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When You and Your Malpractice Insurer Disagree on Your Case
You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.
An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.
But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?
Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.
This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.
Disagreements might include:
- Choice of expert witnesses
- Tactical decisions related to trial strategy
- Public relations considerations
- Admissions of liability
- Allocation of resources
To Settle or Not?
One of the most challenging — and common — disagreements is whether to settle the case.
Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
The Underlying Medical Malpractice Case
Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.
Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.
The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.
The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.
The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.
Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.
A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.
“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”
The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.
Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.
Meanwhile the case inched closer to trial.
The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.
Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.
A committee at the insurance company had decided to proceed with the trial rather than settle.
The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.
Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
The Follow-up
Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.
Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.
The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
Protecting Yourself
The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.
The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:
- You disagree with your insurer on how to proceed in a case.
- You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
- Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.
Retaining independent counsel protects your interests, not those of your insurance company.
Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.
Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.
The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.
A version of this article first appeared on Medscape.com.
You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.
An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.
But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?
Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.
This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.
Disagreements might include:
- Choice of expert witnesses
- Tactical decisions related to trial strategy
- Public relations considerations
- Admissions of liability
- Allocation of resources
To Settle or Not?
One of the most challenging — and common — disagreements is whether to settle the case.
Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
The Underlying Medical Malpractice Case
Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.
Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.
The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.
The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.
The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.
Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.
A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.
“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”
The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.
Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.
Meanwhile the case inched closer to trial.
The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.
Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.
A committee at the insurance company had decided to proceed with the trial rather than settle.
The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.
Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
The Follow-up
Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.
Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.
The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
Protecting Yourself
The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.
The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:
- You disagree with your insurer on how to proceed in a case.
- You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
- Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.
Retaining independent counsel protects your interests, not those of your insurance company.
Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.
Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.
The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.
A version of this article first appeared on Medscape.com.
You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.
An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.
But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?
Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.
This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.
Disagreements might include:
- Choice of expert witnesses
- Tactical decisions related to trial strategy
- Public relations considerations
- Admissions of liability
- Allocation of resources
To Settle or Not?
One of the most challenging — and common — disagreements is whether to settle the case.
Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
The Underlying Medical Malpractice Case
Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.
Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.
The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.
The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.
The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.
Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.
A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.
“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”
The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.
Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.
Meanwhile the case inched closer to trial.
The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.
Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.
A committee at the insurance company had decided to proceed with the trial rather than settle.
The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.
Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
The Follow-up
Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.
Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.
The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
Protecting Yourself
The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.
The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:
- You disagree with your insurer on how to proceed in a case.
- You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
- Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.
Retaining independent counsel protects your interests, not those of your insurance company.
Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.
Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.
The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.
A version of this article first appeared on Medscape.com.
Coffee’s ‘Sweet Spot’: Daily Consumption and Cardiometabolic Risk
Each and every day, 1 billion people on this planet ingest a particular psychoactive substance. This chemical has fairly profound physiologic effects. It increases levels of nitric oxide in the blood, leads to vasodilation, and, of course, makes you feel more awake. The substance comes in many forms but almost always in a liquid medium. Do you have it yet? That’s right. The substance is caffeine, quite possibly the healthiest recreational drug that has ever been discovered.
This might be my New England upbringing speaking, but when it comes to lifestyle and health, one of the rules I’ve internalized is that things that are pleasurable are generally bad for you. I know, I know — some of you love to exercise. Some of you love doing crosswords. But you know what I mean. I’m talking French fries, smoked meats, drugs, smoking, alcohol, binge-watching Firefly. You’d be suspicious if a study came out suggesting that eating ice cream in bed reduces your risk for heart attack, and so would I. So I’m always on the lookout for those unicorns of lifestyle factors, those rare things that you want to do and are also good for you.
So far, the data are strong for three things: sleeping, (safe) sexual activity, and coffee. You’ll have to stay tuned for articles about the first two. Today, we’re brewing up some deeper insights about the power of java.
I was inspired to write this article because of a paper, “Habitual Coffee, Tea, and Caffeine Consumption, Circulating Metabolites, and the Risk of Cardiometabolic Multimorbidity,” appearing September 17 in The Journal of Clinical Endocrinology and Metabolism (JCEM).
This is not the first study to suggest that coffee intake may be beneficial. A 2013 meta-analysis summarized the results of 36 studies with more than a million participants and found a U-shaped relationship between coffee intake and cardiovascular risk. The sweet spot was at three to five cups a day; people drinking that much coffee had about a 15% reduced risk for cardiovascular disease compared with nondrinkers.
But here’s the thing. Coffee contains caffeine, but it is much more than that. It is a heady brew of various chemicals and compounds, phenols, and chlorogenic acids. And, of course, you can get caffeine from stuff that isn’t coffee — natural things like tea — and decidedly unnatural things like energy drinks. How do you figure out where the benefit really lies?
The JCEM study leveraged the impressive UK Biobank dataset to figure this out. The Biobank recruited more than half a million people from the UK between 2006 and 2010 and collected a wealth of data from each of them: surveys, blood samples, biometrics, medical imaging — the works. And then they followed what would happen to those people medically over time. It’s a pretty amazing resource.
But for the purposes of this study, what you need to know is that just under 200,000 of those participants met the key criteria for this study: being free from cardiovascular disease at baseline; having completed a detailed survey about their coffee, tea, and other caffeinated beverage intake; and having adequate follow-up. A subset of that number, just under 100,000, had metabolomic data — which is where this study really gets interesting.
We’ll dive into the metabolome in a moment, but first let’s just talk about the main finding, the relationship between coffee, tea, or caffeine and cardiovascular disease. But to do that, we need to acknowledge that people who drink a lot of coffee are different from people who don’t, and it might be those differences, not the coffee itself, that are beneficial.
What were those differences? People who drank more coffee tended to be a bit older, were less likely to be female, and were slightly more likely to engage in physical activity. They ate less processed meat but also fewer vegetables. Some of those factors, like being female, are generally protective against cardiovascular disease; but some, like age, are definitely not. The authors adjusted for these and multiple other factors, including alcohol intake, BMI, kidney function, and many others to try to disentangle the effect of being the type of person who drinks a lot of coffee from the drinking a lot of coffee itself.
These are the results of the fully adjusted model. Compared with nonconsumers, you can see that people in the higher range of coffee, tea, or just caffeine intake have almost a 40% reduction in cardiovascular disease in follow-up.
Looking at the benefit across the spectrum of intake, you again see that U-shaped curve, suggesting that a sweet spot for daily consumption can be found around 3 cups of coffee or tea (or 250 mg of caffeine). A standard energy drink contains about 120 mg of caffeine. 
But if this is true, it would be good to know why. To figure that out, the authors turned to the metabolome. The idea here is that your body is constantly breaking stuff down, taking all these proteins and chemicals and compounds that we ingest and turning them into metabolites. Using advanced measurement techniques, researchers can measure hundreds or even thousands of metabolites from a single blood sample. They provide information, obviously, about the food you eat and the drinks you drink, but what is really intriguing is that some metabolites are associated with better health and some with worse
In this study, researchers measured 168 individual metabolites. Eighty of them, nearly half, were significantly altered in people who drank more coffee.
This figure summarizes the findings, and yes, this is way too complicated. 
But here’s how to interpret it. The inner ring shows you how certain metabolites are associated with cardiovascular disease. The outer rings show you how those metabolites are associated with coffee, tea, or caffeine. The interesting part is that the sections of the ring (outer rings and inner rings) are very different colors.
Like here.
What you see here is a fairly profound effect that coffee, tea, or caffeine intake has on metabolites of VLDL — bad cholesterol. The beverages lower it, and, of course, higher levels lead to cardiovascular disease. This means that this is a potential causal pathway from coffee intake to heart protection.
And that’s not the only one.
You see a similar relationship for saturated fatty acids. Higher levels lead to cardiovascular disease, and coffee intake lowers levels. The reverse works too: Lower levels of histidine (an amino acid) increase cardiovascular risk, and coffee seems to raise those levels.
Is this all too good to be true? It’s hard to say. The data on coffee’s benefits have been remarkably consistent. Still, I wouldn’t be a good doctor if I didn’t mention that clearly there is a difference between a cup of black coffee and a venti caramel Frappuccino.
Nevertheless, coffee remains firmly in my holy trinity of enjoyable things that are, for whatever reason, still good for you. So, when you’re having that second, or third, or maybe fourth cup of the day, you can take that to heart.
Dr. Wilson, associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator, reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Each and every day, 1 billion people on this planet ingest a particular psychoactive substance. This chemical has fairly profound physiologic effects. It increases levels of nitric oxide in the blood, leads to vasodilation, and, of course, makes you feel more awake. The substance comes in many forms but almost always in a liquid medium. Do you have it yet? That’s right. The substance is caffeine, quite possibly the healthiest recreational drug that has ever been discovered.
This might be my New England upbringing speaking, but when it comes to lifestyle and health, one of the rules I’ve internalized is that things that are pleasurable are generally bad for you. I know, I know — some of you love to exercise. Some of you love doing crosswords. But you know what I mean. I’m talking French fries, smoked meats, drugs, smoking, alcohol, binge-watching Firefly. You’d be suspicious if a study came out suggesting that eating ice cream in bed reduces your risk for heart attack, and so would I. So I’m always on the lookout for those unicorns of lifestyle factors, those rare things that you want to do and are also good for you.
So far, the data are strong for three things: sleeping, (safe) sexual activity, and coffee. You’ll have to stay tuned for articles about the first two. Today, we’re brewing up some deeper insights about the power of java.
I was inspired to write this article because of a paper, “Habitual Coffee, Tea, and Caffeine Consumption, Circulating Metabolites, and the Risk of Cardiometabolic Multimorbidity,” appearing September 17 in The Journal of Clinical Endocrinology and Metabolism (JCEM).
This is not the first study to suggest that coffee intake may be beneficial. A 2013 meta-analysis summarized the results of 36 studies with more than a million participants and found a U-shaped relationship between coffee intake and cardiovascular risk. The sweet spot was at three to five cups a day; people drinking that much coffee had about a 15% reduced risk for cardiovascular disease compared with nondrinkers.
But here’s the thing. Coffee contains caffeine, but it is much more than that. It is a heady brew of various chemicals and compounds, phenols, and chlorogenic acids. And, of course, you can get caffeine from stuff that isn’t coffee — natural things like tea — and decidedly unnatural things like energy drinks. How do you figure out where the benefit really lies?
The JCEM study leveraged the impressive UK Biobank dataset to figure this out. The Biobank recruited more than half a million people from the UK between 2006 and 2010 and collected a wealth of data from each of them: surveys, blood samples, biometrics, medical imaging — the works. And then they followed what would happen to those people medically over time. It’s a pretty amazing resource.
But for the purposes of this study, what you need to know is that just under 200,000 of those participants met the key criteria for this study: being free from cardiovascular disease at baseline; having completed a detailed survey about their coffee, tea, and other caffeinated beverage intake; and having adequate follow-up. A subset of that number, just under 100,000, had metabolomic data — which is where this study really gets interesting.
We’ll dive into the metabolome in a moment, but first let’s just talk about the main finding, the relationship between coffee, tea, or caffeine and cardiovascular disease. But to do that, we need to acknowledge that people who drink a lot of coffee are different from people who don’t, and it might be those differences, not the coffee itself, that are beneficial.
What were those differences? People who drank more coffee tended to be a bit older, were less likely to be female, and were slightly more likely to engage in physical activity. They ate less processed meat but also fewer vegetables. Some of those factors, like being female, are generally protective against cardiovascular disease; but some, like age, are definitely not. The authors adjusted for these and multiple other factors, including alcohol intake, BMI, kidney function, and many others to try to disentangle the effect of being the type of person who drinks a lot of coffee from the drinking a lot of coffee itself.
These are the results of the fully adjusted model. Compared with nonconsumers, you can see that people in the higher range of coffee, tea, or just caffeine intake have almost a 40% reduction in cardiovascular disease in follow-up.
Looking at the benefit across the spectrum of intake, you again see that U-shaped curve, suggesting that a sweet spot for daily consumption can be found around 3 cups of coffee or tea (or 250 mg of caffeine). A standard energy drink contains about 120 mg of caffeine.
But if this is true, it would be good to know why. To figure that out, the authors turned to the metabolome. The idea here is that your body is constantly breaking stuff down, taking all these proteins and chemicals and compounds that we ingest and turning them into metabolites. Using advanced measurement techniques, researchers can measure hundreds or even thousands of metabolites from a single blood sample. They provide information, obviously, about the food you eat and the drinks you drink, but what is really intriguing is that some metabolites are associated with better health and some with worse
In this study, researchers measured 168 individual metabolites. Eighty of them, nearly half, were significantly altered in people who drank more coffee.
This figure summarizes the findings, and yes, this is way too complicated.
But here’s how to interpret it. The inner ring shows you how certain metabolites are associated with cardiovascular disease. The outer rings show you how those metabolites are associated with coffee, tea, or caffeine. The interesting part is that the sections of the ring (outer rings and inner rings) are very different colors.
Like here.
What you see here is a fairly profound effect that coffee, tea, or caffeine intake has on metabolites of VLDL — bad cholesterol. The beverages lower it, and, of course, higher levels lead to cardiovascular disease. This means that this is a potential causal pathway from coffee intake to heart protection.
And that’s not the only one.
You see a similar relationship for saturated fatty acids. Higher levels lead to cardiovascular disease, and coffee intake lowers levels. The reverse works too: Lower levels of histidine (an amino acid) increase cardiovascular risk, and coffee seems to raise those levels.
Is this all too good to be true? It’s hard to say. The data on coffee’s benefits have been remarkably consistent. Still, I wouldn’t be a good doctor if I didn’t mention that clearly there is a difference between a cup of black coffee and a venti caramel Frappuccino.
Nevertheless, coffee remains firmly in my holy trinity of enjoyable things that are, for whatever reason, still good for you. So, when you’re having that second, or third, or maybe fourth cup of the day, you can take that to heart.
Dr. Wilson, associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator, reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Each and every day, 1 billion people on this planet ingest a particular psychoactive substance. This chemical has fairly profound physiologic effects. It increases levels of nitric oxide in the blood, leads to vasodilation, and, of course, makes you feel more awake. The substance comes in many forms but almost always in a liquid medium. Do you have it yet? That’s right. The substance is caffeine, quite possibly the healthiest recreational drug that has ever been discovered.
This might be my New England upbringing speaking, but when it comes to lifestyle and health, one of the rules I’ve internalized is that things that are pleasurable are generally bad for you. I know, I know — some of you love to exercise. Some of you love doing crosswords. But you know what I mean. I’m talking French fries, smoked meats, drugs, smoking, alcohol, binge-watching Firefly. You’d be suspicious if a study came out suggesting that eating ice cream in bed reduces your risk for heart attack, and so would I. So I’m always on the lookout for those unicorns of lifestyle factors, those rare things that you want to do and are also good for you.
So far, the data are strong for three things: sleeping, (safe) sexual activity, and coffee. You’ll have to stay tuned for articles about the first two. Today, we’re brewing up some deeper insights about the power of java.
I was inspired to write this article because of a paper, “Habitual Coffee, Tea, and Caffeine Consumption, Circulating Metabolites, and the Risk of Cardiometabolic Multimorbidity,” appearing September 17 in The Journal of Clinical Endocrinology and Metabolism (JCEM).
This is not the first study to suggest that coffee intake may be beneficial. A 2013 meta-analysis summarized the results of 36 studies with more than a million participants and found a U-shaped relationship between coffee intake and cardiovascular risk. The sweet spot was at three to five cups a day; people drinking that much coffee had about a 15% reduced risk for cardiovascular disease compared with nondrinkers.
But here’s the thing. Coffee contains caffeine, but it is much more than that. It is a heady brew of various chemicals and compounds, phenols, and chlorogenic acids. And, of course, you can get caffeine from stuff that isn’t coffee — natural things like tea — and decidedly unnatural things like energy drinks. How do you figure out where the benefit really lies?
The JCEM study leveraged the impressive UK Biobank dataset to figure this out. The Biobank recruited more than half a million people from the UK between 2006 and 2010 and collected a wealth of data from each of them: surveys, blood samples, biometrics, medical imaging — the works. And then they followed what would happen to those people medically over time. It’s a pretty amazing resource.
But for the purposes of this study, what you need to know is that just under 200,000 of those participants met the key criteria for this study: being free from cardiovascular disease at baseline; having completed a detailed survey about their coffee, tea, and other caffeinated beverage intake; and having adequate follow-up. A subset of that number, just under 100,000, had metabolomic data — which is where this study really gets interesting.
We’ll dive into the metabolome in a moment, but first let’s just talk about the main finding, the relationship between coffee, tea, or caffeine and cardiovascular disease. But to do that, we need to acknowledge that people who drink a lot of coffee are different from people who don’t, and it might be those differences, not the coffee itself, that are beneficial.
What were those differences? People who drank more coffee tended to be a bit older, were less likely to be female, and were slightly more likely to engage in physical activity. They ate less processed meat but also fewer vegetables. Some of those factors, like being female, are generally protective against cardiovascular disease; but some, like age, are definitely not. The authors adjusted for these and multiple other factors, including alcohol intake, BMI, kidney function, and many others to try to disentangle the effect of being the type of person who drinks a lot of coffee from the drinking a lot of coffee itself.
These are the results of the fully adjusted model. Compared with nonconsumers, you can see that people in the higher range of coffee, tea, or just caffeine intake have almost a 40% reduction in cardiovascular disease in follow-up.
Looking at the benefit across the spectrum of intake, you again see that U-shaped curve, suggesting that a sweet spot for daily consumption can be found around 3 cups of coffee or tea (or 250 mg of caffeine). A standard energy drink contains about 120 mg of caffeine.
But if this is true, it would be good to know why. To figure that out, the authors turned to the metabolome. The idea here is that your body is constantly breaking stuff down, taking all these proteins and chemicals and compounds that we ingest and turning them into metabolites. Using advanced measurement techniques, researchers can measure hundreds or even thousands of metabolites from a single blood sample. They provide information, obviously, about the food you eat and the drinks you drink, but what is really intriguing is that some metabolites are associated with better health and some with worse
In this study, researchers measured 168 individual metabolites. Eighty of them, nearly half, were significantly altered in people who drank more coffee.
This figure summarizes the findings, and yes, this is way too complicated.
But here’s how to interpret it. The inner ring shows you how certain metabolites are associated with cardiovascular disease. The outer rings show you how those metabolites are associated with coffee, tea, or caffeine. The interesting part is that the sections of the ring (outer rings and inner rings) are very different colors.
Like here.
What you see here is a fairly profound effect that coffee, tea, or caffeine intake has on metabolites of VLDL — bad cholesterol. The beverages lower it, and, of course, higher levels lead to cardiovascular disease. This means that this is a potential causal pathway from coffee intake to heart protection.
And that’s not the only one.
You see a similar relationship for saturated fatty acids. Higher levels lead to cardiovascular disease, and coffee intake lowers levels. The reverse works too: Lower levels of histidine (an amino acid) increase cardiovascular risk, and coffee seems to raise those levels.
Is this all too good to be true? It’s hard to say. The data on coffee’s benefits have been remarkably consistent. Still, I wouldn’t be a good doctor if I didn’t mention that clearly there is a difference between a cup of black coffee and a venti caramel Frappuccino.
Nevertheless, coffee remains firmly in my holy trinity of enjoyable things that are, for whatever reason, still good for you. So, when you’re having that second, or third, or maybe fourth cup of the day, you can take that to heart.
Dr. Wilson, associate professor of medicine and public health and director of Yale’s Clinical and Translational Research Accelerator, reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
Locally Acquired Dengue Case Confirmed in California
A case of locally acquired dengue fever has been confirmed in a resident of Baldwin Park, California, according to a press release from the Los Angeles County Department of Public Health.
“Dengue is the most common insect-borne viral infection in the world, with a wide geographic spread; we know that we have mosquitoes capable of carrying and transmitting the virus in the United States already, and Los Angeles county is a major epicenter for international travel and trade,” James Lawler, MD, associate director for International Programs and Innovation at the Global Center for Health Security and professor in the Infectious Diseases Division at the University of Nebraska Medical Center, Omaha, Nebraska, said in an interview.
Although the patient had no known history of travel to a dengue-endemic area, the potential risk for widespread transmission of the virus in the Los Angeles County area remains low, and no additional suspected cases of locally acquired dengue have been identified, according to the release. However, the recent cases highlight the need for vigilance on the part of the public to reduce transmission of mosquito-borne infections, the public health department noted.
Most cases of dengue occur in people who have traveled to areas where the disease is more common, mainly tropical and subtropical areas, according to the press release. However, the types of mosquitoes that spread dengue exist in parts of the United States, so locally acquired infections can occur.
The Centers for Disease Control and Prevention (CDC) issued an official health advisory in June 2024 about an increased risk for dengue infections in the United States. According to the advisory, 745 cases of dengue were identified in US travelers to endemic areas between January 1, 2024, and June 24, 2024.
The CDC advises clinicians to maintain a high level of suspicion for dengue among individuals with fever and recent travel to areas with frequent dengue transmission, but also to consider locally acquired disease in areas of mosquito vectors.
In clinical practice, dengue may be difficult to differentiate from other febrile systemic infections, Dr. Lawler noted. “Joint pain, low back pain, and headache (often retro-orbital) are common and can be severe, and a rash often appears several days into illness,” he noted.
Do not delay treatment in suspected cases while waiting for test results, the CDC emphasized in the advisory. Food and Drug Administration–approved tests for dengue include RT-PCR and IgM antibody tests or NS1 and IgM antibody tests.
“Severe dengue can be life-threatening and progress to a hemorrhagic fever-like syndrome, and patients with severe dengue should be cared for on a high-acuity or intensive care setting, with close monitoring of labs and fluid status,” Dr. Lawler told this news organization.
The World Health Organization has published guidelines for the management of dengue, which Dr. Lawler strongly recommends to clinicians in the rare event that they are facing a severe case. The treatment for dengue is supportive care, according to the CDC; a vaccine that was deemed safe and effective is no longer being manufactured because of low demand.
Most symptoms last for 2-7 days, and most patients recover within a week, but approximately 1 in 20 may develop severe disease, according to the Los Angeles County Department of Public Health.
Approximately one quarter of dengue infections are symptomatic, and clinicians should know the signs of progression to severe disease, which include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and liver enlargement, according to the CDC.
Local Dengue Not Unexpected
“Sadly, I am not surprised at another locally acquired case of dengue fever in the United States,” said Dr. Lawler. “We also have seen a trend of more historically tropical, insect-borne diseases popping up with locally acquired cases in the United States,” he noted.
Dr. Lawler suggested that “the erosion of state and local public health” is a major contributor to the increase in dengue cases. For more than 100 years, activities of state and local public health officials had significantly curtailed mosquito-borne diseases through aggressive control programs, “but we seem to be losing ground over the last several years,” he said.
“Locally acquired dengue cases are still rare in the United States,” he added. “However, people can protect themselves against dengue and more common arthropod-borne infections by taking precautions to cover up and wear insect repellent while outdoors.”
In addition, the Los Angeles County Department of Public Health emphasized in its press release that local residents reduce their risk for contact with mosquitoes by removing areas of standing water on their property and ensuring well-fitted screens on doors and windows.
Dr. Lawler had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
A case of locally acquired dengue fever has been confirmed in a resident of Baldwin Park, California, according to a press release from the Los Angeles County Department of Public Health.
“Dengue is the most common insect-borne viral infection in the world, with a wide geographic spread; we know that we have mosquitoes capable of carrying and transmitting the virus in the United States already, and Los Angeles county is a major epicenter for international travel and trade,” James Lawler, MD, associate director for International Programs and Innovation at the Global Center for Health Security and professor in the Infectious Diseases Division at the University of Nebraska Medical Center, Omaha, Nebraska, said in an interview.
Although the patient had no known history of travel to a dengue-endemic area, the potential risk for widespread transmission of the virus in the Los Angeles County area remains low, and no additional suspected cases of locally acquired dengue have been identified, according to the release. However, the recent cases highlight the need for vigilance on the part of the public to reduce transmission of mosquito-borne infections, the public health department noted.
Most cases of dengue occur in people who have traveled to areas where the disease is more common, mainly tropical and subtropical areas, according to the press release. However, the types of mosquitoes that spread dengue exist in parts of the United States, so locally acquired infections can occur.
The Centers for Disease Control and Prevention (CDC) issued an official health advisory in June 2024 about an increased risk for dengue infections in the United States. According to the advisory, 745 cases of dengue were identified in US travelers to endemic areas between January 1, 2024, and June 24, 2024.
The CDC advises clinicians to maintain a high level of suspicion for dengue among individuals with fever and recent travel to areas with frequent dengue transmission, but also to consider locally acquired disease in areas of mosquito vectors.
In clinical practice, dengue may be difficult to differentiate from other febrile systemic infections, Dr. Lawler noted. “Joint pain, low back pain, and headache (often retro-orbital) are common and can be severe, and a rash often appears several days into illness,” he noted.
Do not delay treatment in suspected cases while waiting for test results, the CDC emphasized in the advisory. Food and Drug Administration–approved tests for dengue include RT-PCR and IgM antibody tests or NS1 and IgM antibody tests.
“Severe dengue can be life-threatening and progress to a hemorrhagic fever-like syndrome, and patients with severe dengue should be cared for on a high-acuity or intensive care setting, with close monitoring of labs and fluid status,” Dr. Lawler told this news organization.
The World Health Organization has published guidelines for the management of dengue, which Dr. Lawler strongly recommends to clinicians in the rare event that they are facing a severe case. The treatment for dengue is supportive care, according to the CDC; a vaccine that was deemed safe and effective is no longer being manufactured because of low demand.
Most symptoms last for 2-7 days, and most patients recover within a week, but approximately 1 in 20 may develop severe disease, according to the Los Angeles County Department of Public Health.
Approximately one quarter of dengue infections are symptomatic, and clinicians should know the signs of progression to severe disease, which include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and liver enlargement, according to the CDC.
Local Dengue Not Unexpected
“Sadly, I am not surprised at another locally acquired case of dengue fever in the United States,” said Dr. Lawler. “We also have seen a trend of more historically tropical, insect-borne diseases popping up with locally acquired cases in the United States,” he noted.
Dr. Lawler suggested that “the erosion of state and local public health” is a major contributor to the increase in dengue cases. For more than 100 years, activities of state and local public health officials had significantly curtailed mosquito-borne diseases through aggressive control programs, “but we seem to be losing ground over the last several years,” he said.
“Locally acquired dengue cases are still rare in the United States,” he added. “However, people can protect themselves against dengue and more common arthropod-borne infections by taking precautions to cover up and wear insect repellent while outdoors.”
In addition, the Los Angeles County Department of Public Health emphasized in its press release that local residents reduce their risk for contact with mosquitoes by removing areas of standing water on their property and ensuring well-fitted screens on doors and windows.
Dr. Lawler had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
A case of locally acquired dengue fever has been confirmed in a resident of Baldwin Park, California, according to a press release from the Los Angeles County Department of Public Health.
“Dengue is the most common insect-borne viral infection in the world, with a wide geographic spread; we know that we have mosquitoes capable of carrying and transmitting the virus in the United States already, and Los Angeles county is a major epicenter for international travel and trade,” James Lawler, MD, associate director for International Programs and Innovation at the Global Center for Health Security and professor in the Infectious Diseases Division at the University of Nebraska Medical Center, Omaha, Nebraska, said in an interview.
Although the patient had no known history of travel to a dengue-endemic area, the potential risk for widespread transmission of the virus in the Los Angeles County area remains low, and no additional suspected cases of locally acquired dengue have been identified, according to the release. However, the recent cases highlight the need for vigilance on the part of the public to reduce transmission of mosquito-borne infections, the public health department noted.
Most cases of dengue occur in people who have traveled to areas where the disease is more common, mainly tropical and subtropical areas, according to the press release. However, the types of mosquitoes that spread dengue exist in parts of the United States, so locally acquired infections can occur.
The Centers for Disease Control and Prevention (CDC) issued an official health advisory in June 2024 about an increased risk for dengue infections in the United States. According to the advisory, 745 cases of dengue were identified in US travelers to endemic areas between January 1, 2024, and June 24, 2024.
The CDC advises clinicians to maintain a high level of suspicion for dengue among individuals with fever and recent travel to areas with frequent dengue transmission, but also to consider locally acquired disease in areas of mosquito vectors.
In clinical practice, dengue may be difficult to differentiate from other febrile systemic infections, Dr. Lawler noted. “Joint pain, low back pain, and headache (often retro-orbital) are common and can be severe, and a rash often appears several days into illness,” he noted.
Do not delay treatment in suspected cases while waiting for test results, the CDC emphasized in the advisory. Food and Drug Administration–approved tests for dengue include RT-PCR and IgM antibody tests or NS1 and IgM antibody tests.
“Severe dengue can be life-threatening and progress to a hemorrhagic fever-like syndrome, and patients with severe dengue should be cared for on a high-acuity or intensive care setting, with close monitoring of labs and fluid status,” Dr. Lawler told this news organization.
The World Health Organization has published guidelines for the management of dengue, which Dr. Lawler strongly recommends to clinicians in the rare event that they are facing a severe case. The treatment for dengue is supportive care, according to the CDC; a vaccine that was deemed safe and effective is no longer being manufactured because of low demand.
Most symptoms last for 2-7 days, and most patients recover within a week, but approximately 1 in 20 may develop severe disease, according to the Los Angeles County Department of Public Health.
Approximately one quarter of dengue infections are symptomatic, and clinicians should know the signs of progression to severe disease, which include abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, and liver enlargement, according to the CDC.
Local Dengue Not Unexpected
“Sadly, I am not surprised at another locally acquired case of dengue fever in the United States,” said Dr. Lawler. “We also have seen a trend of more historically tropical, insect-borne diseases popping up with locally acquired cases in the United States,” he noted.
Dr. Lawler suggested that “the erosion of state and local public health” is a major contributor to the increase in dengue cases. For more than 100 years, activities of state and local public health officials had significantly curtailed mosquito-borne diseases through aggressive control programs, “but we seem to be losing ground over the last several years,” he said.
“Locally acquired dengue cases are still rare in the United States,” he added. “However, people can protect themselves against dengue and more common arthropod-borne infections by taking precautions to cover up and wear insect repellent while outdoors.”
In addition, the Los Angeles County Department of Public Health emphasized in its press release that local residents reduce their risk for contact with mosquitoes by removing areas of standing water on their property and ensuring well-fitted screens on doors and windows.
Dr. Lawler had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
‘Reform School’ for Pharmacy Benefit Managers: How Might Legislation Help Patients?
The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.
Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
Policy Categories of PBM Reform
There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.
Patient Access to Medications — Step Therapy Legislation
One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.
While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.
This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:
- The required treatment has been ineffective
- The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
- The treatment will cause or is likely to cause an adverse reaction
- The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
- The individual is stable on their current prescription drugs
- There are other circumstances as determined by the Employee Benefits Security Administration
This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
Patient Access to Medications — Prior Authorizations
Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.
The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:
- Electronic PA: Implementing real-time decisions for routinely approved items and services.
- Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
- Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
- Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.
This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions
Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.
This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.
To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.
Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.
The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).
As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.
Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.
The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.
Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
Policy Categories of PBM Reform
There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.
Patient Access to Medications — Step Therapy Legislation
One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.
While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.
This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:
- The required treatment has been ineffective
- The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
- The treatment will cause or is likely to cause an adverse reaction
- The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
- The individual is stable on their current prescription drugs
- There are other circumstances as determined by the Employee Benefits Security Administration
This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
Patient Access to Medications — Prior Authorizations
Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.
The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:
- Electronic PA: Implementing real-time decisions for routinely approved items and services.
- Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
- Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
- Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.
This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions
Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.
This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.
To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.
Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.
The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).
As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.
Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.
The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.
Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
Policy Categories of PBM Reform
There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.
Patient Access to Medications — Step Therapy Legislation
One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.
While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.
This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:
- The required treatment has been ineffective
- The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
- The treatment will cause or is likely to cause an adverse reaction
- The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
- The individual is stable on their current prescription drugs
- There are other circumstances as determined by the Employee Benefits Security Administration
This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
Patient Access to Medications — Prior Authorizations
Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.
The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:
- Electronic PA: Implementing real-time decisions for routinely approved items and services.
- Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
- Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
- Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.
This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions
Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.
This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.
To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.
Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.
The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).
As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.
Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at rhnews@mdedge.com.
AI-Powered Clinical Documentation Tool Reduces EHR Time for Clinicians
TOPLINE:
An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.
METHODOLOGY:
- Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
- Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
- A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.
TAKEAWAY:
- The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
- The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
- Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).
IN PRACTICE:
“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.
SOURCE:
The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.
LIMITATIONS:
The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.
DISCLOSURES:
Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.
METHODOLOGY:
- Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
- Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
- A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.
TAKEAWAY:
- The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
- The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
- Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).
IN PRACTICE:
“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.
SOURCE:
The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.
LIMITATIONS:
The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.
DISCLOSURES:
Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.
METHODOLOGY:
- Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
- Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
- A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.
TAKEAWAY:
- The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
- The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
- Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).
IN PRACTICE:
“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.
SOURCE:
The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.
LIMITATIONS:
The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.
DISCLOSURES:
Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
FDA OKs Subcutaneous Atezolizumab Formulation for Multiple Cancer Indications
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Osimertinib/Savolitinib Combo Shows Promise in NSCLC
according to results of the phase 2 FLOWERS study.
Compared with EGFR inhibitor osimertinib alone, the combination demonstrated a clinically meaningful improvement in the objective response rate — the study’s primary endpoint — with a positive trend in progression-free survival and a manageable safety profile.
About 30% patients with EGFR-mutated NSCLC fail to respond well to EGFR–tyrosine kinase inhibitors (TKIs), explained Jin-Ji Yang, MD, with Guangdong Lung Cancer Institute, Guangzhou, China, who reported the study results at the annual meeting of the World Conference on Lung Cancer.
Data suggested that de novo MET amplification occurs in up to 5% patients with treatment-naive, EGFR-mutated advanced NSCLC, and MET overexpression occurs in up to 15% these patients.
Coexistence of EGFR mutation and MET amplification/overexpression reduces sensitivity to EGFR-TKI therapy “and is likely the mechanism for mediating primary resistance to first-line EGFR-TKI monotherapy,” Dr. Yang explained in her presentation.
Osimertinib is a third-generation EGFR-TKI recommended as the first-line treatment for EGFR-mutant advanced NSCLC. Savolitinib is a highly selective MET-TKI which has demonstrated antitumor activity in various cancers with MET alterations.
The FLOWERS study is the first to test whether combining the two agents could improve efficacy and overcome MET-driven primary resistance in these patients.
The phase 2 study enrolled 44 treatment-naive patients with de novo MET-aberrant, EGFR-mutant, stage IIIB-IV NSCLC; 23 were randomly allocated to receive oral osimertinib (80 mg once daily) alone and 21 to receive oral osimertinib (80 mg once daily) plus savolitinib (300 mg twice daily).
At a median follow-up of 8.2 months, the objective response rate was 60.9% with osimertinib monotherapy vs 90.5% with combination therapy. The disease control rate was also better with the combination therapy than with monotherapy (95.2% vs 87%).
Median duration of response (not yet mature) was 8.4 months with monotherapy vs 18.6 months with combination therapy.
Preliminary progression-free survival data also showed a trend in favor of combination therapy over monotherapy (a median of 19.3 vs 9.3 months; hazard ratio, 0.59).
Most treatment-related adverse events were grade 1 or 2, and there were no fatal adverse events.
Treatment-related adverse events of grade 3 or higher were more common with combination therapy (57.1% vs 8.7%). The most common events with monotherapy were diarrhea (56.5%), rash (52.2%), and pruritus (43.5%) and with dual therapy were rash (52.4%), thrombocytopenia (52.4%), and peripheral edema (42.9%).
The results showed that the combination therapy has the potential to become a first-line treatment option for patients who do not respond well to EGFR-TKIs alone, Dr. Yang said in a press release.
Discussant for the study Paul Paik, MD, thoracic oncologist at Memorial Sloan Kettering Cancer Center in New York City, said this study “adds to data suggesting high MET expression might be a poor prognostic or predictive marker, the outcomes of which are improved with MET inhibition.”
He cautioned, however, that there appears to be “quality of life, side-effect trade-offs with dual MET plus EGFR TKI upfront.”
Dr. Paik said he looks forward to results from FLOWERS on serial circulating tumor DNA and formal androgen receptor testing, which “might aid in further assessing clonality and characterizing MET as a co-driver in this setting.”
The study was funded by AstraZeneca China. Dr. Yang had no disclosures. Dr. Paik disclosed relationships with EMD Serono, Bicara, Novartis, and Summit.
A version of this article first appeared on Medscape.com.
according to results of the phase 2 FLOWERS study.
Compared with EGFR inhibitor osimertinib alone, the combination demonstrated a clinically meaningful improvement in the objective response rate — the study’s primary endpoint — with a positive trend in progression-free survival and a manageable safety profile.
About 30% patients with EGFR-mutated NSCLC fail to respond well to EGFR–tyrosine kinase inhibitors (TKIs), explained Jin-Ji Yang, MD, with Guangdong Lung Cancer Institute, Guangzhou, China, who reported the study results at the annual meeting of the World Conference on Lung Cancer.
Data suggested that de novo MET amplification occurs in up to 5% patients with treatment-naive, EGFR-mutated advanced NSCLC, and MET overexpression occurs in up to 15% these patients.
Coexistence of EGFR mutation and MET amplification/overexpression reduces sensitivity to EGFR-TKI therapy “and is likely the mechanism for mediating primary resistance to first-line EGFR-TKI monotherapy,” Dr. Yang explained in her presentation.
Osimertinib is a third-generation EGFR-TKI recommended as the first-line treatment for EGFR-mutant advanced NSCLC. Savolitinib is a highly selective MET-TKI which has demonstrated antitumor activity in various cancers with MET alterations.
The FLOWERS study is the first to test whether combining the two agents could improve efficacy and overcome MET-driven primary resistance in these patients.
The phase 2 study enrolled 44 treatment-naive patients with de novo MET-aberrant, EGFR-mutant, stage IIIB-IV NSCLC; 23 were randomly allocated to receive oral osimertinib (80 mg once daily) alone and 21 to receive oral osimertinib (80 mg once daily) plus savolitinib (300 mg twice daily).
At a median follow-up of 8.2 months, the objective response rate was 60.9% with osimertinib monotherapy vs 90.5% with combination therapy. The disease control rate was also better with the combination therapy than with monotherapy (95.2% vs 87%).
Median duration of response (not yet mature) was 8.4 months with monotherapy vs 18.6 months with combination therapy.
Preliminary progression-free survival data also showed a trend in favor of combination therapy over monotherapy (a median of 19.3 vs 9.3 months; hazard ratio, 0.59).
Most treatment-related adverse events were grade 1 or 2, and there were no fatal adverse events.
Treatment-related adverse events of grade 3 or higher were more common with combination therapy (57.1% vs 8.7%). The most common events with monotherapy were diarrhea (56.5%), rash (52.2%), and pruritus (43.5%) and with dual therapy were rash (52.4%), thrombocytopenia (52.4%), and peripheral edema (42.9%).
The results showed that the combination therapy has the potential to become a first-line treatment option for patients who do not respond well to EGFR-TKIs alone, Dr. Yang said in a press release.
Discussant for the study Paul Paik, MD, thoracic oncologist at Memorial Sloan Kettering Cancer Center in New York City, said this study “adds to data suggesting high MET expression might be a poor prognostic or predictive marker, the outcomes of which are improved with MET inhibition.”
He cautioned, however, that there appears to be “quality of life, side-effect trade-offs with dual MET plus EGFR TKI upfront.”
Dr. Paik said he looks forward to results from FLOWERS on serial circulating tumor DNA and formal androgen receptor testing, which “might aid in further assessing clonality and characterizing MET as a co-driver in this setting.”
The study was funded by AstraZeneca China. Dr. Yang had no disclosures. Dr. Paik disclosed relationships with EMD Serono, Bicara, Novartis, and Summit.
A version of this article first appeared on Medscape.com.
according to results of the phase 2 FLOWERS study.
Compared with EGFR inhibitor osimertinib alone, the combination demonstrated a clinically meaningful improvement in the objective response rate — the study’s primary endpoint — with a positive trend in progression-free survival and a manageable safety profile.
About 30% patients with EGFR-mutated NSCLC fail to respond well to EGFR–tyrosine kinase inhibitors (TKIs), explained Jin-Ji Yang, MD, with Guangdong Lung Cancer Institute, Guangzhou, China, who reported the study results at the annual meeting of the World Conference on Lung Cancer.
Data suggested that de novo MET amplification occurs in up to 5% patients with treatment-naive, EGFR-mutated advanced NSCLC, and MET overexpression occurs in up to 15% these patients.
Coexistence of EGFR mutation and MET amplification/overexpression reduces sensitivity to EGFR-TKI therapy “and is likely the mechanism for mediating primary resistance to first-line EGFR-TKI monotherapy,” Dr. Yang explained in her presentation.
Osimertinib is a third-generation EGFR-TKI recommended as the first-line treatment for EGFR-mutant advanced NSCLC. Savolitinib is a highly selective MET-TKI which has demonstrated antitumor activity in various cancers with MET alterations.
The FLOWERS study is the first to test whether combining the two agents could improve efficacy and overcome MET-driven primary resistance in these patients.
The phase 2 study enrolled 44 treatment-naive patients with de novo MET-aberrant, EGFR-mutant, stage IIIB-IV NSCLC; 23 were randomly allocated to receive oral osimertinib (80 mg once daily) alone and 21 to receive oral osimertinib (80 mg once daily) plus savolitinib (300 mg twice daily).
At a median follow-up of 8.2 months, the objective response rate was 60.9% with osimertinib monotherapy vs 90.5% with combination therapy. The disease control rate was also better with the combination therapy than with monotherapy (95.2% vs 87%).
Median duration of response (not yet mature) was 8.4 months with monotherapy vs 18.6 months with combination therapy.
Preliminary progression-free survival data also showed a trend in favor of combination therapy over monotherapy (a median of 19.3 vs 9.3 months; hazard ratio, 0.59).
Most treatment-related adverse events were grade 1 or 2, and there were no fatal adverse events.
Treatment-related adverse events of grade 3 or higher were more common with combination therapy (57.1% vs 8.7%). The most common events with monotherapy were diarrhea (56.5%), rash (52.2%), and pruritus (43.5%) and with dual therapy were rash (52.4%), thrombocytopenia (52.4%), and peripheral edema (42.9%).
The results showed that the combination therapy has the potential to become a first-line treatment option for patients who do not respond well to EGFR-TKIs alone, Dr. Yang said in a press release.
Discussant for the study Paul Paik, MD, thoracic oncologist at Memorial Sloan Kettering Cancer Center in New York City, said this study “adds to data suggesting high MET expression might be a poor prognostic or predictive marker, the outcomes of which are improved with MET inhibition.”
He cautioned, however, that there appears to be “quality of life, side-effect trade-offs with dual MET plus EGFR TKI upfront.”
Dr. Paik said he looks forward to results from FLOWERS on serial circulating tumor DNA and formal androgen receptor testing, which “might aid in further assessing clonality and characterizing MET as a co-driver in this setting.”
The study was funded by AstraZeneca China. Dr. Yang had no disclosures. Dr. Paik disclosed relationships with EMD Serono, Bicara, Novartis, and Summit.
A version of this article first appeared on Medscape.com.
FROM WCLC 2024
UVA Defends Medical School Dean, Hospital CEO After Docs Call for Their Removal
The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.
At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.
Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.
“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.
The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.
The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.
UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.
The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”
The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”
And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.
The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.
It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.
William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.
Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.
“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.
Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”
Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”
A request to see some of these positive testimonials was not answered by press time.
Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.
“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.
A version of this article first appeared on Medscape.com.
The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.
At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.
Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.
“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.
The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.
The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.
UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.
The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”
The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”
And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.
The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.
It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.
William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.
Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.
“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.
Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”
Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”
A request to see some of these positive testimonials was not answered by press time.
Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.
“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.
A version of this article first appeared on Medscape.com.
The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.
At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.
Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.
“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.
The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.
The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.
UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.
The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”
The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”
And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.
The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.
It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.
William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.
Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.
“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.
Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”
Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”
A request to see some of these positive testimonials was not answered by press time.
Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.
“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.
A version of this article first appeared on Medscape.com.
Majority of Hospitalized Patients With COPD Misuse Inhalers
Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.
“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.
“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.
To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.
The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.
The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.
The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.
“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.
Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.
“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.
The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.
The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.
“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.
The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
Changing Clinical Practice
“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.
Limitations and Next Steps
The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.
Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”
However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.
“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
In-Hospital Inhaler Education Falls Short
“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.
“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.
“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.
“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”
Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.
Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.
The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.
“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.
“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.
To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.
The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.
The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.
The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.
“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.
Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.
“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.
The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.
The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.
“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.
The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
Changing Clinical Practice
“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.
Limitations and Next Steps
The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.
Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”
However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.
“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
In-Hospital Inhaler Education Falls Short
“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.
“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.
“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.
“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”
Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.
Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.
The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals.
“Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented,” said lead author Gaël Grandmaison, MD, of the University of Fribourg in Switzerland, in an interview.
“This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient’s specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs,” Dr. Grandmaison said.
To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique.
The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average.
The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors.
The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.
“The inhalation technique was classified as ‘non-teachable’ if the patient continued to exhibit critical errors despite receiving three repetitions of the instructions,” the researchers wrote. Factors associated with inhaler misuse included cognitive disorders, fine motor disorders, poor coordination between inhaler activation and aspiration, and the inability to hold one’s breath.
Overall, the proportion of misused inhalers did not vary by age or gender. In an analysis at the patient level, 79 patients used at least one misused inhaler, 78 used at least one inhaler with a critical error, and 21 used inhalers with insufficient PIF.
“This study is particularly timely because reasons for hospitalization, such as COPD exacerbations or confusional states, could exacerbate the problem, leading to a potentially higher prevalence of suboptimal inhaler use compared to outpatient settings,” Dr. Grandmaison said.
The researchers also examined secondary outcomes including the prevalence of inhalers that were not suited to them and the number of patients using at least one misused inhaler.
The study findings confirm that suboptimal inhaler use is a significant problem in the hospital setting and provide new insights into the specific reasons behind this suboptimal usage, Dr. Grandmaison said.
“In the majority of cases, poor inhalation technique is the primary cause, which can generally be corrected through targeted therapeutic education,” she said. However, the study also revealed that 20% of patients are unable to use at least one of their inhalers correctly because of insufficient inspiratory force. Another 10% struggle despite receiving proper instruction, often because of cognitive impairments or difficulty with fine motor skills.
The results underscore the need for a comprehensive approach to inhaler use in hospitalized patients that combines continuous therapeutic education with personalized assessment in order to improve technique and subsequently enhance patient outcomes, she said.
Changing Clinical Practice
“As hospital physicians, these findings have led us to systematically evaluate the inhalers used by COPD patients, regardless of their reason for hospitalization,” Dr. Grandmaison said. Consequently, the hospital has implemented an assessment of inhaler use among patients that includes a review of techniques, an evaluation of the appropriateness of the inhaler prescribed, and an algorithm to help clinicians choose the most appropriate inhaler. Since its inception, the targeted intervention has significantly reduced improper inhaler use at discharge.
Limitations and Next Steps
The findings were limited by several factors including the possible underreporting of misuse caused by inadequate PIF, a lack of consensus on what constitutes a critical error, and the small sample of patients from a single center.
Despite these limitations, the study adds to the understanding of improper inhaler use in the hospital setting, Dr. Grandmaison said. “Our subsequent research demonstrated that a systematic evaluation of inhalers, combined with therapeutic education and an algorithm to select an inhaler suited to the patient’s characteristics, significantly reduces the number of improperly used inhalers at hospital discharge.”
However, several areas require further investigation, said Dr. Grandmaison. The most effective methods and frequency for teaching inhalation techniques must be defined, and more research is needed to understand the factors influencing PIF and its progression over the course of disease. The next steps for the current research are to evaluate the impact of the intervention on long-term symptom control and disease progression.
“Moreover, adapting the strategy developed in our institution for use in outpatient care is a priority, and multicenter studies would be valuable in validating these findings across different hospital settings,” she added.
In-Hospital Inhaler Education Falls Short
“Poor inhaler technique can lead to ineffective inhaler use and suboptimal treatment of COPD,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview.
“The results from this study are consistent with prior studies showing a high prevalence of suboptimal inhaler use,” said Dr. Baldomero, who was not involved in the current study.
“The investigators also found that therapeutic education led to a significant reduction in the number of critical errors,” she said.
“What is surprising is that it can take up to three lessons to reduce this critical error down to 3.8%,” Dr. Baldomero said. “In most real-world clinic settings, many patients are not taught how to properly use inhalers, and many patients who receive inhaler technique education only receive instructions once.”
Dr. Baldomero’s takeaway from the study is that teaching patients to properly use their inhalers is critical, but that this education may need to be repeated multiple times. The findings also remind clinicians that some types of inhaler delivery are not suited for patients who cannot generate adequate respiratory flow.
Looking ahead, a larger sample size is needed to better identify which patients need additional teaching, Dr. Baldomero said. Also, the current study is limited by the focus on hospitalized patients. “I am interested in learning about the characteristics of patients in the outpatient settings who would benefit from additional inhaler teaching,” she noted.
The study was supported by a grant from the Hospital of Fribourg in Switzerland. The researchers had no financial conflicts to disclose. Dr. Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASES
The Silent Exodus: Are Nurse Practitioners and Physician Assistants Quiet Quitting?
While she cared deeply about her work, Melissa Adams*, a family nurse practitioner (NP) in Madison, Alabama, was being frequently triple-booked, didn’t feel respected by her office manager, and started to worry about becoming burned out. When she sought help, “the administration was tone-deaf,” she said. “When I asked about what I could do to prevent burnout, they sent me an article about it. It was clear to me that asking for respite from triple-booking and asking to be respected by my office manager wasn’t being heard ... so I thought, ‘how do I fly under the radar and get by with what I can?’ ” That meant focusing on patient care and refusing to take on additional responsibilities, like training new hires or working with students.
“You’re overworked and underpaid, and you start giving less and less of yourself,” Ms. Adams said in an interview.
Quiet quitting, defined as performing only the assigned tasks of the job without making any extra effort or going the proverbial extra mile, has gained attention in the press in recent years. A Gallup poll found that about 50% of the workforce were “quiet quitters” or disengaged.
It may be even more prevalent in healthcare, where a recent survey found that 57% of frontline medical staff, including NPs and physician assistants (PAs), report being disengaged at work.
The Causes of Quiet Quitting
Potential causes of quiet quitting among PAs and NPs include:
- Unrealistic care expectations. Ms. Adams said.
- Lack of trust or respect. Physicians don’t always respect the role that PAs and NPs play in a practice.
- Dissatisfaction with leadership or administration. There’s often a feeling that the PA or NP isn’t “heard” or appreciated.
- Dissatisfaction with pay or working conditions.
- Moral injury. “There’s no way to escape being morally injured when you work with an at-risk population,” said Ms. Adams. “You may see someone who has 20-24 determinants of health, and you’re expected to schlep them through in 8 minutes — you know you’re not able to do what they need.”
What Quiet Quitting Looks Like
Terri Smith*, an NP at an academic medical center outpatient clinic in rural Vermont, said that, while she feels appreciated by her patients and her team, there’s poor communication from the administration, which has caused her to quietly quit.
“I stopped saying ‘yes’ to all the normal committee work and the extra stuff that used to add a lot to my professional enjoyment,” she said. “The last couple of years, my whole motto is to nod and smile when administration says to do something — to put your head down and take care of your patients.”
While the term “quiet quitting” may be new, the issue is not, said Bridget Roberts, PhD, a healthcare executive who ran a large physician’s group of 100 healthcare providers in Jacksonville, Florida, for a decade. “Quiet quitting is a fancy title for employees who are completely disengaged,” said Dr. Roberts. “When they’re on the way out, they ‘check the box’. That’s not a new thing.”
“Typically, the first thing you see is a lot of frustration in that they aren’t able to complete the tasks they have at hand,” said Rebecca Day, PMNHP, a doctoral-educated NP and director of nursing practice at a Federally Qualified Health Center in Corbin, Kentucky. “Staff may be overworked and not have enough time to do what’s required of them with patient care as well as the paperwork required behind the scenes. It [quiet quitting] is doing just enough to get by, but shortcutting as much as they can to try to save some time.”
Addressing Quiet Quitting
Those kinds of shortcuts may affect patients, admits Ms. Smith. “I do think it starts to seep into patient care,” she said. “And that really doesn’t feel good ... at our institution, I’m not just an NP — I’m the nurse, the doctor, the secretary — I’m everybody, and for the last year, almost every single day in clinic, I’m apologizing [to a patient] because we can’t do something.”
Watching for this frustration can help alert administrators to NPs and PAs who may be “checking out” at work. Open lines of communication can help you address the issue. “Ask questions like ‘What could we do differently to make your day easier?’” said Dr. Roberts. Understanding the day-to-day issues NPs and PAs face at work can help in developing a plan to address disengagement.
When Dr. Day sees quiet quitting at her practice, she talks with the advance practice provider about what’s causing the issue. “’Are you overworked? Are you understaffed? Are there problems at home? Do you feel you’re receiving inadequate pay?’ ” she said. “The first thing to do is address that and find mutual ground on the issues…deal with the person as a person and then go back and deal with the person as an employee. If your staff isn’t happy, your clinic isn’t going to be productive.”
Finally, while reasons for quiet quitting may vary, cultivating a collaborative atmosphere where NPs and PAs feel appreciated and valued can help reduce the risk for quiet quitting. “Get to know your advanced practice providers,” said Ms. Adams. “Understand their strengths and what they’re about. It’s not an ‘us vs them’ ... there is a lot more commonality when we approach it that way.” Respect for the integral role that NPs and PAs play in your practice can help reduce the risk for quiet quitting — and help provide better patient care.
*Names have been changed.
A version of this article first appeared on Medscape.com.
While she cared deeply about her work, Melissa Adams*, a family nurse practitioner (NP) in Madison, Alabama, was being frequently triple-booked, didn’t feel respected by her office manager, and started to worry about becoming burned out. When she sought help, “the administration was tone-deaf,” she said. “When I asked about what I could do to prevent burnout, they sent me an article about it. It was clear to me that asking for respite from triple-booking and asking to be respected by my office manager wasn’t being heard ... so I thought, ‘how do I fly under the radar and get by with what I can?’ ” That meant focusing on patient care and refusing to take on additional responsibilities, like training new hires or working with students.
“You’re overworked and underpaid, and you start giving less and less of yourself,” Ms. Adams said in an interview.
Quiet quitting, defined as performing only the assigned tasks of the job without making any extra effort or going the proverbial extra mile, has gained attention in the press in recent years. A Gallup poll found that about 50% of the workforce were “quiet quitters” or disengaged.
It may be even more prevalent in healthcare, where a recent survey found that 57% of frontline medical staff, including NPs and physician assistants (PAs), report being disengaged at work.
The Causes of Quiet Quitting
Potential causes of quiet quitting among PAs and NPs include:
- Unrealistic care expectations. Ms. Adams said.
- Lack of trust or respect. Physicians don’t always respect the role that PAs and NPs play in a practice.
- Dissatisfaction with leadership or administration. There’s often a feeling that the PA or NP isn’t “heard” or appreciated.
- Dissatisfaction with pay or working conditions.
- Moral injury. “There’s no way to escape being morally injured when you work with an at-risk population,” said Ms. Adams. “You may see someone who has 20-24 determinants of health, and you’re expected to schlep them through in 8 minutes — you know you’re not able to do what they need.”
What Quiet Quitting Looks Like
Terri Smith*, an NP at an academic medical center outpatient clinic in rural Vermont, said that, while she feels appreciated by her patients and her team, there’s poor communication from the administration, which has caused her to quietly quit.
“I stopped saying ‘yes’ to all the normal committee work and the extra stuff that used to add a lot to my professional enjoyment,” she said. “The last couple of years, my whole motto is to nod and smile when administration says to do something — to put your head down and take care of your patients.”
While the term “quiet quitting” may be new, the issue is not, said Bridget Roberts, PhD, a healthcare executive who ran a large physician’s group of 100 healthcare providers in Jacksonville, Florida, for a decade. “Quiet quitting is a fancy title for employees who are completely disengaged,” said Dr. Roberts. “When they’re on the way out, they ‘check the box’. That’s not a new thing.”
“Typically, the first thing you see is a lot of frustration in that they aren’t able to complete the tasks they have at hand,” said Rebecca Day, PMNHP, a doctoral-educated NP and director of nursing practice at a Federally Qualified Health Center in Corbin, Kentucky. “Staff may be overworked and not have enough time to do what’s required of them with patient care as well as the paperwork required behind the scenes. It [quiet quitting] is doing just enough to get by, but shortcutting as much as they can to try to save some time.”
Addressing Quiet Quitting
Those kinds of shortcuts may affect patients, admits Ms. Smith. “I do think it starts to seep into patient care,” she said. “And that really doesn’t feel good ... at our institution, I’m not just an NP — I’m the nurse, the doctor, the secretary — I’m everybody, and for the last year, almost every single day in clinic, I’m apologizing [to a patient] because we can’t do something.”
Watching for this frustration can help alert administrators to NPs and PAs who may be “checking out” at work. Open lines of communication can help you address the issue. “Ask questions like ‘What could we do differently to make your day easier?’” said Dr. Roberts. Understanding the day-to-day issues NPs and PAs face at work can help in developing a plan to address disengagement.
When Dr. Day sees quiet quitting at her practice, she talks with the advance practice provider about what’s causing the issue. “’Are you overworked? Are you understaffed? Are there problems at home? Do you feel you’re receiving inadequate pay?’ ” she said. “The first thing to do is address that and find mutual ground on the issues…deal with the person as a person and then go back and deal with the person as an employee. If your staff isn’t happy, your clinic isn’t going to be productive.”
Finally, while reasons for quiet quitting may vary, cultivating a collaborative atmosphere where NPs and PAs feel appreciated and valued can help reduce the risk for quiet quitting. “Get to know your advanced practice providers,” said Ms. Adams. “Understand their strengths and what they’re about. It’s not an ‘us vs them’ ... there is a lot more commonality when we approach it that way.” Respect for the integral role that NPs and PAs play in your practice can help reduce the risk for quiet quitting — and help provide better patient care.
*Names have been changed.
A version of this article first appeared on Medscape.com.
While she cared deeply about her work, Melissa Adams*, a family nurse practitioner (NP) in Madison, Alabama, was being frequently triple-booked, didn’t feel respected by her office manager, and started to worry about becoming burned out. When she sought help, “the administration was tone-deaf,” she said. “When I asked about what I could do to prevent burnout, they sent me an article about it. It was clear to me that asking for respite from triple-booking and asking to be respected by my office manager wasn’t being heard ... so I thought, ‘how do I fly under the radar and get by with what I can?’ ” That meant focusing on patient care and refusing to take on additional responsibilities, like training new hires or working with students.
“You’re overworked and underpaid, and you start giving less and less of yourself,” Ms. Adams said in an interview.
Quiet quitting, defined as performing only the assigned tasks of the job without making any extra effort or going the proverbial extra mile, has gained attention in the press in recent years. A Gallup poll found that about 50% of the workforce were “quiet quitters” or disengaged.
It may be even more prevalent in healthcare, where a recent survey found that 57% of frontline medical staff, including NPs and physician assistants (PAs), report being disengaged at work.
The Causes of Quiet Quitting
Potential causes of quiet quitting among PAs and NPs include:
- Unrealistic care expectations. Ms. Adams said.
- Lack of trust or respect. Physicians don’t always respect the role that PAs and NPs play in a practice.
- Dissatisfaction with leadership or administration. There’s often a feeling that the PA or NP isn’t “heard” or appreciated.
- Dissatisfaction with pay or working conditions.
- Moral injury. “There’s no way to escape being morally injured when you work with an at-risk population,” said Ms. Adams. “You may see someone who has 20-24 determinants of health, and you’re expected to schlep them through in 8 minutes — you know you’re not able to do what they need.”
What Quiet Quitting Looks Like
Terri Smith*, an NP at an academic medical center outpatient clinic in rural Vermont, said that, while she feels appreciated by her patients and her team, there’s poor communication from the administration, which has caused her to quietly quit.
“I stopped saying ‘yes’ to all the normal committee work and the extra stuff that used to add a lot to my professional enjoyment,” she said. “The last couple of years, my whole motto is to nod and smile when administration says to do something — to put your head down and take care of your patients.”
While the term “quiet quitting” may be new, the issue is not, said Bridget Roberts, PhD, a healthcare executive who ran a large physician’s group of 100 healthcare providers in Jacksonville, Florida, for a decade. “Quiet quitting is a fancy title for employees who are completely disengaged,” said Dr. Roberts. “When they’re on the way out, they ‘check the box’. That’s not a new thing.”
“Typically, the first thing you see is a lot of frustration in that they aren’t able to complete the tasks they have at hand,” said Rebecca Day, PMNHP, a doctoral-educated NP and director of nursing practice at a Federally Qualified Health Center in Corbin, Kentucky. “Staff may be overworked and not have enough time to do what’s required of them with patient care as well as the paperwork required behind the scenes. It [quiet quitting] is doing just enough to get by, but shortcutting as much as they can to try to save some time.”
Addressing Quiet Quitting
Those kinds of shortcuts may affect patients, admits Ms. Smith. “I do think it starts to seep into patient care,” she said. “And that really doesn’t feel good ... at our institution, I’m not just an NP — I’m the nurse, the doctor, the secretary — I’m everybody, and for the last year, almost every single day in clinic, I’m apologizing [to a patient] because we can’t do something.”
Watching for this frustration can help alert administrators to NPs and PAs who may be “checking out” at work. Open lines of communication can help you address the issue. “Ask questions like ‘What could we do differently to make your day easier?’” said Dr. Roberts. Understanding the day-to-day issues NPs and PAs face at work can help in developing a plan to address disengagement.
When Dr. Day sees quiet quitting at her practice, she talks with the advance practice provider about what’s causing the issue. “’Are you overworked? Are you understaffed? Are there problems at home? Do you feel you’re receiving inadequate pay?’ ” she said. “The first thing to do is address that and find mutual ground on the issues…deal with the person as a person and then go back and deal with the person as an employee. If your staff isn’t happy, your clinic isn’t going to be productive.”
Finally, while reasons for quiet quitting may vary, cultivating a collaborative atmosphere where NPs and PAs feel appreciated and valued can help reduce the risk for quiet quitting. “Get to know your advanced practice providers,” said Ms. Adams. “Understand their strengths and what they’re about. It’s not an ‘us vs them’ ... there is a lot more commonality when we approach it that way.” Respect for the integral role that NPs and PAs play in your practice can help reduce the risk for quiet quitting — and help provide better patient care.
*Names have been changed.
A version of this article first appeared on Medscape.com.