Marcus A. Banks

Good news for people struggling with sensory problems after a bout of COVID-19. Although mild cases of the disease often impair the ability to taste and smell, and the problem can drag on for months, a new study from Italy shows that most people return to their senses, as it were, within 3 years.

“In the vast majority of cases, the loss of the sense of smell is not irreversible,” said Paolo Boscolo-Rizzo, MD, a professor of medicine, surgery, and health sciences at the University of Trieste (Italy), and a co-author of the study, published as a research letter in JAMA Otolaryngology–Head & Neck Surgery.

Dr. Boscolo-Rizzo and his colleagues analyzed data from 88 adults with mild COVID-19, which was defined as having no lower respiratory disease and blood oxygen saturation of 94% or greater. Another group of 88 adults who never contracted the virus but sometimes had difficulties with smell and taste were also studied. In both groups, the average age was 49 years, all participants were White, and 58% were women.

The researchers tested participants’ sense of smell with sticks that contained different odors and checked their sense of taste with strips that had different tastes. Over time, fewer people had difficulty distinguishing odors. Three years after developing COVID-19, only 12 people had impaired smell, compared with 36 people at year 1 and 24 people at year 2. And at the 3-year mark, all participants had at least a partial ability to smell. 

The story was similar with sense of taste, with 10 of 88 people reporting impairments 3 years later. By then, people with COVID-19 were no more likely to have trouble with smell or taste than people who did not get the virus. 

A study this past June showed a strong correlation between severity of COVID-19 symptoms and impaired sense of taste and smell and estimated that millions of Americans maintained altered senses. More than 10% of people in the Italian study still had trouble with smell or taste 3 years later.
 

Emerging treatments, psychological concerns

“We’re seeing fewer people with this problem, but there are still people suffering from it,” said Fernando Carnavali, MD, an internal medicine physician and a site director for the Center for Post-COVID Care at the Icahn School of Medicine at Mount Sinai, New York City.

Dr. Carnavali wasn’t part of this study, but he did find the new results encouraging, and he called for similar studies in diverse populations that have experienced COVID-19. He also noted that an impaired sense of smell is distressing.

“It really has a significant psychological impact,” Dr. Carnavali said.

He recalled a patient crying in his office because her inability to smell made it impossible for her to cook. Dr. Carnavali recommended clinicians refer patients facing protracted loss of smell or taste to mental health professionals for support.

Treatments are emerging for COVID-19 smell loss. One approach is to inject platelet-rich plasma into a patient’s nasal cavities to help neurons related to smell repair themselves.

A randomized trial showed platelet-rich plasma significantly outperformed placebo in patients with smell loss up to a year after getting COVID-19.

“I wish more people would do it,” said Zara Patel, MD, an otolaryngologist at Stanford (Calif.) Medicine, who helped conduct that trial. She said some physicians may be nervous about injecting plasma so close to the skull and are therefore hesitant to try this approach. 

Another technique may help to address the olfactory condition known as parosmia, in which patients generally experience a benign odor as rancid, according to otolaryngologist Nyssa Farrell, MD, of Washington University School of Medicine, St. Louis. Dr. Farrell said around two-thirds of patients who contract COVID-19 develop the condition, and the rates of long-term parosmia range from 10%-50% depending on various studies.

“It is almost always foul; this can profoundly affect someone’s quality of life,” impairing their ability to eat or to be intimate with a partner who now smells unpleasant, said Dr. Farrell, who wasn’t associated with this research.

The treatment, called a stellate ganglion block, is provided through a shot into nerves in the neck. People with parosmia associated with COVID-19 often report that this method cures them. Dr. Patel said that may be because their psychological health is improving, not their sense of smell, because the area of the body where the stellate ganglion block is applied is not part of the olfactory system.

Earlier this year, Dr. Farrell and colleagues reported that parosmia linked to COVID-19 is associated with an increased risk for depression, anxiety, and suicidal ideation. 

One coauthor reported receiving grants from Smell and Taste Lab, Takasago, Baia Foods, and Frequency Therapeutics. The other authors reported no relevant financial relationships.

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

Good news for people struggling with sensory problems after a bout of COVID-19. Although mild cases of the disease often impair the ability to taste and smell, and the problem can drag on for months, a new study from Italy shows that most people return to their senses, as it were, within 3 years.

“In the vast majority of cases, the loss of the sense of smell is not irreversible,” said Paolo Boscolo-Rizzo, MD, a professor of medicine, surgery, and health sciences at the University of Trieste (Italy), and a co-author of the study, published as a research letter in JAMA Otolaryngology–Head & Neck Surgery.

Dr. Boscolo-Rizzo and his colleagues analyzed data from 88 adults with mild COVID-19, which was defined as having no lower respiratory disease and blood oxygen saturation of 94% or greater. Another group of 88 adults who never contracted the virus but sometimes had difficulties with smell and taste were also studied. In both groups, the average age was 49 years, all participants were White, and 58% were women.

The researchers tested participants’ sense of smell with sticks that contained different odors and checked their sense of taste with strips that had different tastes. Over time, fewer people had difficulty distinguishing odors. Three years after developing COVID-19, only 12 people had impaired smell, compared with 36 people at year 1 and 24 people at year 2. And at the 3-year mark, all participants had at least a partial ability to smell. 

The story was similar with sense of taste, with 10 of 88 people reporting impairments 3 years later. By then, people with COVID-19 were no more likely to have trouble with smell or taste than people who did not get the virus. 

A study this past June showed a strong correlation between severity of COVID-19 symptoms and impaired sense of taste and smell and estimated that millions of Americans maintained altered senses. More than 10% of people in the Italian study still had trouble with smell or taste 3 years later.
 

Emerging treatments, psychological concerns

“We’re seeing fewer people with this problem, but there are still people suffering from it,” said Fernando Carnavali, MD, an internal medicine physician and a site director for the Center for Post-COVID Care at the Icahn School of Medicine at Mount Sinai, New York City.

Dr. Carnavali wasn’t part of this study, but he did find the new results encouraging, and he called for similar studies in diverse populations that have experienced COVID-19. He also noted that an impaired sense of smell is distressing.

“It really has a significant psychological impact,” Dr. Carnavali said.

He recalled a patient crying in his office because her inability to smell made it impossible for her to cook. Dr. Carnavali recommended clinicians refer patients facing protracted loss of smell or taste to mental health professionals for support.

Treatments are emerging for COVID-19 smell loss. One approach is to inject platelet-rich plasma into a patient’s nasal cavities to help neurons related to smell repair themselves.

A randomized trial showed platelet-rich plasma significantly outperformed placebo in patients with smell loss up to a year after getting COVID-19.

“I wish more people would do it,” said Zara Patel, MD, an otolaryngologist at Stanford (Calif.) Medicine, who helped conduct that trial. She said some physicians may be nervous about injecting plasma so close to the skull and are therefore hesitant to try this approach. 

Another technique may help to address the olfactory condition known as parosmia, in which patients generally experience a benign odor as rancid, according to otolaryngologist Nyssa Farrell, MD, of Washington University School of Medicine, St. Louis. Dr. Farrell said around two-thirds of patients who contract COVID-19 develop the condition, and the rates of long-term parosmia range from 10%-50% depending on various studies.

“It is almost always foul; this can profoundly affect someone’s quality of life,” impairing their ability to eat or to be intimate with a partner who now smells unpleasant, said Dr. Farrell, who wasn’t associated with this research.

The treatment, called a stellate ganglion block, is provided through a shot into nerves in the neck. People with parosmia associated with COVID-19 often report that this method cures them. Dr. Patel said that may be because their psychological health is improving, not their sense of smell, because the area of the body where the stellate ganglion block is applied is not part of the olfactory system.

Earlier this year, Dr. Farrell and colleagues reported that parosmia linked to COVID-19 is associated with an increased risk for depression, anxiety, and suicidal ideation. 

One coauthor reported receiving grants from Smell and Taste Lab, Takasago, Baia Foods, and Frequency Therapeutics. The other authors reported no relevant financial relationships.

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

Good news for people struggling with sensory problems after a bout of COVID-19. Although mild cases of the disease often impair the ability to taste and smell, and the problem can drag on for months, a new study from Italy shows that most people return to their senses, as it were, within 3 years.

“In the vast majority of cases, the loss of the sense of smell is not irreversible,” said Paolo Boscolo-Rizzo, MD, a professor of medicine, surgery, and health sciences at the University of Trieste (Italy), and a co-author of the study, published as a research letter in JAMA Otolaryngology–Head & Neck Surgery.

Dr. Boscolo-Rizzo and his colleagues analyzed data from 88 adults with mild COVID-19, which was defined as having no lower respiratory disease and blood oxygen saturation of 94% or greater. Another group of 88 adults who never contracted the virus but sometimes had difficulties with smell and taste were also studied. In both groups, the average age was 49 years, all participants were White, and 58% were women.

The researchers tested participants’ sense of smell with sticks that contained different odors and checked their sense of taste with strips that had different tastes. Over time, fewer people had difficulty distinguishing odors. Three years after developing COVID-19, only 12 people had impaired smell, compared with 36 people at year 1 and 24 people at year 2. And at the 3-year mark, all participants had at least a partial ability to smell. 

The story was similar with sense of taste, with 10 of 88 people reporting impairments 3 years later. By then, people with COVID-19 were no more likely to have trouble with smell or taste than people who did not get the virus. 

A study this past June showed a strong correlation between severity of COVID-19 symptoms and impaired sense of taste and smell and estimated that millions of Americans maintained altered senses. More than 10% of people in the Italian study still had trouble with smell or taste 3 years later.
 

Emerging treatments, psychological concerns

“We’re seeing fewer people with this problem, but there are still people suffering from it,” said Fernando Carnavali, MD, an internal medicine physician and a site director for the Center for Post-COVID Care at the Icahn School of Medicine at Mount Sinai, New York City.

Dr. Carnavali wasn’t part of this study, but he did find the new results encouraging, and he called for similar studies in diverse populations that have experienced COVID-19. He also noted that an impaired sense of smell is distressing.

“It really has a significant psychological impact,” Dr. Carnavali said.

He recalled a patient crying in his office because her inability to smell made it impossible for her to cook. Dr. Carnavali recommended clinicians refer patients facing protracted loss of smell or taste to mental health professionals for support.

Treatments are emerging for COVID-19 smell loss. One approach is to inject platelet-rich plasma into a patient’s nasal cavities to help neurons related to smell repair themselves.

A randomized trial showed platelet-rich plasma significantly outperformed placebo in patients with smell loss up to a year after getting COVID-19.

“I wish more people would do it,” said Zara Patel, MD, an otolaryngologist at Stanford (Calif.) Medicine, who helped conduct that trial. She said some physicians may be nervous about injecting plasma so close to the skull and are therefore hesitant to try this approach. 

Another technique may help to address the olfactory condition known as parosmia, in which patients generally experience a benign odor as rancid, according to otolaryngologist Nyssa Farrell, MD, of Washington University School of Medicine, St. Louis. Dr. Farrell said around two-thirds of patients who contract COVID-19 develop the condition, and the rates of long-term parosmia range from 10%-50% depending on various studies.

“It is almost always foul; this can profoundly affect someone’s quality of life,” impairing their ability to eat or to be intimate with a partner who now smells unpleasant, said Dr. Farrell, who wasn’t associated with this research.

The treatment, called a stellate ganglion block, is provided through a shot into nerves in the neck. People with parosmia associated with COVID-19 often report that this method cures them. Dr. Patel said that may be because their psychological health is improving, not their sense of smell, because the area of the body where the stellate ganglion block is applied is not part of the olfactory system.

Earlier this year, Dr. Farrell and colleagues reported that parosmia linked to COVID-19 is associated with an increased risk for depression, anxiety, and suicidal ideation. 

One coauthor reported receiving grants from Smell and Taste Lab, Takasago, Baia Foods, and Frequency Therapeutics. The other authors reported no relevant financial relationships.

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

Routine screenings for signs of cavities and gum disease by primary care clinicians may not catch patients most at risk of these conditions, according to a statement by the U.S. Preventive Services Task Force (USPSTF) that was published in JAMA.

Suggesting ways to improve oral health also may fail to engage the patients who most need the message, the group said in its statement.

The task force is not suggesting that primary care providers stop all oral health screening of adults or that they never discuss ways to improve oral health. But the current evidence of the most effective oral health screenings or enhancement strategies in primary care settings received an “I” rating, for “Inconclusive.” The highest ranking a screening can receive is an “A” or “B,” which indicate that there is strong evidence for conducting a screening, while a “C” would indicate that clinicians could rarely provide a screening, and a “D” would indicate not to, given the current evidence.

Primary care clinicians should immediately refer any patients with apparent caries or gum disease to a dentist, the USPSTF noted. But what clinicians should do for patients who have no obvious oral health problems is up for debate.

“The ‘I’ is a note about where the evidence is at this point and then a call for more research to see if we can’t get some more clarity for next time,” said John Ruiz, PhD, professor of clinical psychology at the University of Arizona, Tucson, who is a member of the task force.

More than 90% of U.S. adults may have caries, including 26% with untreated caries that can cause serious infections or tooth loss. In addition, 42% of adults have some type of gum disease. More than two-thirds of Americans aged 65 or older have gum disease, and it is the leading cause of tooth loss in this population. People earning low incomes and those who do not have health insurance or who belong to a marginalized racial or ethnic group are at greater risk of the harms of caries and gum disease.

“Oral health care is important to overall health,” and any new research on oral health screening and enhancement efforts should be demographically representative of adults affected by these conditions, Dr. Ruiz said.

In an accompanying editorial, oral health researchers from the National Institutes of Health and the University of California, San Francisco, echoed the call for representative research and encouraged closer collaboration between primary care providers and dentists to promote oral health.

“Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health,” the authors wrote. “Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Lack of data

The USPSTF defined oral health screenings for patients older than 18 who have no obvious signs of caries or gum disease as looking at a patient’s mouth during physical exams. Additionally, clinicians might use prediction models to identify patients at greater risk of facing these problems.

Strategies to improve oral health include providing encouragement to patients to reduce intake of refined sugar, to floss and brush effectively to reduce bacteria, and to use fluoride gels, fluoride varnishes, or other kinds of sealants to make caries harder to form.

A literature review found that there has been limited analysis of primary care clinicians performing these tasks. Perhaps unsurprisingly, more such studies about dentists existed, leaving an open field for dedicated studies about what primary care clinicians should do to optimize oral health with patients.

“Clinicians, in the absence of clear guidelines, should continue to use their best judgment,” Dr. Ruiz said.

One dentist interviewed said screening could be as simple as doctors asking patients how often they brush their teeth and giving patients a toothbrush as part of the office visit.

“It all comes down to, ‘Is the person brushing their teeth?’ ” said Jennifer Hartshorn, DDS, who specializes in community and preventive dentistry at the University of Iowa, Iowa City.

“By all means look in their mouth, ask how much they are brushing, and urge them to find a dental home if at all possible,” Dr. Hartshorn said, especially for patients who smoke or have conditions such as dry mouth, which can increase the risk of oral disease.

Dr. Ruiz and Dr. Hartshorn report no relevant financial relationships.

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

Routine screenings for signs of cavities and gum disease by primary care clinicians may not catch patients most at risk of these conditions, according to a statement by the U.S. Preventive Services Task Force (USPSTF) that was published in JAMA.

Suggesting ways to improve oral health also may fail to engage the patients who most need the message, the group said in its statement.

The task force is not suggesting that primary care providers stop all oral health screening of adults or that they never discuss ways to improve oral health. But the current evidence of the most effective oral health screenings or enhancement strategies in primary care settings received an “I” rating, for “Inconclusive.” The highest ranking a screening can receive is an “A” or “B,” which indicate that there is strong evidence for conducting a screening, while a “C” would indicate that clinicians could rarely provide a screening, and a “D” would indicate not to, given the current evidence.

Primary care clinicians should immediately refer any patients with apparent caries or gum disease to a dentist, the USPSTF noted. But what clinicians should do for patients who have no obvious oral health problems is up for debate.

“The ‘I’ is a note about where the evidence is at this point and then a call for more research to see if we can’t get some more clarity for next time,” said John Ruiz, PhD, professor of clinical psychology at the University of Arizona, Tucson, who is a member of the task force.

More than 90% of U.S. adults may have caries, including 26% with untreated caries that can cause serious infections or tooth loss. In addition, 42% of adults have some type of gum disease. More than two-thirds of Americans aged 65 or older have gum disease, and it is the leading cause of tooth loss in this population. People earning low incomes and those who do not have health insurance or who belong to a marginalized racial or ethnic group are at greater risk of the harms of caries and gum disease.

“Oral health care is important to overall health,” and any new research on oral health screening and enhancement efforts should be demographically representative of adults affected by these conditions, Dr. Ruiz said.

In an accompanying editorial, oral health researchers from the National Institutes of Health and the University of California, San Francisco, echoed the call for representative research and encouraged closer collaboration between primary care providers and dentists to promote oral health.

“Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health,” the authors wrote. “Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Lack of data

The USPSTF defined oral health screenings for patients older than 18 who have no obvious signs of caries or gum disease as looking at a patient’s mouth during physical exams. Additionally, clinicians might use prediction models to identify patients at greater risk of facing these problems.

Strategies to improve oral health include providing encouragement to patients to reduce intake of refined sugar, to floss and brush effectively to reduce bacteria, and to use fluoride gels, fluoride varnishes, or other kinds of sealants to make caries harder to form.

A literature review found that there has been limited analysis of primary care clinicians performing these tasks. Perhaps unsurprisingly, more such studies about dentists existed, leaving an open field for dedicated studies about what primary care clinicians should do to optimize oral health with patients.

“Clinicians, in the absence of clear guidelines, should continue to use their best judgment,” Dr. Ruiz said.

One dentist interviewed said screening could be as simple as doctors asking patients how often they brush their teeth and giving patients a toothbrush as part of the office visit.

“It all comes down to, ‘Is the person brushing their teeth?’ ” said Jennifer Hartshorn, DDS, who specializes in community and preventive dentistry at the University of Iowa, Iowa City.

“By all means look in their mouth, ask how much they are brushing, and urge them to find a dental home if at all possible,” Dr. Hartshorn said, especially for patients who smoke or have conditions such as dry mouth, which can increase the risk of oral disease.

Dr. Ruiz and Dr. Hartshorn report no relevant financial relationships.

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

Routine screenings for signs of cavities and gum disease by primary care clinicians may not catch patients most at risk of these conditions, according to a statement by the U.S. Preventive Services Task Force (USPSTF) that was published in JAMA.

Suggesting ways to improve oral health also may fail to engage the patients who most need the message, the group said in its statement.

The task force is not suggesting that primary care providers stop all oral health screening of adults or that they never discuss ways to improve oral health. But the current evidence of the most effective oral health screenings or enhancement strategies in primary care settings received an “I” rating, for “Inconclusive.” The highest ranking a screening can receive is an “A” or “B,” which indicate that there is strong evidence for conducting a screening, while a “C” would indicate that clinicians could rarely provide a screening, and a “D” would indicate not to, given the current evidence.

Primary care clinicians should immediately refer any patients with apparent caries or gum disease to a dentist, the USPSTF noted. But what clinicians should do for patients who have no obvious oral health problems is up for debate.

“The ‘I’ is a note about where the evidence is at this point and then a call for more research to see if we can’t get some more clarity for next time,” said John Ruiz, PhD, professor of clinical psychology at the University of Arizona, Tucson, who is a member of the task force.

More than 90% of U.S. adults may have caries, including 26% with untreated caries that can cause serious infections or tooth loss. In addition, 42% of adults have some type of gum disease. More than two-thirds of Americans aged 65 or older have gum disease, and it is the leading cause of tooth loss in this population. People earning low incomes and those who do not have health insurance or who belong to a marginalized racial or ethnic group are at greater risk of the harms of caries and gum disease.

“Oral health care is important to overall health,” and any new research on oral health screening and enhancement efforts should be demographically representative of adults affected by these conditions, Dr. Ruiz said.

In an accompanying editorial, oral health researchers from the National Institutes of Health and the University of California, San Francisco, echoed the call for representative research and encouraged closer collaboration between primary care providers and dentists to promote oral health.

“Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health,” the authors wrote. “Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Lack of data

The USPSTF defined oral health screenings for patients older than 18 who have no obvious signs of caries or gum disease as looking at a patient’s mouth during physical exams. Additionally, clinicians might use prediction models to identify patients at greater risk of facing these problems.

Strategies to improve oral health include providing encouragement to patients to reduce intake of refined sugar, to floss and brush effectively to reduce bacteria, and to use fluoride gels, fluoride varnishes, or other kinds of sealants to make caries harder to form.

A literature review found that there has been limited analysis of primary care clinicians performing these tasks. Perhaps unsurprisingly, more such studies about dentists existed, leaving an open field for dedicated studies about what primary care clinicians should do to optimize oral health with patients.

“Clinicians, in the absence of clear guidelines, should continue to use their best judgment,” Dr. Ruiz said.

One dentist interviewed said screening could be as simple as doctors asking patients how often they brush their teeth and giving patients a toothbrush as part of the office visit.

“It all comes down to, ‘Is the person brushing their teeth?’ ” said Jennifer Hartshorn, DDS, who specializes in community and preventive dentistry at the University of Iowa, Iowa City.

“By all means look in their mouth, ask how much they are brushing, and urge them to find a dental home if at all possible,” Dr. Hartshorn said, especially for patients who smoke or have conditions such as dry mouth, which can increase the risk of oral disease.

Dr. Ruiz and Dr. Hartshorn report no relevant financial relationships.

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

As of 2023, most people eligible for Medicare are enrolled in Medicare Advantage plans administered by commercial insurers, rather than traditional Medicare plans sponsored by the federal government. The Kaiser Family Foundation reports that 31 million people are now enrolled in a Medicare Advantage plan, with almost half of them (47%) served by United Healthcare or Humana.

This is 51% of all people eligible for Medicare, compared with 19% in 2007. The Congressional Budget Office projects that 62% of Medicare participants will be in Medicare Advantage plans by 2033.

Given the explosive growth in Medicare Advantage participation, many readers have likely seen patients served by Medicare Advantage or will soon. Below is information about the program’s purpose, strengths, limitations, and effect on physicians.

How does Medicare Advantage differ from traditional Medicare?

A Medicare Advantage plan is approved by the U.S. Centers for Medicare & Medicaid Services and competes for customers by offering lower premiums and/or more benefits. Traditional Medicare plans are unified contracts across the country, with the same fees for the same services paid nationwide.

CMS pays Medicare Advantage plans a per-member rate, which can be increased for people who seem sicker than other plan participants – for example, someone with uncontrolled diabetes and multiple comorbidities. This so-called “risk adjustment” doesn’t exist in traditional Medicare.

CMS also gives incentive payments to Medicare Advantage plans whose members receive better care, measured by such metrics as lower unnecessary hospital admissions. There are some analogues to this in traditional Medicare, such as the Making Care Primary program, but value-based care is a larger component of Medicare Advantage.

“Being paid for outcomes is what we as physicians always thought we went into medicine to do,” said Sarah Candler, MD, an internist in Houston. She most recently worked for One Medical and her experiences with Veterans Affairs and One Medical focused on value-based contracts, including for Medicare Advantage plans.

How do patients benefit from Medicare Advantage?

“Honestly the financial benefits to patients are what’s really driving the rise in Medicare Advantage,” said

Claire Ankuda, MD, MPH, is a geriatrician at the Icahn School of Medicine at Mt. Sinai in New York who has published extensively about Medicare Advantage.

A spokesperson for Highmark Health, which provides Medicare Advantage plans, told us that “Medicare Advantage plans are offered by private health insurers, such as Highmark, and typically offer benefits that support members’ total health, such as low-cost access to doctors and preventive care, and cover things like prescription drugs, vision, and hearing services, dental, and chiropractic care. Medicare Advantage plans also protect members from unforeseen costs like hospitalizations, surgery, or an expensive drug. And unlike traditional Medicare, Medicare Advantage plans can offer set copays for doctor’s visits (rather than coinsurance) to help members budget for their costs.”

Dr. Ankuda said hospitalization costs are sometimes higher for Medicare Advantage but agreed that costs for doctor visits are often lower with Medicare Advantage plans than with traditional Medicare.

So while the overarching goal of Medicare Advantage makes sense, Dr. Candler said, the actual physician experience of working with Medicare Advantage can be challenging.

What challenges might physicians experience when treating patients in a Medicare Advantage plan?

“The plan itself has control over what it will pay for and they’re much more aggressive about it than traditional Medicare,” Dr. Candler said. Medicare Advantage plans are often structured as health maintenance organizations, with narrow provider networks and extensive prior authorization requirements.

Dr. Candler gave an example of a plan that offers transportation to medical appointments – a seemingly great benefit. But what if someone needs to see a cardiologist and the only cardiologist within the plan is 100 miles away? That’s too far for the transportation benefit, it turns out.

Or a Medicare Advantage plan requires a physician to first do a physical exam before ordering an MRI, even though in the physician’s judgment only the MRI will have diagnostic value. Or the plan denies coverage for a service that’s already occurred. These practices aim to weed out unnecessary care but at the cost of patient confusion or physician time in arguing why something should be covered.

“The argument from us as physicians would be, ‘Just trust us to practice good medicine,’” Dr. Candler said.

Beside these concerns at the physician level, the regulations surrounding Medicare Advantage plans may open the door to billing fraud.

How do Medicare Advantage Plans interact with diagnosis codes?

“I just can’t stand when I see fraud in the health care system,” said Nancy Keating, MD, MPH, an internist at Brigham and Women’s Hospital and a health policy professor at Harvard Medical School, both in Boston.

This July, Dr. Keating published a report in the Annals of Internal Medicine about a patient of hers whose health insurer – a Medicare Advantage plan – claimed had diabetes with comorbidities and was morbidly obese. None of this was true. But submitting such diagnoses to CMS would suggest that Dr. Keating’s patient was especially ill, leading to greater reimbursements from CMS for covering her care.

“I’m not averse to paying plans that are taking care of sicker patients more, but we need to figure out who those patients truly are,” Dr. Keating said.

“It is absolutely true and widely proven that Medicare Advantage plans do a lot of clever things” to inflate diagnoses, added Dr. Ankuda. Also, she said that Medicare Advantage plan representatives would say this is legitimate work, as the entire point of Medicare Advantage is to pay more for caring for sicker patients.

“I don’t think anyone here is acting in bad faith. It’s just that [there are] very different incentives,” Dr. Ankuda said.

How can Medicare Advantage be improved?

Dr. Keating believes that CMS should reduce the number of diagnosis codes allowed within Medicare Advantage to thwart the potential for upcoding. Dr. Ankuda thinks the biggest problem is that there is no good way for patients to choose among Medicare Advantage plans.

“I don’t see it as Medicare Advantage is bad or Medicare Advantage is good. MA plans are incredibly diverse,” Dr. Ankuda said. The problem is that it’s very hard for patients to tell which plans are delivering the best care, what their out-of-pocket costs will actually be, or how often a plan denies payment.

Dr. Ankuda argues for much more data transparency around such plan factors.

Dr. Candler and Dr. Ankuda had no relevant conflicts. Dr. Keating is a consultant to the Research Triangle Institute, which advises CMS about Medicare Advantage billing codes.

As of 2023, most people eligible for Medicare are enrolled in Medicare Advantage plans administered by commercial insurers, rather than traditional Medicare plans sponsored by the federal government. The Kaiser Family Foundation reports that 31 million people are now enrolled in a Medicare Advantage plan, with almost half of them (47%) served by United Healthcare or Humana.

This is 51% of all people eligible for Medicare, compared with 19% in 2007. The Congressional Budget Office projects that 62% of Medicare participants will be in Medicare Advantage plans by 2033.

Given the explosive growth in Medicare Advantage participation, many readers have likely seen patients served by Medicare Advantage or will soon. Below is information about the program’s purpose, strengths, limitations, and effect on physicians.

How does Medicare Advantage differ from traditional Medicare?

A Medicare Advantage plan is approved by the U.S. Centers for Medicare & Medicaid Services and competes for customers by offering lower premiums and/or more benefits. Traditional Medicare plans are unified contracts across the country, with the same fees for the same services paid nationwide.

CMS pays Medicare Advantage plans a per-member rate, which can be increased for people who seem sicker than other plan participants – for example, someone with uncontrolled diabetes and multiple comorbidities. This so-called “risk adjustment” doesn’t exist in traditional Medicare.

CMS also gives incentive payments to Medicare Advantage plans whose members receive better care, measured by such metrics as lower unnecessary hospital admissions. There are some analogues to this in traditional Medicare, such as the Making Care Primary program, but value-based care is a larger component of Medicare Advantage.

“Being paid for outcomes is what we as physicians always thought we went into medicine to do,” said Sarah Candler, MD, an internist in Houston. She most recently worked for One Medical and her experiences with Veterans Affairs and One Medical focused on value-based contracts, including for Medicare Advantage plans.

How do patients benefit from Medicare Advantage?

“Honestly the financial benefits to patients are what’s really driving the rise in Medicare Advantage,” said

Claire Ankuda, MD, MPH, is a geriatrician at the Icahn School of Medicine at Mt. Sinai in New York who has published extensively about Medicare Advantage.

A spokesperson for Highmark Health, which provides Medicare Advantage plans, told us that “Medicare Advantage plans are offered by private health insurers, such as Highmark, and typically offer benefits that support members’ total health, such as low-cost access to doctors and preventive care, and cover things like prescription drugs, vision, and hearing services, dental, and chiropractic care. Medicare Advantage plans also protect members from unforeseen costs like hospitalizations, surgery, or an expensive drug. And unlike traditional Medicare, Medicare Advantage plans can offer set copays for doctor’s visits (rather than coinsurance) to help members budget for their costs.”

Dr. Ankuda said hospitalization costs are sometimes higher for Medicare Advantage but agreed that costs for doctor visits are often lower with Medicare Advantage plans than with traditional Medicare.

So while the overarching goal of Medicare Advantage makes sense, Dr. Candler said, the actual physician experience of working with Medicare Advantage can be challenging.

What challenges might physicians experience when treating patients in a Medicare Advantage plan?

“The plan itself has control over what it will pay for and they’re much more aggressive about it than traditional Medicare,” Dr. Candler said. Medicare Advantage plans are often structured as health maintenance organizations, with narrow provider networks and extensive prior authorization requirements.

Dr. Candler gave an example of a plan that offers transportation to medical appointments – a seemingly great benefit. But what if someone needs to see a cardiologist and the only cardiologist within the plan is 100 miles away? That’s too far for the transportation benefit, it turns out.

Or a Medicare Advantage plan requires a physician to first do a physical exam before ordering an MRI, even though in the physician’s judgment only the MRI will have diagnostic value. Or the plan denies coverage for a service that’s already occurred. These practices aim to weed out unnecessary care but at the cost of patient confusion or physician time in arguing why something should be covered.

“The argument from us as physicians would be, ‘Just trust us to practice good medicine,’” Dr. Candler said.

Beside these concerns at the physician level, the regulations surrounding Medicare Advantage plans may open the door to billing fraud.

How do Medicare Advantage Plans interact with diagnosis codes?

“I just can’t stand when I see fraud in the health care system,” said Nancy Keating, MD, MPH, an internist at Brigham and Women’s Hospital and a health policy professor at Harvard Medical School, both in Boston.

This July, Dr. Keating published a report in the Annals of Internal Medicine about a patient of hers whose health insurer – a Medicare Advantage plan – claimed had diabetes with comorbidities and was morbidly obese. None of this was true. But submitting such diagnoses to CMS would suggest that Dr. Keating’s patient was especially ill, leading to greater reimbursements from CMS for covering her care.

“I’m not averse to paying plans that are taking care of sicker patients more, but we need to figure out who those patients truly are,” Dr. Keating said.

“It is absolutely true and widely proven that Medicare Advantage plans do a lot of clever things” to inflate diagnoses, added Dr. Ankuda. Also, she said that Medicare Advantage plan representatives would say this is legitimate work, as the entire point of Medicare Advantage is to pay more for caring for sicker patients.

“I don’t think anyone here is acting in bad faith. It’s just that [there are] very different incentives,” Dr. Ankuda said.

How can Medicare Advantage be improved?

Dr. Keating believes that CMS should reduce the number of diagnosis codes allowed within Medicare Advantage to thwart the potential for upcoding. Dr. Ankuda thinks the biggest problem is that there is no good way for patients to choose among Medicare Advantage plans.

“I don’t see it as Medicare Advantage is bad or Medicare Advantage is good. MA plans are incredibly diverse,” Dr. Ankuda said. The problem is that it’s very hard for patients to tell which plans are delivering the best care, what their out-of-pocket costs will actually be, or how often a plan denies payment.

Dr. Ankuda argues for much more data transparency around such plan factors.

Dr. Candler and Dr. Ankuda had no relevant conflicts. Dr. Keating is a consultant to the Research Triangle Institute, which advises CMS about Medicare Advantage billing codes.

As of 2023, most people eligible for Medicare are enrolled in Medicare Advantage plans administered by commercial insurers, rather than traditional Medicare plans sponsored by the federal government. The Kaiser Family Foundation reports that 31 million people are now enrolled in a Medicare Advantage plan, with almost half of them (47%) served by United Healthcare or Humana.

This is 51% of all people eligible for Medicare, compared with 19% in 2007. The Congressional Budget Office projects that 62% of Medicare participants will be in Medicare Advantage plans by 2033.

Given the explosive growth in Medicare Advantage participation, many readers have likely seen patients served by Medicare Advantage or will soon. Below is information about the program’s purpose, strengths, limitations, and effect on physicians.

How does Medicare Advantage differ from traditional Medicare?

A Medicare Advantage plan is approved by the U.S. Centers for Medicare & Medicaid Services and competes for customers by offering lower premiums and/or more benefits. Traditional Medicare plans are unified contracts across the country, with the same fees for the same services paid nationwide.

CMS pays Medicare Advantage plans a per-member rate, which can be increased for people who seem sicker than other plan participants – for example, someone with uncontrolled diabetes and multiple comorbidities. This so-called “risk adjustment” doesn’t exist in traditional Medicare.

CMS also gives incentive payments to Medicare Advantage plans whose members receive better care, measured by such metrics as lower unnecessary hospital admissions. There are some analogues to this in traditional Medicare, such as the Making Care Primary program, but value-based care is a larger component of Medicare Advantage.

“Being paid for outcomes is what we as physicians always thought we went into medicine to do,” said Sarah Candler, MD, an internist in Houston. She most recently worked for One Medical and her experiences with Veterans Affairs and One Medical focused on value-based contracts, including for Medicare Advantage plans.

How do patients benefit from Medicare Advantage?

“Honestly the financial benefits to patients are what’s really driving the rise in Medicare Advantage,” said

Claire Ankuda, MD, MPH, is a geriatrician at the Icahn School of Medicine at Mt. Sinai in New York who has published extensively about Medicare Advantage.

A spokesperson for Highmark Health, which provides Medicare Advantage plans, told us that “Medicare Advantage plans are offered by private health insurers, such as Highmark, and typically offer benefits that support members’ total health, such as low-cost access to doctors and preventive care, and cover things like prescription drugs, vision, and hearing services, dental, and chiropractic care. Medicare Advantage plans also protect members from unforeseen costs like hospitalizations, surgery, or an expensive drug. And unlike traditional Medicare, Medicare Advantage plans can offer set copays for doctor’s visits (rather than coinsurance) to help members budget for their costs.”

Dr. Ankuda said hospitalization costs are sometimes higher for Medicare Advantage but agreed that costs for doctor visits are often lower with Medicare Advantage plans than with traditional Medicare.

So while the overarching goal of Medicare Advantage makes sense, Dr. Candler said, the actual physician experience of working with Medicare Advantage can be challenging.

What challenges might physicians experience when treating patients in a Medicare Advantage plan?

“The plan itself has control over what it will pay for and they’re much more aggressive about it than traditional Medicare,” Dr. Candler said. Medicare Advantage plans are often structured as health maintenance organizations, with narrow provider networks and extensive prior authorization requirements.

Dr. Candler gave an example of a plan that offers transportation to medical appointments – a seemingly great benefit. But what if someone needs to see a cardiologist and the only cardiologist within the plan is 100 miles away? That’s too far for the transportation benefit, it turns out.

Or a Medicare Advantage plan requires a physician to first do a physical exam before ordering an MRI, even though in the physician’s judgment only the MRI will have diagnostic value. Or the plan denies coverage for a service that’s already occurred. These practices aim to weed out unnecessary care but at the cost of patient confusion or physician time in arguing why something should be covered.

“The argument from us as physicians would be, ‘Just trust us to practice good medicine,’” Dr. Candler said.

Beside these concerns at the physician level, the regulations surrounding Medicare Advantage plans may open the door to billing fraud.

How do Medicare Advantage Plans interact with diagnosis codes?

“I just can’t stand when I see fraud in the health care system,” said Nancy Keating, MD, MPH, an internist at Brigham and Women’s Hospital and a health policy professor at Harvard Medical School, both in Boston.

This July, Dr. Keating published a report in the Annals of Internal Medicine about a patient of hers whose health insurer – a Medicare Advantage plan – claimed had diabetes with comorbidities and was morbidly obese. None of this was true. But submitting such diagnoses to CMS would suggest that Dr. Keating’s patient was especially ill, leading to greater reimbursements from CMS for covering her care.

“I’m not averse to paying plans that are taking care of sicker patients more, but we need to figure out who those patients truly are,” Dr. Keating said.

“It is absolutely true and widely proven that Medicare Advantage plans do a lot of clever things” to inflate diagnoses, added Dr. Ankuda. Also, she said that Medicare Advantage plan representatives would say this is legitimate work, as the entire point of Medicare Advantage is to pay more for caring for sicker patients.

“I don’t think anyone here is acting in bad faith. It’s just that [there are] very different incentives,” Dr. Ankuda said.

How can Medicare Advantage be improved?

Dr. Keating believes that CMS should reduce the number of diagnosis codes allowed within Medicare Advantage to thwart the potential for upcoding. Dr. Ankuda thinks the biggest problem is that there is no good way for patients to choose among Medicare Advantage plans.

“I don’t see it as Medicare Advantage is bad or Medicare Advantage is good. MA plans are incredibly diverse,” Dr. Ankuda said. The problem is that it’s very hard for patients to tell which plans are delivering the best care, what their out-of-pocket costs will actually be, or how often a plan denies payment.

Dr. Ankuda argues for much more data transparency around such plan factors.

Dr. Candler and Dr. Ankuda had no relevant conflicts. Dr. Keating is a consultant to the Research Triangle Institute, which advises CMS about Medicare Advantage billing codes.

Young adults who developed type 2 diabetes as children often do not take medications to control blood pressure or cholesterol, according to a new study in JAMA Network Open. Researchers expressed alarm that young people who forgo these medications increase their chances of developing kidney disease or having a stroke.

“We’re learning more and more that those with youth onset [type 2 diabetes] really differ from those with adult onset: It looks like a more virulent form of the disease because kids are getting complications and comorbidities at much earlier ages and more severe levels,” said study author Paula Trief, PhD, a professor of psychiatry and behavioral science at State University of New York, Syracuse.

Participants in the new study were on average aged 26 years. They also had previously been part of the Treating Options for Type 2 Diabetes in Adolescents and Youth study, known as TODAY, which took place from 2004 to 2011. TODAY enrolled children between ages 10 and 17 years with type 2 diabetes who received either metformin, metformin plus rosiglitazone, or metformin plus a lifestyle intervention.

The study included extensive education and contact from medical professionals to the participants about managing diabetes.

“This cohort was followed a long time and they had a lot of support. It may be better than the real world where people haven’t had the history of this much attention,” said Lorraine Katz, MD, who specializes in endocrinology and diabetes at the Children’s Hospital of Philadelphia. Dr. Katz has enrolled participants in TODAY and published about medication adherence rates but was not part of the recent analysis.
 

Unannounced pill counts, addressing concerns about medication

The analysis, known as iCount, included 243 participants from the original TODAY study (159 girls) who had hypertension, neuropathy, or dyslipidemia that required ongoing medication. As the TODAY study was concluding between 2017 and 2019, researchers made unannounced phone calls to participants to request the numbers of pills they had prescribed, number of refills, and the refill date. Participants also counted aloud every pill in their possession twice.

Those phone calls continued for 3 consecutive months after iCount began and again at the same intervals 1 year later.

If the number of pills counted at a later time was at least 80% of the starting total, researchers considered this rate as low adherence. Anything less than 80% was considered high adherence.

“That’s kind of an arbitrary cutoff, but it’s one that’s used consistently in the literature” to measure medication adherence for many conditions including cancer and heart disease, Dr. Trief said. Unannounced calls to initiate pill counts were first used to understand how often people took medications for HIV, and this method was found to be a more reliable method than are self-reports.

Of 196 participants with hypertension or neuropathy, 157 (80.1%) had low adherence. And of the 146 people with high cholesterol, 137 (93.8%) had low adherence. Ninety-nine people with high cholesterol also had neuropathy or diabetes.

“This is new to the literature: We don’t really know as much about this age group,” because medication adherence studies of people who have had diabetes for more than a decade and are still in their 20s are rare, Dr. Katz said.

During the core TODAY study period, all medications were provided for free. In contrast, in the current study, participants had to obtain their prescriptions on their own. The researchers found that many participants who showed low adherence to blood pressure medications reported sometimes having trouble obtaining food (n = 62), struggling with securing stable housing (n = 47), or lacking reliable health care insurance (n = 28), all factors linked to medication adherence success, according to the analysis authors.

Researchers also assessed the impact of concerns that taking blood pressure medications may be harmful and found that people with these concerns were 37% less likely to maintain high adherence than others were by the 1-year follow-up point (odds ratio, 0.63; 95% confidence interval, 0.40-0.96; P = .01).

To some extent, the reasons people avoid medications are understandable, according to pediatric endocrinologist Tamara Hannon, MD, of Indiana University, Indianapolis.

“Rather than taking a medicine to feel better, you’re taking one not to have a problem in the future: You might not feel blood pressure, you certainly don’t feel cholesterol,” Dr. Hannon, who was not involved in the analysis, said. “Scolding them or telling them you’re going to be sorry one day doesn’t generally work.”

Dr. Hannon added that education alone about the benefits of medications does not generally drive people to adherence but that adding reminders to their phone calendar when refills are due could help. Or, the clinician could reach out to a trusted person in the patient’s life and enlist their support in taking medications consistently.

Dr. Trief advised that clinicians should carve out time for people to express their concerns about medications rather than simply writing a prescription and sending them on their way and to ask patients open-ended questions.

“If you just say to people do you have any questions, they usually say, ‘no.’ ”

No disclosures were reported.

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

Young adults who developed type 2 diabetes as children often do not take medications to control blood pressure or cholesterol, according to a new study in JAMA Network Open. Researchers expressed alarm that young people who forgo these medications increase their chances of developing kidney disease or having a stroke.

“We’re learning more and more that those with youth onset [type 2 diabetes] really differ from those with adult onset: It looks like a more virulent form of the disease because kids are getting complications and comorbidities at much earlier ages and more severe levels,” said study author Paula Trief, PhD, a professor of psychiatry and behavioral science at State University of New York, Syracuse.

Participants in the new study were on average aged 26 years. They also had previously been part of the Treating Options for Type 2 Diabetes in Adolescents and Youth study, known as TODAY, which took place from 2004 to 2011. TODAY enrolled children between ages 10 and 17 years with type 2 diabetes who received either metformin, metformin plus rosiglitazone, or metformin plus a lifestyle intervention.

The study included extensive education and contact from medical professionals to the participants about managing diabetes.

“This cohort was followed a long time and they had a lot of support. It may be better than the real world where people haven’t had the history of this much attention,” said Lorraine Katz, MD, who specializes in endocrinology and diabetes at the Children’s Hospital of Philadelphia. Dr. Katz has enrolled participants in TODAY and published about medication adherence rates but was not part of the recent analysis.
 

Unannounced pill counts, addressing concerns about medication

The analysis, known as iCount, included 243 participants from the original TODAY study (159 girls) who had hypertension, neuropathy, or dyslipidemia that required ongoing medication. As the TODAY study was concluding between 2017 and 2019, researchers made unannounced phone calls to participants to request the numbers of pills they had prescribed, number of refills, and the refill date. Participants also counted aloud every pill in their possession twice.

Those phone calls continued for 3 consecutive months after iCount began and again at the same intervals 1 year later.

If the number of pills counted at a later time was at least 80% of the starting total, researchers considered this rate as low adherence. Anything less than 80% was considered high adherence.

“That’s kind of an arbitrary cutoff, but it’s one that’s used consistently in the literature” to measure medication adherence for many conditions including cancer and heart disease, Dr. Trief said. Unannounced calls to initiate pill counts were first used to understand how often people took medications for HIV, and this method was found to be a more reliable method than are self-reports.

Of 196 participants with hypertension or neuropathy, 157 (80.1%) had low adherence. And of the 146 people with high cholesterol, 137 (93.8%) had low adherence. Ninety-nine people with high cholesterol also had neuropathy or diabetes.

“This is new to the literature: We don’t really know as much about this age group,” because medication adherence studies of people who have had diabetes for more than a decade and are still in their 20s are rare, Dr. Katz said.

During the core TODAY study period, all medications were provided for free. In contrast, in the current study, participants had to obtain their prescriptions on their own. The researchers found that many participants who showed low adherence to blood pressure medications reported sometimes having trouble obtaining food (n = 62), struggling with securing stable housing (n = 47), or lacking reliable health care insurance (n = 28), all factors linked to medication adherence success, according to the analysis authors.

Researchers also assessed the impact of concerns that taking blood pressure medications may be harmful and found that people with these concerns were 37% less likely to maintain high adherence than others were by the 1-year follow-up point (odds ratio, 0.63; 95% confidence interval, 0.40-0.96; P = .01).

To some extent, the reasons people avoid medications are understandable, according to pediatric endocrinologist Tamara Hannon, MD, of Indiana University, Indianapolis.

“Rather than taking a medicine to feel better, you’re taking one not to have a problem in the future: You might not feel blood pressure, you certainly don’t feel cholesterol,” Dr. Hannon, who was not involved in the analysis, said. “Scolding them or telling them you’re going to be sorry one day doesn’t generally work.”

Dr. Hannon added that education alone about the benefits of medications does not generally drive people to adherence but that adding reminders to their phone calendar when refills are due could help. Or, the clinician could reach out to a trusted person in the patient’s life and enlist their support in taking medications consistently.

Dr. Trief advised that clinicians should carve out time for people to express their concerns about medications rather than simply writing a prescription and sending them on their way and to ask patients open-ended questions.

“If you just say to people do you have any questions, they usually say, ‘no.’ ”

No disclosures were reported.

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

Young adults who developed type 2 diabetes as children often do not take medications to control blood pressure or cholesterol, according to a new study in JAMA Network Open. Researchers expressed alarm that young people who forgo these medications increase their chances of developing kidney disease or having a stroke.

“We’re learning more and more that those with youth onset [type 2 diabetes] really differ from those with adult onset: It looks like a more virulent form of the disease because kids are getting complications and comorbidities at much earlier ages and more severe levels,” said study author Paula Trief, PhD, a professor of psychiatry and behavioral science at State University of New York, Syracuse.

Participants in the new study were on average aged 26 years. They also had previously been part of the Treating Options for Type 2 Diabetes in Adolescents and Youth study, known as TODAY, which took place from 2004 to 2011. TODAY enrolled children between ages 10 and 17 years with type 2 diabetes who received either metformin, metformin plus rosiglitazone, or metformin plus a lifestyle intervention.

The study included extensive education and contact from medical professionals to the participants about managing diabetes.

“This cohort was followed a long time and they had a lot of support. It may be better than the real world where people haven’t had the history of this much attention,” said Lorraine Katz, MD, who specializes in endocrinology and diabetes at the Children’s Hospital of Philadelphia. Dr. Katz has enrolled participants in TODAY and published about medication adherence rates but was not part of the recent analysis.
 

Unannounced pill counts, addressing concerns about medication

The analysis, known as iCount, included 243 participants from the original TODAY study (159 girls) who had hypertension, neuropathy, or dyslipidemia that required ongoing medication. As the TODAY study was concluding between 2017 and 2019, researchers made unannounced phone calls to participants to request the numbers of pills they had prescribed, number of refills, and the refill date. Participants also counted aloud every pill in their possession twice.

Those phone calls continued for 3 consecutive months after iCount began and again at the same intervals 1 year later.

If the number of pills counted at a later time was at least 80% of the starting total, researchers considered this rate as low adherence. Anything less than 80% was considered high adherence.

“That’s kind of an arbitrary cutoff, but it’s one that’s used consistently in the literature” to measure medication adherence for many conditions including cancer and heart disease, Dr. Trief said. Unannounced calls to initiate pill counts were first used to understand how often people took medications for HIV, and this method was found to be a more reliable method than are self-reports.

Of 196 participants with hypertension or neuropathy, 157 (80.1%) had low adherence. And of the 146 people with high cholesterol, 137 (93.8%) had low adherence. Ninety-nine people with high cholesterol also had neuropathy or diabetes.

“This is new to the literature: We don’t really know as much about this age group,” because medication adherence studies of people who have had diabetes for more than a decade and are still in their 20s are rare, Dr. Katz said.

During the core TODAY study period, all medications were provided for free. In contrast, in the current study, participants had to obtain their prescriptions on their own. The researchers found that many participants who showed low adherence to blood pressure medications reported sometimes having trouble obtaining food (n = 62), struggling with securing stable housing (n = 47), or lacking reliable health care insurance (n = 28), all factors linked to medication adherence success, according to the analysis authors.

Researchers also assessed the impact of concerns that taking blood pressure medications may be harmful and found that people with these concerns were 37% less likely to maintain high adherence than others were by the 1-year follow-up point (odds ratio, 0.63; 95% confidence interval, 0.40-0.96; P = .01).

To some extent, the reasons people avoid medications are understandable, according to pediatric endocrinologist Tamara Hannon, MD, of Indiana University, Indianapolis.

“Rather than taking a medicine to feel better, you’re taking one not to have a problem in the future: You might not feel blood pressure, you certainly don’t feel cholesterol,” Dr. Hannon, who was not involved in the analysis, said. “Scolding them or telling them you’re going to be sorry one day doesn’t generally work.”

Dr. Hannon added that education alone about the benefits of medications does not generally drive people to adherence but that adding reminders to their phone calendar when refills are due could help. Or, the clinician could reach out to a trusted person in the patient’s life and enlist their support in taking medications consistently.

Dr. Trief advised that clinicians should carve out time for people to express their concerns about medications rather than simply writing a prescription and sending them on their way and to ask patients open-ended questions.

“If you just say to people do you have any questions, they usually say, ‘no.’ ”

No disclosures were reported.

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

Less than half of older adults with attention-deficit/hyperactivity disorder are diagnosed with the condition, and many never receive treatment.

Negative consequences can develop from not treating ADHD, including job loss, suppressed income levels, low educational attainment, and difficulty maintaining relationships. Perhaps as many as 5% of adults have ADHD, which is highly hereditary. 

Primary care physicians or family medicine clinicians are often best placed to diagnose ADHD in older adults, according to experts interviewed for this article. But first these providers need to tease out whether a patient has ADHD or another condition that is causing difficulties for these older adults.

However, clinicians may have a hard time discerning the symptoms of ADHD from that of other conditions of aging, such as mild cognitive impairment. Literature is lacking on best practices for screening and treating the condition in this population, according to a recent review published in the Expert Review of Neurotherapeutics, and a 2020 study by the same authors, epidemiologists, and psychiatrists based in Europe.

“If you don’t manage it, who will? It can be very hard to get psychiatric consults, almost impossible in some cases,” said Brendan Montano, MD, an internist in Cromwell, Conn., who specializes in treating ADHD. 
 

A critical role for primary care and family medicine

Although no formal U.S. guidelines exist on diagnosis of adult ADHD, Dr. Montano stressed that adults usually present with symptoms such as chronic forgetfulness, distractibility, or procrastination. Hyperactivity is more internalized as a feeling of internal restlessness in this age group, Dr. Montano said, rather than the more visible hyper behavior seen in children.

“The two big ways that people present are thinking they have it or [being] in chaos of some sort,” perhaps because they have been fired or their spouse has asked for a divorce, Dr. Montano explained.

To assess the possibility of ADHD, a clinician could give a patient a six-item screening test that asks questions such as how often over the previous 6 months have they had trouble completing assignments or remembering appointments. If they report difficulty in four or more of the six areas in the brief screener, clinicians can move on to a longer 18-item screening tool developed by the World Health Organization, Dr. Montano said.

To make an ADHD diagnosis definitively, however, a patient needs to report sustained difficulties in at least two aspects of life: work, home, or social situations. And they have to indicate to a clinician that these troubles began before age 12.

“You have to really sit down and paint the picture with the patient: There are no shortcuts here,” said Lenard Adler, MD, a psychiatrist who directs the Adult ADHD program at New York University. Dr. Adler helped develop the six-item screener and is currently on a committee developing formal screening guidelines for adult ADHD in the United States.

He said that often, “ADHD cotravels with other mental health disorders like depression, bipolar disorders, anxiety disorders, and substance use disorders at least half the time.”

To tease out if a patient really has ADHD, clinicians can start with a more general screening for anxiety and hone in on the possibility of the condition if the anxiety screening reveals challenges with distractibility and forgetfulness, according to Karen Smith, MD, a family physician in Raeford, N.C.

“We can’t expect patients to walk through the door with the diagnosis stamped on their foreheads,” said Dr. Smith, who is a member of the board of directors for the American Academy of Family Physicians.

But a patient’s apparent signs of ADHD could be due to another condition such as hyperthyroidism or diabetes, Dr. Smith said. The driving principle is to take enough time to figure out exactly what is going on, she said, and then to treat accordingly. “If you ask the right questions, patients will give you good answers.”

Medications are often prescribed to help manage ADHD symptoms. These can include stimulants, controlled substances that include methylphenidate or amphetamine, or nonstimulants, such as atomoxetine and bupropion. Dr. Montano starts his patients on a lower dose and titrates them up rapidly until they reach the optimum dose that allows them to sustain focus and feel more productive. Patients complete frequent self-reports during this process.

“Any diversion is inappropriate,” said Dr. Montano, who writes a contract with his patients saying that stimulant medications will not be refilled if they are used more quickly than prescribed.

For older adults, physicians should make sure that stimulants do not exacerbate any underlying cardiovascular conditions, Dr. Montano said, and consult a cardiologist when needed.

The benefits of proper ADHD treatment can be profound, Dr. Adler noted, no matter when it begins.

“Older adults have lived their lives feeling they’ve been disorganized and a burden to their significant others, and only when they’ve taken medication have they really been able to organize their days and feel effective in their social interactions and with their families,” Dr. Adler said.

Dr. Montano has reported relationships with AbbVie, Axsome, Corium, Idorsia, Intracellular, Otsuka, Supernus, Sage/Biogen, Biohaven, Boehringer Ingelheim, Cassava, Eli Lilly, Intracellular, Janssen, Jazz, Sage, Supernus, Otsuka, and Tonix. Dr. Adler has reported relationships with Shire/Takeda Pharmaceuticals, National Football League, Major League Baseball, Corium, Otsuka, Neurocentria, Bracket/Signant, and SUNY; and is receiving royalty payments for developing adult ADHD assessments. Dr. Smith has reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Less than half of older adults with attention-deficit/hyperactivity disorder are diagnosed with the condition, and many never receive treatment.

Negative consequences can develop from not treating ADHD, including job loss, suppressed income levels, low educational attainment, and difficulty maintaining relationships. Perhaps as many as 5% of adults have ADHD, which is highly hereditary. 

Primary care physicians or family medicine clinicians are often best placed to diagnose ADHD in older adults, according to experts interviewed for this article. But first these providers need to tease out whether a patient has ADHD or another condition that is causing difficulties for these older adults.

However, clinicians may have a hard time discerning the symptoms of ADHD from that of other conditions of aging, such as mild cognitive impairment. Literature is lacking on best practices for screening and treating the condition in this population, according to a recent review published in the Expert Review of Neurotherapeutics, and a 2020 study by the same authors, epidemiologists, and psychiatrists based in Europe.

“If you don’t manage it, who will? It can be very hard to get psychiatric consults, almost impossible in some cases,” said Brendan Montano, MD, an internist in Cromwell, Conn., who specializes in treating ADHD. 
 

A critical role for primary care and family medicine

Although no formal U.S. guidelines exist on diagnosis of adult ADHD, Dr. Montano stressed that adults usually present with symptoms such as chronic forgetfulness, distractibility, or procrastination. Hyperactivity is more internalized as a feeling of internal restlessness in this age group, Dr. Montano said, rather than the more visible hyper behavior seen in children.

“The two big ways that people present are thinking they have it or [being] in chaos of some sort,” perhaps because they have been fired or their spouse has asked for a divorce, Dr. Montano explained.

To assess the possibility of ADHD, a clinician could give a patient a six-item screening test that asks questions such as how often over the previous 6 months have they had trouble completing assignments or remembering appointments. If they report difficulty in four or more of the six areas in the brief screener, clinicians can move on to a longer 18-item screening tool developed by the World Health Organization, Dr. Montano said.

To make an ADHD diagnosis definitively, however, a patient needs to report sustained difficulties in at least two aspects of life: work, home, or social situations. And they have to indicate to a clinician that these troubles began before age 12.

“You have to really sit down and paint the picture with the patient: There are no shortcuts here,” said Lenard Adler, MD, a psychiatrist who directs the Adult ADHD program at New York University. Dr. Adler helped develop the six-item screener and is currently on a committee developing formal screening guidelines for adult ADHD in the United States.

He said that often, “ADHD cotravels with other mental health disorders like depression, bipolar disorders, anxiety disorders, and substance use disorders at least half the time.”

To tease out if a patient really has ADHD, clinicians can start with a more general screening for anxiety and hone in on the possibility of the condition if the anxiety screening reveals challenges with distractibility and forgetfulness, according to Karen Smith, MD, a family physician in Raeford, N.C.

“We can’t expect patients to walk through the door with the diagnosis stamped on their foreheads,” said Dr. Smith, who is a member of the board of directors for the American Academy of Family Physicians.

But a patient’s apparent signs of ADHD could be due to another condition such as hyperthyroidism or diabetes, Dr. Smith said. The driving principle is to take enough time to figure out exactly what is going on, she said, and then to treat accordingly. “If you ask the right questions, patients will give you good answers.”

Medications are often prescribed to help manage ADHD symptoms. These can include stimulants, controlled substances that include methylphenidate or amphetamine, or nonstimulants, such as atomoxetine and bupropion. Dr. Montano starts his patients on a lower dose and titrates them up rapidly until they reach the optimum dose that allows them to sustain focus and feel more productive. Patients complete frequent self-reports during this process.

“Any diversion is inappropriate,” said Dr. Montano, who writes a contract with his patients saying that stimulant medications will not be refilled if they are used more quickly than prescribed.

For older adults, physicians should make sure that stimulants do not exacerbate any underlying cardiovascular conditions, Dr. Montano said, and consult a cardiologist when needed.

The benefits of proper ADHD treatment can be profound, Dr. Adler noted, no matter when it begins.

“Older adults have lived their lives feeling they’ve been disorganized and a burden to their significant others, and only when they’ve taken medication have they really been able to organize their days and feel effective in their social interactions and with their families,” Dr. Adler said.

Dr. Montano has reported relationships with AbbVie, Axsome, Corium, Idorsia, Intracellular, Otsuka, Supernus, Sage/Biogen, Biohaven, Boehringer Ingelheim, Cassava, Eli Lilly, Intracellular, Janssen, Jazz, Sage, Supernus, Otsuka, and Tonix. Dr. Adler has reported relationships with Shire/Takeda Pharmaceuticals, National Football League, Major League Baseball, Corium, Otsuka, Neurocentria, Bracket/Signant, and SUNY; and is receiving royalty payments for developing adult ADHD assessments. Dr. Smith has reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Less than half of older adults with attention-deficit/hyperactivity disorder are diagnosed with the condition, and many never receive treatment.

Negative consequences can develop from not treating ADHD, including job loss, suppressed income levels, low educational attainment, and difficulty maintaining relationships. Perhaps as many as 5% of adults have ADHD, which is highly hereditary. 

Primary care physicians or family medicine clinicians are often best placed to diagnose ADHD in older adults, according to experts interviewed for this article. But first these providers need to tease out whether a patient has ADHD or another condition that is causing difficulties for these older adults.

However, clinicians may have a hard time discerning the symptoms of ADHD from that of other conditions of aging, such as mild cognitive impairment. Literature is lacking on best practices for screening and treating the condition in this population, according to a recent review published in the Expert Review of Neurotherapeutics, and a 2020 study by the same authors, epidemiologists, and psychiatrists based in Europe.

“If you don’t manage it, who will? It can be very hard to get psychiatric consults, almost impossible in some cases,” said Brendan Montano, MD, an internist in Cromwell, Conn., who specializes in treating ADHD. 
 

A critical role for primary care and family medicine

Although no formal U.S. guidelines exist on diagnosis of adult ADHD, Dr. Montano stressed that adults usually present with symptoms such as chronic forgetfulness, distractibility, or procrastination. Hyperactivity is more internalized as a feeling of internal restlessness in this age group, Dr. Montano said, rather than the more visible hyper behavior seen in children.

“The two big ways that people present are thinking they have it or [being] in chaos of some sort,” perhaps because they have been fired or their spouse has asked for a divorce, Dr. Montano explained.

To assess the possibility of ADHD, a clinician could give a patient a six-item screening test that asks questions such as how often over the previous 6 months have they had trouble completing assignments or remembering appointments. If they report difficulty in four or more of the six areas in the brief screener, clinicians can move on to a longer 18-item screening tool developed by the World Health Organization, Dr. Montano said.

To make an ADHD diagnosis definitively, however, a patient needs to report sustained difficulties in at least two aspects of life: work, home, or social situations. And they have to indicate to a clinician that these troubles began before age 12.

“You have to really sit down and paint the picture with the patient: There are no shortcuts here,” said Lenard Adler, MD, a psychiatrist who directs the Adult ADHD program at New York University. Dr. Adler helped develop the six-item screener and is currently on a committee developing formal screening guidelines for adult ADHD in the United States.

He said that often, “ADHD cotravels with other mental health disorders like depression, bipolar disorders, anxiety disorders, and substance use disorders at least half the time.”

To tease out if a patient really has ADHD, clinicians can start with a more general screening for anxiety and hone in on the possibility of the condition if the anxiety screening reveals challenges with distractibility and forgetfulness, according to Karen Smith, MD, a family physician in Raeford, N.C.

“We can’t expect patients to walk through the door with the diagnosis stamped on their foreheads,” said Dr. Smith, who is a member of the board of directors for the American Academy of Family Physicians.

But a patient’s apparent signs of ADHD could be due to another condition such as hyperthyroidism or diabetes, Dr. Smith said. The driving principle is to take enough time to figure out exactly what is going on, she said, and then to treat accordingly. “If you ask the right questions, patients will give you good answers.”

Medications are often prescribed to help manage ADHD symptoms. These can include stimulants, controlled substances that include methylphenidate or amphetamine, or nonstimulants, such as atomoxetine and bupropion. Dr. Montano starts his patients on a lower dose and titrates them up rapidly until they reach the optimum dose that allows them to sustain focus and feel more productive. Patients complete frequent self-reports during this process.

“Any diversion is inappropriate,” said Dr. Montano, who writes a contract with his patients saying that stimulant medications will not be refilled if they are used more quickly than prescribed.

For older adults, physicians should make sure that stimulants do not exacerbate any underlying cardiovascular conditions, Dr. Montano said, and consult a cardiologist when needed.

The benefits of proper ADHD treatment can be profound, Dr. Adler noted, no matter when it begins.

“Older adults have lived their lives feeling they’ve been disorganized and a burden to their significant others, and only when they’ve taken medication have they really been able to organize their days and feel effective in their social interactions and with their families,” Dr. Adler said.

Dr. Montano has reported relationships with AbbVie, Axsome, Corium, Idorsia, Intracellular, Otsuka, Supernus, Sage/Biogen, Biohaven, Boehringer Ingelheim, Cassava, Eli Lilly, Intracellular, Janssen, Jazz, Sage, Supernus, Otsuka, and Tonix. Dr. Adler has reported relationships with Shire/Takeda Pharmaceuticals, National Football League, Major League Baseball, Corium, Otsuka, Neurocentria, Bracket/Signant, and SUNY; and is receiving royalty payments for developing adult ADHD assessments. Dr. Smith has reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.

The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.

PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.

“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.

Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.

Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.

Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
 

Possible confounders

“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.

Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.

Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.

“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.

Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.

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

Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.

The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.

PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.

“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.

Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.

Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.

Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
 

Possible confounders

“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.

Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.

Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.

“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.

Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.

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

Researchers in France are warning against the overzealous use of acid-suppressing drugs in infants after finding that the medications are associated with an increase in risk of serious infections later in life.

The focus on the use of proton pump inhibitors (PPIs) during infancy comes as use of the drugs in young children is rising in France, New Zealand, Scandinavia, and the United States. Much of this use is not to manage confirmed cases of gastroesophageal reflux but rather to soothe the jangled nerves of parents of babies in discomfort, according to the researchers, who have studied national prescribing patterns. In addition to concerns about infection, inappropriate or prolonged use of the acid suppressants is also associated with an increase in the risk of such conditions as hospital-acquired acute kidney injury and inflammatory bowel diseases in children.

PPIs such as omeprazole are effective at reducing gastric acid in babies with gastroesophageal reflux disease. But the researchers warned against using the drugs to manage normal spitting up and dribbling that would have resolved of itself anyway.

“In this study, increased risk of serious infections was associated with PPI use in young children, overall and for various sites and pathogens. In this population, PPIs should not be used without a clear indication,” epidemiologist Marion Lassalle, PharmD, PhD, of EPI-PHARE in Saint-Denis, France, and colleagues reported in JAMA Pediatrics.

Drawing on data from a national birth registry, Dr. Lassalle and colleagues compared infection rates among more than 1.2 million infants who received a PPI at an average age of 88 days with infection rates among children who received another kind of acid suppressant (a histamine receptor blocker or antacid) at an average age of 82 days. More than 600,000 children made up each group.

Slightly over half of the participants were boys, and the study followed children to a maximum age of 9 years. Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization (adjusted hazard ratio, 1.34; 95% confidence interval, 1.32-1.36). There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.

Serious infections first appeared 9.7 (range, 3.9-21.3) months after a child stopped using a PPI – a date that Dr. Lassalle’s group determined on the basis of there being a delay of at least 90 days in filling a PPI prescription.
 

Possible confounders

“The study shows an association, it does not show causation,” said Rina Sanghavi, MD, a pediatric gastroenterologist at UT Southwestern Medical Center, Dallas. Dr. Sanghavi noted that the children who continued taking PPIs generally were sicker in their first year of life, as shown by the higher rates of respiratory ailments and corticosteroid use. This could mean that the infections they eventually experienced had many causes and not necessarily the PPI.

Similarly, pediatric gastroenterologist Sophia Patel, MD, of the Cleveland Clinic, pointed to the almost 10-month average lag time between stopping a PPI and developing a first serious infection. That interval is long enough that it is possible that the infection was caused by something else, Dr. Patel said.

Despite the limitations of the study, Dr. Sanghavi and Dr. Patel said the findings serve as a good reminder to clinicians to use PPIs only when needed and to limit their use once begun. The overall evidence base for limiting use of PPIs is strong, both physicians noted, even if this study does not show direct causation between PPI use and infection rates.

“Ask: Does this child need a PPI?” Dr. Sanghavi said. If so, she generally prescribes PPIs for a period of 2 weeks to a maximum of 2 months and she never authorizes automatic refills. Through this approach, a parent and child will come back to the clinic frequently, which in most cases allows faster tapering of the drugs.

Dr. Lassalle, Dr. Sanghavi, and Dr. Patel reported no relevant financial conflicts of interest.

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Sometimes we get what we pay for. Other times we pay too much. 

That’s the message of a study published in Annals of Internal Medicine, which finds that a generic maintenance inhaler is as effective at managing symptoms of chronic obstructive pulmonary disorder (COPD) as a pricier branded alternative. 

In 2019, the Food and Drug Administration approved Wixela Inhub (the combination corticosteroid/long-acting beta² adrenergic agonist fluticasone-salmeterol; Viatris) as a generic dry powder inhaler for managing symptoms of COPD. This approval was based on evidence of the generic’s effectiveness against asthma, although COPD also was on the product label. The study authors compared Wixela’s effectiveness in controlling symptoms of COPD with that of the brand name inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline), which uses the same active ingredients.

The result: “The generic looks to be as safe and effective as the brand name. I don’t see a clinical reason why one would ever need to get the brand name over the generic version,” said study author William Feldman, MD, DPhil, MPH, a health services researcher and pulmonologist at Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
 

Same types of patients, different inhalers, same outcomes

Dr. Feldman and colleagues compared the medical records of 10,000 patients with COPD who began using the branded inhaler to the records of another 10,000 patients with COPD who opted for the generic alternative. Participants in the two groups were evenly matched by age, sex, race, and ethnicity, region, severity of COPD, and presence of other comorbidities, according to the researchers. Participants were all older than age 40, and the average age in both groups was 72 years.

The researchers looked for a difference in a first episode of a moderate exacerbation of COPD, defined as requiring a course of prednisone for 5-14 days. They also looked for cases of severe COPD exacerbation requiring hospitalization in the year after people began using either the generic or brand name inhaler. And they looked for differences across 1 year in rates of hospitalization for pneumonia.

For none of those outcomes, however, did the type of inhaler appear to matter. Compared with the brand-name drug, using the generic was associated with nearly identical rates of moderate or severe COPD exacerbation (hazard ratio, 0.97; 95% confidence interval, 0.90-1.04. The same was true for the proportion of people who went to the hospital for pneumonia at least once (HR, 0.99; 95% CI, 0.86-1.15).

“To get through the FDA as an interchangeable generic, the generic firms have to show that their product can be used in just the same way as the brand-name version,” Dr. Feldman said, which may explain why the generic and brand-name versions of the inhaler performed so similarly.

Dr. Feldman cautioned that the price savings for patients who opt for the generic over the branded product are hard to determine, given the vagaries of different insurance plans and potential rebates when using the branded project. As a general matter, having a single generic competitor will not lower costs much, Dr. Feldman noted, pointing to 2017 research from Harvard that found a profusion of generic competitors is needed to significantly lower health care costs.

“I don’t want to in any way underestimate the importance of getting that first generic onto the market, because it sets the stage for future generics,” Dr. Feldman said.  

“There are very few generic options for patients with COPD,” said Surya Bhatt, MD, director of the Pulmonary Function and Exercise Physiology Lab at the University of Alabama at Birmingham. Even the rescue inhalers that people with COPD use to manage acute episodes of the condition are usually branded at this time, Dr. Bhatt noted, with few generic options.*

“The results are quite compelling,” said Dr. Bhatt, who was not involved in the research. Although the trial was not randomized, he commended the researchers for stratifying participants in the two groups to be as comparable as possible.

Dr. Bhatt noted that the FDA’s 2019 approval – given that the agency requires bioequivalence studies between branded and generic products – was enough to cause him to begin prescribing the generic inhaler. The fact that this approval was based on asthma but not also COPD is not a concern.

“There are so many similarities between asthma, COPD, and some obstructive lung diseases,” Dr. Bhatt noted.

In his experience, the only time someone with COPD continues using the branded inhaler – now that a potentially cheaper generic is available – is when their insurance plan makes their out-of-pocket cost minimal. Otherwise, brand loyalty does not exist.

“Patients are generally okay with being on a generic for inhalers, just because of the high cost,” Dr. Bhatt said.

The study was primarily supported by the National Heart, Lung, and Blood Institute. Dr. Feldman reported funding from Arnold Ventures, the Commonwealth Fund, and the FDA, and consulting relationships with Alosa Health and Aetion. Dr. Bhatt reported no relevant financial relationships.

*Correction, 8/16/23: An earlier version of this article mischaracterized Dr. Bhatt's comments on the availability of generic options.

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

Sometimes we get what we pay for. Other times we pay too much. 

That’s the message of a study published in Annals of Internal Medicine, which finds that a generic maintenance inhaler is as effective at managing symptoms of chronic obstructive pulmonary disorder (COPD) as a pricier branded alternative. 

In 2019, the Food and Drug Administration approved Wixela Inhub (the combination corticosteroid/long-acting beta² adrenergic agonist fluticasone-salmeterol; Viatris) as a generic dry powder inhaler for managing symptoms of COPD. This approval was based on evidence of the generic’s effectiveness against asthma, although COPD also was on the product label. The study authors compared Wixela’s effectiveness in controlling symptoms of COPD with that of the brand name inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline), which uses the same active ingredients.

The result: “The generic looks to be as safe and effective as the brand name. I don’t see a clinical reason why one would ever need to get the brand name over the generic version,” said study author William Feldman, MD, DPhil, MPH, a health services researcher and pulmonologist at Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
 

Same types of patients, different inhalers, same outcomes

Dr. Feldman and colleagues compared the medical records of 10,000 patients with COPD who began using the branded inhaler to the records of another 10,000 patients with COPD who opted for the generic alternative. Participants in the two groups were evenly matched by age, sex, race, and ethnicity, region, severity of COPD, and presence of other comorbidities, according to the researchers. Participants were all older than age 40, and the average age in both groups was 72 years.

The researchers looked for a difference in a first episode of a moderate exacerbation of COPD, defined as requiring a course of prednisone for 5-14 days. They also looked for cases of severe COPD exacerbation requiring hospitalization in the year after people began using either the generic or brand name inhaler. And they looked for differences across 1 year in rates of hospitalization for pneumonia.

For none of those outcomes, however, did the type of inhaler appear to matter. Compared with the brand-name drug, using the generic was associated with nearly identical rates of moderate or severe COPD exacerbation (hazard ratio, 0.97; 95% confidence interval, 0.90-1.04. The same was true for the proportion of people who went to the hospital for pneumonia at least once (HR, 0.99; 95% CI, 0.86-1.15).

“To get through the FDA as an interchangeable generic, the generic firms have to show that their product can be used in just the same way as the brand-name version,” Dr. Feldman said, which may explain why the generic and brand-name versions of the inhaler performed so similarly.

Dr. Feldman cautioned that the price savings for patients who opt for the generic over the branded product are hard to determine, given the vagaries of different insurance plans and potential rebates when using the branded project. As a general matter, having a single generic competitor will not lower costs much, Dr. Feldman noted, pointing to 2017 research from Harvard that found a profusion of generic competitors is needed to significantly lower health care costs.

“I don’t want to in any way underestimate the importance of getting that first generic onto the market, because it sets the stage for future generics,” Dr. Feldman said.  

“There are very few generic options for patients with COPD,” said Surya Bhatt, MD, director of the Pulmonary Function and Exercise Physiology Lab at the University of Alabama at Birmingham. Even the rescue inhalers that people with COPD use to manage acute episodes of the condition are usually branded at this time, Dr. Bhatt noted, with few generic options.*

“The results are quite compelling,” said Dr. Bhatt, who was not involved in the research. Although the trial was not randomized, he commended the researchers for stratifying participants in the two groups to be as comparable as possible.

Dr. Bhatt noted that the FDA’s 2019 approval – given that the agency requires bioequivalence studies between branded and generic products – was enough to cause him to begin prescribing the generic inhaler. The fact that this approval was based on asthma but not also COPD is not a concern.

“There are so many similarities between asthma, COPD, and some obstructive lung diseases,” Dr. Bhatt noted.

In his experience, the only time someone with COPD continues using the branded inhaler – now that a potentially cheaper generic is available – is when their insurance plan makes their out-of-pocket cost minimal. Otherwise, brand loyalty does not exist.

“Patients are generally okay with being on a generic for inhalers, just because of the high cost,” Dr. Bhatt said.

The study was primarily supported by the National Heart, Lung, and Blood Institute. Dr. Feldman reported funding from Arnold Ventures, the Commonwealth Fund, and the FDA, and consulting relationships with Alosa Health and Aetion. Dr. Bhatt reported no relevant financial relationships.

*Correction, 8/16/23: An earlier version of this article mischaracterized Dr. Bhatt's comments on the availability of generic options.

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

Sometimes we get what we pay for. Other times we pay too much. 

That’s the message of a study published in Annals of Internal Medicine, which finds that a generic maintenance inhaler is as effective at managing symptoms of chronic obstructive pulmonary disorder (COPD) as a pricier branded alternative. 

In 2019, the Food and Drug Administration approved Wixela Inhub (the combination corticosteroid/long-acting beta² adrenergic agonist fluticasone-salmeterol; Viatris) as a generic dry powder inhaler for managing symptoms of COPD. This approval was based on evidence of the generic’s effectiveness against asthma, although COPD also was on the product label. The study authors compared Wixela’s effectiveness in controlling symptoms of COPD with that of the brand name inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline), which uses the same active ingredients.

The result: “The generic looks to be as safe and effective as the brand name. I don’t see a clinical reason why one would ever need to get the brand name over the generic version,” said study author William Feldman, MD, DPhil, MPH, a health services researcher and pulmonologist at Harvard Medical School and Brigham and Women’s Hospital, both in Boston.
 

Same types of patients, different inhalers, same outcomes

Dr. Feldman and colleagues compared the medical records of 10,000 patients with COPD who began using the branded inhaler to the records of another 10,000 patients with COPD who opted for the generic alternative. Participants in the two groups were evenly matched by age, sex, race, and ethnicity, region, severity of COPD, and presence of other comorbidities, according to the researchers. Participants were all older than age 40, and the average age in both groups was 72 years.

The researchers looked for a difference in a first episode of a moderate exacerbation of COPD, defined as requiring a course of prednisone for 5-14 days. They also looked for cases of severe COPD exacerbation requiring hospitalization in the year after people began using either the generic or brand name inhaler. And they looked for differences across 1 year in rates of hospitalization for pneumonia.

For none of those outcomes, however, did the type of inhaler appear to matter. Compared with the brand-name drug, using the generic was associated with nearly identical rates of moderate or severe COPD exacerbation (hazard ratio, 0.97; 95% confidence interval, 0.90-1.04. The same was true for the proportion of people who went to the hospital for pneumonia at least once (HR, 0.99; 95% CI, 0.86-1.15).

“To get through the FDA as an interchangeable generic, the generic firms have to show that their product can be used in just the same way as the brand-name version,” Dr. Feldman said, which may explain why the generic and brand-name versions of the inhaler performed so similarly.

Dr. Feldman cautioned that the price savings for patients who opt for the generic over the branded product are hard to determine, given the vagaries of different insurance plans and potential rebates when using the branded project. As a general matter, having a single generic competitor will not lower costs much, Dr. Feldman noted, pointing to 2017 research from Harvard that found a profusion of generic competitors is needed to significantly lower health care costs.

“I don’t want to in any way underestimate the importance of getting that first generic onto the market, because it sets the stage for future generics,” Dr. Feldman said.  

“There are very few generic options for patients with COPD,” said Surya Bhatt, MD, director of the Pulmonary Function and Exercise Physiology Lab at the University of Alabama at Birmingham. Even the rescue inhalers that people with COPD use to manage acute episodes of the condition are usually branded at this time, Dr. Bhatt noted, with few generic options.*

“The results are quite compelling,” said Dr. Bhatt, who was not involved in the research. Although the trial was not randomized, he commended the researchers for stratifying participants in the two groups to be as comparable as possible.

Dr. Bhatt noted that the FDA’s 2019 approval – given that the agency requires bioequivalence studies between branded and generic products – was enough to cause him to begin prescribing the generic inhaler. The fact that this approval was based on asthma but not also COPD is not a concern.

“There are so many similarities between asthma, COPD, and some obstructive lung diseases,” Dr. Bhatt noted.

In his experience, the only time someone with COPD continues using the branded inhaler – now that a potentially cheaper generic is available – is when their insurance plan makes their out-of-pocket cost minimal. Otherwise, brand loyalty does not exist.

“Patients are generally okay with being on a generic for inhalers, just because of the high cost,” Dr. Bhatt said.

The study was primarily supported by the National Heart, Lung, and Blood Institute. Dr. Feldman reported funding from Arnold Ventures, the Commonwealth Fund, and the FDA, and consulting relationships with Alosa Health and Aetion. Dr. Bhatt reported no relevant financial relationships.

*Correction, 8/16/23: An earlier version of this article mischaracterized Dr. Bhatt's comments on the availability of generic options.

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

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.

As with porridge, so with blood pressure: Just right makes all the difference.

Ill-fitting blood pressure measurement cuffs produce erroneous readings that impair hypertension treatment, according to research published in JAMA Internal Medicine.

People whose mid-upper arm circumference exceeds 32 cm require larger cuffs than the standard size, but in many cases the regular-sized cuff is used on everyone. As a result, patients with larger arms may be falsely diagnosed with high blood pressure because of a too-small cuff, leading to overprescribing of medications that could make their health worse, according to the researchers.  

“A person whose blood pressure is 120/80, which is normal – if they’re using the wrong cuff, they could get a measurement that says 140/90, let’s say,” said study author Tammy M. Brady, MD, PhD, vice chair for clinical research in the department of pediatrics at Johns Hopkins University, Baltimore. “They might think they not only have hypertension, but stage 2 hypertension. Providers might give one or even two medicines to lower this, which could lead to hypotension,” Dr. Brady said.

Conversely, someone with smaller arms whose cuff is too big may present with an artificially low blood pressure. The implications of using ill-fitting cuffs are well known. Dr. Brady, among others, has studied the topic extensively. Even so, she said the measurement errors in the latest study were larger than expected.
 

The Goldilocks test

People with an arm circumference of 20-25 cm should use a smaller cuff than the regular size, Dr. Brady and colleagues reported. Circumferences of 25.1-32 cm require a regular-sized cuff; large cuffs are for circumferences of 32.1-40 cm; and extra-large cuffs should be used at 40.1-55 cm.

The study included 195 residents of Baltimore (128 women, 67 men; 132 Black, 58 White, 5 Hispanic) with an average age of 54 years. The researchers measured every participant’s blood pressure using an automated device on four occasions, taking three measurements each time.

The first three sets of measurements used, respectively, an appropriate cuff size for each person’s arm circumference; a cuff that was too big; and a cuff that was too small. This study design ensured that a regular-sized cuff would be used during one of the three measurements – sometimes that cuff was too small, sometimes it was appropriate, and other times it was too big.

The final set of three measurements used the appropriate cuff size for a person’s arm every time. Dr. Brady and colleagues then compared people’s blood pressure measurements when using the right-sized cuff to measurements with a regular-sized cuff that was not suited for them.

They found that using a cuff that was too large for the patient’s arm (i.e., using a regular cuff when a small cuff was the right choice) led to understating systolic blood pressure by –3.6 mm Hg (95% confidence interval [CI], –5.6 to –1.7). A cuff that was one size too small – using regular instead of a large – overestimated systolic blood pressure by 4.8 (3.0-6.6) mm Hg. And a cuff that was two sizes too small – someone who should have received an extra-large cuff but received the regular size – overestimated systolic blood pressure by 19.5 (16.1-22.9) mm Hg. All differences were statistically significant, the researchers reported.

“To our knowledge, this is the first randomized cross-over trial to examine the effect of miscuffing on automated blood pressure readings,” Mathias Lalika, MD, MPH, of the Mayo Clinic in Rochester, Minn.; Stephen P. Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston; and LaPrincess C. Brewer, MD, MPH, of the Mayo Clinic, wrote in an editorial accompanying the journal article.

“Interestingly, the degree of underestimation or overestimation increased as the appropriate cuff size progressed from the regular to extra-large BP cuff. More importantly, the effect of miscuffing did not vary with BP or obesity status,” they wrote.

“This was more of a pragmatic trial to see real world, all comers,” Dr. Brady said, when regular-sized cuffs are used whether or not that made sense.

“This study reaffirms findings of previous studies and highlights a major source of error in blood pressure measurement,” Raj Padwal, MD, director of the University of Alberta Hypertension Clinic, Edmonton, Alta., said in an interview. Dr. Padwal, who was not involved in the study, said the findings highlight the importance of ensuring that technicians who typically measure blood pressure understand the value of using the right-sized cuff.

Dr. Brady noted that measuring arm circumference takes about 15 seconds. He advised health organizations and clinics to carry multiple cuffs sizes to avoid a scramble to find a right-sized cuff. In the editorial, Dr. Lalika, Dr. Juraschek, and Dr. Brewer call for particular attention to providing the right-sized cuffs to facilities that work with underserved populations, such as federally qualified health centers.

Dr. Padwal added that even a perfectly measured blood pressure test at a clinic indicates pressure at a moment in time. Ten minutes later the story could be different. For this reason, he and other clinicians recommend frequent home blood pressure measurements rather than relying solely on the sparse number of readings collected in the clinic setting.

“A properly educated patient can give many readings that are separated in space and time and, when averaged, can give a much better picture of overall blood pressure and future risk,” Dr. Padwal said. 

Dr. Brady agreed with the value of home readings but said home-based readings also can be erroneous if the patient uses a cuff that is the wrong size. She cochairs a committee for the American Medical Association that recommends validated home blood pressure measurement devices on a periodically updated website called Validate BP. The details for each device listing show the cuff sizes available per device. Many devices provide only the standard cuff, Dr. Brady noted, but some offer multiple cuff sizes.

“One of the things that would be great if it came out of this paper is if patients were empowered to ask physicians to measure their arm” and then use that information to select the appropriate cuff for their home device, she said.

Dr. Brady and Dr. Padwal reported no relevant financial relationships. This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill & Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, also known as benign prostate hyperplasia (BPH).

Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.

Olivier Le Moal/Getty Images

“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.

Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.

“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.

More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.

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

The Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, also known as benign prostate hyperplasia (BPH).

Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.

Olivier Le Moal/Getty Images

“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.

Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.

“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.

More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.

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

The Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, also known as benign prostate hyperplasia (BPH).

Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.

Olivier Le Moal/Getty Images

“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.

Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.

“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.

More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.

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