AVAHO

Primary care clinicians across the US are warning cuts to Medicaid in the Trump Administration’s new budget bill could push many of them out of practice and deepen access gaps for patients.

In a recent survey by researchers at the Green Center at Virginia Commonwealth University, in Richmond, Virginia, more than 1 in 4 physicians (26%) said their practice would suffer financially, and those figures were higher for rural doctors (31%) and those working at federally qualified health centers (FQHCs; 60%).

Nearly 70% of the physicians surveyed said the legislation’s tighter eligibility rules would worsen their administrative burdens, according to a June survey of 379 primary care physicians. That figure jumped to 87% among clinicians at FQHCs.

Only 13% of primary care clinicians said the proposed changes to the program were unlikely to affect their practice or patients.

“It’s sobering,” said Rebecca Etz, PhD, a professor of family medicine at Virginia Commonwealth and co-director of the Green Center. “Frontline clinicians are letting us know that reductions in Medicaid, they predict, will severely constrain access — which is already constrained in the US”

For Amy Ellingson, MD, a primary care physician at Three Rivers Family Medicine in Brewster, Washington, those numbers are not abstract.

Medicaid cuts “will seriously hurt our hospital and clinic’s viability since our payer mix is 31% Medicaid,” Ellingson told this news organization. “We are already on the edge due to low reimbursement, and this will only make things worse. It will also reduce patient volumes.”

Her greatest fear, however, is not just for her clinic but also for her patients.

“We don’t have any further cuts to services that we can make,” she said. “So our situation would be about our survival. In the clinic, we are already seeing people get cut from Medicaid due to an increase in paperwork burden. If they don’t have Medicaid, they can’t seek care. This will land them in the ER [emergency room], as all studies have shown.”

That cycle — from loss of primary care to overuse of emergency care to hospital debt — puts institutions like hers on a dangerous path.

“An increase in ER visits with people who are uninsured will then be part of a cycle of bad debt, leaving the hospital further at risk,” she said.

 

Primary Care at Particular Risk

The survey findings came in the wake of the passage in May of the House version of the “One Big Beautiful Bill,” which included more than $800 billion in Medicaid cuts over the next decade. The final version, which passed the Senate by one vote, cut the program by more than $1 trillion between now and 2034 and included monthly work or community service requirements and frequent eligibility verifications.

The Congressional Budget Office estimated roughly 12 million Americans would lose their health care coverage under the bill.

Medicaid currently covers more than 70 million Americans, including low-income families, children, seniors, pregnant women, and people with disabilities. Provisions in the bill would cap state-directed payments to hospitals and nursing facilities, reducing them 10% annually and stripping funding for staffing, patient outreach and care delivery.

Sumana Reddy, MD, a primary care clinician at Acacia Family Medical Group, Salinas, California, said the changes could upend care for the region’s farmworker community.

Requalification requirements for eligibility “will be a real challenge for my patients, many of whom are farmworkers,” Reddy said. “Primary care practices like ours already do a lot of this work, which is unreimbursed. There may be patients who lose Medicaid entirely and will really struggle with their untreated conditions.”

Her practice serves entire families, including young children, parents, and older adults who rely on Medicaid for preventive care, management of chronic diseases, prescriptions, and long-term care.

“This move will adversely affect the health of our community,” Reddy said. “Work requirements may leave elderly uncared for. Everyone will be affected.”

Yalda Jabbarpour, MD, director of the Robert Graham Center for Policy Studies and a practicing family physician in Washington, DC, said the cuts reflect a “deeply concerning trend” in health policy: the “systematic underinvestment” in primary care.

“At a time when more than a third of adults and 15% of children lack a usual source of care, we should be expanding access — not restricting it,” she said.

 

Maternal and Rural Practice in Jeopardy

Midwife Jennifer Seymour, CNM, operates an accredited freestanding birth center in rural New York, where 60% of births are covered by Medicaid. She said any threat to Medicaid funding puts entire communities at risk.

“New York already has too many maternity care deserts as hospitals close because they can’t be financially viable,” said Seymour, founder of Cocoon Wellness and Birth Center in Waverly, New York, about 85 miles south of Syracuse. “If 60% of births are not getting paid for, perinatal deaths of moms and babies will skyrocket over our already abysmal numbers.”

“Where will anyone go for their medical needs when that happens?” she added.

In a Green Center survey conducted in May, 34.7% of clinicians said their practice would become financially unviable if Medicaid reimbursements were cut. Nearly 40% said at least 10% of their patients would likely forgo preventive care.

Etz said while FQHCs and pediatric practices are often hit hardest by Medicaid policy shifts, the data show the financial stress is widespread.

“I was surprised at the large variety of demographics among those who said they’d lose their financial viability,” she said. “It really was small and large practices, hospital-owned, insurance-owned, direct primary care — everybody was predicting an impact.”

 

Ripple Effects Across the System

In the June survey, 74% of respondents predicted an increase in the use of high-cost emergency care by uninsured patients — a number that jumped to 95% among FQHCs.

“What you’re looking at is a reduction in access to primary care, and the ripple effect across the health care system is tremendous,” Etz said. “That means an influx of uninsured patients into hospitals already struggling to repair after the pandemic — patients who are often more complex and expensive to care for.”

Etz cited studies showing the life-and-death stakes of continuous access to primary care.

“A little investment in primary care can yield strong health outcomes,” she said. “When that access is lost, even briefly, mortality rates for manageable conditions like diabetes or Alzheimer’s can skyrocket.”

Jabbarpour agreed.

“In high-cost urban areas like Washington, DC, access to primary care is already strained due to low Medicaid reimbursement rates and provider shortages,” she said. “Cutting Medicaid further will push more patients to delay care until conditions worsen, when treatment becomes more complex and costly.”

 

Clinician Well-Being and the Future Workforce

Clinicians themselves are also under mounting pressure. In the June Green Center survey, 55% of clinicians reported high levels of burnout or moral injury — a number that rose to 68% among FQHC providers.

“Burnout suggests the problem is with the individual. Moral injury is about functioning in an inhumane system, seeing wrong things happen that you could fix, if only someone would let you,” Etz said.

Jabbarpour said the toll on the clinical workforce could be long-lasting.

“Medicaid cuts send a clear signal to early-career physicians: Choosing primary care, especially in underserved communities, comes with greater financial instability and fewer resources to care for patients effectively,” Jabbarpour said. “If we want to retain a new generation of mission-driven doctors, we have to invest in the systems and safety nets that support them.”

Reddy said her practice will likely cease to exist in the long run if reductions restrict what they have done for the past 27 years. “We try to see everyone in the community and provide continuity for our patients,” said Reddy. “It will be emotionally wrenching to have to turn away Medicaid patients we’ve seen for years. So far, we’ve never done that.”

 

A Systemic Warning

Ellingson was blunt about what is at stake.

“Rural hospitals and clinics are at extreme risk of closure should these cuts be put in place,” she said, leading to more health care “deserts.” “Mortality and morbidity in these communities, tragically, will increase quickly if this happens.”

Despite the threat, Etz said many clinicians remain deeply committed to their work.

“Even as they report all the sad things, 77% also reported high professional fulfillment,” she said. “They’re saying, ‘You’re making this hard — but I’ve never felt my work was more important.’”

The sources cited in this story reported having no relevant disclosures.

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

Primary care clinicians across the US are warning cuts to Medicaid in the Trump Administration’s new budget bill could push many of them out of practice and deepen access gaps for patients.

In a recent survey by researchers at the Green Center at Virginia Commonwealth University, in Richmond, Virginia, more than 1 in 4 physicians (26%) said their practice would suffer financially, and those figures were higher for rural doctors (31%) and those working at federally qualified health centers (FQHCs; 60%).

Nearly 70% of the physicians surveyed said the legislation’s tighter eligibility rules would worsen their administrative burdens, according to a June survey of 379 primary care physicians. That figure jumped to 87% among clinicians at FQHCs.

Only 13% of primary care clinicians said the proposed changes to the program were unlikely to affect their practice or patients.

“It’s sobering,” said Rebecca Etz, PhD, a professor of family medicine at Virginia Commonwealth and co-director of the Green Center. “Frontline clinicians are letting us know that reductions in Medicaid, they predict, will severely constrain access — which is already constrained in the US”

For Amy Ellingson, MD, a primary care physician at Three Rivers Family Medicine in Brewster, Washington, those numbers are not abstract.

Medicaid cuts “will seriously hurt our hospital and clinic’s viability since our payer mix is 31% Medicaid,” Ellingson told this news organization. “We are already on the edge due to low reimbursement, and this will only make things worse. It will also reduce patient volumes.”

Her greatest fear, however, is not just for her clinic but also for her patients.

“We don’t have any further cuts to services that we can make,” she said. “So our situation would be about our survival. In the clinic, we are already seeing people get cut from Medicaid due to an increase in paperwork burden. If they don’t have Medicaid, they can’t seek care. This will land them in the ER [emergency room], as all studies have shown.”

That cycle — from loss of primary care to overuse of emergency care to hospital debt — puts institutions like hers on a dangerous path.

“An increase in ER visits with people who are uninsured will then be part of a cycle of bad debt, leaving the hospital further at risk,” she said.

 

Primary Care at Particular Risk

The survey findings came in the wake of the passage in May of the House version of the “One Big Beautiful Bill,” which included more than $800 billion in Medicaid cuts over the next decade. The final version, which passed the Senate by one vote, cut the program by more than $1 trillion between now and 2034 and included monthly work or community service requirements and frequent eligibility verifications.

The Congressional Budget Office estimated roughly 12 million Americans would lose their health care coverage under the bill.

Medicaid currently covers more than 70 million Americans, including low-income families, children, seniors, pregnant women, and people with disabilities. Provisions in the bill would cap state-directed payments to hospitals and nursing facilities, reducing them 10% annually and stripping funding for staffing, patient outreach and care delivery.

Sumana Reddy, MD, a primary care clinician at Acacia Family Medical Group, Salinas, California, said the changes could upend care for the region’s farmworker community.

Requalification requirements for eligibility “will be a real challenge for my patients, many of whom are farmworkers,” Reddy said. “Primary care practices like ours already do a lot of this work, which is unreimbursed. There may be patients who lose Medicaid entirely and will really struggle with their untreated conditions.”

Her practice serves entire families, including young children, parents, and older adults who rely on Medicaid for preventive care, management of chronic diseases, prescriptions, and long-term care.

“This move will adversely affect the health of our community,” Reddy said. “Work requirements may leave elderly uncared for. Everyone will be affected.”

Yalda Jabbarpour, MD, director of the Robert Graham Center for Policy Studies and a practicing family physician in Washington, DC, said the cuts reflect a “deeply concerning trend” in health policy: the “systematic underinvestment” in primary care.

“At a time when more than a third of adults and 15% of children lack a usual source of care, we should be expanding access — not restricting it,” she said.

 

Maternal and Rural Practice in Jeopardy

Midwife Jennifer Seymour, CNM, operates an accredited freestanding birth center in rural New York, where 60% of births are covered by Medicaid. She said any threat to Medicaid funding puts entire communities at risk.

“New York already has too many maternity care deserts as hospitals close because they can’t be financially viable,” said Seymour, founder of Cocoon Wellness and Birth Center in Waverly, New York, about 85 miles south of Syracuse. “If 60% of births are not getting paid for, perinatal deaths of moms and babies will skyrocket over our already abysmal numbers.”

“Where will anyone go for their medical needs when that happens?” she added.

In a Green Center survey conducted in May, 34.7% of clinicians said their practice would become financially unviable if Medicaid reimbursements were cut. Nearly 40% said at least 10% of their patients would likely forgo preventive care.

Etz said while FQHCs and pediatric practices are often hit hardest by Medicaid policy shifts, the data show the financial stress is widespread.

“I was surprised at the large variety of demographics among those who said they’d lose their financial viability,” she said. “It really was small and large practices, hospital-owned, insurance-owned, direct primary care — everybody was predicting an impact.”

 

Ripple Effects Across the System

In the June survey, 74% of respondents predicted an increase in the use of high-cost emergency care by uninsured patients — a number that jumped to 95% among FQHCs.

“What you’re looking at is a reduction in access to primary care, and the ripple effect across the health care system is tremendous,” Etz said. “That means an influx of uninsured patients into hospitals already struggling to repair after the pandemic — patients who are often more complex and expensive to care for.”

Etz cited studies showing the life-and-death stakes of continuous access to primary care.

“A little investment in primary care can yield strong health outcomes,” she said. “When that access is lost, even briefly, mortality rates for manageable conditions like diabetes or Alzheimer’s can skyrocket.”

Jabbarpour agreed.

“In high-cost urban areas like Washington, DC, access to primary care is already strained due to low Medicaid reimbursement rates and provider shortages,” she said. “Cutting Medicaid further will push more patients to delay care until conditions worsen, when treatment becomes more complex and costly.”

 

Clinician Well-Being and the Future Workforce

Clinicians themselves are also under mounting pressure. In the June Green Center survey, 55% of clinicians reported high levels of burnout or moral injury — a number that rose to 68% among FQHC providers.

“Burnout suggests the problem is with the individual. Moral injury is about functioning in an inhumane system, seeing wrong things happen that you could fix, if only someone would let you,” Etz said.

Jabbarpour said the toll on the clinical workforce could be long-lasting.

“Medicaid cuts send a clear signal to early-career physicians: Choosing primary care, especially in underserved communities, comes with greater financial instability and fewer resources to care for patients effectively,” Jabbarpour said. “If we want to retain a new generation of mission-driven doctors, we have to invest in the systems and safety nets that support them.”

Reddy said her practice will likely cease to exist in the long run if reductions restrict what they have done for the past 27 years. “We try to see everyone in the community and provide continuity for our patients,” said Reddy. “It will be emotionally wrenching to have to turn away Medicaid patients we’ve seen for years. So far, we’ve never done that.”

 

A Systemic Warning

Ellingson was blunt about what is at stake.

“Rural hospitals and clinics are at extreme risk of closure should these cuts be put in place,” she said, leading to more health care “deserts.” “Mortality and morbidity in these communities, tragically, will increase quickly if this happens.”

Despite the threat, Etz said many clinicians remain deeply committed to their work.

“Even as they report all the sad things, 77% also reported high professional fulfillment,” she said. “They’re saying, ‘You’re making this hard — but I’ve never felt my work was more important.’”

The sources cited in this story reported having no relevant disclosures.

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

Primary care clinicians across the US are warning cuts to Medicaid in the Trump Administration’s new budget bill could push many of them out of practice and deepen access gaps for patients.

In a recent survey by researchers at the Green Center at Virginia Commonwealth University, in Richmond, Virginia, more than 1 in 4 physicians (26%) said their practice would suffer financially, and those figures were higher for rural doctors (31%) and those working at federally qualified health centers (FQHCs; 60%).

Nearly 70% of the physicians surveyed said the legislation’s tighter eligibility rules would worsen their administrative burdens, according to a June survey of 379 primary care physicians. That figure jumped to 87% among clinicians at FQHCs.

Only 13% of primary care clinicians said the proposed changes to the program were unlikely to affect their practice or patients.

“It’s sobering,” said Rebecca Etz, PhD, a professor of family medicine at Virginia Commonwealth and co-director of the Green Center. “Frontline clinicians are letting us know that reductions in Medicaid, they predict, will severely constrain access — which is already constrained in the US”

For Amy Ellingson, MD, a primary care physician at Three Rivers Family Medicine in Brewster, Washington, those numbers are not abstract.

Medicaid cuts “will seriously hurt our hospital and clinic’s viability since our payer mix is 31% Medicaid,” Ellingson told this news organization. “We are already on the edge due to low reimbursement, and this will only make things worse. It will also reduce patient volumes.”

Her greatest fear, however, is not just for her clinic but also for her patients.

“We don’t have any further cuts to services that we can make,” she said. “So our situation would be about our survival. In the clinic, we are already seeing people get cut from Medicaid due to an increase in paperwork burden. If they don’t have Medicaid, they can’t seek care. This will land them in the ER [emergency room], as all studies have shown.”

That cycle — from loss of primary care to overuse of emergency care to hospital debt — puts institutions like hers on a dangerous path.

“An increase in ER visits with people who are uninsured will then be part of a cycle of bad debt, leaving the hospital further at risk,” she said.

 

Primary Care at Particular Risk

The survey findings came in the wake of the passage in May of the House version of the “One Big Beautiful Bill,” which included more than $800 billion in Medicaid cuts over the next decade. The final version, which passed the Senate by one vote, cut the program by more than $1 trillion between now and 2034 and included monthly work or community service requirements and frequent eligibility verifications.

The Congressional Budget Office estimated roughly 12 million Americans would lose their health care coverage under the bill.

Medicaid currently covers more than 70 million Americans, including low-income families, children, seniors, pregnant women, and people with disabilities. Provisions in the bill would cap state-directed payments to hospitals and nursing facilities, reducing them 10% annually and stripping funding for staffing, patient outreach and care delivery.

Sumana Reddy, MD, a primary care clinician at Acacia Family Medical Group, Salinas, California, said the changes could upend care for the region’s farmworker community.

Requalification requirements for eligibility “will be a real challenge for my patients, many of whom are farmworkers,” Reddy said. “Primary care practices like ours already do a lot of this work, which is unreimbursed. There may be patients who lose Medicaid entirely and will really struggle with their untreated conditions.”

Her practice serves entire families, including young children, parents, and older adults who rely on Medicaid for preventive care, management of chronic diseases, prescriptions, and long-term care.

“This move will adversely affect the health of our community,” Reddy said. “Work requirements may leave elderly uncared for. Everyone will be affected.”

Yalda Jabbarpour, MD, director of the Robert Graham Center for Policy Studies and a practicing family physician in Washington, DC, said the cuts reflect a “deeply concerning trend” in health policy: the “systematic underinvestment” in primary care.

“At a time when more than a third of adults and 15% of children lack a usual source of care, we should be expanding access — not restricting it,” she said.

 

Maternal and Rural Practice in Jeopardy

Midwife Jennifer Seymour, CNM, operates an accredited freestanding birth center in rural New York, where 60% of births are covered by Medicaid. She said any threat to Medicaid funding puts entire communities at risk.

“New York already has too many maternity care deserts as hospitals close because they can’t be financially viable,” said Seymour, founder of Cocoon Wellness and Birth Center in Waverly, New York, about 85 miles south of Syracuse. “If 60% of births are not getting paid for, perinatal deaths of moms and babies will skyrocket over our already abysmal numbers.”

“Where will anyone go for their medical needs when that happens?” she added.

In a Green Center survey conducted in May, 34.7% of clinicians said their practice would become financially unviable if Medicaid reimbursements were cut. Nearly 40% said at least 10% of their patients would likely forgo preventive care.

Etz said while FQHCs and pediatric practices are often hit hardest by Medicaid policy shifts, the data show the financial stress is widespread.

“I was surprised at the large variety of demographics among those who said they’d lose their financial viability,” she said. “It really was small and large practices, hospital-owned, insurance-owned, direct primary care — everybody was predicting an impact.”

 

Ripple Effects Across the System

In the June survey, 74% of respondents predicted an increase in the use of high-cost emergency care by uninsured patients — a number that jumped to 95% among FQHCs.

“What you’re looking at is a reduction in access to primary care, and the ripple effect across the health care system is tremendous,” Etz said. “That means an influx of uninsured patients into hospitals already struggling to repair after the pandemic — patients who are often more complex and expensive to care for.”

Etz cited studies showing the life-and-death stakes of continuous access to primary care.

“A little investment in primary care can yield strong health outcomes,” she said. “When that access is lost, even briefly, mortality rates for manageable conditions like diabetes or Alzheimer’s can skyrocket.”

Jabbarpour agreed.

“In high-cost urban areas like Washington, DC, access to primary care is already strained due to low Medicaid reimbursement rates and provider shortages,” she said. “Cutting Medicaid further will push more patients to delay care until conditions worsen, when treatment becomes more complex and costly.”

 

Clinician Well-Being and the Future Workforce

Clinicians themselves are also under mounting pressure. In the June Green Center survey, 55% of clinicians reported high levels of burnout or moral injury — a number that rose to 68% among FQHC providers.

“Burnout suggests the problem is with the individual. Moral injury is about functioning in an inhumane system, seeing wrong things happen that you could fix, if only someone would let you,” Etz said.

Jabbarpour said the toll on the clinical workforce could be long-lasting.

“Medicaid cuts send a clear signal to early-career physicians: Choosing primary care, especially in underserved communities, comes with greater financial instability and fewer resources to care for patients effectively,” Jabbarpour said. “If we want to retain a new generation of mission-driven doctors, we have to invest in the systems and safety nets that support them.”

Reddy said her practice will likely cease to exist in the long run if reductions restrict what they have done for the past 27 years. “We try to see everyone in the community and provide continuity for our patients,” said Reddy. “It will be emotionally wrenching to have to turn away Medicaid patients we’ve seen for years. So far, we’ve never done that.”

 

A Systemic Warning

Ellingson was blunt about what is at stake.

“Rural hospitals and clinics are at extreme risk of closure should these cuts be put in place,” she said, leading to more health care “deserts.” “Mortality and morbidity in these communities, tragically, will increase quickly if this happens.”

Despite the threat, Etz said many clinicians remain deeply committed to their work.

“Even as they report all the sad things, 77% also reported high professional fulfillment,” she said. “They’re saying, ‘You’re making this hard — but I’ve never felt my work was more important.’”

The sources cited in this story reported having no relevant disclosures.

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

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in combination with sertraline, for the treatment of adults with posttraumatic stress disorder (PTSD).

If approved, it would be the first new treatment for PTSD in more than 20 years.

“It is my hope that the FDA does approve this treatment for two related reasons — the data look positive and compelling, and there’s a tremendous unmet need in PTSD,” Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization.

 

What’s in the Treatment Toolbox Now?

PTSD is a “common, severe, and nonremitting condition,” McIntyre noted. According to the National Center for PTSD, the condition affects roughly 13 million adults in the US in any given year. This represents about 5% of the adult population.

PTSD can develop following exposure to traumatic events such as combat, assault, disasters, or severe accidents. Core symptoms of PTSD include intrusive memories and flashbacks, avoidance behaviors, negative alterations in mood and cognition, and hyperarousal.

Currently, the selective serotonin reuptake inhibitors (SSRI), sertraline and paroxetine, are the only FDA-approved medications for PTSD, and while these medications can be effective, many patients fail to achieve remission or discontinue treatment due to adverse effects or lack of response.

Other medications used off-label to treat PTSD — including prazosin, mirtazapine, atypical antipsychotics, and mood stabilizers — have shown variable efficacy. 

There has not been a new FDA-approved drug for PTSD in over two decades, underscoring the need for better therapeutic options, particularly for patients who do not fully respond to SSRI alone.

 

Why Brexpiprazole Plus Sertraline?

Brexpiprazole is an atypical antipsychotic currently approved as adjunctive treatment of major depressive disorder (MDD) in adults; treatment of schizophrenia in adults and adolescents aged 13 years or older; and treatment of agitation associated with Alzheimer’s dementia.

The combination of brexpiprazole and sertraline could address the limitations of SSRI alone by working synergistically to treat PTSD.

Sertraline increases serotonin levels in the brain to improve mood and reduce anxiety. Brexpiprazole has a complex mechanism of action involving multiple neurotransmitter systems, including but not limited to serotonin and dopamine.

Together, they may target different aspects of PTSD, potentially leading to a more comprehensive reduction in symptoms.

 

What Do the Phase 3 Data Show?

In a pivotal, double-blind, randomized controlled, phase 3 trial, brexpiprazole plus sertraline provided significantly greater relief of PTSD symptoms than sertraline plus placebo.

The results were published late last year in JAMA Psychiatry and reported by this news organization at that time.

The trial enrolled 416 adults (mean age, 37 years; 75% women) aged 18-65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of PTSD and symptoms for at least 6 months prior to screening.

At baseline, participants had a mean Clinician Administered PTSD Scale (CAPS-5) for DSM-5 total score of 38.4, indicating moderate to high severity PTSD. The average time from the index traumatic event was 4 years, and three fourths had no prior exposure to PTSD prescription medications.

Participants underwent a 1-week placebo run-in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

At week 10, brexpiprazole plus sertraline demonstrated statistically significant greater improvement in the CAPS-5 total score (primary outcome) than sertraline plus placebo (mean change, -19.2 points vs -13.6 points; P < .001).

Brexpiprazole plus sertraline also led to statistically significant greater improvement on all key secondary and other efficacy endpoints, both clinician-reported and patient-reported, including measures of anxiety, depression, intrusive symptoms, hyperarousal, and overall functioning.

Combining an atypical antipsychotic with an antidepressant for PTSD “builds on what we’ve been doing in depression,” Elspeth Ritchie, MD, chair of Psychiatry, MedStar Washington Hospital Center, Washington, DC, noted in an interview with this news organization.

“We have found that a combination of a low-dose antipsychotic and an antidepressant is helpful for depression, so it makes sense that it will be helpful for PTSD. However, this has been mostly based on clinical decisions, without a heavy research background. Good science is always helpful to support those clinical decisions,” Ritchie told this news organization.

 

What About Safety?

In the phase 3 trial, brexpiprazole plus sertraline had a safety profile consistent with that of brexpiprazole in approved indications. The rate of discontinuation due to adverse events was low (3.9% for brexpiprazole plus sertraline vs 10.2% for sertraline plus placebo), indicating that most participants tolerated the brexpiprazole and sertraline combination treatment, the study team said.

In both treatment groups, the only treatment-emergent adverse event (TEAE) with incidence greater than 10% was nausea, a known adverse effect of sertraline treatment.

Weight gain was greater in participants receiving the combination. At the last visit, a weight gain of 7% or greater from week 1 was experienced by 8% of participants taking brexpiprazole with the sertraline group and 5% of those taking the sertraline plus placebo. Previous analyses in schizophrenia and MDD show that brexpiprazole is associated with moderate weight gain (+3 to 4 kg over 1 year).

The incidence of sedating TEAEs (a concern with some antipsychotics) was generally low, although fatigue (7% vs 4%) and somnolence (5% vs 3%) were more common with brexpiprazole plus sertraline than with sertraline alone.

There were no clinically meaningful between-group differences in changes in laboratory test parameters, vital signs, or ECG and participant-reported TEAEs related to suicidality.

 

Potential Concerns

As with any new drug application, several questions and issues are likely to be raised by the advisory committee. They could include whether the clinical benefit is substantial enough to warrant approval and how the observed effect sizes compare to existing approved therapies and evidence-based psychotherapies.

McIntyre told this news organization what’s particularly noteworthy is that the magnitude of the improvement in PTSD symptoms with brexpiprazole plus sertraline is greater than with sertraline alone. “That’s a very important statement. And this high level of efficacy was consistent on the secondary outcome measures, and the overall tolerability and safety seemed very acceptable,” he said.

What’s equally important, said McIntyre, is that most people with PTSD have depression and anxiety, and the brexpiprazole plus sertraline combination was more helpful than sertraline alone on the measures of anxiety and depression. “This is really important, especially in light of the fact that this medication [brexpiprazole] is already approved for adults living with major depressive disorder and inadequate response to antidepressants,” McIntyre said.

McIntyre added he suspects some questions the committee may have could relate to the extent to which it’s the case that brexpiprazole is effective in PTSD regardless of the antidepressant that is prescribed with it.

“There also will be the inevitable questions about the absence of long-term data which I think will need to be addressed given how chronic and relapse prone this condition is,” McIntyre said.

The committee may ask how trauma and PTSD will be screened in primary care and how outcomes related to this therapy will be evaluated in everyday clinical practice, McIntyre said.

Overall, McIntyre said brexpiprazole plus sertraline in PTSD is a “very positive” development for the field.

“PTSD is a terrible condition. It’s so darn common, and we just don’t have enough treatments for it. The data look good for my perspective. My fingers are crossed for the patients with PTSD and their families,” said McIntyre.

Ritchie reported having no relevant disclosures. McIntyre received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and atai Life Sciences. McIntyre is a CEO of Braxia Scientific Corp.

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

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in combination with sertraline, for the treatment of adults with posttraumatic stress disorder (PTSD).

If approved, it would be the first new treatment for PTSD in more than 20 years.

“It is my hope that the FDA does approve this treatment for two related reasons — the data look positive and compelling, and there’s a tremendous unmet need in PTSD,” Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization.

 

What’s in the Treatment Toolbox Now?

PTSD is a “common, severe, and nonremitting condition,” McIntyre noted. According to the National Center for PTSD, the condition affects roughly 13 million adults in the US in any given year. This represents about 5% of the adult population.

PTSD can develop following exposure to traumatic events such as combat, assault, disasters, or severe accidents. Core symptoms of PTSD include intrusive memories and flashbacks, avoidance behaviors, negative alterations in mood and cognition, and hyperarousal.

Currently, the selective serotonin reuptake inhibitors (SSRI), sertraline and paroxetine, are the only FDA-approved medications for PTSD, and while these medications can be effective, many patients fail to achieve remission or discontinue treatment due to adverse effects or lack of response.

Other medications used off-label to treat PTSD — including prazosin, mirtazapine, atypical antipsychotics, and mood stabilizers — have shown variable efficacy. 

There has not been a new FDA-approved drug for PTSD in over two decades, underscoring the need for better therapeutic options, particularly for patients who do not fully respond to SSRI alone.

 

Why Brexpiprazole Plus Sertraline?

Brexpiprazole is an atypical antipsychotic currently approved as adjunctive treatment of major depressive disorder (MDD) in adults; treatment of schizophrenia in adults and adolescents aged 13 years or older; and treatment of agitation associated with Alzheimer’s dementia.

The combination of brexpiprazole and sertraline could address the limitations of SSRI alone by working synergistically to treat PTSD.

Sertraline increases serotonin levels in the brain to improve mood and reduce anxiety. Brexpiprazole has a complex mechanism of action involving multiple neurotransmitter systems, including but not limited to serotonin and dopamine.

Together, they may target different aspects of PTSD, potentially leading to a more comprehensive reduction in symptoms.

 

What Do the Phase 3 Data Show?

In a pivotal, double-blind, randomized controlled, phase 3 trial, brexpiprazole plus sertraline provided significantly greater relief of PTSD symptoms than sertraline plus placebo.

The results were published late last year in JAMA Psychiatry and reported by this news organization at that time.

The trial enrolled 416 adults (mean age, 37 years; 75% women) aged 18-65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of PTSD and symptoms for at least 6 months prior to screening.

At baseline, participants had a mean Clinician Administered PTSD Scale (CAPS-5) for DSM-5 total score of 38.4, indicating moderate to high severity PTSD. The average time from the index traumatic event was 4 years, and three fourths had no prior exposure to PTSD prescription medications.

Participants underwent a 1-week placebo run-in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

At week 10, brexpiprazole plus sertraline demonstrated statistically significant greater improvement in the CAPS-5 total score (primary outcome) than sertraline plus placebo (mean change, -19.2 points vs -13.6 points; P < .001).

Brexpiprazole plus sertraline also led to statistically significant greater improvement on all key secondary and other efficacy endpoints, both clinician-reported and patient-reported, including measures of anxiety, depression, intrusive symptoms, hyperarousal, and overall functioning.

Combining an atypical antipsychotic with an antidepressant for PTSD “builds on what we’ve been doing in depression,” Elspeth Ritchie, MD, chair of Psychiatry, MedStar Washington Hospital Center, Washington, DC, noted in an interview with this news organization.

“We have found that a combination of a low-dose antipsychotic and an antidepressant is helpful for depression, so it makes sense that it will be helpful for PTSD. However, this has been mostly based on clinical decisions, without a heavy research background. Good science is always helpful to support those clinical decisions,” Ritchie told this news organization.

 

What About Safety?

In the phase 3 trial, brexpiprazole plus sertraline had a safety profile consistent with that of brexpiprazole in approved indications. The rate of discontinuation due to adverse events was low (3.9% for brexpiprazole plus sertraline vs 10.2% for sertraline plus placebo), indicating that most participants tolerated the brexpiprazole and sertraline combination treatment, the study team said.

In both treatment groups, the only treatment-emergent adverse event (TEAE) with incidence greater than 10% was nausea, a known adverse effect of sertraline treatment.

Weight gain was greater in participants receiving the combination. At the last visit, a weight gain of 7% or greater from week 1 was experienced by 8% of participants taking brexpiprazole with the sertraline group and 5% of those taking the sertraline plus placebo. Previous analyses in schizophrenia and MDD show that brexpiprazole is associated with moderate weight gain (+3 to 4 kg over 1 year).

The incidence of sedating TEAEs (a concern with some antipsychotics) was generally low, although fatigue (7% vs 4%) and somnolence (5% vs 3%) were more common with brexpiprazole plus sertraline than with sertraline alone.

There were no clinically meaningful between-group differences in changes in laboratory test parameters, vital signs, or ECG and participant-reported TEAEs related to suicidality.

 

Potential Concerns

As with any new drug application, several questions and issues are likely to be raised by the advisory committee. They could include whether the clinical benefit is substantial enough to warrant approval and how the observed effect sizes compare to existing approved therapies and evidence-based psychotherapies.

McIntyre told this news organization what’s particularly noteworthy is that the magnitude of the improvement in PTSD symptoms with brexpiprazole plus sertraline is greater than with sertraline alone. “That’s a very important statement. And this high level of efficacy was consistent on the secondary outcome measures, and the overall tolerability and safety seemed very acceptable,” he said.

What’s equally important, said McIntyre, is that most people with PTSD have depression and anxiety, and the brexpiprazole plus sertraline combination was more helpful than sertraline alone on the measures of anxiety and depression. “This is really important, especially in light of the fact that this medication [brexpiprazole] is already approved for adults living with major depressive disorder and inadequate response to antidepressants,” McIntyre said.

McIntyre added he suspects some questions the committee may have could relate to the extent to which it’s the case that brexpiprazole is effective in PTSD regardless of the antidepressant that is prescribed with it.

“There also will be the inevitable questions about the absence of long-term data which I think will need to be addressed given how chronic and relapse prone this condition is,” McIntyre said.

The committee may ask how trauma and PTSD will be screened in primary care and how outcomes related to this therapy will be evaluated in everyday clinical practice, McIntyre said.

Overall, McIntyre said brexpiprazole plus sertraline in PTSD is a “very positive” development for the field.

“PTSD is a terrible condition. It’s so darn common, and we just don’t have enough treatments for it. The data look good for my perspective. My fingers are crossed for the patients with PTSD and their families,” said McIntyre.

Ritchie reported having no relevant disclosures. McIntyre received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and atai Life Sciences. McIntyre is a CEO of Braxia Scientific Corp.

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

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in combination with sertraline, for the treatment of adults with posttraumatic stress disorder (PTSD).

If approved, it would be the first new treatment for PTSD in more than 20 years.

“It is my hope that the FDA does approve this treatment for two related reasons — the data look positive and compelling, and there’s a tremendous unmet need in PTSD,” Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the Mood Disorders Psychopharmacology Unit, University of Toronto, Toronto, Ontario, Canada, told this news organization.

 

What’s in the Treatment Toolbox Now?

PTSD is a “common, severe, and nonremitting condition,” McIntyre noted. According to the National Center for PTSD, the condition affects roughly 13 million adults in the US in any given year. This represents about 5% of the adult population.

PTSD can develop following exposure to traumatic events such as combat, assault, disasters, or severe accidents. Core symptoms of PTSD include intrusive memories and flashbacks, avoidance behaviors, negative alterations in mood and cognition, and hyperarousal.

Currently, the selective serotonin reuptake inhibitors (SSRI), sertraline and paroxetine, are the only FDA-approved medications for PTSD, and while these medications can be effective, many patients fail to achieve remission or discontinue treatment due to adverse effects or lack of response.

Other medications used off-label to treat PTSD — including prazosin, mirtazapine, atypical antipsychotics, and mood stabilizers — have shown variable efficacy. 

There has not been a new FDA-approved drug for PTSD in over two decades, underscoring the need for better therapeutic options, particularly for patients who do not fully respond to SSRI alone.

 

Why Brexpiprazole Plus Sertraline?

Brexpiprazole is an atypical antipsychotic currently approved as adjunctive treatment of major depressive disorder (MDD) in adults; treatment of schizophrenia in adults and adolescents aged 13 years or older; and treatment of agitation associated with Alzheimer’s dementia.

The combination of brexpiprazole and sertraline could address the limitations of SSRI alone by working synergistically to treat PTSD.

Sertraline increases serotonin levels in the brain to improve mood and reduce anxiety. Brexpiprazole has a complex mechanism of action involving multiple neurotransmitter systems, including but not limited to serotonin and dopamine.

Together, they may target different aspects of PTSD, potentially leading to a more comprehensive reduction in symptoms.

 

What Do the Phase 3 Data Show?

In a pivotal, double-blind, randomized controlled, phase 3 trial, brexpiprazole plus sertraline provided significantly greater relief of PTSD symptoms than sertraline plus placebo.

The results were published late last year in JAMA Psychiatry and reported by this news organization at that time.

The trial enrolled 416 adults (mean age, 37 years; 75% women) aged 18-65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of PTSD and symptoms for at least 6 months prior to screening.

At baseline, participants had a mean Clinician Administered PTSD Scale (CAPS-5) for DSM-5 total score of 38.4, indicating moderate to high severity PTSD. The average time from the index traumatic event was 4 years, and three fourths had no prior exposure to PTSD prescription medications.

Participants underwent a 1-week placebo run-in period followed by randomization to daily oral brexpiprazole 2-3 mg plus sertraline 150 mg or daily sertraline 150 mg plus placebo for 11 weeks.

At week 10, brexpiprazole plus sertraline demonstrated statistically significant greater improvement in the CAPS-5 total score (primary outcome) than sertraline plus placebo (mean change, -19.2 points vs -13.6 points; P < .001).

Brexpiprazole plus sertraline also led to statistically significant greater improvement on all key secondary and other efficacy endpoints, both clinician-reported and patient-reported, including measures of anxiety, depression, intrusive symptoms, hyperarousal, and overall functioning.

Combining an atypical antipsychotic with an antidepressant for PTSD “builds on what we’ve been doing in depression,” Elspeth Ritchie, MD, chair of Psychiatry, MedStar Washington Hospital Center, Washington, DC, noted in an interview with this news organization.

“We have found that a combination of a low-dose antipsychotic and an antidepressant is helpful for depression, so it makes sense that it will be helpful for PTSD. However, this has been mostly based on clinical decisions, without a heavy research background. Good science is always helpful to support those clinical decisions,” Ritchie told this news organization.

 

What About Safety?

In the phase 3 trial, brexpiprazole plus sertraline had a safety profile consistent with that of brexpiprazole in approved indications. The rate of discontinuation due to adverse events was low (3.9% for brexpiprazole plus sertraline vs 10.2% for sertraline plus placebo), indicating that most participants tolerated the brexpiprazole and sertraline combination treatment, the study team said.

In both treatment groups, the only treatment-emergent adverse event (TEAE) with incidence greater than 10% was nausea, a known adverse effect of sertraline treatment.

Weight gain was greater in participants receiving the combination. At the last visit, a weight gain of 7% or greater from week 1 was experienced by 8% of participants taking brexpiprazole with the sertraline group and 5% of those taking the sertraline plus placebo. Previous analyses in schizophrenia and MDD show that brexpiprazole is associated with moderate weight gain (+3 to 4 kg over 1 year).

The incidence of sedating TEAEs (a concern with some antipsychotics) was generally low, although fatigue (7% vs 4%) and somnolence (5% vs 3%) were more common with brexpiprazole plus sertraline than with sertraline alone.

There were no clinically meaningful between-group differences in changes in laboratory test parameters, vital signs, or ECG and participant-reported TEAEs related to suicidality.

 

Potential Concerns

As with any new drug application, several questions and issues are likely to be raised by the advisory committee. They could include whether the clinical benefit is substantial enough to warrant approval and how the observed effect sizes compare to existing approved therapies and evidence-based psychotherapies.

McIntyre told this news organization what’s particularly noteworthy is that the magnitude of the improvement in PTSD symptoms with brexpiprazole plus sertraline is greater than with sertraline alone. “That’s a very important statement. And this high level of efficacy was consistent on the secondary outcome measures, and the overall tolerability and safety seemed very acceptable,” he said.

What’s equally important, said McIntyre, is that most people with PTSD have depression and anxiety, and the brexpiprazole plus sertraline combination was more helpful than sertraline alone on the measures of anxiety and depression. “This is really important, especially in light of the fact that this medication [brexpiprazole] is already approved for adults living with major depressive disorder and inadequate response to antidepressants,” McIntyre said.

McIntyre added he suspects some questions the committee may have could relate to the extent to which it’s the case that brexpiprazole is effective in PTSD regardless of the antidepressant that is prescribed with it.

“There also will be the inevitable questions about the absence of long-term data which I think will need to be addressed given how chronic and relapse prone this condition is,” McIntyre said.

The committee may ask how trauma and PTSD will be screened in primary care and how outcomes related to this therapy will be evaluated in everyday clinical practice, McIntyre said.

Overall, McIntyre said brexpiprazole plus sertraline in PTSD is a “very positive” development for the field.

“PTSD is a terrible condition. It’s so darn common, and we just don’t have enough treatments for it. The data look good for my perspective. My fingers are crossed for the patients with PTSD and their families,” said McIntyre.

Ritchie reported having no relevant disclosures. McIntyre received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, and atai Life Sciences. McIntyre is a CEO of Braxia Scientific Corp.

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

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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

“Gold card” programs were supposed to make it easier for frustrated physicians to deal with insurers’ burdensome prior authorization demands.

The idea: Insurers would reward doctors whose past prior authorization requests were typically approved by exempting them from red tape in the future.

At least 10 states have required insurers to establish gold card programs amid mounting concerns nationwide that overuse of prior authorization jeopardizes patient health. Last month, leading insurers joined with the White House in a voluntary pledge to reduce their use of the practice, which they contend is necessary to control costs and minimize unnecessary care.

But Texas’ experience with gold card programs may signal the limits of that approach.

 

Only 3% of Clinicians Qualified

The Lone Star State was an early adopter, passing a 2021 law enabling health providers with a high prior authorization success rate to earn a “gold card” exemption from insurers.

But statewide, only 3% of providers met that bar, according to a testimony provided by the Texas Department of Insurance earlier this year.

“I think it’s safe to say that the impact of this law on prior authorizations for our physicians is underwhelming,” said Ezequiel “Zeke” Silva III, MD, a San Antonio-based interventional radiologist who chairs the Texas Medical Association’s Council on Legislation. “We would have hoped for a greater percentage of our physicians to have been granted the ‘gold card’ status.”

At least nine other states have enacted gold card laws, according to the National Conference of State Legislatures (NCSL).

 

Care Delayed and Denied

Physicians maintain that excessive prior authorization paperwork impedes timely patient care, with clinicians and staffers devoting 13 hours weekly to documentation, according to a 2024 American Medical Association survey.

Insurers view the review as a guardrail against unnecessary care driving up costs. Studies show that restricting prior authorization could boost premiums by 5.6%-16.7%, a Texas Association of Health Plans official testified during the legislative session.

In June, Texas Gov. Greg Abbott signed a revised version of the state’s “gold card” law — part of an emerging national attempt to streamline the prior review process. Cigna, Humana, UnitedHealthcare, and other large insurers have voluntarily committed to reducing the scope of claims involved, according to the America’s Health Insurance Plans trade group.

Meanwhile, federal officials have finalized requirements that direct some insurers, including Medicaid and Medicare Advantage programs, to speed up responses to prior authorization requests, among other measures. Some of those requirements begin in 2026.

 

Gold Card Designs

As in other states, Texas’ “gold card” legislation applies only to state-regulated insurers, which comprise about one fifth of the state’s market. Under HB 3812, which takes effect on September 1, insurers will evaluate health providers based on a year of prior authorization requests rather than 6 months under the 2021 law.

To be evaluated, providers must have submitted at least five requests for a specific health service during that period. To achieve “gold card” status, insurers must approve at least 90% of requests, the same threshold as set by the 2021 law. But the new law stipulates that insurers review a broader pool of requests, including those made directly to the health plan as well as any related affiliates, according to the Texas Department of Insurance. 

The new law continues to limit exemptions only to “top-performing physicians” who repeatedly provide cost-effective care, said Blake Hutson, director of public affairs at the Texas Association of Health Plans. “Even with the change to 1 year, and the bill also adds in a broader array of claims that will be looked at, you still have to meet 90%.”

A key addition requires insurers to release an annual report detailing how many exemptions they have granted or denied, making decisions more transparent to the public, Silva said. “Not just what’s being approved and what’s not being approved, but to potentially evaluate for trends that presently we just have no ability to evaluate,” he said.

Gold card laws vary from state to state, and some exclude prescription drugs, according to an NCSL legislative summary. Other states with gold card programs include Arkansas, Colorado, Illinois, Louisiana, Michigan, New Mexico, Vermont, West Virginia, and Wyoming.

In Illinois, legislation passed last year targeted hospital services for Medicaid patients, as denial rates were routinely higher in that population, said Dave Gross, senior vice president of Government Relations and Communications at the Illinois Health and Hospital Association, Naperville, Illinois. “We’re not seeing this problem in the commercial space,” he noted.

 

Real-World Implications

To some degree, the “gold card” concept makes intuitive sense, recognizing physicians who have a track record of getting their medical care requests approved, said Ravi Gupta, MD, an assistant professor of medicine at Johns Hopkins University School of Medicine, Baltimore, who has studied prior authorization patterns.

But Gupta raised equity concerns. Physicians in large medical groups and hospital systems will have access to staff and other resources to better navigate the prior approval process than those in smaller private practices.

Plus, he added, there’s the potential that physicians who achieve exemptions may become “more indiscriminate” about the services that they recommend.

Insurers’ stated aim is to reduce unnecessary and low-value medical care through prior authorization gatekeeping, Gupta said. But a study he helped conduct, assessing policies across five Medicare Advantage insurers, found a significant lack of consensus on what treatments should be included. Treatments comprising only 12% of Medicare spending would have required prior authorization by all five insurers. Most of that consensus, he wrote, “was devoted to a small number of costly services.”

The administrative burdens affect patients as well. Two thirds of patients with cancer in one 2023 study become personally involved, including calling the insurer or appealing a denial. The patients also reported less trust in insurers and the health system overall, which could have worrisome downstream effects, Fumiko Chino, MD, the study’s lead author and an assistant professor of radiation oncology at Houston’s MD Anderson Cancer Center, said.

“If you don’t trust healthcare,” she said, “why on earth would you get a vaccine or get cancer screening or get your blood pressure checked?”

 

More Than X Percent?

Gupta views the leading health insurers’ pledge as encouraging in concept — but he notes that they are voluntary commitments without any accountability.

In the interim, gold carding remains no more than a workaround, he said.

“Gold cards aren’t really fixing that [prior authorization] problem,” he said. “They’re just rewarding certain clinicians who can demonstrate that they have been able to get through the prior authorization process successfully for X amount of time before they’re rewarded with a gold card.”

In Illinois, regulators are still hashing out gold card rules, including whether the required 90% approval threshold will be based on a specific hospital service or a broader pool of services, Gross said. The hospital association also will closely watch whether Illinois’ experience begins to mirror that in Texas, he said.

“We have some of the best hospitals in the country here in Chicago,” he said. “If we end up with a 3% approval rating of gold cards, we’re going to have to go back to the legislature.”

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

Despite concerns about cognitive decline after cancer treatment, most breast cancer survivors show no increased risk of developing Alzheimer’s disease, and some may have a slightly lower risk than their cancer-free peers, according to a large retrospective study from Korea.

However, any apparent protective effect faded with time, the investigators reported online in JAMA Network Open.

Overall, this is “reassuring news for cancer survivors,” Tim Ahles, PhD, a psychologist with Memorial Sloan Kettering Cancer Center, New York City, who wasn’t involved in the study, told  this news organization.

“I get this question from patients a lot,” Ahles said. And based on these findings, “it doesn’t look like a history of breast cancer and breast cancer treatment increases your risk for Alzheimer’s disease.”

Breast cancer survivors often report cancer-related cognitive impairment, such as difficulties with concentration and memory, both during and after cancer treatment. But evidence surrounding patients’ risk for Alzheimer’s disease is mixed. One large study based in Sweden, for instance, reported a 35% increased risk for Alzheimer’s disease among patients diagnosed with breast cancer after the age of 65 years, but not among younger patients. A population-based study from Taiwan, however, found no increase in the risk for dementia overall compared with cancer-free individuals but did note a lower dementia risk in patients who had received tamoxifen.

To help clarify the evidence, investigators assessed Alzheimer’s disease risk in a large cohort of patients and explored the association by treatment type, age, and important risk factors.

Using the Korean National Health Insurance Service database, the researchers matched 70,701 patients who underwent breast cancer surgery between 2010 and 2016 with 180,360 cancer-free control individuals.

The mean age of breast cancer survivors was 53.1 years. Overall, 72% received radiotherapy. Cyclophosphamide (57%) and anthracycline (50%) were the most commonly used chemotherapies, and tamoxifen (47%) and aromatase inhibitors (30%) were the most commonly used endocrine therapies.

The primary outcome of this study was the incidence of newly diagnosed Alzheimer’s disease, which was defined on the basis of at least one prescription for medications to manage dementia associated with Alzheimer’s disease (donepezil, rivastigmine, galantamine, or memantine).

During a median follow-up of about 7 years, 1229 newly diagnosed Alzheimer’s disease cases were detected in breast cancer survivors and 3430 cases in control individuals — incidence rates of 2.45 and 2.63 per 1000 person-years, respectively.

This corresponded to an 8% lower risk for Alzheimer’s disease in breast cancer survivors compared with cancer-free control individuals at 6 months (subdistribution hazard ratio [SHR], 0.92; 95% CI, 0.86-0.98). The association was especially notable in survivors older than 65 years (SHR, 0.92; 95% CI, 0.85-0.99).

Looking at individual treatment modalities, only radiation therapy was associated with significantly lower risk for Alzheimer’s disease among breast cancer survivors (adjusted HR [aHR], 0.77).

Several risk factors were associated with a significantly higher risk for Alzheimer’s disease: current smoker vs never or ex-smokers (aHR, 2.04), diabetes (aHR, 1.58), and chronic kidney disease (aHR, 3.11). Notably, alcohol use, physical activity level, and hypertension were not associated with Alzheimer’s disease risk.

However, any potential protective effect may be short-lived. The reduced risk for Alzheimer’s disease was no longer significant at 1 year (SHR, 0.94; 95% CI, 0.87-1.01), 3 years (SHR, 0.97; 95% CI, 0.90-1.05), or 5 years (SHR, 0.98; 95% CI, 0.89-1.08).

Even so, breast cancer survivors can still feel reassured by the findings.

“Concerns about chemobrain and the long-term adverse effects of breast cancer treatment on cognition are common, but our findings suggest that this treatment does not directly lead to Alzheimer’s disease,” wrote the authors, led by Su-Min Jeong, MD, with Seoul National University College of Medicine, Seoul, South Korea.

Ahles agreed. The general takeaway from this study is that there is “no strong evidence that the cancer treatment is going to increase your risk for developing Alzheimer’s,” Ahles said. When patients ask about the risk for Alzheimer’s disease, “I can say, ‘Here’s yet another new study that supports the idea that there’s no increased risk.’”

He cautioned, however, that the study doesn’t address whether people with a genetic predisposition to Alzheimer’s might develop it sooner due to cancer treatment.

“Does the cancer treatment increase your probability or nudge you along? The study doesn’t answer that question,” Ahles said.

The study reported having no commercial funding. Jeong and Ahles reported having no relevant disclosures.

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

Despite concerns about cognitive decline after cancer treatment, most breast cancer survivors show no increased risk of developing Alzheimer’s disease, and some may have a slightly lower risk than their cancer-free peers, according to a large retrospective study from Korea.

However, any apparent protective effect faded with time, the investigators reported online in JAMA Network Open.

Overall, this is “reassuring news for cancer survivors,” Tim Ahles, PhD, a psychologist with Memorial Sloan Kettering Cancer Center, New York City, who wasn’t involved in the study, told  this news organization.

“I get this question from patients a lot,” Ahles said. And based on these findings, “it doesn’t look like a history of breast cancer and breast cancer treatment increases your risk for Alzheimer’s disease.”

Breast cancer survivors often report cancer-related cognitive impairment, such as difficulties with concentration and memory, both during and after cancer treatment. But evidence surrounding patients’ risk for Alzheimer’s disease is mixed. One large study based in Sweden, for instance, reported a 35% increased risk for Alzheimer’s disease among patients diagnosed with breast cancer after the age of 65 years, but not among younger patients. A population-based study from Taiwan, however, found no increase in the risk for dementia overall compared with cancer-free individuals but did note a lower dementia risk in patients who had received tamoxifen.

To help clarify the evidence, investigators assessed Alzheimer’s disease risk in a large cohort of patients and explored the association by treatment type, age, and important risk factors.

Using the Korean National Health Insurance Service database, the researchers matched 70,701 patients who underwent breast cancer surgery between 2010 and 2016 with 180,360 cancer-free control individuals.

The mean age of breast cancer survivors was 53.1 years. Overall, 72% received radiotherapy. Cyclophosphamide (57%) and anthracycline (50%) were the most commonly used chemotherapies, and tamoxifen (47%) and aromatase inhibitors (30%) were the most commonly used endocrine therapies.

The primary outcome of this study was the incidence of newly diagnosed Alzheimer’s disease, which was defined on the basis of at least one prescription for medications to manage dementia associated with Alzheimer’s disease (donepezil, rivastigmine, galantamine, or memantine).

During a median follow-up of about 7 years, 1229 newly diagnosed Alzheimer’s disease cases were detected in breast cancer survivors and 3430 cases in control individuals — incidence rates of 2.45 and 2.63 per 1000 person-years, respectively.

This corresponded to an 8% lower risk for Alzheimer’s disease in breast cancer survivors compared with cancer-free control individuals at 6 months (subdistribution hazard ratio [SHR], 0.92; 95% CI, 0.86-0.98). The association was especially notable in survivors older than 65 years (SHR, 0.92; 95% CI, 0.85-0.99).

Looking at individual treatment modalities, only radiation therapy was associated with significantly lower risk for Alzheimer’s disease among breast cancer survivors (adjusted HR [aHR], 0.77).

Several risk factors were associated with a significantly higher risk for Alzheimer’s disease: current smoker vs never or ex-smokers (aHR, 2.04), diabetes (aHR, 1.58), and chronic kidney disease (aHR, 3.11). Notably, alcohol use, physical activity level, and hypertension were not associated with Alzheimer’s disease risk.

However, any potential protective effect may be short-lived. The reduced risk for Alzheimer’s disease was no longer significant at 1 year (SHR, 0.94; 95% CI, 0.87-1.01), 3 years (SHR, 0.97; 95% CI, 0.90-1.05), or 5 years (SHR, 0.98; 95% CI, 0.89-1.08).

Even so, breast cancer survivors can still feel reassured by the findings.

“Concerns about chemobrain and the long-term adverse effects of breast cancer treatment on cognition are common, but our findings suggest that this treatment does not directly lead to Alzheimer’s disease,” wrote the authors, led by Su-Min Jeong, MD, with Seoul National University College of Medicine, Seoul, South Korea.

Ahles agreed. The general takeaway from this study is that there is “no strong evidence that the cancer treatment is going to increase your risk for developing Alzheimer’s,” Ahles said. When patients ask about the risk for Alzheimer’s disease, “I can say, ‘Here’s yet another new study that supports the idea that there’s no increased risk.’”

He cautioned, however, that the study doesn’t address whether people with a genetic predisposition to Alzheimer’s might develop it sooner due to cancer treatment.

“Does the cancer treatment increase your probability or nudge you along? The study doesn’t answer that question,” Ahles said.

The study reported having no commercial funding. Jeong and Ahles reported having no relevant disclosures.

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

Despite concerns about cognitive decline after cancer treatment, most breast cancer survivors show no increased risk of developing Alzheimer’s disease, and some may have a slightly lower risk than their cancer-free peers, according to a large retrospective study from Korea.

However, any apparent protective effect faded with time, the investigators reported online in JAMA Network Open.

Overall, this is “reassuring news for cancer survivors,” Tim Ahles, PhD, a psychologist with Memorial Sloan Kettering Cancer Center, New York City, who wasn’t involved in the study, told  this news organization.

“I get this question from patients a lot,” Ahles said. And based on these findings, “it doesn’t look like a history of breast cancer and breast cancer treatment increases your risk for Alzheimer’s disease.”

Breast cancer survivors often report cancer-related cognitive impairment, such as difficulties with concentration and memory, both during and after cancer treatment. But evidence surrounding patients’ risk for Alzheimer’s disease is mixed. One large study based in Sweden, for instance, reported a 35% increased risk for Alzheimer’s disease among patients diagnosed with breast cancer after the age of 65 years, but not among younger patients. A population-based study from Taiwan, however, found no increase in the risk for dementia overall compared with cancer-free individuals but did note a lower dementia risk in patients who had received tamoxifen.

To help clarify the evidence, investigators assessed Alzheimer’s disease risk in a large cohort of patients and explored the association by treatment type, age, and important risk factors.

Using the Korean National Health Insurance Service database, the researchers matched 70,701 patients who underwent breast cancer surgery between 2010 and 2016 with 180,360 cancer-free control individuals.

The mean age of breast cancer survivors was 53.1 years. Overall, 72% received radiotherapy. Cyclophosphamide (57%) and anthracycline (50%) were the most commonly used chemotherapies, and tamoxifen (47%) and aromatase inhibitors (30%) were the most commonly used endocrine therapies.

The primary outcome of this study was the incidence of newly diagnosed Alzheimer’s disease, which was defined on the basis of at least one prescription for medications to manage dementia associated with Alzheimer’s disease (donepezil, rivastigmine, galantamine, or memantine).

During a median follow-up of about 7 years, 1229 newly diagnosed Alzheimer’s disease cases were detected in breast cancer survivors and 3430 cases in control individuals — incidence rates of 2.45 and 2.63 per 1000 person-years, respectively.

This corresponded to an 8% lower risk for Alzheimer’s disease in breast cancer survivors compared with cancer-free control individuals at 6 months (subdistribution hazard ratio [SHR], 0.92; 95% CI, 0.86-0.98). The association was especially notable in survivors older than 65 years (SHR, 0.92; 95% CI, 0.85-0.99).

Looking at individual treatment modalities, only radiation therapy was associated with significantly lower risk for Alzheimer’s disease among breast cancer survivors (adjusted HR [aHR], 0.77).

Several risk factors were associated with a significantly higher risk for Alzheimer’s disease: current smoker vs never or ex-smokers (aHR, 2.04), diabetes (aHR, 1.58), and chronic kidney disease (aHR, 3.11). Notably, alcohol use, physical activity level, and hypertension were not associated with Alzheimer’s disease risk.

However, any potential protective effect may be short-lived. The reduced risk for Alzheimer’s disease was no longer significant at 1 year (SHR, 0.94; 95% CI, 0.87-1.01), 3 years (SHR, 0.97; 95% CI, 0.90-1.05), or 5 years (SHR, 0.98; 95% CI, 0.89-1.08).

Even so, breast cancer survivors can still feel reassured by the findings.

“Concerns about chemobrain and the long-term adverse effects of breast cancer treatment on cognition are common, but our findings suggest that this treatment does not directly lead to Alzheimer’s disease,” wrote the authors, led by Su-Min Jeong, MD, with Seoul National University College of Medicine, Seoul, South Korea.

Ahles agreed. The general takeaway from this study is that there is “no strong evidence that the cancer treatment is going to increase your risk for developing Alzheimer’s,” Ahles said. When patients ask about the risk for Alzheimer’s disease, “I can say, ‘Here’s yet another new study that supports the idea that there’s no increased risk.’”

He cautioned, however, that the study doesn’t address whether people with a genetic predisposition to Alzheimer’s might develop it sooner due to cancer treatment.

“Does the cancer treatment increase your probability or nudge you along? The study doesn’t answer that question,” Ahles said.

The study reported having no commercial funding. Jeong and Ahles reported having no relevant disclosures.

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

TOPLINE:

Patients with advanced ovarian cancer undergoing interval cytoreductive surgery who received paclitaxel-based hyperthermic intraperitoneal chemotherapy (HIPEC) during surgery appeared to have comparable overall survival and disease-free survival rates to those who received cisplatin-based HIPEC.

METHODOLOGY:

• Although the use of HIPEC remains controversial, cisplatin-based HIPEC during cytoreductive surgery may benefit patients with advanced ovarian cancer; however, there is less evidence for paclitaxel-based HIPEC, typically used in patients who are frail or intolerant to platinum agents.
• To compare the two regimens, researchers analyzed data from the National Registry of Peritoneal Carcinomatosis, which included 846 patients (mean age, 59 years) who underwent interval cytoreductive surgery with either cisplatin-based HIPEC (n = 325) or paclitaxel-based HIPEC (n = 521). After propensity score matching, there were 199 patients per group (total = 398).
• HIPEC was administered post-surgery with cisplatin (75-100 mg/m² for 90 minutes) or paclitaxel (120 mg/m² for 60 minutes), both at 42-43 °C.

TAKEAWAY:

• Using cisplatin as the reference group, the median overall survival was not significantly different between the two options (hazard ratio [HR], 0.74; P = .16); however, the median overall survival was 82 months in the paclitaxel group vs 58 months in the cisplatin group.
• Disease-free survival was also not significantly different between the 2 groups, with a median of 20 months in the cisplatin group and 21 months in the paclitaxel groups (HR, 0.95; 95% CI, 0.72-1.25; P = .70).
• Overall survival was comparable during the first 20 months of follow-up and disease-free survival was equivalent during the first 15 months of follow-up, based on a predefined equivalence margin of 0.1.
• Paclitaxel-based HIPEC was not associated with increased morbidity (odds ratio, 1.32; P = .06).

IN PRACTICE:

“Our study suggests that cisplatin and paclitaxel are two safe and effective drugs to be used for HIPEC in [interval cytoreductive surgery] for advanced ovarian cancer. As cisplatin is the preferred drug according to strong evidence, paclitaxel could be a valuable alternative for patients with any contraindication to cisplatin, with similar oncological and perioperative outcomes,” the authors wrote.

SOURCE:

This study, led by Salud González Sánchez, MD, Reina Sofía University Hospital in Córdoba, Spain, was published online in JAMA Network Open.

LIMITATIONS:

The retrospective design of this study limited causal inference. The BRCA mutation status was not captured in the national registry. Additionally, the matching procedure resulted in a moderate sample size, which could have led to residual confounding.

DISCLOSURES:

The authors did not declare any funding information and reported no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Patients with advanced ovarian cancer undergoing interval cytoreductive surgery who received paclitaxel-based hyperthermic intraperitoneal chemotherapy (HIPEC) during surgery appeared to have comparable overall survival and disease-free survival rates to those who received cisplatin-based HIPEC.

METHODOLOGY:

• Although the use of HIPEC remains controversial, cisplatin-based HIPEC during cytoreductive surgery may benefit patients with advanced ovarian cancer; however, there is less evidence for paclitaxel-based HIPEC, typically used in patients who are frail or intolerant to platinum agents.
• To compare the two regimens, researchers analyzed data from the National Registry of Peritoneal Carcinomatosis, which included 846 patients (mean age, 59 years) who underwent interval cytoreductive surgery with either cisplatin-based HIPEC (n = 325) or paclitaxel-based HIPEC (n = 521). After propensity score matching, there were 199 patients per group (total = 398).
• HIPEC was administered post-surgery with cisplatin (75-100 mg/m² for 90 minutes) or paclitaxel (120 mg/m² for 60 minutes), both at 42-43 °C.

TAKEAWAY:

• Using cisplatin as the reference group, the median overall survival was not significantly different between the two options (hazard ratio [HR], 0.74; P = .16); however, the median overall survival was 82 months in the paclitaxel group vs 58 months in the cisplatin group.
• Disease-free survival was also not significantly different between the 2 groups, with a median of 20 months in the cisplatin group and 21 months in the paclitaxel groups (HR, 0.95; 95% CI, 0.72-1.25; P = .70).
• Overall survival was comparable during the first 20 months of follow-up and disease-free survival was equivalent during the first 15 months of follow-up, based on a predefined equivalence margin of 0.1.
• Paclitaxel-based HIPEC was not associated with increased morbidity (odds ratio, 1.32; P = .06).

IN PRACTICE:

“Our study suggests that cisplatin and paclitaxel are two safe and effective drugs to be used for HIPEC in [interval cytoreductive surgery] for advanced ovarian cancer. As cisplatin is the preferred drug according to strong evidence, paclitaxel could be a valuable alternative for patients with any contraindication to cisplatin, with similar oncological and perioperative outcomes,” the authors wrote.

SOURCE:

This study, led by Salud González Sánchez, MD, Reina Sofía University Hospital in Córdoba, Spain, was published online in JAMA Network Open.

LIMITATIONS:

The retrospective design of this study limited causal inference. The BRCA mutation status was not captured in the national registry. Additionally, the matching procedure resulted in a moderate sample size, which could have led to residual confounding.

DISCLOSURES:

The authors did not declare any funding information and reported no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Patients with advanced ovarian cancer undergoing interval cytoreductive surgery who received paclitaxel-based hyperthermic intraperitoneal chemotherapy (HIPEC) during surgery appeared to have comparable overall survival and disease-free survival rates to those who received cisplatin-based HIPEC.

METHODOLOGY:

• Although the use of HIPEC remains controversial, cisplatin-based HIPEC during cytoreductive surgery may benefit patients with advanced ovarian cancer; however, there is less evidence for paclitaxel-based HIPEC, typically used in patients who are frail or intolerant to platinum agents.
• To compare the two regimens, researchers analyzed data from the National Registry of Peritoneal Carcinomatosis, which included 846 patients (mean age, 59 years) who underwent interval cytoreductive surgery with either cisplatin-based HIPEC (n = 325) or paclitaxel-based HIPEC (n = 521). After propensity score matching, there were 199 patients per group (total = 398).
• HIPEC was administered post-surgery with cisplatin (75-100 mg/m² for 90 minutes) or paclitaxel (120 mg/m² for 60 minutes), both at 42-43 °C.

TAKEAWAY:

• Using cisplatin as the reference group, the median overall survival was not significantly different between the two options (hazard ratio [HR], 0.74; P = .16); however, the median overall survival was 82 months in the paclitaxel group vs 58 months in the cisplatin group.
• Disease-free survival was also not significantly different between the 2 groups, with a median of 20 months in the cisplatin group and 21 months in the paclitaxel groups (HR, 0.95; 95% CI, 0.72-1.25; P = .70).
• Overall survival was comparable during the first 20 months of follow-up and disease-free survival was equivalent during the first 15 months of follow-up, based on a predefined equivalence margin of 0.1.
• Paclitaxel-based HIPEC was not associated with increased morbidity (odds ratio, 1.32; P = .06).

IN PRACTICE:

“Our study suggests that cisplatin and paclitaxel are two safe and effective drugs to be used for HIPEC in [interval cytoreductive surgery] for advanced ovarian cancer. As cisplatin is the preferred drug according to strong evidence, paclitaxel could be a valuable alternative for patients with any contraindication to cisplatin, with similar oncological and perioperative outcomes,” the authors wrote.

SOURCE:

This study, led by Salud González Sánchez, MD, Reina Sofía University Hospital in Córdoba, Spain, was published online in JAMA Network Open.

LIMITATIONS:

The retrospective design of this study limited causal inference. The BRCA mutation status was not captured in the national registry. Additionally, the matching procedure resulted in a moderate sample size, which could have led to residual confounding.

DISCLOSURES:

The authors did not declare any funding information and reported no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

The initial plan to reduce the US Department of Veterans Affairs (VA) workforce by 15%—roughly 83,000 employees—has been revised. The VA announced that it expected to reduce its workforce by 30,000 positions through normal attrition, early retirements, and resignations by the end of fiscal year 2025, “eliminating the need for a large-scale reduction-in-force.” Most of the positions will not be replaced due to the federal hiring freeze, which has been extended for 3 months.

“Since March, we’ve been conducting a holistic review of the department centered on reducing bureaucracy and improving services to Veterans,” VA Secretary Doug Collins said in a press release. “A department-wide RIF is off the table, but that doesn’t mean we’re done improving VA.”

About 17,000 VA employees have left their jobs as of June 1. From now and Sept. 30, the department expects another reduction of nearly 12,000. Pete Kasperowicz, a VA spokesperson, said there would not be any reductions beyond the 30,000 planned.

The VA says it has multiple safeguards in place to ensure the reductions do not impact veteran care or benefits. All VA mission-critical positions are exempt from the voluntary early retirement authority and deferred resignation program, and > 350,000 positions are exempt from the federal hiring freeze. 

The release noted several other improvements regarding VA performance in 2025, among them that the disability claims backlog has been reduced by 30% and a record 2 million disability claims have been processed by June. More than 60,000 VA employees have also returned to the office, according to the release.

“As a result of our efforts, VA is headed in the right direction – both in terms of staff levels and customer service,” Collins said. “Our review has resulted in a host of new ideas for better serving Veterans that we will continue to pursue.” 

The initial plan to reduce the US Department of Veterans Affairs (VA) workforce by 15%—roughly 83,000 employees—has been revised. The VA announced that it expected to reduce its workforce by 30,000 positions through normal attrition, early retirements, and resignations by the end of fiscal year 2025, “eliminating the need for a large-scale reduction-in-force.” Most of the positions will not be replaced due to the federal hiring freeze, which has been extended for 3 months.

“Since March, we’ve been conducting a holistic review of the department centered on reducing bureaucracy and improving services to Veterans,” VA Secretary Doug Collins said in a press release. “A department-wide RIF is off the table, but that doesn’t mean we’re done improving VA.”

About 17,000 VA employees have left their jobs as of June 1. From now and Sept. 30, the department expects another reduction of nearly 12,000. Pete Kasperowicz, a VA spokesperson, said there would not be any reductions beyond the 30,000 planned.

The VA says it has multiple safeguards in place to ensure the reductions do not impact veteran care or benefits. All VA mission-critical positions are exempt from the voluntary early retirement authority and deferred resignation program, and > 350,000 positions are exempt from the federal hiring freeze. 

The release noted several other improvements regarding VA performance in 2025, among them that the disability claims backlog has been reduced by 30% and a record 2 million disability claims have been processed by June. More than 60,000 VA employees have also returned to the office, according to the release.

“As a result of our efforts, VA is headed in the right direction – both in terms of staff levels and customer service,” Collins said. “Our review has resulted in a host of new ideas for better serving Veterans that we will continue to pursue.” 

The initial plan to reduce the US Department of Veterans Affairs (VA) workforce by 15%—roughly 83,000 employees—has been revised. The VA announced that it expected to reduce its workforce by 30,000 positions through normal attrition, early retirements, and resignations by the end of fiscal year 2025, “eliminating the need for a large-scale reduction-in-force.” Most of the positions will not be replaced due to the federal hiring freeze, which has been extended for 3 months.

“Since March, we’ve been conducting a holistic review of the department centered on reducing bureaucracy and improving services to Veterans,” VA Secretary Doug Collins said in a press release. “A department-wide RIF is off the table, but that doesn’t mean we’re done improving VA.”

About 17,000 VA employees have left their jobs as of June 1. From now and Sept. 30, the department expects another reduction of nearly 12,000. Pete Kasperowicz, a VA spokesperson, said there would not be any reductions beyond the 30,000 planned.

The VA says it has multiple safeguards in place to ensure the reductions do not impact veteran care or benefits. All VA mission-critical positions are exempt from the voluntary early retirement authority and deferred resignation program, and > 350,000 positions are exempt from the federal hiring freeze. 

The release noted several other improvements regarding VA performance in 2025, among them that the disability claims backlog has been reduced by 30% and a record 2 million disability claims have been processed by June. More than 60,000 VA employees have also returned to the office, according to the release.

“As a result of our efforts, VA is headed in the right direction – both in terms of staff levels and customer service,” Collins said. “Our review has resulted in a host of new ideas for better serving Veterans that we will continue to pursue.” 

TOPLINE:

Dementia incidence varied significantly by US region in a new study, with the Southeast showing a 25% higher risk and the Northwest and Rocky Mountains each showing a 23% higher risk compared to the Mid-Atlantic. Investigators said the findings highlight the need for a geographically tailored approach to address dementia risk factors and diagnostic services.

METHODOLOGY:

• Researchers conducted a cohort study using data from the US Veterans Health Administration for more than 1.2 million older adults without dementia (mean age, 73.9 years; 98%% men) from 1999 to 2021. The average follow-up was 12.6 years.
• Ten geographical regions across the US were defined using the CDC National Center for Chronic Disease Prevention and Health Promotion definition.
• The diagnosis of dementia was made using International Classification of Diseases, Ninth and Tenth Revision codes from inpatient and outpatient visits.

TAKEAWAY:

• Dementia incidence rates per 1000 person-years were lowest in the Mid-Atlantic (11.2; 95% CI, 11.1-11.4) and highest in the Southeast (14.0; 95% CI, 13.8-14.2).
• After adjusting for demographics, compared with the Mid-Atlantic region, dementia incidence was highest in the Southeast (rate ratio [RR], 1.25), followed by the Northwest and Rocky Mountains (RR for both, 1.23), South (RR, 1.18), Southwest (RR, 1.13), and Midwest and South Atlantic (RR for both, 1.12). The Great Lakes and Northeast regions had < a 10% difference in incidence.
• Results remained consistent after adjusting for rurality and cardiovascular comorbidities, and after accounting for competing risk for death.

IN PRACTICE:

“This study provides valuable insights into the regional variation in dementia incidence among US veterans in that we observed more than 20% greater incidence in several regions compared with the Mid-Atlantic region,” the investigators wrote. 

“By identifying areas with the highest incidence rates, resources can be better allocated and targeted interventions designed to mitigate the impact of dementia on vulnerable populations,” they added.

SOURCE:

This study was led by Christina S. Dintica, PhD, University of California, San Francisco. It was published online on June 9 in JAMA Neurology.

LIMITATIONS:

This study population was limited to US veterans, limiting the generalizability of the findings. Education level was defined using educational attainment rates in the participants’ zip codes rather than individual data. Additionally, because residential history was limited to a single location per participant, migration patterns could not be tracked. 

DISCLOSURES:

This study was supported by grants from the Alzheimer’s Association, the National Institute on Aging, and the Department of Defense. One author reported serving on data and safety monitoring boards for studies sponsored by the National Institutes of Health, as well as holding advisory board membership and receiving personal fees from industry. Full details are listed in the original article. The other four investigators reported no relevant financial conflicts.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Dementia incidence varied significantly by US region in a new study, with the Southeast showing a 25% higher risk and the Northwest and Rocky Mountains each showing a 23% higher risk compared to the Mid-Atlantic. Investigators said the findings highlight the need for a geographically tailored approach to address dementia risk factors and diagnostic services.

METHODOLOGY:

• Researchers conducted a cohort study using data from the US Veterans Health Administration for more than 1.2 million older adults without dementia (mean age, 73.9 years; 98%% men) from 1999 to 2021. The average follow-up was 12.6 years.
• Ten geographical regions across the US were defined using the CDC National Center for Chronic Disease Prevention and Health Promotion definition.
• The diagnosis of dementia was made using International Classification of Diseases, Ninth and Tenth Revision codes from inpatient and outpatient visits.

TAKEAWAY:

• Dementia incidence rates per 1000 person-years were lowest in the Mid-Atlantic (11.2; 95% CI, 11.1-11.4) and highest in the Southeast (14.0; 95% CI, 13.8-14.2).
• After adjusting for demographics, compared with the Mid-Atlantic region, dementia incidence was highest in the Southeast (rate ratio [RR], 1.25), followed by the Northwest and Rocky Mountains (RR for both, 1.23), South (RR, 1.18), Southwest (RR, 1.13), and Midwest and South Atlantic (RR for both, 1.12). The Great Lakes and Northeast regions had < a 10% difference in incidence.
• Results remained consistent after adjusting for rurality and cardiovascular comorbidities, and after accounting for competing risk for death.

IN PRACTICE:

“This study provides valuable insights into the regional variation in dementia incidence among US veterans in that we observed more than 20% greater incidence in several regions compared with the Mid-Atlantic region,” the investigators wrote. 

“By identifying areas with the highest incidence rates, resources can be better allocated and targeted interventions designed to mitigate the impact of dementia on vulnerable populations,” they added.

SOURCE:

This study was led by Christina S. Dintica, PhD, University of California, San Francisco. It was published online on June 9 in JAMA Neurology.

LIMITATIONS:

This study population was limited to US veterans, limiting the generalizability of the findings. Education level was defined using educational attainment rates in the participants’ zip codes rather than individual data. Additionally, because residential history was limited to a single location per participant, migration patterns could not be tracked. 

DISCLOSURES:

This study was supported by grants from the Alzheimer’s Association, the National Institute on Aging, and the Department of Defense. One author reported serving on data and safety monitoring boards for studies sponsored by the National Institutes of Health, as well as holding advisory board membership and receiving personal fees from industry. Full details are listed in the original article. The other four investigators reported no relevant financial conflicts.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

Dementia incidence varied significantly by US region in a new study, with the Southeast showing a 25% higher risk and the Northwest and Rocky Mountains each showing a 23% higher risk compared to the Mid-Atlantic. Investigators said the findings highlight the need for a geographically tailored approach to address dementia risk factors and diagnostic services.

METHODOLOGY:

• Researchers conducted a cohort study using data from the US Veterans Health Administration for more than 1.2 million older adults without dementia (mean age, 73.9 years; 98%% men) from 1999 to 2021. The average follow-up was 12.6 years.
• Ten geographical regions across the US were defined using the CDC National Center for Chronic Disease Prevention and Health Promotion definition.
• The diagnosis of dementia was made using International Classification of Diseases, Ninth and Tenth Revision codes from inpatient and outpatient visits.

TAKEAWAY:

• Dementia incidence rates per 1000 person-years were lowest in the Mid-Atlantic (11.2; 95% CI, 11.1-11.4) and highest in the Southeast (14.0; 95% CI, 13.8-14.2).
• After adjusting for demographics, compared with the Mid-Atlantic region, dementia incidence was highest in the Southeast (rate ratio [RR], 1.25), followed by the Northwest and Rocky Mountains (RR for both, 1.23), South (RR, 1.18), Southwest (RR, 1.13), and Midwest and South Atlantic (RR for both, 1.12). The Great Lakes and Northeast regions had < a 10% difference in incidence.
• Results remained consistent after adjusting for rurality and cardiovascular comorbidities, and after accounting for competing risk for death.

IN PRACTICE:

“This study provides valuable insights into the regional variation in dementia incidence among US veterans in that we observed more than 20% greater incidence in several regions compared with the Mid-Atlantic region,” the investigators wrote. 

“By identifying areas with the highest incidence rates, resources can be better allocated and targeted interventions designed to mitigate the impact of dementia on vulnerable populations,” they added.

SOURCE:

This study was led by Christina S. Dintica, PhD, University of California, San Francisco. It was published online on June 9 in JAMA Neurology.

LIMITATIONS:

This study population was limited to US veterans, limiting the generalizability of the findings. Education level was defined using educational attainment rates in the participants’ zip codes rather than individual data. Additionally, because residential history was limited to a single location per participant, migration patterns could not be tracked. 

DISCLOSURES:

This study was supported by grants from the Alzheimer’s Association, the National Institute on Aging, and the Department of Defense. One author reported serving on data and safety monitoring boards for studies sponsored by the National Institutes of Health, as well as holding advisory board membership and receiving personal fees from industry. Full details are listed in the original article. The other four investigators reported no relevant financial conflicts.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

An 8-week smartphone-based mindfulness program using audio-guided meditation reduced anxiety and improved emotional well-being in patients with chronic obstructive pulmonary disease (COPD), also providing relief from stress, anxiety, and dyspnea following each session.

METHODOLOGY:

• A considerable proportion of patients with COPD experience clinically significant anxiety and depressive symptoms; psychological interventions that are easy to implement as add-on treatments can alleviate these symptoms.
• In this pilot study, 30 patients (mean age, 62.68 y; 60.5% women) with COPD and subclinical symptoms of anxiety or depression were enrolled and allocated to an 8-week self-administered digital mindfulness-based intervention (n = 14) or the waitlist control (n = 16).
• Patients in the intervention group had an introductory face-to-face session, followed by daily smartphone audio-guided meditation adapted for patients with COPD. The waitlist group received the same intervention after the study period ended.
• The primary endpoints were the feasibility of the intervention and its effects on anxiety and depression symptoms at baseline, 4 weeks, and 8 weeks.

TAKEAWAY:

• Patients in the intervention group practiced mindfulness on 81.38% of the 56 intervention days.
• After 8 weeks, the intervention group showed a significant reduction in anxiety (P = .010) compared with the waitlist group; however, no significant improvement was observed for depression.
• Similarly, significant improvements were reported for emotional functioning (P = .004), but no significant reductions in perceived stress and hair cortisol levels were observed after 8 weeks.
• Significant reductions were reported for momentary subjective stress (P < .001), anxiety (P = .022), and dyspnea (P < .001) immediately after meditation sessions.

IN PRACTICE:

“The investigated self-administered digital MBI [mindfulness-based intervention], including brief 10- to 15-minute meditations, was feasible and holds potential as low-threshold add-on treatment to alleviate anxiety after 8 weeks and reduce momentary subjective stress, anxiety, and dyspnea in everyday life,” the study authors wrote.

SOURCE:

This study was led by Hannah Tschenett, Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria, and was published online in Respiratory Research.

LIMITATIONS:

This study had several limitations including a small sample size, lack of a true control group, and potential selection bias due to recruitment from centers with patients already interested in mindfulness, which may have inflated adherence. Additionally, generalizability to all patients with COPD was limited, as many were either ineligible or declined to participate.

DISCLOSURES:

This study was funded by the Scientific Medical Fund of the City of Vienna and the Karl Landsteiner Institute (KLI) for Lung Research and Pulmonary Oncology. The KLI received funding from AstraZeneca, Boehringer Ingelheim, Chiesi, Linde plc, Menarini Pharma, Novartis, and Vivisol Austria. Three authors reported being employees of KLI or receiving lecture fees from some of these pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

An 8-week smartphone-based mindfulness program using audio-guided meditation reduced anxiety and improved emotional well-being in patients with chronic obstructive pulmonary disease (COPD), also providing relief from stress, anxiety, and dyspnea following each session.

METHODOLOGY:

• A considerable proportion of patients with COPD experience clinically significant anxiety and depressive symptoms; psychological interventions that are easy to implement as add-on treatments can alleviate these symptoms.
• In this pilot study, 30 patients (mean age, 62.68 y; 60.5% women) with COPD and subclinical symptoms of anxiety or depression were enrolled and allocated to an 8-week self-administered digital mindfulness-based intervention (n = 14) or the waitlist control (n = 16).
• Patients in the intervention group had an introductory face-to-face session, followed by daily smartphone audio-guided meditation adapted for patients with COPD. The waitlist group received the same intervention after the study period ended.
• The primary endpoints were the feasibility of the intervention and its effects on anxiety and depression symptoms at baseline, 4 weeks, and 8 weeks.

TAKEAWAY:

• Patients in the intervention group practiced mindfulness on 81.38% of the 56 intervention days.
• After 8 weeks, the intervention group showed a significant reduction in anxiety (P = .010) compared with the waitlist group; however, no significant improvement was observed for depression.
• Similarly, significant improvements were reported for emotional functioning (P = .004), but no significant reductions in perceived stress and hair cortisol levels were observed after 8 weeks.
• Significant reductions were reported for momentary subjective stress (P < .001), anxiety (P = .022), and dyspnea (P < .001) immediately after meditation sessions.

IN PRACTICE:

“The investigated self-administered digital MBI [mindfulness-based intervention], including brief 10- to 15-minute meditations, was feasible and holds potential as low-threshold add-on treatment to alleviate anxiety after 8 weeks and reduce momentary subjective stress, anxiety, and dyspnea in everyday life,” the study authors wrote.

SOURCE:

This study was led by Hannah Tschenett, Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria, and was published online in Respiratory Research.

LIMITATIONS:

This study had several limitations including a small sample size, lack of a true control group, and potential selection bias due to recruitment from centers with patients already interested in mindfulness, which may have inflated adherence. Additionally, generalizability to all patients with COPD was limited, as many were either ineligible or declined to participate.

DISCLOSURES:

This study was funded by the Scientific Medical Fund of the City of Vienna and the Karl Landsteiner Institute (KLI) for Lung Research and Pulmonary Oncology. The KLI received funding from AstraZeneca, Boehringer Ingelheim, Chiesi, Linde plc, Menarini Pharma, Novartis, and Vivisol Austria. Three authors reported being employees of KLI or receiving lecture fees from some of these pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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

TOPLINE:

An 8-week smartphone-based mindfulness program using audio-guided meditation reduced anxiety and improved emotional well-being in patients with chronic obstructive pulmonary disease (COPD), also providing relief from stress, anxiety, and dyspnea following each session.

METHODOLOGY:

• A considerable proportion of patients with COPD experience clinically significant anxiety and depressive symptoms; psychological interventions that are easy to implement as add-on treatments can alleviate these symptoms.
• In this pilot study, 30 patients (mean age, 62.68 y; 60.5% women) with COPD and subclinical symptoms of anxiety or depression were enrolled and allocated to an 8-week self-administered digital mindfulness-based intervention (n = 14) or the waitlist control (n = 16).
• Patients in the intervention group had an introductory face-to-face session, followed by daily smartphone audio-guided meditation adapted for patients with COPD. The waitlist group received the same intervention after the study period ended.
• The primary endpoints were the feasibility of the intervention and its effects on anxiety and depression symptoms at baseline, 4 weeks, and 8 weeks.

TAKEAWAY:

• Patients in the intervention group practiced mindfulness on 81.38% of the 56 intervention days.
• After 8 weeks, the intervention group showed a significant reduction in anxiety (P = .010) compared with the waitlist group; however, no significant improvement was observed for depression.
• Similarly, significant improvements were reported for emotional functioning (P = .004), but no significant reductions in perceived stress and hair cortisol levels were observed after 8 weeks.
• Significant reductions were reported for momentary subjective stress (P < .001), anxiety (P = .022), and dyspnea (P < .001) immediately after meditation sessions.

IN PRACTICE:

“The investigated self-administered digital MBI [mindfulness-based intervention], including brief 10- to 15-minute meditations, was feasible and holds potential as low-threshold add-on treatment to alleviate anxiety after 8 weeks and reduce momentary subjective stress, anxiety, and dyspnea in everyday life,” the study authors wrote.

SOURCE:

This study was led by Hannah Tschenett, Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria, and was published online in Respiratory Research.

LIMITATIONS:

This study had several limitations including a small sample size, lack of a true control group, and potential selection bias due to recruitment from centers with patients already interested in mindfulness, which may have inflated adherence. Additionally, generalizability to all patients with COPD was limited, as many were either ineligible or declined to participate.

DISCLOSURES:

This study was funded by the Scientific Medical Fund of the City of Vienna and the Karl Landsteiner Institute (KLI) for Lung Research and Pulmonary Oncology. The KLI received funding from AstraZeneca, Boehringer Ingelheim, Chiesi, Linde plc, Menarini Pharma, Novartis, and Vivisol Austria. Three authors reported being employees of KLI or receiving lecture fees from some of these pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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