Clinical Psychiatry News

Patients with a primary humoral immunodeficiency (PID) are 91% more likely to have a psychiatric disorder and 84% more likely to exhibit suicidal behavior, compared against those without the condition, new research shows.

Results showed that this association, which was stronger in women, could not be fully explained by comorbid autoimmune diseases or by familial confounding.

These findings have important clinical implications, study investigator Josef Isung, MD, PhD, Centre for Psychiatry Research, Karolinska Institute, Stockholm, Sweden, told Medscape Medical News.

Clinicians managing patients with PID “should be aware of this increased association with psychiatric disorders and perhaps screen for them,” said Isung.

The study was published in the November issue of JAMA Psychiatry.
 

Registry study

Mounting evidence suggests immune disruption plays a role in psychiatric disorders through a range of mechanisms, including altered neurodevelopment. However, little is known about the neuropsychiatric consequences resulting from the underproduction of homeostatic antibodies.

PIDs involve a deficiency in antibody production, mainly affecting immunoglobulin, “or the humoral aspect of the immune system,” said Isung. They’re associated with an increased risk for recurrent infections and of developing autoimmune diseases.

The immunodeficiency can be severe, even life threatening, but can also be relatively mild. One of the less severe PID types is selective IgA deficiency, which is linked to increased infections within the mucosa-associated lymphoid tissue (MALT), an important immune barrier.

Experts have long suspected that infections within the MALT are associated with certain forms of psychopathology in children, particularly obsessive-compulsive disorder and chronic tic disorders.

While patients with this selective IgA subtype may be at some increased risk for infection and autoimmune disease, their overall health otherwise is good, said Isung.

The prevalence of PIDs ranges from about 1:250 to 1:20,000, depending on the type of humoral immunodeficiency, although most would fall into the relatively rare category, he added.

Using several linked national Swedish registries, researchers identified individuals with any PID diagnosis affecting immunoglobulin levels, their full siblings, and those with a lifetime diagnosis of selective IgA deficiency. In addition, they collected data on autoimmune diseases.

The study outcome was a lifetime record of a psychiatric disorder, a suicide attempt, or death by suicide.
 

Strong link to autism

Researchers identified 8378 patients (59% women) with PID affecting immunoglobulin levels (median age at first diagnosis, 47.8 years). They compared this group with almost 14.3 million subjects without PID.

In those with PID, 27.6% had an autoimmune disease vs 6.8% of those without PID, a statistically significant difference (P < .001).

About 20.5% of those with PID and 10.7% of unexposed subjects had at least one diagnosis of a psychiatric disorder.

In a model adjusted for year of birth, sex, and history of autoimmune disease, subjects with PID had a 91% higher likelihood of any psychiatric disorder (adjusted odds ratio [AOR] 1.91; 95% CI, 1.81 - 2.01; P < .001) vs their counterparts without PID.

The AORs for individual psychiatric disorders ranged from 1.34 (95% CI, 1.17 - 1.54; P < .001) for schizophrenia and other psychotic disorders to 2.99 (95% CI, 2.42 - 3.70; P < .001) for autism spectrum disorders (ASDs)

It’s unclear why the association with PID was strongest for autism, “but being a neurodevelopmental disorder, maybe autism is logically more associated with this type of disruption,” said Isung.

Research suggests that immunologic disruption may play a role in ASD, either through altered maternal immune function in utero or through immune disruption after birth, the researchers note.

Compared to those without PID, individuals with it had a significantly increased likelihood of any suicidal behavior (AOR, 1.84; 95% CI, 1.66 - 2.04, P < .001) as well as individual outcomes of death by suicide and suicide attempts.

The association with psychiatric disorders and suicidal behavior was markedly stronger for exposure to both PID and autoimmune disease than for exposure to either of these alone, which suggest an additive effect for these immune-related conditions.
 

Sex differences

“It was unclear to us why women seemed particularly vulnerable,” said Isung. He noted that PIDs are generally about as common in women as in men, but women tend to have higher rates of psychiatric disorders.

The analysis of the sibling cohort also revealed an elevated risk for psychiatric disorders, including ASD and suicidal behavior, but to a lesser degree.

“From this we could infer that at least part of the associations would be genetic, but part would be related to the disruption in itself,” said Isung.

An analysis examining selective IgA subtype also revealed a link with psychiatric disorders and suicidal behavior, suggesting this link is not exclusive to severe PID cases.

“Our conclusion here was that it seems like PID itself, or the immune disruption in itself, could explain the association rather than the burden of illness,” said Isung.

However, he acknowledged that the long-term stress and mental health fallout of having a chronic illness like PID may also explain some of the increased risk for psychiatric disorders.

This study, he said, provides more evidence that immune disruptions affect neurodevelopment and the brain. However, he added, the underlying mechanism still isn’t fully understood.

The results highlight the need to raise awareness of the association between immunodeficiency and mental illness, including suicidality among clinicians, patients, and advocates.

These findings may also have implications in patients with other immune deficiencies, said Isung, noting, “it would be interesting to further explore associations with other immunocompromised populations.”
 

No surprises

Commenting on the findings for Medscape Medical News, Igor Galynker, MD, professor of psychiatry at Icahn School of Medicine at Mount Sinai, New York City, said the study was “very well-done” and used “reliable and well-controlled” databases.

However, he added, the results “are neither particularly dramatic nor conclusive” as it makes sense that medical illnesses like PID would “increase risk of psychopathology,” said Galynker.

PID patients are much more likely to have contact with clinicians and to receive a psychiatric diagnosis, he said.

“People with a chronic illness are more stressed and generally have high incidences of depression, anxiety, and suicidal behavior. In addition to that, they may be more likely to be diagnosed with those conditions because they see a clinician more frequently.”

However, that reasoning doesn’t apply to autism, which manifests in early childhood and so is unlikely to be the result of stress, said Galynker, which is why he believes the finding that ASD is the psychiatric outcome most strongly associated with PID is “the most convincing.”

Galynker wasn’t surprised that the association between PID and psychiatric illnesses, and suicidal behaviors, was stronger among women.

“Women attempt suicide four times more often than men to begin with, so you would expect this to be more pronounced” in those with PID.

The study was supported by grants from the Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute; Stockholm Care Services; the Soderstrom Konig Foundation; and the Fredrik & Ingrid Thurings Foundation. Isung and Galynker have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Patients with a primary humoral immunodeficiency (PID) are 91% more likely to have a psychiatric disorder and 84% more likely to exhibit suicidal behavior, compared against those without the condition, new research shows.

Results showed that this association, which was stronger in women, could not be fully explained by comorbid autoimmune diseases or by familial confounding.

These findings have important clinical implications, study investigator Josef Isung, MD, PhD, Centre for Psychiatry Research, Karolinska Institute, Stockholm, Sweden, told Medscape Medical News.

Clinicians managing patients with PID “should be aware of this increased association with psychiatric disorders and perhaps screen for them,” said Isung.

The study was published in the November issue of JAMA Psychiatry.
 

Registry study

Mounting evidence suggests immune disruption plays a role in psychiatric disorders through a range of mechanisms, including altered neurodevelopment. However, little is known about the neuropsychiatric consequences resulting from the underproduction of homeostatic antibodies.

PIDs involve a deficiency in antibody production, mainly affecting immunoglobulin, “or the humoral aspect of the immune system,” said Isung. They’re associated with an increased risk for recurrent infections and of developing autoimmune diseases.

The immunodeficiency can be severe, even life threatening, but can also be relatively mild. One of the less severe PID types is selective IgA deficiency, which is linked to increased infections within the mucosa-associated lymphoid tissue (MALT), an important immune barrier.

Experts have long suspected that infections within the MALT are associated with certain forms of psychopathology in children, particularly obsessive-compulsive disorder and chronic tic disorders.

While patients with this selective IgA subtype may be at some increased risk for infection and autoimmune disease, their overall health otherwise is good, said Isung.

The prevalence of PIDs ranges from about 1:250 to 1:20,000, depending on the type of humoral immunodeficiency, although most would fall into the relatively rare category, he added.

Using several linked national Swedish registries, researchers identified individuals with any PID diagnosis affecting immunoglobulin levels, their full siblings, and those with a lifetime diagnosis of selective IgA deficiency. In addition, they collected data on autoimmune diseases.

The study outcome was a lifetime record of a psychiatric disorder, a suicide attempt, or death by suicide.
 

Strong link to autism

Researchers identified 8378 patients (59% women) with PID affecting immunoglobulin levels (median age at first diagnosis, 47.8 years). They compared this group with almost 14.3 million subjects without PID.

In those with PID, 27.6% had an autoimmune disease vs 6.8% of those without PID, a statistically significant difference (P < .001).

About 20.5% of those with PID and 10.7% of unexposed subjects had at least one diagnosis of a psychiatric disorder.

In a model adjusted for year of birth, sex, and history of autoimmune disease, subjects with PID had a 91% higher likelihood of any psychiatric disorder (adjusted odds ratio [AOR] 1.91; 95% CI, 1.81 - 2.01; P < .001) vs their counterparts without PID.

The AORs for individual psychiatric disorders ranged from 1.34 (95% CI, 1.17 - 1.54; P < .001) for schizophrenia and other psychotic disorders to 2.99 (95% CI, 2.42 - 3.70; P < .001) for autism spectrum disorders (ASDs)

It’s unclear why the association with PID was strongest for autism, “but being a neurodevelopmental disorder, maybe autism is logically more associated with this type of disruption,” said Isung.

Research suggests that immunologic disruption may play a role in ASD, either through altered maternal immune function in utero or through immune disruption after birth, the researchers note.

Compared to those without PID, individuals with it had a significantly increased likelihood of any suicidal behavior (AOR, 1.84; 95% CI, 1.66 - 2.04, P < .001) as well as individual outcomes of death by suicide and suicide attempts.

The association with psychiatric disorders and suicidal behavior was markedly stronger for exposure to both PID and autoimmune disease than for exposure to either of these alone, which suggest an additive effect for these immune-related conditions.
 

Sex differences

“It was unclear to us why women seemed particularly vulnerable,” said Isung. He noted that PIDs are generally about as common in women as in men, but women tend to have higher rates of psychiatric disorders.

The analysis of the sibling cohort also revealed an elevated risk for psychiatric disorders, including ASD and suicidal behavior, but to a lesser degree.

“From this we could infer that at least part of the associations would be genetic, but part would be related to the disruption in itself,” said Isung.

An analysis examining selective IgA subtype also revealed a link with psychiatric disorders and suicidal behavior, suggesting this link is not exclusive to severe PID cases.

“Our conclusion here was that it seems like PID itself, or the immune disruption in itself, could explain the association rather than the burden of illness,” said Isung.

However, he acknowledged that the long-term stress and mental health fallout of having a chronic illness like PID may also explain some of the increased risk for psychiatric disorders.

This study, he said, provides more evidence that immune disruptions affect neurodevelopment and the brain. However, he added, the underlying mechanism still isn’t fully understood.

The results highlight the need to raise awareness of the association between immunodeficiency and mental illness, including suicidality among clinicians, patients, and advocates.

These findings may also have implications in patients with other immune deficiencies, said Isung, noting, “it would be interesting to further explore associations with other immunocompromised populations.”
 

No surprises

Commenting on the findings for Medscape Medical News, Igor Galynker, MD, professor of psychiatry at Icahn School of Medicine at Mount Sinai, New York City, said the study was “very well-done” and used “reliable and well-controlled” databases.

However, he added, the results “are neither particularly dramatic nor conclusive” as it makes sense that medical illnesses like PID would “increase risk of psychopathology,” said Galynker.

PID patients are much more likely to have contact with clinicians and to receive a psychiatric diagnosis, he said.

“People with a chronic illness are more stressed and generally have high incidences of depression, anxiety, and suicidal behavior. In addition to that, they may be more likely to be diagnosed with those conditions because they see a clinician more frequently.”

However, that reasoning doesn’t apply to autism, which manifests in early childhood and so is unlikely to be the result of stress, said Galynker, which is why he believes the finding that ASD is the psychiatric outcome most strongly associated with PID is “the most convincing.”

Galynker wasn’t surprised that the association between PID and psychiatric illnesses, and suicidal behaviors, was stronger among women.

“Women attempt suicide four times more often than men to begin with, so you would expect this to be more pronounced” in those with PID.

The study was supported by grants from the Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute; Stockholm Care Services; the Soderstrom Konig Foundation; and the Fredrik & Ingrid Thurings Foundation. Isung and Galynker have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Patients with a primary humoral immunodeficiency (PID) are 91% more likely to have a psychiatric disorder and 84% more likely to exhibit suicidal behavior, compared against those without the condition, new research shows.

Results showed that this association, which was stronger in women, could not be fully explained by comorbid autoimmune diseases or by familial confounding.

These findings have important clinical implications, study investigator Josef Isung, MD, PhD, Centre for Psychiatry Research, Karolinska Institute, Stockholm, Sweden, told Medscape Medical News.

Clinicians managing patients with PID “should be aware of this increased association with psychiatric disorders and perhaps screen for them,” said Isung.

The study was published in the November issue of JAMA Psychiatry.
 

Registry study

Mounting evidence suggests immune disruption plays a role in psychiatric disorders through a range of mechanisms, including altered neurodevelopment. However, little is known about the neuropsychiatric consequences resulting from the underproduction of homeostatic antibodies.

PIDs involve a deficiency in antibody production, mainly affecting immunoglobulin, “or the humoral aspect of the immune system,” said Isung. They’re associated with an increased risk for recurrent infections and of developing autoimmune diseases.

The immunodeficiency can be severe, even life threatening, but can also be relatively mild. One of the less severe PID types is selective IgA deficiency, which is linked to increased infections within the mucosa-associated lymphoid tissue (MALT), an important immune barrier.

Experts have long suspected that infections within the MALT are associated with certain forms of psychopathology in children, particularly obsessive-compulsive disorder and chronic tic disorders.

While patients with this selective IgA subtype may be at some increased risk for infection and autoimmune disease, their overall health otherwise is good, said Isung.

The prevalence of PIDs ranges from about 1:250 to 1:20,000, depending on the type of humoral immunodeficiency, although most would fall into the relatively rare category, he added.

Using several linked national Swedish registries, researchers identified individuals with any PID diagnosis affecting immunoglobulin levels, their full siblings, and those with a lifetime diagnosis of selective IgA deficiency. In addition, they collected data on autoimmune diseases.

The study outcome was a lifetime record of a psychiatric disorder, a suicide attempt, or death by suicide.
 

Strong link to autism

Researchers identified 8378 patients (59% women) with PID affecting immunoglobulin levels (median age at first diagnosis, 47.8 years). They compared this group with almost 14.3 million subjects without PID.

In those with PID, 27.6% had an autoimmune disease vs 6.8% of those without PID, a statistically significant difference (P < .001).

About 20.5% of those with PID and 10.7% of unexposed subjects had at least one diagnosis of a psychiatric disorder.

In a model adjusted for year of birth, sex, and history of autoimmune disease, subjects with PID had a 91% higher likelihood of any psychiatric disorder (adjusted odds ratio [AOR] 1.91; 95% CI, 1.81 - 2.01; P < .001) vs their counterparts without PID.

The AORs for individual psychiatric disorders ranged from 1.34 (95% CI, 1.17 - 1.54; P < .001) for schizophrenia and other psychotic disorders to 2.99 (95% CI, 2.42 - 3.70; P < .001) for autism spectrum disorders (ASDs)

It’s unclear why the association with PID was strongest for autism, “but being a neurodevelopmental disorder, maybe autism is logically more associated with this type of disruption,” said Isung.

Research suggests that immunologic disruption may play a role in ASD, either through altered maternal immune function in utero or through immune disruption after birth, the researchers note.

Compared to those without PID, individuals with it had a significantly increased likelihood of any suicidal behavior (AOR, 1.84; 95% CI, 1.66 - 2.04, P < .001) as well as individual outcomes of death by suicide and suicide attempts.

The association with psychiatric disorders and suicidal behavior was markedly stronger for exposure to both PID and autoimmune disease than for exposure to either of these alone, which suggest an additive effect for these immune-related conditions.
 

Sex differences

“It was unclear to us why women seemed particularly vulnerable,” said Isung. He noted that PIDs are generally about as common in women as in men, but women tend to have higher rates of psychiatric disorders.

The analysis of the sibling cohort also revealed an elevated risk for psychiatric disorders, including ASD and suicidal behavior, but to a lesser degree.

“From this we could infer that at least part of the associations would be genetic, but part would be related to the disruption in itself,” said Isung.

An analysis examining selective IgA subtype also revealed a link with psychiatric disorders and suicidal behavior, suggesting this link is not exclusive to severe PID cases.

“Our conclusion here was that it seems like PID itself, or the immune disruption in itself, could explain the association rather than the burden of illness,” said Isung.

However, he acknowledged that the long-term stress and mental health fallout of having a chronic illness like PID may also explain some of the increased risk for psychiatric disorders.

This study, he said, provides more evidence that immune disruptions affect neurodevelopment and the brain. However, he added, the underlying mechanism still isn’t fully understood.

The results highlight the need to raise awareness of the association between immunodeficiency and mental illness, including suicidality among clinicians, patients, and advocates.

These findings may also have implications in patients with other immune deficiencies, said Isung, noting, “it would be interesting to further explore associations with other immunocompromised populations.”
 

No surprises

Commenting on the findings for Medscape Medical News, Igor Galynker, MD, professor of psychiatry at Icahn School of Medicine at Mount Sinai, New York City, said the study was “very well-done” and used “reliable and well-controlled” databases.

However, he added, the results “are neither particularly dramatic nor conclusive” as it makes sense that medical illnesses like PID would “increase risk of psychopathology,” said Galynker.

PID patients are much more likely to have contact with clinicians and to receive a psychiatric diagnosis, he said.

“People with a chronic illness are more stressed and generally have high incidences of depression, anxiety, and suicidal behavior. In addition to that, they may be more likely to be diagnosed with those conditions because they see a clinician more frequently.”

However, that reasoning doesn’t apply to autism, which manifests in early childhood and so is unlikely to be the result of stress, said Galynker, which is why he believes the finding that ASD is the psychiatric outcome most strongly associated with PID is “the most convincing.”

Galynker wasn’t surprised that the association between PID and psychiatric illnesses, and suicidal behaviors, was stronger among women.

“Women attempt suicide four times more often than men to begin with, so you would expect this to be more pronounced” in those with PID.

The study was supported by grants from the Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institute; Stockholm Care Services; the Soderstrom Konig Foundation; and the Fredrik & Ingrid Thurings Foundation. Isung and Galynker have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

“Defund the police”: It’s a slogan, or perhaps a battle cry, that has emerged from the Black Lives Matter movement as a response to race-related police brutality and concerns that people of color are profiled, targeted, arrested, charged, manhandled, and killed by law enforcement in a disproportionate and unjust manner. It crosses into our realm as psychiatrists as mental health emergency calls are handled by the police and not by mental health professionals. The result is sometimes tragic: As many as half of police shootings involve people with psychiatric disorders, and the hope is that many of the police shootings could be avoided if crises were handed by mental health clinicians instead of, or in cooperation with, the police.

At best, police officers receive a week of specialized, crisis intervention training about how to approach those with psychiatric disorders; most officers receive no training. This leaves psychiatry as the only field where medical crises are routinely handled by the police – it is demeaning and embarrassing for some of our patients and dangerous for others. The reality remains, however, that there are times when psychiatric disorders result in violent behavior, and patients being taken for involuntary treatment often resist transport, so either way there is risk, both to the patient and to anyone who responds to a call for assistance.

Early this month, the office of New York City Mayor Bill de Blasio announced that a major change would be made in how mental health calls to 911 are handled in two “high-need” areas. The mayor’s website states:

“Beginning in February 2021, new Mental Health Teams will use their physical and mental health expertise, and experience in crisis response to de-escalate emergency situations, will help reduce the number of times police will need to respond to 911 mental health calls in these precincts. These teams will have the expertise to respond to a range of behavioral health problems, such as suicide attempts, substance misuse, and serious mental illness, as well as physical health problems, which can be exacerbated by or mask mental health problems. NYC Health + Hospitals will train and provide ongoing technical assistance and support. In selecting team members for this program, FDNY will prioritize professionals with significant experience with mental health crises.”

The press release goes on to say that, in situations where there is a weapon or reason to believe there is a risk of violence, the police will be dispatched along with the new mental health team.

“This is the first time in our history that health professionals will be the default responders to mental health emergencies,” New York City First Lady Chirlane McCray said as she announced the new program. “Treating mental health crises as mental health challenges and not public safety ones is the modern and more appropriate approach.”

New York City is not the first city to employ this model. In the United States, the CAHOOTS (Crisis Assistance Helping Out on the Streets) program in Eugene, Ore., has been run by the White Bird Clinic since 1989 as part of a community policing initiative. Last year, the team responded to 24,000 calls and police backup was required on only 150 of those responses. The CAHOOTS website states:

“The CAHOOTS model has been in the spotlight recently as our nation struggles to reimagine public safety. The program mobilizes two-person teams consisting of a medic (a nurse, paramedic, or EMT) and a crisis worker who has substantial training and experience in the mental health field. The CAHOOTS teams deal with a wide range of mental health-related crises, including conflict resolution, welfare checks, substance abuse, suicide threats, and more, relying on trauma-informed de-escalation and harm reduction techniques. CAHOOTS staff are not law enforcement officers and do not carry weapons; their training and experience are the tools they use to ensure a non-violent resolution of crisis situations. They also handle non-emergent medical issues, avoiding costly ambulance transport and emergency room treatment.”

Other cities in the United States are also looking at implementing programs where mental health teams, and not the police, respond to emergency calls. Last year, Oakland, Calif.’s city council invested $40,000 in research to assess how they could best implement a program like the one in Eugene. They hope to begin the Mobile Assistance Community Responders of Oakland (MACROS) next year. Sigal Samuel writes in a Vox article, “The goal is to launch the pilot next year with funding from the city budget, and although supporters are not yet sure what its size and duration will be, they’re hopeful it’ll make a big difference to Oakland’s overpoliced community of people without homes. They were among those who first called for a non-policing approach.”

The model is not unique to the United States. In 2005, Stockholm started a program with a psychiatric ambulance – equipped with comfortable seating rather than a stretcher – to respond to mental health emergencies. The ambulance responds to 130 calls a month. It is staffed with a driver and two psychiatric nurses, and for half of the calls, the police also come. While the Swedish program was not about removing resources from the police, it has relieved the police of the responsibility for many psychiatric emergencies.

The New York City program will be modeled after the CAHOOTS initiative in Eugene. It differs from the mobile crisis response services in many other cities because CAHOOTS is hooked directly into the 911 emergency services system. Its website notes that the program has saved money:

“The cost savings are considerable. The CAHOOTS program budget is about $2.1 million annually, while the combined annual budgets for the Eugene and Springfield police departments are $90 million. In 2017, the CAHOOTS teams answered 17% of the Eugene Police Department’s overall call volume. The program saves the city of Eugene an estimated $8.5 million in public safety spending annually.”

Some worry there is an unpredictable aspect to calls for psychiatric emergencies, and the potential for mental health professions to be injured or killed. Annette Hanson, MD, a forensic psychiatrist at University of Maryland, Baltimore, voiced her concerns, “While multidisciplinary teams are useful, there have been rare cases of violence against responding mental health providers. People with serious mental illness are rarely violent but their dangerousness is unpredictable and cannot be predicted by case screening.”

Daniel Felts is a mental health crisis counselor who has worked at CAHOOTS for the past 4* years. He has responded to about 8,000 calls, and called for police backup only three times to request an immediate "Code 3 cover" when someone's safety has been in danger. Mr. Felts calls the police about once a month for concerns that do not require an immediate response for safety.* “Over the last 4 years, I am only aware of three instances when a team member’s safety was compromised because of a client’s violent behavior. No employee has been seriously physically harmed. In 30 years, with hundreds of thousands (millions?) of calls responded to, no CAHOOTS worker has ever been killed, shot, or stabbed in the line of duty,” Mr. Felts noted.

Emergency calls are screened. “It is not uncommon for CAHOOTS to be dispatched to ‘stage’ for calls involving active disputes or acutely suicidal individuals where means are present. “Staging” entails us parking roughly a mile away while police make first contact and advise whether it is safe for CAHOOTS to engage.”

Mr. Felts went on to discuss the program’s relationship with the community. “I believe that one of the biggest things that keeps us safe is the community’s knowledge and understanding of our service and how we operate. Having operated in Eugene for 30 years, our service is well understood to be one that does not kill, harm, or violate personal boundaries or liberties.”

Would a program like the ones in Stockholm or in Eugene work in other places? Eugene is a city with a population of 172,000 with a low crime rate. Whether a program implemented in one city can be mimicked in another very different city is not clear.

Paul Appelbaum, MD, a forensic psychiatrist at Columbia University, New York, is optimistic about New York City’s forthcoming program.

“The proposed pilot project in NYC is a real step forward. Work that we’ve done looking at fatal encounters involving the police found that roughly 25% of all deaths at the hands of the police are of people with mental illness. In many of those cases, police were initially called to bring people who were clearly troubled for psychiatric evaluation, but as the situation escalated, the police turned to their weapons to control it, which led to a fatal outcome. Taking police out of the picture whenever possible in favor of trained mental health personnel is clearly a better approach. It will be important for the city to collect good outcome data to enable independent evaluation of the pilot project – not something that political entities are inclined toward, but a critical element in assessing the effectiveness of this approach.”

There are questions that remain about the new program. Mayor de Blasio’s office has not released information about which areas of the city are being chosen for the new program, how much the program will cost, or what the funding source will be. If it can be implemented safely and effectively, it has the potential to provide more sensitive care to patients in crisis, and to save lives.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

*Correction, 11/27/2020: An earlier version of this article misstated the number of years Daniel Felts has worked at CAHOOTS.

“Defund the police”: It’s a slogan, or perhaps a battle cry, that has emerged from the Black Lives Matter movement as a response to race-related police brutality and concerns that people of color are profiled, targeted, arrested, charged, manhandled, and killed by law enforcement in a disproportionate and unjust manner. It crosses into our realm as psychiatrists as mental health emergency calls are handled by the police and not by mental health professionals. The result is sometimes tragic: As many as half of police shootings involve people with psychiatric disorders, and the hope is that many of the police shootings could be avoided if crises were handed by mental health clinicians instead of, or in cooperation with, the police.

At best, police officers receive a week of specialized, crisis intervention training about how to approach those with psychiatric disorders; most officers receive no training. This leaves psychiatry as the only field where medical crises are routinely handled by the police – it is demeaning and embarrassing for some of our patients and dangerous for others. The reality remains, however, that there are times when psychiatric disorders result in violent behavior, and patients being taken for involuntary treatment often resist transport, so either way there is risk, both to the patient and to anyone who responds to a call for assistance.

Early this month, the office of New York City Mayor Bill de Blasio announced that a major change would be made in how mental health calls to 911 are handled in two “high-need” areas. The mayor’s website states:

“Beginning in February 2021, new Mental Health Teams will use their physical and mental health expertise, and experience in crisis response to de-escalate emergency situations, will help reduce the number of times police will need to respond to 911 mental health calls in these precincts. These teams will have the expertise to respond to a range of behavioral health problems, such as suicide attempts, substance misuse, and serious mental illness, as well as physical health problems, which can be exacerbated by or mask mental health problems. NYC Health + Hospitals will train and provide ongoing technical assistance and support. In selecting team members for this program, FDNY will prioritize professionals with significant experience with mental health crises.”

The press release goes on to say that, in situations where there is a weapon or reason to believe there is a risk of violence, the police will be dispatched along with the new mental health team.

“This is the first time in our history that health professionals will be the default responders to mental health emergencies,” New York City First Lady Chirlane McCray said as she announced the new program. “Treating mental health crises as mental health challenges and not public safety ones is the modern and more appropriate approach.”

New York City is not the first city to employ this model. In the United States, the CAHOOTS (Crisis Assistance Helping Out on the Streets) program in Eugene, Ore., has been run by the White Bird Clinic since 1989 as part of a community policing initiative. Last year, the team responded to 24,000 calls and police backup was required on only 150 of those responses. The CAHOOTS website states:

“The CAHOOTS model has been in the spotlight recently as our nation struggles to reimagine public safety. The program mobilizes two-person teams consisting of a medic (a nurse, paramedic, or EMT) and a crisis worker who has substantial training and experience in the mental health field. The CAHOOTS teams deal with a wide range of mental health-related crises, including conflict resolution, welfare checks, substance abuse, suicide threats, and more, relying on trauma-informed de-escalation and harm reduction techniques. CAHOOTS staff are not law enforcement officers and do not carry weapons; their training and experience are the tools they use to ensure a non-violent resolution of crisis situations. They also handle non-emergent medical issues, avoiding costly ambulance transport and emergency room treatment.”

Other cities in the United States are also looking at implementing programs where mental health teams, and not the police, respond to emergency calls. Last year, Oakland, Calif.’s city council invested $40,000 in research to assess how they could best implement a program like the one in Eugene. They hope to begin the Mobile Assistance Community Responders of Oakland (MACROS) next year. Sigal Samuel writes in a Vox article, “The goal is to launch the pilot next year with funding from the city budget, and although supporters are not yet sure what its size and duration will be, they’re hopeful it’ll make a big difference to Oakland’s overpoliced community of people without homes. They were among those who first called for a non-policing approach.”

The model is not unique to the United States. In 2005, Stockholm started a program with a psychiatric ambulance – equipped with comfortable seating rather than a stretcher – to respond to mental health emergencies. The ambulance responds to 130 calls a month. It is staffed with a driver and two psychiatric nurses, and for half of the calls, the police also come. While the Swedish program was not about removing resources from the police, it has relieved the police of the responsibility for many psychiatric emergencies.

The New York City program will be modeled after the CAHOOTS initiative in Eugene. It differs from the mobile crisis response services in many other cities because CAHOOTS is hooked directly into the 911 emergency services system. Its website notes that the program has saved money:

“The cost savings are considerable. The CAHOOTS program budget is about $2.1 million annually, while the combined annual budgets for the Eugene and Springfield police departments are $90 million. In 2017, the CAHOOTS teams answered 17% of the Eugene Police Department’s overall call volume. The program saves the city of Eugene an estimated $8.5 million in public safety spending annually.”

Some worry there is an unpredictable aspect to calls for psychiatric emergencies, and the potential for mental health professions to be injured or killed. Annette Hanson, MD, a forensic psychiatrist at University of Maryland, Baltimore, voiced her concerns, “While multidisciplinary teams are useful, there have been rare cases of violence against responding mental health providers. People with serious mental illness are rarely violent but their dangerousness is unpredictable and cannot be predicted by case screening.”

Daniel Felts is a mental health crisis counselor who has worked at CAHOOTS for the past 4* years. He has responded to about 8,000 calls, and called for police backup only three times to request an immediate "Code 3 cover" when someone's safety has been in danger. Mr. Felts calls the police about once a month for concerns that do not require an immediate response for safety.* “Over the last 4 years, I am only aware of three instances when a team member’s safety was compromised because of a client’s violent behavior. No employee has been seriously physically harmed. In 30 years, with hundreds of thousands (millions?) of calls responded to, no CAHOOTS worker has ever been killed, shot, or stabbed in the line of duty,” Mr. Felts noted.

Emergency calls are screened. “It is not uncommon for CAHOOTS to be dispatched to ‘stage’ for calls involving active disputes or acutely suicidal individuals where means are present. “Staging” entails us parking roughly a mile away while police make first contact and advise whether it is safe for CAHOOTS to engage.”

Mr. Felts went on to discuss the program’s relationship with the community. “I believe that one of the biggest things that keeps us safe is the community’s knowledge and understanding of our service and how we operate. Having operated in Eugene for 30 years, our service is well understood to be one that does not kill, harm, or violate personal boundaries or liberties.”

Would a program like the ones in Stockholm or in Eugene work in other places? Eugene is a city with a population of 172,000 with a low crime rate. Whether a program implemented in one city can be mimicked in another very different city is not clear.

Paul Appelbaum, MD, a forensic psychiatrist at Columbia University, New York, is optimistic about New York City’s forthcoming program.

“The proposed pilot project in NYC is a real step forward. Work that we’ve done looking at fatal encounters involving the police found that roughly 25% of all deaths at the hands of the police are of people with mental illness. In many of those cases, police were initially called to bring people who were clearly troubled for psychiatric evaluation, but as the situation escalated, the police turned to their weapons to control it, which led to a fatal outcome. Taking police out of the picture whenever possible in favor of trained mental health personnel is clearly a better approach. It will be important for the city to collect good outcome data to enable independent evaluation of the pilot project – not something that political entities are inclined toward, but a critical element in assessing the effectiveness of this approach.”

There are questions that remain about the new program. Mayor de Blasio’s office has not released information about which areas of the city are being chosen for the new program, how much the program will cost, or what the funding source will be. If it can be implemented safely and effectively, it has the potential to provide more sensitive care to patients in crisis, and to save lives.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

*Correction, 11/27/2020: An earlier version of this article misstated the number of years Daniel Felts has worked at CAHOOTS.

“Defund the police”: It’s a slogan, or perhaps a battle cry, that has emerged from the Black Lives Matter movement as a response to race-related police brutality and concerns that people of color are profiled, targeted, arrested, charged, manhandled, and killed by law enforcement in a disproportionate and unjust manner. It crosses into our realm as psychiatrists as mental health emergency calls are handled by the police and not by mental health professionals. The result is sometimes tragic: As many as half of police shootings involve people with psychiatric disorders, and the hope is that many of the police shootings could be avoided if crises were handed by mental health clinicians instead of, or in cooperation with, the police.

At best, police officers receive a week of specialized, crisis intervention training about how to approach those with psychiatric disorders; most officers receive no training. This leaves psychiatry as the only field where medical crises are routinely handled by the police – it is demeaning and embarrassing for some of our patients and dangerous for others. The reality remains, however, that there are times when psychiatric disorders result in violent behavior, and patients being taken for involuntary treatment often resist transport, so either way there is risk, both to the patient and to anyone who responds to a call for assistance.

Early this month, the office of New York City Mayor Bill de Blasio announced that a major change would be made in how mental health calls to 911 are handled in two “high-need” areas. The mayor’s website states:

“Beginning in February 2021, new Mental Health Teams will use their physical and mental health expertise, and experience in crisis response to de-escalate emergency situations, will help reduce the number of times police will need to respond to 911 mental health calls in these precincts. These teams will have the expertise to respond to a range of behavioral health problems, such as suicide attempts, substance misuse, and serious mental illness, as well as physical health problems, which can be exacerbated by or mask mental health problems. NYC Health + Hospitals will train and provide ongoing technical assistance and support. In selecting team members for this program, FDNY will prioritize professionals with significant experience with mental health crises.”

The press release goes on to say that, in situations where there is a weapon or reason to believe there is a risk of violence, the police will be dispatched along with the new mental health team.

“This is the first time in our history that health professionals will be the default responders to mental health emergencies,” New York City First Lady Chirlane McCray said as she announced the new program. “Treating mental health crises as mental health challenges and not public safety ones is the modern and more appropriate approach.”

New York City is not the first city to employ this model. In the United States, the CAHOOTS (Crisis Assistance Helping Out on the Streets) program in Eugene, Ore., has been run by the White Bird Clinic since 1989 as part of a community policing initiative. Last year, the team responded to 24,000 calls and police backup was required on only 150 of those responses. The CAHOOTS website states:

“The CAHOOTS model has been in the spotlight recently as our nation struggles to reimagine public safety. The program mobilizes two-person teams consisting of a medic (a nurse, paramedic, or EMT) and a crisis worker who has substantial training and experience in the mental health field. The CAHOOTS teams deal with a wide range of mental health-related crises, including conflict resolution, welfare checks, substance abuse, suicide threats, and more, relying on trauma-informed de-escalation and harm reduction techniques. CAHOOTS staff are not law enforcement officers and do not carry weapons; their training and experience are the tools they use to ensure a non-violent resolution of crisis situations. They also handle non-emergent medical issues, avoiding costly ambulance transport and emergency room treatment.”

Other cities in the United States are also looking at implementing programs where mental health teams, and not the police, respond to emergency calls. Last year, Oakland, Calif.’s city council invested $40,000 in research to assess how they could best implement a program like the one in Eugene. They hope to begin the Mobile Assistance Community Responders of Oakland (MACROS) next year. Sigal Samuel writes in a Vox article, “The goal is to launch the pilot next year with funding from the city budget, and although supporters are not yet sure what its size and duration will be, they’re hopeful it’ll make a big difference to Oakland’s overpoliced community of people without homes. They were among those who first called for a non-policing approach.”

The model is not unique to the United States. In 2005, Stockholm started a program with a psychiatric ambulance – equipped with comfortable seating rather than a stretcher – to respond to mental health emergencies. The ambulance responds to 130 calls a month. It is staffed with a driver and two psychiatric nurses, and for half of the calls, the police also come. While the Swedish program was not about removing resources from the police, it has relieved the police of the responsibility for many psychiatric emergencies.

The New York City program will be modeled after the CAHOOTS initiative in Eugene. It differs from the mobile crisis response services in many other cities because CAHOOTS is hooked directly into the 911 emergency services system. Its website notes that the program has saved money:

“The cost savings are considerable. The CAHOOTS program budget is about $2.1 million annually, while the combined annual budgets for the Eugene and Springfield police departments are $90 million. In 2017, the CAHOOTS teams answered 17% of the Eugene Police Department’s overall call volume. The program saves the city of Eugene an estimated $8.5 million in public safety spending annually.”

Some worry there is an unpredictable aspect to calls for psychiatric emergencies, and the potential for mental health professions to be injured or killed. Annette Hanson, MD, a forensic psychiatrist at University of Maryland, Baltimore, voiced her concerns, “While multidisciplinary teams are useful, there have been rare cases of violence against responding mental health providers. People with serious mental illness are rarely violent but their dangerousness is unpredictable and cannot be predicted by case screening.”

Daniel Felts is a mental health crisis counselor who has worked at CAHOOTS for the past 4* years. He has responded to about 8,000 calls, and called for police backup only three times to request an immediate "Code 3 cover" when someone's safety has been in danger. Mr. Felts calls the police about once a month for concerns that do not require an immediate response for safety.* “Over the last 4 years, I am only aware of three instances when a team member’s safety was compromised because of a client’s violent behavior. No employee has been seriously physically harmed. In 30 years, with hundreds of thousands (millions?) of calls responded to, no CAHOOTS worker has ever been killed, shot, or stabbed in the line of duty,” Mr. Felts noted.

Emergency calls are screened. “It is not uncommon for CAHOOTS to be dispatched to ‘stage’ for calls involving active disputes or acutely suicidal individuals where means are present. “Staging” entails us parking roughly a mile away while police make first contact and advise whether it is safe for CAHOOTS to engage.”

Mr. Felts went on to discuss the program’s relationship with the community. “I believe that one of the biggest things that keeps us safe is the community’s knowledge and understanding of our service and how we operate. Having operated in Eugene for 30 years, our service is well understood to be one that does not kill, harm, or violate personal boundaries or liberties.”

Would a program like the ones in Stockholm or in Eugene work in other places? Eugene is a city with a population of 172,000 with a low crime rate. Whether a program implemented in one city can be mimicked in another very different city is not clear.

Paul Appelbaum, MD, a forensic psychiatrist at Columbia University, New York, is optimistic about New York City’s forthcoming program.

“The proposed pilot project in NYC is a real step forward. Work that we’ve done looking at fatal encounters involving the police found that roughly 25% of all deaths at the hands of the police are of people with mental illness. In many of those cases, police were initially called to bring people who were clearly troubled for psychiatric evaluation, but as the situation escalated, the police turned to their weapons to control it, which led to a fatal outcome. Taking police out of the picture whenever possible in favor of trained mental health personnel is clearly a better approach. It will be important for the city to collect good outcome data to enable independent evaluation of the pilot project – not something that political entities are inclined toward, but a critical element in assessing the effectiveness of this approach.”

There are questions that remain about the new program. Mayor de Blasio’s office has not released information about which areas of the city are being chosen for the new program, how much the program will cost, or what the funding source will be. If it can be implemented safely and effectively, it has the potential to provide more sensitive care to patients in crisis, and to save lives.
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.

*Correction, 11/27/2020: An earlier version of this article misstated the number of years Daniel Felts has worked at CAHOOTS.

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

Concussion is associated with increased risk for subsequent development of attention-deficit/hyperactivity disorder (ADHD), as well as dementia and Parkinson’s disease, new research suggests. Results from a retrospective, population-based cohort study showed that controlling for socioeconomic status and overall health did not significantly affect this association.

The link between concussion and risk for ADHD and for mood and anxiety disorder was stronger in the women than in the men. In addition, having a history of multiple concussions strengthened the association between concussion and subsequent mood and anxiety disorder, dementia, and Parkinson’s disease compared with experiencing just one concussion.

The findings are similar to those of previous studies, noted lead author Marc P. Morissette, PhD, research assistant at the Pan Am Clinic Foundation in Winnipeg, Manitoba, Canada. “The main methodological differences separating our study from previous studies in this area is a focus on concussion-specific injuries identified from medical records and the potential for study participants to have up to 25 years of follow-up data,” said Dr. Morissette.

The findings were published online July 27 in Family Medicine and Community Health, a BMJ journal.
 

Almost 190,000 participants

Several studies have shown associations between head injury and increased risk for ADHD, depression, anxiety, Alzheimer’s disease, and Parkinson’s disease. However, many of these studies relied on self-reported medical history, included all forms of traumatic brain injury, and failed to adjust for preexisting health conditions.

An improved understanding of concussion and the risks associated with it could help physicians manage their patients’ long-term needs, the investigators noted.

In the current study, the researchers examined anonymized administrative health data collected between the periods of 1990–1991 and 2014–2015 in the Manitoba Population Research Data Repository at the Manitoba Center for Health Policy.

Eligible patients had been diagnosed with concussion in accordance with standard criteria. Participants were excluded if they had been diagnosed with dementia or Parkinson’s disease before the incident concussion during the study period. The investigators matched three control participants to each included patient on the basis of age, sex, and location.

Study outcome was time from index date (date of first concussion) to diagnosis of ADHD, mood and anxiety disorder, dementia, or Parkinson’s disease. The researchers controlled for socioeconomic status using the Socioeconomic Factor Index, version 2 (SEFI2), and for preexisting medical conditions using the Charlson Comorbidity Index (CCI).

The study included 28,021 men (mean age, 25 years) and 19,462 women (mean age, 30 years) in the concussion group and 81,871 men (mean age, 25 years) and 57,159 women (mean age, 30 years) in the control group. Mean SEFI2 score was approximately −0.05, and mean CCI score was approximately 0.2.
 

Dose effect?

Results showed that concussion was associated with an increased risk for ADHD (hazard ratio [HR], 1.39), mood and anxiety disorder (HR, 1.72), dementia (HR, 1.72), and Parkinson’s disease (HR, 1.57).

After a concussion, the risk of developing ADHD was 28% higher and the risk of developing mood and anxiety disorder was 7% higher among women than among men. Gender was not associated with risk for dementia or Parkinson’s disease after concussion.

Sustaining a second concussion increased the strength of the association with risk for dementia compared with sustaining a single concussion (HR, 1.62). Similarly, sustaining more than three concussions increased the strength of the association with the risk for mood and anxiety disorders (HR for more than three vs one concussion, 1.22) and Parkinson›s disease (HR, 3.27).

A sensitivity analysis found similar associations between concussion and risk for mood and anxiety disorder among all age groups. Younger participants were at greater risk for ADHD, however, and older participants were at greater risk for dementia and Parkinson’s disease.

Increased awareness of concussion and the outcomes of interest, along with improved diagnostic tools, may have influenced the study’s findings, Dr. Morissette noted. “The sex-based differences may be due to either pathophysiological differences in response to concussive injuries or potentially a difference in willingness to seek medical care or share symptoms, concussion-related or otherwise, with a medical professional,” he said.

“We are hopeful that our findings will encourage practitioners to be cognizant of various conditions that may present in individuals who have previously experienced a concussion,” Dr. Morissette added. “If physicians are aware of the various associations identified following a concussion, it may lead to more thorough clinical examination at initial presentation, along with more dedicated care throughout the patient’s life.”
 

Association versus causation

Commenting on the research, Steven Erickson, MD, sports medicine specialist at Banner–University Medicine Neuroscience Institute, Phoenix, Ariz., noted that although the study showed an association between concussion and subsequent diagnosis of ADHD, anxiety, and Parkinson’s disease, “this association should not be misconstrued as causation.” He added that the study’s conclusions “are just as likely to be due to labeling theory” or a self-fulfilling prophecy.

“Patients diagnosed with ADHD, anxiety, or Parkinson’s disease may recall concussion and associate the two diagnoses; but patients who have not previously been diagnosed with a concussion cannot draw that conclusion,” said Dr. Erickson, who was not involved with the research.

Citing the apparent gender difference in the strength of the association between concussion and the outcomes of interest, Dr. Erickson noted that women are more likely to report symptoms in general “and therefore are more likely to be diagnosed with ADHD and anxiety disorders” because of differences in reporting rather than incidence of disease.

“Further research needs to be done to definitively determine a causal relationship between concussion and any psychiatric or neurologic diagnosis,” Dr. Erickson concluded.

The study was funded by the Pan Am Clinic Foundation. Dr. Morissette and Dr. Erickson have disclosed no relevant financial relationships.

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

As a result of technology, data to which individuals have long had a legal right of access are now easily accessible. The advent of secure online portals has converted what was once largely a hypothetical proposition – i.e., ready patient access to clinical records – into the increasing reality of open notes. Unsurprisingly, this movement toward greater transparency carries special implications and complexities for mental health professionals concerned with balancing patient autonomy and safety.¹

In setting clinician expectations for incorporating clinical note-sharing into patient care, it is important to clarify the already robust legal rights of patients to obtain copies of their treatment records, including in the mental health context. For example, the provision of access to one’s own health information is one of the rare circumstances in which the HIPAA Privacy Rule compels, rather than merely permits, health care organizations to disclose records to external parties.² This requirement accords with a prevailing principle of medical ethics that records should be furnished to patients or their designees upon request.³

While HIPAA provides mechanisms for denying individuals access to their health records when a licensed health care professional determines that such access is “reasonably likely” to jeopardize someone’s life or physical safety, this standard sets a high bar of physical endangerment. A psychiatrist or other physician’s concern that sharing clinical notes would be therapeutically suboptimal, discomforting, emotionally harmful, confusing, or deleterious to the doctor-patient relationship would not constitute sufficient legal grounds for denial of access.⁴

Moreover, because access is framed as a patient right, denial on the aforementioned safety grounds implicates due process requirements to include a written explanation and appellate review by a designated disinterested official. Importantly, this federally mandated right of access would preempt or override any contrary state law classified as less protective of patient prerogatives.

Contrary to popular misconception, mental health notes are not necessarily entitled to a greater degree of secrecy vis-à-vis patients than records pertaining to physical health. The HIPAA Privacy Rule, for example, generally does not distinguish between medical and mental health information, nor does it provide special rules for the latter.5 Specifically, patients’ access rights remain unchanged regardless of whether the requested record is classified as medical or psychiatric.

One narrow exception involves “psychotherapy notes,” but the legal definition of this term is considerably more restrictive than in common psychiatric usage. Psychotherapy notes under health privacy law include therapists’ private, desk-drawer notes on counseling sessions intended for personal use as memory joggers.They explicitly exclude any discussion of treatment modalities, diagnosis, or clinical progress. To retain their protected status, psychotherapy notes must be kept separate and apart from the patient chart. Indeed, a primary reason why such notes are exempted from patient access is because they have so little legitimate use other than to their creator.

Integrating the proliferation of open notes into practice regimens will likely pose a continuing and growing challenge for mental health professionals. From a medicolegal perspective, however, even psychiatrists who are understandably hesitant about widespread note-sharing would do well to remember that patients’ underlying right of access is generally well established, and is merely being operationalized and automated via web portals. Ultimately, adapting clinical record-keeping to both anticipate patient access – and, where possible, leverage it to improve care – may prove the most effective path forward for practicing psychiatry in the digital age.

Lt. Col. Kels teaches at the U.S. Army Medical Center of Excellence, and Dr. Kels teaches and practices psychiatry at the University of the Incarnate Word School of Osteopathic Medicine, both in San Antonio, Tex. Neither Lt. Col. Kels nor Dr. Kels have any conflicts of interest to disclose. Opinions expressed in this article are those of the authors alone and do not necessarily reflect those of any government agency.

References

1. Lancet Psychiatry. 2020;7(11):924-5.

2. 45 CFR Parts 160 and 164, subparts A and E.

3. American Medical Association. Code of medical ethics, opinion 3.3.1: management of medical records.

4. Department of Health & Human Services. Individuals’ right under HIPAA to access their health information.

5. Department of Health & Human Services. HIPAA privacy rule and sharing information related to mental health.

As a result of technology, data to which individuals have long had a legal right of access are now easily accessible. The advent of secure online portals has converted what was once largely a hypothetical proposition – i.e., ready patient access to clinical records – into the increasing reality of open notes. Unsurprisingly, this movement toward greater transparency carries special implications and complexities for mental health professionals concerned with balancing patient autonomy and safety.¹

In setting clinician expectations for incorporating clinical note-sharing into patient care, it is important to clarify the already robust legal rights of patients to obtain copies of their treatment records, including in the mental health context. For example, the provision of access to one’s own health information is one of the rare circumstances in which the HIPAA Privacy Rule compels, rather than merely permits, health care organizations to disclose records to external parties.² This requirement accords with a prevailing principle of medical ethics that records should be furnished to patients or their designees upon request.³

While HIPAA provides mechanisms for denying individuals access to their health records when a licensed health care professional determines that such access is “reasonably likely” to jeopardize someone’s life or physical safety, this standard sets a high bar of physical endangerment. A psychiatrist or other physician’s concern that sharing clinical notes would be therapeutically suboptimal, discomforting, emotionally harmful, confusing, or deleterious to the doctor-patient relationship would not constitute sufficient legal grounds for denial of access.⁴

Moreover, because access is framed as a patient right, denial on the aforementioned safety grounds implicates due process requirements to include a written explanation and appellate review by a designated disinterested official. Importantly, this federally mandated right of access would preempt or override any contrary state law classified as less protective of patient prerogatives.

Contrary to popular misconception, mental health notes are not necessarily entitled to a greater degree of secrecy vis-à-vis patients than records pertaining to physical health. The HIPAA Privacy Rule, for example, generally does not distinguish between medical and mental health information, nor does it provide special rules for the latter.5 Specifically, patients’ access rights remain unchanged regardless of whether the requested record is classified as medical or psychiatric.

One narrow exception involves “psychotherapy notes,” but the legal definition of this term is considerably more restrictive than in common psychiatric usage. Psychotherapy notes under health privacy law include therapists’ private, desk-drawer notes on counseling sessions intended for personal use as memory joggers.They explicitly exclude any discussion of treatment modalities, diagnosis, or clinical progress. To retain their protected status, psychotherapy notes must be kept separate and apart from the patient chart. Indeed, a primary reason why such notes are exempted from patient access is because they have so little legitimate use other than to their creator.

Integrating the proliferation of open notes into practice regimens will likely pose a continuing and growing challenge for mental health professionals. From a medicolegal perspective, however, even psychiatrists who are understandably hesitant about widespread note-sharing would do well to remember that patients’ underlying right of access is generally well established, and is merely being operationalized and automated via web portals. Ultimately, adapting clinical record-keeping to both anticipate patient access – and, where possible, leverage it to improve care – may prove the most effective path forward for practicing psychiatry in the digital age.

Lt. Col. Kels teaches at the U.S. Army Medical Center of Excellence, and Dr. Kels teaches and practices psychiatry at the University of the Incarnate Word School of Osteopathic Medicine, both in San Antonio, Tex. Neither Lt. Col. Kels nor Dr. Kels have any conflicts of interest to disclose. Opinions expressed in this article are those of the authors alone and do not necessarily reflect those of any government agency.

References

1. Lancet Psychiatry. 2020;7(11):924-5.

2. 45 CFR Parts 160 and 164, subparts A and E.

3. American Medical Association. Code of medical ethics, opinion 3.3.1: management of medical records.

4. Department of Health & Human Services. Individuals’ right under HIPAA to access their health information.

5. Department of Health & Human Services. HIPAA privacy rule and sharing information related to mental health.

As a result of technology, data to which individuals have long had a legal right of access are now easily accessible. The advent of secure online portals has converted what was once largely a hypothetical proposition – i.e., ready patient access to clinical records – into the increasing reality of open notes. Unsurprisingly, this movement toward greater transparency carries special implications and complexities for mental health professionals concerned with balancing patient autonomy and safety.¹

In setting clinician expectations for incorporating clinical note-sharing into patient care, it is important to clarify the already robust legal rights of patients to obtain copies of their treatment records, including in the mental health context. For example, the provision of access to one’s own health information is one of the rare circumstances in which the HIPAA Privacy Rule compels, rather than merely permits, health care organizations to disclose records to external parties.² This requirement accords with a prevailing principle of medical ethics that records should be furnished to patients or their designees upon request.³

While HIPAA provides mechanisms for denying individuals access to their health records when a licensed health care professional determines that such access is “reasonably likely” to jeopardize someone’s life or physical safety, this standard sets a high bar of physical endangerment. A psychiatrist or other physician’s concern that sharing clinical notes would be therapeutically suboptimal, discomforting, emotionally harmful, confusing, or deleterious to the doctor-patient relationship would not constitute sufficient legal grounds for denial of access.⁴

Moreover, because access is framed as a patient right, denial on the aforementioned safety grounds implicates due process requirements to include a written explanation and appellate review by a designated disinterested official. Importantly, this federally mandated right of access would preempt or override any contrary state law classified as less protective of patient prerogatives.

Contrary to popular misconception, mental health notes are not necessarily entitled to a greater degree of secrecy vis-à-vis patients than records pertaining to physical health. The HIPAA Privacy Rule, for example, generally does not distinguish between medical and mental health information, nor does it provide special rules for the latter.5 Specifically, patients’ access rights remain unchanged regardless of whether the requested record is classified as medical or psychiatric.

One narrow exception involves “psychotherapy notes,” but the legal definition of this term is considerably more restrictive than in common psychiatric usage. Psychotherapy notes under health privacy law include therapists’ private, desk-drawer notes on counseling sessions intended for personal use as memory joggers.They explicitly exclude any discussion of treatment modalities, diagnosis, or clinical progress. To retain their protected status, psychotherapy notes must be kept separate and apart from the patient chart. Indeed, a primary reason why such notes are exempted from patient access is because they have so little legitimate use other than to their creator.

Integrating the proliferation of open notes into practice regimens will likely pose a continuing and growing challenge for mental health professionals. From a medicolegal perspective, however, even psychiatrists who are understandably hesitant about widespread note-sharing would do well to remember that patients’ underlying right of access is generally well established, and is merely being operationalized and automated via web portals. Ultimately, adapting clinical record-keeping to both anticipate patient access – and, where possible, leverage it to improve care – may prove the most effective path forward for practicing psychiatry in the digital age.

Lt. Col. Kels teaches at the U.S. Army Medical Center of Excellence, and Dr. Kels teaches and practices psychiatry at the University of the Incarnate Word School of Osteopathic Medicine, both in San Antonio, Tex. Neither Lt. Col. Kels nor Dr. Kels have any conflicts of interest to disclose. Opinions expressed in this article are those of the authors alone and do not necessarily reflect those of any government agency.

References

1. Lancet Psychiatry. 2020;7(11):924-5.

2. 45 CFR Parts 160 and 164, subparts A and E.

3. American Medical Association. Code of medical ethics, opinion 3.3.1: management of medical records.

4. Department of Health & Human Services. Individuals’ right under HIPAA to access their health information.

5. Department of Health & Human Services. HIPAA privacy rule and sharing information related to mental health.

Once the fog lifts on a global pandemic that led to an explosion in telehealth visits in 2020, mental health experts expect virtual and in-person visits to merge to become a standard model of care in clinical psychiatry.

Hybrid care is the future, Peter Yellowlees, MBBS, MD, a professor of psychiatry and chief wellness officer at the University of California, Davis, said in an interview. “I’ve been working this way for several years – where all of my patients get to see me in person or online, or both.”

The model’s increasing popularity reflects a major shift toward virtual consults. Telemedicine offers safer, quicker, and less expensive alternatives, Steven Chan, MD, MBA, of Stanford (Calif.) University, said in an interview. “This continuity is essential to helping to reduce emergency room visits, reduce inpatient hospitalizations and readmissions, and improving adherence to treatment,” Dr. Chan said. State and federal regulators’ actions to lift certain licensing and prescribing restrictions and expand coverage made it easier for clinical psychiatrists to offer and get paid for these services.

The catch is that no one knows whether these easements will remain in place once COVID-19 recedes, ending the national public health emergency, Jay H. Shore, MD, MPH, chairperson of the American Psychiatric Association telepsychiatry committee, and professor and director of telemedicine programming at the University of Colorado at Denver, Aurora’s department of psychiatry, said in an interview. “These all temporarily changed during this time period, but we have no idea when they’re going to end or if they’re going to continue off of COVID. So now, there’s a lot of uncertainty.”

 

‘Suite of different technologies’

New freedoms to deliver telehealth care left some practices scrambling to adopt or refine technology. Once COVID-19 hit, “I can’t think of a psychiatrist or provider or institution that didn’t have to rapidly virtualize and do at least some video conferencing,” Dr. Shore said. This immediate shift signaled a key move toward hybrid patient-doctor relations. “It means you hold a relationship with your patients through multiple different mediums, email, portal, telephone, in person. It’s not just about in-person versus video, it’s about a suite of different technologies.”

Dr. Shore began practicing telehealth 20 years ago, long before the age of COVID. He’s since established rewarding relationships with patients he’s never met. “I’ve done everything from medical management to long-term psychotherapy, group psychotherapy, and I’ve been successful with different populations.”

Many nuances exist around matching the right patient with the right videoconferencing adaptation, Dr. Shore continued. However, “in general, the literature supports that you can get equal clinical outcomes with telehealth versus in-person treatment.”
 

‘I see their garden’

While some may eschew the idea of providing care over a virtual platform, other physicians see it as an insightful window into a person’s mental state. “I think some are actually quite surprised by how much good care you can give using video,” said Dr. Yellowlees. Unlike a phone conversation, video allows you to see a person’s home. “The beauty of a video is not just that you can see the person, you can also look around their home, and learn more about them.”

In his own visits, he asks patients to take him on a virtual “walk” through their house, provided there are no confidentiality issues.

“I get to meet their pets, the carers, the spouses; I get to see their garden. I get to see what their interests are from looking at the paintings on their walls. I learn more about my patients that way. If you use video to purely see people from the neck up, then that’s fine, but I think you can also use it to your advantage, seeing people at home.” He also encourages patients to do visits in their cars – as long as the windows are shut, they’re in a safe area, and most importantly, they’re not driving.

Nina Vasan, MD, MBA, who treats patients at Stanford and in a concierge private practice for executives, agrees that seeing patients in the home offers a more direct view of patients’ lives. “These little extra pieces of information are things that we didn’t get before COVID, when patients would come by themselves into the office week after week. I do feel like I know some patients much better by being able to see their surroundings and home interactions,” Dr. Vasan, founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation and chair of the APA’s committee on innovation, said in an interview.

She uses Zoom for her sessions, and regularly texts with her concierge patients. In both clinics, where most visits have gone virtual, “the no-show rate is near zero. Before COVID, it was around 10%-20%.”

Safety is a key advantage of virtual visits, noted Dr. Shore. “It’s certainly better than some of the risks of seeing people in person.”
 

Lack of integration causes frustration

Some challenges exist around access and adaptation of virtual technology. The pandemic’s sudden onslaught left many clinicians scrambling to adjust to a virtual format without any training or tools to support them. “This has caused some stress,” Dr. Shore said.

Electronic health record systems may or may not integrate video visits, noted Dr. Chan. “For instance, I work at a health system where mental health questionnaires, imaging systems, notes, and video visit scheduling are housed in separate systems.”

Without a seamless national, integrated system in place, physicians are often left to couple different IT formats together. “There are some systems that work pretty well, and there are some that are really clunky where you’re forcing the two together, so that’s a challenge,” Dr. Shore said. Providers may be using one system for their office and another system to provide care. “They may be using different EHRs and different teleconferencing platforms. That adds complexity.” Video conferencing platforms aren’t as challenging to use as EHRs. However, if some people are self-taught, there’s no way of knowing if they’re using best practices, he added.

Many health systems do offer video built into EMRs. Companies such as Epic have provided integrations with Vidyo, Amwell, and other platforms, noted Dr. Chan.

An integrated platform is useful if done well – but isn’t necessarily essential, according to Dr. Yellowlees. In his own setup, he signs a laptop into an EMR and uses an iPad to communicate with patients via video on the iPad and all video on the phone.

“The big advantage of telemedicine is you can type your notes in a socially appropriate way while talking to the patient on video. I do that, and it saves me a considerable amount of time. I don’t have to spend time after a consultation typing up notes.”

Still, others may struggle with bandwidth or connectivity. “Perhaps there’s a problem with privacy or the types of patients you’re dealing with,” Dr. Shore said. Older patients in a nursing home, for example, may require a team of people that works onsite. Suddenly, their care has to transition to a virtual system. “You may need to figure how to put the right team together to do straightforward and individual interactions,” he said.

Virtual care also suffers from the “digital divide,” an issue that predates COVID-19, said Dr. Shore. Not all patients have access to bandwidth and the technology to see clinicians. Other lack expertise and comfort with using the technology, or can’t afford the equipment necessary to bring them online. The pandemic has highlighted all of these disparities, he emphasized.

Dr. Chan offered that the digital divide is part of a larger socioeconomic divide, where barriers to any care – including transportation for in-person care – exist.

Technology and access issues aside, insidious “Zoom fatigue” is affecting everyone right now. “That’s clearly real,” Dr. Shore said. “And it’s not just about videoconferencing; it’s about being in quarantine. We’re all in this virtual lockdown, where people are using the term ‘videoconferencing fatigue.’ It’s a complicated problem.”

To assist with telehealth implementation, the APA has issued practice guidance and a toolkit that includes an extensive set of educational materials, including 40 videos on various topics. It’s also hosted webinars on telehealth policies and written up standard operating procedures on this topic, Dr. Yellowlees said. “The most important thing is APA, like other organizations, is advocating to have the relaxation of regulations during COVID made permanent,” he said.

Reimbursement post pandemic

As virtual visits rose in 2020, so did billing for such services. According to America’s Health Insurance Plans, claims to private insurers exploded by more than 4,000% in 2020. AHIP last July reported that mental health conditions made up one-third or more than 33% of telehealth claims to private insurers during the pandemic. Dr. Yellowlees said the health insurers he’s dealt with “have been good about paying for telehealth visits during the COVID-declared emergency.”

Whether this coverage will continue once the public health emergency ends, is unclear, some contend. “My sense is that there will be a rollback of coverage, but it won’t be back to what we had prepandemic,” said Ateev Mehrotra, MD, MPH, who studies telemedicine trends, in an interview. Right now, there’s still a great deal of uncertainty about reimbursement, “and that’s what’s giving providers pause,” said Dr. Mehrotra, of the department of health care policy and medicine at Harvard Medical School and a hospitalist at Beth Israel Deaconess Medical Center, both in Boston.

AHIP will continue to support federal and state policies to further promote telehealth access during the public health emergency, spokesman David Allen said in a statement. “Insurance providers have independently shifted their policies to increase access to care and services, ranging from acute care needs and triage services to chronic disease management and behavioral health. We are still awaiting information on what changes will remain in place beyond the public health emergency,” he said.

Even before COVID-19, Mr. Allen noted, nearly all large employers (96%) offered access to telehealth services as a covered benefit in 2019. In May, the Kaiser Family Foundation reported that many insurers were reducing or lifting cost sharing for telehealth for limited time periods.

Some of the larger payers said they’re continuing benefits, although it’s not clear how long some benefits will remain in place.

UnitedHealthcare offers no-cost coverage for COVID-19 testing–related telehealth visits, but that benefit is set to expire once the public health emergency presumably ends on Jan. 20, 2021. Through Dec. 31, 2020, the payer said it would offer coverage with no cost sharing for telehealth visits related to COVID-19 treatment and expanded access to telehealth visits not related to COVID-19 through its network. Similarly, Anthem is waiving cost sharing for COVID-19 treatments via telehealth or in-person visits, and for telehealth visits not related to COVID-19 for Medicare members through the end of the year.

Anthem will continue to cover telehealth and encourage members and clinicians to use telehealth for behavioral health, a spokesperson said. Anthem also has a telehealth provider, LiveHealth Online, “another safe and effective way for members to see a doctor to receive health guidance from their home via mobile device or a computer with a webcam,” said the spokesperson.

Dr. Vasan hopes that insurers will increase coverage for telehealth and at the same rate as in-person visits, especially for mental health. “I have not felt that the quality of the clinic has decreased, and in fact, in some ways it’s gotten better, and insurance coverage should reflect this.”
 

Outlook for the hybrid model

As long as there’s COVID-19, psychiatry practices must remain virtual, at least for now, Dr. Shore said. “We will emerge from this pandemic, I suspect in bits and starts.” When that happens, practices will need to have a transition plan in place. “Once we get away from COVID, I don’t think our mental health will ever be the same again. We’ll have much more virtual technology along the lines of a hybrid model, where we’ll see patients in person, but we’ll use more technology to work with patients, but it will be more of a blend.” Practices will also have to address the regulatory, reimbursement, and prescribing conditions the new world offers.

Some practices are already discovering the benefits of relying less on a brick-and-mortar office.

Dr. Chan said his colleagues are finding that they no longer have to deal with the expense and upkeep of renting and furnishing office space. “Many are taking their practice virtual-only because the monthly recurring costs are so cheap, and they can see patients in distant, underserved communities.” In-person visits are now inconvenient and risky, he continued. They require expensive personal protective equipment and cleaning protocols. “Plus, there’s the risk that services must shut down when stay-at-home orders return or when a staff member gets infected.”

Physicians prescribing certain controlled substances will likely continue to use office space, once the public health emergency expires and face-to-face visits resume. “In such cases, they can rent office space part-time,” Dr. Chan added.

Dr. Vasan, also of the department of psychiatry at Stanford and chief medical officer of Real, hopes that such a model prevails. “I do miss seeing patients in person and think a hybrid will be a good balance.”

Most patients want it, as do the influx of Generation Z physicians coming into the profession, Dr. Yellowlees noted. These are young, technologically savvy doctors who grew up in the age of the Internet. “I think the silver lining of COVID is it led telemedicine past the tipping point, where both patients and providers are learning that it’s an appropriate way to get care, as long as you’re careful, use professional guidelines – and don’t drop your standards of care.”

Dr. Yellowlees and Dr. Shore are coauthors of Telepsychiatry and Health Technologies: A Guide for Mental Health Professionals (Washington: American Psychiatric Association Publishing, 2018), and receive royalties from the book. Dr. Shore also reported working with AccessCare and receiving royalties from Springer Press. Dr. Chan reported consulting for Orbit Health. Dr. Vasan reported no conflicts of interest. Dr. Mehrotra has received research funding from several U.S. agencies, including the National Institute of Mental Health and the National Institute of Neurological Disorders and Stroke.

Once the fog lifts on a global pandemic that led to an explosion in telehealth visits in 2020, mental health experts expect virtual and in-person visits to merge to become a standard model of care in clinical psychiatry.

Hybrid care is the future, Peter Yellowlees, MBBS, MD, a professor of psychiatry and chief wellness officer at the University of California, Davis, said in an interview. “I’ve been working this way for several years – where all of my patients get to see me in person or online, or both.”

The model’s increasing popularity reflects a major shift toward virtual consults. Telemedicine offers safer, quicker, and less expensive alternatives, Steven Chan, MD, MBA, of Stanford (Calif.) University, said in an interview. “This continuity is essential to helping to reduce emergency room visits, reduce inpatient hospitalizations and readmissions, and improving adherence to treatment,” Dr. Chan said. State and federal regulators’ actions to lift certain licensing and prescribing restrictions and expand coverage made it easier for clinical psychiatrists to offer and get paid for these services.

The catch is that no one knows whether these easements will remain in place once COVID-19 recedes, ending the national public health emergency, Jay H. Shore, MD, MPH, chairperson of the American Psychiatric Association telepsychiatry committee, and professor and director of telemedicine programming at the University of Colorado at Denver, Aurora’s department of psychiatry, said in an interview. “These all temporarily changed during this time period, but we have no idea when they’re going to end or if they’re going to continue off of COVID. So now, there’s a lot of uncertainty.”

 

‘Suite of different technologies’

New freedoms to deliver telehealth care left some practices scrambling to adopt or refine technology. Once COVID-19 hit, “I can’t think of a psychiatrist or provider or institution that didn’t have to rapidly virtualize and do at least some video conferencing,” Dr. Shore said. This immediate shift signaled a key move toward hybrid patient-doctor relations. “It means you hold a relationship with your patients through multiple different mediums, email, portal, telephone, in person. It’s not just about in-person versus video, it’s about a suite of different technologies.”

Dr. Shore began practicing telehealth 20 years ago, long before the age of COVID. He’s since established rewarding relationships with patients he’s never met. “I’ve done everything from medical management to long-term psychotherapy, group psychotherapy, and I’ve been successful with different populations.”

Many nuances exist around matching the right patient with the right videoconferencing adaptation, Dr. Shore continued. However, “in general, the literature supports that you can get equal clinical outcomes with telehealth versus in-person treatment.”
 

‘I see their garden’

While some may eschew the idea of providing care over a virtual platform, other physicians see it as an insightful window into a person’s mental state. “I think some are actually quite surprised by how much good care you can give using video,” said Dr. Yellowlees. Unlike a phone conversation, video allows you to see a person’s home. “The beauty of a video is not just that you can see the person, you can also look around their home, and learn more about them.”

In his own visits, he asks patients to take him on a virtual “walk” through their house, provided there are no confidentiality issues.

“I get to meet their pets, the carers, the spouses; I get to see their garden. I get to see what their interests are from looking at the paintings on their walls. I learn more about my patients that way. If you use video to purely see people from the neck up, then that’s fine, but I think you can also use it to your advantage, seeing people at home.” He also encourages patients to do visits in their cars – as long as the windows are shut, they’re in a safe area, and most importantly, they’re not driving.

Nina Vasan, MD, MBA, who treats patients at Stanford and in a concierge private practice for executives, agrees that seeing patients in the home offers a more direct view of patients’ lives. “These little extra pieces of information are things that we didn’t get before COVID, when patients would come by themselves into the office week after week. I do feel like I know some patients much better by being able to see their surroundings and home interactions,” Dr. Vasan, founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation and chair of the APA’s committee on innovation, said in an interview.

She uses Zoom for her sessions, and regularly texts with her concierge patients. In both clinics, where most visits have gone virtual, “the no-show rate is near zero. Before COVID, it was around 10%-20%.”

Safety is a key advantage of virtual visits, noted Dr. Shore. “It’s certainly better than some of the risks of seeing people in person.”
 

Lack of integration causes frustration

Some challenges exist around access and adaptation of virtual technology. The pandemic’s sudden onslaught left many clinicians scrambling to adjust to a virtual format without any training or tools to support them. “This has caused some stress,” Dr. Shore said.

Electronic health record systems may or may not integrate video visits, noted Dr. Chan. “For instance, I work at a health system where mental health questionnaires, imaging systems, notes, and video visit scheduling are housed in separate systems.”

Without a seamless national, integrated system in place, physicians are often left to couple different IT formats together. “There are some systems that work pretty well, and there are some that are really clunky where you’re forcing the two together, so that’s a challenge,” Dr. Shore said. Providers may be using one system for their office and another system to provide care. “They may be using different EHRs and different teleconferencing platforms. That adds complexity.” Video conferencing platforms aren’t as challenging to use as EHRs. However, if some people are self-taught, there’s no way of knowing if they’re using best practices, he added.

Many health systems do offer video built into EMRs. Companies such as Epic have provided integrations with Vidyo, Amwell, and other platforms, noted Dr. Chan.

An integrated platform is useful if done well – but isn’t necessarily essential, according to Dr. Yellowlees. In his own setup, he signs a laptop into an EMR and uses an iPad to communicate with patients via video on the iPad and all video on the phone.

“The big advantage of telemedicine is you can type your notes in a socially appropriate way while talking to the patient on video. I do that, and it saves me a considerable amount of time. I don’t have to spend time after a consultation typing up notes.”

Still, others may struggle with bandwidth or connectivity. “Perhaps there’s a problem with privacy or the types of patients you’re dealing with,” Dr. Shore said. Older patients in a nursing home, for example, may require a team of people that works onsite. Suddenly, their care has to transition to a virtual system. “You may need to figure how to put the right team together to do straightforward and individual interactions,” he said.

Virtual care also suffers from the “digital divide,” an issue that predates COVID-19, said Dr. Shore. Not all patients have access to bandwidth and the technology to see clinicians. Other lack expertise and comfort with using the technology, or can’t afford the equipment necessary to bring them online. The pandemic has highlighted all of these disparities, he emphasized.

Dr. Chan offered that the digital divide is part of a larger socioeconomic divide, where barriers to any care – including transportation for in-person care – exist.

Technology and access issues aside, insidious “Zoom fatigue” is affecting everyone right now. “That’s clearly real,” Dr. Shore said. “And it’s not just about videoconferencing; it’s about being in quarantine. We’re all in this virtual lockdown, where people are using the term ‘videoconferencing fatigue.’ It’s a complicated problem.”

To assist with telehealth implementation, the APA has issued practice guidance and a toolkit that includes an extensive set of educational materials, including 40 videos on various topics. It’s also hosted webinars on telehealth policies and written up standard operating procedures on this topic, Dr. Yellowlees said. “The most important thing is APA, like other organizations, is advocating to have the relaxation of regulations during COVID made permanent,” he said.

Reimbursement post pandemic

As virtual visits rose in 2020, so did billing for such services. According to America’s Health Insurance Plans, claims to private insurers exploded by more than 4,000% in 2020. AHIP last July reported that mental health conditions made up one-third or more than 33% of telehealth claims to private insurers during the pandemic. Dr. Yellowlees said the health insurers he’s dealt with “have been good about paying for telehealth visits during the COVID-declared emergency.”

Whether this coverage will continue once the public health emergency ends, is unclear, some contend. “My sense is that there will be a rollback of coverage, but it won’t be back to what we had prepandemic,” said Ateev Mehrotra, MD, MPH, who studies telemedicine trends, in an interview. Right now, there’s still a great deal of uncertainty about reimbursement, “and that’s what’s giving providers pause,” said Dr. Mehrotra, of the department of health care policy and medicine at Harvard Medical School and a hospitalist at Beth Israel Deaconess Medical Center, both in Boston.

AHIP will continue to support federal and state policies to further promote telehealth access during the public health emergency, spokesman David Allen said in a statement. “Insurance providers have independently shifted their policies to increase access to care and services, ranging from acute care needs and triage services to chronic disease management and behavioral health. We are still awaiting information on what changes will remain in place beyond the public health emergency,” he said.

Even before COVID-19, Mr. Allen noted, nearly all large employers (96%) offered access to telehealth services as a covered benefit in 2019. In May, the Kaiser Family Foundation reported that many insurers were reducing or lifting cost sharing for telehealth for limited time periods.

Some of the larger payers said they’re continuing benefits, although it’s not clear how long some benefits will remain in place.

UnitedHealthcare offers no-cost coverage for COVID-19 testing–related telehealth visits, but that benefit is set to expire once the public health emergency presumably ends on Jan. 20, 2021. Through Dec. 31, 2020, the payer said it would offer coverage with no cost sharing for telehealth visits related to COVID-19 treatment and expanded access to telehealth visits not related to COVID-19 through its network. Similarly, Anthem is waiving cost sharing for COVID-19 treatments via telehealth or in-person visits, and for telehealth visits not related to COVID-19 for Medicare members through the end of the year.

Anthem will continue to cover telehealth and encourage members and clinicians to use telehealth for behavioral health, a spokesperson said. Anthem also has a telehealth provider, LiveHealth Online, “another safe and effective way for members to see a doctor to receive health guidance from their home via mobile device or a computer with a webcam,” said the spokesperson.

Dr. Vasan hopes that insurers will increase coverage for telehealth and at the same rate as in-person visits, especially for mental health. “I have not felt that the quality of the clinic has decreased, and in fact, in some ways it’s gotten better, and insurance coverage should reflect this.”
 

Outlook for the hybrid model

As long as there’s COVID-19, psychiatry practices must remain virtual, at least for now, Dr. Shore said. “We will emerge from this pandemic, I suspect in bits and starts.” When that happens, practices will need to have a transition plan in place. “Once we get away from COVID, I don’t think our mental health will ever be the same again. We’ll have much more virtual technology along the lines of a hybrid model, where we’ll see patients in person, but we’ll use more technology to work with patients, but it will be more of a blend.” Practices will also have to address the regulatory, reimbursement, and prescribing conditions the new world offers.

Some practices are already discovering the benefits of relying less on a brick-and-mortar office.

Dr. Chan said his colleagues are finding that they no longer have to deal with the expense and upkeep of renting and furnishing office space. “Many are taking their practice virtual-only because the monthly recurring costs are so cheap, and they can see patients in distant, underserved communities.” In-person visits are now inconvenient and risky, he continued. They require expensive personal protective equipment and cleaning protocols. “Plus, there’s the risk that services must shut down when stay-at-home orders return or when a staff member gets infected.”

Physicians prescribing certain controlled substances will likely continue to use office space, once the public health emergency expires and face-to-face visits resume. “In such cases, they can rent office space part-time,” Dr. Chan added.

Dr. Vasan, also of the department of psychiatry at Stanford and chief medical officer of Real, hopes that such a model prevails. “I do miss seeing patients in person and think a hybrid will be a good balance.”

Most patients want it, as do the influx of Generation Z physicians coming into the profession, Dr. Yellowlees noted. These are young, technologically savvy doctors who grew up in the age of the Internet. “I think the silver lining of COVID is it led telemedicine past the tipping point, where both patients and providers are learning that it’s an appropriate way to get care, as long as you’re careful, use professional guidelines – and don’t drop your standards of care.”

Dr. Yellowlees and Dr. Shore are coauthors of Telepsychiatry and Health Technologies: A Guide for Mental Health Professionals (Washington: American Psychiatric Association Publishing, 2018), and receive royalties from the book. Dr. Shore also reported working with AccessCare and receiving royalties from Springer Press. Dr. Chan reported consulting for Orbit Health. Dr. Vasan reported no conflicts of interest. Dr. Mehrotra has received research funding from several U.S. agencies, including the National Institute of Mental Health and the National Institute of Neurological Disorders and Stroke.

Once the fog lifts on a global pandemic that led to an explosion in telehealth visits in 2020, mental health experts expect virtual and in-person visits to merge to become a standard model of care in clinical psychiatry.

Hybrid care is the future, Peter Yellowlees, MBBS, MD, a professor of psychiatry and chief wellness officer at the University of California, Davis, said in an interview. “I’ve been working this way for several years – where all of my patients get to see me in person or online, or both.”

The model’s increasing popularity reflects a major shift toward virtual consults. Telemedicine offers safer, quicker, and less expensive alternatives, Steven Chan, MD, MBA, of Stanford (Calif.) University, said in an interview. “This continuity is essential to helping to reduce emergency room visits, reduce inpatient hospitalizations and readmissions, and improving adherence to treatment,” Dr. Chan said. State and federal regulators’ actions to lift certain licensing and prescribing restrictions and expand coverage made it easier for clinical psychiatrists to offer and get paid for these services.

The catch is that no one knows whether these easements will remain in place once COVID-19 recedes, ending the national public health emergency, Jay H. Shore, MD, MPH, chairperson of the American Psychiatric Association telepsychiatry committee, and professor and director of telemedicine programming at the University of Colorado at Denver, Aurora’s department of psychiatry, said in an interview. “These all temporarily changed during this time period, but we have no idea when they’re going to end or if they’re going to continue off of COVID. So now, there’s a lot of uncertainty.”

 

‘Suite of different technologies’

New freedoms to deliver telehealth care left some practices scrambling to adopt or refine technology. Once COVID-19 hit, “I can’t think of a psychiatrist or provider or institution that didn’t have to rapidly virtualize and do at least some video conferencing,” Dr. Shore said. This immediate shift signaled a key move toward hybrid patient-doctor relations. “It means you hold a relationship with your patients through multiple different mediums, email, portal, telephone, in person. It’s not just about in-person versus video, it’s about a suite of different technologies.”

Dr. Shore began practicing telehealth 20 years ago, long before the age of COVID. He’s since established rewarding relationships with patients he’s never met. “I’ve done everything from medical management to long-term psychotherapy, group psychotherapy, and I’ve been successful with different populations.”

Many nuances exist around matching the right patient with the right videoconferencing adaptation, Dr. Shore continued. However, “in general, the literature supports that you can get equal clinical outcomes with telehealth versus in-person treatment.”
 

‘I see their garden’

While some may eschew the idea of providing care over a virtual platform, other physicians see it as an insightful window into a person’s mental state. “I think some are actually quite surprised by how much good care you can give using video,” said Dr. Yellowlees. Unlike a phone conversation, video allows you to see a person’s home. “The beauty of a video is not just that you can see the person, you can also look around their home, and learn more about them.”

In his own visits, he asks patients to take him on a virtual “walk” through their house, provided there are no confidentiality issues.

“I get to meet their pets, the carers, the spouses; I get to see their garden. I get to see what their interests are from looking at the paintings on their walls. I learn more about my patients that way. If you use video to purely see people from the neck up, then that’s fine, but I think you can also use it to your advantage, seeing people at home.” He also encourages patients to do visits in their cars – as long as the windows are shut, they’re in a safe area, and most importantly, they’re not driving.

Nina Vasan, MD, MBA, who treats patients at Stanford and in a concierge private practice for executives, agrees that seeing patients in the home offers a more direct view of patients’ lives. “These little extra pieces of information are things that we didn’t get before COVID, when patients would come by themselves into the office week after week. I do feel like I know some patients much better by being able to see their surroundings and home interactions,” Dr. Vasan, founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation and chair of the APA’s committee on innovation, said in an interview.

She uses Zoom for her sessions, and regularly texts with her concierge patients. In both clinics, where most visits have gone virtual, “the no-show rate is near zero. Before COVID, it was around 10%-20%.”

Safety is a key advantage of virtual visits, noted Dr. Shore. “It’s certainly better than some of the risks of seeing people in person.”
 

Lack of integration causes frustration

Some challenges exist around access and adaptation of virtual technology. The pandemic’s sudden onslaught left many clinicians scrambling to adjust to a virtual format without any training or tools to support them. “This has caused some stress,” Dr. Shore said.

Electronic health record systems may or may not integrate video visits, noted Dr. Chan. “For instance, I work at a health system where mental health questionnaires, imaging systems, notes, and video visit scheduling are housed in separate systems.”

Without a seamless national, integrated system in place, physicians are often left to couple different IT formats together. “There are some systems that work pretty well, and there are some that are really clunky where you’re forcing the two together, so that’s a challenge,” Dr. Shore said. Providers may be using one system for their office and another system to provide care. “They may be using different EHRs and different teleconferencing platforms. That adds complexity.” Video conferencing platforms aren’t as challenging to use as EHRs. However, if some people are self-taught, there’s no way of knowing if they’re using best practices, he added.

Many health systems do offer video built into EMRs. Companies such as Epic have provided integrations with Vidyo, Amwell, and other platforms, noted Dr. Chan.

An integrated platform is useful if done well – but isn’t necessarily essential, according to Dr. Yellowlees. In his own setup, he signs a laptop into an EMR and uses an iPad to communicate with patients via video on the iPad and all video on the phone.

“The big advantage of telemedicine is you can type your notes in a socially appropriate way while talking to the patient on video. I do that, and it saves me a considerable amount of time. I don’t have to spend time after a consultation typing up notes.”

Still, others may struggle with bandwidth or connectivity. “Perhaps there’s a problem with privacy or the types of patients you’re dealing with,” Dr. Shore said. Older patients in a nursing home, for example, may require a team of people that works onsite. Suddenly, their care has to transition to a virtual system. “You may need to figure how to put the right team together to do straightforward and individual interactions,” he said.

Virtual care also suffers from the “digital divide,” an issue that predates COVID-19, said Dr. Shore. Not all patients have access to bandwidth and the technology to see clinicians. Other lack expertise and comfort with using the technology, or can’t afford the equipment necessary to bring them online. The pandemic has highlighted all of these disparities, he emphasized.

Dr. Chan offered that the digital divide is part of a larger socioeconomic divide, where barriers to any care – including transportation for in-person care – exist.

Technology and access issues aside, insidious “Zoom fatigue” is affecting everyone right now. “That’s clearly real,” Dr. Shore said. “And it’s not just about videoconferencing; it’s about being in quarantine. We’re all in this virtual lockdown, where people are using the term ‘videoconferencing fatigue.’ It’s a complicated problem.”

To assist with telehealth implementation, the APA has issued practice guidance and a toolkit that includes an extensive set of educational materials, including 40 videos on various topics. It’s also hosted webinars on telehealth policies and written up standard operating procedures on this topic, Dr. Yellowlees said. “The most important thing is APA, like other organizations, is advocating to have the relaxation of regulations during COVID made permanent,” he said.

Reimbursement post pandemic

As virtual visits rose in 2020, so did billing for such services. According to America’s Health Insurance Plans, claims to private insurers exploded by more than 4,000% in 2020. AHIP last July reported that mental health conditions made up one-third or more than 33% of telehealth claims to private insurers during the pandemic. Dr. Yellowlees said the health insurers he’s dealt with “have been good about paying for telehealth visits during the COVID-declared emergency.”

Whether this coverage will continue once the public health emergency ends, is unclear, some contend. “My sense is that there will be a rollback of coverage, but it won’t be back to what we had prepandemic,” said Ateev Mehrotra, MD, MPH, who studies telemedicine trends, in an interview. Right now, there’s still a great deal of uncertainty about reimbursement, “and that’s what’s giving providers pause,” said Dr. Mehrotra, of the department of health care policy and medicine at Harvard Medical School and a hospitalist at Beth Israel Deaconess Medical Center, both in Boston.

AHIP will continue to support federal and state policies to further promote telehealth access during the public health emergency, spokesman David Allen said in a statement. “Insurance providers have independently shifted their policies to increase access to care and services, ranging from acute care needs and triage services to chronic disease management and behavioral health. We are still awaiting information on what changes will remain in place beyond the public health emergency,” he said.

Even before COVID-19, Mr. Allen noted, nearly all large employers (96%) offered access to telehealth services as a covered benefit in 2019. In May, the Kaiser Family Foundation reported that many insurers were reducing or lifting cost sharing for telehealth for limited time periods.

Some of the larger payers said they’re continuing benefits, although it’s not clear how long some benefits will remain in place.

UnitedHealthcare offers no-cost coverage for COVID-19 testing–related telehealth visits, but that benefit is set to expire once the public health emergency presumably ends on Jan. 20, 2021. Through Dec. 31, 2020, the payer said it would offer coverage with no cost sharing for telehealth visits related to COVID-19 treatment and expanded access to telehealth visits not related to COVID-19 through its network. Similarly, Anthem is waiving cost sharing for COVID-19 treatments via telehealth or in-person visits, and for telehealth visits not related to COVID-19 for Medicare members through the end of the year.

Anthem will continue to cover telehealth and encourage members and clinicians to use telehealth for behavioral health, a spokesperson said. Anthem also has a telehealth provider, LiveHealth Online, “another safe and effective way for members to see a doctor to receive health guidance from their home via mobile device or a computer with a webcam,” said the spokesperson.

Dr. Vasan hopes that insurers will increase coverage for telehealth and at the same rate as in-person visits, especially for mental health. “I have not felt that the quality of the clinic has decreased, and in fact, in some ways it’s gotten better, and insurance coverage should reflect this.”
 

Outlook for the hybrid model

As long as there’s COVID-19, psychiatry practices must remain virtual, at least for now, Dr. Shore said. “We will emerge from this pandemic, I suspect in bits and starts.” When that happens, practices will need to have a transition plan in place. “Once we get away from COVID, I don’t think our mental health will ever be the same again. We’ll have much more virtual technology along the lines of a hybrid model, where we’ll see patients in person, but we’ll use more technology to work with patients, but it will be more of a blend.” Practices will also have to address the regulatory, reimbursement, and prescribing conditions the new world offers.

Some practices are already discovering the benefits of relying less on a brick-and-mortar office.

Dr. Chan said his colleagues are finding that they no longer have to deal with the expense and upkeep of renting and furnishing office space. “Many are taking their practice virtual-only because the monthly recurring costs are so cheap, and they can see patients in distant, underserved communities.” In-person visits are now inconvenient and risky, he continued. They require expensive personal protective equipment and cleaning protocols. “Plus, there’s the risk that services must shut down when stay-at-home orders return or when a staff member gets infected.”

Physicians prescribing certain controlled substances will likely continue to use office space, once the public health emergency expires and face-to-face visits resume. “In such cases, they can rent office space part-time,” Dr. Chan added.

Dr. Vasan, also of the department of psychiatry at Stanford and chief medical officer of Real, hopes that such a model prevails. “I do miss seeing patients in person and think a hybrid will be a good balance.”

Most patients want it, as do the influx of Generation Z physicians coming into the profession, Dr. Yellowlees noted. These are young, technologically savvy doctors who grew up in the age of the Internet. “I think the silver lining of COVID is it led telemedicine past the tipping point, where both patients and providers are learning that it’s an appropriate way to get care, as long as you’re careful, use professional guidelines – and don’t drop your standards of care.”

Dr. Yellowlees and Dr. Shore are coauthors of Telepsychiatry and Health Technologies: A Guide for Mental Health Professionals (Washington: American Psychiatric Association Publishing, 2018), and receive royalties from the book. Dr. Shore also reported working with AccessCare and receiving royalties from Springer Press. Dr. Chan reported consulting for Orbit Health. Dr. Vasan reported no conflicts of interest. Dr. Mehrotra has received research funding from several U.S. agencies, including the National Institute of Mental Health and the National Institute of Neurological Disorders and Stroke.

Lawmakers, physicians, and advocates alike have hailed a relaxation of telehealth rules under the COVID-19 emergency declaration, and they’d like things to stay this way.

Regulators previously restricted telemedicine use “by insisting that you could only see patients in the state you’re licensed in, by not reimbursing as widely for telehealth, and by not allowing us to prescribe controlled substances. They also didn’t allow us to see patients on the phone. So, there’s very good reasons to keep those regulations permanently relaxed,” said Peter Yellowlees, MBBS, MD, a professor of psychiatry and chief wellness officer at the University of California, Davis.

In his view, changes should take place in four key areas:

• Licensing. “Traditionally, state medical boards have been very insistent that clinical psychiatrists license in the state the patient resides in. This means physicians must have licenses in many different states. It’s very restrictive, because physicians can’t follow patients from one state to another. Under COVID, we can do this, but physicians want these licensing changes to be made permanent.”
• Reimbursement. “In the past, federal regulators have only allowed reimbursement for telemedicine in very specific, defined rural areas and specified clinical environments. This rule has since been relaxed, allowing us to see patients anywhere, especially in their homes. This is another area that should become permanent. Payers should continue to pay telehealth services on par with in-person visits.”
• Telephony. “Psychiatrists and other physicians haven’t been traditionally paid for telephone visits. But there’s no doubt that telephone follow-up visits can be very beneficial, so while I wouldn’t personally see a new patient on the phone, I now follow up with them on the phone once I have gotten to know them, and this works well.”
• Prescribing. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was introduced to stop overseas pharmacies prescribing narcotics. “It was very successful, but as a side effect, it stopped most physicians from prescribing controlled substances on video. With COVID, we can now do this. For psychiatry, this is very important because it means we can use video to treat people for addictions with medications like buprenorphine and [prescribe] stimulants for children with ADHD. The U.S. Drug Enforcement Administration should finalize regulations for the Ryan Haight Act to allow for the prescribing of controlled substances via telehealth without a prior in-person exam.”

The American Psychiatric Association has called for an extension of the telehealth waiver authority under COVID-19 beyond the emergency declaration to study its impact. It will continue to advocate to allow for telephone-only telehealth to be reimbursed at the same rate as live audio-video, said a spokesperson. “We also will continue to advocate for the removal of geographic and originating site restrictions in Medicare, which prevent Medicare patients from being seen in the home,” with some exceptions, the spokesperson said.

The APA has also issued guidance to practitioners seeking clarity on telehealth coverage and COVID-19.

Lawmakers, physicians, and advocates alike have hailed a relaxation of telehealth rules under the COVID-19 emergency declaration, and they’d like things to stay this way.

Regulators previously restricted telemedicine use “by insisting that you could only see patients in the state you’re licensed in, by not reimbursing as widely for telehealth, and by not allowing us to prescribe controlled substances. They also didn’t allow us to see patients on the phone. So, there’s very good reasons to keep those regulations permanently relaxed,” said Peter Yellowlees, MBBS, MD, a professor of psychiatry and chief wellness officer at the University of California, Davis.

In his view, changes should take place in four key areas:

• Licensing. “Traditionally, state medical boards have been very insistent that clinical psychiatrists license in the state the patient resides in. This means physicians must have licenses in many different states. It’s very restrictive, because physicians can’t follow patients from one state to another. Under COVID, we can do this, but physicians want these licensing changes to be made permanent.”
• Reimbursement. “In the past, federal regulators have only allowed reimbursement for telemedicine in very specific, defined rural areas and specified clinical environments. This rule has since been relaxed, allowing us to see patients anywhere, especially in their homes. This is another area that should become permanent. Payers should continue to pay telehealth services on par with in-person visits.”
• Telephony. “Psychiatrists and other physicians haven’t been traditionally paid for telephone visits. But there’s no doubt that telephone follow-up visits can be very beneficial, so while I wouldn’t personally see a new patient on the phone, I now follow up with them on the phone once I have gotten to know them, and this works well.”
• Prescribing. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was introduced to stop overseas pharmacies prescribing narcotics. “It was very successful, but as a side effect, it stopped most physicians from prescribing controlled substances on video. With COVID, we can now do this. For psychiatry, this is very important because it means we can use video to treat people for addictions with medications like buprenorphine and [prescribe] stimulants for children with ADHD. The U.S. Drug Enforcement Administration should finalize regulations for the Ryan Haight Act to allow for the prescribing of controlled substances via telehealth without a prior in-person exam.”

The American Psychiatric Association has called for an extension of the telehealth waiver authority under COVID-19 beyond the emergency declaration to study its impact. It will continue to advocate to allow for telephone-only telehealth to be reimbursed at the same rate as live audio-video, said a spokesperson. “We also will continue to advocate for the removal of geographic and originating site restrictions in Medicare, which prevent Medicare patients from being seen in the home,” with some exceptions, the spokesperson said.

The APA has also issued guidance to practitioners seeking clarity on telehealth coverage and COVID-19.

Lawmakers, physicians, and advocates alike have hailed a relaxation of telehealth rules under the COVID-19 emergency declaration, and they’d like things to stay this way.

Regulators previously restricted telemedicine use “by insisting that you could only see patients in the state you’re licensed in, by not reimbursing as widely for telehealth, and by not allowing us to prescribe controlled substances. They also didn’t allow us to see patients on the phone. So, there’s very good reasons to keep those regulations permanently relaxed,” said Peter Yellowlees, MBBS, MD, a professor of psychiatry and chief wellness officer at the University of California, Davis.

In his view, changes should take place in four key areas:

• Licensing. “Traditionally, state medical boards have been very insistent that clinical psychiatrists license in the state the patient resides in. This means physicians must have licenses in many different states. It’s very restrictive, because physicians can’t follow patients from one state to another. Under COVID, we can do this, but physicians want these licensing changes to be made permanent.”
• Reimbursement. “In the past, federal regulators have only allowed reimbursement for telemedicine in very specific, defined rural areas and specified clinical environments. This rule has since been relaxed, allowing us to see patients anywhere, especially in their homes. This is another area that should become permanent. Payers should continue to pay telehealth services on par with in-person visits.”
• Telephony. “Psychiatrists and other physicians haven’t been traditionally paid for telephone visits. But there’s no doubt that telephone follow-up visits can be very beneficial, so while I wouldn’t personally see a new patient on the phone, I now follow up with them on the phone once I have gotten to know them, and this works well.”
• Prescribing. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was introduced to stop overseas pharmacies prescribing narcotics. “It was very successful, but as a side effect, it stopped most physicians from prescribing controlled substances on video. With COVID, we can now do this. For psychiatry, this is very important because it means we can use video to treat people for addictions with medications like buprenorphine and [prescribe] stimulants for children with ADHD. The U.S. Drug Enforcement Administration should finalize regulations for the Ryan Haight Act to allow for the prescribing of controlled substances via telehealth without a prior in-person exam.”

The American Psychiatric Association has called for an extension of the telehealth waiver authority under COVID-19 beyond the emergency declaration to study its impact. It will continue to advocate to allow for telephone-only telehealth to be reimbursed at the same rate as live audio-video, said a spokesperson. “We also will continue to advocate for the removal of geographic and originating site restrictions in Medicare, which prevent Medicare patients from being seen in the home,” with some exceptions, the spokesperson said.

The APA has also issued guidance to practitioners seeking clarity on telehealth coverage and COVID-19.

This year saw an unprecedented rise in medical consults over virtual platforms, as the COVID-19 pandemic raged on in the United States and worldwide.

Statistics from major health care groups and payers underscore this effect. Polling 1,004 U.S. adults this fall, the American Psychiatric Association found that 31% had used telehealth services – with 72% reporting they had ventured into this mode of care over the last 6 months.

The Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, was a major catalyst, waiving geographic and Medicare telehealth payment restrictions for mental health services during certain emergency periods. Medicare beneficiaries gained access to telehealth services – they could start seeing doctors via videoconferencing in their homes, regardless of location. The Centers for Medicare and Medicaid Services began paying doctors for telehealth services at the same rate as in-office visits for all diagnoses and issued a toolkit to promote adoption of telehealth coverage policies among state Medicaid agencies.

Most states responded, expanding telehealth in Medicaid programs and relaxing restrictions on provider licensing, online prescribing, and patient consent for telehealth, the Kaiser Family Foundation reported in May. Other federal agencies took actions during the public health emergency. The Drug Enforcement Administration allowed for the prescribing of controlled substances through telemedicine, and the U.S. Department of Health & Human Services’s Office for Civil Rights agreed not to impose penalties for noncompliance of HIPAA during video conferencing, provided that physicians were acting in the best interests of the patient.

“The benefits we’re seeing on both sides – for patients and for doctors – around convenience and access are wonderful,” Nina Vasan, MD, MBA, founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation and chair of APA’s Committee on Innovation, said in an interview. Before COVID began, only a handful of clinicians were seeing patients via televideo at Stanford, said Dr. Vasan. “Now, almost everyone is. The forced uptake and change of behavior was something we’ve needed for years, and now that it has happened, I don’t see it going away.”

This year saw an unprecedented rise in medical consults over virtual platforms, as the COVID-19 pandemic raged on in the United States and worldwide.

Statistics from major health care groups and payers underscore this effect. Polling 1,004 U.S. adults this fall, the American Psychiatric Association found that 31% had used telehealth services – with 72% reporting they had ventured into this mode of care over the last 6 months.

The Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, was a major catalyst, waiving geographic and Medicare telehealth payment restrictions for mental health services during certain emergency periods. Medicare beneficiaries gained access to telehealth services – they could start seeing doctors via videoconferencing in their homes, regardless of location. The Centers for Medicare and Medicaid Services began paying doctors for telehealth services at the same rate as in-office visits for all diagnoses and issued a toolkit to promote adoption of telehealth coverage policies among state Medicaid agencies.

Most states responded, expanding telehealth in Medicaid programs and relaxing restrictions on provider licensing, online prescribing, and patient consent for telehealth, the Kaiser Family Foundation reported in May. Other federal agencies took actions during the public health emergency. The Drug Enforcement Administration allowed for the prescribing of controlled substances through telemedicine, and the U.S. Department of Health & Human Services’s Office for Civil Rights agreed not to impose penalties for noncompliance of HIPAA during video conferencing, provided that physicians were acting in the best interests of the patient.

“The benefits we’re seeing on both sides – for patients and for doctors – around convenience and access are wonderful,” Nina Vasan, MD, MBA, founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation and chair of APA’s Committee on Innovation, said in an interview. Before COVID began, only a handful of clinicians were seeing patients via televideo at Stanford, said Dr. Vasan. “Now, almost everyone is. The forced uptake and change of behavior was something we’ve needed for years, and now that it has happened, I don’t see it going away.”

This year saw an unprecedented rise in medical consults over virtual platforms, as the COVID-19 pandemic raged on in the United States and worldwide.

Statistics from major health care groups and payers underscore this effect. Polling 1,004 U.S. adults this fall, the American Psychiatric Association found that 31% had used telehealth services – with 72% reporting they had ventured into this mode of care over the last 6 months.

The Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, was a major catalyst, waiving geographic and Medicare telehealth payment restrictions for mental health services during certain emergency periods. Medicare beneficiaries gained access to telehealth services – they could start seeing doctors via videoconferencing in their homes, regardless of location. The Centers for Medicare and Medicaid Services began paying doctors for telehealth services at the same rate as in-office visits for all diagnoses and issued a toolkit to promote adoption of telehealth coverage policies among state Medicaid agencies.

Most states responded, expanding telehealth in Medicaid programs and relaxing restrictions on provider licensing, online prescribing, and patient consent for telehealth, the Kaiser Family Foundation reported in May. Other federal agencies took actions during the public health emergency. The Drug Enforcement Administration allowed for the prescribing of controlled substances through telemedicine, and the U.S. Department of Health & Human Services’s Office for Civil Rights agreed not to impose penalties for noncompliance of HIPAA during video conferencing, provided that physicians were acting in the best interests of the patient.

“The benefits we’re seeing on both sides – for patients and for doctors – around convenience and access are wonderful,” Nina Vasan, MD, MBA, founder and executive director of Brainstorm: The Stanford Lab for Mental Health Innovation and chair of APA’s Committee on Innovation, said in an interview. Before COVID began, only a handful of clinicians were seeing patients via televideo at Stanford, said Dr. Vasan. “Now, almost everyone is. The forced uptake and change of behavior was something we’ve needed for years, and now that it has happened, I don’t see it going away.”

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

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

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

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

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

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

The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.

Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.

“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.

“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
 

Many doctors have been contemplating closing

The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.

In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.

“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.

“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.

Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
 

Will your practice be hard to sell?

With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.

“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”

In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.

“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
 

Practice values have (temporarily) fallen

Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.

COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”

Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”

Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.

“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
 

How long will it take to sell your practice?

Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.

Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.

The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
 

What’s the right price for your practice?

For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.

An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.

Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.

COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.

Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
 

Using valuations to set the price

A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.

Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”

A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.

Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.

This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.

For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”

Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
 

Buyers’ valuations

Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.

Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”

When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.

Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.

Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.

Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
 

A primer on valuations

As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”

Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”

The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.

With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.

“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”

The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.

The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.

“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
 

Will the buyer pay for goodwill?

Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.

“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”

One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.

Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.

Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
 

Selling to other doctors

Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.

“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”

A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.

The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.

COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”

He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
 

Selling to or merging with other practices

The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”

Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”

One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
 

Hospitals as buyers

Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.

Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”

Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.

Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
 

Selling to private-equity firms

Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.

The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.

Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.

Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.

Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”

The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.

“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.

When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
 

Do you really want to sell?

“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.

“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.

“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”

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

The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.

Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.

“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.

“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
 

Many doctors have been contemplating closing

The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.

In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.

“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.

“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.

Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
 

Will your practice be hard to sell?

With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.

“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”

In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.

“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
 

Practice values have (temporarily) fallen

Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.

COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”

Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”

Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.

“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
 

How long will it take to sell your practice?

Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.

Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.

The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
 

What’s the right price for your practice?

For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.

An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.

Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.

COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.

Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
 

Using valuations to set the price

A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.

Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”

A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.

Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.

This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.

For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”

Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
 

Buyers’ valuations

Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.

Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”

When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.

Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.

Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.

Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
 

A primer on valuations

As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”

Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”

The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.

With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.

“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”

The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.

The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.

“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
 

Will the buyer pay for goodwill?

Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.

“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”

One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.

Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.

Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
 

Selling to other doctors

Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.

“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”

A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.

The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.

COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”

He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
 

Selling to or merging with other practices

The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”

Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”

One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
 

Hospitals as buyers

Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.

Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”

Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.

Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
 

Selling to private-equity firms

Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.

The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.

Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.

Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.

Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”

The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.

“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.

When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
 

Do you really want to sell?

“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.

“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.

“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”

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

The COVID-19 pandemic has decimated the bottom lines of many private practices, prompting physician-owners to seriously contemplate selling.

Physician-owners have had to sell at lower prices, reflecting lower cash flow under COVID-19. But sales prices may rebound following news on Nov. 9 that a COVID-19 vaccine candidate produced by Pfizer and its German partner, BioNTech, may be ready for initial distribution before the end of the year.

“There are a lot of ifs still, but if things go according to expectations, we may see an increase in the value of practices,” said Mark O. Dietrich, a CPA in Framingham, Mass., who deals mostly with valuations of physician practices.

“Practice valuations have been lower because many patients have kept away and cash flow has been reduced,” Mr. Dietrich said. “But once patients feel safe, that barrier would be removed, and cash flow, which sales prices are generally based on, could rise. However, this may take a while. One major hurdle would be getting people to take the vaccine.”
 

Many doctors have been contemplating closing

The nation is currently undergoing a significant spike in COVID-19 hospitalizations, which could prompt another COVID-19–related downturn in practice volume, as occurred earlier in the year. That downturn forced many private practitioners to contemplate selling their practices.

In a survey released this summer by McKinsey & Company, 53% of independent physicians reported that they were worried about their practices surviving. Although many physicians have now reopened their offices, patient volume is reduced, and physicians are earning far less than before.

“In many cases, physicians who had been considering retirement in the next few years have moved their planning up and want to sell as soon as possible,” said John D. Fanburg, an attorney at Brach Eichler, a law firm in Roseland, N.J., who specializes in medical practice sales and mergers.

“For physicians over age 65, it’s not just worries about finances; it’s also worries about the health risks of staying open,” Mr. Fanburg added.

Mid-career physicians are also selling their practices. Many of them become employees of the hospital, large practice, or private-equity firm that bought the practice – receiving a level of compensation set by the sales agreement.
 

Will your practice be hard to sell?

With so many physicians ready to sell, are there enough potential buyers to acquire them all? Probably not, said Mr. Dietrich.

“Many hospitals may not need new practices right now,” he said. “In the depths of the pandemic, they furloughed many of their existing doctors and may not have brought all of them back yet.”

In fact, because of the pandemic, some buyers have delayed sales that were already in progress, said Monica H. Kaden, director of business valuations at Sobel Valuations, based in Livingston, N.J.

“Buyers are not only worried about their own cash flow but also about the possibility of lower revenues of the selling practices due to COVID-19,” she said, citing a very large multispecialty group that has put its purchase of a another large multispecialty group on hold.
 

Practice values have (temporarily) fallen

Many potential buyers are still looking, though. One thing that drives them is the possibility of discounted sales because of COVID-19. “The sense I get is that a lot of hospitals see this as an opportunity to pick up practices on the cheap,” Mr. Dietrich said.

COVID-19 has been reducing practice values somewhat, said Reed Tinsley, a CPA in Houston who performs medical practice valuations and runs a practice brokerage firm. “Practice revenues and net income are lower under COVID-19, so prices are lower.”

Ms. Kadan advised physicians to hold off selling if they can afford to wait. “It’s always best to sell when the practice volume looks the best, because then the practice is worth more. But there are doctors who can’t wait because revenues are really falling and they are running out of money. They may have no choice but to sell.”

Even in the best of times, not all practices can be sold, said Sean Tinsley, a broker and licensed financial adviser at Tinsley Medical Practice Brokers in Austin, Tex., which he runs with his father, Reed Tinsley.

“We turn down about as many deals to sell practices as we accept,” he said. “Brokers have to be very selective because we don’t get paid until the practice gets sold. Generally, we won’t take practices in rural areas or practices that still only have a fraction of their pre–COVID-19 volume.”
 

How long will it take to sell your practice?

Some practices find a buyer within weeks, but in other cases, it can take as long as a year, he said. Once the buyer is located, preparing the paperwork for the sale can take 45-60 days.

Doctors can sell their practices on their own, but a broker can help them find potential buyers and select the right price. Business brokers generally receive a greater percentage of the sales price than residential brokers. They have greater command of business and finance, and the sale is more complex than a residential sale.

The broker may also help with selling the building where the practice is located, which is usually a separate sale, said Bruce E. Wood, an attorney at CCB Law in Syracuse, N.Y., who deals with practice sales. “A hospital buying your practice may not want to buy the building, so it has to be sold separately. You can always sell the space to a different buyer.”
 

What’s the right price for your practice?

For small practices, brokers often set a price by establishing a multiple, such as two times net earnings, Sean Tinsley said. In many cases, practices haven’t retained net earnings, so the broker uses gross annual revenue and sets the price at 50%-55% of that figure.

An alternative that is widely used in the business world and for many large practices is to base the price on earnings before interest, taxes, depreciation, and amortization (EBITDA). To determine a price, the EBITDA is then multiplied by a particular multiple, which depends on the perceived value of the practice.

Higher multiples go to practices that have a qualified management team, have documented financial policies and procedures, or have had significant past growth. Generally, the multiple of EBITDA at smaller practices is 1 or 2; larger practices have a multiple of 5-7 times EBITDA, Sean Tinsley said.

COVID-19 has had the effect of reducing the multiple somewhat. “As market forces shift from a seller’s market to a buyer’s market, multiples will likely remain below pre–COVID-19 levels for the remainder of 2020 and the first half of 2021,” one report stated.

Certified valuators like Reed Tinsley have more complex ways to establish the value of a practice, but as a broker, Sean Tinsley tends to use the multiples approach. He asserted that the prices derived from this method are on the mark. “Almost all the time we sell at the asking price.”
 

Using valuations to set the price

A more complex and expensive way to set a price for a practice is to order a valuation of the practice. The valuator issues a report that runs dozens of pages and costs thousands of dollars.

Mr. Fanburg said that very few physicians selling practices order valuation reports, owing to the cost and complexity. As a result, “they don’t have a clear idea what their practices are worth.”

A comprehensive report is called a conclusion of value. The amount it finds – expressed as a range – is called “fair market value.” The report can be used in the courts for legal disputes as well as for deriving a sales price.

Practices that don’t want to pay for a conclusion of value can ask a valuator to assemble a less extensive report, called an opinion of calculated value. Also known as a calculation engagement or engagement letter, it still costs several thousand dollars.

This report has limited validity and can’t be used in the courts, according to Jarrod Barraza, a certified valuator in the Nashville, Tenn., office of Horne, a health care business valuator. “When I issue an engagement letter, I am not talking as an appraiser but as a valuation consultant, and I don’t call the result fair market value; it’s only estimating,” he said.

For all of the precision of formal reports, however, valuations of a practice can vary widely, according to Reed Tinsley. “Two valuations using the same methodology can differ by $300,000.”

Also, the valuation can be well above a reasonable asking price, said Sean Tinsley. “The market dictates the price. A traditional valuation almost invariably quotes a higher return than the market is willing to pay.”
 

Buyers’ valuations

Physicians who decide not to get a valuation still have to deal with valuations ordered by buyers. Hospitals and large practices often order valuations of the practices they want to buy, and private-equity firms use methods much like a valuation for the practices they are interested in.

Buyers rarely share the valuation report with the seller, so the seller has to accept the buyer’s price without being able to review the thought process behind it, Mr. Fanburg said. “Relying on the buyer to tell you what you’re worth means you may sell your practice well below its true value.”

When the buyer orders a valuation, the valuator interviews managers of the practice and asks for a great deal of information, says G. Don Barbo, managing director at VMG Health, a health care valuation firm based in Dallas.

Mr. Barbo said these documents include financial statements for the practice, usually going back 3-5 years; productivity reports for doctors and other providers; accounts receivables; reports of fixed assets; a roster of employees; employment agreements and management services agreements; reports on payer mix; facility leases and equipment lease agreements; budgets and projections; and tax returns.

Mr. Dietrich said valuators hone in on the practice’s current procedural terminology codes. “If the practice is coding too high, this would artificially increase the profit and purported value of the practice. For example, coding at 99214 rather than 99213 for an established patient means that the practice is being paid 45% more for each visit.” The valuator then reduces the value of the practice on the basis of the extent of the improper up-coding.

Mr. Barbo said some sellers don’t want all the scrutiny of the buyer’s valuation and just sell the practice’s tangible assets – furnishings, fixtures, and equipment – which do not require a great deal of documentation but yield a much lower price.
 

A primer on valuations

As a valuator, “my job is to project into the future,” Mr. Barraza said. “I am trying to see how the practice will fare going forward.”

Mr. Dietrich agreed, with one caveat: “As Yogi Berra said: ‘It’s difficult to make predictions, especially about the future.’ ”

The formal valuation assesses the practice in three ways: measuring income, assets, and what other practices sell for, called the market approach.

With the income approach, the most used measurement for practices, one tries to determine future income, which is what buyers are most interested in, Mr. Dietrich said. The income equals revenue (total collections) minus operating expenses and overhead.

“You are then left with all the money the physician is paid,” he said. “The issue is, how much is attributed to the physician’s own labor and how much to his or her ownership of the practice? This second category helps determine the value of the practice.”

The market approach is often used as a way to double-check the accuracy of the income approach. The appraiser looks for the prices of similar practices that have already been sold and then adjusts the price on the basis of differences with the practice up for sale.

The asset approach may be used when the practice has no positive cash flow. It establishes a price for tangible assets, which are often much lower in value than the values that the other approaches come up with. The asset approach can be a lower-priced alternative for practices that can’t be measured under the income or market approach.

“Equipment appraisers can do an inventory of your equipment,” Mr. Wood said. “Generally, equipment that is more than 3 years old, such as computers, is not that valuable, but an ultrasound machine probably has some resale value.”
 

Will the buyer pay for goodwill?

Many practice owners hope they can get money for the “goodwill” of their practice when they sell. Goodwill basically represents the reputation of the practice, which is difficult to pinpoint, and Mr. Wood said buyers often don’t want to pay for it.

“The goodwill is a wild card,” Mr. Wood said. “It can range from zero to crazy numbers. There is a Goodwill Registry – a list of the goodwill in other practice sales – that you can consult.”

One simple way to calculate the goodwill, he said, is to take the value of the practice based on examining income and remove the value of tangible assets. What is left is considered the goodwill.

Another form of intangible asset that is sometimes lumped together with goodwill is the value of the practice’s trained staff. “Some buyers agree to pay for the staff in place, because they plan to use that staff,” Ms. Kadan said. In one large deal she was involved with, the buyer agreed to pay something for the selling practice’s staff of 180 people.

Another item that buyers also do not typically pay for is the practice’s accounts receivable. They may also not pay for any liabilities the practice holds, such as the facility lease, equipment lease, and maintenance contracts, Mr. Barbo said. “The buyer then often stipulates that all liabilities are left to the practice, or stipulates any specific liabilities that it may assume.”
 

Selling to other doctors

Doctors can sell practices or shares in practices to other doctors. A retiring physician, for example, can sell his or her share to the other partners. A valuator may be brought in to establish the value of the doctor’s equity interest in the practice.

“Generally, practice buyouts aren’t lucrative for selling physician,” Mr. Wood said. “There are exceptions, of course, such as specialty practices in some cases.”

A practice can also be sold to a new doctor or to a previously employed physician who wants to be an owner. These physicians usually need to get a bank loan to buy the practice.

The bank assesses the finances of the selling practice to determine whether the buying physician will earn enough money to pay back the loan. “Banks don’t want lend more than the gross annual revenue of the practice, and some banks will only lend at 65% of gross annual revenue,” Sean Tinsley said.

COVID-19 has seriously affected banks’ lending decisions. Banks stopped lending to practice buyers at the beginning of the pandemic, and when they started lending again, they were more cautious, Sean Tinsley said. “Generally, banks want to see the practice at 85%-90% of pre–COVID-19 numbers before they make a loan.”

He added that, if a buyer can’t get a bank loan, the selling doctor may decide to finance the sale. The buyer agrees to a payment schedule to pay off the full price over several years.
 

Selling to or merging with other practices

The usual buyer is another practice, Reed Tinsley said. “You can sell to a group, but prices are low because, with COVID-19, buyers don’t want to incur a lot of money up front. Or you can merge with the practice, which means the selling doctor usually doesn’t get any money, but he does get a share in the larger practice. In that case, the partnership is the object of value, and it can be cashed out when the physician leaves the practice.”

Mergers can get very complicated. Mr. Fanburg said he has been working with seven groups that are merging into one. “The merger was scheduled to go live last January, but it was slowed down over negotiations about new managed care contracts and putting together a management structure, plus the groups were a little wary of each other. Now the deal is scheduled to go live next January.”

One advantage to selling to a larger entity, such as a big group practice or a hospital, is that the selling physician benefits from the higher reimbursement rates that large providers usually command. “If the buyer has more favorable reimbursement rates with insurers, it could pay the selling doctor much more than he is making now,” Mr. Barraza said.
 

Hospitals as buyers

Because of COVID-19, currently many hospitals don’t have money to buy more practices. However, this is most likely a temporary situation.

Hospitals typically offer less money than other buyers, according to Sean Tinsley. “We have never sold to a hospital, because hospitals generally don’t pay for goodwill. They pay for the practice assets and offer a dollar amount for each chart.”

Hospitals have to be careful not to pay physicians more than the usual amount for their practices, because the extra amount could be seen as a kickback for referrals, which would violate the federal Stark law and Anti-Kickback Statute. Not-for-profit hospitals also have to comply with regulations at the Internal Revenue Service.

Hospitals usually require that the selling physician continue to work in the practice after it is sold. The selling physician’s presence helps ensure that the practice’s output will not decline after sale. Although the sales price may be low, the hospital may make up for it by paying a higher compensation, Sean Tinsley said.
 

Selling to private-equity firms

Private-equity purchases are financed by investors who essentially want to “flip” practices – that is, they want to make them more profitable and then sell them to someone else. The private-equity firm starts by buying a “platform” practice, which forms the core of the venture. It then buys smaller practices that will be managed by the platform practice.

The number of private-equity deals increased continually through 2019, then plummeted in March because of COVID-19, but by the summer, activity began to rise again.

Physicians are very intrigued about selling to private-equity firms because they are known to pay the most for practices. But private-equity buyers focus on a fairly narrow group of specialties.

Generally, Sean Tinsley said, private-equity firms only look for pain, dermatology, and ophthalmology practices, but they have been starting to branch out to specialties such as gastroenterology. In 2018, there were only two private-equity deals for gastroenterology practices, but in 2019, there were 16, according to one assessment.

Private-equity firms buy very few of the practices they initially review, according to Mr. Fanburg. “Private equity negotiates with dozens or even hundreds of physician practices at a time, with only 1%-5% of those practices actually being acquired.”

The private-equity firm’s upfront payment to selling physicians is quite high, but then the physicians become employees of the new group and earn much less in compensation than they earned on this own.

“In order for the venture to get any value out of the acquisition, the doctors have to make less going forward than they did historically,” Mr. Dietrich said. That freed-up money boosts the value of the venture.

When the platform practice is sold – usually after 5 years or so – “chances are the management team will be replaced,” Mr. Fanburg said. “There could be new policies and objectives, which could mean a bumpy ride for physicians.”
 

Do you really want to sell?

“When a group of physicians comes to me asking for help selling their practice, my first question is, Why are you doing this?” Mr. Fanburg said. “You need a better reason for selling than just the money.

“Once you make the leap, there is a certain amount of autonomy you lose,” he continued. “The sale gives you an economic boost, but it may not be enough for the long haul. If you stay on with the buyer, your compensation is often lower. That makes sense if you’re retiring, but not if you’re a younger physician with many years of practice in the years ahead.

“When physicians say they see no other way out except to sell,” Mr. Fanburg said, “I tell them that their buyer will see a path to future growth for your practice. If you think reimbursements are getting worse, why are the buyers pressing ahead?”

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

Adjunctive use of sodium benzoate (BZ), a common food preservative that has previously shown promise in the treatment of chronic refractory psychosis, appears to be ineffective in the early stages of the disorder, new research suggests.

Results of a randomized controlled trial show the agent was no more effective than placebo in reducing early psychosis symptoms, although it was safe and well tolerated.

“Both groups of patients improved over the 12 weeks of the study, [suggesting] that most people with early psychosis will get well with antipsychotic medication and psychosocial interventions and adding sodium benzoate to their treatment does not add any additional benefits,” the study’s lead author, James Scott, MBBS, PhD, head of mental health research, QIMR Berghofer Medical Research Institute, Herston, Australia, told Medscape Medical News.

The paper was published online November 10 in JAMA Network Open.
 

Positive outcomes in chronic disease

Despite treatment with antipsychotics, many patients with psychosis experience persistent impairment, the investigators note.

Most antipsychotics are dopaminergic in action, but it is now recognized that the pathophysiology underlying psychosis extends beyond dopaminergic dysregulation with hypofunction of the N-methyl-D-aspartate (NMDA) receptors also implicated but not addressed by standard antipsychotics, they add.

NMDA receptors consist of two main subunits – the glutamate and glycine-binding sites. D-amino acids (DAAs) are agonists of the glycine subunit and have shown promise as adjunctive therapies for the treatment of schizophrenia, the investigators note.

DAAs are subject to oxidation by the flavoenzyme D-amino acid oxidase (DAAO). The oxidation limits their bioavailability and can cause nephrotoxic side effects. The food preservative BZ, which is not related to the benzodiazepine class of medications, inhibits DAAO and therefore may make DAAs safer and more effective.

Scott noted that two previous trials of BZ – a 2013 study and a 2017 investigation – in chronic, treatment-refractory schizophrenia have “reported excellent outcomes with significant improvement in clinical symptoms.”

“We saw that sodium benzoate was a safe and well-tolerated agent, and we thought it was important to conduct a trial of this medication in people in the early stages of psychotic illness,” he said.

To investigate, the researchers randomly assigned 100 individuals who were experiencing early psychosis, which was defined as illness onset within the last 2 years, to receive either 500 mg of BZ twice daily or placebo for 12 weeks.

Participants (mean [SD] age 21.4 [4.1] years, 73% male) were required to be taking antipsychotic medications for at least 1 continuous month during the previous 2 years and to be free of comorbid physical illnesses requiring additional treatment or hospitalization.

Most participants (84%) had schizophrenia and the remainder had affective psychoses. Most participants (88%) lived independently.

The BZ and the placebo groups were similar with respect to baseline characteristics, except that the mean waist circumference was higher in the placebo group than in the BZ group.

The majority of patients were being treated with antipsychotics alone (83%), followed by antipsychotics in combination with mood stabilizers (13%) and a small number were taking mood stabilizers alone (4%). The most commonly used antipsychotics were olanzapine and aripiprazole.
 

Not recommended

Psychosis was confirmed using the Positive and Negative Syndrome Scale (PANSS), and the inclusion criteria was a baseline score of ≥ 55. Secondary outcomes were scores on the Hamilton Depression Rating Scale, the clinician-rated Global Assessment of Function, and the Assessment of Quality of Life Scale.

The researchers also measured concentrations of the amino acids oxidized by DAAO (D-alanine and L-alanine, D-serine and L-serine).

Although both groups experienced a reduction in total PANSS scores during the study, there were no significant differences in PANSS total score between the BZ and the placebo groups at 12 weeks (endpoint least-square mean difference [SE] −1.2 [2.4] t = −0.49, P = .63).

There were also no significant differences between the groups on all PANSS subscales as well as any of the secondary clinical measures (P < .007).

A total of 122 adverse events (AEs) overall were reported by 66 participants, but rates of AEs were comparable between the BZ and placebo groups at 55% vs. 46% respectively. There were 11 serious AEs reported by 10 participants. Only one of these was related to the study drug.

There were no statistically significant changes in amino acid concentrations between the two groups.

The authors note several limitations of the study, including the possibility that protective agents may need longer times than 12 weeks – possibly as long as 6 to 12 months – to show efficacy. Moreover, the dose of BZ needed to produce a response remains “uncertain.”

“Future clinical trials should restrict participants to those who are treatment refractory and should further investigate whether benzoate acts by altering amino acid levels or by reducing oxidative stress in people with schizophrenia,” the authors suggest.

Scott added that further research in patients with treatment-refractory schizophrenia is needed to determine whether BZ “has a role in this patient population.”

The authors conclude that at present, “the routine use of this agent as an adjunctive treatment for early psychosis is not recommended.”
 

No surprise?

Commenting on the study for Medscape Medical News, Kenji Hashimoto, PhD, Division of Clinical Neuroscience, Chiba University Center for Forensic Mental Health, Chiba, Japan, said that, although previous studies of BZ showed benefit in stable patients with chronic schizophrenia, “it is unlikely that [sodium] benzoate may have beneficial effects in the acute phase of psychosis.”

Hashimoto, who was not involved with the study, noted that BZ is a “weak DAAO inhibitor and that DAAO expression in the frontal cortex of human beings is very low.”

This project was supported by a John Cade Fellowship from the National Health and Medical Research Council and support from the Queensland Centre for Mental Health Research, which receives funding from the Queensland Health Department. Scott is supported by an NHMRC Practitioner Fellowship. The other authors’ disclosures are listed on the original article. Hashimoto has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Adjunctive use of sodium benzoate (BZ), a common food preservative that has previously shown promise in the treatment of chronic refractory psychosis, appears to be ineffective in the early stages of the disorder, new research suggests.

Results of a randomized controlled trial show the agent was no more effective than placebo in reducing early psychosis symptoms, although it was safe and well tolerated.

“Both groups of patients improved over the 12 weeks of the study, [suggesting] that most people with early psychosis will get well with antipsychotic medication and psychosocial interventions and adding sodium benzoate to their treatment does not add any additional benefits,” the study’s lead author, James Scott, MBBS, PhD, head of mental health research, QIMR Berghofer Medical Research Institute, Herston, Australia, told Medscape Medical News.

The paper was published online November 10 in JAMA Network Open.
 

Positive outcomes in chronic disease

Despite treatment with antipsychotics, many patients with psychosis experience persistent impairment, the investigators note.

Most antipsychotics are dopaminergic in action, but it is now recognized that the pathophysiology underlying psychosis extends beyond dopaminergic dysregulation with hypofunction of the N-methyl-D-aspartate (NMDA) receptors also implicated but not addressed by standard antipsychotics, they add.

NMDA receptors consist of two main subunits – the glutamate and glycine-binding sites. D-amino acids (DAAs) are agonists of the glycine subunit and have shown promise as adjunctive therapies for the treatment of schizophrenia, the investigators note.

DAAs are subject to oxidation by the flavoenzyme D-amino acid oxidase (DAAO). The oxidation limits their bioavailability and can cause nephrotoxic side effects. The food preservative BZ, which is not related to the benzodiazepine class of medications, inhibits DAAO and therefore may make DAAs safer and more effective.

Scott noted that two previous trials of BZ – a 2013 study and a 2017 investigation – in chronic, treatment-refractory schizophrenia have “reported excellent outcomes with significant improvement in clinical symptoms.”

“We saw that sodium benzoate was a safe and well-tolerated agent, and we thought it was important to conduct a trial of this medication in people in the early stages of psychotic illness,” he said.

To investigate, the researchers randomly assigned 100 individuals who were experiencing early psychosis, which was defined as illness onset within the last 2 years, to receive either 500 mg of BZ twice daily or placebo for 12 weeks.

Participants (mean [SD] age 21.4 [4.1] years, 73% male) were required to be taking antipsychotic medications for at least 1 continuous month during the previous 2 years and to be free of comorbid physical illnesses requiring additional treatment or hospitalization.

Most participants (84%) had schizophrenia and the remainder had affective psychoses. Most participants (88%) lived independently.

The BZ and the placebo groups were similar with respect to baseline characteristics, except that the mean waist circumference was higher in the placebo group than in the BZ group.

The majority of patients were being treated with antipsychotics alone (83%), followed by antipsychotics in combination with mood stabilizers (13%) and a small number were taking mood stabilizers alone (4%). The most commonly used antipsychotics were olanzapine and aripiprazole.
 

Not recommended

Psychosis was confirmed using the Positive and Negative Syndrome Scale (PANSS), and the inclusion criteria was a baseline score of ≥ 55. Secondary outcomes were scores on the Hamilton Depression Rating Scale, the clinician-rated Global Assessment of Function, and the Assessment of Quality of Life Scale.

The researchers also measured concentrations of the amino acids oxidized by DAAO (D-alanine and L-alanine, D-serine and L-serine).

Although both groups experienced a reduction in total PANSS scores during the study, there were no significant differences in PANSS total score between the BZ and the placebo groups at 12 weeks (endpoint least-square mean difference [SE] −1.2 [2.4] t = −0.49, P = .63).

There were also no significant differences between the groups on all PANSS subscales as well as any of the secondary clinical measures (P < .007).

A total of 122 adverse events (AEs) overall were reported by 66 participants, but rates of AEs were comparable between the BZ and placebo groups at 55% vs. 46% respectively. There were 11 serious AEs reported by 10 participants. Only one of these was related to the study drug.

There were no statistically significant changes in amino acid concentrations between the two groups.

The authors note several limitations of the study, including the possibility that protective agents may need longer times than 12 weeks – possibly as long as 6 to 12 months – to show efficacy. Moreover, the dose of BZ needed to produce a response remains “uncertain.”

“Future clinical trials should restrict participants to those who are treatment refractory and should further investigate whether benzoate acts by altering amino acid levels or by reducing oxidative stress in people with schizophrenia,” the authors suggest.

Scott added that further research in patients with treatment-refractory schizophrenia is needed to determine whether BZ “has a role in this patient population.”

The authors conclude that at present, “the routine use of this agent as an adjunctive treatment for early psychosis is not recommended.”
 

No surprise?

Commenting on the study for Medscape Medical News, Kenji Hashimoto, PhD, Division of Clinical Neuroscience, Chiba University Center for Forensic Mental Health, Chiba, Japan, said that, although previous studies of BZ showed benefit in stable patients with chronic schizophrenia, “it is unlikely that [sodium] benzoate may have beneficial effects in the acute phase of psychosis.”

Hashimoto, who was not involved with the study, noted that BZ is a “weak DAAO inhibitor and that DAAO expression in the frontal cortex of human beings is very low.”

This project was supported by a John Cade Fellowship from the National Health and Medical Research Council and support from the Queensland Centre for Mental Health Research, which receives funding from the Queensland Health Department. Scott is supported by an NHMRC Practitioner Fellowship. The other authors’ disclosures are listed on the original article. Hashimoto has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Adjunctive use of sodium benzoate (BZ), a common food preservative that has previously shown promise in the treatment of chronic refractory psychosis, appears to be ineffective in the early stages of the disorder, new research suggests.

Results of a randomized controlled trial show the agent was no more effective than placebo in reducing early psychosis symptoms, although it was safe and well tolerated.

“Both groups of patients improved over the 12 weeks of the study, [suggesting] that most people with early psychosis will get well with antipsychotic medication and psychosocial interventions and adding sodium benzoate to their treatment does not add any additional benefits,” the study’s lead author, James Scott, MBBS, PhD, head of mental health research, QIMR Berghofer Medical Research Institute, Herston, Australia, told Medscape Medical News.

The paper was published online November 10 in JAMA Network Open.
 

Positive outcomes in chronic disease

Despite treatment with antipsychotics, many patients with psychosis experience persistent impairment, the investigators note.

Most antipsychotics are dopaminergic in action, but it is now recognized that the pathophysiology underlying psychosis extends beyond dopaminergic dysregulation with hypofunction of the N-methyl-D-aspartate (NMDA) receptors also implicated but not addressed by standard antipsychotics, they add.

NMDA receptors consist of two main subunits – the glutamate and glycine-binding sites. D-amino acids (DAAs) are agonists of the glycine subunit and have shown promise as adjunctive therapies for the treatment of schizophrenia, the investigators note.

DAAs are subject to oxidation by the flavoenzyme D-amino acid oxidase (DAAO). The oxidation limits their bioavailability and can cause nephrotoxic side effects. The food preservative BZ, which is not related to the benzodiazepine class of medications, inhibits DAAO and therefore may make DAAs safer and more effective.

Scott noted that two previous trials of BZ – a 2013 study and a 2017 investigation – in chronic, treatment-refractory schizophrenia have “reported excellent outcomes with significant improvement in clinical symptoms.”

“We saw that sodium benzoate was a safe and well-tolerated agent, and we thought it was important to conduct a trial of this medication in people in the early stages of psychotic illness,” he said.

To investigate, the researchers randomly assigned 100 individuals who were experiencing early psychosis, which was defined as illness onset within the last 2 years, to receive either 500 mg of BZ twice daily or placebo for 12 weeks.

Participants (mean [SD] age 21.4 [4.1] years, 73% male) were required to be taking antipsychotic medications for at least 1 continuous month during the previous 2 years and to be free of comorbid physical illnesses requiring additional treatment or hospitalization.

Most participants (84%) had schizophrenia and the remainder had affective psychoses. Most participants (88%) lived independently.

The BZ and the placebo groups were similar with respect to baseline characteristics, except that the mean waist circumference was higher in the placebo group than in the BZ group.

The majority of patients were being treated with antipsychotics alone (83%), followed by antipsychotics in combination with mood stabilizers (13%) and a small number were taking mood stabilizers alone (4%). The most commonly used antipsychotics were olanzapine and aripiprazole.
 

Not recommended

Psychosis was confirmed using the Positive and Negative Syndrome Scale (PANSS), and the inclusion criteria was a baseline score of ≥ 55. Secondary outcomes were scores on the Hamilton Depression Rating Scale, the clinician-rated Global Assessment of Function, and the Assessment of Quality of Life Scale.

The researchers also measured concentrations of the amino acids oxidized by DAAO (D-alanine and L-alanine, D-serine and L-serine).

Although both groups experienced a reduction in total PANSS scores during the study, there were no significant differences in PANSS total score between the BZ and the placebo groups at 12 weeks (endpoint least-square mean difference [SE] −1.2 [2.4] t = −0.49, P = .63).

There were also no significant differences between the groups on all PANSS subscales as well as any of the secondary clinical measures (P < .007).

A total of 122 adverse events (AEs) overall were reported by 66 participants, but rates of AEs were comparable between the BZ and placebo groups at 55% vs. 46% respectively. There were 11 serious AEs reported by 10 participants. Only one of these was related to the study drug.

There were no statistically significant changes in amino acid concentrations between the two groups.

The authors note several limitations of the study, including the possibility that protective agents may need longer times than 12 weeks – possibly as long as 6 to 12 months – to show efficacy. Moreover, the dose of BZ needed to produce a response remains “uncertain.”

“Future clinical trials should restrict participants to those who are treatment refractory and should further investigate whether benzoate acts by altering amino acid levels or by reducing oxidative stress in people with schizophrenia,” the authors suggest.

Scott added that further research in patients with treatment-refractory schizophrenia is needed to determine whether BZ “has a role in this patient population.”

The authors conclude that at present, “the routine use of this agent as an adjunctive treatment for early psychosis is not recommended.”
 

No surprise?

Commenting on the study for Medscape Medical News, Kenji Hashimoto, PhD, Division of Clinical Neuroscience, Chiba University Center for Forensic Mental Health, Chiba, Japan, said that, although previous studies of BZ showed benefit in stable patients with chronic schizophrenia, “it is unlikely that [sodium] benzoate may have beneficial effects in the acute phase of psychosis.”

Hashimoto, who was not involved with the study, noted that BZ is a “weak DAAO inhibitor and that DAAO expression in the frontal cortex of human beings is very low.”

This project was supported by a John Cade Fellowship from the National Health and Medical Research Council and support from the Queensland Centre for Mental Health Research, which receives funding from the Queensland Health Department. Scott is supported by an NHMRC Practitioner Fellowship. The other authors’ disclosures are listed on the original article. Hashimoto has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.