Federal Practitioner

This time, it didn’t take much persuading for Mary Murphy to embrace home hospice. When her mother was dying from Alzheimer’s disease in 2020, she had been reluctant until she saw what a help it was. So when her husband, Willie, neared the end of his life, she embraced hospice again.

The Murphys’ house in a leafy Nashville, Tenn., neighborhood is their happy place – full of their treasures.

“He’s good to me – buys me anything I want,” she said, as she pulled a milky glass vase out of a floor-to-ceiling cabinet with mirrored shelves.

Willie bought Mary the display case to help her to show off the trinkets she picks up at estate sales.

Down the hall, Willie was lying in their bed, now unable to speak. His heart was giving out.

“You gonna wake up for a minute?” she asked, cradling his head. She patted his back while he cleared his throat. “Cough it out.”

Mary had been the primary caregiver for her husband, but she gets help from a new hospice agency in Nashville focused on increasing the use of end-of-life comfort care by Black families. Heart and Soul Hospice is owned and operated by people who share the same cultural background as the patients they aim to serve.

In their application to obtain a certificate of need in Tennessee, the hospice owners made it clear they are Black and intend to serve everyone but will focus on African Americans, who are currently underserved. Tennessee data shows that in Nashville just 19% of hospice patients are Black, although they make up 27% of the capital city’s population.

Though the area already had numerous hospice agencies, regulators granted Heart and Soul permission to operate, based primarily on the value of educating an underserved group.

In Ms. Murphy’s first hospice experience, her mother had been living with dementia for decades. Still, Ms. Murphy had concerns about transitioning her mother to hospice. She felt as if she was giving up on her mom.

“My first thought was death,” she said.

National data shows that Black Medicare patients and their families are not making the move to comfort care as often as white patients are. Roughly 41% of Black Medicare beneficiaries who died in 2019 were enrolled in hospice, compared with 54% of White patients, according to data compiled annually by the National Hospice and Palliative Care Organization.

Ms. Murphy’s mother survived nearly 3 years on hospice. The benefit is meant for those in the final 6 months of life, but predicting when the end will come is difficult, especially in cases of dementia. Hospice provides palliative care for the dying and support for caregivers for a long as the process lasts.

Ms. Murphy did most of the caregiving – which can be overwhelming – but hospice helped with a few baths a week, medication in the mail and any medical equipment they needed.

And most important to Ms. Murphy was the emotional support, which came mostly from her hospice nurse.

“Wasn’t no doctor going to come here, hold my hand, stay here until the funeral home came for her,” she said about the day her mother died.

Last year, on the day after Thanksgiving, Willie Murphy died. And the same hospice nurse was at the Murphy home within minutes. She’d already stopped by that morning to check on him and returned as soon as Mary called and told her he wasn’t breathing.

“If you don’t feel like: ‘Oh my God, thank God I have hospice,’ if you can’t say that, then we’re doing something wrong,” said Keisha Mason, Heart and Soul’s director of nursing.

Ms. Mason, like Ms. Murphy, is Black and said that in her view there’s nothing fundamental keeping Black patients from using hospice except learning what the service can offer and that it’s basically free to patients – paid for by Medicare, Medicaid, and most private health plans.

“I say to them, ‘If you see a bill, then call us, because you should not,’” she said.

As Ms. Mason helped launch this new hospice agency, she began using new language, calling hospice more than a Medicare benefit. She describes it as an entitlement.

“Just as you are entitled to unemployment, as you are entitled to Social Security, you are entitled to a hospice benefit,” she said.

The investors in Heart and Soul include David Turner, owner of CNS Hospice in Detroit; Nashville pastor the Rev. Sandy McClain; and André Lee, a former hospital administrator on the campus of Meharry Medical College, a historically Black institution in Nashville.

Mr. Lee and Mr. Turner also started a Black-focused hospice agency in Michigan and have plans to replicate the model in other states.

More families need to consider home hospice as an alternative for end-of-life care, Mr. Lee said. Nursing homes are pricey. And even with Medicare, a hospital bill can be hefty.

“You’ll go in there and they’ll eat you alive,” he said. “I hate to say [something] bad about hospitals, but it’s true.”

Hospice research hasn’t come up with clear reasons to explain the gap between White and Black families’ use of the benefit. Some experts speculate it’s related to spiritual beliefs and widespread mistrust in the medical system because of decades of discrimination.

The hospice industry’s national trade group, the National Hospice and Palliative Care Organization, released a diversity and inclusion toolkit and a guide to reaching more Black patients. It recommends connecting with influential DJs, partnering with Black pastors and simply hiring more Black nurses.

Bridging the gap is not overly complicated, Mr. Lee said.

“A lot of hospices don’t employ enough Black people,” he said. “We all feel comfortable when you see someone over there that looks like you.”

Well-established hospice agencies have attempted to minimize barriers with their own diversity initiatives. Michelle Drayton of Visiting Nurse Service of New York said her large agency has met with ministers who counsel families dealing with failing health.

“Many of them did not fully understand what hospice was,” she said. “They had many of the same sort of misperceptions.”

Every hospice company, whether it’s an upstart or one of the nation’s oldest, can promote end-of-life education and ease care disparities, Ms. Drayton said. “We’re not just handing out a brochure,” she added.

This story is part of a partnership that includes Nashville Public Radio, NPR, and KHN. 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.

This time, it didn’t take much persuading for Mary Murphy to embrace home hospice. When her mother was dying from Alzheimer’s disease in 2020, she had been reluctant until she saw what a help it was. So when her husband, Willie, neared the end of his life, she embraced hospice again.

The Murphys’ house in a leafy Nashville, Tenn., neighborhood is their happy place – full of their treasures.

“He’s good to me – buys me anything I want,” she said, as she pulled a milky glass vase out of a floor-to-ceiling cabinet with mirrored shelves.

Willie bought Mary the display case to help her to show off the trinkets she picks up at estate sales.

Down the hall, Willie was lying in their bed, now unable to speak. His heart was giving out.

“You gonna wake up for a minute?” she asked, cradling his head. She patted his back while he cleared his throat. “Cough it out.”

Mary had been the primary caregiver for her husband, but she gets help from a new hospice agency in Nashville focused on increasing the use of end-of-life comfort care by Black families. Heart and Soul Hospice is owned and operated by people who share the same cultural background as the patients they aim to serve.

In their application to obtain a certificate of need in Tennessee, the hospice owners made it clear they are Black and intend to serve everyone but will focus on African Americans, who are currently underserved. Tennessee data shows that in Nashville just 19% of hospice patients are Black, although they make up 27% of the capital city’s population.

Though the area already had numerous hospice agencies, regulators granted Heart and Soul permission to operate, based primarily on the value of educating an underserved group.

In Ms. Murphy’s first hospice experience, her mother had been living with dementia for decades. Still, Ms. Murphy had concerns about transitioning her mother to hospice. She felt as if she was giving up on her mom.

“My first thought was death,” she said.

National data shows that Black Medicare patients and their families are not making the move to comfort care as often as white patients are. Roughly 41% of Black Medicare beneficiaries who died in 2019 were enrolled in hospice, compared with 54% of White patients, according to data compiled annually by the National Hospice and Palliative Care Organization.

Ms. Murphy’s mother survived nearly 3 years on hospice. The benefit is meant for those in the final 6 months of life, but predicting when the end will come is difficult, especially in cases of dementia. Hospice provides palliative care for the dying and support for caregivers for a long as the process lasts.

Ms. Murphy did most of the caregiving – which can be overwhelming – but hospice helped with a few baths a week, medication in the mail and any medical equipment they needed.

And most important to Ms. Murphy was the emotional support, which came mostly from her hospice nurse.

“Wasn’t no doctor going to come here, hold my hand, stay here until the funeral home came for her,” she said about the day her mother died.

Last year, on the day after Thanksgiving, Willie Murphy died. And the same hospice nurse was at the Murphy home within minutes. She’d already stopped by that morning to check on him and returned as soon as Mary called and told her he wasn’t breathing.

“If you don’t feel like: ‘Oh my God, thank God I have hospice,’ if you can’t say that, then we’re doing something wrong,” said Keisha Mason, Heart and Soul’s director of nursing.

Ms. Mason, like Ms. Murphy, is Black and said that in her view there’s nothing fundamental keeping Black patients from using hospice except learning what the service can offer and that it’s basically free to patients – paid for by Medicare, Medicaid, and most private health plans.

“I say to them, ‘If you see a bill, then call us, because you should not,’” she said.

As Ms. Mason helped launch this new hospice agency, she began using new language, calling hospice more than a Medicare benefit. She describes it as an entitlement.

“Just as you are entitled to unemployment, as you are entitled to Social Security, you are entitled to a hospice benefit,” she said.

The investors in Heart and Soul include David Turner, owner of CNS Hospice in Detroit; Nashville pastor the Rev. Sandy McClain; and André Lee, a former hospital administrator on the campus of Meharry Medical College, a historically Black institution in Nashville.

Mr. Lee and Mr. Turner also started a Black-focused hospice agency in Michigan and have plans to replicate the model in other states.

More families need to consider home hospice as an alternative for end-of-life care, Mr. Lee said. Nursing homes are pricey. And even with Medicare, a hospital bill can be hefty.

“You’ll go in there and they’ll eat you alive,” he said. “I hate to say [something] bad about hospitals, but it’s true.”

Hospice research hasn’t come up with clear reasons to explain the gap between White and Black families’ use of the benefit. Some experts speculate it’s related to spiritual beliefs and widespread mistrust in the medical system because of decades of discrimination.

The hospice industry’s national trade group, the National Hospice and Palliative Care Organization, released a diversity and inclusion toolkit and a guide to reaching more Black patients. It recommends connecting with influential DJs, partnering with Black pastors and simply hiring more Black nurses.

Bridging the gap is not overly complicated, Mr. Lee said.

“A lot of hospices don’t employ enough Black people,” he said. “We all feel comfortable when you see someone over there that looks like you.”

Well-established hospice agencies have attempted to minimize barriers with their own diversity initiatives. Michelle Drayton of Visiting Nurse Service of New York said her large agency has met with ministers who counsel families dealing with failing health.

“Many of them did not fully understand what hospice was,” she said. “They had many of the same sort of misperceptions.”

Every hospice company, whether it’s an upstart or one of the nation’s oldest, can promote end-of-life education and ease care disparities, Ms. Drayton said. “We’re not just handing out a brochure,” she added.

This story is part of a partnership that includes Nashville Public Radio, NPR, and KHN. 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.

This time, it didn’t take much persuading for Mary Murphy to embrace home hospice. When her mother was dying from Alzheimer’s disease in 2020, she had been reluctant until she saw what a help it was. So when her husband, Willie, neared the end of his life, she embraced hospice again.

The Murphys’ house in a leafy Nashville, Tenn., neighborhood is their happy place – full of their treasures.

“He’s good to me – buys me anything I want,” she said, as she pulled a milky glass vase out of a floor-to-ceiling cabinet with mirrored shelves.

Willie bought Mary the display case to help her to show off the trinkets she picks up at estate sales.

Down the hall, Willie was lying in their bed, now unable to speak. His heart was giving out.

“You gonna wake up for a minute?” she asked, cradling his head. She patted his back while he cleared his throat. “Cough it out.”

Mary had been the primary caregiver for her husband, but she gets help from a new hospice agency in Nashville focused on increasing the use of end-of-life comfort care by Black families. Heart and Soul Hospice is owned and operated by people who share the same cultural background as the patients they aim to serve.

In their application to obtain a certificate of need in Tennessee, the hospice owners made it clear they are Black and intend to serve everyone but will focus on African Americans, who are currently underserved. Tennessee data shows that in Nashville just 19% of hospice patients are Black, although they make up 27% of the capital city’s population.

Though the area already had numerous hospice agencies, regulators granted Heart and Soul permission to operate, based primarily on the value of educating an underserved group.

In Ms. Murphy’s first hospice experience, her mother had been living with dementia for decades. Still, Ms. Murphy had concerns about transitioning her mother to hospice. She felt as if she was giving up on her mom.

“My first thought was death,” she said.

National data shows that Black Medicare patients and their families are not making the move to comfort care as often as white patients are. Roughly 41% of Black Medicare beneficiaries who died in 2019 were enrolled in hospice, compared with 54% of White patients, according to data compiled annually by the National Hospice and Palliative Care Organization.

Ms. Murphy’s mother survived nearly 3 years on hospice. The benefit is meant for those in the final 6 months of life, but predicting when the end will come is difficult, especially in cases of dementia. Hospice provides palliative care for the dying and support for caregivers for a long as the process lasts.

Ms. Murphy did most of the caregiving – which can be overwhelming – but hospice helped with a few baths a week, medication in the mail and any medical equipment they needed.

And most important to Ms. Murphy was the emotional support, which came mostly from her hospice nurse.

“Wasn’t no doctor going to come here, hold my hand, stay here until the funeral home came for her,” she said about the day her mother died.

Last year, on the day after Thanksgiving, Willie Murphy died. And the same hospice nurse was at the Murphy home within minutes. She’d already stopped by that morning to check on him and returned as soon as Mary called and told her he wasn’t breathing.

“If you don’t feel like: ‘Oh my God, thank God I have hospice,’ if you can’t say that, then we’re doing something wrong,” said Keisha Mason, Heart and Soul’s director of nursing.

Ms. Mason, like Ms. Murphy, is Black and said that in her view there’s nothing fundamental keeping Black patients from using hospice except learning what the service can offer and that it’s basically free to patients – paid for by Medicare, Medicaid, and most private health plans.

“I say to them, ‘If you see a bill, then call us, because you should not,’” she said.

As Ms. Mason helped launch this new hospice agency, she began using new language, calling hospice more than a Medicare benefit. She describes it as an entitlement.

“Just as you are entitled to unemployment, as you are entitled to Social Security, you are entitled to a hospice benefit,” she said.

The investors in Heart and Soul include David Turner, owner of CNS Hospice in Detroit; Nashville pastor the Rev. Sandy McClain; and André Lee, a former hospital administrator on the campus of Meharry Medical College, a historically Black institution in Nashville.

Mr. Lee and Mr. Turner also started a Black-focused hospice agency in Michigan and have plans to replicate the model in other states.

More families need to consider home hospice as an alternative for end-of-life care, Mr. Lee said. Nursing homes are pricey. And even with Medicare, a hospital bill can be hefty.

“You’ll go in there and they’ll eat you alive,” he said. “I hate to say [something] bad about hospitals, but it’s true.”

Hospice research hasn’t come up with clear reasons to explain the gap between White and Black families’ use of the benefit. Some experts speculate it’s related to spiritual beliefs and widespread mistrust in the medical system because of decades of discrimination.

The hospice industry’s national trade group, the National Hospice and Palliative Care Organization, released a diversity and inclusion toolkit and a guide to reaching more Black patients. It recommends connecting with influential DJs, partnering with Black pastors and simply hiring more Black nurses.

Bridging the gap is not overly complicated, Mr. Lee said.

“A lot of hospices don’t employ enough Black people,” he said. “We all feel comfortable when you see someone over there that looks like you.”

Well-established hospice agencies have attempted to minimize barriers with their own diversity initiatives. Michelle Drayton of Visiting Nurse Service of New York said her large agency has met with ministers who counsel families dealing with failing health.

“Many of them did not fully understand what hospice was,” she said. “They had many of the same sort of misperceptions.”

Every hospice company, whether it’s an upstart or one of the nation’s oldest, can promote end-of-life education and ease care disparities, Ms. Drayton said. “We’re not just handing out a brochure,” she added.

This story is part of a partnership that includes Nashville Public Radio, NPR, and KHN. 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.

Some Americans with a weakened immune system who face high risks for severe COVID-19 become eligible this week to receive a fourth dose of a coronavirus vaccine.

The Centers for Disease Control and Prevention endorsed a third dose of the Pfizer or Moderna vaccines  for moderately and severely immunocompromised people on Aug. 13, which is considered part of their first immunization series rather than a booster shot.

In October, the CDC said moderately and severely immunocompromised people could receive a booster shot, or a fourth dose of the vaccine , 6 months after their third dose.

But the CDC last week shortened the timeline to 5 months for a booster shot of the Pfizer or Moderna vaccines. That means immunocompromised people could begin signing up for a fourth shot later this week, the New York Times reported.

About 2.7% of U.S. adults, or about 7 million adults, are considered immunocompromised, according to the CDC. They’re more likely to contract severe COVID-19, have a higher risk for long COVID, have lower antibody levels after vaccination, and develop serious breakthrough infections. About 40% of hospitalized breakthrough cases are among immunocompromised people.

According to  CDC guidance, people are considered to be “moderately or severely immunocompromised” if they have:

• Active cancer treatment for tumors or cancers of the blood
• Had an organ transplant and are taking medicine to suppress the immune system
• Had a stem cell transplant in the last 2 years and are taking medicine to suppress the immune system
• Advanced or untreated HIV infection
• Moderate or severe primary immunodeficiency, such as DiGeorge syndrome or Wiskott-Aldrich syndrome
• Active treatment with high-dose corticosteroids or other drugs that suppress the immune response

So far, only moderately and severely immunocompromised Americans are eligible for a fourth shot. Israel has begun offering fourth doses to high-risk groups, including older adults, but the Biden administration hasn’t yet said whether the United States will follow, the Times reported.

Overall, the focus remains on getting third shots to Americans who are eligible for boosters, Rochelle Walensky, MD, the CDC director, told reporters Jan. 7. U.S. officials will remain in touch with Israel to follow their data on fourth shots.

“We will be following our own data carefully as well, to see how these boosters are working in terms of waning effectiveness, not just for infection but, importantly, for severe disease,” she said.

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

Some Americans with a weakened immune system who face high risks for severe COVID-19 become eligible this week to receive a fourth dose of a coronavirus vaccine.

The Centers for Disease Control and Prevention endorsed a third dose of the Pfizer or Moderna vaccines  for moderately and severely immunocompromised people on Aug. 13, which is considered part of their first immunization series rather than a booster shot.

In October, the CDC said moderately and severely immunocompromised people could receive a booster shot, or a fourth dose of the vaccine , 6 months after their third dose.

But the CDC last week shortened the timeline to 5 months for a booster shot of the Pfizer or Moderna vaccines. That means immunocompromised people could begin signing up for a fourth shot later this week, the New York Times reported.

About 2.7% of U.S. adults, or about 7 million adults, are considered immunocompromised, according to the CDC. They’re more likely to contract severe COVID-19, have a higher risk for long COVID, have lower antibody levels after vaccination, and develop serious breakthrough infections. About 40% of hospitalized breakthrough cases are among immunocompromised people.

According to  CDC guidance, people are considered to be “moderately or severely immunocompromised” if they have:

• Active cancer treatment for tumors or cancers of the blood
• Had an organ transplant and are taking medicine to suppress the immune system
• Had a stem cell transplant in the last 2 years and are taking medicine to suppress the immune system
• Advanced or untreated HIV infection
• Moderate or severe primary immunodeficiency, such as DiGeorge syndrome or Wiskott-Aldrich syndrome
• Active treatment with high-dose corticosteroids or other drugs that suppress the immune response

So far, only moderately and severely immunocompromised Americans are eligible for a fourth shot. Israel has begun offering fourth doses to high-risk groups, including older adults, but the Biden administration hasn’t yet said whether the United States will follow, the Times reported.

Overall, the focus remains on getting third shots to Americans who are eligible for boosters, Rochelle Walensky, MD, the CDC director, told reporters Jan. 7. U.S. officials will remain in touch with Israel to follow their data on fourth shots.

“We will be following our own data carefully as well, to see how these boosters are working in terms of waning effectiveness, not just for infection but, importantly, for severe disease,” she said.

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

Some Americans with a weakened immune system who face high risks for severe COVID-19 become eligible this week to receive a fourth dose of a coronavirus vaccine.

The Centers for Disease Control and Prevention endorsed a third dose of the Pfizer or Moderna vaccines  for moderately and severely immunocompromised people on Aug. 13, which is considered part of their first immunization series rather than a booster shot.

In October, the CDC said moderately and severely immunocompromised people could receive a booster shot, or a fourth dose of the vaccine , 6 months after their third dose.

But the CDC last week shortened the timeline to 5 months for a booster shot of the Pfizer or Moderna vaccines. That means immunocompromised people could begin signing up for a fourth shot later this week, the New York Times reported.

About 2.7% of U.S. adults, or about 7 million adults, are considered immunocompromised, according to the CDC. They’re more likely to contract severe COVID-19, have a higher risk for long COVID, have lower antibody levels after vaccination, and develop serious breakthrough infections. About 40% of hospitalized breakthrough cases are among immunocompromised people.

According to  CDC guidance, people are considered to be “moderately or severely immunocompromised” if they have:

• Active cancer treatment for tumors or cancers of the blood
• Had an organ transplant and are taking medicine to suppress the immune system
• Had a stem cell transplant in the last 2 years and are taking medicine to suppress the immune system
• Advanced or untreated HIV infection
• Moderate or severe primary immunodeficiency, such as DiGeorge syndrome or Wiskott-Aldrich syndrome
• Active treatment with high-dose corticosteroids or other drugs that suppress the immune response

So far, only moderately and severely immunocompromised Americans are eligible for a fourth shot. Israel has begun offering fourth doses to high-risk groups, including older adults, but the Biden administration hasn’t yet said whether the United States will follow, the Times reported.

Overall, the focus remains on getting third shots to Americans who are eligible for boosters, Rochelle Walensky, MD, the CDC director, told reporters Jan. 7. U.S. officials will remain in touch with Israel to follow their data on fourth shots.

“We will be following our own data carefully as well, to see how these boosters are working in terms of waning effectiveness, not just for infection but, importantly, for severe disease,” she said.

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

The Food and Drug Administration has approved the dual orexin receptor antagonist daridorexant (Quviviq) for the treatment of insomnia in adults, the drug’s manufacturer, Idorsia, has announced.

The FDA’s decision was based partly on a phase 3 trial of adults with moderate to severe insomnia who were randomly assigned to receive 25 or 50 mg of daridorexant or matching placebo. Daridorexant was associated with dose-dependent improvements in wake after sleep onset, total sleep time, and latency to persistent sleep.

Whereas the overall results are very positive, the improvements in daytime functioning are especially “exciting,” Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, said in an interview.

“That’s sort of a big deal. For me, that’s the biggest deal there is,” said Dr. Roth, who was a consultant on the design of the phase 3 trial and on the interpretation of the data.

The drug will be available in doses of 25 mg and 50 mg, and the FDA has recommended that it be classified as a controlled substance. After it is scheduled by the Drug Enforcement Administration, daridorexant is expected to be made available in May.
 

Favorable safety profile

Insomnia is a common disorder characterized by difficulty falling asleep or staying asleep and by early-morning awakenings. Patients with insomnia often report fatigue, irritability, and difficulty with concentration. The condition can also result in significant problems with work and social activities, thus contributing to anxiety or depression.

As with other dual orexin receptor antagonists, daridorexant competitively binds with both orexin receptors in the lateral hypothalamus to block the activity of orexin in a reversible way. This approach decreases the downstream action of the wake-promoting neurotransmitters that are overactive in patients with insomnia.

The phase 3 trial measured daytime functioning using the new Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a patient-reported outcome instrument. Daridorexant was associated with significant improvements in daytime function, particularly in sleepiness and mood.

Previous trials of other dual orexin receptor antagonists did not use the IDSIQ as an outcome, so it is not possible to compare daridorexant with those drugs in this respect, Dr. Roth noted. Researchers also have not conducted head-to-head trials of the drug with other dual orexin receptor antagonists.

Daridorexant also had a favorable safety profile and was not associated with rebound insomnia or withdrawal effects. The most common adverse events were headache and somnolence or fatigue.

“They had no effect on sleep stage distribution [and] they had no significant effects on sleep and breathing in people with mild to moderate sleep apnea,” said Dr. Roth, who presented the phase 3 findings at SLEEP 2020. 

In addition to serving as a consultant for Idorsia on the trial design and interpretation of results, Dr. Roth has also served as a consultant for other companies that develop sleep agents.

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

The Food and Drug Administration has approved the dual orexin receptor antagonist daridorexant (Quviviq) for the treatment of insomnia in adults, the drug’s manufacturer, Idorsia, has announced.

The FDA’s decision was based partly on a phase 3 trial of adults with moderate to severe insomnia who were randomly assigned to receive 25 or 50 mg of daridorexant or matching placebo. Daridorexant was associated with dose-dependent improvements in wake after sleep onset, total sleep time, and latency to persistent sleep.

Whereas the overall results are very positive, the improvements in daytime functioning are especially “exciting,” Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, said in an interview.

“That’s sort of a big deal. For me, that’s the biggest deal there is,” said Dr. Roth, who was a consultant on the design of the phase 3 trial and on the interpretation of the data.

The drug will be available in doses of 25 mg and 50 mg, and the FDA has recommended that it be classified as a controlled substance. After it is scheduled by the Drug Enforcement Administration, daridorexant is expected to be made available in May.
 

Favorable safety profile

Insomnia is a common disorder characterized by difficulty falling asleep or staying asleep and by early-morning awakenings. Patients with insomnia often report fatigue, irritability, and difficulty with concentration. The condition can also result in significant problems with work and social activities, thus contributing to anxiety or depression.

As with other dual orexin receptor antagonists, daridorexant competitively binds with both orexin receptors in the lateral hypothalamus to block the activity of orexin in a reversible way. This approach decreases the downstream action of the wake-promoting neurotransmitters that are overactive in patients with insomnia.

The phase 3 trial measured daytime functioning using the new Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a patient-reported outcome instrument. Daridorexant was associated with significant improvements in daytime function, particularly in sleepiness and mood.

Previous trials of other dual orexin receptor antagonists did not use the IDSIQ as an outcome, so it is not possible to compare daridorexant with those drugs in this respect, Dr. Roth noted. Researchers also have not conducted head-to-head trials of the drug with other dual orexin receptor antagonists.

Daridorexant also had a favorable safety profile and was not associated with rebound insomnia or withdrawal effects. The most common adverse events were headache and somnolence or fatigue.

“They had no effect on sleep stage distribution [and] they had no significant effects on sleep and breathing in people with mild to moderate sleep apnea,” said Dr. Roth, who presented the phase 3 findings at SLEEP 2020. 

In addition to serving as a consultant for Idorsia on the trial design and interpretation of results, Dr. Roth has also served as a consultant for other companies that develop sleep agents.

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

The Food and Drug Administration has approved the dual orexin receptor antagonist daridorexant (Quviviq) for the treatment of insomnia in adults, the drug’s manufacturer, Idorsia, has announced.

The FDA’s decision was based partly on a phase 3 trial of adults with moderate to severe insomnia who were randomly assigned to receive 25 or 50 mg of daridorexant or matching placebo. Daridorexant was associated with dose-dependent improvements in wake after sleep onset, total sleep time, and latency to persistent sleep.

Whereas the overall results are very positive, the improvements in daytime functioning are especially “exciting,” Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, said in an interview.

“That’s sort of a big deal. For me, that’s the biggest deal there is,” said Dr. Roth, who was a consultant on the design of the phase 3 trial and on the interpretation of the data.

The drug will be available in doses of 25 mg and 50 mg, and the FDA has recommended that it be classified as a controlled substance. After it is scheduled by the Drug Enforcement Administration, daridorexant is expected to be made available in May.
 

Favorable safety profile

Insomnia is a common disorder characterized by difficulty falling asleep or staying asleep and by early-morning awakenings. Patients with insomnia often report fatigue, irritability, and difficulty with concentration. The condition can also result in significant problems with work and social activities, thus contributing to anxiety or depression.

As with other dual orexin receptor antagonists, daridorexant competitively binds with both orexin receptors in the lateral hypothalamus to block the activity of orexin in a reversible way. This approach decreases the downstream action of the wake-promoting neurotransmitters that are overactive in patients with insomnia.

The phase 3 trial measured daytime functioning using the new Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a patient-reported outcome instrument. Daridorexant was associated with significant improvements in daytime function, particularly in sleepiness and mood.

Previous trials of other dual orexin receptor antagonists did not use the IDSIQ as an outcome, so it is not possible to compare daridorexant with those drugs in this respect, Dr. Roth noted. Researchers also have not conducted head-to-head trials of the drug with other dual orexin receptor antagonists.

Daridorexant also had a favorable safety profile and was not associated with rebound insomnia or withdrawal effects. The most common adverse events were headache and somnolence or fatigue.

“They had no effect on sleep stage distribution [and] they had no significant effects on sleep and breathing in people with mild to moderate sleep apnea,” said Dr. Roth, who presented the phase 3 findings at SLEEP 2020. 

In addition to serving as a consultant for Idorsia on the trial design and interpretation of results, Dr. Roth has also served as a consultant for other companies that develop sleep agents.

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

SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.

The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.

Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.

The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.

Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.

“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.

Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
 

Not clear if diabetes after COVID-19 is transient or permanent

From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.

From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.

Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.

Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.

In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.

Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.

Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.

Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.

Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.

“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.

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

SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.

The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.

Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.

The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.

Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.

“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.

Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
 

Not clear if diabetes after COVID-19 is transient or permanent

From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.

From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.

Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.

Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.

In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.

Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.

Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.

Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.

Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.

“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.

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

SARS-CoV-2 infection was associated with an increased risk for diabetes among youth, whereas other acute respiratory infections were not, new data from the U.S. Centers for Disease Control and Prevention indicate.

The results from two large U.S. health claims databases were published in an early release in the CDC’s Morbidity and Mortality Weekly Report by Catherine E. Barrett, PhD, and colleagues of the CDC’s COVID-19 Emergency Response Team and Division of Diabetes Translation.

Clinicians should monitor individuals younger than 18 years in the months following a SARS-CoV-2 infection for new diabetes onset, they advise.

The findings, which are supported by independent studies in adults, “underscore the importance of COVID-19 prevention among all age groups, including vaccination for all eligible children and adolescents, and chronic disease prevention and treatment,” Dr. Barrett and colleagues say.

Diabetes type couldn’t be reliably distinguished from the databases, which is noted as an important study limitation.

“SARS-CoV-2 infection might lead to type 1 or type 2 diabetes through complex and differing mechanisms,” they say.

Emerging evidence began to suggest, in mid-2020, that COVID-19 may trigger the onset of diabetes in healthy people. A new global registry was subsequently established to collect data on patients with COVID-19–related diabetes, called the CoviDiab registry.
 

Not clear if diabetes after COVID-19 is transient or permanent

From one of the databases used in the new study, known as IQVIA, 80,893 individuals aged younger than 18 years diagnosed with COVID-19 during March 2020 to February 26, 2021, were compared with age- and sex-matched people during that period who did not have COVID-19 and to prepandemic groups with and without a diagnosis of acute respiratory illness during March 1, 2017, to February 26, 2018.

From the second database, HealthVerity, 439,439 youth diagnosed with COVID-19 during March 1, 2020, to June 28, 2021, were compared with age- and sex-matched youth without COVID-19. Here, there was no prepandemic comparison group.

Diabetes diagnoses were coded in 0.08% with COVID-19 vs. 0.03% without COVID-19 in IQVIA and in 0.25% vs. 0.19% in HealthVerity.

Thus, new diabetes diagnoses were 166% and 31% more likely to occur in those with COVID-19 in IQVIA and HealthVerity, respectively. And in IQVIA, those with COVID-19 were 116% more likely to develop diabetes than were those with prepandemic acute respiratory illnesses. Those differences were all significant, whereas non–SARS-CoV-2 respiratory infections were not associated with diabetes, Dr. Barrett and colleagues say.

In both databases, diabetic ketoacidosis (DKA) was more common at diabetes onset among those with, vs. without, COVID-19: 48.5% vs. 13.6% in IQVIA and 40.2% vs. 29.7% in HealthVerity. In IQVIA, 22.0% with prepandemic acute respiratory illness presented with DKA.

Dr. Barrett and colleagues offer several potential explanations for the observed association between COVID-19 and diabetes, including a direct attack on pancreatic beta cells expressing angiotensin-converting enzyme 2 receptors, or via stress hyperglycemia resulting from cytokine storm and alterations in glucose metabolism.

Another possibility is the precipitation to diabetes from prediabetes; the latter is a condition present in one in five U.S. adolescents.

Steroid treatment during hospitalization might have led to transient hyperglycemia, but only 1.5% to 2.2% of diabetes codes were for drug- or chemical-induced diabetes. The majority were for type 1 or 2.

Alternatively, pandemic-associated weight gain might have also contributed to risks for both severe COVID-19 and type 2 diabetes.

“Although this study can provide information on the risk for diabetes following SARS-CoV-2 infection, additional data are needed to understand underlying pathogenic mechanisms, either those caused by SARS-CoV-2 infection itself or resulting from treatments, and whether a COVID-19–associated diabetes diagnosis is transient or leads to a chronic condition,” Dr. Barrett and colleagues conclude.

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

Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

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

Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

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

Many states have restored restrictions on telehealth use that they suspended earlier in the COVID-19 pandemic, according to a new report jointly prepared by the Reason Institute, the Pioneer Institute, and the Cicero Institute.

Among the most important restrictions that have been reinstated in some states are those barring requirements for insurers to cover telehealth and regulations that prohibit telehealth visits across state lines, unless the physician is licensed in both states.

“Only three states – Arizona, Florida, and Indiana – allow all health care providers to easily practice telehealth across state lines,” says a news release on the think tanks’ report. “Forty-seven others have arbitrary barriers in place that limit patients’ access to specialists and available appointments based purely on residency.”

“Once the [state-based] public health emergency declarations started to end or executive orders were withdrawn, many of the new flexibilities for providers, insurers, and patients were lost overnight,” Vittorio Nastasi, a policy analyst at Reason Foundation and a co-author of the report, says in the news release. “States need to adopt a number of telehealth reforms to provide their residents better access to this safe and effective virtual care.”

On a positive note, the report says, most states have removed the requirement that a patient must first see a provider in person before they can use telehealth services. The exceptions are Tennessee, Alaska, and West Virginia, which require an in-person visit before certain telehealth services can be provided.

In addition, 20 states allow nurse practitioners to conduct telehealth visits without being under the supervision of a physician. Prior to the pandemic, some states allowed only doctors to use telehealth, the report says, but, during the COVID crisis, “the acute shortage of providers in many counties adds to the need for more kinds of providers to be able to use it.”

A number of states place restrictions on the telehealth modalities that can be utilized. Under the definition by the American Telemedicine Association, telehealth includes audio-video visits, remote patient monitoring, and “store and forward” telemedicine, which entails collecting clinical information and sending it to another site for evaluation. The latter method is particularly useful for consultations with specialists, the report notes.
 

Coverage mandates and payment parity

The report also examines other parameters of telehealth regulations in each state, including whether they have telehealth coverage mandates and whether they require physicians to be paid the same amount for similar types of in-person and telehealth visits.

The report views insurance mandates as beneficial, but not if they require coverage of all virtual services. While telehealth can be a game changer for post-stroke care and for other “treatment-intensive conditions,” the report says, the evidence of better outcomes for other conditions treated through telehealth is far less certain. Therefore, it advises states to “protect flexibility so that new innovative models can emerge.”

Ateev Mehrotra, MD, a professor at Harvard Medical School who studies telehealth, agrees that it offers more value in some clinical situations than in others. “High value is improving quality or outcomes at a reasonable cost,” he told this news organization. “If a telemedicine visit for stroke can save a person’s life and prevent disability, let’s pay for it. A telemedicine visit for a cold may not be necessary. Mom’s chicken soup is fine.”

A little over half of the states still require payment parity, according to the report. While these regulations are intended to promote the use of telehealth, the authors note, they can increase the growth of health care costs. Moreover, they argue, it’s hard to defend equal payments for virtual visits when the overhead required to deliver them – such as office rental, utility, and labor costs – is much lower than that for in-person visits. Also, it makes no sense for health systems to charge facility fees for telehealth visits when these visits can be initiated from anywhere, they say.

Dr. Mehrotra concurs with this view. “If you see someone in your office, your fee includes all the overhead for your office, and it’s a substantial cost,” he says. “For many procedures, it’s more than half of the cost. If you have a telemedicine visit and you’re at home, why would you pay the same amount? The visit may take the same amount of time, but all the money that goes for overhead is not accounted for.”
 

Telemedicine across state lines

The report’s contention about the difficulty of conducting telehealth encounters across most state lines seems to be at odds with the growth in the Interstate Medical Licensure Compact, which makes it easier for physicians in one compact member state to get licensed in others. Currently, 35 states belong to the compact, Joe Knickrehm, vice president of communications for the Federation of State Medical Boards, told this news organization.

In addition, he says, “12 state boards issue a special purpose license, telemedicine license or certificate, or license to practice medicine across state lines to allow for the practice of telemedicine.”

The catch, Dr. Mehrotra says, is that, despite the streamlining of license applications in compact member states, the fees charged by the state boards are still very high – a point that the report also makes. “If I want to have broad scope of practice, I’d have to pay thousands of dollars to many states. The license fees start to add up. Also, I have to keep track of each state’s CME requirements, which are all different. Keeping up with all of that is an administration burden, and it’s a pain.”

Mr. Knickrehm contends that obtaining multiple licenses via the compact “is generally less expensive for physicians than the cost of requesting transcripts, fingerprints, and other necessary paperwork each time they apply for licensure in a new state. Physicians are seeing the benefits of an expedited process that allows them to begin practicing more quickly [in other states].”

Dr. Mehrotra says he has seen the same retrenchment in state telehealth regulations that the report references. However, he says, “CMS [the Centers for Medicare & Medicaid Services] has signaled that at least through 2022 and maybe into 2023, they’ll continue their extensions of telemedicine [pandemic regulations].” After that, Congress would have to decide whether to make the changes permanent.

“Right now, it’s hard for me to see how a payer is going to pull back on telehealth, unless there’s ample evidence of overuse of telehealth,” he argues. “With the public and providers liking telehealth, it’s hard to say on theoretical grounds that we should stop using it. That’s why Medicare and others have extended it and why Congress will too.”

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

Patients with complex coronary artery disease (CAD) – either three-vessel disease and/or left main disease – who also had heavy coronary artery calcification (CAC) had greater all-cause mortality 10 years after revascularization, compared with those without such lesions.

However, perhaps unexpectedly, patients with heavily calcified lesions (HCLs) had similar 10-year survival whether they had undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).

These findings from a post hoc analysis of the SYNTAX Extended Survival (SYNTAXES) study led by Hideyuki Kawashima, MD, PhD, National University of Ireland, Galway, and the University of Amsterdam, were published online Dec. 29, 2021, in JACC: Cardiovascular Interventions.

“There was an apparent lack of benefit at very long-term with CABG versus PCI in the presence of HCL,” Dr. Kawashima and corresponding author Patrick W. Serruys, MD, PhD, National University of Ireland and Imperial College London, summarized in a joint email to this news organization.

“Since HCLs – the final status of atherosclerosis and inflammation – reflect the aging process, complexity, and extensiveness of CAD, and comorbidity, it is possible that the currently available revascularization methods do not provide benefit in the prevention of long-term [10-year] mortality,” they suggested.  

In an accompanying editorial, Usman Baber, MD, commented that this study provides a “novel insight.”

Specifically, while patients without HCLs had significantly lower 10-year mortality with CABG versus PCI (18.8% vs. 26.0%; P = .003), an opposite trend was observed among those with HCLs (39.0% vs. 34.0%; P = .26; P int = .005).

The patients with HCLs had higher SYNTAX scores (30.8 vs. 22.4; P < .001) and more complex CAD, so their lack of 10-year mortality benefit with CABG “is somewhat unexpected and warrants further scrutiny,” added Dr. Baber, from the University of Oklahoma Health Sciences Center in Oklahoma City.

Dr. Serruys and Dr. Kawashima agreed that “this study highlights the need for further research on this topic focusing on this specific population with HCLs,” which were 30% of the patients with complex lesions who participated in SYNTAXES.
 

Consider factors beyond coronary anatomy

The current findings reinforce “the importance of considering not just coronary anatomy, but patient age and other comorbid factors when evaluating mode of revascularization,” said Dr. Baber.

“Coronary calcification is a strong factor in deciding between CABG versus PCI, as multiple studies have shown that CAC increases risk after PCI, even with contemporary safe stent platforms,” he explained in an email.

The current study suggests the adverse prognosis associated with CAC also persists for patients treated with CABG.

Dr. Baber said that, “for patients in whom PCI may not be feasible due to extensive and bulky coronary calcification, it is important to emphasize that the benefits of CABG (versus PCI) may not be as significant or durable.”

“The lack of benefit with CABG,” he added, “is likely due to comorbid factors that tend to increase in prevalence with vascular calcification (older age, peripheral arterial disease, renal impairment, etc).”

This study reinforces “the importance of not just considering coronary complexity, but also additional noncoronary factors that influence long-term prognosis in patients with advanced multivessel CAD,” Dr. Baber stressed.

More aggressive lipid-lowering or antithrombotic therapy may improve the prognosis for such patients, he suggested.

“In general,” Dr. Serruys and Dr. Kawashima similarly noted, “for short-/mid-term outcomes, CABG is preferred to PCI in patients with HCLs because of a higher rate of complete revascularization and less need for repeat revascularization.”

“Our findings at 10 years are in line with the general findings preferring CABG in mid and long term, whereas the benefit of very long-term follow-up might be more complex to capture and comprehend,” they concluded. “Whether HCLs require special consideration when deciding the mode of revascularization beyond their contribution to the SYNTAX score deserves further evaluation.

“Newer PCI technology or CABG methods may become a game-changer in the future,” they speculated.
 

Worse clinical outcomes

Heavy coronary calcification is associated with worse clinical outcomes after PCI or CABG, but to date, no trial has compared 10-year outcomes after PCI or CABG in patients with complex CAD with versus without HCLs.

To look at this, Dr. Kawashima and colleagues performed a subanalysis of patients in the SYNTAXES study. The original SYNTAX trial had randomized 1,800 patients with complex CAD who were eligible for either PCI or CABG 1:1 to these two treatments, with a 5-year follow-up, and SYNTAXES extended the follow-up to 10 years.  

Of the 1,800 patients, 532 (29.6%) had at least one HCL and the rest (70.4%) did not.

The median follow-up in SYNTAXES was 11.2 years overall and 11.9 years in survivors.

At baseline, compared with other patients, those with HCLs were older and had a lower body mass index and higher rates of insulin-treated diabetes, hypertension, previous cerebrovascular disease, peripheral vascular disease, chronic obstructive pulmonary disease, chronic kidney disease, and heart failure.

After adjusting for multiple variables, having a HCL was an independent predictor of greater risk of 10-year mortality (hazard ratio, 1.36; 95% confidence interval, 1.09-1.69; P = .006).

In patients without HCLs, mortality was significantly higher after PCI than CABG (HR, 1.44; 95% CI, 1.14-1.83; P = .003), whereas in those with HCLs, there was no significant difference (HR, 0.85; 95% CI, 0.64-1.13; P = .264).

The location of the HCL did not have any impact on 10-year mortality regardless of the assigned treatment.

Among patients with at least one HCL who underwent CABG, those with at least two HCLs had greater 10-year all-cause mortality than those with one HCL; this difference was not seen among patients with at least one HCL who underwent PCI.

The researchers acknowledge study limitations include that it was a post hoc analysis, so it should be considered hypothesis generating.

In addition, SYNTAX was conducted between 2005 and 2007, when PCI mainly used first-generation paclitaxel drug-eluting stents, so the findings may not be generalizable to current practice.

SYNTAXES was supported by the German Foundation of Heart Research. SYNTAX, during 0- to 5-year follow-up, was funded by Boston Scientific. Dr. Serruys reported receiving personal fees from SMT, Philips/Volcano, Xeltis, Novartis, and Meril Life. Dr. Kawashima reported no relevant financial relationships. Dr. Baber reported receiving honoraria and speaker fees from AstraZeneca, Biotronik, and Amgen.

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

Patients with complex coronary artery disease (CAD) – either three-vessel disease and/or left main disease – who also had heavy coronary artery calcification (CAC) had greater all-cause mortality 10 years after revascularization, compared with those without such lesions.

However, perhaps unexpectedly, patients with heavily calcified lesions (HCLs) had similar 10-year survival whether they had undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).

These findings from a post hoc analysis of the SYNTAX Extended Survival (SYNTAXES) study led by Hideyuki Kawashima, MD, PhD, National University of Ireland, Galway, and the University of Amsterdam, were published online Dec. 29, 2021, in JACC: Cardiovascular Interventions.

“There was an apparent lack of benefit at very long-term with CABG versus PCI in the presence of HCL,” Dr. Kawashima and corresponding author Patrick W. Serruys, MD, PhD, National University of Ireland and Imperial College London, summarized in a joint email to this news organization.

“Since HCLs – the final status of atherosclerosis and inflammation – reflect the aging process, complexity, and extensiveness of CAD, and comorbidity, it is possible that the currently available revascularization methods do not provide benefit in the prevention of long-term [10-year] mortality,” they suggested.  

In an accompanying editorial, Usman Baber, MD, commented that this study provides a “novel insight.”

Specifically, while patients without HCLs had significantly lower 10-year mortality with CABG versus PCI (18.8% vs. 26.0%; P = .003), an opposite trend was observed among those with HCLs (39.0% vs. 34.0%; P = .26; P int = .005).

The patients with HCLs had higher SYNTAX scores (30.8 vs. 22.4; P < .001) and more complex CAD, so their lack of 10-year mortality benefit with CABG “is somewhat unexpected and warrants further scrutiny,” added Dr. Baber, from the University of Oklahoma Health Sciences Center in Oklahoma City.

Dr. Serruys and Dr. Kawashima agreed that “this study highlights the need for further research on this topic focusing on this specific population with HCLs,” which were 30% of the patients with complex lesions who participated in SYNTAXES.
 

Consider factors beyond coronary anatomy

The current findings reinforce “the importance of considering not just coronary anatomy, but patient age and other comorbid factors when evaluating mode of revascularization,” said Dr. Baber.

“Coronary calcification is a strong factor in deciding between CABG versus PCI, as multiple studies have shown that CAC increases risk after PCI, even with contemporary safe stent platforms,” he explained in an email.

The current study suggests the adverse prognosis associated with CAC also persists for patients treated with CABG.

Dr. Baber said that, “for patients in whom PCI may not be feasible due to extensive and bulky coronary calcification, it is important to emphasize that the benefits of CABG (versus PCI) may not be as significant or durable.”

“The lack of benefit with CABG,” he added, “is likely due to comorbid factors that tend to increase in prevalence with vascular calcification (older age, peripheral arterial disease, renal impairment, etc).”

This study reinforces “the importance of not just considering coronary complexity, but also additional noncoronary factors that influence long-term prognosis in patients with advanced multivessel CAD,” Dr. Baber stressed.

More aggressive lipid-lowering or antithrombotic therapy may improve the prognosis for such patients, he suggested.

“In general,” Dr. Serruys and Dr. Kawashima similarly noted, “for short-/mid-term outcomes, CABG is preferred to PCI in patients with HCLs because of a higher rate of complete revascularization and less need for repeat revascularization.”

“Our findings at 10 years are in line with the general findings preferring CABG in mid and long term, whereas the benefit of very long-term follow-up might be more complex to capture and comprehend,” they concluded. “Whether HCLs require special consideration when deciding the mode of revascularization beyond their contribution to the SYNTAX score deserves further evaluation.

“Newer PCI technology or CABG methods may become a game-changer in the future,” they speculated.
 

Worse clinical outcomes

Heavy coronary calcification is associated with worse clinical outcomes after PCI or CABG, but to date, no trial has compared 10-year outcomes after PCI or CABG in patients with complex CAD with versus without HCLs.

To look at this, Dr. Kawashima and colleagues performed a subanalysis of patients in the SYNTAXES study. The original SYNTAX trial had randomized 1,800 patients with complex CAD who were eligible for either PCI or CABG 1:1 to these two treatments, with a 5-year follow-up, and SYNTAXES extended the follow-up to 10 years.  

Of the 1,800 patients, 532 (29.6%) had at least one HCL and the rest (70.4%) did not.

The median follow-up in SYNTAXES was 11.2 years overall and 11.9 years in survivors.

At baseline, compared with other patients, those with HCLs were older and had a lower body mass index and higher rates of insulin-treated diabetes, hypertension, previous cerebrovascular disease, peripheral vascular disease, chronic obstructive pulmonary disease, chronic kidney disease, and heart failure.

After adjusting for multiple variables, having a HCL was an independent predictor of greater risk of 10-year mortality (hazard ratio, 1.36; 95% confidence interval, 1.09-1.69; P = .006).

In patients without HCLs, mortality was significantly higher after PCI than CABG (HR, 1.44; 95% CI, 1.14-1.83; P = .003), whereas in those with HCLs, there was no significant difference (HR, 0.85; 95% CI, 0.64-1.13; P = .264).

The location of the HCL did not have any impact on 10-year mortality regardless of the assigned treatment.

Among patients with at least one HCL who underwent CABG, those with at least two HCLs had greater 10-year all-cause mortality than those with one HCL; this difference was not seen among patients with at least one HCL who underwent PCI.

The researchers acknowledge study limitations include that it was a post hoc analysis, so it should be considered hypothesis generating.

In addition, SYNTAX was conducted between 2005 and 2007, when PCI mainly used first-generation paclitaxel drug-eluting stents, so the findings may not be generalizable to current practice.

SYNTAXES was supported by the German Foundation of Heart Research. SYNTAX, during 0- to 5-year follow-up, was funded by Boston Scientific. Dr. Serruys reported receiving personal fees from SMT, Philips/Volcano, Xeltis, Novartis, and Meril Life. Dr. Kawashima reported no relevant financial relationships. Dr. Baber reported receiving honoraria and speaker fees from AstraZeneca, Biotronik, and Amgen.

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

Patients with complex coronary artery disease (CAD) – either three-vessel disease and/or left main disease – who also had heavy coronary artery calcification (CAC) had greater all-cause mortality 10 years after revascularization, compared with those without such lesions.

However, perhaps unexpectedly, patients with heavily calcified lesions (HCLs) had similar 10-year survival whether they had undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).

These findings from a post hoc analysis of the SYNTAX Extended Survival (SYNTAXES) study led by Hideyuki Kawashima, MD, PhD, National University of Ireland, Galway, and the University of Amsterdam, were published online Dec. 29, 2021, in JACC: Cardiovascular Interventions.

“There was an apparent lack of benefit at very long-term with CABG versus PCI in the presence of HCL,” Dr. Kawashima and corresponding author Patrick W. Serruys, MD, PhD, National University of Ireland and Imperial College London, summarized in a joint email to this news organization.

“Since HCLs – the final status of atherosclerosis and inflammation – reflect the aging process, complexity, and extensiveness of CAD, and comorbidity, it is possible that the currently available revascularization methods do not provide benefit in the prevention of long-term [10-year] mortality,” they suggested.  

In an accompanying editorial, Usman Baber, MD, commented that this study provides a “novel insight.”

Specifically, while patients without HCLs had significantly lower 10-year mortality with CABG versus PCI (18.8% vs. 26.0%; P = .003), an opposite trend was observed among those with HCLs (39.0% vs. 34.0%; P = .26; P int = .005).

The patients with HCLs had higher SYNTAX scores (30.8 vs. 22.4; P < .001) and more complex CAD, so their lack of 10-year mortality benefit with CABG “is somewhat unexpected and warrants further scrutiny,” added Dr. Baber, from the University of Oklahoma Health Sciences Center in Oklahoma City.

Dr. Serruys and Dr. Kawashima agreed that “this study highlights the need for further research on this topic focusing on this specific population with HCLs,” which were 30% of the patients with complex lesions who participated in SYNTAXES.
 

Consider factors beyond coronary anatomy

The current findings reinforce “the importance of considering not just coronary anatomy, but patient age and other comorbid factors when evaluating mode of revascularization,” said Dr. Baber.

“Coronary calcification is a strong factor in deciding between CABG versus PCI, as multiple studies have shown that CAC increases risk after PCI, even with contemporary safe stent platforms,” he explained in an email.

The current study suggests the adverse prognosis associated with CAC also persists for patients treated with CABG.

Dr. Baber said that, “for patients in whom PCI may not be feasible due to extensive and bulky coronary calcification, it is important to emphasize that the benefits of CABG (versus PCI) may not be as significant or durable.”

“The lack of benefit with CABG,” he added, “is likely due to comorbid factors that tend to increase in prevalence with vascular calcification (older age, peripheral arterial disease, renal impairment, etc).”

This study reinforces “the importance of not just considering coronary complexity, but also additional noncoronary factors that influence long-term prognosis in patients with advanced multivessel CAD,” Dr. Baber stressed.

More aggressive lipid-lowering or antithrombotic therapy may improve the prognosis for such patients, he suggested.

“In general,” Dr. Serruys and Dr. Kawashima similarly noted, “for short-/mid-term outcomes, CABG is preferred to PCI in patients with HCLs because of a higher rate of complete revascularization and less need for repeat revascularization.”

“Our findings at 10 years are in line with the general findings preferring CABG in mid and long term, whereas the benefit of very long-term follow-up might be more complex to capture and comprehend,” they concluded. “Whether HCLs require special consideration when deciding the mode of revascularization beyond their contribution to the SYNTAX score deserves further evaluation.

“Newer PCI technology or CABG methods may become a game-changer in the future,” they speculated.
 

Worse clinical outcomes

Heavy coronary calcification is associated with worse clinical outcomes after PCI or CABG, but to date, no trial has compared 10-year outcomes after PCI or CABG in patients with complex CAD with versus without HCLs.

To look at this, Dr. Kawashima and colleagues performed a subanalysis of patients in the SYNTAXES study. The original SYNTAX trial had randomized 1,800 patients with complex CAD who were eligible for either PCI or CABG 1:1 to these two treatments, with a 5-year follow-up, and SYNTAXES extended the follow-up to 10 years.  

Of the 1,800 patients, 532 (29.6%) had at least one HCL and the rest (70.4%) did not.

The median follow-up in SYNTAXES was 11.2 years overall and 11.9 years in survivors.

At baseline, compared with other patients, those with HCLs were older and had a lower body mass index and higher rates of insulin-treated diabetes, hypertension, previous cerebrovascular disease, peripheral vascular disease, chronic obstructive pulmonary disease, chronic kidney disease, and heart failure.

After adjusting for multiple variables, having a HCL was an independent predictor of greater risk of 10-year mortality (hazard ratio, 1.36; 95% confidence interval, 1.09-1.69; P = .006).

In patients without HCLs, mortality was significantly higher after PCI than CABG (HR, 1.44; 95% CI, 1.14-1.83; P = .003), whereas in those with HCLs, there was no significant difference (HR, 0.85; 95% CI, 0.64-1.13; P = .264).

The location of the HCL did not have any impact on 10-year mortality regardless of the assigned treatment.

Among patients with at least one HCL who underwent CABG, those with at least two HCLs had greater 10-year all-cause mortality than those with one HCL; this difference was not seen among patients with at least one HCL who underwent PCI.

The researchers acknowledge study limitations include that it was a post hoc analysis, so it should be considered hypothesis generating.

In addition, SYNTAX was conducted between 2005 and 2007, when PCI mainly used first-generation paclitaxel drug-eluting stents, so the findings may not be generalizable to current practice.

SYNTAXES was supported by the German Foundation of Heart Research. SYNTAX, during 0- to 5-year follow-up, was funded by Boston Scientific. Dr. Serruys reported receiving personal fees from SMT, Philips/Volcano, Xeltis, Novartis, and Meril Life. Dr. Kawashima reported no relevant financial relationships. Dr. Baber reported receiving honoraria and speaker fees from AstraZeneca, Biotronik, and Amgen.

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

Alcohol is the most common substance misused by veterans. ¹ Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. ² One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. ³ The disease is characterized by altered mental status, oculomotor findings, and ataxia. ³ Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. ⁴ Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. ³

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.^4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.^5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.⁷ With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.^1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.^9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.¹¹ Acetaminophen may impact an individual’s social well-being as social pain processes.¹¹ It has been shown to blunt reactivity to both physical pain as well as negative stimuli.¹¹

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.¹² In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.¹³ Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

Alcohol is the most common substance misused by veterans. ¹ Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. ² One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. ³ The disease is characterized by altered mental status, oculomotor findings, and ataxia. ³ Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. ⁴ Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. ³

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.^4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.^5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.⁷ With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.^1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.^9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.¹¹ Acetaminophen may impact an individual’s social well-being as social pain processes.¹¹ It has been shown to blunt reactivity to both physical pain as well as negative stimuli.¹¹

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.¹² In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.¹³ Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

Alcohol is the most common substance misused by veterans. ¹ Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. ² One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. ³ The disease is characterized by altered mental status, oculomotor findings, and ataxia. ³ Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. ⁴ Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. ³

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.^4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.^5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.⁷ With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.^1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.^9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.¹¹ Acetaminophen may impact an individual’s social well-being as social pain processes.¹¹ It has been shown to blunt reactivity to both physical pain as well as negative stimuli.¹¹

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.¹² In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.¹³ Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.

According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, AD is associated with difficulty falling asleep, nighttime awakenings, early morning awakenings, increased daytime sleepiness, decreased sleep efficiency, increased arousals, awakenings, and sleep fragmentation, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.

During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:

When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.

How long does it take for you to fall asleep?

Do you wake up in the middle of the night, and for how long? What do you do if you wake up?

When do you wake up in the morning? Is it on your own, or with an alarm clock?

Does this schedule change on nonworkdays?

Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?

Do you snore? Meaning, is there concern for sleep apnea?

Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.

The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”

Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.

Dr. Abbott reported having no financial disclosures.

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