Jennifer Lubell

Two illicit drugs are contributing to a sharp rise in fentanyl-related deaths, a new study from the Centers for Disease Control and Prevention shows.

Para-fluorofentanyl, a schedule I substance often found in heroin packets and counterfeit pills, is making a comeback on the illicit drug market, Jordan Trecki, PhD, and associates reported in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2022 Jan 28;71[4]:153-5). U.S. medical examiner reports and national law enforcement seizure data point to a rise in encounters of this drug along with metonitazene, a benzimidazole-opioid, in combination with fentanyl.

On their own, para-fluorofentanyl and metonitazene can kill the user through respiratory depression. Combinations of these substances and other opioids, including fentanyl-related compounds or adulterants, “pose an even greater potential harm to the patient than previously observed,” reported Dr. Trecki, a pharmacologist affiliated with the Drug Enforcement Administration, and colleagues.

Opioids contribute to about 75% of all U.S. drug overdose deaths, which rose by 28.5% during 2020-2021, according to the National Center for Health Statistics. And fentanyl is replacing heroin as the primary drug of use, said addiction specialist Brian Fuehrlein, MD, PhD, in an interview.

“For patients with stimulant use disorder and even cannabis use disorder, fentanyl is becoming more and more common as an adulterant in those substances, often resulting in inadvertent use. Hence, fentanyl and fentanyl-like drugs and fentanyl analogues are becoming increasingly common and important,” said Dr. Fuehrlein, director of the psychiatric emergency room at the VA Connecticut Healthcare System. He was not involved with the MMWR study.
 

Tennessee data reflect national problem

Recent data from a medical examiner in Knoxville, Tenn., illustrate what might be happening nationwide with those two emerging substances.

Over the last 2 years, the Knox County Regional Forensic Center has identified para-fluorofentanyl in the toxicology results of drug overdose victims, and metonitazene – either on its own or in combination with fentanyl and para-fluorofentanyl. Fentanyl appeared in 562 or 73% of 770 unintentional drug overdose deaths from November 2020 to August 2021. Forty-eight of these cases involved para-fluorofentanyl, and 26 involved metonitazene.

“Although the percentage of law enforcement encounters with these substances in Tennessee decreased relative to the national total percentage within this time frame, the increase in encounters both within Tennessee and nationally reflect an increased distribution of para-fluorofentanyl and metonitazene throughout the United States,” the authors reported.
 

How to identify substances, manage overdoses

The authors encouraged physicians, labs, and medical examiners to be on the lookout for these two substances either in the emergency department or when identifying the cause of drug overdose deaths.

They also advised that stronger opioids, such as fentanyl, para-fluorofentanyl, metonitazene, or other benzimidazoles may warrant additional doses of the opioid-reversal drug naloxone.

While he hasn’t personally seen any of these drugs in his practice, “I would assume that these are on the rise due to inexpensive cost to manufacture and potency of effect,” said Dr. Fuehrlein, also an associate professor of psychiatry at Yale University, New Haven, Conn.

The need for additional naloxone to manage acute overdoses is a key takeaway of the MMWR paper, he added. Clinicians should also educate patients about harm reduction strategies to avoid overdose death when using potentially powerful and unknown drugs. “Things like start low and go slow, buy from the same supplier, do not use opioids with alcohol or benzos, have Narcan available, do not use alone, etc.”

Dr. Fuehrlein had no disclosures.

Two illicit drugs are contributing to a sharp rise in fentanyl-related deaths, a new study from the Centers for Disease Control and Prevention shows.

Para-fluorofentanyl, a schedule I substance often found in heroin packets and counterfeit pills, is making a comeback on the illicit drug market, Jordan Trecki, PhD, and associates reported in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2022 Jan 28;71[4]:153-5). U.S. medical examiner reports and national law enforcement seizure data point to a rise in encounters of this drug along with metonitazene, a benzimidazole-opioid, in combination with fentanyl.

On their own, para-fluorofentanyl and metonitazene can kill the user through respiratory depression. Combinations of these substances and other opioids, including fentanyl-related compounds or adulterants, “pose an even greater potential harm to the patient than previously observed,” reported Dr. Trecki, a pharmacologist affiliated with the Drug Enforcement Administration, and colleagues.

Opioids contribute to about 75% of all U.S. drug overdose deaths, which rose by 28.5% during 2020-2021, according to the National Center for Health Statistics. And fentanyl is replacing heroin as the primary drug of use, said addiction specialist Brian Fuehrlein, MD, PhD, in an interview.

“For patients with stimulant use disorder and even cannabis use disorder, fentanyl is becoming more and more common as an adulterant in those substances, often resulting in inadvertent use. Hence, fentanyl and fentanyl-like drugs and fentanyl analogues are becoming increasingly common and important,” said Dr. Fuehrlein, director of the psychiatric emergency room at the VA Connecticut Healthcare System. He was not involved with the MMWR study.
 

Tennessee data reflect national problem

Recent data from a medical examiner in Knoxville, Tenn., illustrate what might be happening nationwide with those two emerging substances.

Over the last 2 years, the Knox County Regional Forensic Center has identified para-fluorofentanyl in the toxicology results of drug overdose victims, and metonitazene – either on its own or in combination with fentanyl and para-fluorofentanyl. Fentanyl appeared in 562 or 73% of 770 unintentional drug overdose deaths from November 2020 to August 2021. Forty-eight of these cases involved para-fluorofentanyl, and 26 involved metonitazene.

“Although the percentage of law enforcement encounters with these substances in Tennessee decreased relative to the national total percentage within this time frame, the increase in encounters both within Tennessee and nationally reflect an increased distribution of para-fluorofentanyl and metonitazene throughout the United States,” the authors reported.
 

How to identify substances, manage overdoses

The authors encouraged physicians, labs, and medical examiners to be on the lookout for these two substances either in the emergency department or when identifying the cause of drug overdose deaths.

They also advised that stronger opioids, such as fentanyl, para-fluorofentanyl, metonitazene, or other benzimidazoles may warrant additional doses of the opioid-reversal drug naloxone.

While he hasn’t personally seen any of these drugs in his practice, “I would assume that these are on the rise due to inexpensive cost to manufacture and potency of effect,” said Dr. Fuehrlein, also an associate professor of psychiatry at Yale University, New Haven, Conn.

The need for additional naloxone to manage acute overdoses is a key takeaway of the MMWR paper, he added. Clinicians should also educate patients about harm reduction strategies to avoid overdose death when using potentially powerful and unknown drugs. “Things like start low and go slow, buy from the same supplier, do not use opioids with alcohol or benzos, have Narcan available, do not use alone, etc.”

Dr. Fuehrlein had no disclosures.

Two illicit drugs are contributing to a sharp rise in fentanyl-related deaths, a new study from the Centers for Disease Control and Prevention shows.

Para-fluorofentanyl, a schedule I substance often found in heroin packets and counterfeit pills, is making a comeback on the illicit drug market, Jordan Trecki, PhD, and associates reported in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2022 Jan 28;71[4]:153-5). U.S. medical examiner reports and national law enforcement seizure data point to a rise in encounters of this drug along with metonitazene, a benzimidazole-opioid, in combination with fentanyl.

On their own, para-fluorofentanyl and metonitazene can kill the user through respiratory depression. Combinations of these substances and other opioids, including fentanyl-related compounds or adulterants, “pose an even greater potential harm to the patient than previously observed,” reported Dr. Trecki, a pharmacologist affiliated with the Drug Enforcement Administration, and colleagues.

Opioids contribute to about 75% of all U.S. drug overdose deaths, which rose by 28.5% during 2020-2021, according to the National Center for Health Statistics. And fentanyl is replacing heroin as the primary drug of use, said addiction specialist Brian Fuehrlein, MD, PhD, in an interview.

“For patients with stimulant use disorder and even cannabis use disorder, fentanyl is becoming more and more common as an adulterant in those substances, often resulting in inadvertent use. Hence, fentanyl and fentanyl-like drugs and fentanyl analogues are becoming increasingly common and important,” said Dr. Fuehrlein, director of the psychiatric emergency room at the VA Connecticut Healthcare System. He was not involved with the MMWR study.
 

Tennessee data reflect national problem

Recent data from a medical examiner in Knoxville, Tenn., illustrate what might be happening nationwide with those two emerging substances.

Over the last 2 years, the Knox County Regional Forensic Center has identified para-fluorofentanyl in the toxicology results of drug overdose victims, and metonitazene – either on its own or in combination with fentanyl and para-fluorofentanyl. Fentanyl appeared in 562 or 73% of 770 unintentional drug overdose deaths from November 2020 to August 2021. Forty-eight of these cases involved para-fluorofentanyl, and 26 involved metonitazene.

“Although the percentage of law enforcement encounters with these substances in Tennessee decreased relative to the national total percentage within this time frame, the increase in encounters both within Tennessee and nationally reflect an increased distribution of para-fluorofentanyl and metonitazene throughout the United States,” the authors reported.
 

How to identify substances, manage overdoses

The authors encouraged physicians, labs, and medical examiners to be on the lookout for these two substances either in the emergency department or when identifying the cause of drug overdose deaths.

They also advised that stronger opioids, such as fentanyl, para-fluorofentanyl, metonitazene, or other benzimidazoles may warrant additional doses of the opioid-reversal drug naloxone.

While he hasn’t personally seen any of these drugs in his practice, “I would assume that these are on the rise due to inexpensive cost to manufacture and potency of effect,” said Dr. Fuehrlein, also an associate professor of psychiatry at Yale University, New Haven, Conn.

The need for additional naloxone to manage acute overdoses is a key takeaway of the MMWR paper, he added. Clinicians should also educate patients about harm reduction strategies to avoid overdose death when using potentially powerful and unknown drugs. “Things like start low and go slow, buy from the same supplier, do not use opioids with alcohol or benzos, have Narcan available, do not use alone, etc.”

Dr. Fuehrlein had no disclosures.

Rheumatologists seeking fellowships continue to show a preference for adult programs. Adult rheumatology programs filled nearly 100% of positions this year, but pediatric rheumatology programs filled only 69% of available slots, echoing trends of previous years.

The National Resident Matching Program (NRMP) issued results for 2021’s Medical Specialties Matching Program (MSMP) and Pediatric Specialties Match (PSM) in December.

“In pediatric rheumatology, like many other pediatric specialties, the limiting factor is the number of interested candidates. The number of available positions has not really changed over the last several years, but multiple positions again remained unfilled this year,” said Beth Marston, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, in a statement.

Rheumatology was one of seven medical specialties that filled at least 95% of fellowship positions this year.

The specialty filled 120 of 125 enrolled programs (96%) and 266 of 272 certified positions (97.8%) in 2021. A total of 42.1% of the matched applicants comprised MD graduates, followed by foreign (27.1%), U.S. foreign (16.5%), and DO graduates (14.3%).

Among 357 applicants preferring this specialty in 2021, 73.9% (n = 264) matched to rheumatology. This meant that 22.1% did not match to any program. This scenario has played out over the last several years, Dr. Marston noted. Additional support for funding and the creation of more fellowship positions would translate to an increase in rheumatology graduates entering the workforce.

This could help mitigate workforce shortages that the ACR projected in 2015, she added.

Pediatric program applicants remain stagnant

For pediatric fellowships, the numbers weren’t as robust. Just 60% of 32 enrolled programs and 69.2% positions filled in 2021. MD graduates comprised most of the matched applicants (77.8%), followed by U.S. foreign (14.8%) and foreign and DO graduates (3.7% each). Overall, 27 out of 28 applicants or 96.4% matched to this specialty, a metric that’s remained steady but has not grown in recent years, Dr. Marston said.

This “suggests the need for additional efforts to understand and address barriers to choosing rheumatology fellowship training as a career path for pediatricians,” she said. The ACR’s Committee on Training and Workforce recently initiated a survey of combined medicine-pediatrics graduates in rheumatology to gain insights on why these graduates chose this career path.

The ACR is also looking into increasing access to rheumatology specialty care in underserved areas and finding creative solutions for increasing and filling rheumatology fellowship positions.
 

Largest match on record

Overall, 7,435 applicants participated in the 2021 MSMP, the largest on record. NRMP reported that 2,277 programs submitted rank order lists and offered 6,368 positions, an increase of more than 11% from 2020, respectively. A total of 90.4% positions (n = 5,759) were filled.

“The 2021 MSMP matched a record number of applicants to subspecialty training programs for positions set to begin July 2022,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, said in a statement. “It’s rewarding to watch the MSMP grow, not only in terms of applicant interest and available training positions, but also from its launch 20 years ago with only three internal medicine subspecialties.”

NRMP largely attributed the increase in positions to the addition of critical care medicine, the latest subspecialty to join the MSMP. All fellows begin their training in July 2022.

The PSM also saw notable increases this year in several metrics. It offered 1,735 positions this year, a 5.9% increase from 2020. Overall, 1,507 positions (86.9%) were filled, a 6.6% increase from last year. 854 programs participated.

Rheumatologists seeking fellowships continue to show a preference for adult programs. Adult rheumatology programs filled nearly 100% of positions this year, but pediatric rheumatology programs filled only 69% of available slots, echoing trends of previous years.

The National Resident Matching Program (NRMP) issued results for 2021’s Medical Specialties Matching Program (MSMP) and Pediatric Specialties Match (PSM) in December.

“In pediatric rheumatology, like many other pediatric specialties, the limiting factor is the number of interested candidates. The number of available positions has not really changed over the last several years, but multiple positions again remained unfilled this year,” said Beth Marston, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, in a statement.

Rheumatology was one of seven medical specialties that filled at least 95% of fellowship positions this year.

The specialty filled 120 of 125 enrolled programs (96%) and 266 of 272 certified positions (97.8%) in 2021. A total of 42.1% of the matched applicants comprised MD graduates, followed by foreign (27.1%), U.S. foreign (16.5%), and DO graduates (14.3%).

Among 357 applicants preferring this specialty in 2021, 73.9% (n = 264) matched to rheumatology. This meant that 22.1% did not match to any program. This scenario has played out over the last several years, Dr. Marston noted. Additional support for funding and the creation of more fellowship positions would translate to an increase in rheumatology graduates entering the workforce.

This could help mitigate workforce shortages that the ACR projected in 2015, she added.

Pediatric program applicants remain stagnant

For pediatric fellowships, the numbers weren’t as robust. Just 60% of 32 enrolled programs and 69.2% positions filled in 2021. MD graduates comprised most of the matched applicants (77.8%), followed by U.S. foreign (14.8%) and foreign and DO graduates (3.7% each). Overall, 27 out of 28 applicants or 96.4% matched to this specialty, a metric that’s remained steady but has not grown in recent years, Dr. Marston said.

This “suggests the need for additional efforts to understand and address barriers to choosing rheumatology fellowship training as a career path for pediatricians,” she said. The ACR’s Committee on Training and Workforce recently initiated a survey of combined medicine-pediatrics graduates in rheumatology to gain insights on why these graduates chose this career path.

The ACR is also looking into increasing access to rheumatology specialty care in underserved areas and finding creative solutions for increasing and filling rheumatology fellowship positions.
 

Largest match on record

Overall, 7,435 applicants participated in the 2021 MSMP, the largest on record. NRMP reported that 2,277 programs submitted rank order lists and offered 6,368 positions, an increase of more than 11% from 2020, respectively. A total of 90.4% positions (n = 5,759) were filled.

“The 2021 MSMP matched a record number of applicants to subspecialty training programs for positions set to begin July 2022,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, said in a statement. “It’s rewarding to watch the MSMP grow, not only in terms of applicant interest and available training positions, but also from its launch 20 years ago with only three internal medicine subspecialties.”

NRMP largely attributed the increase in positions to the addition of critical care medicine, the latest subspecialty to join the MSMP. All fellows begin their training in July 2022.

The PSM also saw notable increases this year in several metrics. It offered 1,735 positions this year, a 5.9% increase from 2020. Overall, 1,507 positions (86.9%) were filled, a 6.6% increase from last year. 854 programs participated.

Rheumatologists seeking fellowships continue to show a preference for adult programs. Adult rheumatology programs filled nearly 100% of positions this year, but pediatric rheumatology programs filled only 69% of available slots, echoing trends of previous years.

The National Resident Matching Program (NRMP) issued results for 2021’s Medical Specialties Matching Program (MSMP) and Pediatric Specialties Match (PSM) in December.

“In pediatric rheumatology, like many other pediatric specialties, the limiting factor is the number of interested candidates. The number of available positions has not really changed over the last several years, but multiple positions again remained unfilled this year,” said Beth Marston, MD, chair of the American College of Rheumatology’s Committee on Rheumatology Training and Workforce Issues, in a statement.

Rheumatology was one of seven medical specialties that filled at least 95% of fellowship positions this year.

The specialty filled 120 of 125 enrolled programs (96%) and 266 of 272 certified positions (97.8%) in 2021. A total of 42.1% of the matched applicants comprised MD graduates, followed by foreign (27.1%), U.S. foreign (16.5%), and DO graduates (14.3%).

Among 357 applicants preferring this specialty in 2021, 73.9% (n = 264) matched to rheumatology. This meant that 22.1% did not match to any program. This scenario has played out over the last several years, Dr. Marston noted. Additional support for funding and the creation of more fellowship positions would translate to an increase in rheumatology graduates entering the workforce.

This could help mitigate workforce shortages that the ACR projected in 2015, she added.

Pediatric program applicants remain stagnant

For pediatric fellowships, the numbers weren’t as robust. Just 60% of 32 enrolled programs and 69.2% positions filled in 2021. MD graduates comprised most of the matched applicants (77.8%), followed by U.S. foreign (14.8%) and foreign and DO graduates (3.7% each). Overall, 27 out of 28 applicants or 96.4% matched to this specialty, a metric that’s remained steady but has not grown in recent years, Dr. Marston said.

This “suggests the need for additional efforts to understand and address barriers to choosing rheumatology fellowship training as a career path for pediatricians,” she said. The ACR’s Committee on Training and Workforce recently initiated a survey of combined medicine-pediatrics graduates in rheumatology to gain insights on why these graduates chose this career path.

The ACR is also looking into increasing access to rheumatology specialty care in underserved areas and finding creative solutions for increasing and filling rheumatology fellowship positions.
 

Largest match on record

Overall, 7,435 applicants participated in the 2021 MSMP, the largest on record. NRMP reported that 2,277 programs submitted rank order lists and offered 6,368 positions, an increase of more than 11% from 2020, respectively. A total of 90.4% positions (n = 5,759) were filled.

“The 2021 MSMP matched a record number of applicants to subspecialty training programs for positions set to begin July 2022,” NRMP President and CEO Donna L. Lamb, DHSc, MBA, said in a statement. “It’s rewarding to watch the MSMP grow, not only in terms of applicant interest and available training positions, but also from its launch 20 years ago with only three internal medicine subspecialties.”

NRMP largely attributed the increase in positions to the addition of critical care medicine, the latest subspecialty to join the MSMP. All fellows begin their training in July 2022.

The PSM also saw notable increases this year in several metrics. It offered 1,735 positions this year, a 5.9% increase from 2020. Overall, 1,507 positions (86.9%) were filled, a 6.6% increase from last year. 854 programs participated.

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

The advisory on youth mental health from Surgeon General Vivek Murthy, MD, casts a necessary spotlight on the crisis, clinical psychiatrists say. But some think it could have produced more specifics about funding and payment parity for reimbursement.

The 53-page advisory says that about one in five U.S. children and adolescents aged 3-17 suffer from a mental, emotional, developmental, or behavioral disorder. In the decade before COVID, feelings of sadness and hopelessness, as well as suicidal behaviors, were on the rise. The pandemic has exacerbated symptoms of anxiety, depression, and other mental health issues in young people. Compared with 2019, ED visits in early 2021 for suspected suicide attempts rose 51% in adolescent girls and 4% in boys. “Depressive and anxiety symptoms doubled during the pandemic,” the advisory said.
 

Scope of the advisory

The advisory, released Dec. 7, covers all sectors and considers all social and policy factors that might be contributing to this crisis, said Jessica (Jessi) Gold, MD, MS, an assistant professor in the department of psychiatry at Washington University, St. Louis.

“It is always possible to reimagine health care to be more patient centered and mental health forward.” But changes of this magnitude take time, Dr. Gold, also director of wellness, engagement, and outreach at the university, said in an interview.

She has seen the impact of the pandemic firsthand in her clinic among students and frontline health care workers aged 18-30. People in that age group “feel everything deeply,” Dr. Gold said. Emotions tied to COVID-19 are just a part of it. Confounding factors, such as climate change, racism, and school shootings all contribute to their overall mental health.

Some children and adolescents with social anxiety have fared better during the pandemic, but those who are part of demographic groups such as racial and ethnic minorities, LGBTQ individuals, low-income youth, and those involved in juvenile justice or welfare systems face a higher risk of mental health challenges, the pandemic notwithstanding.

In her work with schools, Denese Shervington, MD, MPH, has witnessed more mental health challenges related to isolation and separation. “There’s an overall worry about the loss of what used to be, the seeming predictability and certainty of prepandemic life,” said Dr. Shervington, clinical professor of psychiatry at Tulane University, and president and CEO of the Institute for Women and Ethnic Studies, both in New Orleans.
 

A systems of care plan

The advisory lists actionable items for health care and 10 other industry sectors to improve mental health of children and young adults.

Health care organizations and professionals were advised to take the following six steps:

• Implement trauma-informed care principles and other prevention strategies. This may involve referring patients to resources such as economic and legal supports, school enrichment programs, and educating families on healthy child development in the clinic.
• Routinely screen children for mental health challenges and risk factors such as adverse childhood experiences during primary care well-visits or annual physicals, or at schools or EDs. Primary care physicians should use principles of trauma-informed care to conduct these screenings.
• Screen parents, caregivers, and other family members for depression, intimate partner violence, substance use, and other challenges. These can be done in tandem with broader assessments of social determinants of health such as food or housing insecurity.
• Combine efforts of clinical staff with trusted community partners and child welfare and juvenile justice. Hospital-based violence intervention programs, for example, identify patients at risk of repeat violent injury and refer them to hospital- and community-based resources.
• Build multidisciplinary teams, enlisting children and families to develop services that are tailored to their needs for screening and treatment. Such services should reflect cultural diversity and offered in multiple languages.
• Support the well-being of mental health workers and community leaders to foster their ability to help youth and their families.

Dr. Murthy is talking about a “systems of care” approach, in which all sectors that touch children and youth – not just health care – must work together and do their jobs effectively but collaboratively to address this public health crisis, said Aradhana (Bela) Sood MD, MSHA, FAACAP, senior professor of child mental health policy at Virginia Commonwealth University, Richmond. “An investment in infrastructure support of positive mental health in early childhood, be it in schools, communities, or family well-being will lead to a future where illness is not the result of major preventable societal factors, such as a lack of social supports and trauma.”
 

Changes will ‘take a lot of buy-in’

The recommendations are actionable in the real world – but there are a lot of them, said Dr. Gold. Dr. Murthy doesn’t specify what the plan is to accomplish these metrics or fund them, she added. He “has money and funders like foundations as steps, but foundations have also suffered in the pandemic, so it is not that simple.” Many of these changes are wide in scope and will take a lot of buy-in.

Dr. Shervington would like to have seen more of a focus on educator well-being, given that young people spend a lot of time in educational settings.

“My organization just completed a study in New Orleans that showed teachers having elevated levels of trauma-based conditions since the pandemic,” she said. Schools are indeed a key place to support holistic mental health by focusing on school climate, Dr. Sood added. “If school administrators became uniformly consistent with recognizing the importance of psychological wellness as a prerequisite of good learning, they will create environments where teachers are keenly aware of a child’s mental wellness and make reduction of bullying, wellness check-ins, [and] school-based mental health clinics a priority.

“These are ways nonmedical, community-based supports can enhance student well-being, and reduce depression and other mental health conditions,” Dr. Sood added.
 

Child psychiatrists stretched ‘even thinner’

Despite mental health parity rules, health plans have not been held accountable. That failure, combined with excessive demands for prior authorization for mental health treatments “have led to dangerous shortages of psychiatrists able to accept insurance,” said Paul S. Nestadt, MD, an assistant professor and public mental health researcher at Johns Hopkins University, Baltimore.

“This is particularly true for child psychiatrists, who are stretched even thinner than those of us in general practice,” Dr. Nestadt said.

While he doesn’t address it head on, Dr. Murthy uses classic parity language when he states that “mental health is no less important than physical health,” said Dr. Nestadt, who consulted with the surgeon general on developing this advisory. “While many of us would have liked to see parity highlighted more directly, this advisory was designed to be an overview.”
 

Highlighting social media, gun violence

Dr. Nestadt said he was pleased that the advisory emphasized the importance of restricting access to lethal means in preventing youth suicide.

“With youth suicide rates rising faster than in other age groups, and suicide mortality tied so closely to method availability, the surgeon general made the right choice in highlighting the role of guns in suicide,” he said.

The advisory also discussed the role of media and social media companies in addressing the crisis, which is important, said Dr. Gold.

“I believe very strongly that the way we talk about and portray mental health in the media matters,” she said. “I have seen it matter in the clinic with patients. They’ll wonder if someone will think they are now violent if they are diagnosed with a mental illness. Stories change the narrative.”

While the advisory isn’t perfect, the state of youth mental health “will only get worse if we don’t do something,” noted Dr. Gold. “It is critical that this is validated and discussed at the highest level and messages like Dr. Murthy’s get heard.”

Dr. Gold, Dr. Shervington, and Dr. Sood had no disclosures. Dr. Nestadt disclosed serving as a consultant to the surgeon general advisory.

Elizabeth Ortiz, MD, knew she needed a change. Working at an academic county clinic, she was often worn down and pulled in different directions. “When I thought about what I really liked about my job, it was patient care and spending time with my patients, which I wasn’t able to do,” Dr. Ortiz said during the annual meeting of the American College of Rheumatology.

She’d heard of direct or concierge care but wasn’t sure if it was a good fit for her. COVID-19 offered a catalyst of sorts for a move to a new care model.

Ten weeks after she moved to Dallas, the pandemic hit full force. Seeing how telehealth was taking off, Dr. Ortiz began crafting a new model of care, a hybrid of telemedicine and house calls that offered multiple venues to connect with patients. The practice is just a year old, and “it’s working and it’s a constant experiment,” said Dr. Ortiz, who offers membership plans and prepaid appointments. She also does “a la carte” visits where established patients can see her at a one-off price. Her goal is to achieve 100% membership.

Although she operates through a direct pay and cash-only model, only recently has she become comfortable with the word “concierge.” There’s a preconceived notion of what that word means, she said.
 

Direct care: A definition

Following the trend of some primary care practices, more rheumatologists who are dissatisfied with the status quo are embracing these models of care.

Direct and concierge care are often mentioned in tandem, but there are nuanced differences. Direct specialty care removes third-party payers to protect the best interests of patients, according to Diana Girnita, MD, founder and CEO of Rheumatologist OnCall, a direct care practice. Her patient base hails from rural and urban areas in least 10 states. She also created a Facebook group for specialists in direct care and is the cofounder of the Direct Specialty Care Alliance.

Direct care offers a membership fee and additional fees for “as needed” services. “As the physician, I do not have to be contracted to an insurance company to see patients. I contract directly with patients. It is the patient’s choice to contract with an insurance and use the insurance for ancillary services and medication,” Dr. Girnita said. Patients with out-of-network benefits can claim the insurance to cover part of the consultation cost, she added.

In concierge or retainer medicine, a patient pays an annual or monthly fee or retainer to get access to the physician practice. In addition to this fee, the practice can bill the patient’s insurance for consultations or other services. “The concierge model does not eliminate the sub payer. You still contract with the patient’s insurance,” explained Dr. Girnita.

Physicians who establish these models sometimes do a hybrid of cash only and insurance. Micah Yu, MD, who practices rheumatology in Newport Beach, Calif., only takes Medicare. “Otherwise, patients are private pay. I am mainly fee for service, so patients are paying me for my time,” he said.

By tailoring their patient base and services, adopters find they have more time to spend with patients. “In my model, I spend 30 minutes for follow-up and 1 hour for new patients,” Dr. Yu said.
 

Limitations of traditional care

Carrying insurance doesn’t guarantee you the right care, Dr. Girnita said. Wait times to see a rheumatologist range from 4 to 6 months. For physicians who contract with insurance companies, reimbursement for services isn’t always paid promptly and decreases every year. A new cut in reimbursement is expected for rheumatology services in 2022.

Patients in direct care “pay a small amount for memberships that cover the cost of their visits and the time physicians spend in coordinating their additional care between the visits. The cost of the visits is always transparent,” Dr. Girnita said.

Irene Kazmers, MD, a solo private rheumatology practitioner in northern Michigan, was seeing 20-plus patients a day before she made the leap to a concierge model. “The paperwork and administrative burdens of practicing rheumatology as a solo [physician] have mushroomed in the last 10 years,” she said during the ACR meeting. She and staff were spending an inordinate amount of time on prior authorizations, step therapy requirements, electronic health record documentation, and other administrative burdens.

Reimbursements from payers have progressively declined as administrative challenges have necessitated more staff. “I was struggling to maintain an ample financial margin,” she said.
 

Improved communication, unlimited visits

Dr. Kazmers attests that the transition to the concierge model has enabled and fostered a higher level of communication and specialty care for her patients.

Patients who enroll in the practice pay an annual membership fee and get access to her personal cell phone number and email address. “If they need an urgent appointment, it is typically arranged the same or next day,” she said in an interview. “Visits are not as rushed as in the traditional model, conducive to incorporating beneficial integrative medicine modalities such as dietary, exercise, and mind-body approaches as appropriate, in addition to state-of-the-art treatment.”

She also has more time to coordinate care with her patients’ primary care providers and other care team professionals and to give patients feedback on lab and study results.

Dr. Girnita has ramped down from 28 to 15 patients a day. She’s able to spend 60 minutes for new patients and 30 minutes for follow-ups. Like Dr. Kazmers, she feels she has more time to address patient needs and listen to their concerns.

She’s kept her hospital affiliations but finds that she doesn’t have to go to the hospital as much as she used to. Direct care “reduces hospital visits because physicians significantly have much more time to spend with the patient and address the needs of the patient.” A patient with a gout flare, for example, may end up in the hospital under traditional care because there’s no room in the physician’s schedule to address the patient’s needs.

Dr. Girnita recalled when she assisted a patient who had developed inflammatory arthritis and was desperate to see a doctor. The patient had good insurance, but appointments in her area weren’t available for at least 6 months. “Her primary care physician called me. I saw her and provided her with the appropriate care. A couple of months later she is doing great.”
 

What insurance does and doesn’t cover

Many patients who seek out direct or concierge models retain their insurance. At least 90% of Dr. Girnita’s patients have insurance with high deductibles. The other 10% have other types of insurance or no insurance.

Ellen McKnight, MD, who has a hybrid rheumatology practice in Pensacola, Fla., still accepts commercial insurance, but has opted out of Medicare. Her patients mostly come from rural areas in Florida, and their insurance situations vary widely. “In my practice, I estimate that 65% have insurance and 35% do not. Most of my patients have commercial insurance, and a substantial portion, about 40%, are just paying cash. My cash pay patients have Medicare, HMOs, and others are uninsured,” she said in an interview.

Direct care practices may continue to bill traditional insurance for items like visits, injections, and ultrasound.

Dr. Girnita’s patients have the option of submitting a “superbill” or invoice to insurance companies for patients to be reimbursed by their insurance for the cost of the visit. It contains the CPT code for the visit along with the ICD-10 codes for diagnoses. “I use a company called Reimbursify to help patients submit their invoice to their insurance company,” Dr. Girnita said.

Dr. Ortiz takes a different approach, offering superbills for consults and individual appointments, but not for patients enrolled in her membership program.

Some in the payer industry contend that direct care arrangements increase costs and distort risk pools. If most direct care patients already have a comprehensive health insurance policy, it’s likely they’re being billed twice for services, said David Allen, spokesperson for America’s Health Insurance Plans.

“Duplicative payments inflate the cost of care at a convenience to the providers and increase the cost of insurance premiums when insurers receive bills for those same services from providers. In other words, patients are being double billed,” Mr. Allen said.

These providers are assuming risk without state insurance oversight or regulations to ensure patient protections and safeguards are in place, he continued. “If utilization of services outpaces capacity, the provider may ultimately be unable to provide the amount of care expected by the patient because their practice agreed to unlimited visits and services with little or no restrictions.”
 

Eliminating ‘surprise’ bills

Adopters of direct care/concierge services counter that it’s the insurance and pharmaceutical companies driving up costs. Patients – especially those who have high-deductible plans – save money through these models. “In the direct care model, doctors have worked out advocacy for patients that are unsurpassed. Insurance companies don’t do that,” Dr. McKnight said.

Consumers know up front what the price is for other services. When you go to a restaurant, you always look on the menu to see what the price is for a bottle of wine or steak, Dr. Girnita said. “Only in the medical field you don’t know anything. And you’re shocked about the price you must pay.” Not many practices list their prices on their website, although federal rules seek to further increase price transparency in hospitals and among insurers.

Patients will sometimes get a “surprise” bill for their visit, laboratory, or imaging tests. According to Dr. Girnita, “that doesn’t happen in my practice. I discuss all prices with them before they get to the lab or MRI. I don’t charge copayments or anything extra.” Without a copayment – usually $50-$75 for specialist services – or a surprise bill, patients are always paying less, she said.

Costs through insurance are oftentimes higher, she continued. For routine lab work, a patient in a direct care practice pays about $30-$40. If they request this work through a lab, they’re likely to pay $150. “Think about an MRI. Through a direct care practice like mine, you pay $450-$700. In a hospital setting, you pay at least $5,000.”

Patients with high-deductible insurance plans often pay thousands of dollars before meeting their deductible, Dr. Girnita and others noted. A patient with this type of plan may pay $250 for a vitamin D lab if they haven’t met their deductible, Dr. McKnight explained. “With direct care, you’ll be paying $12.50.”

Dr. Girnita said her members get excellent discounts for labs and imaging. In the direct care models, physicians can help with this by contracting directly with labs, imaging centers, and independent pharmacies, giving patients access to affordable and transparent prices for their medical care.
 

What patients pay for services

In direct and concierge care membership models, coverage for services and fees vary widely from practice to practice.

Dr. Girnita offers several membership options. One package, which is $199 a month, is for patients with stable symptoms that guarantee continuity of care. It includes four visits a year and immediate access to the practice in case of emergency (including two additional urgent visits). “This works for a lot of patients. They consider that affordable, and they have all the benefits of a concierge practice. They can have direct communication with me, and they have guaranteed continuity of care,” Dr. Girnita said.

The other model, which is $299 per month, is for patients who need monthly contact with the rheumatologist for visits, telephone and email communications, urgent appointments, integrative medicine consultations, and many other benefits. For 1-hour consultations, Dr. Girnita charges $399.

Dr. Ortiz, who offers a direct pay model, charges $899 for an initial consult, which covers 3.5 hours of her time. “We do an hour of telemedicine, and we do a house call, which is 1.5-2 hours.” She follows up with a telehealth visit. Labs and x-rays are not included and go through the patient’s insurance.

Once the consult takes place, she assesses what a patient needs and offers them either a 6- or 12-month membership, which includes unlimited visits.

Patients can also buy a prepaid, six-appointment package with a 12% discount. Dr. Ortiz prices her telehealth visits at $350 and house calls at $550.

Dr. McKnight’s cash-only model for established patients offers four visits a year, reducing the fee for each visit. For example, a patient will pay $95 for the first visit, then $90, $85, and $80 for subsequent visits.

Accessing medications through direct care

One challenge with this model is finding affordable medications for patients outside of insurance.

Insurance dictates what’s covered, leaving fewer options for patients, Dr. McKnight said. “You have to jump through hoops, and there’s prior authorizations.” For a condition like severe osteoporosis, treatment should start sequentially with the true bone builders first, then move on to a medication like alendronate (Fosamax).

“Insurers will make you go to Fosamax first and then fail it,” she said. This results in the patient potentially developing worsening bone loss or possibly even sustaining a fracture.

Prior authorization requirements demand excessive staff time and effort, Dr. Kazmers said. This can translate to more than $90,000 a year in human resource costs for rheumatologists, who often deal with many specialty drug authorizations. “Every practice needs to hire staff to handle prior authorizations. We receive no compensation for this from the pharmaceutical companies and middlemen who ultimately profit from this cumbersome process,” she added.

Among the two big classes for rheumatology patients, conventional synthetic disease-modifying antirheumatic drugs (DMARDs) are the most widely available. Pharmacies can offer DMARDs for cash, although some are limited in terms of where they can ship, Dr. Girnita said.

The other class, biologic DMARDs, are the most expensive medications rheumatologists use for conditions such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.

With biologics, it’s more difficult, as they’re very expensive, typically $6,000 a month or more, sources told this news organization.

“Unfortunately, we can’t partner at this time with pharmaceutical companies that produce biologics or independent pharmacies,” Dr. Girnita said. Physicians can’t control biologic prices either. “Insurance companies and pharmacy benefit managers have the control on these prices.”

Physicians can direct patients to multiple resources where they can find assistance.

Biologics companies that offer patient assistance programs can sometimes offer medications for free, while others offer savings cards or copay cards, “which helps a lot,” Dr. Girnita said. She assists her patients by filing some of the paperwork necessary to qualify for these programs, and the patients submit the rest.

“For these companies to help the patient, they need the patient’s financial information,” she said. “But I do most of that work; I complete the forms and send to the company and justify need for the medication.”
 

What’s ahead for direct specialty care

While some patients have benefited, others have had to seek alternatives as their doctors transition to alternative models.

Not everyone can afford the concierge retainer fee, said Dr. Kazmers, who practices in a rural area of Michigan, where rheumatologists are scarce. Enrollment in her concierge practice filled months before the switchover from her traditional practice took place. There are 70 patients on a waiting list.

Patients who elect not to enroll in the concierge practice need to find another source of rheumatology care. This is a downside to the practice transition, she acknowledged. “The closest rheumatologist taking new patients is a 3- to 4-hour drive away, which simply reflects the shortage of medical school graduates choosing to go into rheumatology in the United States,” Dr. Kazmers added.

One physician caring for thousands of chronically ill, complicated patients within systems that don’t allow them the time to really care for their patients threatens to make the access problem worse, Dr. Ortiz said. The direct care/concierge model offers an alternative for the provider “and is a way to keep providers in the workforce, who may otherwise consider leaving.”

Direct care/concierge medicine isn’t for all doctors. But for Dr. Kazmers, it’s the best option for her at this point in her career. “I’ve been practicing for 45 years in various models, including academic positions and private practice employment. I have worked for years in settings accepting Medicaid. I understand that if every rheumatologist went concierge tomorrow, this would constrict access to needed specialty care. But in my case, it provided a viable alternative to closing the practice’s doors altogether.”

Ultimately, the U.S. medical system needs more rheumatologists and other specialists. “If you really want to increase the service, then Medicare or other sources should support opening more residency and fellowship spots for medical graduates to pursue,” Dr. Girnita said.

Other solutions call for more systemic and institutional changes, such as expanding rheumatology divisions and faculties at institutions that train fellows and addressing medical school debt, Dr. Ortiz said.

Some practices see themselves branching out from individual patient care and partnering with local businesses to provide care for employees. That’s the future for direct specialty care, said Dr. Girnita, who’s been in discussions with a few employers to make such arrangements.

The direct primary care community has already started to contract with employers. “Their employees get care they need for just a fraction of the cost. These discussions are arising more and more,” she said.

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

Elizabeth Ortiz, MD, knew she needed a change. Working at an academic county clinic, she was often worn down and pulled in different directions. “When I thought about what I really liked about my job, it was patient care and spending time with my patients, which I wasn’t able to do,” Dr. Ortiz said during the annual meeting of the American College of Rheumatology.

She’d heard of direct or concierge care but wasn’t sure if it was a good fit for her. COVID-19 offered a catalyst of sorts for a move to a new care model.

Ten weeks after she moved to Dallas, the pandemic hit full force. Seeing how telehealth was taking off, Dr. Ortiz began crafting a new model of care, a hybrid of telemedicine and house calls that offered multiple venues to connect with patients. The practice is just a year old, and “it’s working and it’s a constant experiment,” said Dr. Ortiz, who offers membership plans and prepaid appointments. She also does “a la carte” visits where established patients can see her at a one-off price. Her goal is to achieve 100% membership.

Although she operates through a direct pay and cash-only model, only recently has she become comfortable with the word “concierge.” There’s a preconceived notion of what that word means, she said.
 

Direct care: A definition

Following the trend of some primary care practices, more rheumatologists who are dissatisfied with the status quo are embracing these models of care.

Direct and concierge care are often mentioned in tandem, but there are nuanced differences. Direct specialty care removes third-party payers to protect the best interests of patients, according to Diana Girnita, MD, founder and CEO of Rheumatologist OnCall, a direct care practice. Her patient base hails from rural and urban areas in least 10 states. She also created a Facebook group for specialists in direct care and is the cofounder of the Direct Specialty Care Alliance.

Direct care offers a membership fee and additional fees for “as needed” services. “As the physician, I do not have to be contracted to an insurance company to see patients. I contract directly with patients. It is the patient’s choice to contract with an insurance and use the insurance for ancillary services and medication,” Dr. Girnita said. Patients with out-of-network benefits can claim the insurance to cover part of the consultation cost, she added.

In concierge or retainer medicine, a patient pays an annual or monthly fee or retainer to get access to the physician practice. In addition to this fee, the practice can bill the patient’s insurance for consultations or other services. “The concierge model does not eliminate the sub payer. You still contract with the patient’s insurance,” explained Dr. Girnita.

Physicians who establish these models sometimes do a hybrid of cash only and insurance. Micah Yu, MD, who practices rheumatology in Newport Beach, Calif., only takes Medicare. “Otherwise, patients are private pay. I am mainly fee for service, so patients are paying me for my time,” he said.

By tailoring their patient base and services, adopters find they have more time to spend with patients. “In my model, I spend 30 minutes for follow-up and 1 hour for new patients,” Dr. Yu said.
 

Limitations of traditional care

Carrying insurance doesn’t guarantee you the right care, Dr. Girnita said. Wait times to see a rheumatologist range from 4 to 6 months. For physicians who contract with insurance companies, reimbursement for services isn’t always paid promptly and decreases every year. A new cut in reimbursement is expected for rheumatology services in 2022.

Patients in direct care “pay a small amount for memberships that cover the cost of their visits and the time physicians spend in coordinating their additional care between the visits. The cost of the visits is always transparent,” Dr. Girnita said.

Irene Kazmers, MD, a solo private rheumatology practitioner in northern Michigan, was seeing 20-plus patients a day before she made the leap to a concierge model. “The paperwork and administrative burdens of practicing rheumatology as a solo [physician] have mushroomed in the last 10 years,” she said during the ACR meeting. She and staff were spending an inordinate amount of time on prior authorizations, step therapy requirements, electronic health record documentation, and other administrative burdens.

Reimbursements from payers have progressively declined as administrative challenges have necessitated more staff. “I was struggling to maintain an ample financial margin,” she said.
 

Improved communication, unlimited visits

Dr. Kazmers attests that the transition to the concierge model has enabled and fostered a higher level of communication and specialty care for her patients.

Patients who enroll in the practice pay an annual membership fee and get access to her personal cell phone number and email address. “If they need an urgent appointment, it is typically arranged the same or next day,” she said in an interview. “Visits are not as rushed as in the traditional model, conducive to incorporating beneficial integrative medicine modalities such as dietary, exercise, and mind-body approaches as appropriate, in addition to state-of-the-art treatment.”

She also has more time to coordinate care with her patients’ primary care providers and other care team professionals and to give patients feedback on lab and study results.

Dr. Girnita has ramped down from 28 to 15 patients a day. She’s able to spend 60 minutes for new patients and 30 minutes for follow-ups. Like Dr. Kazmers, she feels she has more time to address patient needs and listen to their concerns.

She’s kept her hospital affiliations but finds that she doesn’t have to go to the hospital as much as she used to. Direct care “reduces hospital visits because physicians significantly have much more time to spend with the patient and address the needs of the patient.” A patient with a gout flare, for example, may end up in the hospital under traditional care because there’s no room in the physician’s schedule to address the patient’s needs.

Dr. Girnita recalled when she assisted a patient who had developed inflammatory arthritis and was desperate to see a doctor. The patient had good insurance, but appointments in her area weren’t available for at least 6 months. “Her primary care physician called me. I saw her and provided her with the appropriate care. A couple of months later she is doing great.”
 

What insurance does and doesn’t cover

Many patients who seek out direct or concierge models retain their insurance. At least 90% of Dr. Girnita’s patients have insurance with high deductibles. The other 10% have other types of insurance or no insurance.

Ellen McKnight, MD, who has a hybrid rheumatology practice in Pensacola, Fla., still accepts commercial insurance, but has opted out of Medicare. Her patients mostly come from rural areas in Florida, and their insurance situations vary widely. “In my practice, I estimate that 65% have insurance and 35% do not. Most of my patients have commercial insurance, and a substantial portion, about 40%, are just paying cash. My cash pay patients have Medicare, HMOs, and others are uninsured,” she said in an interview.

Direct care practices may continue to bill traditional insurance for items like visits, injections, and ultrasound.

Dr. Girnita’s patients have the option of submitting a “superbill” or invoice to insurance companies for patients to be reimbursed by their insurance for the cost of the visit. It contains the CPT code for the visit along with the ICD-10 codes for diagnoses. “I use a company called Reimbursify to help patients submit their invoice to their insurance company,” Dr. Girnita said.

Dr. Ortiz takes a different approach, offering superbills for consults and individual appointments, but not for patients enrolled in her membership program.

Some in the payer industry contend that direct care arrangements increase costs and distort risk pools. If most direct care patients already have a comprehensive health insurance policy, it’s likely they’re being billed twice for services, said David Allen, spokesperson for America’s Health Insurance Plans.

“Duplicative payments inflate the cost of care at a convenience to the providers and increase the cost of insurance premiums when insurers receive bills for those same services from providers. In other words, patients are being double billed,” Mr. Allen said.

These providers are assuming risk without state insurance oversight or regulations to ensure patient protections and safeguards are in place, he continued. “If utilization of services outpaces capacity, the provider may ultimately be unable to provide the amount of care expected by the patient because their practice agreed to unlimited visits and services with little or no restrictions.”
 

Eliminating ‘surprise’ bills

Adopters of direct care/concierge services counter that it’s the insurance and pharmaceutical companies driving up costs. Patients – especially those who have high-deductible plans – save money through these models. “In the direct care model, doctors have worked out advocacy for patients that are unsurpassed. Insurance companies don’t do that,” Dr. McKnight said.

Consumers know up front what the price is for other services. When you go to a restaurant, you always look on the menu to see what the price is for a bottle of wine or steak, Dr. Girnita said. “Only in the medical field you don’t know anything. And you’re shocked about the price you must pay.” Not many practices list their prices on their website, although federal rules seek to further increase price transparency in hospitals and among insurers.

Patients will sometimes get a “surprise” bill for their visit, laboratory, or imaging tests. According to Dr. Girnita, “that doesn’t happen in my practice. I discuss all prices with them before they get to the lab or MRI. I don’t charge copayments or anything extra.” Without a copayment – usually $50-$75 for specialist services – or a surprise bill, patients are always paying less, she said.

Costs through insurance are oftentimes higher, she continued. For routine lab work, a patient in a direct care practice pays about $30-$40. If they request this work through a lab, they’re likely to pay $150. “Think about an MRI. Through a direct care practice like mine, you pay $450-$700. In a hospital setting, you pay at least $5,000.”

Patients with high-deductible insurance plans often pay thousands of dollars before meeting their deductible, Dr. Girnita and others noted. A patient with this type of plan may pay $250 for a vitamin D lab if they haven’t met their deductible, Dr. McKnight explained. “With direct care, you’ll be paying $12.50.”

Dr. Girnita said her members get excellent discounts for labs and imaging. In the direct care models, physicians can help with this by contracting directly with labs, imaging centers, and independent pharmacies, giving patients access to affordable and transparent prices for their medical care.
 

What patients pay for services

In direct and concierge care membership models, coverage for services and fees vary widely from practice to practice.

Dr. Girnita offers several membership options. One package, which is $199 a month, is for patients with stable symptoms that guarantee continuity of care. It includes four visits a year and immediate access to the practice in case of emergency (including two additional urgent visits). “This works for a lot of patients. They consider that affordable, and they have all the benefits of a concierge practice. They can have direct communication with me, and they have guaranteed continuity of care,” Dr. Girnita said.

The other model, which is $299 per month, is for patients who need monthly contact with the rheumatologist for visits, telephone and email communications, urgent appointments, integrative medicine consultations, and many other benefits. For 1-hour consultations, Dr. Girnita charges $399.

Dr. Ortiz, who offers a direct pay model, charges $899 for an initial consult, which covers 3.5 hours of her time. “We do an hour of telemedicine, and we do a house call, which is 1.5-2 hours.” She follows up with a telehealth visit. Labs and x-rays are not included and go through the patient’s insurance.

Once the consult takes place, she assesses what a patient needs and offers them either a 6- or 12-month membership, which includes unlimited visits.

Patients can also buy a prepaid, six-appointment package with a 12% discount. Dr. Ortiz prices her telehealth visits at $350 and house calls at $550.

Dr. McKnight’s cash-only model for established patients offers four visits a year, reducing the fee for each visit. For example, a patient will pay $95 for the first visit, then $90, $85, and $80 for subsequent visits.

Accessing medications through direct care

One challenge with this model is finding affordable medications for patients outside of insurance.

Insurance dictates what’s covered, leaving fewer options for patients, Dr. McKnight said. “You have to jump through hoops, and there’s prior authorizations.” For a condition like severe osteoporosis, treatment should start sequentially with the true bone builders first, then move on to a medication like alendronate (Fosamax).

“Insurers will make you go to Fosamax first and then fail it,” she said. This results in the patient potentially developing worsening bone loss or possibly even sustaining a fracture.

Prior authorization requirements demand excessive staff time and effort, Dr. Kazmers said. This can translate to more than $90,000 a year in human resource costs for rheumatologists, who often deal with many specialty drug authorizations. “Every practice needs to hire staff to handle prior authorizations. We receive no compensation for this from the pharmaceutical companies and middlemen who ultimately profit from this cumbersome process,” she added.

Among the two big classes for rheumatology patients, conventional synthetic disease-modifying antirheumatic drugs (DMARDs) are the most widely available. Pharmacies can offer DMARDs for cash, although some are limited in terms of where they can ship, Dr. Girnita said.

The other class, biologic DMARDs, are the most expensive medications rheumatologists use for conditions such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.

With biologics, it’s more difficult, as they’re very expensive, typically $6,000 a month or more, sources told this news organization.

“Unfortunately, we can’t partner at this time with pharmaceutical companies that produce biologics or independent pharmacies,” Dr. Girnita said. Physicians can’t control biologic prices either. “Insurance companies and pharmacy benefit managers have the control on these prices.”

Physicians can direct patients to multiple resources where they can find assistance.

Biologics companies that offer patient assistance programs can sometimes offer medications for free, while others offer savings cards or copay cards, “which helps a lot,” Dr. Girnita said. She assists her patients by filing some of the paperwork necessary to qualify for these programs, and the patients submit the rest.

“For these companies to help the patient, they need the patient’s financial information,” she said. “But I do most of that work; I complete the forms and send to the company and justify need for the medication.”
 

What’s ahead for direct specialty care

While some patients have benefited, others have had to seek alternatives as their doctors transition to alternative models.

Not everyone can afford the concierge retainer fee, said Dr. Kazmers, who practices in a rural area of Michigan, where rheumatologists are scarce. Enrollment in her concierge practice filled months before the switchover from her traditional practice took place. There are 70 patients on a waiting list.

Patients who elect not to enroll in the concierge practice need to find another source of rheumatology care. This is a downside to the practice transition, she acknowledged. “The closest rheumatologist taking new patients is a 3- to 4-hour drive away, which simply reflects the shortage of medical school graduates choosing to go into rheumatology in the United States,” Dr. Kazmers added.

One physician caring for thousands of chronically ill, complicated patients within systems that don’t allow them the time to really care for their patients threatens to make the access problem worse, Dr. Ortiz said. The direct care/concierge model offers an alternative for the provider “and is a way to keep providers in the workforce, who may otherwise consider leaving.”

Direct care/concierge medicine isn’t for all doctors. But for Dr. Kazmers, it’s the best option for her at this point in her career. “I’ve been practicing for 45 years in various models, including academic positions and private practice employment. I have worked for years in settings accepting Medicaid. I understand that if every rheumatologist went concierge tomorrow, this would constrict access to needed specialty care. But in my case, it provided a viable alternative to closing the practice’s doors altogether.”

Ultimately, the U.S. medical system needs more rheumatologists and other specialists. “If you really want to increase the service, then Medicare or other sources should support opening more residency and fellowship spots for medical graduates to pursue,” Dr. Girnita said.

Other solutions call for more systemic and institutional changes, such as expanding rheumatology divisions and faculties at institutions that train fellows and addressing medical school debt, Dr. Ortiz said.

Some practices see themselves branching out from individual patient care and partnering with local businesses to provide care for employees. That’s the future for direct specialty care, said Dr. Girnita, who’s been in discussions with a few employers to make such arrangements.

The direct primary care community has already started to contract with employers. “Their employees get care they need for just a fraction of the cost. These discussions are arising more and more,” she said.

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

Elizabeth Ortiz, MD, knew she needed a change. Working at an academic county clinic, she was often worn down and pulled in different directions. “When I thought about what I really liked about my job, it was patient care and spending time with my patients, which I wasn’t able to do,” Dr. Ortiz said during the annual meeting of the American College of Rheumatology.

She’d heard of direct or concierge care but wasn’t sure if it was a good fit for her. COVID-19 offered a catalyst of sorts for a move to a new care model.

Ten weeks after she moved to Dallas, the pandemic hit full force. Seeing how telehealth was taking off, Dr. Ortiz began crafting a new model of care, a hybrid of telemedicine and house calls that offered multiple venues to connect with patients. The practice is just a year old, and “it’s working and it’s a constant experiment,” said Dr. Ortiz, who offers membership plans and prepaid appointments. She also does “a la carte” visits where established patients can see her at a one-off price. Her goal is to achieve 100% membership.

Although she operates through a direct pay and cash-only model, only recently has she become comfortable with the word “concierge.” There’s a preconceived notion of what that word means, she said.
 

Direct care: A definition

Following the trend of some primary care practices, more rheumatologists who are dissatisfied with the status quo are embracing these models of care.

Direct and concierge care are often mentioned in tandem, but there are nuanced differences. Direct specialty care removes third-party payers to protect the best interests of patients, according to Diana Girnita, MD, founder and CEO of Rheumatologist OnCall, a direct care practice. Her patient base hails from rural and urban areas in least 10 states. She also created a Facebook group for specialists in direct care and is the cofounder of the Direct Specialty Care Alliance.

Direct care offers a membership fee and additional fees for “as needed” services. “As the physician, I do not have to be contracted to an insurance company to see patients. I contract directly with patients. It is the patient’s choice to contract with an insurance and use the insurance for ancillary services and medication,” Dr. Girnita said. Patients with out-of-network benefits can claim the insurance to cover part of the consultation cost, she added.

In concierge or retainer medicine, a patient pays an annual or monthly fee or retainer to get access to the physician practice. In addition to this fee, the practice can bill the patient’s insurance for consultations or other services. “The concierge model does not eliminate the sub payer. You still contract with the patient’s insurance,” explained Dr. Girnita.

Physicians who establish these models sometimes do a hybrid of cash only and insurance. Micah Yu, MD, who practices rheumatology in Newport Beach, Calif., only takes Medicare. “Otherwise, patients are private pay. I am mainly fee for service, so patients are paying me for my time,” he said.

By tailoring their patient base and services, adopters find they have more time to spend with patients. “In my model, I spend 30 minutes for follow-up and 1 hour for new patients,” Dr. Yu said.
 

Limitations of traditional care

Carrying insurance doesn’t guarantee you the right care, Dr. Girnita said. Wait times to see a rheumatologist range from 4 to 6 months. For physicians who contract with insurance companies, reimbursement for services isn’t always paid promptly and decreases every year. A new cut in reimbursement is expected for rheumatology services in 2022.

Patients in direct care “pay a small amount for memberships that cover the cost of their visits and the time physicians spend in coordinating their additional care between the visits. The cost of the visits is always transparent,” Dr. Girnita said.

Irene Kazmers, MD, a solo private rheumatology practitioner in northern Michigan, was seeing 20-plus patients a day before she made the leap to a concierge model. “The paperwork and administrative burdens of practicing rheumatology as a solo [physician] have mushroomed in the last 10 years,” she said during the ACR meeting. She and staff were spending an inordinate amount of time on prior authorizations, step therapy requirements, electronic health record documentation, and other administrative burdens.

Reimbursements from payers have progressively declined as administrative challenges have necessitated more staff. “I was struggling to maintain an ample financial margin,” she said.
 

Improved communication, unlimited visits

Dr. Kazmers attests that the transition to the concierge model has enabled and fostered a higher level of communication and specialty care for her patients.

Patients who enroll in the practice pay an annual membership fee and get access to her personal cell phone number and email address. “If they need an urgent appointment, it is typically arranged the same or next day,” she said in an interview. “Visits are not as rushed as in the traditional model, conducive to incorporating beneficial integrative medicine modalities such as dietary, exercise, and mind-body approaches as appropriate, in addition to state-of-the-art treatment.”

She also has more time to coordinate care with her patients’ primary care providers and other care team professionals and to give patients feedback on lab and study results.

Dr. Girnita has ramped down from 28 to 15 patients a day. She’s able to spend 60 minutes for new patients and 30 minutes for follow-ups. Like Dr. Kazmers, she feels she has more time to address patient needs and listen to their concerns.

She’s kept her hospital affiliations but finds that she doesn’t have to go to the hospital as much as she used to. Direct care “reduces hospital visits because physicians significantly have much more time to spend with the patient and address the needs of the patient.” A patient with a gout flare, for example, may end up in the hospital under traditional care because there’s no room in the physician’s schedule to address the patient’s needs.

Dr. Girnita recalled when she assisted a patient who had developed inflammatory arthritis and was desperate to see a doctor. The patient had good insurance, but appointments in her area weren’t available for at least 6 months. “Her primary care physician called me. I saw her and provided her with the appropriate care. A couple of months later she is doing great.”
 

What insurance does and doesn’t cover

Many patients who seek out direct or concierge models retain their insurance. At least 90% of Dr. Girnita’s patients have insurance with high deductibles. The other 10% have other types of insurance or no insurance.

Ellen McKnight, MD, who has a hybrid rheumatology practice in Pensacola, Fla., still accepts commercial insurance, but has opted out of Medicare. Her patients mostly come from rural areas in Florida, and their insurance situations vary widely. “In my practice, I estimate that 65% have insurance and 35% do not. Most of my patients have commercial insurance, and a substantial portion, about 40%, are just paying cash. My cash pay patients have Medicare, HMOs, and others are uninsured,” she said in an interview.

Direct care practices may continue to bill traditional insurance for items like visits, injections, and ultrasound.

Dr. Girnita’s patients have the option of submitting a “superbill” or invoice to insurance companies for patients to be reimbursed by their insurance for the cost of the visit. It contains the CPT code for the visit along with the ICD-10 codes for diagnoses. “I use a company called Reimbursify to help patients submit their invoice to their insurance company,” Dr. Girnita said.

Dr. Ortiz takes a different approach, offering superbills for consults and individual appointments, but not for patients enrolled in her membership program.

Some in the payer industry contend that direct care arrangements increase costs and distort risk pools. If most direct care patients already have a comprehensive health insurance policy, it’s likely they’re being billed twice for services, said David Allen, spokesperson for America’s Health Insurance Plans.

“Duplicative payments inflate the cost of care at a convenience to the providers and increase the cost of insurance premiums when insurers receive bills for those same services from providers. In other words, patients are being double billed,” Mr. Allen said.

These providers are assuming risk without state insurance oversight or regulations to ensure patient protections and safeguards are in place, he continued. “If utilization of services outpaces capacity, the provider may ultimately be unable to provide the amount of care expected by the patient because their practice agreed to unlimited visits and services with little or no restrictions.”
 

Eliminating ‘surprise’ bills

Adopters of direct care/concierge services counter that it’s the insurance and pharmaceutical companies driving up costs. Patients – especially those who have high-deductible plans – save money through these models. “In the direct care model, doctors have worked out advocacy for patients that are unsurpassed. Insurance companies don’t do that,” Dr. McKnight said.

Consumers know up front what the price is for other services. When you go to a restaurant, you always look on the menu to see what the price is for a bottle of wine or steak, Dr. Girnita said. “Only in the medical field you don’t know anything. And you’re shocked about the price you must pay.” Not many practices list their prices on their website, although federal rules seek to further increase price transparency in hospitals and among insurers.

Patients will sometimes get a “surprise” bill for their visit, laboratory, or imaging tests. According to Dr. Girnita, “that doesn’t happen in my practice. I discuss all prices with them before they get to the lab or MRI. I don’t charge copayments or anything extra.” Without a copayment – usually $50-$75 for specialist services – or a surprise bill, patients are always paying less, she said.

Costs through insurance are oftentimes higher, she continued. For routine lab work, a patient in a direct care practice pays about $30-$40. If they request this work through a lab, they’re likely to pay $150. “Think about an MRI. Through a direct care practice like mine, you pay $450-$700. In a hospital setting, you pay at least $5,000.”

Patients with high-deductible insurance plans often pay thousands of dollars before meeting their deductible, Dr. Girnita and others noted. A patient with this type of plan may pay $250 for a vitamin D lab if they haven’t met their deductible, Dr. McKnight explained. “With direct care, you’ll be paying $12.50.”

Dr. Girnita said her members get excellent discounts for labs and imaging. In the direct care models, physicians can help with this by contracting directly with labs, imaging centers, and independent pharmacies, giving patients access to affordable and transparent prices for their medical care.
 

What patients pay for services

In direct and concierge care membership models, coverage for services and fees vary widely from practice to practice.

Dr. Girnita offers several membership options. One package, which is $199 a month, is for patients with stable symptoms that guarantee continuity of care. It includes four visits a year and immediate access to the practice in case of emergency (including two additional urgent visits). “This works for a lot of patients. They consider that affordable, and they have all the benefits of a concierge practice. They can have direct communication with me, and they have guaranteed continuity of care,” Dr. Girnita said.

The other model, which is $299 per month, is for patients who need monthly contact with the rheumatologist for visits, telephone and email communications, urgent appointments, integrative medicine consultations, and many other benefits. For 1-hour consultations, Dr. Girnita charges $399.

Dr. Ortiz, who offers a direct pay model, charges $899 for an initial consult, which covers 3.5 hours of her time. “We do an hour of telemedicine, and we do a house call, which is 1.5-2 hours.” She follows up with a telehealth visit. Labs and x-rays are not included and go through the patient’s insurance.

Once the consult takes place, she assesses what a patient needs and offers them either a 6- or 12-month membership, which includes unlimited visits.

Patients can also buy a prepaid, six-appointment package with a 12% discount. Dr. Ortiz prices her telehealth visits at $350 and house calls at $550.

Dr. McKnight’s cash-only model for established patients offers four visits a year, reducing the fee for each visit. For example, a patient will pay $95 for the first visit, then $90, $85, and $80 for subsequent visits.

Accessing medications through direct care

One challenge with this model is finding affordable medications for patients outside of insurance.

Insurance dictates what’s covered, leaving fewer options for patients, Dr. McKnight said. “You have to jump through hoops, and there’s prior authorizations.” For a condition like severe osteoporosis, treatment should start sequentially with the true bone builders first, then move on to a medication like alendronate (Fosamax).

“Insurers will make you go to Fosamax first and then fail it,” she said. This results in the patient potentially developing worsening bone loss or possibly even sustaining a fracture.

Prior authorization requirements demand excessive staff time and effort, Dr. Kazmers said. This can translate to more than $90,000 a year in human resource costs for rheumatologists, who often deal with many specialty drug authorizations. “Every practice needs to hire staff to handle prior authorizations. We receive no compensation for this from the pharmaceutical companies and middlemen who ultimately profit from this cumbersome process,” she added.

Among the two big classes for rheumatology patients, conventional synthetic disease-modifying antirheumatic drugs (DMARDs) are the most widely available. Pharmacies can offer DMARDs for cash, although some are limited in terms of where they can ship, Dr. Girnita said.

The other class, biologic DMARDs, are the most expensive medications rheumatologists use for conditions such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.

With biologics, it’s more difficult, as they’re very expensive, typically $6,000 a month or more, sources told this news organization.

“Unfortunately, we can’t partner at this time with pharmaceutical companies that produce biologics or independent pharmacies,” Dr. Girnita said. Physicians can’t control biologic prices either. “Insurance companies and pharmacy benefit managers have the control on these prices.”

Physicians can direct patients to multiple resources where they can find assistance.

Biologics companies that offer patient assistance programs can sometimes offer medications for free, while others offer savings cards or copay cards, “which helps a lot,” Dr. Girnita said. She assists her patients by filing some of the paperwork necessary to qualify for these programs, and the patients submit the rest.

“For these companies to help the patient, they need the patient’s financial information,” she said. “But I do most of that work; I complete the forms and send to the company and justify need for the medication.”
 

What’s ahead for direct specialty care

While some patients have benefited, others have had to seek alternatives as their doctors transition to alternative models.

Not everyone can afford the concierge retainer fee, said Dr. Kazmers, who practices in a rural area of Michigan, where rheumatologists are scarce. Enrollment in her concierge practice filled months before the switchover from her traditional practice took place. There are 70 patients on a waiting list.

Patients who elect not to enroll in the concierge practice need to find another source of rheumatology care. This is a downside to the practice transition, she acknowledged. “The closest rheumatologist taking new patients is a 3- to 4-hour drive away, which simply reflects the shortage of medical school graduates choosing to go into rheumatology in the United States,” Dr. Kazmers added.

One physician caring for thousands of chronically ill, complicated patients within systems that don’t allow them the time to really care for their patients threatens to make the access problem worse, Dr. Ortiz said. The direct care/concierge model offers an alternative for the provider “and is a way to keep providers in the workforce, who may otherwise consider leaving.”

Direct care/concierge medicine isn’t for all doctors. But for Dr. Kazmers, it’s the best option for her at this point in her career. “I’ve been practicing for 45 years in various models, including academic positions and private practice employment. I have worked for years in settings accepting Medicaid. I understand that if every rheumatologist went concierge tomorrow, this would constrict access to needed specialty care. But in my case, it provided a viable alternative to closing the practice’s doors altogether.”

Ultimately, the U.S. medical system needs more rheumatologists and other specialists. “If you really want to increase the service, then Medicare or other sources should support opening more residency and fellowship spots for medical graduates to pursue,” Dr. Girnita said.

Other solutions call for more systemic and institutional changes, such as expanding rheumatology divisions and faculties at institutions that train fellows and addressing medical school debt, Dr. Ortiz said.

Some practices see themselves branching out from individual patient care and partnering with local businesses to provide care for employees. That’s the future for direct specialty care, said Dr. Girnita, who’s been in discussions with a few employers to make such arrangements.

The direct primary care community has already started to contract with employers. “Their employees get care they need for just a fraction of the cost. These discussions are arising more and more,” she said.

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

A survey of more than 12,000 women of reproductive age found that one in three had experienced changes to their menstrual cycles and symptoms during the COVID-19 pandemic. Noticeably higher stress levels than prepandemic benchmarks could be affecting menstruation.

This has implications for women trying to conceive or struggling with infertility, said Shannon M. Malloy, a research and data associate with Ovia Health, a women’s and family health technology company in Boston. Ms. Malloy presented this study at the American Society of Reproductive Medicine’s 2021 meeting.

COVID-19 has introduced new psychosocial, interpersonal, and environmental stressors. The pandemic is “one of the most stressful, collectively experienced disasters modern society has ever seen,” said Ms. Malloy. Once imagined as an explicit event in time, COVID-19 has ingrained itself into daily life for the foreseeable future.

Research has shown that chronic, long-term stress produces high cortisol levels, which can alter endocrinology and regulation of menstrual cycles. This can make family building even more challenging, said Ms. Malloy. Physicians and other providers have always taken stress into account when managing patients, but never at this level of chronic, episodic stress, she said.
 

Survey examines impact on ART

Ovia Health decided to investigate the relationship between perceived stress and menstrual cycle and symptom changes during the COVID-19 pandemic, to see how it might affect assisted reproductive technology (ART).

From March 2020 to April 2021, users of Ovia Health’s Fertility mobile application in the United States took part in a survey. Items captured changes in menstruation pattern and symptomatology and included the Perceived Stress Scale 4-item version (PSS-4). A paired t-test evaluated differences between groups (menstrual changes versus no menstrual changes). The survey asked participants what changes they noticed in their menstrual cycle and why they thought cycle patterns or symptoms changed.
 

One-third report changes in cycle, symptoms

Among 12,302 respondents, 1 in 3 (36%) reported changes in cycle or symptoms. Eighty-seven percent said that their cycle started early or late. Twenty-nine percent reported stronger symptoms during menstruation such as low back pain, cramping, or discharge changes, and 27% said bleeding was heavier during periods.

These results are similar to other studies investigating the affect of episodic stress on menstruation, said Ms. Malloy.

Those who reported menstrual cycle or symptom changes scored higher on average on the PSS-4 compared with those who didn’t report any changes (8.5 v. 8.3, respectively, P < .05). PSS-4 scores across the board were notably higher in all respondents, regardless of cycle/symptom irregularity, compared with prepandemic benchmarking in similar populations.

Slightly more than half (55%) thought stress contributed to their menstrual cycle pattern and/or symptom changes, whereas 33% pointed to changes in mental health, such as depression or anxiety. “Interestingly, many users believed the COVID-19 vaccine impacted their menstrual cycle symptom changes,” said Ms. Malloy.
 

No definitive link between vaccine, menstruation

While known side effects of the vaccine include sore arm, fever, fatigue, and myalgia, some women have reported changes in their menstrual cycle, Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida and director of the IVF Center in Orlando, said in an interview.

“Vaccination reaction from the immune response rather than the vaccine may be the implicating factor,” said Dr. Trolice, who was not involved in the study.

Currently, there’s no direct link between the vaccine and subsequent effects on menstruation, he continued. “Most women experience resumption of normal intervals 1 month following vaccination. Further, there is no credible evidence that links the vaccine to infertility.

“Nevertheless, research in this area is vital and underway,” he added.
 

Physicians can help with stress

Menstrual cycle disruption is especially frustrating for women trying to build a family, said Ms. Malloy. Providers may be observing more menstrual irregularity in their patient populations, and seeing more patients struggle to conceive on their own, turning to ART.

Providers can’t make COVID-19 go away, but they could help patients by doing a better job of integrating mental health screening, connecting patients to treatments that optimize conception and fertility treatment outcomes, said Ms. Malloy.

The survey was limited in that its questions didn’t consider proper diagnostic criteria for irregularity, versus self-reported changes. But it does highlight the need for more research on the pandemic’s affect on menstruation and the vaccine on menstruation, said Ms. Malloy. “The National Institutes of Health in August committed $1.6 million to explore this connection. We’re looking forward to seeing what their results are.” 

Dr. Trolice and Ms. Malloy had no disclosures.

A survey of more than 12,000 women of reproductive age found that one in three had experienced changes to their menstrual cycles and symptoms during the COVID-19 pandemic. Noticeably higher stress levels than prepandemic benchmarks could be affecting menstruation.

This has implications for women trying to conceive or struggling with infertility, said Shannon M. Malloy, a research and data associate with Ovia Health, a women’s and family health technology company in Boston. Ms. Malloy presented this study at the American Society of Reproductive Medicine’s 2021 meeting.

COVID-19 has introduced new psychosocial, interpersonal, and environmental stressors. The pandemic is “one of the most stressful, collectively experienced disasters modern society has ever seen,” said Ms. Malloy. Once imagined as an explicit event in time, COVID-19 has ingrained itself into daily life for the foreseeable future.

Research has shown that chronic, long-term stress produces high cortisol levels, which can alter endocrinology and regulation of menstrual cycles. This can make family building even more challenging, said Ms. Malloy. Physicians and other providers have always taken stress into account when managing patients, but never at this level of chronic, episodic stress, she said.
 

Survey examines impact on ART

Ovia Health decided to investigate the relationship between perceived stress and menstrual cycle and symptom changes during the COVID-19 pandemic, to see how it might affect assisted reproductive technology (ART).

From March 2020 to April 2021, users of Ovia Health’s Fertility mobile application in the United States took part in a survey. Items captured changes in menstruation pattern and symptomatology and included the Perceived Stress Scale 4-item version (PSS-4). A paired t-test evaluated differences between groups (menstrual changes versus no menstrual changes). The survey asked participants what changes they noticed in their menstrual cycle and why they thought cycle patterns or symptoms changed.
 

One-third report changes in cycle, symptoms

Among 12,302 respondents, 1 in 3 (36%) reported changes in cycle or symptoms. Eighty-seven percent said that their cycle started early or late. Twenty-nine percent reported stronger symptoms during menstruation such as low back pain, cramping, or discharge changes, and 27% said bleeding was heavier during periods.

These results are similar to other studies investigating the affect of episodic stress on menstruation, said Ms. Malloy.

Those who reported menstrual cycle or symptom changes scored higher on average on the PSS-4 compared with those who didn’t report any changes (8.5 v. 8.3, respectively, P < .05). PSS-4 scores across the board were notably higher in all respondents, regardless of cycle/symptom irregularity, compared with prepandemic benchmarking in similar populations.

Slightly more than half (55%) thought stress contributed to their menstrual cycle pattern and/or symptom changes, whereas 33% pointed to changes in mental health, such as depression or anxiety. “Interestingly, many users believed the COVID-19 vaccine impacted their menstrual cycle symptom changes,” said Ms. Malloy.
 

No definitive link between vaccine, menstruation

While known side effects of the vaccine include sore arm, fever, fatigue, and myalgia, some women have reported changes in their menstrual cycle, Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida and director of the IVF Center in Orlando, said in an interview.

“Vaccination reaction from the immune response rather than the vaccine may be the implicating factor,” said Dr. Trolice, who was not involved in the study.

Currently, there’s no direct link between the vaccine and subsequent effects on menstruation, he continued. “Most women experience resumption of normal intervals 1 month following vaccination. Further, there is no credible evidence that links the vaccine to infertility.

“Nevertheless, research in this area is vital and underway,” he added.
 

Physicians can help with stress

Menstrual cycle disruption is especially frustrating for women trying to build a family, said Ms. Malloy. Providers may be observing more menstrual irregularity in their patient populations, and seeing more patients struggle to conceive on their own, turning to ART.

Providers can’t make COVID-19 go away, but they could help patients by doing a better job of integrating mental health screening, connecting patients to treatments that optimize conception and fertility treatment outcomes, said Ms. Malloy.

The survey was limited in that its questions didn’t consider proper diagnostic criteria for irregularity, versus self-reported changes. But it does highlight the need for more research on the pandemic’s affect on menstruation and the vaccine on menstruation, said Ms. Malloy. “The National Institutes of Health in August committed $1.6 million to explore this connection. We’re looking forward to seeing what their results are.” 

Dr. Trolice and Ms. Malloy had no disclosures.

A survey of more than 12,000 women of reproductive age found that one in three had experienced changes to their menstrual cycles and symptoms during the COVID-19 pandemic. Noticeably higher stress levels than prepandemic benchmarks could be affecting menstruation.

This has implications for women trying to conceive or struggling with infertility, said Shannon M. Malloy, a research and data associate with Ovia Health, a women’s and family health technology company in Boston. Ms. Malloy presented this study at the American Society of Reproductive Medicine’s 2021 meeting.

COVID-19 has introduced new psychosocial, interpersonal, and environmental stressors. The pandemic is “one of the most stressful, collectively experienced disasters modern society has ever seen,” said Ms. Malloy. Once imagined as an explicit event in time, COVID-19 has ingrained itself into daily life for the foreseeable future.

Research has shown that chronic, long-term stress produces high cortisol levels, which can alter endocrinology and regulation of menstrual cycles. This can make family building even more challenging, said Ms. Malloy. Physicians and other providers have always taken stress into account when managing patients, but never at this level of chronic, episodic stress, she said.
 

Survey examines impact on ART

Ovia Health decided to investigate the relationship between perceived stress and menstrual cycle and symptom changes during the COVID-19 pandemic, to see how it might affect assisted reproductive technology (ART).

From March 2020 to April 2021, users of Ovia Health’s Fertility mobile application in the United States took part in a survey. Items captured changes in menstruation pattern and symptomatology and included the Perceived Stress Scale 4-item version (PSS-4). A paired t-test evaluated differences between groups (menstrual changes versus no menstrual changes). The survey asked participants what changes they noticed in their menstrual cycle and why they thought cycle patterns or symptoms changed.
 

One-third report changes in cycle, symptoms

Among 12,302 respondents, 1 in 3 (36%) reported changes in cycle or symptoms. Eighty-seven percent said that their cycle started early or late. Twenty-nine percent reported stronger symptoms during menstruation such as low back pain, cramping, or discharge changes, and 27% said bleeding was heavier during periods.

These results are similar to other studies investigating the affect of episodic stress on menstruation, said Ms. Malloy.

Those who reported menstrual cycle or symptom changes scored higher on average on the PSS-4 compared with those who didn’t report any changes (8.5 v. 8.3, respectively, P < .05). PSS-4 scores across the board were notably higher in all respondents, regardless of cycle/symptom irregularity, compared with prepandemic benchmarking in similar populations.

Slightly more than half (55%) thought stress contributed to their menstrual cycle pattern and/or symptom changes, whereas 33% pointed to changes in mental health, such as depression or anxiety. “Interestingly, many users believed the COVID-19 vaccine impacted their menstrual cycle symptom changes,” said Ms. Malloy.
 

No definitive link between vaccine, menstruation

While known side effects of the vaccine include sore arm, fever, fatigue, and myalgia, some women have reported changes in their menstrual cycle, Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida and director of the IVF Center in Orlando, said in an interview.

“Vaccination reaction from the immune response rather than the vaccine may be the implicating factor,” said Dr. Trolice, who was not involved in the study.

Currently, there’s no direct link between the vaccine and subsequent effects on menstruation, he continued. “Most women experience resumption of normal intervals 1 month following vaccination. Further, there is no credible evidence that links the vaccine to infertility.

“Nevertheless, research in this area is vital and underway,” he added.
 

Physicians can help with stress

Menstrual cycle disruption is especially frustrating for women trying to build a family, said Ms. Malloy. Providers may be observing more menstrual irregularity in their patient populations, and seeing more patients struggle to conceive on their own, turning to ART.

Providers can’t make COVID-19 go away, but they could help patients by doing a better job of integrating mental health screening, connecting patients to treatments that optimize conception and fertility treatment outcomes, said Ms. Malloy.

The survey was limited in that its questions didn’t consider proper diagnostic criteria for irregularity, versus self-reported changes. But it does highlight the need for more research on the pandemic’s affect on menstruation and the vaccine on menstruation, said Ms. Malloy. “The National Institutes of Health in August committed $1.6 million to explore this connection. We’re looking forward to seeing what their results are.” 

Dr. Trolice and Ms. Malloy had no disclosures.

Physicians could be doing a better job of counseling patients with obesity and overweight on weight loss and fertility. A study of 48 women seeking infertility care at a large academic center found that less than half received advice on weight loss from their primary ob.gyn. prior to referral for infertility treatment.

Patients are thinking about this – many attempt to lose weight independently of support from their health care providers, said lead study author Margaret R. O’Neill, MD, a resident at the University of Massachusetts Medical Center in Worcester. Dr. O’Neill discussed these results at the American Society of Reproductive Medicine’s 2021 meeting.

Nearly half of all U.S. women of reproductive age have overweight or obesity, with a body mass index of >25 kg/m². Menstrual irregularity, ovulatory dysfunction, reduced fecundity, and lower efficacy of infertility treatment are some of the consequences of obesity on fertility, said Dr. O’Neill. Obesity also affects the health of expectant mothers and fetuses, increasing the likelihood of gestational diabetes, preterm delivery, and preeclampsia, and increased incidence of fetal anomalies.

“Unfortunately, even though the prevalence of obesity has been increasing substantially in our country, there’s not excellent rates of this being addressed by physicians,” said Dr. O’Neill. BMI is often left out of documentation and rates of referrals to weight loss specialists are also low.

Conversations have been taking place about IVF centers instituting different BMI cutoffs for certain types of assisted reproductive technology, she noted.

Dr. O’Neill and her colleagues undertook a survey to see what advice community providers were dispensing about weight management on fertility.
 

Infertility specialists offer the most guidance

The prospective study included 48 nonpregnant women of reproductive age women presenting for IVF who needed an anesthesia consultation because of elevated BMI (> 35) prior to initiation of IVF. Mean age was 36 years and mean BMI was 38.5. More than 70% of the patients were White and they were predominantly English speakers.

All participants had attempted weight loss, including an attempt in the last year, and 93.8% reported trying to lose weight in the last year. On average, patients weighed about 20 pounds less than their heaviest adult weight. Nineteen percent of the participants were at their heaviest adult weight.

While 60% said they’d received weight loss/infertility counseling by any health care provider, just 41.7% reported that their primary ob.gyn. counseled them about weight loss before referring them for treatment. Infertility specialists seem to provide the most assistance: Nearly 70% of the respondents said they’ve been counseled by these providers.

Women with a higher-than-average BMI (39) were more likely to report a referral to weight loss counseling compared with women not referred (37.9, P = .2). 

Investigators also asked patients about their knowledge of obesity and its relationship to other health conditions. About 90% understood that infertility and excess weight were related. Overall, they were less sure about the link between obesity and still birth, breast cancer, and birth defects. Only 37% were able to identify a normal BMI range.
 

Avoiding a touchy subject

BMI is a highly sensitive area for many women, despite its detrimental effect on fertility, Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida and director of the IVF Center in Orlando, said in an interview.

“By the time their journey has led them to an infertility specialist, most women are very anxious to begin treatment,” said Dr. Trolice, who was not involved in the survey. These patients, however, could interpret any medical advice to achieve a more optimal BMI and healthier lifestyle as a negative judgment that could delay their goal of having a healthy child, he said.

Physicians in turn may avoid these conversations because they don’t want to encourage the ire of patients and/or risk a negative online rating review, he added.

Don’t say ‘just lose weight’

When asked what type of counseling works best, many said that nonspecific recommendations such as “you need to lose weight” or “exercise more” were the least helpful. Targeted advice such as “avoid eating at night and take walks every day,” works more effectively. “Any kind of referral to a bariatrics team or weight loss program was seen as helpful by patients,” said Dr. O’Neill.

Suggestions that considered the difficulty of this process, such as seeking therapy, were also helpful. “Patients appreciated empathy, compassion, and encouragement” from their physicians, she said.
 

The role of physicians in weight loss

Physicians can make a difference. Studies show that patients who received weight loss counseling were more likely to attempt weight loss and report clinically significant weight loss.

The American College of Obstetricians and Gynecologists and ASRM recommend counseling patients with overweight and obesity to lose weight before getting pregnant. A modest weight loss of 10% is associated with improved ovulatory function and higher pregnancy rates, said Dr. O’Neill.

“Appropriately, the infertility specialist should strongly recommend [that women who are obese] obtain a more optimal BMI prior to fertility treatment. While there is no guarantee of decreased infertility and decreased pregnancy complications following weight loss, a lower BMI improves outcomes,” said Dr. Trolice.

Future research should address the fertility outcomes of women who have been counseled by their providers to lose weight and the most effective method of counseling, noted Dr. O’Neill. “We have to find the best ways to address this at each fertility institution.”

The study had limited generalizability because of its narrow patient population and regional differences in access to insurance and weight loss specialists. COVID-19 also reduced the sample size, said Dr. O’Neill. She noted that patient perceptions might not equate with actual counseling delivered.

Dr. O’Neill and Dr. Trolice had no disclosures.

Physicians could be doing a better job of counseling patients with obesity and overweight on weight loss and fertility. A study of 48 women seeking infertility care at a large academic center found that less than half received advice on weight loss from their primary ob.gyn. prior to referral for infertility treatment.

Patients are thinking about this – many attempt to lose weight independently of support from their health care providers, said lead study author Margaret R. O’Neill, MD, a resident at the University of Massachusetts Medical Center in Worcester. Dr. O’Neill discussed these results at the American Society of Reproductive Medicine’s 2021 meeting.

Nearly half of all U.S. women of reproductive age have overweight or obesity, with a body mass index of >25 kg/m². Menstrual irregularity, ovulatory dysfunction, reduced fecundity, and lower efficacy of infertility treatment are some of the consequences of obesity on fertility, said Dr. O’Neill. Obesity also affects the health of expectant mothers and fetuses, increasing the likelihood of gestational diabetes, preterm delivery, and preeclampsia, and increased incidence of fetal anomalies.

“Unfortunately, even though the prevalence of obesity has been increasing substantially in our country, there’s not excellent rates of this being addressed by physicians,” said Dr. O’Neill. BMI is often left out of documentation and rates of referrals to weight loss specialists are also low.

Conversations have been taking place about IVF centers instituting different BMI cutoffs for certain types of assisted reproductive technology, she noted.

Dr. O’Neill and her colleagues undertook a survey to see what advice community providers were dispensing about weight management on fertility.
 

Infertility specialists offer the most guidance

The prospective study included 48 nonpregnant women of reproductive age women presenting for IVF who needed an anesthesia consultation because of elevated BMI (> 35) prior to initiation of IVF. Mean age was 36 years and mean BMI was 38.5. More than 70% of the patients were White and they were predominantly English speakers.

All participants had attempted weight loss, including an attempt in the last year, and 93.8% reported trying to lose weight in the last year. On average, patients weighed about 20 pounds less than their heaviest adult weight. Nineteen percent of the participants were at their heaviest adult weight.

While 60% said they’d received weight loss/infertility counseling by any health care provider, just 41.7% reported that their primary ob.gyn. counseled them about weight loss before referring them for treatment. Infertility specialists seem to provide the most assistance: Nearly 70% of the respondents said they’ve been counseled by these providers.

Women with a higher-than-average BMI (39) were more likely to report a referral to weight loss counseling compared with women not referred (37.9, P = .2). 

Investigators also asked patients about their knowledge of obesity and its relationship to other health conditions. About 90% understood that infertility and excess weight were related. Overall, they were less sure about the link between obesity and still birth, breast cancer, and birth defects. Only 37% were able to identify a normal BMI range.
 

Avoiding a touchy subject

BMI is a highly sensitive area for many women, despite its detrimental effect on fertility, Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida and director of the IVF Center in Orlando, said in an interview.

“By the time their journey has led them to an infertility specialist, most women are very anxious to begin treatment,” said Dr. Trolice, who was not involved in the survey. These patients, however, could interpret any medical advice to achieve a more optimal BMI and healthier lifestyle as a negative judgment that could delay their goal of having a healthy child, he said.

Physicians in turn may avoid these conversations because they don’t want to encourage the ire of patients and/or risk a negative online rating review, he added.

Don’t say ‘just lose weight’

When asked what type of counseling works best, many said that nonspecific recommendations such as “you need to lose weight” or “exercise more” were the least helpful. Targeted advice such as “avoid eating at night and take walks every day,” works more effectively. “Any kind of referral to a bariatrics team or weight loss program was seen as helpful by patients,” said Dr. O’Neill.

Suggestions that considered the difficulty of this process, such as seeking therapy, were also helpful. “Patients appreciated empathy, compassion, and encouragement” from their physicians, she said.
 

The role of physicians in weight loss

Physicians can make a difference. Studies show that patients who received weight loss counseling were more likely to attempt weight loss and report clinically significant weight loss.

The American College of Obstetricians and Gynecologists and ASRM recommend counseling patients with overweight and obesity to lose weight before getting pregnant. A modest weight loss of 10% is associated with improved ovulatory function and higher pregnancy rates, said Dr. O’Neill.

“Appropriately, the infertility specialist should strongly recommend [that women who are obese] obtain a more optimal BMI prior to fertility treatment. While there is no guarantee of decreased infertility and decreased pregnancy complications following weight loss, a lower BMI improves outcomes,” said Dr. Trolice.

Future research should address the fertility outcomes of women who have been counseled by their providers to lose weight and the most effective method of counseling, noted Dr. O’Neill. “We have to find the best ways to address this at each fertility institution.”

The study had limited generalizability because of its narrow patient population and regional differences in access to insurance and weight loss specialists. COVID-19 also reduced the sample size, said Dr. O’Neill. She noted that patient perceptions might not equate with actual counseling delivered.

Dr. O’Neill and Dr. Trolice had no disclosures.

Physicians could be doing a better job of counseling patients with obesity and overweight on weight loss and fertility. A study of 48 women seeking infertility care at a large academic center found that less than half received advice on weight loss from their primary ob.gyn. prior to referral for infertility treatment.

Patients are thinking about this – many attempt to lose weight independently of support from their health care providers, said lead study author Margaret R. O’Neill, MD, a resident at the University of Massachusetts Medical Center in Worcester. Dr. O’Neill discussed these results at the American Society of Reproductive Medicine’s 2021 meeting.

Nearly half of all U.S. women of reproductive age have overweight or obesity, with a body mass index of >25 kg/m². Menstrual irregularity, ovulatory dysfunction, reduced fecundity, and lower efficacy of infertility treatment are some of the consequences of obesity on fertility, said Dr. O’Neill. Obesity also affects the health of expectant mothers and fetuses, increasing the likelihood of gestational diabetes, preterm delivery, and preeclampsia, and increased incidence of fetal anomalies.

“Unfortunately, even though the prevalence of obesity has been increasing substantially in our country, there’s not excellent rates of this being addressed by physicians,” said Dr. O’Neill. BMI is often left out of documentation and rates of referrals to weight loss specialists are also low.

Conversations have been taking place about IVF centers instituting different BMI cutoffs for certain types of assisted reproductive technology, she noted.

Dr. O’Neill and her colleagues undertook a survey to see what advice community providers were dispensing about weight management on fertility.
 

Infertility specialists offer the most guidance

The prospective study included 48 nonpregnant women of reproductive age women presenting for IVF who needed an anesthesia consultation because of elevated BMI (> 35) prior to initiation of IVF. Mean age was 36 years and mean BMI was 38.5. More than 70% of the patients were White and they were predominantly English speakers.

All participants had attempted weight loss, including an attempt in the last year, and 93.8% reported trying to lose weight in the last year. On average, patients weighed about 20 pounds less than their heaviest adult weight. Nineteen percent of the participants were at their heaviest adult weight.

While 60% said they’d received weight loss/infertility counseling by any health care provider, just 41.7% reported that their primary ob.gyn. counseled them about weight loss before referring them for treatment. Infertility specialists seem to provide the most assistance: Nearly 70% of the respondents said they’ve been counseled by these providers.

Women with a higher-than-average BMI (39) were more likely to report a referral to weight loss counseling compared with women not referred (37.9, P = .2). 

Investigators also asked patients about their knowledge of obesity and its relationship to other health conditions. About 90% understood that infertility and excess weight were related. Overall, they were less sure about the link between obesity and still birth, breast cancer, and birth defects. Only 37% were able to identify a normal BMI range.
 

Avoiding a touchy subject

BMI is a highly sensitive area for many women, despite its detrimental effect on fertility, Mark P. Trolice, MD, professor of obstetrics and gynecology at the University of Central Florida and director of the IVF Center in Orlando, said in an interview.

“By the time their journey has led them to an infertility specialist, most women are very anxious to begin treatment,” said Dr. Trolice, who was not involved in the survey. These patients, however, could interpret any medical advice to achieve a more optimal BMI and healthier lifestyle as a negative judgment that could delay their goal of having a healthy child, he said.

Physicians in turn may avoid these conversations because they don’t want to encourage the ire of patients and/or risk a negative online rating review, he added.

Don’t say ‘just lose weight’

When asked what type of counseling works best, many said that nonspecific recommendations such as “you need to lose weight” or “exercise more” were the least helpful. Targeted advice such as “avoid eating at night and take walks every day,” works more effectively. “Any kind of referral to a bariatrics team or weight loss program was seen as helpful by patients,” said Dr. O’Neill.

Suggestions that considered the difficulty of this process, such as seeking therapy, were also helpful. “Patients appreciated empathy, compassion, and encouragement” from their physicians, she said.
 

The role of physicians in weight loss

Physicians can make a difference. Studies show that patients who received weight loss counseling were more likely to attempt weight loss and report clinically significant weight loss.

The American College of Obstetricians and Gynecologists and ASRM recommend counseling patients with overweight and obesity to lose weight before getting pregnant. A modest weight loss of 10% is associated with improved ovulatory function and higher pregnancy rates, said Dr. O’Neill.

“Appropriately, the infertility specialist should strongly recommend [that women who are obese] obtain a more optimal BMI prior to fertility treatment. While there is no guarantee of decreased infertility and decreased pregnancy complications following weight loss, a lower BMI improves outcomes,” said Dr. Trolice.

Future research should address the fertility outcomes of women who have been counseled by their providers to lose weight and the most effective method of counseling, noted Dr. O’Neill. “We have to find the best ways to address this at each fertility institution.”

The study had limited generalizability because of its narrow patient population and regional differences in access to insurance and weight loss specialists. COVID-19 also reduced the sample size, said Dr. O’Neill. She noted that patient perceptions might not equate with actual counseling delivered.

Dr. O’Neill and Dr. Trolice had no disclosures.

COVID-19 has killed Native Americans at twice the rate of White Americans, underscoring the health inequities and deep-rooted distrust tribal nations have of federal government entities.

And yet, Native Americans have the highest vaccination rates of any major racial or ethnic group in the United States. Like many other tribal nations, the Navajo had to embrace Western science to reclaim its social customs and ceremonies. “We’re a very social culture, so having to isolate really impacted our mental health,” said Mary Hasbah Roessel, MD, DLFAPA, a Navajo psychiatrist who is affiliated with Santa Fe Indian Hospital in New Mexico.

The Navajo nation occupies the largest Native American reservation in the United States, spanning New Mexico, Arizona, and Utah. As of mid-October, the nation had reported more than 34,000 COVID-19 cases and 1,400 deaths in its jurisdiction.

In an interview with this news organization, Dr. Roessel described the partnerships that mobilized a nation of more than 250,000 individuals to get vaccinated.

Question: Why has the death rate been so high in the Navajo nation?

Answer: A lot of health disparities before the pandemic were blatantly revealed during COVID. Only 40% of people on the reservation had running water. Having to stay home and isolate led to food insecurity. Further insecurity issues affected our ability to stay healthy, such as having good sanitation. There’s a lot of poverty, a high unemployment rate. Some people had to go to work off reservation and were potentially bringing the virus home. A lot of generations live in the same household. Elders were vulnerable to getting the infection, and there was little ability to isolate if someone wasn’t having symptoms. Hospitals nearby didn’t have ICUs.

Therefore, the rate of cases skyrocketed early on. We were disproportionately affected. The Navajo nation per capita had the highest rate of cases in any state.
 

Q: What changes took place within the Navajo nation to get people vaccinated? What role did the federal Indian Health Service have in promoting this?

A: There had to be a shift in acceptance of the vaccinations. I think what particularly helped the Navajo nation was seeing the IHS rise up and provide access for treatments and vaccinations early on.

With the IHS, we went into a disaster response mode with all-hands-on deck meetings. We had to figure out how we could access mass vaccination clinics. Partnering with the Navajo Department of Health, we did that right away with hospitals and small clinics across the Navajo nation. Casinos owned by tribal entities that closed during COVID reopened and were used as vaccination clinics.

Vaccinations were sent to us fairly quickly. I ended up getting vaccinated in December 2020, when it was first rolled out.

Native and Navajo individuals have been reluctant to rely on government services. Because IHS came through with the vaccines, COVID reduced that stigma to access its services. Even the Navajo Department of Health partnered with the Indian Health Service to provide culturally relevant campaigns that explain why the vaccine is valuable.

I think because people were so impacted, they saw something valuable with the vaccine. Given the education and access, people were ready to get vaccinated. They realized if a whole household got vaccinated, they could see early on that they could be social again.
 

Q: What cultural factors have been contributing to this positive development?

A: In our Navajo culture, we’ve dealt with monsters before. We talk about that in terms of how we teach our young people to be strong and resilient. We talked about this virus as being another monster we had to tackle and control. The teaching was along those lines. We’ve dealt with this before, and we can handle it. We’re resilient. Our culture is very strong in that way. So how do we do it? We have to partner; we have to embrace Western medicine to return back to the ceremonies we want to have again and be social again. We focus on positive things, so if we see something as potentially positive, such as the vaccine, we see that and know that’s something to help us come into our life again.

Q: I would expect that protecting elders in the tribe would be a big incentive in taking the vaccine.

A: Yes, we didn’t want to lose our language and culture, and we wanted to protect our elders. Having a way to do that was very important as well. They were among the first to get vaccinated.

Q: What is the current vaccination rate in the Navajo nation?

A: I think it’s in the upper 80th percentile. It’s very high.

Q: What have been the biggest takeaways so far, and what are your hopes for the future?

A: Even though the Navajo Nation has been impacted and devastated with the loss of elders and knowledge keepers, we still have our culture and ceremonies intact to the point that we know we can be resilient get through this difficult time.

Through collaborations with the federal and state governments and the clinics, we see that things are different now. Going forward, my hope is these partnerships will continue, that we’ll build those relationships and not be so siloed in our care. When the New Mexico Department of Health rolled out its first vaccination clinic, for example, we jumped on and saw how they did it. We were then able to do our own, collaborating with the state.

We also saw how important our culture was, how it helped our Navajo people through these difficult times.

Dr. Roessel, a distinguished fellow of the American Psychiatric Association, has special expertise in cultural psychiatry. Her childhood was spent growing up in the Navajo nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating Indigenous knowledge and principles.

References

American Public Media Research Lab. “The Color of Coronavirus: COVID-19 Deaths by Race and Ethnicity in the U.S.” 2021 Mar 5.

Centers for Disease Control and Prevention. “Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States.” Data as of 2021 Oct 14.

Navajo Nation. Indian Health Service. U.S. Department of Health & Human Services.

The Navajo Nation’s Office of the President and Vice President. “11 New Cases, 32,735 Recoveries, and Six Recent Deaths Related to COVID-19.” 2021 Oct 13.

Navajo Nation Government web page.

COVID-19 has killed Native Americans at twice the rate of White Americans, underscoring the health inequities and deep-rooted distrust tribal nations have of federal government entities.

And yet, Native Americans have the highest vaccination rates of any major racial or ethnic group in the United States. Like many other tribal nations, the Navajo had to embrace Western science to reclaim its social customs and ceremonies. “We’re a very social culture, so having to isolate really impacted our mental health,” said Mary Hasbah Roessel, MD, DLFAPA, a Navajo psychiatrist who is affiliated with Santa Fe Indian Hospital in New Mexico.

The Navajo nation occupies the largest Native American reservation in the United States, spanning New Mexico, Arizona, and Utah. As of mid-October, the nation had reported more than 34,000 COVID-19 cases and 1,400 deaths in its jurisdiction.

In an interview with this news organization, Dr. Roessel described the partnerships that mobilized a nation of more than 250,000 individuals to get vaccinated.

Question: Why has the death rate been so high in the Navajo nation?

Answer: A lot of health disparities before the pandemic were blatantly revealed during COVID. Only 40% of people on the reservation had running water. Having to stay home and isolate led to food insecurity. Further insecurity issues affected our ability to stay healthy, such as having good sanitation. There’s a lot of poverty, a high unemployment rate. Some people had to go to work off reservation and were potentially bringing the virus home. A lot of generations live in the same household. Elders were vulnerable to getting the infection, and there was little ability to isolate if someone wasn’t having symptoms. Hospitals nearby didn’t have ICUs.

Therefore, the rate of cases skyrocketed early on. We were disproportionately affected. The Navajo nation per capita had the highest rate of cases in any state.
 

Q: What changes took place within the Navajo nation to get people vaccinated? What role did the federal Indian Health Service have in promoting this?

A: There had to be a shift in acceptance of the vaccinations. I think what particularly helped the Navajo nation was seeing the IHS rise up and provide access for treatments and vaccinations early on.

With the IHS, we went into a disaster response mode with all-hands-on deck meetings. We had to figure out how we could access mass vaccination clinics. Partnering with the Navajo Department of Health, we did that right away with hospitals and small clinics across the Navajo nation. Casinos owned by tribal entities that closed during COVID reopened and were used as vaccination clinics.

Vaccinations were sent to us fairly quickly. I ended up getting vaccinated in December 2020, when it was first rolled out.

Native and Navajo individuals have been reluctant to rely on government services. Because IHS came through with the vaccines, COVID reduced that stigma to access its services. Even the Navajo Department of Health partnered with the Indian Health Service to provide culturally relevant campaigns that explain why the vaccine is valuable.

I think because people were so impacted, they saw something valuable with the vaccine. Given the education and access, people were ready to get vaccinated. They realized if a whole household got vaccinated, they could see early on that they could be social again.
 

Q: What cultural factors have been contributing to this positive development?

A: In our Navajo culture, we’ve dealt with monsters before. We talk about that in terms of how we teach our young people to be strong and resilient. We talked about this virus as being another monster we had to tackle and control. The teaching was along those lines. We’ve dealt with this before, and we can handle it. We’re resilient. Our culture is very strong in that way. So how do we do it? We have to partner; we have to embrace Western medicine to return back to the ceremonies we want to have again and be social again. We focus on positive things, so if we see something as potentially positive, such as the vaccine, we see that and know that’s something to help us come into our life again.

Q: I would expect that protecting elders in the tribe would be a big incentive in taking the vaccine.

A: Yes, we didn’t want to lose our language and culture, and we wanted to protect our elders. Having a way to do that was very important as well. They were among the first to get vaccinated.

Q: What is the current vaccination rate in the Navajo nation?

A: I think it’s in the upper 80th percentile. It’s very high.

Q: What have been the biggest takeaways so far, and what are your hopes for the future?

A: Even though the Navajo Nation has been impacted and devastated with the loss of elders and knowledge keepers, we still have our culture and ceremonies intact to the point that we know we can be resilient get through this difficult time.

Through collaborations with the federal and state governments and the clinics, we see that things are different now. Going forward, my hope is these partnerships will continue, that we’ll build those relationships and not be so siloed in our care. When the New Mexico Department of Health rolled out its first vaccination clinic, for example, we jumped on and saw how they did it. We were then able to do our own, collaborating with the state.

We also saw how important our culture was, how it helped our Navajo people through these difficult times.

Dr. Roessel, a distinguished fellow of the American Psychiatric Association, has special expertise in cultural psychiatry. Her childhood was spent growing up in the Navajo nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating Indigenous knowledge and principles.

References

American Public Media Research Lab. “The Color of Coronavirus: COVID-19 Deaths by Race and Ethnicity in the U.S.” 2021 Mar 5.

Centers for Disease Control and Prevention. “Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States.” Data as of 2021 Oct 14.

Navajo Nation. Indian Health Service. U.S. Department of Health & Human Services.

The Navajo Nation’s Office of the President and Vice President. “11 New Cases, 32,735 Recoveries, and Six Recent Deaths Related to COVID-19.” 2021 Oct 13.

Navajo Nation Government web page.

COVID-19 has killed Native Americans at twice the rate of White Americans, underscoring the health inequities and deep-rooted distrust tribal nations have of federal government entities.

And yet, Native Americans have the highest vaccination rates of any major racial or ethnic group in the United States. Like many other tribal nations, the Navajo had to embrace Western science to reclaim its social customs and ceremonies. “We’re a very social culture, so having to isolate really impacted our mental health,” said Mary Hasbah Roessel, MD, DLFAPA, a Navajo psychiatrist who is affiliated with Santa Fe Indian Hospital in New Mexico.

The Navajo nation occupies the largest Native American reservation in the United States, spanning New Mexico, Arizona, and Utah. As of mid-October, the nation had reported more than 34,000 COVID-19 cases and 1,400 deaths in its jurisdiction.

In an interview with this news organization, Dr. Roessel described the partnerships that mobilized a nation of more than 250,000 individuals to get vaccinated.

Question: Why has the death rate been so high in the Navajo nation?

Answer: A lot of health disparities before the pandemic were blatantly revealed during COVID. Only 40% of people on the reservation had running water. Having to stay home and isolate led to food insecurity. Further insecurity issues affected our ability to stay healthy, such as having good sanitation. There’s a lot of poverty, a high unemployment rate. Some people had to go to work off reservation and were potentially bringing the virus home. A lot of generations live in the same household. Elders were vulnerable to getting the infection, and there was little ability to isolate if someone wasn’t having symptoms. Hospitals nearby didn’t have ICUs.

Therefore, the rate of cases skyrocketed early on. We were disproportionately affected. The Navajo nation per capita had the highest rate of cases in any state.
 

Q: What changes took place within the Navajo nation to get people vaccinated? What role did the federal Indian Health Service have in promoting this?

A: There had to be a shift in acceptance of the vaccinations. I think what particularly helped the Navajo nation was seeing the IHS rise up and provide access for treatments and vaccinations early on.

With the IHS, we went into a disaster response mode with all-hands-on deck meetings. We had to figure out how we could access mass vaccination clinics. Partnering with the Navajo Department of Health, we did that right away with hospitals and small clinics across the Navajo nation. Casinos owned by tribal entities that closed during COVID reopened and were used as vaccination clinics.

Vaccinations were sent to us fairly quickly. I ended up getting vaccinated in December 2020, when it was first rolled out.

Native and Navajo individuals have been reluctant to rely on government services. Because IHS came through with the vaccines, COVID reduced that stigma to access its services. Even the Navajo Department of Health partnered with the Indian Health Service to provide culturally relevant campaigns that explain why the vaccine is valuable.

I think because people were so impacted, they saw something valuable with the vaccine. Given the education and access, people were ready to get vaccinated. They realized if a whole household got vaccinated, they could see early on that they could be social again.
 

Q: What cultural factors have been contributing to this positive development?

A: In our Navajo culture, we’ve dealt with monsters before. We talk about that in terms of how we teach our young people to be strong and resilient. We talked about this virus as being another monster we had to tackle and control. The teaching was along those lines. We’ve dealt with this before, and we can handle it. We’re resilient. Our culture is very strong in that way. So how do we do it? We have to partner; we have to embrace Western medicine to return back to the ceremonies we want to have again and be social again. We focus on positive things, so if we see something as potentially positive, such as the vaccine, we see that and know that’s something to help us come into our life again.

Q: I would expect that protecting elders in the tribe would be a big incentive in taking the vaccine.

A: Yes, we didn’t want to lose our language and culture, and we wanted to protect our elders. Having a way to do that was very important as well. They were among the first to get vaccinated.

Q: What is the current vaccination rate in the Navajo nation?

A: I think it’s in the upper 80th percentile. It’s very high.

Q: What have been the biggest takeaways so far, and what are your hopes for the future?

A: Even though the Navajo Nation has been impacted and devastated with the loss of elders and knowledge keepers, we still have our culture and ceremonies intact to the point that we know we can be resilient get through this difficult time.

Through collaborations with the federal and state governments and the clinics, we see that things are different now. Going forward, my hope is these partnerships will continue, that we’ll build those relationships and not be so siloed in our care. When the New Mexico Department of Health rolled out its first vaccination clinic, for example, we jumped on and saw how they did it. We were then able to do our own, collaborating with the state.

We also saw how important our culture was, how it helped our Navajo people through these difficult times.

Dr. Roessel, a distinguished fellow of the American Psychiatric Association, has special expertise in cultural psychiatry. Her childhood was spent growing up in the Navajo nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating Indigenous knowledge and principles.

References

American Public Media Research Lab. “The Color of Coronavirus: COVID-19 Deaths by Race and Ethnicity in the U.S.” 2021 Mar 5.

Centers for Disease Control and Prevention. “Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States.” Data as of 2021 Oct 14.

Navajo Nation. Indian Health Service. U.S. Department of Health & Human Services.

The Navajo Nation’s Office of the President and Vice President. “11 New Cases, 32,735 Recoveries, and Six Recent Deaths Related to COVID-19.” 2021 Oct 13.

Navajo Nation Government web page.

A study that compared three types of direct oral anticoagulants (DOACs) found that rivaroxaban was associated with a much higher risk of overall and major gastrointestinal bleeding than apixaban or dabigatran.

The results, which were published in the Annals of Internal Medicine, could help guide DOAC selection for high-risk groups with a prior history of peptic ulcer disease or major GI bleeding, said lead study authors Arnar Bragi Ingason, MD and Einar S. Björnsson, MD, PhD, in an email.

DOACs treat conditions such as atrial fibrillation, venous thromboembolism, and ischemic stroke and are known to cause GI bleeding. Previous studies have suggested that rivaroxaban poses a higher GI-bleeding risk than other DOACs.

These studies, which used large administrative databases, “had an inherent risk of selection bias due to insurance status, age, and comorbidities due to their origin from insurance/administrative databases. In addition, they lacked phenotypic details on GI bleeding events,” said Dr. Björnsson and Dr. Ingason, who are both of Landspitali University Hospital, Reykjavik, Iceland,

Daily dosage may exacerbate risk

Rivaroxaban is administered as a single daily dose, compared with apixaban’s and dabigatran’s twice-daily regimens. “We hypothesized that this may lead to a greater variance in drug plasma concentration, making these patients more susceptible to GI bleeding,” the lead authors said.

Using data from the Icelandic Medicine Registry, a national database of outpatient prescription information, they compared rates of GI bleeding among new users of apixaban, dabigatran, and rivaroxaban from 2014 to 2019. Overall, 5,868 patients receiving one of the DOACs took part in the study. Among these participants, 3,217 received rivaroxaban, 2,157 received apixaban, and 494 received dabigatran. The researchers used inverse probability weighting, Kaplan–Meier survival estimates, and Cox regression to compare GI bleeding.

Compared with dabigatran, rivaroxaban was associated with a 63%-104% higher overall risk for GI bleeding and 39%-95% higher risk for major GI bleeding. Rivaroxaban also had a 40%-42% higher overall risk for GI bleeding and 49%-50% higher risk for major GI bleeding, compared with apixaban.

The investigators were surprised by the low rate of upper GI bleeding for dabigatran, compared with the other two drugs. “However, these results must be interpreted in the context that the dabigatran group was relatively small,” said Dr. Björnsson and Dr. Ingason via email.

Overall, the study cohort was small, compared with previous registry studies.

Investigators also did not account for account for socioeconomic status or lifestyle factors, such as alcohol consumption or smoking. “However, because the cost of all DOACs is similar in Iceland, selection bias due to socioeconomic status is unlikely,” the investigators reported in their paper. “We are currently working on comparing the rates of thromboembolisms and overall major bleeding events between the drugs,” the lead authors said.
 

Clinicians should consider location of bleeding

Though retrospective, the study by Ingason et. al. “is likely as close as is feasible to a randomized trial as is possible,” said Don C. Rockey, MD, a professor of medicine at the Medical University of South Carolina, Charleston, in an interview.

“From the clinician’s perspective, it is important to take away that there may be differences among the DOACs in terms of where in the GI tract the bleeding occurs,” said Dr. Rockey. In the study, the greatest differences appeared to be in the upper GI tract, with rivaroxaban outpacing apixaban and dabigatran. In patients who are at risk for upper GI bleeding, it may be reasonable to consider use of dabigatran or apixaban, he suggested.

“A limitation of the study is that it is likely underpowered overall,” said Dr. Rockey. It also wasn’t clear how many deaths occurred either directly from GI bleeding or as a complication of GI bleeding, he said.The study also didn’t differentiate major bleeding among DOACs specifically in the upper or lower GI tract, Dr. Rockey added.
 

Other studies yield similar results

Dr. Ingason and Dr. Björnsson said their work complements previous studies, and Neena S. Abraham, MD, MSc , who has conducted a similar investigation to the new study, agreed with that statement.

Data from the last 4 years overwhelmingly show that rivaroxaban is most likely to cause GI bleeding, said Dr. Abraham, professor of medicine and a consultant with Mayo Clinic’s division of gastroenterology and hepatology, in an interview.

A comparative safety study Dr. Abraham coauthored in 2017 of rivaroxaban, apixaban, and dabigatran in a much larger U.S. cohort of 372,380 patients revealed that rivaroxaban had the worst GI bleeding profile. Apixaban was 66% safer than rivaroxaban and 64% safer than dabigatran to prevent gastrointestinal bleeding.

“I believe our group was the first to conduct this study and show clinically significant differences in GI safety of the available direct oral anticoagulants,” she said. Other investigators have since published similar results, and the topic of the new study needs no further investigation, according to Dr. Abraham.

“It is time for physicians to choose a better choice when prescribing a direct oral anticoagulant to their atrial fibrillation patients, and that choice is not rivaroxaban,” she said.

The Icelandic Centre for Research and the Landspítali University Hospital Research Fund provided funds for this study. Dr. Ingason, Dr. Björnsson, Dr. Rockey, and Dr. Abraham reported no disclosures.

A study that compared three types of direct oral anticoagulants (DOACs) found that rivaroxaban was associated with a much higher risk of overall and major gastrointestinal bleeding than apixaban or dabigatran.

The results, which were published in the Annals of Internal Medicine, could help guide DOAC selection for high-risk groups with a prior history of peptic ulcer disease or major GI bleeding, said lead study authors Arnar Bragi Ingason, MD and Einar S. Björnsson, MD, PhD, in an email.

DOACs treat conditions such as atrial fibrillation, venous thromboembolism, and ischemic stroke and are known to cause GI bleeding. Previous studies have suggested that rivaroxaban poses a higher GI-bleeding risk than other DOACs.

These studies, which used large administrative databases, “had an inherent risk of selection bias due to insurance status, age, and comorbidities due to their origin from insurance/administrative databases. In addition, they lacked phenotypic details on GI bleeding events,” said Dr. Björnsson and Dr. Ingason, who are both of Landspitali University Hospital, Reykjavik, Iceland,

Daily dosage may exacerbate risk

Rivaroxaban is administered as a single daily dose, compared with apixaban’s and dabigatran’s twice-daily regimens. “We hypothesized that this may lead to a greater variance in drug plasma concentration, making these patients more susceptible to GI bleeding,” the lead authors said.

Using data from the Icelandic Medicine Registry, a national database of outpatient prescription information, they compared rates of GI bleeding among new users of apixaban, dabigatran, and rivaroxaban from 2014 to 2019. Overall, 5,868 patients receiving one of the DOACs took part in the study. Among these participants, 3,217 received rivaroxaban, 2,157 received apixaban, and 494 received dabigatran. The researchers used inverse probability weighting, Kaplan–Meier survival estimates, and Cox regression to compare GI bleeding.

Compared with dabigatran, rivaroxaban was associated with a 63%-104% higher overall risk for GI bleeding and 39%-95% higher risk for major GI bleeding. Rivaroxaban also had a 40%-42% higher overall risk for GI bleeding and 49%-50% higher risk for major GI bleeding, compared with apixaban.

The investigators were surprised by the low rate of upper GI bleeding for dabigatran, compared with the other two drugs. “However, these results must be interpreted in the context that the dabigatran group was relatively small,” said Dr. Björnsson and Dr. Ingason via email.

Overall, the study cohort was small, compared with previous registry studies.

Investigators also did not account for account for socioeconomic status or lifestyle factors, such as alcohol consumption or smoking. “However, because the cost of all DOACs is similar in Iceland, selection bias due to socioeconomic status is unlikely,” the investigators reported in their paper. “We are currently working on comparing the rates of thromboembolisms and overall major bleeding events between the drugs,” the lead authors said.
 

Clinicians should consider location of bleeding

Though retrospective, the study by Ingason et. al. “is likely as close as is feasible to a randomized trial as is possible,” said Don C. Rockey, MD, a professor of medicine at the Medical University of South Carolina, Charleston, in an interview.

“From the clinician’s perspective, it is important to take away that there may be differences among the DOACs in terms of where in the GI tract the bleeding occurs,” said Dr. Rockey. In the study, the greatest differences appeared to be in the upper GI tract, with rivaroxaban outpacing apixaban and dabigatran. In patients who are at risk for upper GI bleeding, it may be reasonable to consider use of dabigatran or apixaban, he suggested.

“A limitation of the study is that it is likely underpowered overall,” said Dr. Rockey. It also wasn’t clear how many deaths occurred either directly from GI bleeding or as a complication of GI bleeding, he said.The study also didn’t differentiate major bleeding among DOACs specifically in the upper or lower GI tract, Dr. Rockey added.
 

Other studies yield similar results

Dr. Ingason and Dr. Björnsson said their work complements previous studies, and Neena S. Abraham, MD, MSc , who has conducted a similar investigation to the new study, agreed with that statement.

Data from the last 4 years overwhelmingly show that rivaroxaban is most likely to cause GI bleeding, said Dr. Abraham, professor of medicine and a consultant with Mayo Clinic’s division of gastroenterology and hepatology, in an interview.

A comparative safety study Dr. Abraham coauthored in 2017 of rivaroxaban, apixaban, and dabigatran in a much larger U.S. cohort of 372,380 patients revealed that rivaroxaban had the worst GI bleeding profile. Apixaban was 66% safer than rivaroxaban and 64% safer than dabigatran to prevent gastrointestinal bleeding.

“I believe our group was the first to conduct this study and show clinically significant differences in GI safety of the available direct oral anticoagulants,” she said. Other investigators have since published similar results, and the topic of the new study needs no further investigation, according to Dr. Abraham.

“It is time for physicians to choose a better choice when prescribing a direct oral anticoagulant to their atrial fibrillation patients, and that choice is not rivaroxaban,” she said.

The Icelandic Centre for Research and the Landspítali University Hospital Research Fund provided funds for this study. Dr. Ingason, Dr. Björnsson, Dr. Rockey, and Dr. Abraham reported no disclosures.

A study that compared three types of direct oral anticoagulants (DOACs) found that rivaroxaban was associated with a much higher risk of overall and major gastrointestinal bleeding than apixaban or dabigatran.

The results, which were published in the Annals of Internal Medicine, could help guide DOAC selection for high-risk groups with a prior history of peptic ulcer disease or major GI bleeding, said lead study authors Arnar Bragi Ingason, MD and Einar S. Björnsson, MD, PhD, in an email.

DOACs treat conditions such as atrial fibrillation, venous thromboembolism, and ischemic stroke and are known to cause GI bleeding. Previous studies have suggested that rivaroxaban poses a higher GI-bleeding risk than other DOACs.

These studies, which used large administrative databases, “had an inherent risk of selection bias due to insurance status, age, and comorbidities due to their origin from insurance/administrative databases. In addition, they lacked phenotypic details on GI bleeding events,” said Dr. Björnsson and Dr. Ingason, who are both of Landspitali University Hospital, Reykjavik, Iceland,

Daily dosage may exacerbate risk

Rivaroxaban is administered as a single daily dose, compared with apixaban’s and dabigatran’s twice-daily regimens. “We hypothesized that this may lead to a greater variance in drug plasma concentration, making these patients more susceptible to GI bleeding,” the lead authors said.

Using data from the Icelandic Medicine Registry, a national database of outpatient prescription information, they compared rates of GI bleeding among new users of apixaban, dabigatran, and rivaroxaban from 2014 to 2019. Overall, 5,868 patients receiving one of the DOACs took part in the study. Among these participants, 3,217 received rivaroxaban, 2,157 received apixaban, and 494 received dabigatran. The researchers used inverse probability weighting, Kaplan–Meier survival estimates, and Cox regression to compare GI bleeding.

Compared with dabigatran, rivaroxaban was associated with a 63%-104% higher overall risk for GI bleeding and 39%-95% higher risk for major GI bleeding. Rivaroxaban also had a 40%-42% higher overall risk for GI bleeding and 49%-50% higher risk for major GI bleeding, compared with apixaban.

The investigators were surprised by the low rate of upper GI bleeding for dabigatran, compared with the other two drugs. “However, these results must be interpreted in the context that the dabigatran group was relatively small,” said Dr. Björnsson and Dr. Ingason via email.

Overall, the study cohort was small, compared with previous registry studies.

Investigators also did not account for account for socioeconomic status or lifestyle factors, such as alcohol consumption or smoking. “However, because the cost of all DOACs is similar in Iceland, selection bias due to socioeconomic status is unlikely,” the investigators reported in their paper. “We are currently working on comparing the rates of thromboembolisms and overall major bleeding events between the drugs,” the lead authors said.
 

Clinicians should consider location of bleeding

Though retrospective, the study by Ingason et. al. “is likely as close as is feasible to a randomized trial as is possible,” said Don C. Rockey, MD, a professor of medicine at the Medical University of South Carolina, Charleston, in an interview.

“From the clinician’s perspective, it is important to take away that there may be differences among the DOACs in terms of where in the GI tract the bleeding occurs,” said Dr. Rockey. In the study, the greatest differences appeared to be in the upper GI tract, with rivaroxaban outpacing apixaban and dabigatran. In patients who are at risk for upper GI bleeding, it may be reasonable to consider use of dabigatran or apixaban, he suggested.

“A limitation of the study is that it is likely underpowered overall,” said Dr. Rockey. It also wasn’t clear how many deaths occurred either directly from GI bleeding or as a complication of GI bleeding, he said.The study also didn’t differentiate major bleeding among DOACs specifically in the upper or lower GI tract, Dr. Rockey added.
 

Other studies yield similar results

Dr. Ingason and Dr. Björnsson said their work complements previous studies, and Neena S. Abraham, MD, MSc , who has conducted a similar investigation to the new study, agreed with that statement.

Data from the last 4 years overwhelmingly show that rivaroxaban is most likely to cause GI bleeding, said Dr. Abraham, professor of medicine and a consultant with Mayo Clinic’s division of gastroenterology and hepatology, in an interview.

A comparative safety study Dr. Abraham coauthored in 2017 of rivaroxaban, apixaban, and dabigatran in a much larger U.S. cohort of 372,380 patients revealed that rivaroxaban had the worst GI bleeding profile. Apixaban was 66% safer than rivaroxaban and 64% safer than dabigatran to prevent gastrointestinal bleeding.

“I believe our group was the first to conduct this study and show clinically significant differences in GI safety of the available direct oral anticoagulants,” she said. Other investigators have since published similar results, and the topic of the new study needs no further investigation, according to Dr. Abraham.

“It is time for physicians to choose a better choice when prescribing a direct oral anticoagulant to their atrial fibrillation patients, and that choice is not rivaroxaban,” she said.

The Icelandic Centre for Research and the Landspítali University Hospital Research Fund provided funds for this study. Dr. Ingason, Dr. Björnsson, Dr. Rockey, and Dr. Abraham reported no disclosures.

Borderline personality disorder (BPD) has suffered from underdiagnosis, in part because not enough clinicians know how to handle patients with BPD. “They don’t have the tools to know how to manage these situations effectively,” Lois W. Choi-Kain, MEd, MD, director of the Gunderson Personality Disorders Institute, McLean Hospital, Belmont, Mass., said in an interview.

As a result, the clinician avoids the BPD patient, who feels demeaned and never finds the capacity to get better.

Psychiatry training in residency tends to emphasize biomedical treatments and does not focus enough on learning psychotherapy and other psychosocial treatments, according to Eric M. Plakun, MD, DLFAPA, FACPsych, medical director/CEO of the Austen Riggs Center in Stockbridge, Mass.

“This is where I see the need for a greater psychotherapy teaching focus in residency, along with teaching of general principles for working with patients with BPD,” said Dr. Plakun.

In his last phase of his career, BPD pioneer John G. Gunderson, MD, worked with Dr. Choi-Kain to train clinicians on general psychiatric management (GPM), which employs a sensitive, nonattacking approach to diffuse and calm situations with BPD patients.

As interest grows in combining GPM with manual treatments, GPM alone offers a more accessible approach for therapist and patient, said Dr. Choi-Kain, who has been trying to promote its use and do research on its techniques.

“It’s trying to boil it down to make it simple,” she said. As much as evidence-based, manualized approaches have advanced the field, they’re just not that widely available, she said.

Orchestrating treatments such as dialectical behavior therapy and mentalization-based therapy takes a lot of specialization, noted Dr. Choi-Kain. “And because of the amount of work that it involves for both the clinician and the patient, it decreases the capacity that clinicians and systems have to offer treatment to a wider number of patients.”

Learning a manualized treatment for BPD is asking a lot from residents, agreed Dr. Plakun. “Those who want more immersion in treating these patients can pursue further training in residency electives, in postresidency graduate medical education programs or through psychoanalytic training.”

Borderline personality disorder (BPD) has suffered from underdiagnosis, in part because not enough clinicians know how to handle patients with BPD. “They don’t have the tools to know how to manage these situations effectively,” Lois W. Choi-Kain, MEd, MD, director of the Gunderson Personality Disorders Institute, McLean Hospital, Belmont, Mass., said in an interview.

As a result, the clinician avoids the BPD patient, who feels demeaned and never finds the capacity to get better.

Psychiatry training in residency tends to emphasize biomedical treatments and does not focus enough on learning psychotherapy and other psychosocial treatments, according to Eric M. Plakun, MD, DLFAPA, FACPsych, medical director/CEO of the Austen Riggs Center in Stockbridge, Mass.

“This is where I see the need for a greater psychotherapy teaching focus in residency, along with teaching of general principles for working with patients with BPD,” said Dr. Plakun.

In his last phase of his career, BPD pioneer John G. Gunderson, MD, worked with Dr. Choi-Kain to train clinicians on general psychiatric management (GPM), which employs a sensitive, nonattacking approach to diffuse and calm situations with BPD patients.

As interest grows in combining GPM with manual treatments, GPM alone offers a more accessible approach for therapist and patient, said Dr. Choi-Kain, who has been trying to promote its use and do research on its techniques.

“It’s trying to boil it down to make it simple,” she said. As much as evidence-based, manualized approaches have advanced the field, they’re just not that widely available, she said.

Orchestrating treatments such as dialectical behavior therapy and mentalization-based therapy takes a lot of specialization, noted Dr. Choi-Kain. “And because of the amount of work that it involves for both the clinician and the patient, it decreases the capacity that clinicians and systems have to offer treatment to a wider number of patients.”

Learning a manualized treatment for BPD is asking a lot from residents, agreed Dr. Plakun. “Those who want more immersion in treating these patients can pursue further training in residency electives, in postresidency graduate medical education programs or through psychoanalytic training.”

Borderline personality disorder (BPD) has suffered from underdiagnosis, in part because not enough clinicians know how to handle patients with BPD. “They don’t have the tools to know how to manage these situations effectively,” Lois W. Choi-Kain, MEd, MD, director of the Gunderson Personality Disorders Institute, McLean Hospital, Belmont, Mass., said in an interview.

As a result, the clinician avoids the BPD patient, who feels demeaned and never finds the capacity to get better.

Psychiatry training in residency tends to emphasize biomedical treatments and does not focus enough on learning psychotherapy and other psychosocial treatments, according to Eric M. Plakun, MD, DLFAPA, FACPsych, medical director/CEO of the Austen Riggs Center in Stockbridge, Mass.

“This is where I see the need for a greater psychotherapy teaching focus in residency, along with teaching of general principles for working with patients with BPD,” said Dr. Plakun.

In his last phase of his career, BPD pioneer John G. Gunderson, MD, worked with Dr. Choi-Kain to train clinicians on general psychiatric management (GPM), which employs a sensitive, nonattacking approach to diffuse and calm situations with BPD patients.

As interest grows in combining GPM with manual treatments, GPM alone offers a more accessible approach for therapist and patient, said Dr. Choi-Kain, who has been trying to promote its use and do research on its techniques.

“It’s trying to boil it down to make it simple,” she said. As much as evidence-based, manualized approaches have advanced the field, they’re just not that widely available, she said.

Orchestrating treatments such as dialectical behavior therapy and mentalization-based therapy takes a lot of specialization, noted Dr. Choi-Kain. “And because of the amount of work that it involves for both the clinician and the patient, it decreases the capacity that clinicians and systems have to offer treatment to a wider number of patients.”

Learning a manualized treatment for BPD is asking a lot from residents, agreed Dr. Plakun. “Those who want more immersion in treating these patients can pursue further training in residency electives, in postresidency graduate medical education programs or through psychoanalytic training.”

Michael A. Cummings, MD, has never liked the term “borderline personality disorder” (BPD). In his view, it’s a misnomer and needs to be changed.

“What is it bordering on? It’s not bordering on something, it’s a disorder on its own,” said Dr. Cummings of the department of psychiatry at the University of California, Riverside, and a psychopharmacology consultant with the California Department of State Hospitals’ Psychopharmacology Resource Network.

BPD grew out of the concept that patients were bordering on something, perhaps becoming bipolar. “In many ways, I don’t think it is even a personality disorder. It appears to be an inherent temperament that evolves into an inability to regulate mood.”

In his view, this puts it in the category of a mood dysregulation disorder.

Changing the label would not necessarily improve treatment, he added. However, transitioning from a pejorative to a more neutral label could make it easier for people to say, “this is just a type of mood disorder. It’s not necessarily easy, but it’s workable,” said Dr. Cummings.

Others in the field contend that the term fits the condition. BPD “describes how it encompasses a lot of complex psychological difficulties, undermining functioning of patients in a specific way,” said Lois W. Choi-Kain, MD, MEd, director of the Gunderson Personality Disorders Institute, McLean Hospital, Belmont, Mass. The disorder was identified because of its relationship with other known psychiatric disorders, said Dr. Choi-Kain. “There’s an element of BPD that borders on mood disorders because moods are so unstable with BPD. It also borders on trauma-related disorders. It borders on psychotic disorders because there’s sometimes stress-induced experiences of losing contact with realistic thinking.”

If anything needs to change, it’s the attitude toward the disorder, not the name. “I don’t think the term itself is pejorative. But I think that associations with the term have been very stigmatizing. For a long time, there was an attitude that these patients could not be treated or had negative therapeutic reactions.”

Data suggest that these patients are highly prevalent in clinical settings. “And I interpret that as them seeking the care that they need rather than resisting care or not responding to care,” said Dr. Choi-Kain.

Michael A. Cummings, MD, has never liked the term “borderline personality disorder” (BPD). In his view, it’s a misnomer and needs to be changed.

“What is it bordering on? It’s not bordering on something, it’s a disorder on its own,” said Dr. Cummings of the department of psychiatry at the University of California, Riverside, and a psychopharmacology consultant with the California Department of State Hospitals’ Psychopharmacology Resource Network.

BPD grew out of the concept that patients were bordering on something, perhaps becoming bipolar. “In many ways, I don’t think it is even a personality disorder. It appears to be an inherent temperament that evolves into an inability to regulate mood.”

In his view, this puts it in the category of a mood dysregulation disorder.

Changing the label would not necessarily improve treatment, he added. However, transitioning from a pejorative to a more neutral label could make it easier for people to say, “this is just a type of mood disorder. It’s not necessarily easy, but it’s workable,” said Dr. Cummings.

Others in the field contend that the term fits the condition. BPD “describes how it encompasses a lot of complex psychological difficulties, undermining functioning of patients in a specific way,” said Lois W. Choi-Kain, MD, MEd, director of the Gunderson Personality Disorders Institute, McLean Hospital, Belmont, Mass. The disorder was identified because of its relationship with other known psychiatric disorders, said Dr. Choi-Kain. “There’s an element of BPD that borders on mood disorders because moods are so unstable with BPD. It also borders on trauma-related disorders. It borders on psychotic disorders because there’s sometimes stress-induced experiences of losing contact with realistic thinking.”

If anything needs to change, it’s the attitude toward the disorder, not the name. “I don’t think the term itself is pejorative. But I think that associations with the term have been very stigmatizing. For a long time, there was an attitude that these patients could not be treated or had negative therapeutic reactions.”

Data suggest that these patients are highly prevalent in clinical settings. “And I interpret that as them seeking the care that they need rather than resisting care or not responding to care,” said Dr. Choi-Kain.

Michael A. Cummings, MD, has never liked the term “borderline personality disorder” (BPD). In his view, it’s a misnomer and needs to be changed.

“What is it bordering on? It’s not bordering on something, it’s a disorder on its own,” said Dr. Cummings of the department of psychiatry at the University of California, Riverside, and a psychopharmacology consultant with the California Department of State Hospitals’ Psychopharmacology Resource Network.

BPD grew out of the concept that patients were bordering on something, perhaps becoming bipolar. “In many ways, I don’t think it is even a personality disorder. It appears to be an inherent temperament that evolves into an inability to regulate mood.”

In his view, this puts it in the category of a mood dysregulation disorder.

Changing the label would not necessarily improve treatment, he added. However, transitioning from a pejorative to a more neutral label could make it easier for people to say, “this is just a type of mood disorder. It’s not necessarily easy, but it’s workable,” said Dr. Cummings.

Others in the field contend that the term fits the condition. BPD “describes how it encompasses a lot of complex psychological difficulties, undermining functioning of patients in a specific way,” said Lois W. Choi-Kain, MD, MEd, director of the Gunderson Personality Disorders Institute, McLean Hospital, Belmont, Mass. The disorder was identified because of its relationship with other known psychiatric disorders, said Dr. Choi-Kain. “There’s an element of BPD that borders on mood disorders because moods are so unstable with BPD. It also borders on trauma-related disorders. It borders on psychotic disorders because there’s sometimes stress-induced experiences of losing contact with realistic thinking.”

If anything needs to change, it’s the attitude toward the disorder, not the name. “I don’t think the term itself is pejorative. But I think that associations with the term have been very stigmatizing. For a long time, there was an attitude that these patients could not be treated or had negative therapeutic reactions.”

Data suggest that these patients are highly prevalent in clinical settings. “And I interpret that as them seeking the care that they need rather than resisting care or not responding to care,” said Dr. Choi-Kain.