Many patients with chronic progressive pulmonary disease feel anxious and depressed as their conditions advance, as breathing becomes increasingly labored and difficult, and as performing even small daily tasks leaves them exhausted.

Persons with severe COPD frequently report fears of suffocation and death, as well as anxieties about abandoning family and friends, and these negative, intrusive thoughts can have an adverse effect on COPD outcomes.

Disease-related mental distress can lead to increased disability, more frequent use of costly healthcare resources, higher morbidity, and elevated risk of death, investigators say.

“Individuals with severe COPD are twice as likely to develop depression than patients with mild COPD. Prevalence rates for clinical anxiety in COPD range from 13% to 46% in outpatients and 10% to 55% among inpatients,” wrote Abebaw Mengitsu Yohannes, PhD, then from Azusa Pacific University in Azusa, California, and colleagues in an article published jointly by The Journal of Family Practice and The Cleveland Clinic Journal of Medicine.

Patients with COPD may experience major depressive disorders, chronic mild depression (dysthymias), and minor depression, as well as generalized anxiety disorder, phobias, and panic disorders, the investigators say.

“Growing evidence suggests that the relationship between mood disorders — particularly depression — and COPD is bidirectional, meaning that mood disorders adversely impact prognosis in COPD, whereas COPD increases the risk of developing depression,” Yohannes et al. wrote.

Jamie Garfield, MD, professor of thoracic medicine and surgery at Temple University’s Lewis Katz School of Medicine in Philadelphia, Pennsylvania, told Chest Physician that the association between severe chronic diseases and mood disorders is well known.

“I don’t think that it’s specific to chronic lung diseases; in people with chronic heart disease or malignancies we see that coexistence of depression and anxiety will worsen the course of disease,” she said.

Dr. Johannes, who is currently a professor of physical therapy at the University of Alabama School of Health Professionals in Birmingham, said that depression and anxiety are often underdiagnosed and undertreated in patients with obstructive pulmonary diseases because the conditions can share symptoms such as dyspnea (for example, in anxiety) or fatigue (in depression).

“Therefore, unless one begins to explore further, it’s hard for physicians to be able to identify these conditions,” he said in an interview with Chest Physician.

Fears of dying (and living)

The causes of depression and anxiety among patients with obstructive pulmonary disorders are multifactorial, and may require a variety of treatment and coping strategies, according to Susann Strang, RN, PhD, and colleagues from the University of Gothenburg, Gothenburg, Sweden.

They conducted qualitative in-depth interviews with 31 men and women with stage III or IV COPD, and found that the majority of patients had anxiety associated with their disease.

“Analyses revealed three major themes: death anxiety, life anxiety, and counterweights to anxiety,” the investigators wrote in a study published in the journal Palliative and Supportive Care in 2014.

Factors contributing to anxiety surrounding death included fear of suffocation, awareness of impending death, fear of the process of death, and anxiety about being separated from loved ones.

In contrast, some patients expressed dread of living with the limitations and loneliness imposed on them by their disease — so-called “life anxiety.”

The patients also reported “counterweights” to anxiety as a way of coping. For some this involved trust in their healthcare professionals and adherence to medication, inhalers, and supplemental oxygen.

“The patients also placed hope in new treatments, better medication, surgery, stem cell treatment, or lung transplants,” Dr. Strang and colleagues reported.

Others reported avoiding talking about death, sleeping more, or using humor to “laugh off this difficult subject.”

Screening and diagnosis

Primary care practitioners are often the first health professionals that patients with COPD see, but these clinicians often don’t have the time to add screening to their already crammed schedules. In addition, “the lack of a standardized approach in diagnosis, and inadequate knowledge or confidence in assessing psychological status (particularly given the number of strategies available for screening patients for mood disorders),” can make it difficult for PCPs to detect and manage anxiety and depression in their patients with significant healthcare burdens from COPD and other obstructive lung diseases, Dr. Yohannes and colleagues noted.

In addition to commonly used screening tools for anxiety and depression such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) Patient Health Questionnaire (PHQ-9), there are at least two designed to evaluate patients with lung disease: the Anxiety Inventory for Respiratory (AIR) Disease scale, developed by Dr. Yohannes and colleagues, and the COPD Anxiety Questionnaire.

The COPD Assessment Test and Clinical COPD Questionnaire, while not specifically designed to screen for mental disorders, include questions that can point to symptoms of distress in patients with COPD, Dr. Yohannes said.

“In truth I think that there are few providers who will routinely do this on all their patients in terms of quantifying the severity or the presence or absence of depression, but in my own practice I very much ask questions that align with the questions in these tools to determine whether my patient appears to have high levels of anxiety and depression,” Dr. Garfield said.

Listen to patients and families

Among the most powerful tools that clinicians have at their disposal for treating anxiety and depression in patients with chronic lung disease are their ears and their minds, said Anthony Saleh, MD, a pulmonologist at New York-Presbyterian Brooklyn Methodist Hospital in Brooklyn, New York.

“I think just listening to the patient, that’s a little bit forgotten yet so important,” he said in an interview with CHEST Physician.

“When I have someone with advanced lung disease, like idiopathic pulmonary fibrosis, like advanced emphysema, one of the most important things I think is to listen to the patient, and not just to listen to the answers of your perfunctory ‘how’s your breathing? Any chest pain?’ and those sort of rote medical questions, but listen to their thoughts, and it will given them a safe space to say ‘Hey, I’m nervous, hey I’m worried about my family, hey I’m worried if I die what’s going to happen to my wife and kids,’ and that’s something I think is invaluable.”

It’s also vital to listen to the concerns of the patients family members, who may be the primary caregivers and may share the patient’s stresses and anxieties, he said.

Pulmonary Rehabilitation

All of the experts interviewed for this article agreed that a combination of medical, social and mental health support services is important for treatment for patients with chronic obstructive lung diseases.

One of the most effective means of helping patients with both acute breathing problems and with disease-related anxiety and depression is pulmonary rehabilitation. Depending on disease severity, this multidisciplinary approach may involve exercise, patient education, psychological and nutrition counseling, and training patients how to conserve energy and adopt breathing strategies to help them better manage their symptoms.

“I think that pulmonary rehabilitation is one of the first interventions that we should be recommending for our patients,” Dr. Garfield said. “It’s physical therapy for patients with chronic lung diseases, backed by respiratory therapists, and it offers not only physical rehabilitation — improving strength and coordination, but also it helps our patients get as much as possible out of what they’ve got.”

For example, patients can be taught how to decrease their respiratory rate when they’re feeling a sense of urgency or panic. Patients can also learn how to change body positions to help them breathe more effectively when they feel that their breath is limited or restricted, she said.

“Once you’re into medical interventions, pulmonary rehab is phenomenal,” Dr. Saleh said.

Pulmonary rehabilitation helps patients to feel better about themselves and about their abilities, but “unfortunately it’s not as available as we like,” he said.

Many patients don’t live near a pulmonary rehabilitation center, and the typical two to three weekly sessions for 4-12 weeks or longer can be a significant burden for patients and caregivers, he acknowledged.

“You have to sit [with the patient] and be honest and tell them it’s a lot of diligence involved and you have to be really motivated,” he said.

Other treatment options include pharmacological therapy with antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and anxiolytic agents.

“SSRIs are the current first-line drug treatment for depression, and have been shown to significantly improve depression and anxiety in patients with COPD in some, but not all, trials published to date. However, it is important to note that a diagnosis of bipolar disorder must be ruled out before initiating standard antidepressant therapy,” Dr. Johannes and colleagues wrote.

Defiant joy

Importantly, even with the burden of life with COPD, many patients found ways to experience what Strang et al. called “a defiant joy.”

“It was remarkable that when the patients were asked about what gave their lives meaning today, many talked about what had given their life meaning in the past, prior to becoming ill. In the light of the things they had lost because of the disease, many felt that their previous sources of joy no longer existed. Despite this, many still hoped to be able to get out into the fresh air, to be able to do errands, or that tomorrow might be better,” the investigators wrote.

Dr. Yohannes, Dr. Garfield, and Dr. Saleh all reported having no relevant conflicts of interest to report.

Many patients with chronic progressive pulmonary disease feel anxious and depressed as their conditions advance, as breathing becomes increasingly labored and difficult, and as performing even small daily tasks leaves them exhausted.

Persons with severe COPD frequently report fears of suffocation and death, as well as anxieties about abandoning family and friends, and these negative, intrusive thoughts can have an adverse effect on COPD outcomes.

Disease-related mental distress can lead to increased disability, more frequent use of costly healthcare resources, higher morbidity, and elevated risk of death, investigators say.

“Individuals with severe COPD are twice as likely to develop depression than patients with mild COPD. Prevalence rates for clinical anxiety in COPD range from 13% to 46% in outpatients and 10% to 55% among inpatients,” wrote Abebaw Mengitsu Yohannes, PhD, then from Azusa Pacific University in Azusa, California, and colleagues in an article published jointly by The Journal of Family Practice and The Cleveland Clinic Journal of Medicine.

Patients with COPD may experience major depressive disorders, chronic mild depression (dysthymias), and minor depression, as well as generalized anxiety disorder, phobias, and panic disorders, the investigators say.

“Growing evidence suggests that the relationship between mood disorders — particularly depression — and COPD is bidirectional, meaning that mood disorders adversely impact prognosis in COPD, whereas COPD increases the risk of developing depression,” Yohannes et al. wrote.

Jamie Garfield, MD, professor of thoracic medicine and surgery at Temple University’s Lewis Katz School of Medicine in Philadelphia, Pennsylvania, told Chest Physician that the association between severe chronic diseases and mood disorders is well known.

“I don’t think that it’s specific to chronic lung diseases; in people with chronic heart disease or malignancies we see that coexistence of depression and anxiety will worsen the course of disease,” she said.

Dr. Johannes, who is currently a professor of physical therapy at the University of Alabama School of Health Professionals in Birmingham, said that depression and anxiety are often underdiagnosed and undertreated in patients with obstructive pulmonary diseases because the conditions can share symptoms such as dyspnea (for example, in anxiety) or fatigue (in depression).

“Therefore, unless one begins to explore further, it’s hard for physicians to be able to identify these conditions,” he said in an interview with Chest Physician.

Fears of dying (and living)

The causes of depression and anxiety among patients with obstructive pulmonary disorders are multifactorial, and may require a variety of treatment and coping strategies, according to Susann Strang, RN, PhD, and colleagues from the University of Gothenburg, Gothenburg, Sweden.

They conducted qualitative in-depth interviews with 31 men and women with stage III or IV COPD, and found that the majority of patients had anxiety associated with their disease.

“Analyses revealed three major themes: death anxiety, life anxiety, and counterweights to anxiety,” the investigators wrote in a study published in the journal Palliative and Supportive Care in 2014.

Factors contributing to anxiety surrounding death included fear of suffocation, awareness of impending death, fear of the process of death, and anxiety about being separated from loved ones.

In contrast, some patients expressed dread of living with the limitations and loneliness imposed on them by their disease — so-called “life anxiety.”

The patients also reported “counterweights” to anxiety as a way of coping. For some this involved trust in their healthcare professionals and adherence to medication, inhalers, and supplemental oxygen.

“The patients also placed hope in new treatments, better medication, surgery, stem cell treatment, or lung transplants,” Dr. Strang and colleagues reported.

Others reported avoiding talking about death, sleeping more, or using humor to “laugh off this difficult subject.”

Screening and diagnosis

Primary care practitioners are often the first health professionals that patients with COPD see, but these clinicians often don’t have the time to add screening to their already crammed schedules. In addition, “the lack of a standardized approach in diagnosis, and inadequate knowledge or confidence in assessing psychological status (particularly given the number of strategies available for screening patients for mood disorders),” can make it difficult for PCPs to detect and manage anxiety and depression in their patients with significant healthcare burdens from COPD and other obstructive lung diseases, Dr. Yohannes and colleagues noted.

In addition to commonly used screening tools for anxiety and depression such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) Patient Health Questionnaire (PHQ-9), there are at least two designed to evaluate patients with lung disease: the Anxiety Inventory for Respiratory (AIR) Disease scale, developed by Dr. Yohannes and colleagues, and the COPD Anxiety Questionnaire.

The COPD Assessment Test and Clinical COPD Questionnaire, while not specifically designed to screen for mental disorders, include questions that can point to symptoms of distress in patients with COPD, Dr. Yohannes said.

“In truth I think that there are few providers who will routinely do this on all their patients in terms of quantifying the severity or the presence or absence of depression, but in my own practice I very much ask questions that align with the questions in these tools to determine whether my patient appears to have high levels of anxiety and depression,” Dr. Garfield said.

Listen to patients and families

Among the most powerful tools that clinicians have at their disposal for treating anxiety and depression in patients with chronic lung disease are their ears and their minds, said Anthony Saleh, MD, a pulmonologist at New York-Presbyterian Brooklyn Methodist Hospital in Brooklyn, New York.

“I think just listening to the patient, that’s a little bit forgotten yet so important,” he said in an interview with CHEST Physician.

“When I have someone with advanced lung disease, like idiopathic pulmonary fibrosis, like advanced emphysema, one of the most important things I think is to listen to the patient, and not just to listen to the answers of your perfunctory ‘how’s your breathing? Any chest pain?’ and those sort of rote medical questions, but listen to their thoughts, and it will given them a safe space to say ‘Hey, I’m nervous, hey I’m worried about my family, hey I’m worried if I die what’s going to happen to my wife and kids,’ and that’s something I think is invaluable.”

It’s also vital to listen to the concerns of the patients family members, who may be the primary caregivers and may share the patient’s stresses and anxieties, he said.

Pulmonary Rehabilitation

All of the experts interviewed for this article agreed that a combination of medical, social and mental health support services is important for treatment for patients with chronic obstructive lung diseases.

One of the most effective means of helping patients with both acute breathing problems and with disease-related anxiety and depression is pulmonary rehabilitation. Depending on disease severity, this multidisciplinary approach may involve exercise, patient education, psychological and nutrition counseling, and training patients how to conserve energy and adopt breathing strategies to help them better manage their symptoms.

“I think that pulmonary rehabilitation is one of the first interventions that we should be recommending for our patients,” Dr. Garfield said. “It’s physical therapy for patients with chronic lung diseases, backed by respiratory therapists, and it offers not only physical rehabilitation — improving strength and coordination, but also it helps our patients get as much as possible out of what they’ve got.”

For example, patients can be taught how to decrease their respiratory rate when they’re feeling a sense of urgency or panic. Patients can also learn how to change body positions to help them breathe more effectively when they feel that their breath is limited or restricted, she said.

“Once you’re into medical interventions, pulmonary rehab is phenomenal,” Dr. Saleh said.

Pulmonary rehabilitation helps patients to feel better about themselves and about their abilities, but “unfortunately it’s not as available as we like,” he said.

Many patients don’t live near a pulmonary rehabilitation center, and the typical two to three weekly sessions for 4-12 weeks or longer can be a significant burden for patients and caregivers, he acknowledged.

“You have to sit [with the patient] and be honest and tell them it’s a lot of diligence involved and you have to be really motivated,” he said.

Other treatment options include pharmacological therapy with antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and anxiolytic agents.

“SSRIs are the current first-line drug treatment for depression, and have been shown to significantly improve depression and anxiety in patients with COPD in some, but not all, trials published to date. However, it is important to note that a diagnosis of bipolar disorder must be ruled out before initiating standard antidepressant therapy,” Dr. Johannes and colleagues wrote.

Defiant joy

Importantly, even with the burden of life with COPD, many patients found ways to experience what Strang et al. called “a defiant joy.”

“It was remarkable that when the patients were asked about what gave their lives meaning today, many talked about what had given their life meaning in the past, prior to becoming ill. In the light of the things they had lost because of the disease, many felt that their previous sources of joy no longer existed. Despite this, many still hoped to be able to get out into the fresh air, to be able to do errands, or that tomorrow might be better,” the investigators wrote.

Dr. Yohannes, Dr. Garfield, and Dr. Saleh all reported having no relevant conflicts of interest to report.

Many patients with chronic progressive pulmonary disease feel anxious and depressed as their conditions advance, as breathing becomes increasingly labored and difficult, and as performing even small daily tasks leaves them exhausted.

Persons with severe COPD frequently report fears of suffocation and death, as well as anxieties about abandoning family and friends, and these negative, intrusive thoughts can have an adverse effect on COPD outcomes.

Disease-related mental distress can lead to increased disability, more frequent use of costly healthcare resources, higher morbidity, and elevated risk of death, investigators say.

“Individuals with severe COPD are twice as likely to develop depression than patients with mild COPD. Prevalence rates for clinical anxiety in COPD range from 13% to 46% in outpatients and 10% to 55% among inpatients,” wrote Abebaw Mengitsu Yohannes, PhD, then from Azusa Pacific University in Azusa, California, and colleagues in an article published jointly by The Journal of Family Practice and The Cleveland Clinic Journal of Medicine.

Patients with COPD may experience major depressive disorders, chronic mild depression (dysthymias), and minor depression, as well as generalized anxiety disorder, phobias, and panic disorders, the investigators say.

“Growing evidence suggests that the relationship between mood disorders — particularly depression — and COPD is bidirectional, meaning that mood disorders adversely impact prognosis in COPD, whereas COPD increases the risk of developing depression,” Yohannes et al. wrote.

Jamie Garfield, MD, professor of thoracic medicine and surgery at Temple University’s Lewis Katz School of Medicine in Philadelphia, Pennsylvania, told Chest Physician that the association between severe chronic diseases and mood disorders is well known.

“I don’t think that it’s specific to chronic lung diseases; in people with chronic heart disease or malignancies we see that coexistence of depression and anxiety will worsen the course of disease,” she said.

Dr. Johannes, who is currently a professor of physical therapy at the University of Alabama School of Health Professionals in Birmingham, said that depression and anxiety are often underdiagnosed and undertreated in patients with obstructive pulmonary diseases because the conditions can share symptoms such as dyspnea (for example, in anxiety) or fatigue (in depression).

“Therefore, unless one begins to explore further, it’s hard for physicians to be able to identify these conditions,” he said in an interview with Chest Physician.

Fears of dying (and living)

The causes of depression and anxiety among patients with obstructive pulmonary disorders are multifactorial, and may require a variety of treatment and coping strategies, according to Susann Strang, RN, PhD, and colleagues from the University of Gothenburg, Gothenburg, Sweden.

They conducted qualitative in-depth interviews with 31 men and women with stage III or IV COPD, and found that the majority of patients had anxiety associated with their disease.

“Analyses revealed three major themes: death anxiety, life anxiety, and counterweights to anxiety,” the investigators wrote in a study published in the journal Palliative and Supportive Care in 2014.

Factors contributing to anxiety surrounding death included fear of suffocation, awareness of impending death, fear of the process of death, and anxiety about being separated from loved ones.

In contrast, some patients expressed dread of living with the limitations and loneliness imposed on them by their disease — so-called “life anxiety.”

The patients also reported “counterweights” to anxiety as a way of coping. For some this involved trust in their healthcare professionals and adherence to medication, inhalers, and supplemental oxygen.

“The patients also placed hope in new treatments, better medication, surgery, stem cell treatment, or lung transplants,” Dr. Strang and colleagues reported.

Others reported avoiding talking about death, sleeping more, or using humor to “laugh off this difficult subject.”

Screening and diagnosis

Primary care practitioners are often the first health professionals that patients with COPD see, but these clinicians often don’t have the time to add screening to their already crammed schedules. In addition, “the lack of a standardized approach in diagnosis, and inadequate knowledge or confidence in assessing psychological status (particularly given the number of strategies available for screening patients for mood disorders),” can make it difficult for PCPs to detect and manage anxiety and depression in their patients with significant healthcare burdens from COPD and other obstructive lung diseases, Dr. Yohannes and colleagues noted.

In addition to commonly used screening tools for anxiety and depression such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) Patient Health Questionnaire (PHQ-9), there are at least two designed to evaluate patients with lung disease: the Anxiety Inventory for Respiratory (AIR) Disease scale, developed by Dr. Yohannes and colleagues, and the COPD Anxiety Questionnaire.

The COPD Assessment Test and Clinical COPD Questionnaire, while not specifically designed to screen for mental disorders, include questions that can point to symptoms of distress in patients with COPD, Dr. Yohannes said.

“In truth I think that there are few providers who will routinely do this on all their patients in terms of quantifying the severity or the presence or absence of depression, but in my own practice I very much ask questions that align with the questions in these tools to determine whether my patient appears to have high levels of anxiety and depression,” Dr. Garfield said.

Listen to patients and families

Among the most powerful tools that clinicians have at their disposal for treating anxiety and depression in patients with chronic lung disease are their ears and their minds, said Anthony Saleh, MD, a pulmonologist at New York-Presbyterian Brooklyn Methodist Hospital in Brooklyn, New York.

“I think just listening to the patient, that’s a little bit forgotten yet so important,” he said in an interview with CHEST Physician.

“When I have someone with advanced lung disease, like idiopathic pulmonary fibrosis, like advanced emphysema, one of the most important things I think is to listen to the patient, and not just to listen to the answers of your perfunctory ‘how’s your breathing? Any chest pain?’ and those sort of rote medical questions, but listen to their thoughts, and it will given them a safe space to say ‘Hey, I’m nervous, hey I’m worried about my family, hey I’m worried if I die what’s going to happen to my wife and kids,’ and that’s something I think is invaluable.”

It’s also vital to listen to the concerns of the patients family members, who may be the primary caregivers and may share the patient’s stresses and anxieties, he said.

Pulmonary Rehabilitation

All of the experts interviewed for this article agreed that a combination of medical, social and mental health support services is important for treatment for patients with chronic obstructive lung diseases.

One of the most effective means of helping patients with both acute breathing problems and with disease-related anxiety and depression is pulmonary rehabilitation. Depending on disease severity, this multidisciplinary approach may involve exercise, patient education, psychological and nutrition counseling, and training patients how to conserve energy and adopt breathing strategies to help them better manage their symptoms.

“I think that pulmonary rehabilitation is one of the first interventions that we should be recommending for our patients,” Dr. Garfield said. “It’s physical therapy for patients with chronic lung diseases, backed by respiratory therapists, and it offers not only physical rehabilitation — improving strength and coordination, but also it helps our patients get as much as possible out of what they’ve got.”

For example, patients can be taught how to decrease their respiratory rate when they’re feeling a sense of urgency or panic. Patients can also learn how to change body positions to help them breathe more effectively when they feel that their breath is limited or restricted, she said.

“Once you’re into medical interventions, pulmonary rehab is phenomenal,” Dr. Saleh said.

Pulmonary rehabilitation helps patients to feel better about themselves and about their abilities, but “unfortunately it’s not as available as we like,” he said.

Many patients don’t live near a pulmonary rehabilitation center, and the typical two to three weekly sessions for 4-12 weeks or longer can be a significant burden for patients and caregivers, he acknowledged.

“You have to sit [with the patient] and be honest and tell them it’s a lot of diligence involved and you have to be really motivated,” he said.

Other treatment options include pharmacological therapy with antidepressants such as selective serotonin reuptake inhibitors (SSRIs) and anxiolytic agents.

“SSRIs are the current first-line drug treatment for depression, and have been shown to significantly improve depression and anxiety in patients with COPD in some, but not all, trials published to date. However, it is important to note that a diagnosis of bipolar disorder must be ruled out before initiating standard antidepressant therapy,” Dr. Johannes and colleagues wrote.

Defiant joy

Importantly, even with the burden of life with COPD, many patients found ways to experience what Strang et al. called “a defiant joy.”

“It was remarkable that when the patients were asked about what gave their lives meaning today, many talked about what had given their life meaning in the past, prior to becoming ill. In the light of the things they had lost because of the disease, many felt that their previous sources of joy no longer existed. Despite this, many still hoped to be able to get out into the fresh air, to be able to do errands, or that tomorrow might be better,” the investigators wrote.

Dr. Yohannes, Dr. Garfield, and Dr. Saleh all reported having no relevant conflicts of interest to report.

A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.

The civil suit alleges that Aledade Inc.’s billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.

“Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.

For example, the suit alleges that Aledade “conflated” anxiety into depression, which could boost payments by $3300 a year per patient. And Aledade decided that patients over 65 years old who said they had more than one drink per day had substance use issues, which could bring in $3680 extra per patient, the suit says.

The whistleblower case was filed by Khushwinder Singh in federal court in Seattle in 2021 but remained under seal until January of this year. Singh, a “senior medical director of risk and wellness product” at Aledade from January 2021 through May 2021, alleges the company fired him after he objected to its “fraudulent course of conduct,” according to the suit. He declined to comment on the suit.

The case is pending, and Aledade has yet to file a legal response in court. Julie Bataille, Aledade’s senior vice president for communications, denied the allegations, saying in an interview that “the whole case is totally baseless and meritless.”

Based in Bethesda, Maryland, Aledade helps manage independent primary care clinics and medical offices in more than 40 states, serving some 2 million people.

Aledade is one of hundreds of groups known as accountable care organizations. ACOs enjoy strong support from federal health officials who hope they can keep people healthier and achieve measurable cost savings.

Aledade was co-founded in 2014 by Farzad Mostashari, a former health information technology chief in the Obama administration, and has welcomed other ex-government health figures into its ranks. In June 2023, President Joe Biden appointed Mandy Cohen, then executive vice president at Aledade, to head the Centers for Disease Control and Prevention in Atlanta.

Aledade has grown rapidly behind hundreds of millions of dollars in venture capital financing and was valued at $3.5 billion in 2023.

Mostashari, Aledade’s chief executive officer, declined to be interviewed on the record.

“As this is an active legal matter, we will not respond to individual allegations in the complaint,” Aledade said in a statement to KFF Health News. “We remain focused on our top priority of delivering high-quality, value-based care with our physician partners and will defend ourselves vigorously if needed in a court of law.”

The lawsuit also names as defendants 19 independent physician practices, many in small cities in Delaware, Kansas, Louisiana, North Carolina, Pennsylvania, and West Virginia. According to the suit, the doctors knowingly used Aledade software to trigger illegal billings, a practice known in the medical industry as “upcoding.” None has filed an answer in court.

More than two dozen whistleblower lawsuits, some dating back more than a decade, have accused Medicare health plans of overcharging the government by billing for medical conditions not supported by patient medical records. These cases have resulted in hundreds of millions of dollars in penalties. In September 2023, Cigna agreed to pay $37 million to settle one such case, for instance.

But the whistleblower suit filed against Aledade appears to be the first to allege upcoding within accountable care organizations, which describe part of their mission as foiling wasteful spending. ACOs including Aledade made headlines recently for helping to expose an alleged massive Medicare fraud involving urinary catheters, for instance.

Finding the ‘Gravy’

Singh’s suit targets Aledade’s use of coding software and guidance to medical practices that joined its network. Some doctors treated patients on standard Medicare through the ACO networks, while others cared for seniors enrolled in Medicare Advantage plans, according to the suit.

Medicare Advantage is a privately run alternative to standard Medicare that has surged in popularity and now cares for more than 30 million people. Aledade has sought to expand its services to Medicare Advantage enrollees.

The lawsuit alleges Aledade encouraged doctors to tack on suspect medical diagnoses that paid extra money. Aledade called it finding “the gravy sitting in the [patient’s] chart,” according to the suit.

The company “instructed” providers to diagnose diabetes with complications, “even if the patient’s diabetes was under control or the complicating factor no longer existed,” according to the suit.

Some medical practices in Delaware, North Carolina, and West Virginia billed the inflated code for more than 90% of their Medicare Advantage patients with diabetes, according to the suit.

The lawsuit also alleges that Aledade “rigged” the software to change a diagnosis of overweight to “morbid obesity,” which could pay about $2500 more per patient. Some providers coded morbid obesity for patients on traditional Medicare at 10 times the national average, according to the suit.

“This fraudulent coding guidance was known as ‘Aledade gospel,’ ” according to the suit, and following it “paid dividends in the form of millions of dollars in increased revenue.”

These tactics “usurped” the clinical judgment of doctors, according to the suit.

‘No Diagnosis Left Behind’

In its statement to KFF Health News, Aledade said its software offers doctors a range of data and guidance that helps them evaluate and treat patients.

“Aledade’s independent physicians remain solely responsible for all medical decision-making for their patients,” the statement read.

The company said it will “continue to advocate for changes to improve Medicare’s risk adjustment process to promote accuracy while also reducing unnecessary administrative burdens.”

In a message to employees and partner practices sent on Feb. 29, Mostashari noted that the Justice Department had declined to take over the False Claims Act case.

“We recently learned that the federal government has declined to join the case U.S. ex rel. Khushwinder Singh v. Aledade, Inc., et al. That’s good news, and a decision we wholeheartedly applaud given the baseless allegations about improper coding practices and wrongful termination brought by a former Aledade employee 3 years ago. We do not yet know how the full legal situation will play out but will defend ourselves vigorously if needed in a court of law,” the statement said.

The Justice Department advised the Seattle court on Jan. 9 that it would not intervene in the case “at this time,” which prompted an order to unseal it, court records show. Under the false claims law, whistleblowers can proceed with the case on their own. The Justice Department does not state a reason for declining a case but has said in other court cases that doing so has no bearing on its merits.

Singh argues in his complaint that many “unsupported” diagnosis codes were added during annual “wellness visits” and that they did not result in the patients receiving any additional medical care.

Aledade maintained Slack channels in which doctors could discuss the financial incentives for adding higher-paying diagnostic codes, according to the suit.

The company also closely monitored how doctors coded as part of an initiative dubbed “no diagnosis left behind,” according to the suit.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism.

A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.

The civil suit alleges that Aledade Inc.’s billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.

“Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.

For example, the suit alleges that Aledade “conflated” anxiety into depression, which could boost payments by $3300 a year per patient. And Aledade decided that patients over 65 years old who said they had more than one drink per day had substance use issues, which could bring in $3680 extra per patient, the suit says.

The whistleblower case was filed by Khushwinder Singh in federal court in Seattle in 2021 but remained under seal until January of this year. Singh, a “senior medical director of risk and wellness product” at Aledade from January 2021 through May 2021, alleges the company fired him after he objected to its “fraudulent course of conduct,” according to the suit. He declined to comment on the suit.

The case is pending, and Aledade has yet to file a legal response in court. Julie Bataille, Aledade’s senior vice president for communications, denied the allegations, saying in an interview that “the whole case is totally baseless and meritless.”

Based in Bethesda, Maryland, Aledade helps manage independent primary care clinics and medical offices in more than 40 states, serving some 2 million people.

Aledade is one of hundreds of groups known as accountable care organizations. ACOs enjoy strong support from federal health officials who hope they can keep people healthier and achieve measurable cost savings.

Aledade was co-founded in 2014 by Farzad Mostashari, a former health information technology chief in the Obama administration, and has welcomed other ex-government health figures into its ranks. In June 2023, President Joe Biden appointed Mandy Cohen, then executive vice president at Aledade, to head the Centers for Disease Control and Prevention in Atlanta.

Aledade has grown rapidly behind hundreds of millions of dollars in venture capital financing and was valued at $3.5 billion in 2023.

Mostashari, Aledade’s chief executive officer, declined to be interviewed on the record.

“As this is an active legal matter, we will not respond to individual allegations in the complaint,” Aledade said in a statement to KFF Health News. “We remain focused on our top priority of delivering high-quality, value-based care with our physician partners and will defend ourselves vigorously if needed in a court of law.”

The lawsuit also names as defendants 19 independent physician practices, many in small cities in Delaware, Kansas, Louisiana, North Carolina, Pennsylvania, and West Virginia. According to the suit, the doctors knowingly used Aledade software to trigger illegal billings, a practice known in the medical industry as “upcoding.” None has filed an answer in court.

More than two dozen whistleblower lawsuits, some dating back more than a decade, have accused Medicare health plans of overcharging the government by billing for medical conditions not supported by patient medical records. These cases have resulted in hundreds of millions of dollars in penalties. In September 2023, Cigna agreed to pay $37 million to settle one such case, for instance.

But the whistleblower suit filed against Aledade appears to be the first to allege upcoding within accountable care organizations, which describe part of their mission as foiling wasteful spending. ACOs including Aledade made headlines recently for helping to expose an alleged massive Medicare fraud involving urinary catheters, for instance.

Finding the ‘Gravy’

Singh’s suit targets Aledade’s use of coding software and guidance to medical practices that joined its network. Some doctors treated patients on standard Medicare through the ACO networks, while others cared for seniors enrolled in Medicare Advantage plans, according to the suit.

Medicare Advantage is a privately run alternative to standard Medicare that has surged in popularity and now cares for more than 30 million people. Aledade has sought to expand its services to Medicare Advantage enrollees.

The lawsuit alleges Aledade encouraged doctors to tack on suspect medical diagnoses that paid extra money. Aledade called it finding “the gravy sitting in the [patient’s] chart,” according to the suit.

The company “instructed” providers to diagnose diabetes with complications, “even if the patient’s diabetes was under control or the complicating factor no longer existed,” according to the suit.

Some medical practices in Delaware, North Carolina, and West Virginia billed the inflated code for more than 90% of their Medicare Advantage patients with diabetes, according to the suit.

The lawsuit also alleges that Aledade “rigged” the software to change a diagnosis of overweight to “morbid obesity,” which could pay about $2500 more per patient. Some providers coded morbid obesity for patients on traditional Medicare at 10 times the national average, according to the suit.

“This fraudulent coding guidance was known as ‘Aledade gospel,’ ” according to the suit, and following it “paid dividends in the form of millions of dollars in increased revenue.”

These tactics “usurped” the clinical judgment of doctors, according to the suit.

‘No Diagnosis Left Behind’

In its statement to KFF Health News, Aledade said its software offers doctors a range of data and guidance that helps them evaluate and treat patients.

“Aledade’s independent physicians remain solely responsible for all medical decision-making for their patients,” the statement read.

The company said it will “continue to advocate for changes to improve Medicare’s risk adjustment process to promote accuracy while also reducing unnecessary administrative burdens.”

In a message to employees and partner practices sent on Feb. 29, Mostashari noted that the Justice Department had declined to take over the False Claims Act case.

“We recently learned that the federal government has declined to join the case U.S. ex rel. Khushwinder Singh v. Aledade, Inc., et al. That’s good news, and a decision we wholeheartedly applaud given the baseless allegations about improper coding practices and wrongful termination brought by a former Aledade employee 3 years ago. We do not yet know how the full legal situation will play out but will defend ourselves vigorously if needed in a court of law,” the statement said.

The Justice Department advised the Seattle court on Jan. 9 that it would not intervene in the case “at this time,” which prompted an order to unseal it, court records show. Under the false claims law, whistleblowers can proceed with the case on their own. The Justice Department does not state a reason for declining a case but has said in other court cases that doing so has no bearing on its merits.

Singh argues in his complaint that many “unsupported” diagnosis codes were added during annual “wellness visits” and that they did not result in the patients receiving any additional medical care.

Aledade maintained Slack channels in which doctors could discuss the financial incentives for adding higher-paying diagnostic codes, according to the suit.

The company also closely monitored how doctors coded as part of an initiative dubbed “no diagnosis left behind,” according to the suit.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism.

A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.

The civil suit alleges that Aledade Inc.’s billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.

“Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.

For example, the suit alleges that Aledade “conflated” anxiety into depression, which could boost payments by $3300 a year per patient. And Aledade decided that patients over 65 years old who said they had more than one drink per day had substance use issues, which could bring in $3680 extra per patient, the suit says.

The whistleblower case was filed by Khushwinder Singh in federal court in Seattle in 2021 but remained under seal until January of this year. Singh, a “senior medical director of risk and wellness product” at Aledade from January 2021 through May 2021, alleges the company fired him after he objected to its “fraudulent course of conduct,” according to the suit. He declined to comment on the suit.

The case is pending, and Aledade has yet to file a legal response in court. Julie Bataille, Aledade’s senior vice president for communications, denied the allegations, saying in an interview that “the whole case is totally baseless and meritless.”

Based in Bethesda, Maryland, Aledade helps manage independent primary care clinics and medical offices in more than 40 states, serving some 2 million people.

Aledade is one of hundreds of groups known as accountable care organizations. ACOs enjoy strong support from federal health officials who hope they can keep people healthier and achieve measurable cost savings.

Aledade was co-founded in 2014 by Farzad Mostashari, a former health information technology chief in the Obama administration, and has welcomed other ex-government health figures into its ranks. In June 2023, President Joe Biden appointed Mandy Cohen, then executive vice president at Aledade, to head the Centers for Disease Control and Prevention in Atlanta.

Aledade has grown rapidly behind hundreds of millions of dollars in venture capital financing and was valued at $3.5 billion in 2023.

Mostashari, Aledade’s chief executive officer, declined to be interviewed on the record.

“As this is an active legal matter, we will not respond to individual allegations in the complaint,” Aledade said in a statement to KFF Health News. “We remain focused on our top priority of delivering high-quality, value-based care with our physician partners and will defend ourselves vigorously if needed in a court of law.”

The lawsuit also names as defendants 19 independent physician practices, many in small cities in Delaware, Kansas, Louisiana, North Carolina, Pennsylvania, and West Virginia. According to the suit, the doctors knowingly used Aledade software to trigger illegal billings, a practice known in the medical industry as “upcoding.” None has filed an answer in court.

More than two dozen whistleblower lawsuits, some dating back more than a decade, have accused Medicare health plans of overcharging the government by billing for medical conditions not supported by patient medical records. These cases have resulted in hundreds of millions of dollars in penalties. In September 2023, Cigna agreed to pay $37 million to settle one such case, for instance.

But the whistleblower suit filed against Aledade appears to be the first to allege upcoding within accountable care organizations, which describe part of their mission as foiling wasteful spending. ACOs including Aledade made headlines recently for helping to expose an alleged massive Medicare fraud involving urinary catheters, for instance.

Finding the ‘Gravy’

Singh’s suit targets Aledade’s use of coding software and guidance to medical practices that joined its network. Some doctors treated patients on standard Medicare through the ACO networks, while others cared for seniors enrolled in Medicare Advantage plans, according to the suit.

Medicare Advantage is a privately run alternative to standard Medicare that has surged in popularity and now cares for more than 30 million people. Aledade has sought to expand its services to Medicare Advantage enrollees.

The lawsuit alleges Aledade encouraged doctors to tack on suspect medical diagnoses that paid extra money. Aledade called it finding “the gravy sitting in the [patient’s] chart,” according to the suit.

The company “instructed” providers to diagnose diabetes with complications, “even if the patient’s diabetes was under control or the complicating factor no longer existed,” according to the suit.

Some medical practices in Delaware, North Carolina, and West Virginia billed the inflated code for more than 90% of their Medicare Advantage patients with diabetes, according to the suit.

The lawsuit also alleges that Aledade “rigged” the software to change a diagnosis of overweight to “morbid obesity,” which could pay about $2500 more per patient. Some providers coded morbid obesity for patients on traditional Medicare at 10 times the national average, according to the suit.

“This fraudulent coding guidance was known as ‘Aledade gospel,’ ” according to the suit, and following it “paid dividends in the form of millions of dollars in increased revenue.”

These tactics “usurped” the clinical judgment of doctors, according to the suit.

‘No Diagnosis Left Behind’

In its statement to KFF Health News, Aledade said its software offers doctors a range of data and guidance that helps them evaluate and treat patients.

“Aledade’s independent physicians remain solely responsible for all medical decision-making for their patients,” the statement read.

The company said it will “continue to advocate for changes to improve Medicare’s risk adjustment process to promote accuracy while also reducing unnecessary administrative burdens.”

In a message to employees and partner practices sent on Feb. 29, Mostashari noted that the Justice Department had declined to take over the False Claims Act case.

“We recently learned that the federal government has declined to join the case U.S. ex rel. Khushwinder Singh v. Aledade, Inc., et al. That’s good news, and a decision we wholeheartedly applaud given the baseless allegations about improper coding practices and wrongful termination brought by a former Aledade employee 3 years ago. We do not yet know how the full legal situation will play out but will defend ourselves vigorously if needed in a court of law,” the statement said.

The Justice Department advised the Seattle court on Jan. 9 that it would not intervene in the case “at this time,” which prompted an order to unseal it, court records show. Under the false claims law, whistleblowers can proceed with the case on their own. The Justice Department does not state a reason for declining a case but has said in other court cases that doing so has no bearing on its merits.

Singh argues in his complaint that many “unsupported” diagnosis codes were added during annual “wellness visits” and that they did not result in the patients receiving any additional medical care.

Aledade maintained Slack channels in which doctors could discuss the financial incentives for adding higher-paying diagnostic codes, according to the suit.

The company also closely monitored how doctors coded as part of an initiative dubbed “no diagnosis left behind,” according to the suit.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism.

This transcript has been edited for clarity.

Hospital administrators and some department heads have been vocal about the potential for unions to affect both the attending-resident relationship and the ability for residents to directly discuss concerns and educational plans.

Critics feel that having a third party at the table, such as a union representative who isn’t as knowledgeable about the nuances of medical education, could complicate the decision-making process.

Sometimes, there are institution-specific issues as well. One example was at Loma Linda. They argued that unionization would go against their religious principles. They filed a lawsuit. That didn’t go through, and the residents won a few months later.

I know there’s always that one senior, older doctor who says, “Back in our day, we just worked, and we never complained.”

Look at the current situation that residents are facing now, with housing and rent prices and increasing costs of childcare. Sprinkle in some inflation, poor hospital staffing, increasing workload, and add in the fact that the average first-year resident salary in 2023 was around $64,000.

Now, if you look back to 2012, the average salary was around $55,000. If you adjust that for inflation, it would be around $75,000 today, which is more than what the average resident is getting paid.

Then, there are hospital administrators who say that the hospital does not have the money to meet these demands; meanwhile, hospital graduate medical education (GME) offices receive about $150,000 of Medicare funds per resident.

Obviously, there are additional costs when it comes to training and supporting residents. In general, unionizing freaks out the people handling all the cash.

There’s also the threat of a strike, which no hospital wants on their public record. A recent highly publicized event happened at New York’s Elmhurst Hospital, when 160 residents went on strike for 3 days until a deal was made.

Critics of unionizing also cite a particular study in JAMA, which included a survey of 5700 general surgery residents at 285 programs. It found that while unions helped with vacation time and housing stipends, the unions were not associated with improved burnout rates, suicidality, job satisfaction, duty hour violations, mistreatment, educational environment, or salary.

Now, granted, this isn’t the strongest study. It only sampled one group of residents, so I wouldn’t generalize these findings, but it’s still commonly cited by anti-union advocates.

Another potential downside, which is purely anecdotal because I can’t find any data to support this, is potential retaliation against residents or harm to the attending-resident relationship.

I’m an attending. I don’t really understand this one. I don’t exactly own stock in my hospital, nor am I making millions of dollars by siphoning GME money. I’m just trying to focus on educating and supporting my residents the best I can.

Dr. Patel is Clinical Instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons; Pediatric Hospitalist, Morgan Stanley Children’s Hospital of NewYork–Presbyterian, and Benioff Children’s Hospital, University of California San Francisco. He disclosed ties with Medumo Inc.

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

This transcript has been edited for clarity.

Hospital administrators and some department heads have been vocal about the potential for unions to affect both the attending-resident relationship and the ability for residents to directly discuss concerns and educational plans.

Critics feel that having a third party at the table, such as a union representative who isn’t as knowledgeable about the nuances of medical education, could complicate the decision-making process.

Sometimes, there are institution-specific issues as well. One example was at Loma Linda. They argued that unionization would go against their religious principles. They filed a lawsuit. That didn’t go through, and the residents won a few months later.

I know there’s always that one senior, older doctor who says, “Back in our day, we just worked, and we never complained.”

Look at the current situation that residents are facing now, with housing and rent prices and increasing costs of childcare. Sprinkle in some inflation, poor hospital staffing, increasing workload, and add in the fact that the average first-year resident salary in 2023 was around $64,000.

Now, if you look back to 2012, the average salary was around $55,000. If you adjust that for inflation, it would be around $75,000 today, which is more than what the average resident is getting paid.

Then, there are hospital administrators who say that the hospital does not have the money to meet these demands; meanwhile, hospital graduate medical education (GME) offices receive about $150,000 of Medicare funds per resident.

Obviously, there are additional costs when it comes to training and supporting residents. In general, unionizing freaks out the people handling all the cash.

There’s also the threat of a strike, which no hospital wants on their public record. A recent highly publicized event happened at New York’s Elmhurst Hospital, when 160 residents went on strike for 3 days until a deal was made.

Critics of unionizing also cite a particular study in JAMA, which included a survey of 5700 general surgery residents at 285 programs. It found that while unions helped with vacation time and housing stipends, the unions were not associated with improved burnout rates, suicidality, job satisfaction, duty hour violations, mistreatment, educational environment, or salary.

Now, granted, this isn’t the strongest study. It only sampled one group of residents, so I wouldn’t generalize these findings, but it’s still commonly cited by anti-union advocates.

Another potential downside, which is purely anecdotal because I can’t find any data to support this, is potential retaliation against residents or harm to the attending-resident relationship.

I’m an attending. I don’t really understand this one. I don’t exactly own stock in my hospital, nor am I making millions of dollars by siphoning GME money. I’m just trying to focus on educating and supporting my residents the best I can.

Dr. Patel is Clinical Instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons; Pediatric Hospitalist, Morgan Stanley Children’s Hospital of NewYork–Presbyterian, and Benioff Children’s Hospital, University of California San Francisco. He disclosed ties with Medumo Inc.

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

This transcript has been edited for clarity.

Hospital administrators and some department heads have been vocal about the potential for unions to affect both the attending-resident relationship and the ability for residents to directly discuss concerns and educational plans.

Critics feel that having a third party at the table, such as a union representative who isn’t as knowledgeable about the nuances of medical education, could complicate the decision-making process.

Sometimes, there are institution-specific issues as well. One example was at Loma Linda. They argued that unionization would go against their religious principles. They filed a lawsuit. That didn’t go through, and the residents won a few months later.

I know there’s always that one senior, older doctor who says, “Back in our day, we just worked, and we never complained.”

Look at the current situation that residents are facing now, with housing and rent prices and increasing costs of childcare. Sprinkle in some inflation, poor hospital staffing, increasing workload, and add in the fact that the average first-year resident salary in 2023 was around $64,000.

Now, if you look back to 2012, the average salary was around $55,000. If you adjust that for inflation, it would be around $75,000 today, which is more than what the average resident is getting paid.

Then, there are hospital administrators who say that the hospital does not have the money to meet these demands; meanwhile, hospital graduate medical education (GME) offices receive about $150,000 of Medicare funds per resident.

Obviously, there are additional costs when it comes to training and supporting residents. In general, unionizing freaks out the people handling all the cash.

There’s also the threat of a strike, which no hospital wants on their public record. A recent highly publicized event happened at New York’s Elmhurst Hospital, when 160 residents went on strike for 3 days until a deal was made.

Critics of unionizing also cite a particular study in JAMA, which included a survey of 5700 general surgery residents at 285 programs. It found that while unions helped with vacation time and housing stipends, the unions were not associated with improved burnout rates, suicidality, job satisfaction, duty hour violations, mistreatment, educational environment, or salary.

Now, granted, this isn’t the strongest study. It only sampled one group of residents, so I wouldn’t generalize these findings, but it’s still commonly cited by anti-union advocates.

Another potential downside, which is purely anecdotal because I can’t find any data to support this, is potential retaliation against residents or harm to the attending-resident relationship.

I’m an attending. I don’t really understand this one. I don’t exactly own stock in my hospital, nor am I making millions of dollars by siphoning GME money. I’m just trying to focus on educating and supporting my residents the best I can.

Dr. Patel is Clinical Instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons; Pediatric Hospitalist, Morgan Stanley Children’s Hospital of NewYork–Presbyterian, and Benioff Children’s Hospital, University of California San Francisco. He disclosed ties with Medumo Inc.

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

TOPLINE:

Exposure to organophosphate ester (OPE) metabolites, a newer group of widely used chemical flame retardants, is linked to a higher risk for thyroid disease, bis(2-chloroethyl) phosphate (BCEP) being the main contributor.

METHODOLOGY:

• Prior studies have reported that OPEs — used in building materials, electronic products, furniture, and textiles — may interfere with thyroid function, hinting at a possible association of OPEs with thyroid disease.
• Researchers assessed the association between OPE exposure and the risk for thyroid disease using data from the 2011-2014 US National Health and Nutrition Examination Survey cycle.
• They included 2449 participants (mean age, 46 years; half of whom were women) who had complete values for seven OPE metabolites through urinalysis and completed questionnaires regarding the presence of thyroid disease.
• The seven OPE metabolites assessed in this study were diphenyl phosphate (DPHP), bis(1,3-dichloro-2-propyl) phosphate, bis(1-chloro-2-propyl) phosphate, BCEP, dibutyl phosphate, dibenzyl phosphate, and 2,3,4,5-tetrabromobenzoic acid.
• Several mixed exposure models were used to investigate the associations between the risk for thyroid disease and exposure to individual and mixed OPEs.

TAKEAWAY:

• A history of thyroid disease was self-reported by 228 participants.
• In one model, the risk for thyroid disease was 57% higher in people in the highest vs the lowest tertile of BCEP exposure (P = .005).
• A newer method confirmed the positive association between exposure to mixed OPE metabolites and a higher risk for thyroid disease (odds ratio, 1.03; P = .013), with BCEP (65%) being the main contributing factor, followed by DPHP (35%).
• A model from another new method showed a J-shaped relationship between the risk for thyroid disease and increasing levels of BCEP exposure, in which the risk first dropped but then rose with increasing exposure.

IN PRACTICE:

“The three models in our study provided similar results, with exposure to mixed OPEs having a tendency to increase the risk of thyroid disease and pointing to BCEP as the most significant compound responsible for this trend,” wrote the authors.

SOURCE:

This study was led by Yuxin Lin, from the Department of Epidemiology and Health Statistics, School of Public Health, Fujian Medical University, Fuzhou, China, and published online in Frontiers in Endocrinology.

LIMITATIONS:

The cross-sectional design cannot establish a causal relationship between OPE exposure and thyroid disease. The study used unweighted data, which could have limited the generalizability of the findings. Moreover, urine sample measurements were performed only once.

DISCLOSURES:

The study was supported by the Fujian Natural Science Foundation Program and the Scientific Research Program of High-level Talents of Fujian Medical University. The authors declared no potential conflicts of interest.

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

TOPLINE:

Exposure to organophosphate ester (OPE) metabolites, a newer group of widely used chemical flame retardants, is linked to a higher risk for thyroid disease, bis(2-chloroethyl) phosphate (BCEP) being the main contributor.

METHODOLOGY:

• Prior studies have reported that OPEs — used in building materials, electronic products, furniture, and textiles — may interfere with thyroid function, hinting at a possible association of OPEs with thyroid disease.
• Researchers assessed the association between OPE exposure and the risk for thyroid disease using data from the 2011-2014 US National Health and Nutrition Examination Survey cycle.
• They included 2449 participants (mean age, 46 years; half of whom were women) who had complete values for seven OPE metabolites through urinalysis and completed questionnaires regarding the presence of thyroid disease.
• The seven OPE metabolites assessed in this study were diphenyl phosphate (DPHP), bis(1,3-dichloro-2-propyl) phosphate, bis(1-chloro-2-propyl) phosphate, BCEP, dibutyl phosphate, dibenzyl phosphate, and 2,3,4,5-tetrabromobenzoic acid.
• Several mixed exposure models were used to investigate the associations between the risk for thyroid disease and exposure to individual and mixed OPEs.

TAKEAWAY:

• A history of thyroid disease was self-reported by 228 participants.
• In one model, the risk for thyroid disease was 57% higher in people in the highest vs the lowest tertile of BCEP exposure (P = .005).
• A newer method confirmed the positive association between exposure to mixed OPE metabolites and a higher risk for thyroid disease (odds ratio, 1.03; P = .013), with BCEP (65%) being the main contributing factor, followed by DPHP (35%).
• A model from another new method showed a J-shaped relationship between the risk for thyroid disease and increasing levels of BCEP exposure, in which the risk first dropped but then rose with increasing exposure.

IN PRACTICE:

“The three models in our study provided similar results, with exposure to mixed OPEs having a tendency to increase the risk of thyroid disease and pointing to BCEP as the most significant compound responsible for this trend,” wrote the authors.

SOURCE:

This study was led by Yuxin Lin, from the Department of Epidemiology and Health Statistics, School of Public Health, Fujian Medical University, Fuzhou, China, and published online in Frontiers in Endocrinology.

LIMITATIONS:

The cross-sectional design cannot establish a causal relationship between OPE exposure and thyroid disease. The study used unweighted data, which could have limited the generalizability of the findings. Moreover, urine sample measurements were performed only once.

DISCLOSURES:

The study was supported by the Fujian Natural Science Foundation Program and the Scientific Research Program of High-level Talents of Fujian Medical University. The authors declared no potential conflicts of interest.

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

TOPLINE:

Exposure to organophosphate ester (OPE) metabolites, a newer group of widely used chemical flame retardants, is linked to a higher risk for thyroid disease, bis(2-chloroethyl) phosphate (BCEP) being the main contributor.

METHODOLOGY:

• Prior studies have reported that OPEs — used in building materials, electronic products, furniture, and textiles — may interfere with thyroid function, hinting at a possible association of OPEs with thyroid disease.
• Researchers assessed the association between OPE exposure and the risk for thyroid disease using data from the 2011-2014 US National Health and Nutrition Examination Survey cycle.
• They included 2449 participants (mean age, 46 years; half of whom were women) who had complete values for seven OPE metabolites through urinalysis and completed questionnaires regarding the presence of thyroid disease.
• The seven OPE metabolites assessed in this study were diphenyl phosphate (DPHP), bis(1,3-dichloro-2-propyl) phosphate, bis(1-chloro-2-propyl) phosphate, BCEP, dibutyl phosphate, dibenzyl phosphate, and 2,3,4,5-tetrabromobenzoic acid.
• Several mixed exposure models were used to investigate the associations between the risk for thyroid disease and exposure to individual and mixed OPEs.

TAKEAWAY:

• A history of thyroid disease was self-reported by 228 participants.
• In one model, the risk for thyroid disease was 57% higher in people in the highest vs the lowest tertile of BCEP exposure (P = .005).
• A newer method confirmed the positive association between exposure to mixed OPE metabolites and a higher risk for thyroid disease (odds ratio, 1.03; P = .013), with BCEP (65%) being the main contributing factor, followed by DPHP (35%).
• A model from another new method showed a J-shaped relationship between the risk for thyroid disease and increasing levels of BCEP exposure, in which the risk first dropped but then rose with increasing exposure.

IN PRACTICE:

“The three models in our study provided similar results, with exposure to mixed OPEs having a tendency to increase the risk of thyroid disease and pointing to BCEP as the most significant compound responsible for this trend,” wrote the authors.

SOURCE:

This study was led by Yuxin Lin, from the Department of Epidemiology and Health Statistics, School of Public Health, Fujian Medical University, Fuzhou, China, and published online in Frontiers in Endocrinology.

LIMITATIONS:

The cross-sectional design cannot establish a causal relationship between OPE exposure and thyroid disease. The study used unweighted data, which could have limited the generalizability of the findings. Moreover, urine sample measurements were performed only once.

DISCLOSURES:

The study was supported by the Fujian Natural Science Foundation Program and the Scientific Research Program of High-level Talents of Fujian Medical University. The authors declared no potential conflicts of interest.

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

TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

TOPLINE:

The anti-inflammatory shift in mid-pregnancy may be linked to changes in gut microbiota, which, in turn, may wield their influence through fecal and plasma metabolites.

METHODOLOGY:

• Midway through a normal pregnancy, the maternal immune system shifts to a more anti-inflammatory state, which may be linked to changes in the gut microbial community by unknown mechanisms.
• The study explored the associations between the gut microbiota, fecal and plasma metabolites, and cytokine levels of pregnant women and compared them with those of nonpregnant women.
• The study recruited 30 pregnant women (ages 18-34 years; prepregnancy body mass index [BMI], 18.5-21.9) who conceived naturally with a singleton pregnancy and 15 nonpregnant women of similar age and BMI from the First Affiliated Hospital of Jinan University, Guangzhou, China, between February 2019 and August 2020.
• All participants had not used probiotics or antibiotics in the 6 months prior to participating in the study.
• Fecal and blood samples were collected during or after the 37th week of pregnancy in pregnant women until their labor and on the 14th day of the menstrual cycle in nonpregnant women.

TAKEAWAY:

• Pregnant women had more Actinobacteriota than nonpregnant women (9.15% vs 2.98%, respectively; P = .002) in their gut microbiomes, and the most enriched other microbes showed a negative correlation with pro-inflammatory cytokines.
• Pregnant women had differences in 44 fecal and 53 plasma metabolites, with certain enriched metabolites negatively correlated with pro-inflammatory cytokines and certain depleted ones positively correlated.
• Levels of pro-inflammatory plasma cytokines such as interleukins (IL)-1β, IL-2, IL-6, IL-12, interferon gamma, and tumor necrosis factor alpha were reduced, while levels of the anti-inflammatory cytokine IL-4 were elevated in pregnant vs nonpregnant women.
• Researchers identified a total of 46 connections between gut microbes, metabolites, and cytokines, with details suggesting that gut microbes may alter plasma cytokine levels by interacting with host metabolites.

IN PRACTICE:

“Our study revealed complicated associations among gut microbiota, metabolites, and immune system during pregnancy and identified some specific metabolites which may act as mediators between symbiotic microorganisms and immune homeostasis,” the authors wrote.

SOURCE:

The study, led by Ting Huang, Department of Obstetrics and Gynecology, the First Affiliated Hospital of Jinan University, Guangzhou, China, was published online on February 7, 2024, in mSystems.

LIMITATIONS:

The small sample size of the study may have limited capacity to address errors resulting from individual differences. No causal relationships between gut microbiota, metabolites, and immune system response could be confirmed. Researchers were unable to account for the possible effects of confounding variables, such as diet, because of the cross-sectional nature of this study.

DISCLOSURES:

This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

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

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

An FDA advisory committee has recommended that the United States switch from a quadrivalent to trivalent influenza vaccine for the next flu season.

The flu vaccine currently in use targets two A strains and two B strains. But the Yamagata/B subtype, which was already in decline, has not been detected worldwide since March 2020, the FDA said. Social distancing and other precautions used to avoid COVID apparently finished it off. 

In response to that change, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 5 to recommend the three-strain flu shot.

VRBPAC recommended the egg-based flu vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The committee recommended the cell- or recombinant-based flu vaccines contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The move is no surprise. The World Health Organization and FDA experts had been recommending the change since last year. 

Jerry Weir, MD, director of the FDA’s Division of Viral Products, said companies that make flu vaccines should have the trivalent shot ready for the 2024-2025  flu season.

“Each of the U.S. influenza vaccine manufacturers have submitted updated regulatory files related to a trivalent influenza vaccine, and approval of all the necessary regulatory submissions is on track for 2024-25,” he said during the advisory committee’s meeting, according to CNN.

“FDA anticipates that there will be an adequate and diverse supply of approved trivalent seasonal influenza vaccines for the United States in the coming season,” the agency said.

U.S. flu vaccine manufacturers will still make a four-strain vaccine for distribution to overseas markets, CNN said.
 

A version of this article appeared on WebMD.com.

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

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

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

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

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

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

Thunderstorm asthma can strike with little warning, leaving people with the symptoms of an asthma attack during or after the dark clouds pass. 

If you’re unfamiliar, the risk for a thunderstorm asthma attack grows when heavy storms arrive on a day with very high pollen or spores. The storm uplifts these particles, adds water, and causes them to explode into smaller grains. The electrical activity in a storm can do the same. Next, strong winds sweep these particles down and across the ground. People in the path of the storm can experience shortness of breath, coughing, and wheezing.

If thunderstorms are predicted to become more frequent and more severe with climate change, will the same hold true for thunderstorm asthma?   

“Yes, if only because the amount of pollen appears to be increasing in many areas due to climate change,” said Frank S. Virant, MD, chief of the Allergy Division at Seattle Children’s Hospital in Washington.

Most cases of thunderstorm asthma occur in the spring and early summer, but that also could change. Pollen seasons “have been getting longer and more intense,” said Shaan M. Waqar, MD, an allergist at ENT and Allergy Associates in Plainview, NY. 

“Thunderstorm asthma events are rare, but our changing environment and the increase in the number of people with allergies may make such events more common and more severe into the future,” agreed Paul J. Beggs, PhD, associate professor in the School of Natural Sciences at Macquarie University in Sydney, Australia.

How to Minimize Your Risk

If your patients are sensitive to pollen, advise them to continue to monitor outdoor levels, particularly during tree, grass, and weed pollen season, Dr. Virant recommended. Also patients should pay attention to weather reports. Watch for thunderstorms that could “amplify exposure to the pollen with 40-plus mile per hour winds and often colder air downdrafts.” Cold is an additional asthma trigger, he noted. 

People with asthma should try to stay indoors with windows and doors closed during strong thunderstorms and for several hours afterward. Using air filters can also help reduce risk, said Deepti V. Manian, MD, an allergist and immunologist at Stormont Vail Health in Topeka, Kansas.

Patients should continue controller therapies -- such as longer-acting inhalers and allergy medications -- and use a rescue inhaler or nebulizer for prompt treatment of symptoms, recommended Donald J. Dvorin, MD, of The Allergy and Asthma Doctors in Mount Laurel, NJ. Ideally, people seeking shelter indoors during storms should be “accompanied by friends or family who can help them transport quickly to a hospital if needed.”

Asthma Diagnosis Not Required

Even peoples who would not consider themselves to have asthma can be seriously affected. For example, people with hay fever, or allergic rhinitis as it’s also known, are also at risk, said Ajay Kevat, MBBS, MPH, of the respiratory department at Queensland Children’s Hospital in Brisbane, Australia.

People with hay fever can also experience stronger symptoms during and after thunderstorms. Optimally treating allergic rhinitis during the pollen season with non-sedation antihistamines and nasal steroids can help, Dr. Virant said, instead of “chasing symptoms with medication after they are already severe.” 

Part of the challenge is connecting severe weather to worse asthma symptoms. “In my experience, there is a lack of awareness surrounding thunderstorm asthma,” Dr. Manian said. For example, people with non-allergic rhinitis, also known as vasomotor rhinitis, can also experience the effects. “It often surprises many of my patients when I introduce the concept of vasomotor rhinitis, which can be triggered by environmental fluctuations.”

Gathering Clouds, Gathering Evidence

Climate change could also change which Americans experience the most storms. Researchers in a June 2022 study predicted fewer storms in the Southern plains and more storms in the Midwest and the Southeastern United States in the future.

Dr. Dvorin practices in Southern New Jersey, and in this area, “we fortunate in this area not to experience thunderstorm-induced asthma exacerbations,” he said. 

But climate change means that in the future, thunderstorm asthma could strike in places it has never been seen before, said Dr. Kevat, who wrote a thunderstorm asthma review article published online June 2020 in the Journal of Asthma and Allergy.

And this is not just a concern in the United States. Major thunderstorm asthma events have been reported in Italy, the United Kingdom, the Middle East, Asia, and Australia. In  November 2016, for instance, a strong set of storms swept across Melbourne, Australia. Temperatures dropped 10C (about 18F), humidity rose above 70%, and particulate matter like pollen became more concentrated in the air. 

This event spurred a “thunderstorm asthma epidemic of unprecedented magnitude, tempo, and geographical range and severity,” Dr. Beggs and colleagues wrote in their June 2018 report in The Lancet Planetary Health. 

Large-scale events like this can affect entire communities and quickly overwhelm local health care resources. Within 30 hours of the Melbourne storms, 3,365 people more than usual came to local emergency departments with respiratory issues — and 476 with asthma were admitted to the hospital. Ten people died: five in the hospital and five who could not be resuscitated or died while waiting for emergency services.

More research is needed “so as to best prepare for this unpredictable, significant public health threat,” Dr. Kevat wrote.

People whose asthma is triggered by pollen or mold spores are particularly at risk for thunderstorm asthma, Dr. Waqar said. If you’re unsure, an allergist can help diagnose and treat your allergic risks.

More severe thunderstorms are just one asthma trigger associated with climate change. Last summer, Canadian wildfires sent smoke across the northern U.S. and triggered widespread asthma exacerbations.

A version of this article appeared on WebMD.com. 

Thunderstorm asthma can strike with little warning, leaving people with the symptoms of an asthma attack during or after the dark clouds pass. 

If you’re unfamiliar, the risk for a thunderstorm asthma attack grows when heavy storms arrive on a day with very high pollen or spores. The storm uplifts these particles, adds water, and causes them to explode into smaller grains. The electrical activity in a storm can do the same. Next, strong winds sweep these particles down and across the ground. People in the path of the storm can experience shortness of breath, coughing, and wheezing.

If thunderstorms are predicted to become more frequent and more severe with climate change, will the same hold true for thunderstorm asthma?   

“Yes, if only because the amount of pollen appears to be increasing in many areas due to climate change,” said Frank S. Virant, MD, chief of the Allergy Division at Seattle Children’s Hospital in Washington.

Most cases of thunderstorm asthma occur in the spring and early summer, but that also could change. Pollen seasons “have been getting longer and more intense,” said Shaan M. Waqar, MD, an allergist at ENT and Allergy Associates in Plainview, NY. 

“Thunderstorm asthma events are rare, but our changing environment and the increase in the number of people with allergies may make such events more common and more severe into the future,” agreed Paul J. Beggs, PhD, associate professor in the School of Natural Sciences at Macquarie University in Sydney, Australia.

How to Minimize Your Risk

If your patients are sensitive to pollen, advise them to continue to monitor outdoor levels, particularly during tree, grass, and weed pollen season, Dr. Virant recommended. Also patients should pay attention to weather reports. Watch for thunderstorms that could “amplify exposure to the pollen with 40-plus mile per hour winds and often colder air downdrafts.” Cold is an additional asthma trigger, he noted. 

People with asthma should try to stay indoors with windows and doors closed during strong thunderstorms and for several hours afterward. Using air filters can also help reduce risk, said Deepti V. Manian, MD, an allergist and immunologist at Stormont Vail Health in Topeka, Kansas.

Patients should continue controller therapies -- such as longer-acting inhalers and allergy medications -- and use a rescue inhaler or nebulizer for prompt treatment of symptoms, recommended Donald J. Dvorin, MD, of The Allergy and Asthma Doctors in Mount Laurel, NJ. Ideally, people seeking shelter indoors during storms should be “accompanied by friends or family who can help them transport quickly to a hospital if needed.”

Asthma Diagnosis Not Required

Even peoples who would not consider themselves to have asthma can be seriously affected. For example, people with hay fever, or allergic rhinitis as it’s also known, are also at risk, said Ajay Kevat, MBBS, MPH, of the respiratory department at Queensland Children’s Hospital in Brisbane, Australia.

People with hay fever can also experience stronger symptoms during and after thunderstorms. Optimally treating allergic rhinitis during the pollen season with non-sedation antihistamines and nasal steroids can help, Dr. Virant said, instead of “chasing symptoms with medication after they are already severe.” 

Part of the challenge is connecting severe weather to worse asthma symptoms. “In my experience, there is a lack of awareness surrounding thunderstorm asthma,” Dr. Manian said. For example, people with non-allergic rhinitis, also known as vasomotor rhinitis, can also experience the effects. “It often surprises many of my patients when I introduce the concept of vasomotor rhinitis, which can be triggered by environmental fluctuations.”

Gathering Clouds, Gathering Evidence

Climate change could also change which Americans experience the most storms. Researchers in a June 2022 study predicted fewer storms in the Southern plains and more storms in the Midwest and the Southeastern United States in the future.

Dr. Dvorin practices in Southern New Jersey, and in this area, “we fortunate in this area not to experience thunderstorm-induced asthma exacerbations,” he said. 

But climate change means that in the future, thunderstorm asthma could strike in places it has never been seen before, said Dr. Kevat, who wrote a thunderstorm asthma review article published online June 2020 in the Journal of Asthma and Allergy.

And this is not just a concern in the United States. Major thunderstorm asthma events have been reported in Italy, the United Kingdom, the Middle East, Asia, and Australia. In  November 2016, for instance, a strong set of storms swept across Melbourne, Australia. Temperatures dropped 10C (about 18F), humidity rose above 70%, and particulate matter like pollen became more concentrated in the air. 

This event spurred a “thunderstorm asthma epidemic of unprecedented magnitude, tempo, and geographical range and severity,” Dr. Beggs and colleagues wrote in their June 2018 report in The Lancet Planetary Health. 

Large-scale events like this can affect entire communities and quickly overwhelm local health care resources. Within 30 hours of the Melbourne storms, 3,365 people more than usual came to local emergency departments with respiratory issues — and 476 with asthma were admitted to the hospital. Ten people died: five in the hospital and five who could not be resuscitated or died while waiting for emergency services.

More research is needed “so as to best prepare for this unpredictable, significant public health threat,” Dr. Kevat wrote.

People whose asthma is triggered by pollen or mold spores are particularly at risk for thunderstorm asthma, Dr. Waqar said. If you’re unsure, an allergist can help diagnose and treat your allergic risks.

More severe thunderstorms are just one asthma trigger associated with climate change. Last summer, Canadian wildfires sent smoke across the northern U.S. and triggered widespread asthma exacerbations.

A version of this article appeared on WebMD.com. 

Thunderstorm asthma can strike with little warning, leaving people with the symptoms of an asthma attack during or after the dark clouds pass. 

If you’re unfamiliar, the risk for a thunderstorm asthma attack grows when heavy storms arrive on a day with very high pollen or spores. The storm uplifts these particles, adds water, and causes them to explode into smaller grains. The electrical activity in a storm can do the same. Next, strong winds sweep these particles down and across the ground. People in the path of the storm can experience shortness of breath, coughing, and wheezing.

If thunderstorms are predicted to become more frequent and more severe with climate change, will the same hold true for thunderstorm asthma?   

“Yes, if only because the amount of pollen appears to be increasing in many areas due to climate change,” said Frank S. Virant, MD, chief of the Allergy Division at Seattle Children’s Hospital in Washington.

Most cases of thunderstorm asthma occur in the spring and early summer, but that also could change. Pollen seasons “have been getting longer and more intense,” said Shaan M. Waqar, MD, an allergist at ENT and Allergy Associates in Plainview, NY. 

“Thunderstorm asthma events are rare, but our changing environment and the increase in the number of people with allergies may make such events more common and more severe into the future,” agreed Paul J. Beggs, PhD, associate professor in the School of Natural Sciences at Macquarie University in Sydney, Australia.

How to Minimize Your Risk

If your patients are sensitive to pollen, advise them to continue to monitor outdoor levels, particularly during tree, grass, and weed pollen season, Dr. Virant recommended. Also patients should pay attention to weather reports. Watch for thunderstorms that could “amplify exposure to the pollen with 40-plus mile per hour winds and often colder air downdrafts.” Cold is an additional asthma trigger, he noted. 

People with asthma should try to stay indoors with windows and doors closed during strong thunderstorms and for several hours afterward. Using air filters can also help reduce risk, said Deepti V. Manian, MD, an allergist and immunologist at Stormont Vail Health in Topeka, Kansas.

Patients should continue controller therapies -- such as longer-acting inhalers and allergy medications -- and use a rescue inhaler or nebulizer for prompt treatment of symptoms, recommended Donald J. Dvorin, MD, of The Allergy and Asthma Doctors in Mount Laurel, NJ. Ideally, people seeking shelter indoors during storms should be “accompanied by friends or family who can help them transport quickly to a hospital if needed.”

Asthma Diagnosis Not Required

Even peoples who would not consider themselves to have asthma can be seriously affected. For example, people with hay fever, or allergic rhinitis as it’s also known, are also at risk, said Ajay Kevat, MBBS, MPH, of the respiratory department at Queensland Children’s Hospital in Brisbane, Australia.

People with hay fever can also experience stronger symptoms during and after thunderstorms. Optimally treating allergic rhinitis during the pollen season with non-sedation antihistamines and nasal steroids can help, Dr. Virant said, instead of “chasing symptoms with medication after they are already severe.” 

Part of the challenge is connecting severe weather to worse asthma symptoms. “In my experience, there is a lack of awareness surrounding thunderstorm asthma,” Dr. Manian said. For example, people with non-allergic rhinitis, also known as vasomotor rhinitis, can also experience the effects. “It often surprises many of my patients when I introduce the concept of vasomotor rhinitis, which can be triggered by environmental fluctuations.”

Gathering Clouds, Gathering Evidence

Climate change could also change which Americans experience the most storms. Researchers in a June 2022 study predicted fewer storms in the Southern plains and more storms in the Midwest and the Southeastern United States in the future.

Dr. Dvorin practices in Southern New Jersey, and in this area, “we fortunate in this area not to experience thunderstorm-induced asthma exacerbations,” he said. 

But climate change means that in the future, thunderstorm asthma could strike in places it has never been seen before, said Dr. Kevat, who wrote a thunderstorm asthma review article published online June 2020 in the Journal of Asthma and Allergy.

And this is not just a concern in the United States. Major thunderstorm asthma events have been reported in Italy, the United Kingdom, the Middle East, Asia, and Australia. In  November 2016, for instance, a strong set of storms swept across Melbourne, Australia. Temperatures dropped 10C (about 18F), humidity rose above 70%, and particulate matter like pollen became more concentrated in the air. 

This event spurred a “thunderstorm asthma epidemic of unprecedented magnitude, tempo, and geographical range and severity,” Dr. Beggs and colleagues wrote in their June 2018 report in The Lancet Planetary Health. 

Large-scale events like this can affect entire communities and quickly overwhelm local health care resources. Within 30 hours of the Melbourne storms, 3,365 people more than usual came to local emergency departments with respiratory issues — and 476 with asthma were admitted to the hospital. Ten people died: five in the hospital and five who could not be resuscitated or died while waiting for emergency services.

More research is needed “so as to best prepare for this unpredictable, significant public health threat,” Dr. Kevat wrote.

People whose asthma is triggered by pollen or mold spores are particularly at risk for thunderstorm asthma, Dr. Waqar said. If you’re unsure, an allergist can help diagnose and treat your allergic risks.

More severe thunderstorms are just one asthma trigger associated with climate change. Last summer, Canadian wildfires sent smoke across the northern U.S. and triggered widespread asthma exacerbations.

A version of this article appeared on WebMD.com. 

The US Food and Drug Administration has expanded the indication of inotuzumab ozogamicin (Besponsa, Pfizer) to include children aged ≥ 1 year with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition. 

Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m^{2 per} cycle and the rest with an initial dose of 1.8 mg/m² per cycle for a median of two cycles and a range of one to four cycles. 

Premedications included methylprednisolone plus an antipyretic and antihistamine.

Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months. 

All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.

Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.

The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.

The initial recommended dose is 1.8 mg/m² per cycle, divided into 0.8 mg/m² on day 1, followed by 0.5 mg/m² on day 9 and 0.5 mg/m² on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities. 

According to drugs.com, 0.9 mg costs $23,423.47.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has expanded the indication of inotuzumab ozogamicin (Besponsa, Pfizer) to include children aged ≥ 1 year with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition. 

Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m^{2 per} cycle and the rest with an initial dose of 1.8 mg/m² per cycle for a median of two cycles and a range of one to four cycles. 

Premedications included methylprednisolone plus an antipyretic and antihistamine.

Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months. 

All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.

Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.

The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.

The initial recommended dose is 1.8 mg/m² per cycle, divided into 0.8 mg/m² on day 1, followed by 0.5 mg/m² on day 9 and 0.5 mg/m² on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities. 

According to drugs.com, 0.9 mg costs $23,423.47.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has expanded the indication of inotuzumab ozogamicin (Besponsa, Pfizer) to include children aged ≥ 1 year with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition. 

Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m^{2 per} cycle and the rest with an initial dose of 1.8 mg/m² per cycle for a median of two cycles and a range of one to four cycles. 

Premedications included methylprednisolone plus an antipyretic and antihistamine.

Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months. 

All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.

Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.

The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.

The initial recommended dose is 1.8 mg/m² per cycle, divided into 0.8 mg/m² on day 1, followed by 0.5 mg/m² on day 9 and 0.5 mg/m² on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities. 

According to drugs.com, 0.9 mg costs $23,423.47.
 

A version of this article appeared on Medscape.com.

A new AGA white paper, published in Clinical Gastroenterology and Hepatology, highlights barriers to care and calls for collaboration among our healthcare community, insurers, pharmaceutical companies, and legislators to improve and optimize care for more than 3 million Americans living with inflammatory bowel disease (IBD).

Over the last two decades, there has been a revolution in therapeutics fueled by exciting research and development that continues to expand the treatment options for IBD, offering tools for better disease control. However, the most effective therapies are cost prohibitive and have largely become inaccessible due to insurer-mandated barriers to care, such as prior authorization and step therapy.

AGA has created a plan that addresses these barriers and proposes tangible solutions to provide patients with high quality, high value care.

1. The lived experiences and valuable insights from both patients and expert clinicians should be reflected in the data and research represented in the field.

2. AGA recognizes the powerful benefit of individually tailoring IBD therapy based on risk, comorbidities and response, and encourages all stakeholders to do the same.

3. As a field, we need to move beyond insurer-mandated step therapy and fail first policies.

4. AGA urges insurers to cover all necessary disease activity and drug level monitoring, which will ensure patients are able to achieve treat-to-target-driven outcomes.

5. Streamlined and expedited expert reviews should be guaranteed to all providers when they are mandated by an insurer.

6. To ensure transparency and accountability, AGA wants to require that payors publish their denial and appeals data.

7. AGA believes that holistic patient-centered multidisciplinary care, including psychosocial and dietary support, should be covered by insurance. Having access to such care contributes to improved patient resilience and well-being, which will lead to decreased health care utilization and better health outcomes.

8. AGA supports the creation and continuation of a variety of patient education programs to improve health literacy and awareness of complex health care systems.

9. AGA is committed to improving patients’ access to expert specialized clinical IBD care. This includes flexible delivery models to ensure that underserved populations are being reached. In addition, AGA supports training and educating specialty providers across the spectrum of medical care (advanced practice providers, nurse educators, etc.) to increase the number of qualified IBD providers.

10. Piloting innovative shared incentive partnerships between high value subspecialty care practices and payors will be a new shared goal.

11. AGA wants to engage pharmaceutical partners in developing equitable programs to address prohibitive drug costs while also expanding patient access and support.

12. AGA plans to continue to advocate for legislation to make access to therapy equitable for Medicare and Medicaid patients.

“Unaffordable drug costs, step therapy, and other insurer-mandated barriers are fixable problems,” said M. Anthony Sofia, MD, a coauthor of the AGA white paper and an IBD specialist at Oregon Health and Science University, Portland.

Oregon Health and Science University

“Every day, we see people that have been harmed by delayed and inadequate care. Solving these barriers would lift an unimaginable weight off our patient’s shoulders and allow them to lead healthier lives. We must work together to collaborate on solutions to strengthen and advance the care for all people with IBD.”

View the full white paper here.

A new AGA white paper, published in Clinical Gastroenterology and Hepatology, highlights barriers to care and calls for collaboration among our healthcare community, insurers, pharmaceutical companies, and legislators to improve and optimize care for more than 3 million Americans living with inflammatory bowel disease (IBD).

Over the last two decades, there has been a revolution in therapeutics fueled by exciting research and development that continues to expand the treatment options for IBD, offering tools for better disease control. However, the most effective therapies are cost prohibitive and have largely become inaccessible due to insurer-mandated barriers to care, such as prior authorization and step therapy.

AGA has created a plan that addresses these barriers and proposes tangible solutions to provide patients with high quality, high value care.

1. The lived experiences and valuable insights from both patients and expert clinicians should be reflected in the data and research represented in the field.

2. AGA recognizes the powerful benefit of individually tailoring IBD therapy based on risk, comorbidities and response, and encourages all stakeholders to do the same.

3. As a field, we need to move beyond insurer-mandated step therapy and fail first policies.

4. AGA urges insurers to cover all necessary disease activity and drug level monitoring, which will ensure patients are able to achieve treat-to-target-driven outcomes.

5. Streamlined and expedited expert reviews should be guaranteed to all providers when they are mandated by an insurer.

6. To ensure transparency and accountability, AGA wants to require that payors publish their denial and appeals data.

7. AGA believes that holistic patient-centered multidisciplinary care, including psychosocial and dietary support, should be covered by insurance. Having access to such care contributes to improved patient resilience and well-being, which will lead to decreased health care utilization and better health outcomes.

8. AGA supports the creation and continuation of a variety of patient education programs to improve health literacy and awareness of complex health care systems.

9. AGA is committed to improving patients’ access to expert specialized clinical IBD care. This includes flexible delivery models to ensure that underserved populations are being reached. In addition, AGA supports training and educating specialty providers across the spectrum of medical care (advanced practice providers, nurse educators, etc.) to increase the number of qualified IBD providers.

10. Piloting innovative shared incentive partnerships between high value subspecialty care practices and payors will be a new shared goal.

11. AGA wants to engage pharmaceutical partners in developing equitable programs to address prohibitive drug costs while also expanding patient access and support.

12. AGA plans to continue to advocate for legislation to make access to therapy equitable for Medicare and Medicaid patients.

“Unaffordable drug costs, step therapy, and other insurer-mandated barriers are fixable problems,” said M. Anthony Sofia, MD, a coauthor of the AGA white paper and an IBD specialist at Oregon Health and Science University, Portland.

Oregon Health and Science University

“Every day, we see people that have been harmed by delayed and inadequate care. Solving these barriers would lift an unimaginable weight off our patient’s shoulders and allow them to lead healthier lives. We must work together to collaborate on solutions to strengthen and advance the care for all people with IBD.”

View the full white paper here.

A new AGA white paper, published in Clinical Gastroenterology and Hepatology, highlights barriers to care and calls for collaboration among our healthcare community, insurers, pharmaceutical companies, and legislators to improve and optimize care for more than 3 million Americans living with inflammatory bowel disease (IBD).

Over the last two decades, there has been a revolution in therapeutics fueled by exciting research and development that continues to expand the treatment options for IBD, offering tools for better disease control. However, the most effective therapies are cost prohibitive and have largely become inaccessible due to insurer-mandated barriers to care, such as prior authorization and step therapy.

AGA has created a plan that addresses these barriers and proposes tangible solutions to provide patients with high quality, high value care.

1. The lived experiences and valuable insights from both patients and expert clinicians should be reflected in the data and research represented in the field.

2. AGA recognizes the powerful benefit of individually tailoring IBD therapy based on risk, comorbidities and response, and encourages all stakeholders to do the same.

3. As a field, we need to move beyond insurer-mandated step therapy and fail first policies.

4. AGA urges insurers to cover all necessary disease activity and drug level monitoring, which will ensure patients are able to achieve treat-to-target-driven outcomes.

5. Streamlined and expedited expert reviews should be guaranteed to all providers when they are mandated by an insurer.

6. To ensure transparency and accountability, AGA wants to require that payors publish their denial and appeals data.

7. AGA believes that holistic patient-centered multidisciplinary care, including psychosocial and dietary support, should be covered by insurance. Having access to such care contributes to improved patient resilience and well-being, which will lead to decreased health care utilization and better health outcomes.

8. AGA supports the creation and continuation of a variety of patient education programs to improve health literacy and awareness of complex health care systems.

9. AGA is committed to improving patients’ access to expert specialized clinical IBD care. This includes flexible delivery models to ensure that underserved populations are being reached. In addition, AGA supports training and educating specialty providers across the spectrum of medical care (advanced practice providers, nurse educators, etc.) to increase the number of qualified IBD providers.

10. Piloting innovative shared incentive partnerships between high value subspecialty care practices and payors will be a new shared goal.

11. AGA wants to engage pharmaceutical partners in developing equitable programs to address prohibitive drug costs while also expanding patient access and support.

12. AGA plans to continue to advocate for legislation to make access to therapy equitable for Medicare and Medicaid patients.

“Unaffordable drug costs, step therapy, and other insurer-mandated barriers are fixable problems,” said M. Anthony Sofia, MD, a coauthor of the AGA white paper and an IBD specialist at Oregon Health and Science University, Portland.

Oregon Health and Science University

“Every day, we see people that have been harmed by delayed and inadequate care. Solving these barriers would lift an unimaginable weight off our patient’s shoulders and allow them to lead healthier lives. We must work together to collaborate on solutions to strengthen and advance the care for all people with IBD.”

View the full white paper here.