital has opted to automate submission of prior authorization requests on behalf of more than 100 mostly orthopedic surgeons on staff. 

After 5 years using this system, “we can say that automation definitely works,” said Lidiya Hadzhieva, director of patient access at the hospital. The software has reduced write-offs by 30% and staff costs by 25%. Prior authorization gets approved 3 days after scheduling, compared with 11 days previously, she said.

“This software not only saves staff time, but it can also more accurately predict when prior authorization is needed,” she added.

For practices deluged with required prior authorizations by insurers, automation is emerging as a way for practices to make the process less time-consuming and save money. However, the software can be costly and may not be adoptable to many practices, and many physicians are not even aware it exists.

So far, the software is mainly used at large organizations like hospital systems. But as word gets out and the software becomes easier to use, private practices and other smaller entities may join the automation trend.

There is definitely a need to automate prior authorization. The American Medical Association reports that physicians spend 16 hours per week on prior authorizations. In a recent AMA survey, more than 60% of physicians indicated that it’s difficult to know when prior authorization is needed. And 93% of physicians reported care delays while waiting for authorization, the AMA said.  

Experts estimate that 80% of prior authorization work could be automated, but most practices still use the phone or fax, even as numbers of prior authorizations continue to increase.
 

How it works

Automation software connects directly to the practice’s electronic health record (EHR). “When the doctor places an order in the EHR, the process starts automatically,” Ms. Hadzhieva said. “The doctor may not even notice it.” 

In addition to using an EHR connection, many software products can communicate with the payer through its portal or by fax or phone, while still automating other parts of the process.

The software’s first step is to decide whether prior authorization is needed. This requires having an updated list of the rules that each payer uses for prior authorization. Manually keeping track of payer rules is very time-consuming, but automation uses bots to visit each payer site to look for rules changes. One vendor, Infinitus, uses a voice-based bot called Eva that calls up each payer and speaks with a representative.

“Automatically updating payer rules is not a new technology,” said YiDing Yu, MD, chief product officer at Olive, the automation vendor for New England Baptist. “What is new in the last 5 years is extracting the information needed for the prior authorization out of the clinical notes.”

This is challenging because each doctor has different ways to describe each step of clinical work. To identify this shorthand, Dr. Yu said Olive uses natural language processing, which is a form of artificial intelligence that learns how each doctor describes things.

Dr. Yu asserts that Olive is actually better than a practice’s staff at digging out clinical information. She said staff without much clinical training may miss terms that the software can catch, and they don’t have the time to go back many months into the record to find valuable information. But automation can do that.

In some instances, however, the software may not be able to find the information, in which case it alerts staff through a prompt in the EHR and the information is retrieved manually, Dr. Yu said.

Next, the Olive software puts the information it found into the request form and sends it to the payer. After submission, the software constantly checks on the status of each request, again visiting payer sites with a bot.

At New England Baptist, the software is used mainly by physicians in fairly small private practices who are on staff. They are using the software on the hospital’s dime, but it only works inside the hospital, Ms. Hadzhieva said. For their work outside of the hospital, they would have to purchase the Olive software on their own, she said.
 

Automation hasn’t spread to practices yet

Despite the promising outcomes for products like Olive, automation software is still primarily used by large organizations. Vendors say very few private practices have bought it yet. “The technology works, but it is still in the early-adopter phase,” Dr. Yu said.

For one thing, the software can be expensive. Very few vendors reveal their prices, but Dr. Yu did so. She said Olive normally costs about $50,000 a year for even a small organization. She insisted, however, that the savings from avoiding just one denial each month for a hip surgery would justify the expense.

On the other hand, some automation software is free, such as the Surescripts product for prior authorization of prescriptions. But it is unclear whether Surescripts does as much as Olive. Vendors’ descriptions of their products tend to be vague.

Also, Surescripts and Olive have entirely separate functions. Dr. Yu said Olive is limited to procedures, so it benefits specialties like oncology, neurosurgery, colorectal surgery, vascular surgery, and cardiology. Olive does not cover prescriptions, because they operate on a different technology.

Dr. Yu said another hurdle for adopting the software is the kind of EHR systems that doctors use. At this point, only a few EHR systems – such as Epic, Cerner, and Athena – are compatible with Olive. Large organizations tend to use Epic and Cerner, while many practices often use Athena or a variety of other systems, she said.

Despite stunted demand, there is no shortage of companies offering automation software for medical (that is, non-prescription) prior authorization. One compilation lists 25 such vendors, including companies like Myndshft, Rhyme, Infinitus, Infinx, and Waystar. As with any start-up technology, companies occasionally buy each other out.

In addition to issues like cost, specialty, and EHR compatibility, another hurdle is that few doctors even know the technology exists. Vendors say marketing focuses on larger provider organizations, not smaller practices.

Even many tech-savvy doctors, like Adam Bruggeman, MD, an orthopedist and CEO of Texas Spine Care Center in San Antonio, say they know little about the technology. “There is definitely a need to automate prior authorization,” he said. “But I don’t know of any colleagues who use it.” He has only just begun to explore vendors, he said.

Many medical practice consultants also have not yet explored the technology. “Automation makes a lot of sense, because there are a lot of repetitive tasks in prior authorization,” said Jill Arena, CEO of Portland, Ore.–based Health e Practices. “But I haven’t looked into it yet, and none of my clients has even asked about it.”

“I could see how it could be an easier sell for large organizations,” she added. “They have an IT person and a CFO who can explore the issue. Smaller practices usually don’t have that kind of expertise.”
 

Where does automation go from here?

Until now, clinicians who want to fully automate prior authorizations would have to buy two products – one for medical procedures and one for prescriptions. This has to do with incompatible electronic transmission standards, which are used to digitize information, said Susan Lawson-Dawson, content marketing strategist for the vendor Myndshft Health.

Myndshft has long been selling automation software for medical prior authorizations, but now it is introducing a product for prescriptions, Ms. Lawson-Dawson said. She said Myndshft will then be the only vendor to automate both kinds of prior authorizations.

Ms. Lawson-Dawson said Myndshft has 685 customers to date and is looking for more business. Recently the company entered the Google Cloud Marketplace. Google Cloud customers can now direct their committed spend with Google to purchasing Myndshft, meaning they could get it at a discount.

Software like Olive and Myndshft can operate independently of payers, but a vendor called Rhyme depends on payers for its software to function, said Rhyme CEO Joe Anstine. He said more than 300 payers have agreed to install the Rhyme system, and Rhyme has signed up a number of large health systems to use the product. Initially, he said, clinicians paid for the service, but now Rhyme is beginning to find payers to foot the costs and to let clinicians use it for free, which would open Rhyme up to smaller practices.

EHR companies themselves are beginning to offer automation, too. Epic, for example, has created a tool for prior authorization as part of its Epic Payer Platform. Like Rhyme, it requires payer cooperation, because information goes back and forth between clinician and payer in what is called bi-directional exchange.

The Epic product is still in its pilot phase. Epic reported that several large health systems were using its product in conjunction with a specific payer – for instance, Mayo Clinic with Blue Cross and Blue Shield of Minnesota and Ochsner Health with Humana. According to Epic, the arrangement reduced Mayo’s denials due to additional documentation requests by 63% for professional billing.

Automating with just one payer still means the clinician has to deal with manual processes at other payers, but a large clinician could have sufficient volume with that one payer to make the arrangement useful.
 

Will payers automate prior authorization?

Ultimately, payers may take the automation business away from vendors, offering a free product to all clinicians. But don’t hold your breath. Payers first have to rebuild their electronic systems to accommodate an electronic connection with providers. Even then, some payers might hold back from automating, forcing practices to continue manually processing some prior authorizations.

Efforts are underway, however, to mandate payers to support prior authorization automation. For this to happen, payers would have to revamp their data so that it could be easily read by practices’ EHRs. This would mean adopting a specific interoperability standard called Health Level 7 Fast Healthcare Interoperability Resources (FHIR).

Toward this goal, the Centers for Medicare & Medicaid Services proposes to require payers to adopt FHIR by January 2026. (CMS still has to finalize the rule.) Experts say the two-year ramp-up time is needed because it takes extensive work for payers to translate their data into FHIR.

The only payer so far to switch to FHIR for prior authorization is Regence in Washington state. In a pilot project, it has automated prior authorization with just one provider, MultiCare Connected Care, an accountable care organization (ACO), also in Washington state.

Anna Taylor, associate vice president of population health and value-based care at MultiCare, explained how the arrangement works. “Two separate entities are sharing one operational process,” she told this news organization. “That means they can have a digital conversation back and forth, so it is much easier to resolve prior authorization issues.” 

Unlike many vendor products, the Regence service is free. And while the vendors market only to large organizations, most doctors in the MultiCare arrangement are in independent practices. Ms. Taylor said these doctors have been “enthusiastic” about the arrangement.

The results of the pilot are impressive. Ms. Taylor said automation has resulted in a 233% productivity gain for MultiCare clinicians, and 89% of submissions to Regence get an immediate response.

There is a potential downside, however, to working directly with payers. A direct connection to clinicians allows payers to access the doctor’s clinical notes, which could make many doctors uneasy. But Ms. Taylor said Regence only has access to the “discrete data fields” on MultiCare’s EHR dashboard, not to the notes themselves.

The ultimate goal of the Regence-Multicare project is to include more payers and clinicians. Ms. Taylor said two of the 27 other payers that MultiCare works with are “highly interested,” but it would take a lot of work for them to get connected with practices and other clinicians. 

Ultimately, payers could offer automation and third-party vendors might then fade away. However, physicians may resist working directly with payers if the arrangement requires full access to their medical records.

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

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.