Clinical Endocrinology News

Underdiagnosis, reluctant doctors, patient preconceptions: Treating low testosterone levels is a tricky business in France despite the proven benefits of replacement therapy. About 20% of patients with symptomatic low testosterone levels are treated for the deficiency, said Eric Huygue, MD, PhD, urologic surgeon at Toulouse University Hospital in France, at the 117th annual conference of the French Urology Association (AFU).

“Treatment for low testosterone is effective and risk-free. It improves a patient’s quality of life and general health,” particularly affecting fatigue, mood, and libido, said Dr. Huygue, who was involved in drawing up the first French recommendations on treating low testosterone in 2021.

“We must keep up communication efforts to make patients and doctors aware” of the benefits of supplementation, he said.
 

Testosterone Levels

Testosterone deficiency mostly affects men older than 40 years. A drop in androgen levels, which varies by individual, can lead to sexual problems (such as erectile dysfunction and low libido), physical symptoms (fatigue, hot flashes, loss of muscle mass, and osteoporosis), and mental disorders (anxiety, irritability, and depression).

There are an estimated 340,000 men with symptomatic testosterone deficiency in France. Just 70,000 of these are receiving replacement therapy (see box), which accounts for only 20% of those affected. For Dr. Huygue, this low treatment rate is due to underdiagnosis, as well as reluctance on the part of doctors and patients.

Although routine screening of low testosterone in the general population is not recommended, some individuals are particularly at risk, noted the urologist.

This is especially true for patients with metabolic disorders associated with insulin resistance (such as obesity and type 2 diabetes), cardiovascular diseases (hypertension, heart failure, and atrial fibrillation), or other chronic conditions (chronic obstructive pulmonary disease, cancer, and depression). Some medications (corticosteroids, antipsychotics, chemotherapy drugs, and antiretroviral therapies) can also lead to low testosterone.

Per the French recommendations for managing low testosterone, diagnosis must be based on free or bioavailable testosterone and not total testosterone levels, which can give a skewed result. Levels must be tested twice, 1 month apart, in the morning and while fasting. The reference range is determined by taking the lower threshold level of young men as measured in the laboratory.

Threshold Values

The current practice of using the reference range associated with the patient’s age group undoubtedly contributes to the underdiagnosis of low testosterone, said Dr. Huygue. According to a survey of AFU members in 2021, the year in which the recommendations were published, 77% of urologists interviewed reported referring to reference ranges for patients of the same age.

In their defense, “this method has long been in use, but it has eventually become apparent that symptomatic patients with an undiagnosed deficiency could be in the reference patients’ group,” Dr. Huygue explained.

Once a deficiency has been diagnosed, doctors may be reluctant to prescribe replacement therapy due to the perceived risk of developing prostate cancer. Several international studies have shown that “the risk of prostate cancer is the single biggest reason for doctors refusing to prescribe testosterone,” said Dr. Huygue.

Despite this reluctance, numerous studies have clearly shown that there is no link between a high testosterone level and the risk of developing prostate cancer. It even seems that a low testosterone level might expose a person to an increased risk for an aggressive form of cancer.

“This is a time of many surprising discoveries concerning the link between the prostate and testosterone, which go against what we have thought up to now. It has been observed that men with low testosterone develop more serious types of cancer,” said Dr. Huygue at a previous meeting of the AFU, during which he announced the publication of the French recommendations.
 

Prostate Cancer Recurrence

Urologists are also wary of testosterone supplementation in patients with a previous history of prostate cancer. According to the AFU’s survey, 40% of urologists questioned think that testosterone is contraindicated in this population. One in two urologists prescribe testosterone after radical prostatectomy for low or intermediate risk and most commonly after 3 years of undetectable prostate-specific antigen (PSA) levels.

Nevertheless, “several retrospective studies show the safety of testosterone replacement therapy in men who have undergone radical prostatectomy or radiotherapy or who are under active monitoring,” said Dr. Huygue. Testosterone “does not appear to increase the risk of relapse” after treatment of prostate cancer.

Dr. Huygue invited prescribing physicians to refer to the French recommendations, which specify that 1 year of undetectable PSA after prostatectomy is sufficient before prescribing replacement therapy. “This is clearly indicated in the recommendations for patients with a previous history of prostate cancer.”

Neither prostate cancer nor benign prostatic hyperplasia is a contraindication. According to the recommendations, the only contraindications to testosterone prescription are the following:

• Hematocrit > 54%
• Current breast or prostate cancer
• Cardiovascular event less than 3-6 months prior
• Trying to conceive

Cardiovascular Benefits

Another more commonly used argument by general practitioners and endocrinologists to justify their reluctance to prescribe testosterone is the risk to cardiovascular health. In early 2010, a series of American studies alerted clinicians to this risk when taking testosterone. Since then, other studies have had reassuring findings.

In response to the alert issued by the United States, the European Medicines Agency specified that “the data are not sufficient for a warning,” before the American Heart Association colleagues concluded that testosterone should only be avoided in the first 6 months following a severe cardiovascular event.

Conversely, in 2021, the European Society of Cardiology put forward the benefits of testosterone in an article in favor of replacement therapy to prevent cardiovascular risk. In particular, the hormone is thought to have a beneficial effect on arterial stiffness, the appearance of calcified plaques, and coronary artery dilatation.

The final hurdle to overcome before a testosterone prescription is filled relates to patients themselves, who often regard such treatment unfavorably. Many wrongly believe that androgens are hormones that “increase the risk of cancer, make you aggressive, cause weight gain, lead to hair loss, and cause body hair growth,” said Dr. Huygue.

Finally, breaks in the supply chain for Androtardyl, the only injectable form available for reimbursement by French social security schemes, were reported in the country in 2023, said Dr. Huygue. This situation only complicates further the prescription and use of testosterone replacement therapy.
 

Which Supplement?

Testosterone replacement therapies are available on the market in the following formulations:

Via transcutaneous administration: Testosterone-based gels, not covered by the French social security system (Androgel and Fortigel), to be applied daily. Users must be careful to avoid any potential transfer of the product to women or children in case of contact with the site after application.

Via an injection: Androtardyl (testosterone enanthate), covered by French social security, to be administered intramuscularly once a month. Nebido (testosterone undecanoate), not covered by French social security, with a more beneficial bioavailability profile, to be administered once every 3 months.

Pantestone (testosterone undecanoate), administered orally, is not marketed since 2021. It had the major disadvantage of requiring a high-fat diet to ensure optimal absorption.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Underdiagnosis, reluctant doctors, patient preconceptions: Treating low testosterone levels is a tricky business in France despite the proven benefits of replacement therapy. About 20% of patients with symptomatic low testosterone levels are treated for the deficiency, said Eric Huygue, MD, PhD, urologic surgeon at Toulouse University Hospital in France, at the 117th annual conference of the French Urology Association (AFU).

“Treatment for low testosterone is effective and risk-free. It improves a patient’s quality of life and general health,” particularly affecting fatigue, mood, and libido, said Dr. Huygue, who was involved in drawing up the first French recommendations on treating low testosterone in 2021.

“We must keep up communication efforts to make patients and doctors aware” of the benefits of supplementation, he said.
 

Testosterone Levels

Testosterone deficiency mostly affects men older than 40 years. A drop in androgen levels, which varies by individual, can lead to sexual problems (such as erectile dysfunction and low libido), physical symptoms (fatigue, hot flashes, loss of muscle mass, and osteoporosis), and mental disorders (anxiety, irritability, and depression).

There are an estimated 340,000 men with symptomatic testosterone deficiency in France. Just 70,000 of these are receiving replacement therapy (see box), which accounts for only 20% of those affected. For Dr. Huygue, this low treatment rate is due to underdiagnosis, as well as reluctance on the part of doctors and patients.

Although routine screening of low testosterone in the general population is not recommended, some individuals are particularly at risk, noted the urologist.

This is especially true for patients with metabolic disorders associated with insulin resistance (such as obesity and type 2 diabetes), cardiovascular diseases (hypertension, heart failure, and atrial fibrillation), or other chronic conditions (chronic obstructive pulmonary disease, cancer, and depression). Some medications (corticosteroids, antipsychotics, chemotherapy drugs, and antiretroviral therapies) can also lead to low testosterone.

Per the French recommendations for managing low testosterone, diagnosis must be based on free or bioavailable testosterone and not total testosterone levels, which can give a skewed result. Levels must be tested twice, 1 month apart, in the morning and while fasting. The reference range is determined by taking the lower threshold level of young men as measured in the laboratory.

Threshold Values

The current practice of using the reference range associated with the patient’s age group undoubtedly contributes to the underdiagnosis of low testosterone, said Dr. Huygue. According to a survey of AFU members in 2021, the year in which the recommendations were published, 77% of urologists interviewed reported referring to reference ranges for patients of the same age.

In their defense, “this method has long been in use, but it has eventually become apparent that symptomatic patients with an undiagnosed deficiency could be in the reference patients’ group,” Dr. Huygue explained.

Once a deficiency has been diagnosed, doctors may be reluctant to prescribe replacement therapy due to the perceived risk of developing prostate cancer. Several international studies have shown that “the risk of prostate cancer is the single biggest reason for doctors refusing to prescribe testosterone,” said Dr. Huygue.

Despite this reluctance, numerous studies have clearly shown that there is no link between a high testosterone level and the risk of developing prostate cancer. It even seems that a low testosterone level might expose a person to an increased risk for an aggressive form of cancer.

“This is a time of many surprising discoveries concerning the link between the prostate and testosterone, which go against what we have thought up to now. It has been observed that men with low testosterone develop more serious types of cancer,” said Dr. Huygue at a previous meeting of the AFU, during which he announced the publication of the French recommendations.
 

Prostate Cancer Recurrence

Urologists are also wary of testosterone supplementation in patients with a previous history of prostate cancer. According to the AFU’s survey, 40% of urologists questioned think that testosterone is contraindicated in this population. One in two urologists prescribe testosterone after radical prostatectomy for low or intermediate risk and most commonly after 3 years of undetectable prostate-specific antigen (PSA) levels.

Nevertheless, “several retrospective studies show the safety of testosterone replacement therapy in men who have undergone radical prostatectomy or radiotherapy or who are under active monitoring,” said Dr. Huygue. Testosterone “does not appear to increase the risk of relapse” after treatment of prostate cancer.

Dr. Huygue invited prescribing physicians to refer to the French recommendations, which specify that 1 year of undetectable PSA after prostatectomy is sufficient before prescribing replacement therapy. “This is clearly indicated in the recommendations for patients with a previous history of prostate cancer.”

Neither prostate cancer nor benign prostatic hyperplasia is a contraindication. According to the recommendations, the only contraindications to testosterone prescription are the following:

• Hematocrit > 54%
• Current breast or prostate cancer
• Cardiovascular event less than 3-6 months prior
• Trying to conceive

Cardiovascular Benefits

Another more commonly used argument by general practitioners and endocrinologists to justify their reluctance to prescribe testosterone is the risk to cardiovascular health. In early 2010, a series of American studies alerted clinicians to this risk when taking testosterone. Since then, other studies have had reassuring findings.

In response to the alert issued by the United States, the European Medicines Agency specified that “the data are not sufficient for a warning,” before the American Heart Association colleagues concluded that testosterone should only be avoided in the first 6 months following a severe cardiovascular event.

Conversely, in 2021, the European Society of Cardiology put forward the benefits of testosterone in an article in favor of replacement therapy to prevent cardiovascular risk. In particular, the hormone is thought to have a beneficial effect on arterial stiffness, the appearance of calcified plaques, and coronary artery dilatation.

The final hurdle to overcome before a testosterone prescription is filled relates to patients themselves, who often regard such treatment unfavorably. Many wrongly believe that androgens are hormones that “increase the risk of cancer, make you aggressive, cause weight gain, lead to hair loss, and cause body hair growth,” said Dr. Huygue.

Finally, breaks in the supply chain for Androtardyl, the only injectable form available for reimbursement by French social security schemes, were reported in the country in 2023, said Dr. Huygue. This situation only complicates further the prescription and use of testosterone replacement therapy.
 

Which Supplement?

Testosterone replacement therapies are available on the market in the following formulations:

Via transcutaneous administration: Testosterone-based gels, not covered by the French social security system (Androgel and Fortigel), to be applied daily. Users must be careful to avoid any potential transfer of the product to women or children in case of contact with the site after application.

Via an injection: Androtardyl (testosterone enanthate), covered by French social security, to be administered intramuscularly once a month. Nebido (testosterone undecanoate), not covered by French social security, with a more beneficial bioavailability profile, to be administered once every 3 months.

Pantestone (testosterone undecanoate), administered orally, is not marketed since 2021. It had the major disadvantage of requiring a high-fat diet to ensure optimal absorption.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Underdiagnosis, reluctant doctors, patient preconceptions: Treating low testosterone levels is a tricky business in France despite the proven benefits of replacement therapy. About 20% of patients with symptomatic low testosterone levels are treated for the deficiency, said Eric Huygue, MD, PhD, urologic surgeon at Toulouse University Hospital in France, at the 117th annual conference of the French Urology Association (AFU).

“Treatment for low testosterone is effective and risk-free. It improves a patient’s quality of life and general health,” particularly affecting fatigue, mood, and libido, said Dr. Huygue, who was involved in drawing up the first French recommendations on treating low testosterone in 2021.

“We must keep up communication efforts to make patients and doctors aware” of the benefits of supplementation, he said.
 

Testosterone Levels

Testosterone deficiency mostly affects men older than 40 years. A drop in androgen levels, which varies by individual, can lead to sexual problems (such as erectile dysfunction and low libido), physical symptoms (fatigue, hot flashes, loss of muscle mass, and osteoporosis), and mental disorders (anxiety, irritability, and depression).

There are an estimated 340,000 men with symptomatic testosterone deficiency in France. Just 70,000 of these are receiving replacement therapy (see box), which accounts for only 20% of those affected. For Dr. Huygue, this low treatment rate is due to underdiagnosis, as well as reluctance on the part of doctors and patients.

Although routine screening of low testosterone in the general population is not recommended, some individuals are particularly at risk, noted the urologist.

This is especially true for patients with metabolic disorders associated with insulin resistance (such as obesity and type 2 diabetes), cardiovascular diseases (hypertension, heart failure, and atrial fibrillation), or other chronic conditions (chronic obstructive pulmonary disease, cancer, and depression). Some medications (corticosteroids, antipsychotics, chemotherapy drugs, and antiretroviral therapies) can also lead to low testosterone.

Per the French recommendations for managing low testosterone, diagnosis must be based on free or bioavailable testosterone and not total testosterone levels, which can give a skewed result. Levels must be tested twice, 1 month apart, in the morning and while fasting. The reference range is determined by taking the lower threshold level of young men as measured in the laboratory.

Threshold Values

The current practice of using the reference range associated with the patient’s age group undoubtedly contributes to the underdiagnosis of low testosterone, said Dr. Huygue. According to a survey of AFU members in 2021, the year in which the recommendations were published, 77% of urologists interviewed reported referring to reference ranges for patients of the same age.

In their defense, “this method has long been in use, but it has eventually become apparent that symptomatic patients with an undiagnosed deficiency could be in the reference patients’ group,” Dr. Huygue explained.

Once a deficiency has been diagnosed, doctors may be reluctant to prescribe replacement therapy due to the perceived risk of developing prostate cancer. Several international studies have shown that “the risk of prostate cancer is the single biggest reason for doctors refusing to prescribe testosterone,” said Dr. Huygue.

Despite this reluctance, numerous studies have clearly shown that there is no link between a high testosterone level and the risk of developing prostate cancer. It even seems that a low testosterone level might expose a person to an increased risk for an aggressive form of cancer.

“This is a time of many surprising discoveries concerning the link between the prostate and testosterone, which go against what we have thought up to now. It has been observed that men with low testosterone develop more serious types of cancer,” said Dr. Huygue at a previous meeting of the AFU, during which he announced the publication of the French recommendations.
 

Prostate Cancer Recurrence

Urologists are also wary of testosterone supplementation in patients with a previous history of prostate cancer. According to the AFU’s survey, 40% of urologists questioned think that testosterone is contraindicated in this population. One in two urologists prescribe testosterone after radical prostatectomy for low or intermediate risk and most commonly after 3 years of undetectable prostate-specific antigen (PSA) levels.

Nevertheless, “several retrospective studies show the safety of testosterone replacement therapy in men who have undergone radical prostatectomy or radiotherapy or who are under active monitoring,” said Dr. Huygue. Testosterone “does not appear to increase the risk of relapse” after treatment of prostate cancer.

Dr. Huygue invited prescribing physicians to refer to the French recommendations, which specify that 1 year of undetectable PSA after prostatectomy is sufficient before prescribing replacement therapy. “This is clearly indicated in the recommendations for patients with a previous history of prostate cancer.”

Neither prostate cancer nor benign prostatic hyperplasia is a contraindication. According to the recommendations, the only contraindications to testosterone prescription are the following:

• Hematocrit > 54%
• Current breast or prostate cancer
• Cardiovascular event less than 3-6 months prior
• Trying to conceive

Cardiovascular Benefits

Another more commonly used argument by general practitioners and endocrinologists to justify their reluctance to prescribe testosterone is the risk to cardiovascular health. In early 2010, a series of American studies alerted clinicians to this risk when taking testosterone. Since then, other studies have had reassuring findings.

In response to the alert issued by the United States, the European Medicines Agency specified that “the data are not sufficient for a warning,” before the American Heart Association colleagues concluded that testosterone should only be avoided in the first 6 months following a severe cardiovascular event.

Conversely, in 2021, the European Society of Cardiology put forward the benefits of testosterone in an article in favor of replacement therapy to prevent cardiovascular risk. In particular, the hormone is thought to have a beneficial effect on arterial stiffness, the appearance of calcified plaques, and coronary artery dilatation.

The final hurdle to overcome before a testosterone prescription is filled relates to patients themselves, who often regard such treatment unfavorably. Many wrongly believe that androgens are hormones that “increase the risk of cancer, make you aggressive, cause weight gain, lead to hair loss, and cause body hair growth,” said Dr. Huygue.

Finally, breaks in the supply chain for Androtardyl, the only injectable form available for reimbursement by French social security schemes, were reported in the country in 2023, said Dr. Huygue. This situation only complicates further the prescription and use of testosterone replacement therapy.
 

Which Supplement?

Testosterone replacement therapies are available on the market in the following formulations:

Via transcutaneous administration: Testosterone-based gels, not covered by the French social security system (Androgel and Fortigel), to be applied daily. Users must be careful to avoid any potential transfer of the product to women or children in case of contact with the site after application.

Via an injection: Androtardyl (testosterone enanthate), covered by French social security, to be administered intramuscularly once a month. Nebido (testosterone undecanoate), not covered by French social security, with a more beneficial bioavailability profile, to be administered once every 3 months.

Pantestone (testosterone undecanoate), administered orally, is not marketed since 2021. It had the major disadvantage of requiring a high-fat diet to ensure optimal absorption.

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

“You have psoriasis,” I say all the time. I mean it when I say it, of course. But I don’t always to the same degree. Sometimes I’m trying to say, “You probably have psoriasis.” Other times I mean, “You most definitely have psoriasis.” I rarely use those terms though.

One 36-year-old man with a flaky scalp and scaly elbows wasn’t satisfied with my assessment. His dad has psoriasis. So does his older brother. He was in to see me to find out if he had psoriasis too. “Probably” was what I gave him. He pushed back, “What percent chance?” That’s a good question — must be an engineer. I’m unsure.

Kaiser Permanente

With the exception of the poker players, our species is notoriously bad at probabilities. We’re wired to notice the significance of events, but terrible at understanding their likelihood. This is salient in lottery ticket holders and some NFL offensive coordinators who persist despite very long odds of things working out. It’s also reflected in the language we use. Rarely do we say, there’s a sixty percent chance something will happen. Rather, we say, “it’s likely.” There are two problems here. One, we often misjudge the actual probability of something occurring and two, the terms we use are subjective and differences in interpretation can lead to misunderstandings.

Let’s take a look. A 55-year-old man with a chronic eczematous rash on his trunk and extremities is getting worse despite dupilumab. He recently had night sweats. Do you think he has atopic dermatitis or cutaneous T-cell lymphoma? If you had to place a $100 bet, would you change your answer? Immanuel Kant thinks you would. In his “Critique of Pure Reason,” the German philosopher proposes that betting helps clarify the mind, an antidote to brashness. The example Kant uses is of a physician who observes a patient and concludes he has phthisis (tuberculosis), but we really don’t know if the physician is confident. Kant proposes that if he had to bet on his conclusion, then we’d have insight into just how convinced he is of phthisis. So, what’s your bet?

If you’re a bad poker player, then you might bet he has cutaneous T-cell lymphoma. However, not having any additional information, the smart call is atopic dermatitis, which has a base rate 1000-fold higher than CTCL. It is therefore more probable to be eczema even in a case that worsens despite dupilumab or with recent night sweats, both of which could be a result of common variables such as weather and COVID. Failure to account for the base rate is a mistake we physicians sometimes make. Economists rarely do. Try to think like one before answering a likelihood question.

For my scaly patient, we know psoriasis is common and so it’s likely he has it. The trouble is what “probably” means to me might mean something different to him. If you think about it, “probably” means something different even to me, depending on the situation. I might say I’ll probably go to Montana this summer and I’ll probably retire at 65. The actual likelihoods might be 95% and 70%. That’s a big difference. What about between probably and likely? Or possibly and maybe? Do they mean the same to you as to the person you’re speaking with? For much of the work we do, precise likelihoods aren’t critical. Yet, it can be important in decision making and in discussing probabilities, such as the risk of hepatitis on terbinafine or of melanoma recurrence after Mohs.

I told my patient “I say about a 70% chance you have psoriasis. I could do a biopsy today to confirm.” He thought for a second and asked, “What is the chance it’s psoriasis if the biopsy shows it?” “Eighty six percent,” I replied.

Seemed like a good bet to me.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

“You have psoriasis,” I say all the time. I mean it when I say it, of course. But I don’t always to the same degree. Sometimes I’m trying to say, “You probably have psoriasis.” Other times I mean, “You most definitely have psoriasis.” I rarely use those terms though.

One 36-year-old man with a flaky scalp and scaly elbows wasn’t satisfied with my assessment. His dad has psoriasis. So does his older brother. He was in to see me to find out if he had psoriasis too. “Probably” was what I gave him. He pushed back, “What percent chance?” That’s a good question — must be an engineer. I’m unsure.

Kaiser Permanente

With the exception of the poker players, our species is notoriously bad at probabilities. We’re wired to notice the significance of events, but terrible at understanding their likelihood. This is salient in lottery ticket holders and some NFL offensive coordinators who persist despite very long odds of things working out. It’s also reflected in the language we use. Rarely do we say, there’s a sixty percent chance something will happen. Rather, we say, “it’s likely.” There are two problems here. One, we often misjudge the actual probability of something occurring and two, the terms we use are subjective and differences in interpretation can lead to misunderstandings.

Let’s take a look. A 55-year-old man with a chronic eczematous rash on his trunk and extremities is getting worse despite dupilumab. He recently had night sweats. Do you think he has atopic dermatitis or cutaneous T-cell lymphoma? If you had to place a $100 bet, would you change your answer? Immanuel Kant thinks you would. In his “Critique of Pure Reason,” the German philosopher proposes that betting helps clarify the mind, an antidote to brashness. The example Kant uses is of a physician who observes a patient and concludes he has phthisis (tuberculosis), but we really don’t know if the physician is confident. Kant proposes that if he had to bet on his conclusion, then we’d have insight into just how convinced he is of phthisis. So, what’s your bet?

If you’re a bad poker player, then you might bet he has cutaneous T-cell lymphoma. However, not having any additional information, the smart call is atopic dermatitis, which has a base rate 1000-fold higher than CTCL. It is therefore more probable to be eczema even in a case that worsens despite dupilumab or with recent night sweats, both of which could be a result of common variables such as weather and COVID. Failure to account for the base rate is a mistake we physicians sometimes make. Economists rarely do. Try to think like one before answering a likelihood question.

For my scaly patient, we know psoriasis is common and so it’s likely he has it. The trouble is what “probably” means to me might mean something different to him. If you think about it, “probably” means something different even to me, depending on the situation. I might say I’ll probably go to Montana this summer and I’ll probably retire at 65. The actual likelihoods might be 95% and 70%. That’s a big difference. What about between probably and likely? Or possibly and maybe? Do they mean the same to you as to the person you’re speaking with? For much of the work we do, precise likelihoods aren’t critical. Yet, it can be important in decision making and in discussing probabilities, such as the risk of hepatitis on terbinafine or of melanoma recurrence after Mohs.

I told my patient “I say about a 70% chance you have psoriasis. I could do a biopsy today to confirm.” He thought for a second and asked, “What is the chance it’s psoriasis if the biopsy shows it?” “Eighty six percent,” I replied.

Seemed like a good bet to me.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

“You have psoriasis,” I say all the time. I mean it when I say it, of course. But I don’t always to the same degree. Sometimes I’m trying to say, “You probably have psoriasis.” Other times I mean, “You most definitely have psoriasis.” I rarely use those terms though.

One 36-year-old man with a flaky scalp and scaly elbows wasn’t satisfied with my assessment. His dad has psoriasis. So does his older brother. He was in to see me to find out if he had psoriasis too. “Probably” was what I gave him. He pushed back, “What percent chance?” That’s a good question — must be an engineer. I’m unsure.

Kaiser Permanente

With the exception of the poker players, our species is notoriously bad at probabilities. We’re wired to notice the significance of events, but terrible at understanding their likelihood. This is salient in lottery ticket holders and some NFL offensive coordinators who persist despite very long odds of things working out. It’s also reflected in the language we use. Rarely do we say, there’s a sixty percent chance something will happen. Rather, we say, “it’s likely.” There are two problems here. One, we often misjudge the actual probability of something occurring and two, the terms we use are subjective and differences in interpretation can lead to misunderstandings.

Let’s take a look. A 55-year-old man with a chronic eczematous rash on his trunk and extremities is getting worse despite dupilumab. He recently had night sweats. Do you think he has atopic dermatitis or cutaneous T-cell lymphoma? If you had to place a $100 bet, would you change your answer? Immanuel Kant thinks you would. In his “Critique of Pure Reason,” the German philosopher proposes that betting helps clarify the mind, an antidote to brashness. The example Kant uses is of a physician who observes a patient and concludes he has phthisis (tuberculosis), but we really don’t know if the physician is confident. Kant proposes that if he had to bet on his conclusion, then we’d have insight into just how convinced he is of phthisis. So, what’s your bet?

If you’re a bad poker player, then you might bet he has cutaneous T-cell lymphoma. However, not having any additional information, the smart call is atopic dermatitis, which has a base rate 1000-fold higher than CTCL. It is therefore more probable to be eczema even in a case that worsens despite dupilumab or with recent night sweats, both of which could be a result of common variables such as weather and COVID. Failure to account for the base rate is a mistake we physicians sometimes make. Economists rarely do. Try to think like one before answering a likelihood question.

For my scaly patient, we know psoriasis is common and so it’s likely he has it. The trouble is what “probably” means to me might mean something different to him. If you think about it, “probably” means something different even to me, depending on the situation. I might say I’ll probably go to Montana this summer and I’ll probably retire at 65. The actual likelihoods might be 95% and 70%. That’s a big difference. What about between probably and likely? Or possibly and maybe? Do they mean the same to you as to the person you’re speaking with? For much of the work we do, precise likelihoods aren’t critical. Yet, it can be important in decision making and in discussing probabilities, such as the risk of hepatitis on terbinafine or of melanoma recurrence after Mohs.

I told my patient “I say about a 70% chance you have psoriasis. I could do a biopsy today to confirm.” He thought for a second and asked, “What is the chance it’s psoriasis if the biopsy shows it?” “Eighty six percent,” I replied.

Seemed like a good bet to me.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at [email protected].

This transcript has been edited for clarity.

According to the Centers for Disease Control and Prevention, the obesity prevalence in America was 41.9% between 2017 and 2020. Just 10 years ago, no state had an obesity prevalence above 35%.

Over the past 3 years, many patients gained weight during the COVID-19 pandemic as a result of adopting more sedentary lifestyles, staying at home, avoiding the gym owing to the potential for respiratory spread, and working remotely. For a long time, patients were avoiding attending social events and, as a result, were walking much less.

Today, gastroenterologists are hearing more of their patients ask for help with weight loss. Therefore, we wanted to provide a helpful guide with 10 recommendations for gastroenterologists and other physicians to help patients with obesity realize their goal of achieving weight loss.
 

1. Embracing the GLP-1 Revolution, With Some Caveats

Glucagon-like peptide-1 (GLP-1) receptor agonists have become a popular treatment for type 2 diabetes and weight loss. These medications, which are given as an injection either weekly or daily depending on the type, have helped patients achieve weight loss with tremendous success.

They work by stimulating the body to produce insulin, which in turn lowers blood sugar. GLP-1 receptor agonists also slow peristalsis and the movement of food from the stomach into the small bowel, which allows patients to eat less by feeling fuller for longer and decreasing hunger.

Two GLP-1 receptor agonists are approved by the US Food and Drug Administration (FDA) for weight loss in patients without diabetes: liraglutide (Saxenda) and semaglutide (Wegovy). There are also lower-dose versions of these active ingredients with the trade names Ozempic and Victoza, designed to help patients with diabetes achieve better glucose and A1c control. In November 2023, the FDA approved a new medication called tirzepatide (Zepbound), which is a glucose-dependent insulinotropic polypeptide (GIP) plus GLP-1 receptor agonist.

This is a very exciting time for the management of type 2 diabetes and weight loss. Gastroenterologists can work with endocrinologists and primary care physicians to help patients choose appropriate weight loss medications.

However, gastroenterologists should also be aware of common GLP-1 receptor agonist side effects, including nausea, vomiting, diarrhea, and — in severe cases — hypoglycemia. These medications can also cause pancreatitis, acute kidney injury, worsening diabetes-related retinopathy, tachycardia, headaches, indigestion, gastroparesis, bowel obstruction, or ileus. We don’t use these medications in patients with a family or personal history of medullary thyroid cancer or multiple endocrine neoplasia. Consider avoiding their use as well in patients with a personal history of pancreatitis.

Recently, the American Society of Anesthesiologists (ASA) suggested holding off on the use of GLP-1 receptor agonists prior to elective endoscopy procedures owing to case reports of aspiration. Gastroenterologists and anesthesiologists are working together to make esophagogastroduodenoscopy (EGD) and colonoscopy as safe as possible in patients taking these treatments.

According to the ASA recommendations, GLP-1 receptor agonists that are given at a daily dose should be held on the day of their procedure. Weekly-dose versions are supposed to be held for 1 week prior to colonoscopy or EGD. During EGD procedures, I also recommend keeping the head of the bed at a 45° angle to help prevent aspiration even further.

Gastroenterologists are eagerly awaiting additional studies to determine whether holding GLP-1 receptor agonists prior to endoscopy is really necessary. But for now, we recommend following the ASA guidelines.
 

2. Substituting Out Sugary Drinks

Gastroenterologists and primary care physicians constantly advise their patients to avoid consuming sugary drinks, such as soda, fruit juices, calorie-laden coffee drinks, sweetened tea, hot chocolate, and, of course, alcohol. Many of our patients drink three to six of these sugary drinks a day.

As a gastroenterologist, it’s important to counsel our overweight patients and obtain an accurate history about their daily and weekly consumption of excess calories.

Recommend substituting sugary drinks with water, unsweetened tea (either hot or cold), and coffee.

To prevent constipation, encourage patients to drink at least eight 8-ounce glasses of fluid per day. Drinking water, tea, and coffee can also help keep patients feeling fuller for longer and avoid those tempting snacks.
 

3. Adopting the Right Diet

Every day, I encourage my patients to avoid eating fried fatty foods and processed meats. We also advise patients to avoid junk food filled with carbohydrates and salt.

Instead, patients should try to eat a piece of fruit or some vegetables with every single meal, which keeps patients feeling fuller for longer, prevents diverticulitis from forming, and can even help prevent colon cancer.

Making small dietary changes can dramatically reduce daily calorie consumption, which adds up over time and can help patients lose weight in a safe way.

Meal prepping for the week ahead, perhaps on a Sunday, is a very simple way to eat more nutritious foods instead of constantly getting takeout and fast food.

Many of our patients have also successfully lost weight through intermittent fasting, although I recommend working with a nutritionist on this one.

A Mediterranean diet is also a great option.
 

4. Getting Active

I encourage patients to take daily walks, swim, play sports, take fitness classes, do yoga or Pilates, and use weights at a gym.

Exercise burns calories, which is great for our hearts, prevents hepatic steatosis, and helps relieve stress. Exercise also stimulates peristalsis, which can help our constipated patients achieve more regular bowel movements.

There are a few other things to keep in mind in this area. Try to avoid strenuous exercise right after eating, because this will help prevent both heartburn and gastroesophageal reflux disease (GERD).
 

5. Reducing Stomach Volume With a Gastric Balloon

A gastric balloon procedure is a temporary obesity treatment that helps patients lose weight by reducing the volume of the stomach so that they feel full more easily. This can be accomplished endoscopically through the mouth without the need for surgery.

Basically, a deflated balloon is placed through the mouth using an endoscope and advanced into the stomach by a gastroenterologist or surgeon. The balloon is inflated with salt water and can remain in the stomach for 6 months before it is removed.

This procedure can help patients feel full and consequently eat less, thereby leading to gradual and safe weight loss.
 

6. Using the Accordion Procedure

An endoscopic sleeve gastroplasty procedure, sometimes called an accordion procedure, is used for patients with a body mass index ≥ 30 when diet and exercise alone have failed. An EGD tube is equipped with small stitching instruments that are used to reduce the size of the stomach.

This procedure has less complications than open or laparoscopic surgery and can be reversed.
 

7. Injecting Botulinum Toxin

Another technique is having the gastroenterologist inject botulinum toxin into the stomach wall. This works by relaxing the stomach propulsion muscles, which delays gastric emptying so that patients feel fuller longer and more easily.

This approach is good for achieving moderate weight loss of approximately 5%-10% of body weight. It works best in combination with a good diet and exercise. The effects of the botulinum toxin can last for 3 months, and the procedure can be repeated every 6 months.
 

8. Adjusting Certain Lifestyle Factors

Gastroenterologists should also counsel our patients about exercise, stress management, and the importance of sleep to prevent overeating. Self-care is extremely important for patients. Walk, swim, lift weights, and play sports; I personally love basketball and tennis.

I also recommend allocating enough time for sleep each night. At least 7-9 hours of sleep is ideal. Good sleep hygiene can help keep a stable schedule. Create a comfortable bedroom that is free of disruptions like TV watching or playing on your phone or computer.

Gastroenterologists can provide simple instructions to their patients on how to achieve this. For example, unplug from electronics 30-60 minutes prior to sleep. Try also to avoid eating late at night, which will help patients prevent GERD and heartburn symptoms too.
 

9. Considering Orlistat as an Option

Orlistat is an oral over-the-counter lipase inhibitor that inhibits fat absorption in the intestines. This drug can interfere with the absorption of fat-soluble vitamins A, D, E, and K. Therefore, it’s important to take a multivitamin 2 hours before or 2 hours after taking orlistat.

However, orlistat can cause steatorrhea, so it’s often not our first choice.
 

10. Working With Dietitians

I highly recommend that gastroenterologists regularly refer patients to a registered dietitian for medical nutrition therapy. Dietitians help patients establish nutritional goals with calorie limits. I find that many of my patients like the nutritional counseling the dietitians provide, and this can even be done via telemedicine.

A dietitian will examine a patient’s eating habits and help them set weight loss goals that are both realistic and achievable. Having a dietitian motivate a patient through several clinic visits is important for success. A dietitian can plan how many calories a patient should consume in a day while maintaining food, protein, and vitamin intake.

With this therapy, many patients are able to lose approximately 1-1.5 pounds each week. A dietitian can help keep patients accountable for their weight loss goals. I encourage my patients to use their dietitian as a weight loss teacher and a coach who can personalize a diet plan that tastes great.

Some of our patients also have overlapping gastrointestinal issues, such as celiac disease or irritable bowel syndrome. Dietitians can also formulate diets that are great for these other diagnoses too.

There are also apps available on our phones to help with diet and weight loss.
 

Having a Difficult Conversation to Prevent Long-Term Disease

It’s important for gastroenterologists to work with patients to achieve weight loss. Addressing obesity is sometimes a difficult topic to bring up with patients, but it’s nonetheless very important.

Together, we can help treat obesity plus improve and prevent hepatic steatosis, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH). The estimated global prevalence of MASLD is 32% in adults, so gastroenterologists and hepatologists are working together to try to treat obesity and to prevent long-term liver disease.
 

Dr. Levy is a gastroenterologist at the University of Chicago. In 2017, Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of  colorectal cancer  screening campaigns. Levy, who recently gave a TEDx Talk about building health education campaigns using music and concerts, organizes Tune It Up: A Concert To Raise Colorectal Cancer Awareness with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

According to the Centers for Disease Control and Prevention, the obesity prevalence in America was 41.9% between 2017 and 2020. Just 10 years ago, no state had an obesity prevalence above 35%.

Over the past 3 years, many patients gained weight during the COVID-19 pandemic as a result of adopting more sedentary lifestyles, staying at home, avoiding the gym owing to the potential for respiratory spread, and working remotely. For a long time, patients were avoiding attending social events and, as a result, were walking much less.

Today, gastroenterologists are hearing more of their patients ask for help with weight loss. Therefore, we wanted to provide a helpful guide with 10 recommendations for gastroenterologists and other physicians to help patients with obesity realize their goal of achieving weight loss.
 

1. Embracing the GLP-1 Revolution, With Some Caveats

Glucagon-like peptide-1 (GLP-1) receptor agonists have become a popular treatment for type 2 diabetes and weight loss. These medications, which are given as an injection either weekly or daily depending on the type, have helped patients achieve weight loss with tremendous success.

They work by stimulating the body to produce insulin, which in turn lowers blood sugar. GLP-1 receptor agonists also slow peristalsis and the movement of food from the stomach into the small bowel, which allows patients to eat less by feeling fuller for longer and decreasing hunger.

Two GLP-1 receptor agonists are approved by the US Food and Drug Administration (FDA) for weight loss in patients without diabetes: liraglutide (Saxenda) and semaglutide (Wegovy). There are also lower-dose versions of these active ingredients with the trade names Ozempic and Victoza, designed to help patients with diabetes achieve better glucose and A1c control. In November 2023, the FDA approved a new medication called tirzepatide (Zepbound), which is a glucose-dependent insulinotropic polypeptide (GIP) plus GLP-1 receptor agonist.

This is a very exciting time for the management of type 2 diabetes and weight loss. Gastroenterologists can work with endocrinologists and primary care physicians to help patients choose appropriate weight loss medications.

However, gastroenterologists should also be aware of common GLP-1 receptor agonist side effects, including nausea, vomiting, diarrhea, and — in severe cases — hypoglycemia. These medications can also cause pancreatitis, acute kidney injury, worsening diabetes-related retinopathy, tachycardia, headaches, indigestion, gastroparesis, bowel obstruction, or ileus. We don’t use these medications in patients with a family or personal history of medullary thyroid cancer or multiple endocrine neoplasia. Consider avoiding their use as well in patients with a personal history of pancreatitis.

Recently, the American Society of Anesthesiologists (ASA) suggested holding off on the use of GLP-1 receptor agonists prior to elective endoscopy procedures owing to case reports of aspiration. Gastroenterologists and anesthesiologists are working together to make esophagogastroduodenoscopy (EGD) and colonoscopy as safe as possible in patients taking these treatments.

According to the ASA recommendations, GLP-1 receptor agonists that are given at a daily dose should be held on the day of their procedure. Weekly-dose versions are supposed to be held for 1 week prior to colonoscopy or EGD. During EGD procedures, I also recommend keeping the head of the bed at a 45° angle to help prevent aspiration even further.

Gastroenterologists are eagerly awaiting additional studies to determine whether holding GLP-1 receptor agonists prior to endoscopy is really necessary. But for now, we recommend following the ASA guidelines.
 

2. Substituting Out Sugary Drinks

Gastroenterologists and primary care physicians constantly advise their patients to avoid consuming sugary drinks, such as soda, fruit juices, calorie-laden coffee drinks, sweetened tea, hot chocolate, and, of course, alcohol. Many of our patients drink three to six of these sugary drinks a day.

As a gastroenterologist, it’s important to counsel our overweight patients and obtain an accurate history about their daily and weekly consumption of excess calories.

Recommend substituting sugary drinks with water, unsweetened tea (either hot or cold), and coffee.

To prevent constipation, encourage patients to drink at least eight 8-ounce glasses of fluid per day. Drinking water, tea, and coffee can also help keep patients feeling fuller for longer and avoid those tempting snacks.
 

3. Adopting the Right Diet

Every day, I encourage my patients to avoid eating fried fatty foods and processed meats. We also advise patients to avoid junk food filled with carbohydrates and salt.

Instead, patients should try to eat a piece of fruit or some vegetables with every single meal, which keeps patients feeling fuller for longer, prevents diverticulitis from forming, and can even help prevent colon cancer.

Making small dietary changes can dramatically reduce daily calorie consumption, which adds up over time and can help patients lose weight in a safe way.

Meal prepping for the week ahead, perhaps on a Sunday, is a very simple way to eat more nutritious foods instead of constantly getting takeout and fast food.

Many of our patients have also successfully lost weight through intermittent fasting, although I recommend working with a nutritionist on this one.

A Mediterranean diet is also a great option.
 

4. Getting Active

I encourage patients to take daily walks, swim, play sports, take fitness classes, do yoga or Pilates, and use weights at a gym.

Exercise burns calories, which is great for our hearts, prevents hepatic steatosis, and helps relieve stress. Exercise also stimulates peristalsis, which can help our constipated patients achieve more regular bowel movements.

There are a few other things to keep in mind in this area. Try to avoid strenuous exercise right after eating, because this will help prevent both heartburn and gastroesophageal reflux disease (GERD).
 

5. Reducing Stomach Volume With a Gastric Balloon

A gastric balloon procedure is a temporary obesity treatment that helps patients lose weight by reducing the volume of the stomach so that they feel full more easily. This can be accomplished endoscopically through the mouth without the need for surgery.

Basically, a deflated balloon is placed through the mouth using an endoscope and advanced into the stomach by a gastroenterologist or surgeon. The balloon is inflated with salt water and can remain in the stomach for 6 months before it is removed.

This procedure can help patients feel full and consequently eat less, thereby leading to gradual and safe weight loss.
 

6. Using the Accordion Procedure

An endoscopic sleeve gastroplasty procedure, sometimes called an accordion procedure, is used for patients with a body mass index ≥ 30 when diet and exercise alone have failed. An EGD tube is equipped with small stitching instruments that are used to reduce the size of the stomach.

This procedure has less complications than open or laparoscopic surgery and can be reversed.
 

7. Injecting Botulinum Toxin

Another technique is having the gastroenterologist inject botulinum toxin into the stomach wall. This works by relaxing the stomach propulsion muscles, which delays gastric emptying so that patients feel fuller longer and more easily.

This approach is good for achieving moderate weight loss of approximately 5%-10% of body weight. It works best in combination with a good diet and exercise. The effects of the botulinum toxin can last for 3 months, and the procedure can be repeated every 6 months.
 

8. Adjusting Certain Lifestyle Factors

Gastroenterologists should also counsel our patients about exercise, stress management, and the importance of sleep to prevent overeating. Self-care is extremely important for patients. Walk, swim, lift weights, and play sports; I personally love basketball and tennis.

I also recommend allocating enough time for sleep each night. At least 7-9 hours of sleep is ideal. Good sleep hygiene can help keep a stable schedule. Create a comfortable bedroom that is free of disruptions like TV watching or playing on your phone or computer.

Gastroenterologists can provide simple instructions to their patients on how to achieve this. For example, unplug from electronics 30-60 minutes prior to sleep. Try also to avoid eating late at night, which will help patients prevent GERD and heartburn symptoms too.
 

9. Considering Orlistat as an Option

Orlistat is an oral over-the-counter lipase inhibitor that inhibits fat absorption in the intestines. This drug can interfere with the absorption of fat-soluble vitamins A, D, E, and K. Therefore, it’s important to take a multivitamin 2 hours before or 2 hours after taking orlistat.

However, orlistat can cause steatorrhea, so it’s often not our first choice.
 

10. Working With Dietitians

I highly recommend that gastroenterologists regularly refer patients to a registered dietitian for medical nutrition therapy. Dietitians help patients establish nutritional goals with calorie limits. I find that many of my patients like the nutritional counseling the dietitians provide, and this can even be done via telemedicine.

A dietitian will examine a patient’s eating habits and help them set weight loss goals that are both realistic and achievable. Having a dietitian motivate a patient through several clinic visits is important for success. A dietitian can plan how many calories a patient should consume in a day while maintaining food, protein, and vitamin intake.

With this therapy, many patients are able to lose approximately 1-1.5 pounds each week. A dietitian can help keep patients accountable for their weight loss goals. I encourage my patients to use their dietitian as a weight loss teacher and a coach who can personalize a diet plan that tastes great.

Some of our patients also have overlapping gastrointestinal issues, such as celiac disease or irritable bowel syndrome. Dietitians can also formulate diets that are great for these other diagnoses too.

There are also apps available on our phones to help with diet and weight loss.
 

Having a Difficult Conversation to Prevent Long-Term Disease

It’s important for gastroenterologists to work with patients to achieve weight loss. Addressing obesity is sometimes a difficult topic to bring up with patients, but it’s nonetheless very important.

Together, we can help treat obesity plus improve and prevent hepatic steatosis, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH). The estimated global prevalence of MASLD is 32% in adults, so gastroenterologists and hepatologists are working together to try to treat obesity and to prevent long-term liver disease.
 

Dr. Levy is a gastroenterologist at the University of Chicago. In 2017, Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of  colorectal cancer  screening campaigns. Levy, who recently gave a TEDx Talk about building health education campaigns using music and concerts, organizes Tune It Up: A Concert To Raise Colorectal Cancer Awareness with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

According to the Centers for Disease Control and Prevention, the obesity prevalence in America was 41.9% between 2017 and 2020. Just 10 years ago, no state had an obesity prevalence above 35%.

Over the past 3 years, many patients gained weight during the COVID-19 pandemic as a result of adopting more sedentary lifestyles, staying at home, avoiding the gym owing to the potential for respiratory spread, and working remotely. For a long time, patients were avoiding attending social events and, as a result, were walking much less.

Today, gastroenterologists are hearing more of their patients ask for help with weight loss. Therefore, we wanted to provide a helpful guide with 10 recommendations for gastroenterologists and other physicians to help patients with obesity realize their goal of achieving weight loss.
 

1. Embracing the GLP-1 Revolution, With Some Caveats

Glucagon-like peptide-1 (GLP-1) receptor agonists have become a popular treatment for type 2 diabetes and weight loss. These medications, which are given as an injection either weekly or daily depending on the type, have helped patients achieve weight loss with tremendous success.

They work by stimulating the body to produce insulin, which in turn lowers blood sugar. GLP-1 receptor agonists also slow peristalsis and the movement of food from the stomach into the small bowel, which allows patients to eat less by feeling fuller for longer and decreasing hunger.

Two GLP-1 receptor agonists are approved by the US Food and Drug Administration (FDA) for weight loss in patients without diabetes: liraglutide (Saxenda) and semaglutide (Wegovy). There are also lower-dose versions of these active ingredients with the trade names Ozempic and Victoza, designed to help patients with diabetes achieve better glucose and A1c control. In November 2023, the FDA approved a new medication called tirzepatide (Zepbound), which is a glucose-dependent insulinotropic polypeptide (GIP) plus GLP-1 receptor agonist.

This is a very exciting time for the management of type 2 diabetes and weight loss. Gastroenterologists can work with endocrinologists and primary care physicians to help patients choose appropriate weight loss medications.

However, gastroenterologists should also be aware of common GLP-1 receptor agonist side effects, including nausea, vomiting, diarrhea, and — in severe cases — hypoglycemia. These medications can also cause pancreatitis, acute kidney injury, worsening diabetes-related retinopathy, tachycardia, headaches, indigestion, gastroparesis, bowel obstruction, or ileus. We don’t use these medications in patients with a family or personal history of medullary thyroid cancer or multiple endocrine neoplasia. Consider avoiding their use as well in patients with a personal history of pancreatitis.

Recently, the American Society of Anesthesiologists (ASA) suggested holding off on the use of GLP-1 receptor agonists prior to elective endoscopy procedures owing to case reports of aspiration. Gastroenterologists and anesthesiologists are working together to make esophagogastroduodenoscopy (EGD) and colonoscopy as safe as possible in patients taking these treatments.

According to the ASA recommendations, GLP-1 receptor agonists that are given at a daily dose should be held on the day of their procedure. Weekly-dose versions are supposed to be held for 1 week prior to colonoscopy or EGD. During EGD procedures, I also recommend keeping the head of the bed at a 45° angle to help prevent aspiration even further.

Gastroenterologists are eagerly awaiting additional studies to determine whether holding GLP-1 receptor agonists prior to endoscopy is really necessary. But for now, we recommend following the ASA guidelines.
 

2. Substituting Out Sugary Drinks

Gastroenterologists and primary care physicians constantly advise their patients to avoid consuming sugary drinks, such as soda, fruit juices, calorie-laden coffee drinks, sweetened tea, hot chocolate, and, of course, alcohol. Many of our patients drink three to six of these sugary drinks a day.

As a gastroenterologist, it’s important to counsel our overweight patients and obtain an accurate history about their daily and weekly consumption of excess calories.

Recommend substituting sugary drinks with water, unsweetened tea (either hot or cold), and coffee.

To prevent constipation, encourage patients to drink at least eight 8-ounce glasses of fluid per day. Drinking water, tea, and coffee can also help keep patients feeling fuller for longer and avoid those tempting snacks.
 

3. Adopting the Right Diet

Every day, I encourage my patients to avoid eating fried fatty foods and processed meats. We also advise patients to avoid junk food filled with carbohydrates and salt.

Instead, patients should try to eat a piece of fruit or some vegetables with every single meal, which keeps patients feeling fuller for longer, prevents diverticulitis from forming, and can even help prevent colon cancer.

Making small dietary changes can dramatically reduce daily calorie consumption, which adds up over time and can help patients lose weight in a safe way.

Meal prepping for the week ahead, perhaps on a Sunday, is a very simple way to eat more nutritious foods instead of constantly getting takeout and fast food.

Many of our patients have also successfully lost weight through intermittent fasting, although I recommend working with a nutritionist on this one.

A Mediterranean diet is also a great option.
 

4. Getting Active

I encourage patients to take daily walks, swim, play sports, take fitness classes, do yoga or Pilates, and use weights at a gym.

Exercise burns calories, which is great for our hearts, prevents hepatic steatosis, and helps relieve stress. Exercise also stimulates peristalsis, which can help our constipated patients achieve more regular bowel movements.

There are a few other things to keep in mind in this area. Try to avoid strenuous exercise right after eating, because this will help prevent both heartburn and gastroesophageal reflux disease (GERD).
 

5. Reducing Stomach Volume With a Gastric Balloon

A gastric balloon procedure is a temporary obesity treatment that helps patients lose weight by reducing the volume of the stomach so that they feel full more easily. This can be accomplished endoscopically through the mouth without the need for surgery.

Basically, a deflated balloon is placed through the mouth using an endoscope and advanced into the stomach by a gastroenterologist or surgeon. The balloon is inflated with salt water and can remain in the stomach for 6 months before it is removed.

This procedure can help patients feel full and consequently eat less, thereby leading to gradual and safe weight loss.
 

6. Using the Accordion Procedure

An endoscopic sleeve gastroplasty procedure, sometimes called an accordion procedure, is used for patients with a body mass index ≥ 30 when diet and exercise alone have failed. An EGD tube is equipped with small stitching instruments that are used to reduce the size of the stomach.

This procedure has less complications than open or laparoscopic surgery and can be reversed.
 

7. Injecting Botulinum Toxin

Another technique is having the gastroenterologist inject botulinum toxin into the stomach wall. This works by relaxing the stomach propulsion muscles, which delays gastric emptying so that patients feel fuller longer and more easily.

This approach is good for achieving moderate weight loss of approximately 5%-10% of body weight. It works best in combination with a good diet and exercise. The effects of the botulinum toxin can last for 3 months, and the procedure can be repeated every 6 months.
 

8. Adjusting Certain Lifestyle Factors

Gastroenterologists should also counsel our patients about exercise, stress management, and the importance of sleep to prevent overeating. Self-care is extremely important for patients. Walk, swim, lift weights, and play sports; I personally love basketball and tennis.

I also recommend allocating enough time for sleep each night. At least 7-9 hours of sleep is ideal. Good sleep hygiene can help keep a stable schedule. Create a comfortable bedroom that is free of disruptions like TV watching or playing on your phone or computer.

Gastroenterologists can provide simple instructions to their patients on how to achieve this. For example, unplug from electronics 30-60 minutes prior to sleep. Try also to avoid eating late at night, which will help patients prevent GERD and heartburn symptoms too.
 

9. Considering Orlistat as an Option

Orlistat is an oral over-the-counter lipase inhibitor that inhibits fat absorption in the intestines. This drug can interfere with the absorption of fat-soluble vitamins A, D, E, and K. Therefore, it’s important to take a multivitamin 2 hours before or 2 hours after taking orlistat.

However, orlistat can cause steatorrhea, so it’s often not our first choice.
 

10. Working With Dietitians

I highly recommend that gastroenterologists regularly refer patients to a registered dietitian for medical nutrition therapy. Dietitians help patients establish nutritional goals with calorie limits. I find that many of my patients like the nutritional counseling the dietitians provide, and this can even be done via telemedicine.

A dietitian will examine a patient’s eating habits and help them set weight loss goals that are both realistic and achievable. Having a dietitian motivate a patient through several clinic visits is important for success. A dietitian can plan how many calories a patient should consume in a day while maintaining food, protein, and vitamin intake.

With this therapy, many patients are able to lose approximately 1-1.5 pounds each week. A dietitian can help keep patients accountable for their weight loss goals. I encourage my patients to use their dietitian as a weight loss teacher and a coach who can personalize a diet plan that tastes great.

Some of our patients also have overlapping gastrointestinal issues, such as celiac disease or irritable bowel syndrome. Dietitians can also formulate diets that are great for these other diagnoses too.

There are also apps available on our phones to help with diet and weight loss.
 

Having a Difficult Conversation to Prevent Long-Term Disease

It’s important for gastroenterologists to work with patients to achieve weight loss. Addressing obesity is sometimes a difficult topic to bring up with patients, but it’s nonetheless very important.

Together, we can help treat obesity plus improve and prevent hepatic steatosis, metabolic dysfunction–associated steatotic liver disease (MASLD), and metabolic dysfunction–associated steatohepatitis (MASH). The estimated global prevalence of MASLD is 32% in adults, so gastroenterologists and hepatologists are working together to try to treat obesity and to prevent long-term liver disease.
 

Dr. Levy is a gastroenterologist at the University of Chicago. In 2017, Levy, a previous Fulbright Fellow in France, also started a gastroenterology clinic for refugees resettling in Chicago. His clinical projects focus on the development of  colorectal cancer  screening campaigns. Levy, who recently gave a TEDx Talk about building health education campaigns using music and concerts, organizes Tune It Up: A Concert To Raise Colorectal Cancer Awareness with the American College of Gastroenterology (ACG). He frequently publishes on a variety of gastroenterology topics and serves on ACG’s Public Relations Committee and FDA-Related Matters Committee. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

In middle-aged and older men with hypogonadism, excluding those at high prostate cancer risk, testosterone replacement therapy (TRT) showed low rates of adverse prostate events, including cancer.

METHODOLOGY:

• Uncertainty and concern exist about a link between prostate cancer risk and testosterone levels. Most professional society guidelines recommend against TRT in men with a history of or an increased risk for prostate cancer.
• The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men  included 5204 men (ages 45-80, 17% Black, 80% White), randomly assigned to receive testosterone gel or placebo.
• Men with a history of cardiovascular disease or increased cardiovascular risk were evaluated to exclude those at increased prostate cancer risk (fasting testosterone < 300 ng/dL, ≥ 1 hypogonadal symptoms).
• The primary prostate safety endpoint was high-grade prostate cancer incidence (Gleason score, ≥ 4 + 3).
• Secondary endpoints were incidences of any prostate cancer, acute urinary retention, invasive procedure for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

• During 14,304 person-years of follow-up, high-grade prostate cancer incidence did not differ significantly between the TRT and placebo (0.19% vs 0.12%; P = .51) groups.
• The incidences of prostate cancer, acute urinary retention, invasive procedures for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms were also similar between the groups.
• TRT did not lead to an increase in lower urinary tract symptoms.
• The increase in prostate-specific antigen (PSA) levels was higher in the TRT group than in the placebo group (P < .001). However, the between-group difference did not widen after 12 months.

IN PRACTICE:

For “clinicians and patients who are considering testosterone replacement therapy for hypogonadism,” wrote the authors, “the study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, led the study. It was published online in JAMA Network Open.

LIMITATIONS:

• The study findings do not apply to men with known prostate cancer or higher PSA values or those without confirmed hypogonadism.
• Although the TRAVERSE study was longer than many contemporary trials, carcinogens may require many years to induce malignant neoplasms.
• The trial’s structured evaluation of men after PSA testing did not include prostate imaging or other biomarker tests, which could affect the decision to perform a biopsy.

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corp, and Upsher-Smith Laboratories. Mr. Bhasin and two coauthors declared receiving grants, consulting and personal fees, and other ties with pharmaceutical and device companies and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

In middle-aged and older men with hypogonadism, excluding those at high prostate cancer risk, testosterone replacement therapy (TRT) showed low rates of adverse prostate events, including cancer.

METHODOLOGY:

• Uncertainty and concern exist about a link between prostate cancer risk and testosterone levels. Most professional society guidelines recommend against TRT in men with a history of or an increased risk for prostate cancer.
• The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men  included 5204 men (ages 45-80, 17% Black, 80% White), randomly assigned to receive testosterone gel or placebo.
• Men with a history of cardiovascular disease or increased cardiovascular risk were evaluated to exclude those at increased prostate cancer risk (fasting testosterone < 300 ng/dL, ≥ 1 hypogonadal symptoms).
• The primary prostate safety endpoint was high-grade prostate cancer incidence (Gleason score, ≥ 4 + 3).
• Secondary endpoints were incidences of any prostate cancer, acute urinary retention, invasive procedure for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

• During 14,304 person-years of follow-up, high-grade prostate cancer incidence did not differ significantly between the TRT and placebo (0.19% vs 0.12%; P = .51) groups.
• The incidences of prostate cancer, acute urinary retention, invasive procedures for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms were also similar between the groups.
• TRT did not lead to an increase in lower urinary tract symptoms.
• The increase in prostate-specific antigen (PSA) levels was higher in the TRT group than in the placebo group (P < .001). However, the between-group difference did not widen after 12 months.

IN PRACTICE:

For “clinicians and patients who are considering testosterone replacement therapy for hypogonadism,” wrote the authors, “the study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, led the study. It was published online in JAMA Network Open.

LIMITATIONS:

• The study findings do not apply to men with known prostate cancer or higher PSA values or those without confirmed hypogonadism.
• Although the TRAVERSE study was longer than many contemporary trials, carcinogens may require many years to induce malignant neoplasms.
• The trial’s structured evaluation of men after PSA testing did not include prostate imaging or other biomarker tests, which could affect the decision to perform a biopsy.

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corp, and Upsher-Smith Laboratories. Mr. Bhasin and two coauthors declared receiving grants, consulting and personal fees, and other ties with pharmaceutical and device companies and other sources.

A version of this article appeared on Medscape.com.

TOPLINE:

In middle-aged and older men with hypogonadism, excluding those at high prostate cancer risk, testosterone replacement therapy (TRT) showed low rates of adverse prostate events, including cancer.

METHODOLOGY:

• Uncertainty and concern exist about a link between prostate cancer risk and testosterone levels. Most professional society guidelines recommend against TRT in men with a history of or an increased risk for prostate cancer.
• The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men  included 5204 men (ages 45-80, 17% Black, 80% White), randomly assigned to receive testosterone gel or placebo.
• Men with a history of cardiovascular disease or increased cardiovascular risk were evaluated to exclude those at increased prostate cancer risk (fasting testosterone < 300 ng/dL, ≥ 1 hypogonadal symptoms).
• The primary prostate safety endpoint was high-grade prostate cancer incidence (Gleason score, ≥ 4 + 3).
• Secondary endpoints were incidences of any prostate cancer, acute urinary retention, invasive procedure for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms.

TAKEAWAY:

• During 14,304 person-years of follow-up, high-grade prostate cancer incidence did not differ significantly between the TRT and placebo (0.19% vs 0.12%; P = .51) groups.
• The incidences of prostate cancer, acute urinary retention, invasive procedures for benign prostatic hyperplasia, prostate biopsy, and new pharmacologic treatment for lower urinary tract symptoms were also similar between the groups.
• TRT did not lead to an increase in lower urinary tract symptoms.
• The increase in prostate-specific antigen (PSA) levels was higher in the TRT group than in the placebo group (P < .001). However, the between-group difference did not widen after 12 months.

IN PRACTICE:

For “clinicians and patients who are considering testosterone replacement therapy for hypogonadism,” wrote the authors, “the study’s findings will facilitate a more informed appraisal of the potential prostate risks of testosterone replacement therapy.”

SOURCE:

Shalender Bhasin, MB, BS, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, led the study. It was published online in JAMA Network Open.

LIMITATIONS:

• The study findings do not apply to men with known prostate cancer or higher PSA values or those without confirmed hypogonadism.
• Although the TRAVERSE study was longer than many contemporary trials, carcinogens may require many years to induce malignant neoplasms.
• The trial’s structured evaluation of men after PSA testing did not include prostate imaging or other biomarker tests, which could affect the decision to perform a biopsy.

DISCLOSURES:

This study was funded by a consortium of testosterone manufacturers led by AbbVie Inc with additional financial support from Endo Pharmaceuticals, Acerus Pharmaceuticals Corp, and Upsher-Smith Laboratories. Mr. Bhasin and two coauthors declared receiving grants, consulting and personal fees, and other ties with pharmaceutical and device companies and other sources.

A version of this article appeared on Medscape.com.

The US Preventive Services Task Force (USPSTF) has published draft recommendations that 6-year-olds with obesity be lectured to about diet and exercise.

Never mind that there are no reproducible or scalable studies demonstrating durable and clinically meaningful benefits of this for adults let alone children. Never mind that children are not household decision-makers on matters of grocery shopping, cooking, or exercise. Never mind the corollary that many children so lectured who fail to see an impact on their weight will perceive that as their own personal failures. And of course, never mind that we’re privileged to be in an era with safe, effective, pharmacotherapeutic options for obesity. No. We must teach children it’s their fault if they’re fat. Because ultimately that’s what many of them will learn.

That’s not to say there’s no room for counseling. But with children as young as 6, that counseling should be delivered exclusively to their parents and caregivers. That counseling should focus as much if not more so on the impact of weight bias and the biological basis of obesity rather than diet and exercise, while explicitly teaching parents the means to discuss nutrition without risking their children feeling worse about themselves, increasing the risk for conflict over changes, or heightening their children’s chance of developing eating disorders or maladaptive relationships with food.

But back to the USPSTF’s actual recommendation for those 6 years old and up. They’re recommending “at least” 26 hours of lectures over a year-long interprofessional intervention. Putting aside the reality that this isn’t scalable time-wise or cost-wise to reach even a fraction of the roughly 15 million US children with obesity, there is also the issue of service provision. Because when it comes to obesity, if the intervention is purely educational, even if you want to believe there is a syllabus out there that would have a dramatic impact, its impact will vary wildly depending on the skill and approach of the service providers. This inconvenient truth is also the one that makes it impossible to meaningfully compare program outcomes even when they share the same content.

The USPSTF’s draft recommendations also explicitly avoid what the American Academy of Pediatrics has rightly embraced: the use where appropriate of medications or surgery. While opponents of the use of pharmacotherapy for childhood obesity tend to point to a lack of long-term data as rationale for its denial, something that the USPSTF has done, again, we have long-term data demonstrating a lack of scalable, clinically meaningful efficacy for service only based programs.

Childhood obesity is a flood and its ongoing current is relentless. Given its tremendous impact, especially at its extremes, on both physical and mental health, this is yet another example of systemic weight bias in action — it’s as if the USPSTF is recommending a swimming lesson–only approach while actively fearmongering, despite an absence of plausible mechanistic risk, about the long-term use of life jackets.

Dr. Freedhoff is associate professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. Dr. Freedhoff has disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

The US Preventive Services Task Force (USPSTF) has published draft recommendations that 6-year-olds with obesity be lectured to about diet and exercise.

Never mind that there are no reproducible or scalable studies demonstrating durable and clinically meaningful benefits of this for adults let alone children. Never mind that children are not household decision-makers on matters of grocery shopping, cooking, or exercise. Never mind the corollary that many children so lectured who fail to see an impact on their weight will perceive that as their own personal failures. And of course, never mind that we’re privileged to be in an era with safe, effective, pharmacotherapeutic options for obesity. No. We must teach children it’s their fault if they’re fat. Because ultimately that’s what many of them will learn.

That’s not to say there’s no room for counseling. But with children as young as 6, that counseling should be delivered exclusively to their parents and caregivers. That counseling should focus as much if not more so on the impact of weight bias and the biological basis of obesity rather than diet and exercise, while explicitly teaching parents the means to discuss nutrition without risking their children feeling worse about themselves, increasing the risk for conflict over changes, or heightening their children’s chance of developing eating disorders or maladaptive relationships with food.

But back to the USPSTF’s actual recommendation for those 6 years old and up. They’re recommending “at least” 26 hours of lectures over a year-long interprofessional intervention. Putting aside the reality that this isn’t scalable time-wise or cost-wise to reach even a fraction of the roughly 15 million US children with obesity, there is also the issue of service provision. Because when it comes to obesity, if the intervention is purely educational, even if you want to believe there is a syllabus out there that would have a dramatic impact, its impact will vary wildly depending on the skill and approach of the service providers. This inconvenient truth is also the one that makes it impossible to meaningfully compare program outcomes even when they share the same content.

The USPSTF’s draft recommendations also explicitly avoid what the American Academy of Pediatrics has rightly embraced: the use where appropriate of medications or surgery. While opponents of the use of pharmacotherapy for childhood obesity tend to point to a lack of long-term data as rationale for its denial, something that the USPSTF has done, again, we have long-term data demonstrating a lack of scalable, clinically meaningful efficacy for service only based programs.

Childhood obesity is a flood and its ongoing current is relentless. Given its tremendous impact, especially at its extremes, on both physical and mental health, this is yet another example of systemic weight bias in action — it’s as if the USPSTF is recommending a swimming lesson–only approach while actively fearmongering, despite an absence of plausible mechanistic risk, about the long-term use of life jackets.

Dr. Freedhoff is associate professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. Dr. Freedhoff has disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

The US Preventive Services Task Force (USPSTF) has published draft recommendations that 6-year-olds with obesity be lectured to about diet and exercise.

Never mind that there are no reproducible or scalable studies demonstrating durable and clinically meaningful benefits of this for adults let alone children. Never mind that children are not household decision-makers on matters of grocery shopping, cooking, or exercise. Never mind the corollary that many children so lectured who fail to see an impact on their weight will perceive that as their own personal failures. And of course, never mind that we’re privileged to be in an era with safe, effective, pharmacotherapeutic options for obesity. No. We must teach children it’s their fault if they’re fat. Because ultimately that’s what many of them will learn.

That’s not to say there’s no room for counseling. But with children as young as 6, that counseling should be delivered exclusively to their parents and caregivers. That counseling should focus as much if not more so on the impact of weight bias and the biological basis of obesity rather than diet and exercise, while explicitly teaching parents the means to discuss nutrition without risking their children feeling worse about themselves, increasing the risk for conflict over changes, or heightening their children’s chance of developing eating disorders or maladaptive relationships with food.

But back to the USPSTF’s actual recommendation for those 6 years old and up. They’re recommending “at least” 26 hours of lectures over a year-long interprofessional intervention. Putting aside the reality that this isn’t scalable time-wise or cost-wise to reach even a fraction of the roughly 15 million US children with obesity, there is also the issue of service provision. Because when it comes to obesity, if the intervention is purely educational, even if you want to believe there is a syllabus out there that would have a dramatic impact, its impact will vary wildly depending on the skill and approach of the service providers. This inconvenient truth is also the one that makes it impossible to meaningfully compare program outcomes even when they share the same content.

The USPSTF’s draft recommendations also explicitly avoid what the American Academy of Pediatrics has rightly embraced: the use where appropriate of medications or surgery. While opponents of the use of pharmacotherapy for childhood obesity tend to point to a lack of long-term data as rationale for its denial, something that the USPSTF has done, again, we have long-term data demonstrating a lack of scalable, clinically meaningful efficacy for service only based programs.

Childhood obesity is a flood and its ongoing current is relentless. Given its tremendous impact, especially at its extremes, on both physical and mental health, this is yet another example of systemic weight bias in action — it’s as if the USPSTF is recommending a swimming lesson–only approach while actively fearmongering, despite an absence of plausible mechanistic risk, about the long-term use of life jackets.

Dr. Freedhoff is associate professor, Department of Family Medicine, University of Ottawa; Medical Director, Bariatric Medical Institute, Ottawa, Ontario, Canada. Dr. Freedhoff has disclosed ties with Bariatric Medical Institute, Constant Health, and Novo Nordisk.

A version of this article appeared on Medscape.com.

Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.

But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor. 

In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.

Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds. 

Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results. 

The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis. 

The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.

“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.

Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).

“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.” 

Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.

According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.

When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said. 

“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.” 

Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures. 
 

A version of this article appeared on Medscape.com.

Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.

But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor. 

In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.

Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds. 

Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results. 

The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis. 

The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.

“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.

Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).

“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.” 

Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.

According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.

When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said. 

“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.” 

Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures. 
 

A version of this article appeared on Medscape.com.

Primary aldosteronism (PA) is a frequently overlooked yet common cause of secondary hypertension, presenting significant risk for cardiovascular morbidity and mortality.

But fewer than 4% of at-risk patients receive the recommended screening for PA, leaving a substantial gap in early detection and management, according to Adina F. Turcu, MD, MS, associate professor in endocrinology and internal medicine at University of Michigan Health in Ann Arbor. 

In response to this clinical challenge, Dr. Turcu and her colleagues developed a best-practice advisory (BPA) to identify patients who were at risk for PA and embedded it into electronic health record at University of Michigan ambulatory clinics. Her team found that use of the tool led to increased rates of screening for PA, particularly among primary care physicians.

Over a 15-month period, Dr. Turcu and her colleagues tested the BPA through a quality improvement study, identifying 14,603 unique candidates for PA screening, with a mean age of 65.5 years and a diverse representation of ethnic backgrounds. 

Notably, 48.1% of these candidates had treatment-resistant hypertension, 43.5% exhibited hypokalemia, 10.5% were younger than 35 years, and 3.1% had adrenal nodules. Of these candidates, 14.0% received orders for PA screening, with 70.5% completing the recommended screening within the system, and 17.4% receiving positive screening results. 

The study, conducted over 6 months in 2023, targeted adults with hypertension and at least one of the following: Those who took four or more antihypertensive medications, exhibited hypokalemia, were younger than age 35 years, or had adrenal nodules. Patients previously tested for PA were excluded from the analysis. 

The noninterruptive BPA was triggered during outpatient visits with clinicians who specialized in hypertension. The advisory would then offer an order set for PA screening and provide a link to interpretation guidance for results. Clinicians had the option to use, ignore, or decline the BPA.

“Although we were hoping for broader uptake of this EHR-embedded BPA, we were delighted to see an increase in PA screening rates to 14% of identified candidates as compared to an average of less than 3% in retrospective studies of similar populations, including in our own institution prior to implementing this BPA,” Dr. Turcu told this news organization.

Physician specialty played a crucial role in the utilization of the BPA. Internists and family medicine physicians accounted for the majority of screening orders, placing 40.0% and 28.1% of these, respectively. Family practitioners and internists predominantly used the embedded order set (80.3% and 68.9%, respectively).

“Hypertension often gets treated rather than screening for [causes of] secondary hypertension prior to treatment,” said Kaniksha Desai, MD, clinical associate professor and endocrinology quality director at Stanford University School of Medicine, Stanford, California, who was not involved in the research. But “primary hyperaldosteronism is a condition that can be treated surgically and has increased long term cardiovascular consequences if not identified. While guidelines recommend screening at-risk patients, this often can get lost in translation in clinical practice due to many factors, including time constraints and volume of patients.” 

Patients who did vs did not undergo screening were more likely to be women, Black, and younger than age 35 years. Additionally, the likelihood of screening was higher among patients with obesity and dyslipidemia, whereas it was lower in those with chronic kidney disease and established cardiovascular complications.

According to Dr. Turcu, the findings from this study suggest that noninterruptive BPAs, especially when integrated into primary care workflows, hold promise as effective tools for PA screening.

When coupled with artificial intelligence to optimize detection yield, these refined BPAs could significantly contribute to personalized care for hypertension, the investigators said. 

“Considering that in the United States almost one in two adults has hypertension, such automatized tools become instrumental to busy clinicians, particularly those in primary care,” Dr. Turcu said. “Our results indicate a promising opportunity to meaningfully improve PA awareness and enhance its diagnosis.” 

Dr. Turcu reported receiving grants from the National Heart, Lung, and Blood Institute and Doris Duke Foundation, served as an investigator in a CinCor Pharma clinical trial, and received financial support to her institution during the conduct of the study. Dr. Desai reported no relevant financial disclosures. 
 

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.

A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.

A1c level strongly predicts the risk of developing type 2 diabetes among adolescents with overweight or obesity, new data suggested.

In a large California healthcare database over a 10-year period, the incidence of type 2 diabetes was relatively low overall among adolescents with overweight and obesity. However, the risk increased with baseline A1c levels above 6.0% as well as in those with more severe obesity, women, and Asian or Pacific Islanders.

The new findings were published online in JAMA Network Open by pediatric endocrinologist Francis M. Hoe, MD, of Kaiser Permanente Roseville Medical Center, Roseville, California, and colleagues.

Previous studies have examined the incidence of type 2 diabetes among all youth, regardless of weight class. This is one of the first large population studies to examine the incidence and risk for type 2 diabetes by incremental level of A1c in a racially and ethnically diverse group of youth with overweight and obesity, Dr. Hoe told this news organization in an interview.

“This study was only possible to do because Kaiser Permanente Northern California has nearly 1 million pediatric members. The biggest thing we learned is that risk for type 2 diabetes is low in overweight and obese youth, especially those with an HbA1c less than 5.9%,” he said.
 

Zeroing in on Those at Greatest Risk for Type 2 Diabetes

Currently, the American Diabetes Association (ADA) recommends screening for type 2 diabetes in adolescents with overweight (body mass index [BMI], 85th percentile or greater) or obesity (≥ 95th) who have at least one additional risk factor, including family history of type 2 diabetes and Native American, Black, or Hispanic ethnicity. About one in four US adolescents qualify by those criteria, the authors noted in the paper.

And, as for adults, ADA recommends subsequent annual diabetes screening in youth identified as having “prediabetes,” that is, a A1c level between 5.7% and 6.5%.

The new study confirmed that adolescents with A1c in the upper end of the prediabetes range were at a greater risk for type 2 diabetes. But those individuals were the minority. Adolescents with overweight/obesity who had baseline A1c levels in the lower end of the prediabetes range, 5.7%-5.8%, accounted for two thirds of those with prediabetes in the study population and had a very low incidence of type 2 diabetes compared with those with higher A1c levels.

“Specifically, we found an annual type 2 diabetes incidence of 0.2% for HbA1c of 5.7%-5.8%, which is much lower than adults. These adolescents will likely benefit from lifestyle intervention. But because their risk of developing type 2 diabetes is lower, they probably don’t need to be screened annually, as currently recommended by the ADA,” Dr. Hoe said.

Similarly, he added, “since obesity severity was associated with a higher risk for type 2 diabetes, increases in BMI percentile should also prompt consideration of repeat diabetes screening.”
 

Large Database Allows for Detailed Findings

The study population was 74,552 adolescents aged 10-17 years with overweight or obesity, of whom 49.4% were male, 64.6% were younger than 15 years, and 73.1% had obesity. Only 21.6% were White, while 43.6% were Hispanic, 11.1% Black, and 17.6% Asian or Pacific Islander.

Nearly a quarter, 22.9%, had baseline A1c in the prediabetes range of 5.7%-6.4%. Mean A1c rose with BMI category from overweight to moderate to severe obesity (P < .001 for each comparison). Baseline A1c was highest (5.53%) in Black adolescents and lowest in White teens (5.38%), also significant differences by group (P < .001).

Of the total 698 who developed diabetes during the follow-up, 89.7% were classified as having type 2 diabetes, with a median 3.8 years from baseline to diagnosis.

The overall incidence rate of type 2 diabetes during the follow-up was 2.1 per 1000 person-years. As the baseline A1c rose from less than 5.5% to 6.0%, from 6.1% to 6.2%, and from 6.3% to 6.4%, those incidence rates were 0.8, 8.1, 21.8, and 68.9 per 1000 person-years, respectively.

In a multivariate analysis, compared to baseline A1c below 5.5%, increased risk was ninefold for A1c 5.9%-6.0%, 23-fold for 6.1%-6.2%, and 72-fold for 6.3%-6.4%.

The incidence rates were higher in female than in male adolescents (2.4 vs 1.8 per 1000 person-years) and increased by BMI category from 0.6 to 1.3 to 4.3 for those with overweight, moderate obesity, and severe obesity, respectively.

Type 2 diabetes incidence per 1000 person-years also varied by race and ethnicity, ranging from 1.3 for White adolescents to 3.0 for Asian or Pacific Islanders.

“We plan on further exploring the effect of the weight and BMI change over time and how that may affect type 2 diabetes risk,” Dr. Hoe told this news organization.

This study was supported by a grant from the Kaiser Permanente Northern California Community Health program. Dr. Hoe and his coauthors had no further disclosures.

A version of this article appeared on Medscape.com.

Intake of protein, especially from plants, in middle age is associated with higher odds of healthy aging and positive mental and physical health status in older women, a recent analysis of the Nurses’ Health Study (NHS) data suggests.

The study is said to be the first to examine the long-term impact of midlife protein consumption on later health status.

Writing in the American Journal of Clinical Nutrition, a team led by Andres V. Ardisson Korat, DSc, a nutritional epidemiologist at the USDA Human Nutrition Research Center on Aging at Tufts University in Boston, Massachusetts, found the following midlife protein–related odds ratios (ORs) for later healthy aging measured at ages 70-93.

For each 3% energy increment from various protein sources:

• 1.05 (95% confidence interval, 1.01-1.10) for total protein
• 1.07 (1.02-1.11) for animal protein
• 1.14 (1.06-1.23) for dairy protein
• 1.38 (1.24-1.54) for plant protein 

In substitution analyses, significant positive associations were observed for the isocaloric replacement of animal or dairy protein, carbohydrate, or fat with plant protein — with increased ORs for healthy aging of 1.22-1.58 for each 3% of energy replacement.

On the measure of physical function, for example, replacing calories from all macronutrient variables with equivalent calories from plant protein was associated with 20%-60% higher odds of having no physical function limitations. Plant protein was also associated with higher odds for good mental status.

“Other studies have looked at protein intake in older adults, but we felt midlife was a more relevant etiological window,” Dr. Ardisson Korat said in an interview. “Our findings generally align, however, with those of protein intake in older populations, which have shown that protein can reduce the risk of frailty.”

He added that the benefits of protein, especially from plant sources, would likely apply to men as well and increasing plant protein intake is not difficult. “If you want a snack during the day, eat a handful of nuts instead of potato chips,” he advised. And eating several meals a week featuring beans, peas, lentils, tofu, whole grains, or seeds is an easy way to boost dietary plant protein, which comes with health-promoting soluble and insoluble fiber as well as antioxidant and anti-inflammatory polyphenols and other phytochemicals.

Conversely, plant but not animal protein consumption in older adulthood was linked to a lower risk of frailty in a previous NHS trial.

Higher plant protein intake was associated with a better probability of achieving healthy aging defined by changes in functional impairments, self-reported health/vitality, mental health, and use of health services in the Spanish Seniors-Estudio Sobre Nutricion y Riesgo Cardiovascular.

In contrast, animal protein intake in middle adulthood has been linked to an increased risk of premature death from chronic diseases driven by cardiovascular disease mortality.

The present findings are consistent with those observed for protein intakes in older adulthood, Dr. Ardisson Korat said.

“This study underscores the health advantages for midlife adults consuming adequate dietary protein — particularly plant protein — as one component of pursuing a healthy lifestyle,” said Douglas R. Dirschl, MD, chair of orthopedic surgery at Baylor College of Medicine in Houston, Texas. Most Americans consume adequate amounts of protein, but according to Dr. Dirschl, who treats many older patients for osteoporotic fractures and other musculoskeletal conditions, many US diets are subpar in this nutrient.

While protein is essential for bone and muscle formation and maintenance, “a surprising number of Americans are protein deficient, even those who seem hale and are overweight,” he said.


 

Dietary Recommendations for Midlife Patients

Physicians should therefore advise midlife patients to meet or perhaps modestly exceed the recommended dietary allowance (RDA) for protein of 0.8 g/kg per day and to make plant protein a substantial component of daily dietary protein intake, Dr. Dirschl said.

Luke D. Kim, MD, MEd, a geriatrician at the Cleveland Clinic in Cleveland, Ohio, noted that patients with lower socioeconomic status or with difficulty in day-to-day functioning are likely to have suboptimal protein intake. Such patients may need encouragement to eat more protein. “But we should keep in mind that showing a higher associated odds ratio of better health with increased protein take does not mean causality,” he said.

According to Rachel L. Amdur, MD, an internist at Northwestern Medicine in Chicago, Illinois, the long-term follow-up data from the NHS are uniquely helpful. “Middle-aged persons may think they no longer need much dietary protein and need to be reminded. Sometimes eating carbohydrates is just easier,” she said in an interview. Physicians need to asses and counsel patients on nutrition at all stages of life. “As I tell my patients, it’s best to think of your future self now.”

In agreement is Louis J. Morledge, MD, an internist at Northwell Health in New York City. “I firmly counsel my patients about adequate and often increased protein intake in middle life. But this is always within a larger framework of overall nutritional health.” He added that middle-aged persons often find themselves “stuck in food ruts,” and one of his clinical focuses is to advise patients about the importance of healthier food choices so they can better adjust to mental, emotional, physical, and skeletal changes as they age.
 

Study Details

The NHS analysis drew on prospective data from 48,762 nurses under age 60 in 1984. Total protein, animal protein, dairy protein, and plant protein were derived from validated food-frequency questionnaires.

Adjusting for lifestyle, demographics, and health status, the investigators identified 3721 (7.6% of cohort) eligible participants. The mean age of participants at baseline was 48.6 years; 38.6% had body mass indexes (BMI; in kg/m²) greater than 25; 22.9% were current smokers; and 88.2% were married.

Healthy aging was defined as freedom from 11 major chronic diseases, good mental health, and no impairments in cognitive or physical function, as assessed in the 2014 or 2016 NHS participant questionnaires. Diseases/treatments included cancer, type 2 diabetes, myocardial infarction, coronary artery bypass graft or coronary angioplasty, congestive heart failure, stroke, kidney failure, chronic obstructive pulmonary disease, Parkinson disease, multiple sclerosis, and amyotrophic lateral sclerosis.

Mean total protein consumption as a percentage of energy was 18.3% (standard deviation 3%), slightly higher than the average 16% in the US diet. Of this, 13.3% derived from animals, 3.6% from dairy products, and 4.9% from plants.

Total protein intake was positively associated with higher education levels, being physically active, higher BMI, and a baseline history of hypertension and hypercholesterolemia. Conversely, total protein intake was inversely associated with intakes of total carbohydrates, nuts, alcohol, and sugar-sweetened beverages.

The associations between protein intake and healthy aging are complex and not fully understood, the authors stated.
 

Effects of Protein Intake

In studies of older adult populations lower protein intake has been associated with lean mass loss. Animal protein supplementation studies in older adults have shown lean mass gains potentially related to amino acid composition.

In terms of mechanisms, evidence suggests that protein-related activation of the rapamycin complex 1 pathway may play a role, the authors suggested. The activity of this signaling pathway decreases with age.

Rapamycin, a compound used to prevent organ transplant rejection, has been associated with delayed aging. In the body, dietary protein and exercise activate this pathway, thereby stimulating muscle protein synthesis and possibly improving physical function.

As for the differential associations of plant and animal protein on the chronic disease domain of the healthy aging phenotype, Dr. Ardisson Korat and coauthors said plant protein has been associated with favorable levels of important risk factors for cardiometabolic diseases, such as reduced LDL cholesterol, lower blood pressure, and insulin sensitivity, as well as decreased levels of proinflammatory markers.

Conversely, total and animal protein intakes have been positively associated with concentrations of insulin-like growth factor 1, which is implicated in the growth of malignant cells in breast and prostate tissue.

This study is the first step in evaluating the long-term health effect of protein intake in midlife, the relevant development window for most chronic conditions, the NHS study authors said. More research is needed, however, to corroborate the study findings in other populations and identify underlying mechanisms.

This study was supported by the USDA Agricultural Research Service and the National Institutes of Health. The authors reported no conflicts of interest. The commentators disclosed no relevant competing interests.

Intake of protein, especially from plants, in middle age is associated with higher odds of healthy aging and positive mental and physical health status in older women, a recent analysis of the Nurses’ Health Study (NHS) data suggests.

The study is said to be the first to examine the long-term impact of midlife protein consumption on later health status.

Writing in the American Journal of Clinical Nutrition, a team led by Andres V. Ardisson Korat, DSc, a nutritional epidemiologist at the USDA Human Nutrition Research Center on Aging at Tufts University in Boston, Massachusetts, found the following midlife protein–related odds ratios (ORs) for later healthy aging measured at ages 70-93.

For each 3% energy increment from various protein sources:

• 1.05 (95% confidence interval, 1.01-1.10) for total protein
• 1.07 (1.02-1.11) for animal protein
• 1.14 (1.06-1.23) for dairy protein
• 1.38 (1.24-1.54) for plant protein 

In substitution analyses, significant positive associations were observed for the isocaloric replacement of animal or dairy protein, carbohydrate, or fat with plant protein — with increased ORs for healthy aging of 1.22-1.58 for each 3% of energy replacement.

On the measure of physical function, for example, replacing calories from all macronutrient variables with equivalent calories from plant protein was associated with 20%-60% higher odds of having no physical function limitations. Plant protein was also associated with higher odds for good mental status.

“Other studies have looked at protein intake in older adults, but we felt midlife was a more relevant etiological window,” Dr. Ardisson Korat said in an interview. “Our findings generally align, however, with those of protein intake in older populations, which have shown that protein can reduce the risk of frailty.”

He added that the benefits of protein, especially from plant sources, would likely apply to men as well and increasing plant protein intake is not difficult. “If you want a snack during the day, eat a handful of nuts instead of potato chips,” he advised. And eating several meals a week featuring beans, peas, lentils, tofu, whole grains, or seeds is an easy way to boost dietary plant protein, which comes with health-promoting soluble and insoluble fiber as well as antioxidant and anti-inflammatory polyphenols and other phytochemicals.

Conversely, plant but not animal protein consumption in older adulthood was linked to a lower risk of frailty in a previous NHS trial.

Higher plant protein intake was associated with a better probability of achieving healthy aging defined by changes in functional impairments, self-reported health/vitality, mental health, and use of health services in the Spanish Seniors-Estudio Sobre Nutricion y Riesgo Cardiovascular.

In contrast, animal protein intake in middle adulthood has been linked to an increased risk of premature death from chronic diseases driven by cardiovascular disease mortality.

The present findings are consistent with those observed for protein intakes in older adulthood, Dr. Ardisson Korat said.

“This study underscores the health advantages for midlife adults consuming adequate dietary protein — particularly plant protein — as one component of pursuing a healthy lifestyle,” said Douglas R. Dirschl, MD, chair of orthopedic surgery at Baylor College of Medicine in Houston, Texas. Most Americans consume adequate amounts of protein, but according to Dr. Dirschl, who treats many older patients for osteoporotic fractures and other musculoskeletal conditions, many US diets are subpar in this nutrient.

While protein is essential for bone and muscle formation and maintenance, “a surprising number of Americans are protein deficient, even those who seem hale and are overweight,” he said.


 

Dietary Recommendations for Midlife Patients

Physicians should therefore advise midlife patients to meet or perhaps modestly exceed the recommended dietary allowance (RDA) for protein of 0.8 g/kg per day and to make plant protein a substantial component of daily dietary protein intake, Dr. Dirschl said.

Luke D. Kim, MD, MEd, a geriatrician at the Cleveland Clinic in Cleveland, Ohio, noted that patients with lower socioeconomic status or with difficulty in day-to-day functioning are likely to have suboptimal protein intake. Such patients may need encouragement to eat more protein. “But we should keep in mind that showing a higher associated odds ratio of better health with increased protein take does not mean causality,” he said.

According to Rachel L. Amdur, MD, an internist at Northwestern Medicine in Chicago, Illinois, the long-term follow-up data from the NHS are uniquely helpful. “Middle-aged persons may think they no longer need much dietary protein and need to be reminded. Sometimes eating carbohydrates is just easier,” she said in an interview. Physicians need to asses and counsel patients on nutrition at all stages of life. “As I tell my patients, it’s best to think of your future self now.”

In agreement is Louis J. Morledge, MD, an internist at Northwell Health in New York City. “I firmly counsel my patients about adequate and often increased protein intake in middle life. But this is always within a larger framework of overall nutritional health.” He added that middle-aged persons often find themselves “stuck in food ruts,” and one of his clinical focuses is to advise patients about the importance of healthier food choices so they can better adjust to mental, emotional, physical, and skeletal changes as they age.
 

Study Details

The NHS analysis drew on prospective data from 48,762 nurses under age 60 in 1984. Total protein, animal protein, dairy protein, and plant protein were derived from validated food-frequency questionnaires.

Adjusting for lifestyle, demographics, and health status, the investigators identified 3721 (7.6% of cohort) eligible participants. The mean age of participants at baseline was 48.6 years; 38.6% had body mass indexes (BMI; in kg/m²) greater than 25; 22.9% were current smokers; and 88.2% were married.

Healthy aging was defined as freedom from 11 major chronic diseases, good mental health, and no impairments in cognitive or physical function, as assessed in the 2014 or 2016 NHS participant questionnaires. Diseases/treatments included cancer, type 2 diabetes, myocardial infarction, coronary artery bypass graft or coronary angioplasty, congestive heart failure, stroke, kidney failure, chronic obstructive pulmonary disease, Parkinson disease, multiple sclerosis, and amyotrophic lateral sclerosis.

Mean total protein consumption as a percentage of energy was 18.3% (standard deviation 3%), slightly higher than the average 16% in the US diet. Of this, 13.3% derived from animals, 3.6% from dairy products, and 4.9% from plants.

Total protein intake was positively associated with higher education levels, being physically active, higher BMI, and a baseline history of hypertension and hypercholesterolemia. Conversely, total protein intake was inversely associated with intakes of total carbohydrates, nuts, alcohol, and sugar-sweetened beverages.

The associations between protein intake and healthy aging are complex and not fully understood, the authors stated.
 

Effects of Protein Intake

In studies of older adult populations lower protein intake has been associated with lean mass loss. Animal protein supplementation studies in older adults have shown lean mass gains potentially related to amino acid composition.

In terms of mechanisms, evidence suggests that protein-related activation of the rapamycin complex 1 pathway may play a role, the authors suggested. The activity of this signaling pathway decreases with age.

Rapamycin, a compound used to prevent organ transplant rejection, has been associated with delayed aging. In the body, dietary protein and exercise activate this pathway, thereby stimulating muscle protein synthesis and possibly improving physical function.

As for the differential associations of plant and animal protein on the chronic disease domain of the healthy aging phenotype, Dr. Ardisson Korat and coauthors said plant protein has been associated with favorable levels of important risk factors for cardiometabolic diseases, such as reduced LDL cholesterol, lower blood pressure, and insulin sensitivity, as well as decreased levels of proinflammatory markers.

Conversely, total and animal protein intakes have been positively associated with concentrations of insulin-like growth factor 1, which is implicated in the growth of malignant cells in breast and prostate tissue.

This study is the first step in evaluating the long-term health effect of protein intake in midlife, the relevant development window for most chronic conditions, the NHS study authors said. More research is needed, however, to corroborate the study findings in other populations and identify underlying mechanisms.

This study was supported by the USDA Agricultural Research Service and the National Institutes of Health. The authors reported no conflicts of interest. The commentators disclosed no relevant competing interests.

Intake of protein, especially from plants, in middle age is associated with higher odds of healthy aging and positive mental and physical health status in older women, a recent analysis of the Nurses’ Health Study (NHS) data suggests.

The study is said to be the first to examine the long-term impact of midlife protein consumption on later health status.

Writing in the American Journal of Clinical Nutrition, a team led by Andres V. Ardisson Korat, DSc, a nutritional epidemiologist at the USDA Human Nutrition Research Center on Aging at Tufts University in Boston, Massachusetts, found the following midlife protein–related odds ratios (ORs) for later healthy aging measured at ages 70-93.

For each 3% energy increment from various protein sources:

• 1.05 (95% confidence interval, 1.01-1.10) for total protein
• 1.07 (1.02-1.11) for animal protein
• 1.14 (1.06-1.23) for dairy protein
• 1.38 (1.24-1.54) for plant protein 

In substitution analyses, significant positive associations were observed for the isocaloric replacement of animal or dairy protein, carbohydrate, or fat with plant protein — with increased ORs for healthy aging of 1.22-1.58 for each 3% of energy replacement.

On the measure of physical function, for example, replacing calories from all macronutrient variables with equivalent calories from plant protein was associated with 20%-60% higher odds of having no physical function limitations. Plant protein was also associated with higher odds for good mental status.

“Other studies have looked at protein intake in older adults, but we felt midlife was a more relevant etiological window,” Dr. Ardisson Korat said in an interview. “Our findings generally align, however, with those of protein intake in older populations, which have shown that protein can reduce the risk of frailty.”

He added that the benefits of protein, especially from plant sources, would likely apply to men as well and increasing plant protein intake is not difficult. “If you want a snack during the day, eat a handful of nuts instead of potato chips,” he advised. And eating several meals a week featuring beans, peas, lentils, tofu, whole grains, or seeds is an easy way to boost dietary plant protein, which comes with health-promoting soluble and insoluble fiber as well as antioxidant and anti-inflammatory polyphenols and other phytochemicals.

Conversely, plant but not animal protein consumption in older adulthood was linked to a lower risk of frailty in a previous NHS trial.

Higher plant protein intake was associated with a better probability of achieving healthy aging defined by changes in functional impairments, self-reported health/vitality, mental health, and use of health services in the Spanish Seniors-Estudio Sobre Nutricion y Riesgo Cardiovascular.

In contrast, animal protein intake in middle adulthood has been linked to an increased risk of premature death from chronic diseases driven by cardiovascular disease mortality.

The present findings are consistent with those observed for protein intakes in older adulthood, Dr. Ardisson Korat said.

“This study underscores the health advantages for midlife adults consuming adequate dietary protein — particularly plant protein — as one component of pursuing a healthy lifestyle,” said Douglas R. Dirschl, MD, chair of orthopedic surgery at Baylor College of Medicine in Houston, Texas. Most Americans consume adequate amounts of protein, but according to Dr. Dirschl, who treats many older patients for osteoporotic fractures and other musculoskeletal conditions, many US diets are subpar in this nutrient.

While protein is essential for bone and muscle formation and maintenance, “a surprising number of Americans are protein deficient, even those who seem hale and are overweight,” he said.


 

Dietary Recommendations for Midlife Patients

Physicians should therefore advise midlife patients to meet or perhaps modestly exceed the recommended dietary allowance (RDA) for protein of 0.8 g/kg per day and to make plant protein a substantial component of daily dietary protein intake, Dr. Dirschl said.

Luke D. Kim, MD, MEd, a geriatrician at the Cleveland Clinic in Cleveland, Ohio, noted that patients with lower socioeconomic status or with difficulty in day-to-day functioning are likely to have suboptimal protein intake. Such patients may need encouragement to eat more protein. “But we should keep in mind that showing a higher associated odds ratio of better health with increased protein take does not mean causality,” he said.

According to Rachel L. Amdur, MD, an internist at Northwestern Medicine in Chicago, Illinois, the long-term follow-up data from the NHS are uniquely helpful. “Middle-aged persons may think they no longer need much dietary protein and need to be reminded. Sometimes eating carbohydrates is just easier,” she said in an interview. Physicians need to asses and counsel patients on nutrition at all stages of life. “As I tell my patients, it’s best to think of your future self now.”

In agreement is Louis J. Morledge, MD, an internist at Northwell Health in New York City. “I firmly counsel my patients about adequate and often increased protein intake in middle life. But this is always within a larger framework of overall nutritional health.” He added that middle-aged persons often find themselves “stuck in food ruts,” and one of his clinical focuses is to advise patients about the importance of healthier food choices so they can better adjust to mental, emotional, physical, and skeletal changes as they age.
 

Study Details

The NHS analysis drew on prospective data from 48,762 nurses under age 60 in 1984. Total protein, animal protein, dairy protein, and plant protein were derived from validated food-frequency questionnaires.

Adjusting for lifestyle, demographics, and health status, the investigators identified 3721 (7.6% of cohort) eligible participants. The mean age of participants at baseline was 48.6 years; 38.6% had body mass indexes (BMI; in kg/m²) greater than 25; 22.9% were current smokers; and 88.2% were married.

Healthy aging was defined as freedom from 11 major chronic diseases, good mental health, and no impairments in cognitive or physical function, as assessed in the 2014 or 2016 NHS participant questionnaires. Diseases/treatments included cancer, type 2 diabetes, myocardial infarction, coronary artery bypass graft or coronary angioplasty, congestive heart failure, stroke, kidney failure, chronic obstructive pulmonary disease, Parkinson disease, multiple sclerosis, and amyotrophic lateral sclerosis.

Mean total protein consumption as a percentage of energy was 18.3% (standard deviation 3%), slightly higher than the average 16% in the US diet. Of this, 13.3% derived from animals, 3.6% from dairy products, and 4.9% from plants.

Total protein intake was positively associated with higher education levels, being physically active, higher BMI, and a baseline history of hypertension and hypercholesterolemia. Conversely, total protein intake was inversely associated with intakes of total carbohydrates, nuts, alcohol, and sugar-sweetened beverages.

The associations between protein intake and healthy aging are complex and not fully understood, the authors stated.
 

Effects of Protein Intake

In studies of older adult populations lower protein intake has been associated with lean mass loss. Animal protein supplementation studies in older adults have shown lean mass gains potentially related to amino acid composition.

In terms of mechanisms, evidence suggests that protein-related activation of the rapamycin complex 1 pathway may play a role, the authors suggested. The activity of this signaling pathway decreases with age.

Rapamycin, a compound used to prevent organ transplant rejection, has been associated with delayed aging. In the body, dietary protein and exercise activate this pathway, thereby stimulating muscle protein synthesis and possibly improving physical function.

As for the differential associations of plant and animal protein on the chronic disease domain of the healthy aging phenotype, Dr. Ardisson Korat and coauthors said plant protein has been associated with favorable levels of important risk factors for cardiometabolic diseases, such as reduced LDL cholesterol, lower blood pressure, and insulin sensitivity, as well as decreased levels of proinflammatory markers.

Conversely, total and animal protein intakes have been positively associated with concentrations of insulin-like growth factor 1, which is implicated in the growth of malignant cells in breast and prostate tissue.

This study is the first step in evaluating the long-term health effect of protein intake in midlife, the relevant development window for most chronic conditions, the NHS study authors said. More research is needed, however, to corroborate the study findings in other populations and identify underlying mechanisms.

This study was supported by the USDA Agricultural Research Service and the National Institutes of Health. The authors reported no conflicts of interest. The commentators disclosed no relevant competing interests.

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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