MDedge Pediatrics

TOPLINE:

COVID-19 vaccines from Moderna and Pfizer-BioNTech are safe for children under age 5 years, according to findings from a study funded by the Centers for Disease Control and Prevention.

METHODOLOGY:

• Data came from the Vaccine Safety Datalink, which gathers information from eight health systems in the United States.
• Analyzed data from 135,005 doses given to children age 4 and younger who received the Pfizer-BioNTech , and 112,006 doses given to children aged 5 and younger who received the Moderna version.
• Assessed for 23 safety outcomes, including myocarditis, pericarditis, and seizures.

TAKEAWAY:

• None of the adverse outcomes, including myocarditis or pericarditis, was detected among the children in the 21 days following receipt of either vaccine.
• One case of hemorrhagic stroke and one case of pulmonary embolism occurred after vaccination but these were linked to preexisting congenital abnormalities.

IN PRACTICE:

“These results can provide reassurance to clinicians, parents, and policymakers alike.”

STUDY DETAILS:

The study was led by Kristin Goddard, MPH, a researcher at the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and was funded by the Centers for Disease Control and Prevention.

LIMITATIONS:

The researchers reported low statistical power for early analysis, especially for rare outcomes. In addition, fewer than 25% of children in the database had received a vaccine at the time of analysis.  

DISCLOSURES:

A coauthor reported receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. Another coauthor reported receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines, and from Merck, GSK, and Sanofi Pasteur for unrelated research.

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

TOPLINE:

COVID-19 vaccines from Moderna and Pfizer-BioNTech are safe for children under age 5 years, according to findings from a study funded by the Centers for Disease Control and Prevention.

METHODOLOGY:

• Data came from the Vaccine Safety Datalink, which gathers information from eight health systems in the United States.
• Analyzed data from 135,005 doses given to children age 4 and younger who received the Pfizer-BioNTech , and 112,006 doses given to children aged 5 and younger who received the Moderna version.
• Assessed for 23 safety outcomes, including myocarditis, pericarditis, and seizures.

TAKEAWAY:

• None of the adverse outcomes, including myocarditis or pericarditis, was detected among the children in the 21 days following receipt of either vaccine.
• One case of hemorrhagic stroke and one case of pulmonary embolism occurred after vaccination but these were linked to preexisting congenital abnormalities.

IN PRACTICE:

“These results can provide reassurance to clinicians, parents, and policymakers alike.”

STUDY DETAILS:

The study was led by Kristin Goddard, MPH, a researcher at the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and was funded by the Centers for Disease Control and Prevention.

LIMITATIONS:

The researchers reported low statistical power for early analysis, especially for rare outcomes. In addition, fewer than 25% of children in the database had received a vaccine at the time of analysis.  

DISCLOSURES:

A coauthor reported receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. Another coauthor reported receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines, and from Merck, GSK, and Sanofi Pasteur for unrelated research.

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

TOPLINE:

COVID-19 vaccines from Moderna and Pfizer-BioNTech are safe for children under age 5 years, according to findings from a study funded by the Centers for Disease Control and Prevention.

METHODOLOGY:

• Data came from the Vaccine Safety Datalink, which gathers information from eight health systems in the United States.
• Analyzed data from 135,005 doses given to children age 4 and younger who received the Pfizer-BioNTech , and 112,006 doses given to children aged 5 and younger who received the Moderna version.
• Assessed for 23 safety outcomes, including myocarditis, pericarditis, and seizures.

TAKEAWAY:

• None of the adverse outcomes, including myocarditis or pericarditis, was detected among the children in the 21 days following receipt of either vaccine.
• One case of hemorrhagic stroke and one case of pulmonary embolism occurred after vaccination but these were linked to preexisting congenital abnormalities.

IN PRACTICE:

“These results can provide reassurance to clinicians, parents, and policymakers alike.”

STUDY DETAILS:

The study was led by Kristin Goddard, MPH, a researcher at the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and was funded by the Centers for Disease Control and Prevention.

LIMITATIONS:

The researchers reported low statistical power for early analysis, especially for rare outcomes. In addition, fewer than 25% of children in the database had received a vaccine at the time of analysis.  

DISCLOSURES:

A coauthor reported receiving funding from Janssen Vaccines and Prevention for a study unrelated to COVID-19 vaccines. Another coauthor reported receiving grants from Pfizer in 2019 for clinical trials for coronavirus vaccines, and from Merck, GSK, and Sanofi Pasteur for unrelated research.

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

A new review drafted by three Canadian psychiatrists aims to help primary care physicians diagnose and manage depression in adolescents. 

Depression is common among Canadian adolescents and often goes unnoticed. Many family physicians report feeling unprepared to identify and manage depression in these patients.

“Depression is an increasingly common but treatable condition among adolescents,” the authors wrote. “Primary care physicians and pediatricians are well positioned to support the assessment and first-line management of depression in this group, helping patients to regain their health and function.”

The article was published in CMAJ.
 

Distinct presentation

More than 40% of cases of depression begin during childhood. Onset at this life stage is associated with worse severity of depression in adulthood and worse social, occupational, and physical health outcomes.

Depression is influenced by genetic and environmental factors. Family history of depression is associated with a three- to fivefold increased risk of depression among older children. Genetic loci are known to be associated with depression, but exposure to parental depression, adverse childhood experiences, and family conflict are also linked to greater risk. Bullying and stigma are associated with greater risk among lesbian, gay, bisexual, and transgender youth.

Compared with adults, adolescents with depression are more likely to be irritable and to have a labile mood, rather than a low mood. Social withdrawal is also more common among adolescents than among adults. Unusual features, such as hypersomnia and increased appetite, may also be present. Anxiety, somatic symptoms, psychomotor agitation, and hallucinations are more common in adolescents than in younger persons with depression. It is vital to assess risk of suicidality and self-injury as well as support systems, and validated scales such as the Columbia Suicide Severity Rating Scale can be useful.

There is no consensus as to whether universal screening for depression is beneficial among adolescents. “Screening in this age group may be a reasonable approach, however, when implemented together with adequate systems that ensure accurate diagnosis and appropriate follow-up,” wrote the authors.

Management of depression in adolescents should begin with psychoeducation and may include lifestyle modification, psychotherapy, and medication. “Importantly, a suicide risk assessment must be done to ensure appropriateness of an outpatient management plan and facilitate safety planning,” the authors wrote.

Lifestyle interventions may target physical activity, diet, and sleep, since unhealthy patterns in all three are associated with heightened symptoms of depression in this population. Regular moderate to vigorous physical activity, and perhaps physical activity of short duration, can improve mood in adolescents. Reduced consumption of sugar-sweetened drinks, processed foods, and meats, along with greater consumption of fruits and legumes, has been shown to reduce depressive symptoms in randomized, controlled trials with adults.

Among psychotherapeutic approaches, cognitive-behavioral therapy has shown the most evidence of efficacy among adolescents with depression, though it is less effective for those with more severe symptoms, poor coping skills, and nonsuicidal self-injury. Some evidence supports interpersonal therapy, which focuses on relationships and social functioning. The involvement of caregivers may improve the response, compared with psychotherapy that only includes the adolescent.

The authors recommend antidepressant medications in more severe cases or when psychotherapy is ineffective or impossible. Guidelines generally support trials with at least two SSRIs before switching to another drug class, since efficacy data for them are sparser, and other drugs have worse side effect profiles.

About 2% of adolescents with depression experience an increase in suicidal ideation and behavior after exposure to antidepressants, usually within the first weeks of initiation, so this potential risk should be discussed with patients and caregivers.
 

Clinicians feel unprepared

Commenting on the review, Pierre-Paul Tellier, MD, an associate professor of family medicine at McGill University, Montreal, said that clinicians frequently report that they do not feel confident in their ability to manage and diagnose adolescent depression. “We did two systematic reviews to look at the continuing professional development of family physicians in adolescent health, and it turned out that there’s really a very large lack. When we looked at residents and the training that they were getting in adolescent medicine, it was very similar, so they felt unprepared to deal with issues around mental health.”

Medication can be effective, but it can be seen as “an easy way out,” Dr. Tellier added. “It’s not necessarily an ideal plan. What we need to do is to change the person’s way of thinking, the person’s way of responding to a variety of things which will occur throughout their lives. People will have other transition periods in their lives. It’s best if they learn a variety of techniques to deal with depression.”

These techniques include exercise, relaxation methods [which reduce anxiety], and wellness training. Through such techniques, patients “learn a healthier way of living with themselves and who they are, and then this is a lifelong way of learning,” said Dr. Tellier. “If I give you a pill, what I’m teaching is, yes, you can feel better. But you’re not dealing with the problem, you’re just dealing with the symptoms.”

He frequently refers his patients to YouTube videos that outline and explain various strategies. A favorite is a deep breathing exercise presented by Jeremy Howick.

The authors and Dr. Tellier disclosed no relevant financial relationships.

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

A new review drafted by three Canadian psychiatrists aims to help primary care physicians diagnose and manage depression in adolescents. 

Depression is common among Canadian adolescents and often goes unnoticed. Many family physicians report feeling unprepared to identify and manage depression in these patients.

“Depression is an increasingly common but treatable condition among adolescents,” the authors wrote. “Primary care physicians and pediatricians are well positioned to support the assessment and first-line management of depression in this group, helping patients to regain their health and function.”

The article was published in CMAJ.
 

Distinct presentation

More than 40% of cases of depression begin during childhood. Onset at this life stage is associated with worse severity of depression in adulthood and worse social, occupational, and physical health outcomes.

Depression is influenced by genetic and environmental factors. Family history of depression is associated with a three- to fivefold increased risk of depression among older children. Genetic loci are known to be associated with depression, but exposure to parental depression, adverse childhood experiences, and family conflict are also linked to greater risk. Bullying and stigma are associated with greater risk among lesbian, gay, bisexual, and transgender youth.

Compared with adults, adolescents with depression are more likely to be irritable and to have a labile mood, rather than a low mood. Social withdrawal is also more common among adolescents than among adults. Unusual features, such as hypersomnia and increased appetite, may also be present. Anxiety, somatic symptoms, psychomotor agitation, and hallucinations are more common in adolescents than in younger persons with depression. It is vital to assess risk of suicidality and self-injury as well as support systems, and validated scales such as the Columbia Suicide Severity Rating Scale can be useful.

There is no consensus as to whether universal screening for depression is beneficial among adolescents. “Screening in this age group may be a reasonable approach, however, when implemented together with adequate systems that ensure accurate diagnosis and appropriate follow-up,” wrote the authors.

Management of depression in adolescents should begin with psychoeducation and may include lifestyle modification, psychotherapy, and medication. “Importantly, a suicide risk assessment must be done to ensure appropriateness of an outpatient management plan and facilitate safety planning,” the authors wrote.

Lifestyle interventions may target physical activity, diet, and sleep, since unhealthy patterns in all three are associated with heightened symptoms of depression in this population. Regular moderate to vigorous physical activity, and perhaps physical activity of short duration, can improve mood in adolescents. Reduced consumption of sugar-sweetened drinks, processed foods, and meats, along with greater consumption of fruits and legumes, has been shown to reduce depressive symptoms in randomized, controlled trials with adults.

Among psychotherapeutic approaches, cognitive-behavioral therapy has shown the most evidence of efficacy among adolescents with depression, though it is less effective for those with more severe symptoms, poor coping skills, and nonsuicidal self-injury. Some evidence supports interpersonal therapy, which focuses on relationships and social functioning. The involvement of caregivers may improve the response, compared with psychotherapy that only includes the adolescent.

The authors recommend antidepressant medications in more severe cases or when psychotherapy is ineffective or impossible. Guidelines generally support trials with at least two SSRIs before switching to another drug class, since efficacy data for them are sparser, and other drugs have worse side effect profiles.

About 2% of adolescents with depression experience an increase in suicidal ideation and behavior after exposure to antidepressants, usually within the first weeks of initiation, so this potential risk should be discussed with patients and caregivers.
 

Clinicians feel unprepared

Commenting on the review, Pierre-Paul Tellier, MD, an associate professor of family medicine at McGill University, Montreal, said that clinicians frequently report that they do not feel confident in their ability to manage and diagnose adolescent depression. “We did two systematic reviews to look at the continuing professional development of family physicians in adolescent health, and it turned out that there’s really a very large lack. When we looked at residents and the training that they were getting in adolescent medicine, it was very similar, so they felt unprepared to deal with issues around mental health.”

Medication can be effective, but it can be seen as “an easy way out,” Dr. Tellier added. “It’s not necessarily an ideal plan. What we need to do is to change the person’s way of thinking, the person’s way of responding to a variety of things which will occur throughout their lives. People will have other transition periods in their lives. It’s best if they learn a variety of techniques to deal with depression.”

These techniques include exercise, relaxation methods [which reduce anxiety], and wellness training. Through such techniques, patients “learn a healthier way of living with themselves and who they are, and then this is a lifelong way of learning,” said Dr. Tellier. “If I give you a pill, what I’m teaching is, yes, you can feel better. But you’re not dealing with the problem, you’re just dealing with the symptoms.”

He frequently refers his patients to YouTube videos that outline and explain various strategies. A favorite is a deep breathing exercise presented by Jeremy Howick.

The authors and Dr. Tellier disclosed no relevant financial relationships.

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

A new review drafted by three Canadian psychiatrists aims to help primary care physicians diagnose and manage depression in adolescents. 

Depression is common among Canadian adolescents and often goes unnoticed. Many family physicians report feeling unprepared to identify and manage depression in these patients.

“Depression is an increasingly common but treatable condition among adolescents,” the authors wrote. “Primary care physicians and pediatricians are well positioned to support the assessment and first-line management of depression in this group, helping patients to regain their health and function.”

The article was published in CMAJ.
 

Distinct presentation

More than 40% of cases of depression begin during childhood. Onset at this life stage is associated with worse severity of depression in adulthood and worse social, occupational, and physical health outcomes.

Depression is influenced by genetic and environmental factors. Family history of depression is associated with a three- to fivefold increased risk of depression among older children. Genetic loci are known to be associated with depression, but exposure to parental depression, adverse childhood experiences, and family conflict are also linked to greater risk. Bullying and stigma are associated with greater risk among lesbian, gay, bisexual, and transgender youth.

Compared with adults, adolescents with depression are more likely to be irritable and to have a labile mood, rather than a low mood. Social withdrawal is also more common among adolescents than among adults. Unusual features, such as hypersomnia and increased appetite, may also be present. Anxiety, somatic symptoms, psychomotor agitation, and hallucinations are more common in adolescents than in younger persons with depression. It is vital to assess risk of suicidality and self-injury as well as support systems, and validated scales such as the Columbia Suicide Severity Rating Scale can be useful.

There is no consensus as to whether universal screening for depression is beneficial among adolescents. “Screening in this age group may be a reasonable approach, however, when implemented together with adequate systems that ensure accurate diagnosis and appropriate follow-up,” wrote the authors.

Management of depression in adolescents should begin with psychoeducation and may include lifestyle modification, psychotherapy, and medication. “Importantly, a suicide risk assessment must be done to ensure appropriateness of an outpatient management plan and facilitate safety planning,” the authors wrote.

Lifestyle interventions may target physical activity, diet, and sleep, since unhealthy patterns in all three are associated with heightened symptoms of depression in this population. Regular moderate to vigorous physical activity, and perhaps physical activity of short duration, can improve mood in adolescents. Reduced consumption of sugar-sweetened drinks, processed foods, and meats, along with greater consumption of fruits and legumes, has been shown to reduce depressive symptoms in randomized, controlled trials with adults.

Among psychotherapeutic approaches, cognitive-behavioral therapy has shown the most evidence of efficacy among adolescents with depression, though it is less effective for those with more severe symptoms, poor coping skills, and nonsuicidal self-injury. Some evidence supports interpersonal therapy, which focuses on relationships and social functioning. The involvement of caregivers may improve the response, compared with psychotherapy that only includes the adolescent.

The authors recommend antidepressant medications in more severe cases or when psychotherapy is ineffective or impossible. Guidelines generally support trials with at least two SSRIs before switching to another drug class, since efficacy data for them are sparser, and other drugs have worse side effect profiles.

About 2% of adolescents with depression experience an increase in suicidal ideation and behavior after exposure to antidepressants, usually within the first weeks of initiation, so this potential risk should be discussed with patients and caregivers.
 

Clinicians feel unprepared

Commenting on the review, Pierre-Paul Tellier, MD, an associate professor of family medicine at McGill University, Montreal, said that clinicians frequently report that they do not feel confident in their ability to manage and diagnose adolescent depression. “We did two systematic reviews to look at the continuing professional development of family physicians in adolescent health, and it turned out that there’s really a very large lack. When we looked at residents and the training that they were getting in adolescent medicine, it was very similar, so they felt unprepared to deal with issues around mental health.”

Medication can be effective, but it can be seen as “an easy way out,” Dr. Tellier added. “It’s not necessarily an ideal plan. What we need to do is to change the person’s way of thinking, the person’s way of responding to a variety of things which will occur throughout their lives. People will have other transition periods in their lives. It’s best if they learn a variety of techniques to deal with depression.”

These techniques include exercise, relaxation methods [which reduce anxiety], and wellness training. Through such techniques, patients “learn a healthier way of living with themselves and who they are, and then this is a lifelong way of learning,” said Dr. Tellier. “If I give you a pill, what I’m teaching is, yes, you can feel better. But you’re not dealing with the problem, you’re just dealing with the symptoms.”

He frequently refers his patients to YouTube videos that outline and explain various strategies. A favorite is a deep breathing exercise presented by Jeremy Howick.

The authors and Dr. Tellier disclosed no relevant financial relationships.

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

Suicide risk in young people appears to follow a diurnal pattern, increasing at night, new research shows.

Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.

“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.

The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
 

Urgent need

Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.

“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.

The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.

More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).

They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.

They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.

As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).

There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
 

True variation or mechanics?

Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”

Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”

The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.

“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
 

A vulnerable time

Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.

Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.

“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.

Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.

“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.

These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.

“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.

The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.

Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.

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

Suicide risk in young people appears to follow a diurnal pattern, increasing at night, new research shows.

Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.

“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.

The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
 

Urgent need

Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.

“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.

The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.

More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).

They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.

They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.

As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).

There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
 

True variation or mechanics?

Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”

Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”

The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.

“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
 

A vulnerable time

Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.

Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.

“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.

Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.

“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.

These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.

“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.

The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.

Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.

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

Suicide risk in young people appears to follow a diurnal pattern, increasing at night, new research shows.

Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.

“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.

The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
 

Urgent need

Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.

“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.

The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.

More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).

They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.

They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.

As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).

There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
 

True variation or mechanics?

Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”

Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”

The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.

“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
 

A vulnerable time

Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.

Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.

“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.

Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.

“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.

These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.

“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.

The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.

Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.

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

The once-weekly growth hormone analog somapacitan (Sogroya, Novo Nordisk) has been given the green light in both Europe and the United States for the treatment of children and adolescents with growth failure due to growth hormone deficiency.

On May 26, the European Medicine Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the product for replacement of endogenous growth hormone in children aged 3 years and older.   

That decision followed the Food and Drug Administration’s approval in April of the new indication for somapacitan injection in 5 mg, 10 mg, or 15 mg doses for children aged 2.5 years and older. The FDA approved the treatment for adults with growth hormone deficiency in September 2020.

Growth hormone deficiency is estimated to affect between 1 in 3,500 to 1 in 10,000 children. If left untreated, the condition can lead to shortened stature, reduced bone mineral density, and delayed appearance of teeth.

The European and American regulatory decisions were based on data from the phase 3 multinational REAL4 trial, published in the Journal of Clinical Endocrinology & Metabolism, in 200 prepubertal children with growth hormone deficiency randomly assigned 2:1 to weekly subcutaneous somapacitan or daily somatropin. At 52 weeks, height velocity was 11.2 cm/year with the once-weekly drug, compared with 11.7 cm/year with daily somatropin, a nonsignificant difference.

There were no major differences between the drugs in safety or tolerability. Adverse reactions in the REAL4 study that occurred in more than 5% of patients included nasopharyngitis, headache, pyrexia, extremity pain, and injection site reactions. A 3-year extension trial is ongoing.

The European Commission is expected to make a final decision in the coming months, and if approved somapacitan will be available in some European countries beginning in late 2023.

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

The once-weekly growth hormone analog somapacitan (Sogroya, Novo Nordisk) has been given the green light in both Europe and the United States for the treatment of children and adolescents with growth failure due to growth hormone deficiency.

On May 26, the European Medicine Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the product for replacement of endogenous growth hormone in children aged 3 years and older.   

That decision followed the Food and Drug Administration’s approval in April of the new indication for somapacitan injection in 5 mg, 10 mg, or 15 mg doses for children aged 2.5 years and older. The FDA approved the treatment for adults with growth hormone deficiency in September 2020.

Growth hormone deficiency is estimated to affect between 1 in 3,500 to 1 in 10,000 children. If left untreated, the condition can lead to shortened stature, reduced bone mineral density, and delayed appearance of teeth.

The European and American regulatory decisions were based on data from the phase 3 multinational REAL4 trial, published in the Journal of Clinical Endocrinology & Metabolism, in 200 prepubertal children with growth hormone deficiency randomly assigned 2:1 to weekly subcutaneous somapacitan or daily somatropin. At 52 weeks, height velocity was 11.2 cm/year with the once-weekly drug, compared with 11.7 cm/year with daily somatropin, a nonsignificant difference.

There were no major differences between the drugs in safety or tolerability. Adverse reactions in the REAL4 study that occurred in more than 5% of patients included nasopharyngitis, headache, pyrexia, extremity pain, and injection site reactions. A 3-year extension trial is ongoing.

The European Commission is expected to make a final decision in the coming months, and if approved somapacitan will be available in some European countries beginning in late 2023.

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

The once-weekly growth hormone analog somapacitan (Sogroya, Novo Nordisk) has been given the green light in both Europe and the United States for the treatment of children and adolescents with growth failure due to growth hormone deficiency.

On May 26, the European Medicine Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the product for replacement of endogenous growth hormone in children aged 3 years and older.   

That decision followed the Food and Drug Administration’s approval in April of the new indication for somapacitan injection in 5 mg, 10 mg, or 15 mg doses for children aged 2.5 years and older. The FDA approved the treatment for adults with growth hormone deficiency in September 2020.

Growth hormone deficiency is estimated to affect between 1 in 3,500 to 1 in 10,000 children. If left untreated, the condition can lead to shortened stature, reduced bone mineral density, and delayed appearance of teeth.

The European and American regulatory decisions were based on data from the phase 3 multinational REAL4 trial, published in the Journal of Clinical Endocrinology & Metabolism, in 200 prepubertal children with growth hormone deficiency randomly assigned 2:1 to weekly subcutaneous somapacitan or daily somatropin. At 52 weeks, height velocity was 11.2 cm/year with the once-weekly drug, compared with 11.7 cm/year with daily somatropin, a nonsignificant difference.

There were no major differences between the drugs in safety or tolerability. Adverse reactions in the REAL4 study that occurred in more than 5% of patients included nasopharyngitis, headache, pyrexia, extremity pain, and injection site reactions. A 3-year extension trial is ongoing.

The European Commission is expected to make a final decision in the coming months, and if approved somapacitan will be available in some European countries beginning in late 2023.

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

The European Commission has approved secukinumab (Cosentyx) as a treatment for adults with active, moderate to severe hidradenitis suppurativa (HS) that didn’t respond to conventional therapy.

The biologic is the first interleukin-17A (IL-17A) inhibitor to be approved for the treatment of moderate to severe HS. The manufacturer, Novartis, expects a regulatory decision from the U.S. Food and Drug Administration later this year, according to a company press release announcing the approval.

The European approval is based on the results from the phase 3 SUNSHINE and SUNRISE trials, which evaluated the efficacy, safety, and tolerability of the drug. The multicenter, randomized, placebo-controlled, double-blind trials enrolled a total of more than 1,000 adults with moderate to severe HS.

Patients were randomly assigned either to receive subcutaneous secukinumab 300 mg every 2 weeks or 4 weeks or to receive placebo. The treatment was effective at improving the symptoms of HS when given every 2 weeks, according to results recently published in The Lancet.

The primary outcome measure for both trials was HS clinical response – defined as a decrease in abscess and inflammatory nodule count by 50% or more with no increase in the number of abscesses or draining fistulae, compared with baseline.

In the studies, 42% and 45% of patients treated with secukinumab every 2 weeks in the SUNRISE and SUNSHINE trials, respectively, had a clinical response at 16 weeks, compared with 31% and 34% among those who received placebo, which were statistically significant differences. A significant clinical response was seen at week 4 in the SUNSHINE trial and in week 2 in the SUNRISE trial. In both trials, clinical efficacy was sustained to the end of the trial, at week 52.

Headaches were the most common side effect. They affected approximately 1 in 10 patients in both trials.

HS, also called acne inversa, is a chronic skin condition that causes painful lesions. The condition affects 1%- 2% of the U.S. population, according to the nonprofit Hidradenitis Suppurativa Foundation. It also disproportionately affects young adults, women, and Black patients.

In Europe, about 200,000 people live with moderate to severe stages of the condition, according to the Novartis press release.

Secukinumab inhibits IL-17A, a cytokine involved in the inflammation of psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondylarthritis. It has been approved for the treatment of those conditions, as well as for the treatment of juvenile idiopathic arthritis and enthesitis-related arthritis in the United States and the European Union.

The only other approved biologic therapy for HS is the tumor necrosis factor inhibitor adalimumab.

Novartis is investigating the potential application of secukinumab for the treatment of lupus nephritis and giant cell arteritis, as well as polymyalgia rheumatica and rotator cuff tendinopathy, according to the company press release.

The study published in The Lancet was funded by Novartis.

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

The European Commission has approved secukinumab (Cosentyx) as a treatment for adults with active, moderate to severe hidradenitis suppurativa (HS) that didn’t respond to conventional therapy.

The biologic is the first interleukin-17A (IL-17A) inhibitor to be approved for the treatment of moderate to severe HS. The manufacturer, Novartis, expects a regulatory decision from the U.S. Food and Drug Administration later this year, according to a company press release announcing the approval.

The European approval is based on the results from the phase 3 SUNSHINE and SUNRISE trials, which evaluated the efficacy, safety, and tolerability of the drug. The multicenter, randomized, placebo-controlled, double-blind trials enrolled a total of more than 1,000 adults with moderate to severe HS.

Patients were randomly assigned either to receive subcutaneous secukinumab 300 mg every 2 weeks or 4 weeks or to receive placebo. The treatment was effective at improving the symptoms of HS when given every 2 weeks, according to results recently published in The Lancet.

The primary outcome measure for both trials was HS clinical response – defined as a decrease in abscess and inflammatory nodule count by 50% or more with no increase in the number of abscesses or draining fistulae, compared with baseline.

In the studies, 42% and 45% of patients treated with secukinumab every 2 weeks in the SUNRISE and SUNSHINE trials, respectively, had a clinical response at 16 weeks, compared with 31% and 34% among those who received placebo, which were statistically significant differences. A significant clinical response was seen at week 4 in the SUNSHINE trial and in week 2 in the SUNRISE trial. In both trials, clinical efficacy was sustained to the end of the trial, at week 52.

Headaches were the most common side effect. They affected approximately 1 in 10 patients in both trials.

HS, also called acne inversa, is a chronic skin condition that causes painful lesions. The condition affects 1%- 2% of the U.S. population, according to the nonprofit Hidradenitis Suppurativa Foundation. It also disproportionately affects young adults, women, and Black patients.

In Europe, about 200,000 people live with moderate to severe stages of the condition, according to the Novartis press release.

Secukinumab inhibits IL-17A, a cytokine involved in the inflammation of psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondylarthritis. It has been approved for the treatment of those conditions, as well as for the treatment of juvenile idiopathic arthritis and enthesitis-related arthritis in the United States and the European Union.

The only other approved biologic therapy for HS is the tumor necrosis factor inhibitor adalimumab.

Novartis is investigating the potential application of secukinumab for the treatment of lupus nephritis and giant cell arteritis, as well as polymyalgia rheumatica and rotator cuff tendinopathy, according to the company press release.

The study published in The Lancet was funded by Novartis.

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

The European Commission has approved secukinumab (Cosentyx) as a treatment for adults with active, moderate to severe hidradenitis suppurativa (HS) that didn’t respond to conventional therapy.

The biologic is the first interleukin-17A (IL-17A) inhibitor to be approved for the treatment of moderate to severe HS. The manufacturer, Novartis, expects a regulatory decision from the U.S. Food and Drug Administration later this year, according to a company press release announcing the approval.

The European approval is based on the results from the phase 3 SUNSHINE and SUNRISE trials, which evaluated the efficacy, safety, and tolerability of the drug. The multicenter, randomized, placebo-controlled, double-blind trials enrolled a total of more than 1,000 adults with moderate to severe HS.

Patients were randomly assigned either to receive subcutaneous secukinumab 300 mg every 2 weeks or 4 weeks or to receive placebo. The treatment was effective at improving the symptoms of HS when given every 2 weeks, according to results recently published in The Lancet.

The primary outcome measure for both trials was HS clinical response – defined as a decrease in abscess and inflammatory nodule count by 50% or more with no increase in the number of abscesses or draining fistulae, compared with baseline.

In the studies, 42% and 45% of patients treated with secukinumab every 2 weeks in the SUNRISE and SUNSHINE trials, respectively, had a clinical response at 16 weeks, compared with 31% and 34% among those who received placebo, which were statistically significant differences. A significant clinical response was seen at week 4 in the SUNSHINE trial and in week 2 in the SUNRISE trial. In both trials, clinical efficacy was sustained to the end of the trial, at week 52.

Headaches were the most common side effect. They affected approximately 1 in 10 patients in both trials.

HS, also called acne inversa, is a chronic skin condition that causes painful lesions. The condition affects 1%- 2% of the U.S. population, according to the nonprofit Hidradenitis Suppurativa Foundation. It also disproportionately affects young adults, women, and Black patients.

In Europe, about 200,000 people live with moderate to severe stages of the condition, according to the Novartis press release.

Secukinumab inhibits IL-17A, a cytokine involved in the inflammation of psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and nonradiographic axial spondylarthritis. It has been approved for the treatment of those conditions, as well as for the treatment of juvenile idiopathic arthritis and enthesitis-related arthritis in the United States and the European Union.

The only other approved biologic therapy for HS is the tumor necrosis factor inhibitor adalimumab.

Novartis is investigating the potential application of secukinumab for the treatment of lupus nephritis and giant cell arteritis, as well as polymyalgia rheumatica and rotator cuff tendinopathy, according to the company press release.

The study published in The Lancet was funded by Novartis.

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

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.

WASHINGTON – The LIBERTY AD open-label extension study of dupilumab is closing after 5 years with the small number of remaining patients showing stable and sustained improvements in skin lesions and pruritus and no new emergent side effects, Lisa Beck, MD, reported during a late-breaking session at the annual Revolutionizing Atopic Dermatitis conference.

Other recent research on the biologic has shown that it improves lesional skin barrier function and rapidly reduces the abundance of Staphylococcus aureus on lesional skin, Dr. Beck, professor of dermatology at the University of Rochester (N.Y.), said during another session at the meeting on long-term control of AD. Dr. Beck directs a laboratory at the University of Rochester Medical Center that focuses on understanding AD and is involved in the National Institute of Allergy and Infectious Diseases (NIAID)-funded Atopic Dermatitis Research Network (ADRN).

The LIBERTY AD open-label extension (OLE) study was a phase 3 trial of 2,677 adults with moderate to severe AD who had participated in previous dupilumab clinical trials and were treated with 300 mg dupilumab weekly or every other week. Concomitant treatments were permitted, including topical corticosteroids and topical calcineurin inhibitors. (The proportion of patients dosed on an every-other-week or weekly dosing schedule was not available.)

Of 334 patients (12.5%) who remained in the trial at week 260, or 5 years, 88.9% achieved at least a 75% improvement in lesion extent and severity (Eczema Area and Severity Index [EASI]-75), and 76.2% achieved an EASI-90. The proportion achieving at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (NRS) or a score of 0 was 66.5%. At 5 years, improvements “seem very stable,” with “no loss in efficacy,” Dr. Beck said.

The majority of patients who withdrew from the open-label extension trial did so because the study was terminated at their site or because of the drug’s approval and commercialization – not for a medical reason, Dr. Beck said. Over the course of the extension trial, 4% of those enrolled withdrew because of adverse events and about 2% withdrew because of lack of efficacy.

Safety of dupilumab

The extension trial lacked a control arm, so Dr. Beck and her colleagues compared safety results to those in the final data set for patients in the LIBERTY AD CHRONOS study who received dupilumab 300 mg weekly with concomitant corticosteroids. The CHRONOS study was a 1-year randomized, double-blinded placebo-controlled phase 3 trial.

The exposure-adjusted incidence rate of severe treatment-emergent adverse events (TEAE) was lower at the close of the extension trial (5 patients/100 patient years [PY]) than at the end of the CHRONOS study (5.9 patients/100 PY). The incidence of serious adverse events related to treatment was 0.6 patients/100 PY in the final open label extension study data set, compared with 0.7 patients/100 PY in the CHRONOS final data set.

Adverse event rates “are really, if anything, slightly less in the OLE study versus the CHRONOS study, which was 1 year of treatment,” Dr. Beck said. And “no new adverse events have emerged.”

During a question and answer period, Dr. Beck pointed out that existing and future “real world” registries of patients on dupilumab and other new therapies will better inform dermatologists of adverse events than clinical trials have done.
 

Ocular surface disease

In a separate presentation on the safety of biologics, Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, Portland, said that in routine care, ocular surface disease is the most predominant side effect associated with dupilumab. “We don’t know the mechanism of action. But it’s not infectious, it’s not pink eye, and importantly, it’s not allergic conjunctivitis,” he said, noting that the spectrum of disease ranges from dry eye and eye itching to “frank conjunctivitis” and keratitis.

Most cases are mild to moderate and can often be managed with lubricating eye drops and periodic use of corticosteroid eye drops. Co-management with an ophthalmologist is often advisable, he said.

Dupilumab-associated erythema/eczema of the face was “not seen much” in clinical trials but is also being reported in the literature, largely by European researchers, Dr. Blauvelt said. “We hear a lot about red face, but I don’t think it’s much of an issue,” he said. “Most of the time, in my experience, it will [reflect] breakthrough residual AD, and I like to treat it with non-steroidal topicals.”

Occasionally, the withdrawal of steroids or allergic contact dermatitis are at play, Dr. Blauvelt said. “If you see red face in a person on dupilumab, use your clinical prowess, do a differential diagnosis, and treat accordingly.”
 

Effect on S. aureus

The vast majority of adults with moderate to severe AD have skin colonization with S. aureus, Dr. Beck said during the session on long-term control of AD. The presence of S. aureus in skin cultures correlates strongly with AD severity, type 2 immunity polarization, skin barrier disruption, and allergen sensitization, she said.

“So if we could do something to get rid of the staph and keep it away, one might imagine that would help” control the AD disease process, she said.

An ADRN study evaluated S. aureus in the skin of 71 patients who were randomized to receive dupilumab or placebo and found a “profound” effect of the biologic. “We were truly shocked by how quickly we saw a reduction in Staph aureus ... in lesional skin as early as 3 days” into treatment with dupilumab, she said of the unpublished findings. “And there is a pretty nice association with improvement in disease severity.”

Dr. Beck reported consultancy/advisory board work with Regeneron, Sanofi/Genzyme, among other disclosures. Dr. Blauvelt reported consultancy/advisory board work for Regeneron and Sanofi Genzyme and has received speakers bureau/honoraria for non-CME work for Regeneron and Sanofi, among other disclosures.

While physicians are getting less of a Medicare pay cut than they thought this year (Congress voted to cut Medicare payments by 2%, which was less than the expected 8.5%), Medicare still pays physicians only 80% of what many third-party insurers pay.

Moreover, those reimbursements are often slow to arrive, and the paperwork is burdensome. In fact, about 65% of doctors won’t accept new Medicare patients, down from 71% just 5 years ago, according to the Medscape Physician Compensation Report 2023.

Worse, inflation makes continuous cuts feel even steeper and trickles down to physicians and their patients as more and more doctors become disenchanted and consider dropping Medicare.
 

Medicare at a glance

Medicare pays physicians about 80% of the “reasonable charge” for covered services. At the same time, private insurers pay nearly double Medicare rates for hospital services.

The Medicare fee schedule is released each year. Physicians who accept Medicare can choose to be a “participating provider” by agreeing to the fee schedule and to not charging more than this amount. “Nonparticipating” providers can charge up to 15% more. Physicians can also opt out of Medicare entirely.

The earliest that physicians receive their payment is 14 days after electronic filing to 28 days after paper filing, but it often can take months.

Physicians lose an estimated 7.3% of Medicare claims to billing problems. With private insurers, an estimated 4.8% is lost.

In 2000, there were 50 million Medicare enrollees; it is projected that by 2050, there will be 87 million enrollees.
 

Why are doctors disenchanted?

“When Medicare started, the concept of the program was good,” said Rahul Gupta, MD, a geriatrician in Westport, Conn., and chief of internal medicine at St. Vincent’s Medical Center, Bridgeport, Conn. “However, over the years, with new developments in medicine and the explosion of the Medicare-eligible population, the program hasn’t kept up with coverages.” In addition, Medicare’s behemoth power as a government-run agency has ramifications that trickle down irrespective of a patient’s insurance carrier.

“Medicare sets the tone on price and reimbursement, and everyone follows suit,” Dr. Gupta said. “It’s a race to the bottom.”

“The program is great for patients when people need hospitalizations, skilled nursing, and physical therapy,” Dr. Gupta said. “But it’s not great about keeping people healthier and maintaining function via preventive treatments.” Many private insurers must become more adept at that too.

For instance, Dr. Gupta laments the lack of coverage for hearing aids, something his patients could greatly benefit from. Thanks to the Build Back Better bill, coverage of hearing aids will begin in 2024. But, again, most private insurers don’t cover hearing aids either. Some Medicare Advantage plans do.

Medicare doesn’t cover eye health (except for eye exams for diabetes patients), which is an issue for Daniel Laroche, MD, a glaucoma specialist and clinical associate professor of ophthalmology at Mount Sinai Medical Center, New York.

“I get paid less for Medicare patients by about 20% because of ‘lesser-of’ payments,” said Dr. Laroche. For example, as per Medicare, after patients meet their Part B deductible, they pay 20% of the Medicare-approved amount for glaucoma testing. “It would be nice to get the full amount for Medicare patients.”

“In addition, getting approvals for testing takes time and exhaustive amounts of paperwork, says Adeeti Gupta, MD, a gynecologist and founder of Walk In GYN Care in New York.

“Medicare only covers gynecologist visits every 2 years after the age of 65,” she said. “Any additional testing requires authorization, and Medicare doesn’t cover hormone replacement at all, which really makes me crazy. They will cover Viagra for men, but they won’t cover HRT, which prolongs life, reduces dementia, and prevents bone loss.”

While these three doctors find Medicare lacking in its coverage of their specialty, and their reimbursements are too low, many physicians also find fault regarding Medicare billing, which can put their patients at risk.
 

The problem with Medicare billing

Because claims are processed by Medicare administrative contractors, it can take about a month for the approval or denial process and for doctors to receive reimbursement.

Prior authorizations, especially with Medicare Advantage plans, are also problematic. For example, one 2022 study found that 18% of payment denials were for services that met coverage and billing rules.

Worse, all of this jockeying for coverage takes time. The average health care provider spends 16.4 hours a week on paperwork and on securing prior authorizations to cover services, according to the American Medical Association.

“A good 40% of my time is exclusively Medicare red tape paperwork,” Rahul Gupta says. “There’s a reason I spend 2-3 hours a night catching up on that stuff.”

Not only does this lead to burnout, but it also means that most physicians must hire an administrator to help with the paperwork.

In comparison, industry averages put the denial rate for all Medicare and private insurance claims at 20%.

“Excessive authorization controls required by health insurers are persistently responsible for serious harm to physician practices and patients when necessary medical care is delayed, denied, or disrupted in an attempt to increase profits,” Dr. Laroche said.

“Our office spends nearly 2 days per week on prior authorizations, creating costly administrative burdens.”

For Adeeti Gupta, the frustrations with Medicare have continued to mount. “We’re just at a dead end,” she said. “Authorizations keep getting denied, and the back-end paperwork is only increasing for us.”
 

Will more doctors opt out of Medicare?

When doctors don’t accept Medicare, it hurts the patients using it, especially patients who have selected either a Medicare Advantage plan or who become eligible for Medicare at age 65 only to find that fewer doctors take the government-sponsored insurance than in the past.

As of 2020, only 1% of nonpediatric physicians had formally opted out, per the Centers for Medicare & Medicaid Services. Psychiatrists account for the largest share of opt-outs (7.2%).

“Unfortunately, most doctors outside of hospital-based practices will reach a point when they can’t deal with Medicare paperwork, so they’ll stop taking it,” Rahul Gupta says.

A coalition of 120 physicians’ groups, including the American Medical Association, disputes that Medicare is paying a fair reimbursement rate to physicians and calls for an overhaul in how they adjust physician pay.

“Nothing much changes no matter how much the AMA shouts,” Rahul Gupta said in an interview.
 

What can doctors do

Prescription prices are another example of the challenges posed by Medicare. When prescriptions are denied because of Medicare’s medigap (or donut hole) program, which puts a cap on medication coverage, which was $4,660 in 2023, Dr. Gupta says she turns to alternative ways to fill them.

“I’ve been telling patients to pay out of pocket and use GoodRx, or we get medications compounded,” she said. “That’s cheaper. For example, for HRT, GoodRx can bring down the cost 40% to 50%.”

The American Medical Association as well as 150 other medical advocacy groups continue to urge Congress to work with the physician community to address the systematic problems within Medicare, especially reimbursement.

Despite the daily challenges, Rahul Gupta says he remains committed to caring for his patients.

“I want to care for the elderly, especially because they already have very few physicians to take care of them, and fortunately, I have a good practice with other coverages,” he said. “I can’t give up.”

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

While physicians are getting less of a Medicare pay cut than they thought this year (Congress voted to cut Medicare payments by 2%, which was less than the expected 8.5%), Medicare still pays physicians only 80% of what many third-party insurers pay.

Moreover, those reimbursements are often slow to arrive, and the paperwork is burdensome. In fact, about 65% of doctors won’t accept new Medicare patients, down from 71% just 5 years ago, according to the Medscape Physician Compensation Report 2023.

Worse, inflation makes continuous cuts feel even steeper and trickles down to physicians and their patients as more and more doctors become disenchanted and consider dropping Medicare.
 

Medicare at a glance

Medicare pays physicians about 80% of the “reasonable charge” for covered services. At the same time, private insurers pay nearly double Medicare rates for hospital services.

The Medicare fee schedule is released each year. Physicians who accept Medicare can choose to be a “participating provider” by agreeing to the fee schedule and to not charging more than this amount. “Nonparticipating” providers can charge up to 15% more. Physicians can also opt out of Medicare entirely.

The earliest that physicians receive their payment is 14 days after electronic filing to 28 days after paper filing, but it often can take months.

Physicians lose an estimated 7.3% of Medicare claims to billing problems. With private insurers, an estimated 4.8% is lost.

In 2000, there were 50 million Medicare enrollees; it is projected that by 2050, there will be 87 million enrollees.
 

Why are doctors disenchanted?

“When Medicare started, the concept of the program was good,” said Rahul Gupta, MD, a geriatrician in Westport, Conn., and chief of internal medicine at St. Vincent’s Medical Center, Bridgeport, Conn. “However, over the years, with new developments in medicine and the explosion of the Medicare-eligible population, the program hasn’t kept up with coverages.” In addition, Medicare’s behemoth power as a government-run agency has ramifications that trickle down irrespective of a patient’s insurance carrier.

“Medicare sets the tone on price and reimbursement, and everyone follows suit,” Dr. Gupta said. “It’s a race to the bottom.”

“The program is great for patients when people need hospitalizations, skilled nursing, and physical therapy,” Dr. Gupta said. “But it’s not great about keeping people healthier and maintaining function via preventive treatments.” Many private insurers must become more adept at that too.

For instance, Dr. Gupta laments the lack of coverage for hearing aids, something his patients could greatly benefit from. Thanks to the Build Back Better bill, coverage of hearing aids will begin in 2024. But, again, most private insurers don’t cover hearing aids either. Some Medicare Advantage plans do.

Medicare doesn’t cover eye health (except for eye exams for diabetes patients), which is an issue for Daniel Laroche, MD, a glaucoma specialist and clinical associate professor of ophthalmology at Mount Sinai Medical Center, New York.

“I get paid less for Medicare patients by about 20% because of ‘lesser-of’ payments,” said Dr. Laroche. For example, as per Medicare, after patients meet their Part B deductible, they pay 20% of the Medicare-approved amount for glaucoma testing. “It would be nice to get the full amount for Medicare patients.”

“In addition, getting approvals for testing takes time and exhaustive amounts of paperwork, says Adeeti Gupta, MD, a gynecologist and founder of Walk In GYN Care in New York.

“Medicare only covers gynecologist visits every 2 years after the age of 65,” she said. “Any additional testing requires authorization, and Medicare doesn’t cover hormone replacement at all, which really makes me crazy. They will cover Viagra for men, but they won’t cover HRT, which prolongs life, reduces dementia, and prevents bone loss.”

While these three doctors find Medicare lacking in its coverage of their specialty, and their reimbursements are too low, many physicians also find fault regarding Medicare billing, which can put their patients at risk.
 

The problem with Medicare billing

Because claims are processed by Medicare administrative contractors, it can take about a month for the approval or denial process and for doctors to receive reimbursement.

Prior authorizations, especially with Medicare Advantage plans, are also problematic. For example, one 2022 study found that 18% of payment denials were for services that met coverage and billing rules.

Worse, all of this jockeying for coverage takes time. The average health care provider spends 16.4 hours a week on paperwork and on securing prior authorizations to cover services, according to the American Medical Association.

“A good 40% of my time is exclusively Medicare red tape paperwork,” Rahul Gupta says. “There’s a reason I spend 2-3 hours a night catching up on that stuff.”

Not only does this lead to burnout, but it also means that most physicians must hire an administrator to help with the paperwork.

In comparison, industry averages put the denial rate for all Medicare and private insurance claims at 20%.

“Excessive authorization controls required by health insurers are persistently responsible for serious harm to physician practices and patients when necessary medical care is delayed, denied, or disrupted in an attempt to increase profits,” Dr. Laroche said.

“Our office spends nearly 2 days per week on prior authorizations, creating costly administrative burdens.”

For Adeeti Gupta, the frustrations with Medicare have continued to mount. “We’re just at a dead end,” she said. “Authorizations keep getting denied, and the back-end paperwork is only increasing for us.”
 

Will more doctors opt out of Medicare?

When doctors don’t accept Medicare, it hurts the patients using it, especially patients who have selected either a Medicare Advantage plan or who become eligible for Medicare at age 65 only to find that fewer doctors take the government-sponsored insurance than in the past.

As of 2020, only 1% of nonpediatric physicians had formally opted out, per the Centers for Medicare & Medicaid Services. Psychiatrists account for the largest share of opt-outs (7.2%).

“Unfortunately, most doctors outside of hospital-based practices will reach a point when they can’t deal with Medicare paperwork, so they’ll stop taking it,” Rahul Gupta says.

A coalition of 120 physicians’ groups, including the American Medical Association, disputes that Medicare is paying a fair reimbursement rate to physicians and calls for an overhaul in how they adjust physician pay.

“Nothing much changes no matter how much the AMA shouts,” Rahul Gupta said in an interview.
 

What can doctors do

Prescription prices are another example of the challenges posed by Medicare. When prescriptions are denied because of Medicare’s medigap (or donut hole) program, which puts a cap on medication coverage, which was $4,660 in 2023, Dr. Gupta says she turns to alternative ways to fill them.

“I’ve been telling patients to pay out of pocket and use GoodRx, or we get medications compounded,” she said. “That’s cheaper. For example, for HRT, GoodRx can bring down the cost 40% to 50%.”

The American Medical Association as well as 150 other medical advocacy groups continue to urge Congress to work with the physician community to address the systematic problems within Medicare, especially reimbursement.

Despite the daily challenges, Rahul Gupta says he remains committed to caring for his patients.

“I want to care for the elderly, especially because they already have very few physicians to take care of them, and fortunately, I have a good practice with other coverages,” he said. “I can’t give up.”

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

While physicians are getting less of a Medicare pay cut than they thought this year (Congress voted to cut Medicare payments by 2%, which was less than the expected 8.5%), Medicare still pays physicians only 80% of what many third-party insurers pay.

Moreover, those reimbursements are often slow to arrive, and the paperwork is burdensome. In fact, about 65% of doctors won’t accept new Medicare patients, down from 71% just 5 years ago, according to the Medscape Physician Compensation Report 2023.

Worse, inflation makes continuous cuts feel even steeper and trickles down to physicians and their patients as more and more doctors become disenchanted and consider dropping Medicare.
 

Medicare at a glance

Medicare pays physicians about 80% of the “reasonable charge” for covered services. At the same time, private insurers pay nearly double Medicare rates for hospital services.

The Medicare fee schedule is released each year. Physicians who accept Medicare can choose to be a “participating provider” by agreeing to the fee schedule and to not charging more than this amount. “Nonparticipating” providers can charge up to 15% more. Physicians can also opt out of Medicare entirely.

The earliest that physicians receive their payment is 14 days after electronic filing to 28 days after paper filing, but it often can take months.

Physicians lose an estimated 7.3% of Medicare claims to billing problems. With private insurers, an estimated 4.8% is lost.

In 2000, there were 50 million Medicare enrollees; it is projected that by 2050, there will be 87 million enrollees.
 

Why are doctors disenchanted?

“When Medicare started, the concept of the program was good,” said Rahul Gupta, MD, a geriatrician in Westport, Conn., and chief of internal medicine at St. Vincent’s Medical Center, Bridgeport, Conn. “However, over the years, with new developments in medicine and the explosion of the Medicare-eligible population, the program hasn’t kept up with coverages.” In addition, Medicare’s behemoth power as a government-run agency has ramifications that trickle down irrespective of a patient’s insurance carrier.

“Medicare sets the tone on price and reimbursement, and everyone follows suit,” Dr. Gupta said. “It’s a race to the bottom.”

“The program is great for patients when people need hospitalizations, skilled nursing, and physical therapy,” Dr. Gupta said. “But it’s not great about keeping people healthier and maintaining function via preventive treatments.” Many private insurers must become more adept at that too.

For instance, Dr. Gupta laments the lack of coverage for hearing aids, something his patients could greatly benefit from. Thanks to the Build Back Better bill, coverage of hearing aids will begin in 2024. But, again, most private insurers don’t cover hearing aids either. Some Medicare Advantage plans do.

Medicare doesn’t cover eye health (except for eye exams for diabetes patients), which is an issue for Daniel Laroche, MD, a glaucoma specialist and clinical associate professor of ophthalmology at Mount Sinai Medical Center, New York.

“I get paid less for Medicare patients by about 20% because of ‘lesser-of’ payments,” said Dr. Laroche. For example, as per Medicare, after patients meet their Part B deductible, they pay 20% of the Medicare-approved amount for glaucoma testing. “It would be nice to get the full amount for Medicare patients.”

“In addition, getting approvals for testing takes time and exhaustive amounts of paperwork, says Adeeti Gupta, MD, a gynecologist and founder of Walk In GYN Care in New York.

“Medicare only covers gynecologist visits every 2 years after the age of 65,” she said. “Any additional testing requires authorization, and Medicare doesn’t cover hormone replacement at all, which really makes me crazy. They will cover Viagra for men, but they won’t cover HRT, which prolongs life, reduces dementia, and prevents bone loss.”

While these three doctors find Medicare lacking in its coverage of their specialty, and their reimbursements are too low, many physicians also find fault regarding Medicare billing, which can put their patients at risk.
 

The problem with Medicare billing

Because claims are processed by Medicare administrative contractors, it can take about a month for the approval or denial process and for doctors to receive reimbursement.

Prior authorizations, especially with Medicare Advantage plans, are also problematic. For example, one 2022 study found that 18% of payment denials were for services that met coverage and billing rules.

Worse, all of this jockeying for coverage takes time. The average health care provider spends 16.4 hours a week on paperwork and on securing prior authorizations to cover services, according to the American Medical Association.

“A good 40% of my time is exclusively Medicare red tape paperwork,” Rahul Gupta says. “There’s a reason I spend 2-3 hours a night catching up on that stuff.”

Not only does this lead to burnout, but it also means that most physicians must hire an administrator to help with the paperwork.

In comparison, industry averages put the denial rate for all Medicare and private insurance claims at 20%.

“Excessive authorization controls required by health insurers are persistently responsible for serious harm to physician practices and patients when necessary medical care is delayed, denied, or disrupted in an attempt to increase profits,” Dr. Laroche said.

“Our office spends nearly 2 days per week on prior authorizations, creating costly administrative burdens.”

For Adeeti Gupta, the frustrations with Medicare have continued to mount. “We’re just at a dead end,” she said. “Authorizations keep getting denied, and the back-end paperwork is only increasing for us.”
 

Will more doctors opt out of Medicare?

When doctors don’t accept Medicare, it hurts the patients using it, especially patients who have selected either a Medicare Advantage plan or who become eligible for Medicare at age 65 only to find that fewer doctors take the government-sponsored insurance than in the past.

As of 2020, only 1% of nonpediatric physicians had formally opted out, per the Centers for Medicare & Medicaid Services. Psychiatrists account for the largest share of opt-outs (7.2%).

“Unfortunately, most doctors outside of hospital-based practices will reach a point when they can’t deal with Medicare paperwork, so they’ll stop taking it,” Rahul Gupta says.

A coalition of 120 physicians’ groups, including the American Medical Association, disputes that Medicare is paying a fair reimbursement rate to physicians and calls for an overhaul in how they adjust physician pay.

“Nothing much changes no matter how much the AMA shouts,” Rahul Gupta said in an interview.
 

What can doctors do

Prescription prices are another example of the challenges posed by Medicare. When prescriptions are denied because of Medicare’s medigap (or donut hole) program, which puts a cap on medication coverage, which was $4,660 in 2023, Dr. Gupta says she turns to alternative ways to fill them.

“I’ve been telling patients to pay out of pocket and use GoodRx, or we get medications compounded,” she said. “That’s cheaper. For example, for HRT, GoodRx can bring down the cost 40% to 50%.”

The American Medical Association as well as 150 other medical advocacy groups continue to urge Congress to work with the physician community to address the systematic problems within Medicare, especially reimbursement.

Despite the daily challenges, Rahul Gupta says he remains committed to caring for his patients.

“I want to care for the elderly, especially because they already have very few physicians to take care of them, and fortunately, I have a good practice with other coverages,” he said. “I can’t give up.”

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

The costs of providing evidence-based interventions in primary care to address social needs far exceed current federal funding streams, say the authors of a new analysis.

A microsimulation analysis by Sanjay Basu, MD, PhD, with Clinical Product Development, Waymark Care, San Francisco, and colleagues found that, as primary care practices are being asked to screen for social needs, the cost of providing evidence-based interventions for these needs averaged $60 per member/person per month (PMPM) (95% confidence interval, $55-$65).

However, less than half ($27) of the $60 cost had existing federal financing in place to pay for it. Of the $60, $5 was for screening and referral.

The study results were published in JAMA Internal Medicine.

The researchers looked at key social needs areas and found major gaps between what interventions cost and what’s covered by federal payers. They demonstrate the gaps in four key areas. Many people in the analysis have more than one need:

• Food insecurity: Cost was $23 PMPM and the proportion borne by existing federal payers was 61.6%.
• Housing insecurity: Cost was $3 PMPM; proportion borne by federal payers was 45.6%.
• Transportation insecurity: Cost was $0.1 PMPM; proportion borne by federal payers was 27.8%.
• Community-based care coordination: Cost was $0.6 PMPM; proportion borne by federal payers is 6.4%.

Gaps varied by type of center

Primary care practices were grouped into federally qualified health centers; non-FQHC urban practices in high-poverty areas; non-FQHC rural practices in high-poverty areas; and practices in lower-poverty areas. Gaps varied among the groups.

While disproportionate funding was available to populations seen at FQHCs, populations seen at non-FQHC practices in high-poverty areas had larger funding gaps.

The study population consisted of 19,225 patients seen in primary care practices; data on social needs were pulled from the National Center for Health Statistics from 2015 to 2018.

Dr. Basu said in an interview with the journal’s deputy editor, Mitchell Katz, MD, that new sustainable revenue streams need to be identified to close the gap. Primary care physicians should not be charged with tasks such as researching the best housing programs and food benefits.

“I can’t imagine fitting this into my primary care appointments,” he said.
 

Is primary care the best setting for addressing these needs?

In an accompanying comment, Jenifer Clapp, MPA, with the Office of Ambulatory Care and Population Health, NYC Health + Hospitals, New York, and colleagues wrote that the study raises the question of whether the health care setting is the right place for addressing social needs. Some aspects have to be addressed in health care, such as asking about the home environment for a patient with environmentally triggered asthma.

“But how involved should health care professionals be in identifying needs unrelated to illness and solving those needs?” Ms. Clapp and colleagues asked.

They wrote that the health care sector in the United States must address these needs because in the United States, unlike in many European countries, “there is an insufficient social service sector to address the basic human needs of children and working-age adults.”
 

Eligible but not enrolled

Importantly, both the study authors and editorialists pointed out, in many cases, intervening doesn’t mean paying for the social services, but helping patients enroll in the services for which they already qualify.

The study authors wrote that among people who had food and housing needs, most met the criteria for federally funded programs, but had low enrollment for reasons including inadequate program capacity.

For example, 78% of people with housing needs were eligible for federal programs but only 24% were enrolled, and 95.6% of people with food needs were eligible for programs but only 70.2% were enrolled in programs like the Supplemental Nutrition and Assistance Program and Women, Infants and Children.

Commentary coauthor Nichola Davis, MD, also with NYC Health + Hospitals, said one thing they’ve done at NYC Health + Hospitals is partner with community-based organizations that provide food navigators so when patients screen positive for food insecurity they can then be seen by a food navigator to pinpoint appropriate programs.

The referral for those who indicate food insecurity is automatically generated by the electronic health system and appears on the after-visit summary.

“At the bare minimum, the patient would leave with a list of resources,” Dr. Davis said.
 

One place primary care providers can make a difference

Dr. Katz said that the $60 cost per person is much lower than that for a service such as an MRI.

“We should be able to achieve that,” he said.

Will Bleser, PhD, MSPH, assistant research director of health care transformation for social needs and health equity at the Duke-Margolis Center for Health Policy, Washington, said it’s exciting to see the per-person cost for social needs quantified.

He pointed to existing revenue options that have been underutilized.

Through Medicare, he noted, if you are part of a Medicare Advantage plan, there is a program implemented in 2020 called Special Supplemental Benefits for the Chronically Ill. “That authorizes Medicare Advantage plans to offer non–primarily health-related services through Medicare Advantage to individuals who meet certain chronic illness conditions.”

Non–primarily health-related services may include meals, transportation, and pest control, for example, the Centers for Medicare & Medicaid Services notes.

Also, within the shared-savings program of traditional Medicare, if an accountable care organization is providing quality care under the cost target and is reaping the savings, “you could use those bonuses to do things that you couldn’t do under the normal Medicare fee schedule like address social needs,” Dr. Bleser said.

Medicaid, he said, offers the most opportunities to address social needs through the health system. One policy mechanism within Medicaid is the Section 1115 Waiver, where states can propose to provide new services as long as they comply with the core rules of Medicaid and meet certain qualifications.
 

Avoiding checking boxes with no benefit to patients

Ms. Clapp and colleagues noted that whether health care professionals agree that social needs can or should be addressed in primary care, CMS will mandate social needs screening and reporting for all hospitalized adults starting in 2024. Additionally, the Joint Commission will require health care systems to gauge social needs and report on resources.

“We need to ensure that these mandates do not become administrative checkboxes that frustrate clinical staff and ratchet up health care costs with no benefit to patients,” they wrote.

Dr. Basu reported receiving personal fees from the University of California, Healthright360, Waymark and Collective Health outside the submitted work; he has a patent issued for a multimodel member outreach system; and a patent pending for operationalizing predicted changes in risk based on interventions. A coauthor reported grants from the North Carolina Department of Health and Human Services, Blue Cross Blue Shield of North Carolina, and personal fees from several nonprofit organizations outside the submitted work. Another coauthor reported personal fees from ZealCare outside the submitted work.

The costs of providing evidence-based interventions in primary care to address social needs far exceed current federal funding streams, say the authors of a new analysis.

A microsimulation analysis by Sanjay Basu, MD, PhD, with Clinical Product Development, Waymark Care, San Francisco, and colleagues found that, as primary care practices are being asked to screen for social needs, the cost of providing evidence-based interventions for these needs averaged $60 per member/person per month (PMPM) (95% confidence interval, $55-$65).

However, less than half ($27) of the $60 cost had existing federal financing in place to pay for it. Of the $60, $5 was for screening and referral.

The study results were published in JAMA Internal Medicine.

The researchers looked at key social needs areas and found major gaps between what interventions cost and what’s covered by federal payers. They demonstrate the gaps in four key areas. Many people in the analysis have more than one need:

• Food insecurity: Cost was $23 PMPM and the proportion borne by existing federal payers was 61.6%.
• Housing insecurity: Cost was $3 PMPM; proportion borne by federal payers was 45.6%.
• Transportation insecurity: Cost was $0.1 PMPM; proportion borne by federal payers was 27.8%.
• Community-based care coordination: Cost was $0.6 PMPM; proportion borne by federal payers is 6.4%.

Gaps varied by type of center

Primary care practices were grouped into federally qualified health centers; non-FQHC urban practices in high-poverty areas; non-FQHC rural practices in high-poverty areas; and practices in lower-poverty areas. Gaps varied among the groups.

While disproportionate funding was available to populations seen at FQHCs, populations seen at non-FQHC practices in high-poverty areas had larger funding gaps.

The study population consisted of 19,225 patients seen in primary care practices; data on social needs were pulled from the National Center for Health Statistics from 2015 to 2018.

Dr. Basu said in an interview with the journal’s deputy editor, Mitchell Katz, MD, that new sustainable revenue streams need to be identified to close the gap. Primary care physicians should not be charged with tasks such as researching the best housing programs and food benefits.

“I can’t imagine fitting this into my primary care appointments,” he said.
 

Is primary care the best setting for addressing these needs?

In an accompanying comment, Jenifer Clapp, MPA, with the Office of Ambulatory Care and Population Health, NYC Health + Hospitals, New York, and colleagues wrote that the study raises the question of whether the health care setting is the right place for addressing social needs. Some aspects have to be addressed in health care, such as asking about the home environment for a patient with environmentally triggered asthma.

“But how involved should health care professionals be in identifying needs unrelated to illness and solving those needs?” Ms. Clapp and colleagues asked.

They wrote that the health care sector in the United States must address these needs because in the United States, unlike in many European countries, “there is an insufficient social service sector to address the basic human needs of children and working-age adults.”
 

Eligible but not enrolled

Importantly, both the study authors and editorialists pointed out, in many cases, intervening doesn’t mean paying for the social services, but helping patients enroll in the services for which they already qualify.

The study authors wrote that among people who had food and housing needs, most met the criteria for federally funded programs, but had low enrollment for reasons including inadequate program capacity.

For example, 78% of people with housing needs were eligible for federal programs but only 24% were enrolled, and 95.6% of people with food needs were eligible for programs but only 70.2% were enrolled in programs like the Supplemental Nutrition and Assistance Program and Women, Infants and Children.

Commentary coauthor Nichola Davis, MD, also with NYC Health + Hospitals, said one thing they’ve done at NYC Health + Hospitals is partner with community-based organizations that provide food navigators so when patients screen positive for food insecurity they can then be seen by a food navigator to pinpoint appropriate programs.

The referral for those who indicate food insecurity is automatically generated by the electronic health system and appears on the after-visit summary.

“At the bare minimum, the patient would leave with a list of resources,” Dr. Davis said.
 

One place primary care providers can make a difference

Dr. Katz said that the $60 cost per person is much lower than that for a service such as an MRI.

“We should be able to achieve that,” he said.

Will Bleser, PhD, MSPH, assistant research director of health care transformation for social needs and health equity at the Duke-Margolis Center for Health Policy, Washington, said it’s exciting to see the per-person cost for social needs quantified.

He pointed to existing revenue options that have been underutilized.

Through Medicare, he noted, if you are part of a Medicare Advantage plan, there is a program implemented in 2020 called Special Supplemental Benefits for the Chronically Ill. “That authorizes Medicare Advantage plans to offer non–primarily health-related services through Medicare Advantage to individuals who meet certain chronic illness conditions.”

Non–primarily health-related services may include meals, transportation, and pest control, for example, the Centers for Medicare & Medicaid Services notes.

Also, within the shared-savings program of traditional Medicare, if an accountable care organization is providing quality care under the cost target and is reaping the savings, “you could use those bonuses to do things that you couldn’t do under the normal Medicare fee schedule like address social needs,” Dr. Bleser said.

Medicaid, he said, offers the most opportunities to address social needs through the health system. One policy mechanism within Medicaid is the Section 1115 Waiver, where states can propose to provide new services as long as they comply with the core rules of Medicaid and meet certain qualifications.
 

Avoiding checking boxes with no benefit to patients

Ms. Clapp and colleagues noted that whether health care professionals agree that social needs can or should be addressed in primary care, CMS will mandate social needs screening and reporting for all hospitalized adults starting in 2024. Additionally, the Joint Commission will require health care systems to gauge social needs and report on resources.

“We need to ensure that these mandates do not become administrative checkboxes that frustrate clinical staff and ratchet up health care costs with no benefit to patients,” they wrote.

Dr. Basu reported receiving personal fees from the University of California, Healthright360, Waymark and Collective Health outside the submitted work; he has a patent issued for a multimodel member outreach system; and a patent pending for operationalizing predicted changes in risk based on interventions. A coauthor reported grants from the North Carolina Department of Health and Human Services, Blue Cross Blue Shield of North Carolina, and personal fees from several nonprofit organizations outside the submitted work. Another coauthor reported personal fees from ZealCare outside the submitted work.

The costs of providing evidence-based interventions in primary care to address social needs far exceed current federal funding streams, say the authors of a new analysis.

A microsimulation analysis by Sanjay Basu, MD, PhD, with Clinical Product Development, Waymark Care, San Francisco, and colleagues found that, as primary care practices are being asked to screen for social needs, the cost of providing evidence-based interventions for these needs averaged $60 per member/person per month (PMPM) (95% confidence interval, $55-$65).

However, less than half ($27) of the $60 cost had existing federal financing in place to pay for it. Of the $60, $5 was for screening and referral.

The study results were published in JAMA Internal Medicine.

The researchers looked at key social needs areas and found major gaps between what interventions cost and what’s covered by federal payers. They demonstrate the gaps in four key areas. Many people in the analysis have more than one need:

• Food insecurity: Cost was $23 PMPM and the proportion borne by existing federal payers was 61.6%.
• Housing insecurity: Cost was $3 PMPM; proportion borne by federal payers was 45.6%.
• Transportation insecurity: Cost was $0.1 PMPM; proportion borne by federal payers was 27.8%.
• Community-based care coordination: Cost was $0.6 PMPM; proportion borne by federal payers is 6.4%.

Gaps varied by type of center

Primary care practices were grouped into federally qualified health centers; non-FQHC urban practices in high-poverty areas; non-FQHC rural practices in high-poverty areas; and practices in lower-poverty areas. Gaps varied among the groups.

While disproportionate funding was available to populations seen at FQHCs, populations seen at non-FQHC practices in high-poverty areas had larger funding gaps.

The study population consisted of 19,225 patients seen in primary care practices; data on social needs were pulled from the National Center for Health Statistics from 2015 to 2018.

Dr. Basu said in an interview with the journal’s deputy editor, Mitchell Katz, MD, that new sustainable revenue streams need to be identified to close the gap. Primary care physicians should not be charged with tasks such as researching the best housing programs and food benefits.

“I can’t imagine fitting this into my primary care appointments,” he said.
 

Is primary care the best setting for addressing these needs?

In an accompanying comment, Jenifer Clapp, MPA, with the Office of Ambulatory Care and Population Health, NYC Health + Hospitals, New York, and colleagues wrote that the study raises the question of whether the health care setting is the right place for addressing social needs. Some aspects have to be addressed in health care, such as asking about the home environment for a patient with environmentally triggered asthma.

“But how involved should health care professionals be in identifying needs unrelated to illness and solving those needs?” Ms. Clapp and colleagues asked.

They wrote that the health care sector in the United States must address these needs because in the United States, unlike in many European countries, “there is an insufficient social service sector to address the basic human needs of children and working-age adults.”
 

Eligible but not enrolled

Importantly, both the study authors and editorialists pointed out, in many cases, intervening doesn’t mean paying for the social services, but helping patients enroll in the services for which they already qualify.

The study authors wrote that among people who had food and housing needs, most met the criteria for federally funded programs, but had low enrollment for reasons including inadequate program capacity.

For example, 78% of people with housing needs were eligible for federal programs but only 24% were enrolled, and 95.6% of people with food needs were eligible for programs but only 70.2% were enrolled in programs like the Supplemental Nutrition and Assistance Program and Women, Infants and Children.

Commentary coauthor Nichola Davis, MD, also with NYC Health + Hospitals, said one thing they’ve done at NYC Health + Hospitals is partner with community-based organizations that provide food navigators so when patients screen positive for food insecurity they can then be seen by a food navigator to pinpoint appropriate programs.

The referral for those who indicate food insecurity is automatically generated by the electronic health system and appears on the after-visit summary.

“At the bare minimum, the patient would leave with a list of resources,” Dr. Davis said.
 

One place primary care providers can make a difference

Dr. Katz said that the $60 cost per person is much lower than that for a service such as an MRI.

“We should be able to achieve that,” he said.

Will Bleser, PhD, MSPH, assistant research director of health care transformation for social needs and health equity at the Duke-Margolis Center for Health Policy, Washington, said it’s exciting to see the per-person cost for social needs quantified.

He pointed to existing revenue options that have been underutilized.

Through Medicare, he noted, if you are part of a Medicare Advantage plan, there is a program implemented in 2020 called Special Supplemental Benefits for the Chronically Ill. “That authorizes Medicare Advantage plans to offer non–primarily health-related services through Medicare Advantage to individuals who meet certain chronic illness conditions.”

Non–primarily health-related services may include meals, transportation, and pest control, for example, the Centers for Medicare & Medicaid Services notes.

Also, within the shared-savings program of traditional Medicare, if an accountable care organization is providing quality care under the cost target and is reaping the savings, “you could use those bonuses to do things that you couldn’t do under the normal Medicare fee schedule like address social needs,” Dr. Bleser said.

Medicaid, he said, offers the most opportunities to address social needs through the health system. One policy mechanism within Medicaid is the Section 1115 Waiver, where states can propose to provide new services as long as they comply with the core rules of Medicaid and meet certain qualifications.
 

Avoiding checking boxes with no benefit to patients

Ms. Clapp and colleagues noted that whether health care professionals agree that social needs can or should be addressed in primary care, CMS will mandate social needs screening and reporting for all hospitalized adults starting in 2024. Additionally, the Joint Commission will require health care systems to gauge social needs and report on resources.

“We need to ensure that these mandates do not become administrative checkboxes that frustrate clinical staff and ratchet up health care costs with no benefit to patients,” they wrote.

Dr. Basu reported receiving personal fees from the University of California, Healthright360, Waymark and Collective Health outside the submitted work; he has a patent issued for a multimodel member outreach system; and a patent pending for operationalizing predicted changes in risk based on interventions. A coauthor reported grants from the North Carolina Department of Health and Human Services, Blue Cross Blue Shield of North Carolina, and personal fees from several nonprofit organizations outside the submitted work. Another coauthor reported personal fees from ZealCare outside the submitted work.

More than 600,000 Americans have lost Medicaid coverage since pandemic protections ended on April 1. And a KFF Health News analysis of state data shows the vast majority were removed from state rolls for not completing paperwork.

Under normal circumstances, states review their Medicaid enrollment lists regularly to ensure every recipient qualifies for coverage. But because of a nationwide pause in those reviews during the pandemic, the health insurance program for low-income and disabled Americans kept people covered even if they no longer qualified.

Now, in what’s known as the Medicaid unwinding, states are combing through rolls and deciding who stays and who goes. People who are no longer eligible or don’t complete paperwork in time will be dropped.

The overwhelming majority of people who have lost coverage in most states were dropped because of technicalities, not because state officials determined they no longer meet Medicaid income limits. Four out of every five people dropped so far either never returned the paperwork or omitted required documents, according to a KFF Health News analysis of data from 11 states that provided details on recent cancellations. Now, lawmakers and advocates are expressing alarm over the volume of people losing coverage and, in some states, calling to pause the process.

KFF Health News sought data from the 19 states that started cancellations by May 1. Based on records from 14 states that provided detailed numbers, either in response to a public records request or by posting online, 36% of people whose eligibility was reviewed have been disenrolled.

In Indiana, 53,000 residents lost coverage in the first month of the unwinding, 89% for procedural reasons like not returning renewal forms. State Rep. Ed Clere, a Republican, expressed dismay at those “staggering numbers” in a May 24 Medicaid advisory group meeting, repeatedly questioning state officials about forms mailed to out-of-date addresses and urging them to give people more than 2 weeks’ notice before canceling their coverage.

Rep. Clere warned that the cancellations set in motion an avoidable revolving door. Some people dropped from Medicaid will have to forgo filling prescriptions and cancel doctor visits because they can’t afford care. Months down the line, after untreated chronic illnesses spiral out of control, they’ll end up in the emergency room where social workers will need to again help them join the program, he said.

Before the unwinding, more than one in four Americans – 93 million – were covered by Medicaid or CHIP, the Children’s Health Insurance Program, according to KFF Health News’ analysis of the latest enrollment data. Half of all kids are covered by the programs.

About 15 million people will be dropped over the next year as states review participants’ eligibility in monthly tranches.

Most people will find health coverage through new jobs or qualify for subsidized plans through the Affordable Care Act. But millions of others, including many children, will become uninsured and unable to afford basic prescriptions or preventive care. The uninsured rate among those under 65 is projected to rise from a historical low of 8.3% today to 9.3% next year, according to the Congressional Budget Office.

Because each state is handling the unwinding differently, the share of enrollees dropped in the first weeks varies widely.

Several states are first reviewing people officials believe are no longer eligible or who haven’t recently used their insurance. High cancellation rates in those states should level out as the agencies move on to people who likely still qualify.

In Utah, nearly 56% of people included in early reviews were dropped. In New Hampshire, 44% received cancellation letters within the first 2 months – almost all for procedural reasons, like not returning paperwork.

But New Hampshire officials found that thousands of people who didn’t fill out the forms indeed earn too much to qualify, according to Henry Lipman, the state’s Medicaid director. They would have been denied anyway. Even so, more people than he expected are not returning renewal forms. “That tells us that we need to change up our strategy,” said Mr. Lipman.

In other states, like Virginia and Nebraska, which aren’t prioritizing renewals by likely eligibility, about 90% have been renewed.

Because of the 3-year pause in renewals, many people on Medicaid have never been through the process or aren’t aware they may need to fill out long verification forms, as a recent KFF poll found. Some people moved and didn’t update their contact information.

And while agencies are required to assist enrollees who don’t speak English well, many are sending the forms in only a few common languages.

Tens of thousands of children are losing coverage, as researchers have warned, even though some may still qualify for Medicaid or CHIP. In its first month of reviews, South Dakota ended coverage for 10% of all Medicaid and CHIP enrollees in the state. More than half of them were children. In Arkansas, about 40% were kids.

Many parents don’t know that limits on household income are significantly higher for children than adults. Parents should fill out renewal forms even if they don’t qualify themselves, said Joan Alker, executive director of the Georgetown University Center for Children and Families, Washington.

New Hampshire has moved most families with children to the end of the review process. Mr. Lipman said his biggest worry is that a child will end up uninsured. Florida also planned to push kids with serious health conditions and other vulnerable groups to the end of the review line.

But according to Miriam Harmatz, advocacy director and founder of the Florida Health Justice Project, state officials sent cancellation letters to several clients with disabled children who probably still qualify. She’s helping those families appeal.

Nearly 250,000 Floridians reviewed in the first month of the unwinding lost coverage, 82% of them for reasons like incomplete paperwork, the state reported to federal authorities. House Democrats from the state petitioned Republican Gov. Ron DeSantis to pause the unwinding.

Advocacy coalitions in both Florida and Arkansas also have called for investigations into the review process and a pause on cancellations.

The state is contacting enrollees by phone, email, and text, and continues to process late applications, said Tori Cuddy, a spokesperson for the Florida Department of Children and Families. Ms. Cuddy did not respond to questions about issues raised in the petitions.

Federal officials are investigating those complaints and any other problems that emerge, said Dan Tsai, director of the Center for Medicaid & CHIP Services. “If we find that the rules are not being followed, we will take action.”

His agency has directed states to automatically reenroll residents using data from other government programs like unemployment and food assistance when possible. Anyone who can’t be approved through that process must act quickly.

“For the past 3 years, people have been told to ignore the mail around this, that the renewal was not going to lead to a termination.” Suddenly that mail matters, he said.

Federal law requires states to tell people why they’re losing Medicaid coverage and how to appeal the decision.

Ms. Harmatz said some cancellation notices in Florida are vague and could violate due process rules. Letters that she’s seen say “your Medicaid for this period is ending” rather than providing a specific reason for disenrollment, like having too high an income or incomplete paperwork.
If a person requests a hearing before their cancellation takes effect, they can stay covered during the appeals process. Even after being disenrolled, many still have a 90-day window to restore coverage.

In New Hampshire, 13% of people deemed ineligible in the first month have asked for extra time to provide the necessary records. “If you’re eligible for Medicaid, we don’t want you to lose it,” said Mr. Lipman.

Rep. Clere pushed Indiana’s Medicaid officials during the May meeting to immediately make changes to avoid people unnecessarily becoming uninsured. One official responded that they’ll learn and improve over time.

“I’m just concerned that we’re going to be ‘learning’ as a result of people losing coverage,” Rep. Clere replied. “So I don’t want to learn at their expense.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

More than 600,000 Americans have lost Medicaid coverage since pandemic protections ended on April 1. And a KFF Health News analysis of state data shows the vast majority were removed from state rolls for not completing paperwork.

Under normal circumstances, states review their Medicaid enrollment lists regularly to ensure every recipient qualifies for coverage. But because of a nationwide pause in those reviews during the pandemic, the health insurance program for low-income and disabled Americans kept people covered even if they no longer qualified.

Now, in what’s known as the Medicaid unwinding, states are combing through rolls and deciding who stays and who goes. People who are no longer eligible or don’t complete paperwork in time will be dropped.

The overwhelming majority of people who have lost coverage in most states were dropped because of technicalities, not because state officials determined they no longer meet Medicaid income limits. Four out of every five people dropped so far either never returned the paperwork or omitted required documents, according to a KFF Health News analysis of data from 11 states that provided details on recent cancellations. Now, lawmakers and advocates are expressing alarm over the volume of people losing coverage and, in some states, calling to pause the process.

KFF Health News sought data from the 19 states that started cancellations by May 1. Based on records from 14 states that provided detailed numbers, either in response to a public records request or by posting online, 36% of people whose eligibility was reviewed have been disenrolled.

In Indiana, 53,000 residents lost coverage in the first month of the unwinding, 89% for procedural reasons like not returning renewal forms. State Rep. Ed Clere, a Republican, expressed dismay at those “staggering numbers” in a May 24 Medicaid advisory group meeting, repeatedly questioning state officials about forms mailed to out-of-date addresses and urging them to give people more than 2 weeks’ notice before canceling their coverage.

Rep. Clere warned that the cancellations set in motion an avoidable revolving door. Some people dropped from Medicaid will have to forgo filling prescriptions and cancel doctor visits because they can’t afford care. Months down the line, after untreated chronic illnesses spiral out of control, they’ll end up in the emergency room where social workers will need to again help them join the program, he said.

Before the unwinding, more than one in four Americans – 93 million – were covered by Medicaid or CHIP, the Children’s Health Insurance Program, according to KFF Health News’ analysis of the latest enrollment data. Half of all kids are covered by the programs.

About 15 million people will be dropped over the next year as states review participants’ eligibility in monthly tranches.

Most people will find health coverage through new jobs or qualify for subsidized plans through the Affordable Care Act. But millions of others, including many children, will become uninsured and unable to afford basic prescriptions or preventive care. The uninsured rate among those under 65 is projected to rise from a historical low of 8.3% today to 9.3% next year, according to the Congressional Budget Office.

Because each state is handling the unwinding differently, the share of enrollees dropped in the first weeks varies widely.

Several states are first reviewing people officials believe are no longer eligible or who haven’t recently used their insurance. High cancellation rates in those states should level out as the agencies move on to people who likely still qualify.

In Utah, nearly 56% of people included in early reviews were dropped. In New Hampshire, 44% received cancellation letters within the first 2 months – almost all for procedural reasons, like not returning paperwork.

But New Hampshire officials found that thousands of people who didn’t fill out the forms indeed earn too much to qualify, according to Henry Lipman, the state’s Medicaid director. They would have been denied anyway. Even so, more people than he expected are not returning renewal forms. “That tells us that we need to change up our strategy,” said Mr. Lipman.

In other states, like Virginia and Nebraska, which aren’t prioritizing renewals by likely eligibility, about 90% have been renewed.

Because of the 3-year pause in renewals, many people on Medicaid have never been through the process or aren’t aware they may need to fill out long verification forms, as a recent KFF poll found. Some people moved and didn’t update their contact information.

And while agencies are required to assist enrollees who don’t speak English well, many are sending the forms in only a few common languages.

Tens of thousands of children are losing coverage, as researchers have warned, even though some may still qualify for Medicaid or CHIP. In its first month of reviews, South Dakota ended coverage for 10% of all Medicaid and CHIP enrollees in the state. More than half of them were children. In Arkansas, about 40% were kids.

Many parents don’t know that limits on household income are significantly higher for children than adults. Parents should fill out renewal forms even if they don’t qualify themselves, said Joan Alker, executive director of the Georgetown University Center for Children and Families, Washington.

New Hampshire has moved most families with children to the end of the review process. Mr. Lipman said his biggest worry is that a child will end up uninsured. Florida also planned to push kids with serious health conditions and other vulnerable groups to the end of the review line.

But according to Miriam Harmatz, advocacy director and founder of the Florida Health Justice Project, state officials sent cancellation letters to several clients with disabled children who probably still qualify. She’s helping those families appeal.

Nearly 250,000 Floridians reviewed in the first month of the unwinding lost coverage, 82% of them for reasons like incomplete paperwork, the state reported to federal authorities. House Democrats from the state petitioned Republican Gov. Ron DeSantis to pause the unwinding.

Advocacy coalitions in both Florida and Arkansas also have called for investigations into the review process and a pause on cancellations.

The state is contacting enrollees by phone, email, and text, and continues to process late applications, said Tori Cuddy, a spokesperson for the Florida Department of Children and Families. Ms. Cuddy did not respond to questions about issues raised in the petitions.

Federal officials are investigating those complaints and any other problems that emerge, said Dan Tsai, director of the Center for Medicaid & CHIP Services. “If we find that the rules are not being followed, we will take action.”

His agency has directed states to automatically reenroll residents using data from other government programs like unemployment and food assistance when possible. Anyone who can’t be approved through that process must act quickly.

“For the past 3 years, people have been told to ignore the mail around this, that the renewal was not going to lead to a termination.” Suddenly that mail matters, he said.

Federal law requires states to tell people why they’re losing Medicaid coverage and how to appeal the decision.

Ms. Harmatz said some cancellation notices in Florida are vague and could violate due process rules. Letters that she’s seen say “your Medicaid for this period is ending” rather than providing a specific reason for disenrollment, like having too high an income or incomplete paperwork.
If a person requests a hearing before their cancellation takes effect, they can stay covered during the appeals process. Even after being disenrolled, many still have a 90-day window to restore coverage.

In New Hampshire, 13% of people deemed ineligible in the first month have asked for extra time to provide the necessary records. “If you’re eligible for Medicaid, we don’t want you to lose it,” said Mr. Lipman.

Rep. Clere pushed Indiana’s Medicaid officials during the May meeting to immediately make changes to avoid people unnecessarily becoming uninsured. One official responded that they’ll learn and improve over time.

“I’m just concerned that we’re going to be ‘learning’ as a result of people losing coverage,” Rep. Clere replied. “So I don’t want to learn at their expense.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

More than 600,000 Americans have lost Medicaid coverage since pandemic protections ended on April 1. And a KFF Health News analysis of state data shows the vast majority were removed from state rolls for not completing paperwork.

Under normal circumstances, states review their Medicaid enrollment lists regularly to ensure every recipient qualifies for coverage. But because of a nationwide pause in those reviews during the pandemic, the health insurance program for low-income and disabled Americans kept people covered even if they no longer qualified.

Now, in what’s known as the Medicaid unwinding, states are combing through rolls and deciding who stays and who goes. People who are no longer eligible or don’t complete paperwork in time will be dropped.

The overwhelming majority of people who have lost coverage in most states were dropped because of technicalities, not because state officials determined they no longer meet Medicaid income limits. Four out of every five people dropped so far either never returned the paperwork or omitted required documents, according to a KFF Health News analysis of data from 11 states that provided details on recent cancellations. Now, lawmakers and advocates are expressing alarm over the volume of people losing coverage and, in some states, calling to pause the process.

KFF Health News sought data from the 19 states that started cancellations by May 1. Based on records from 14 states that provided detailed numbers, either in response to a public records request or by posting online, 36% of people whose eligibility was reviewed have been disenrolled.

In Indiana, 53,000 residents lost coverage in the first month of the unwinding, 89% for procedural reasons like not returning renewal forms. State Rep. Ed Clere, a Republican, expressed dismay at those “staggering numbers” in a May 24 Medicaid advisory group meeting, repeatedly questioning state officials about forms mailed to out-of-date addresses and urging them to give people more than 2 weeks’ notice before canceling their coverage.

Rep. Clere warned that the cancellations set in motion an avoidable revolving door. Some people dropped from Medicaid will have to forgo filling prescriptions and cancel doctor visits because they can’t afford care. Months down the line, after untreated chronic illnesses spiral out of control, they’ll end up in the emergency room where social workers will need to again help them join the program, he said.

Before the unwinding, more than one in four Americans – 93 million – were covered by Medicaid or CHIP, the Children’s Health Insurance Program, according to KFF Health News’ analysis of the latest enrollment data. Half of all kids are covered by the programs.

About 15 million people will be dropped over the next year as states review participants’ eligibility in monthly tranches.

Most people will find health coverage through new jobs or qualify for subsidized plans through the Affordable Care Act. But millions of others, including many children, will become uninsured and unable to afford basic prescriptions or preventive care. The uninsured rate among those under 65 is projected to rise from a historical low of 8.3% today to 9.3% next year, according to the Congressional Budget Office.

Because each state is handling the unwinding differently, the share of enrollees dropped in the first weeks varies widely.

Several states are first reviewing people officials believe are no longer eligible or who haven’t recently used their insurance. High cancellation rates in those states should level out as the agencies move on to people who likely still qualify.

In Utah, nearly 56% of people included in early reviews were dropped. In New Hampshire, 44% received cancellation letters within the first 2 months – almost all for procedural reasons, like not returning paperwork.

But New Hampshire officials found that thousands of people who didn’t fill out the forms indeed earn too much to qualify, according to Henry Lipman, the state’s Medicaid director. They would have been denied anyway. Even so, more people than he expected are not returning renewal forms. “That tells us that we need to change up our strategy,” said Mr. Lipman.

In other states, like Virginia and Nebraska, which aren’t prioritizing renewals by likely eligibility, about 90% have been renewed.

Because of the 3-year pause in renewals, many people on Medicaid have never been through the process or aren’t aware they may need to fill out long verification forms, as a recent KFF poll found. Some people moved and didn’t update their contact information.

And while agencies are required to assist enrollees who don’t speak English well, many are sending the forms in only a few common languages.

Tens of thousands of children are losing coverage, as researchers have warned, even though some may still qualify for Medicaid or CHIP. In its first month of reviews, South Dakota ended coverage for 10% of all Medicaid and CHIP enrollees in the state. More than half of them were children. In Arkansas, about 40% were kids.

Many parents don’t know that limits on household income are significantly higher for children than adults. Parents should fill out renewal forms even if they don’t qualify themselves, said Joan Alker, executive director of the Georgetown University Center for Children and Families, Washington.

New Hampshire has moved most families with children to the end of the review process. Mr. Lipman said his biggest worry is that a child will end up uninsured. Florida also planned to push kids with serious health conditions and other vulnerable groups to the end of the review line.

But according to Miriam Harmatz, advocacy director and founder of the Florida Health Justice Project, state officials sent cancellation letters to several clients with disabled children who probably still qualify. She’s helping those families appeal.

Nearly 250,000 Floridians reviewed in the first month of the unwinding lost coverage, 82% of them for reasons like incomplete paperwork, the state reported to federal authorities. House Democrats from the state petitioned Republican Gov. Ron DeSantis to pause the unwinding.

Advocacy coalitions in both Florida and Arkansas also have called for investigations into the review process and a pause on cancellations.

The state is contacting enrollees by phone, email, and text, and continues to process late applications, said Tori Cuddy, a spokesperson for the Florida Department of Children and Families. Ms. Cuddy did not respond to questions about issues raised in the petitions.

Federal officials are investigating those complaints and any other problems that emerge, said Dan Tsai, director of the Center for Medicaid & CHIP Services. “If we find that the rules are not being followed, we will take action.”

His agency has directed states to automatically reenroll residents using data from other government programs like unemployment and food assistance when possible. Anyone who can’t be approved through that process must act quickly.

“For the past 3 years, people have been told to ignore the mail around this, that the renewal was not going to lead to a termination.” Suddenly that mail matters, he said.

Federal law requires states to tell people why they’re losing Medicaid coverage and how to appeal the decision.

Ms. Harmatz said some cancellation notices in Florida are vague and could violate due process rules. Letters that she’s seen say “your Medicaid for this period is ending” rather than providing a specific reason for disenrollment, like having too high an income or incomplete paperwork.
If a person requests a hearing before their cancellation takes effect, they can stay covered during the appeals process. Even after being disenrolled, many still have a 90-day window to restore coverage.

In New Hampshire, 13% of people deemed ineligible in the first month have asked for extra time to provide the necessary records. “If you’re eligible for Medicaid, we don’t want you to lose it,” said Mr. Lipman.

Rep. Clere pushed Indiana’s Medicaid officials during the May meeting to immediately make changes to avoid people unnecessarily becoming uninsured. One official responded that they’ll learn and improve over time.

“I’m just concerned that we’re going to be ‘learning’ as a result of people losing coverage,” Rep. Clere replied. “So I don’t want to learn at their expense.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

A new study reveals health concerns about the sugar substitute sucralose so alarming that researchers said people should stop eating it and the government should regulate it more.

Sucralose is sold under the brand name Splenda and is also used as an ingredient in packaged foods and beverages.

The findings were published in the Journal of Toxicology and Environmental Health, Part B. The researchers conducted a series of laboratory experiments exposing human blood cells and gut tissue to sucralose-6-acetate. The findings build on previous research that linked sucralose to gut health problems.

The researchers found that sucralose causes DNA to break apart, putting people at risk for disease. They also linked sucralose to leaky gut syndrome, which means the lining of the intestines are worn down and become permeable. Symptoms are a burning sensation, painful digestion, diarrhea, gas, and bloating.

When a substance damages DNA, it is called genotoxic. Researchers have found that eating sucralose results in the body producing a substance called sucralose-6-acetate, which the new study now shows is genotoxic. The researchers also found sucralose-6-acetate in trace amounts in off-the-shelf products that are so high, they would exceed the safety levels currently allowed in Europe.

“It’s time to revisit the safety and regulatory status of sucralose because the evidence is mounting that it carries significant risks. If nothing else, I encourage people to avoid products containing sucralose,” researcher Susan Schiffman, PhD, adjunct professor of biomedical engineering at North Carolina State University, Raleigh, said in a statement. “It’s something you should not be eating.”

The FDA says sucralose is safe, describing it as 600 times sweeter than table sugar and used in “baked goods, beverages, chewing gum, gelatins, and frozen dairy desserts.”

“To determine the safety of sucralose, the FDA reviewed more than 110 studies designed to identify possible toxic effects, including studies on the reproductive and nervous systems, carcinogenicity, and metabolism,” the agency explained on its website. “The FDA also reviewed human clinical trials to address metabolism and effects on patients with diabetes.”

The study authors reported that they had no conflicts of interest.A version of this article first appeared on WebMD.com.

A new study reveals health concerns about the sugar substitute sucralose so alarming that researchers said people should stop eating it and the government should regulate it more.

Sucralose is sold under the brand name Splenda and is also used as an ingredient in packaged foods and beverages.

The findings were published in the Journal of Toxicology and Environmental Health, Part B. The researchers conducted a series of laboratory experiments exposing human blood cells and gut tissue to sucralose-6-acetate. The findings build on previous research that linked sucralose to gut health problems.

The researchers found that sucralose causes DNA to break apart, putting people at risk for disease. They also linked sucralose to leaky gut syndrome, which means the lining of the intestines are worn down and become permeable. Symptoms are a burning sensation, painful digestion, diarrhea, gas, and bloating.

When a substance damages DNA, it is called genotoxic. Researchers have found that eating sucralose results in the body producing a substance called sucralose-6-acetate, which the new study now shows is genotoxic. The researchers also found sucralose-6-acetate in trace amounts in off-the-shelf products that are so high, they would exceed the safety levels currently allowed in Europe.

“It’s time to revisit the safety and regulatory status of sucralose because the evidence is mounting that it carries significant risks. If nothing else, I encourage people to avoid products containing sucralose,” researcher Susan Schiffman, PhD, adjunct professor of biomedical engineering at North Carolina State University, Raleigh, said in a statement. “It’s something you should not be eating.”

The FDA says sucralose is safe, describing it as 600 times sweeter than table sugar and used in “baked goods, beverages, chewing gum, gelatins, and frozen dairy desserts.”

“To determine the safety of sucralose, the FDA reviewed more than 110 studies designed to identify possible toxic effects, including studies on the reproductive and nervous systems, carcinogenicity, and metabolism,” the agency explained on its website. “The FDA also reviewed human clinical trials to address metabolism and effects on patients with diabetes.”

The study authors reported that they had no conflicts of interest.A version of this article first appeared on WebMD.com.

A new study reveals health concerns about the sugar substitute sucralose so alarming that researchers said people should stop eating it and the government should regulate it more.

Sucralose is sold under the brand name Splenda and is also used as an ingredient in packaged foods and beverages.

The findings were published in the Journal of Toxicology and Environmental Health, Part B. The researchers conducted a series of laboratory experiments exposing human blood cells and gut tissue to sucralose-6-acetate. The findings build on previous research that linked sucralose to gut health problems.

The researchers found that sucralose causes DNA to break apart, putting people at risk for disease. They also linked sucralose to leaky gut syndrome, which means the lining of the intestines are worn down and become permeable. Symptoms are a burning sensation, painful digestion, diarrhea, gas, and bloating.

When a substance damages DNA, it is called genotoxic. Researchers have found that eating sucralose results in the body producing a substance called sucralose-6-acetate, which the new study now shows is genotoxic. The researchers also found sucralose-6-acetate in trace amounts in off-the-shelf products that are so high, they would exceed the safety levels currently allowed in Europe.

“It’s time to revisit the safety and regulatory status of sucralose because the evidence is mounting that it carries significant risks. If nothing else, I encourage people to avoid products containing sucralose,” researcher Susan Schiffman, PhD, adjunct professor of biomedical engineering at North Carolina State University, Raleigh, said in a statement. “It’s something you should not be eating.”

The FDA says sucralose is safe, describing it as 600 times sweeter than table sugar and used in “baked goods, beverages, chewing gum, gelatins, and frozen dairy desserts.”

“To determine the safety of sucralose, the FDA reviewed more than 110 studies designed to identify possible toxic effects, including studies on the reproductive and nervous systems, carcinogenicity, and metabolism,” the agency explained on its website. “The FDA also reviewed human clinical trials to address metabolism and effects on patients with diabetes.”

The study authors reported that they had no conflicts of interest.A version of this article first appeared on WebMD.com.