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Turning Late-Night Advice into Big Business: Two Nurses’ Story
Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.
It was the mid-1990s, and theirs was the only practice in town that offered on-call nurse responses around the clock. Ms. Hunter and Ms. Walker alternated work-from-home shifts, chatting with many of the practice’s families.
The pair answered the same questions from panicked parents over and over. And they found themselves bridging the gap between medical advice and parenting advice when supporting families.
“Parents were calling us at 2:00 in the morning with all kinds of things they were worried about, and that’s where Moms on Call was born,” Ms. Walker said.
A few decades later, Ms. Walker and Ms. Hunter turned that experience, empathy, and expertise into a thriving business. Moms on Call is often referred to as the “instruction manual for babies,” and the two nurses have consulted with more than 10,000 families. Along the way, they’ve sold more than a million copies of multiple books, created a deep well of online resources, and trained others in their techniques.
So how did they do it?
A Folder, a Swaddle, and a Mission
Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.
“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.
The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”
“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.
The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.
Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.
It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
The Ripple Effect
The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”
Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.
One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”
But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
The Gambler Calls
After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.
“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.
Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.
More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
‘They Don’t Teach You That in Nursing School’
The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.
The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.
A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said.
Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”
Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.
Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said.
On Call 24/7 in the Car, in the Checkout Line ...
The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.
“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”
Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.
Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.
“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
Do You Have a Business Idea?
“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.
“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”
In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.
The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.
Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”
A version of this article appeared on Medscape.com.
Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.
It was the mid-1990s, and theirs was the only practice in town that offered on-call nurse responses around the clock. Ms. Hunter and Ms. Walker alternated work-from-home shifts, chatting with many of the practice’s families.
The pair answered the same questions from panicked parents over and over. And they found themselves bridging the gap between medical advice and parenting advice when supporting families.
“Parents were calling us at 2:00 in the morning with all kinds of things they were worried about, and that’s where Moms on Call was born,” Ms. Walker said.
A few decades later, Ms. Walker and Ms. Hunter turned that experience, empathy, and expertise into a thriving business. Moms on Call is often referred to as the “instruction manual for babies,” and the two nurses have consulted with more than 10,000 families. Along the way, they’ve sold more than a million copies of multiple books, created a deep well of online resources, and trained others in their techniques.
So how did they do it?
A Folder, a Swaddle, and a Mission
Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.
“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.
The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”
“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.
The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.
Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.
It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
The Ripple Effect
The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”
Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.
One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”
But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
The Gambler Calls
After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.
“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.
Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.
More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
‘They Don’t Teach You That in Nursing School’
The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.
The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.
A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said.
Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”
Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.
Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said.
On Call 24/7 in the Car, in the Checkout Line ...
The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.
“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”
Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.
Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.
“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
Do You Have a Business Idea?
“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.
“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”
In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.
The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.
Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”
A version of this article appeared on Medscape.com.
Fevers? Vomiting? Fussiness? How to manage the first night home from the hospital? These are just a few of the hundreds of questions from parents that Atlanta, Georgia–based pediatric nurses Jennifer Walker and Laura Hunter answered well into the night.
It was the mid-1990s, and theirs was the only practice in town that offered on-call nurse responses around the clock. Ms. Hunter and Ms. Walker alternated work-from-home shifts, chatting with many of the practice’s families.
The pair answered the same questions from panicked parents over and over. And they found themselves bridging the gap between medical advice and parenting advice when supporting families.
“Parents were calling us at 2:00 in the morning with all kinds of things they were worried about, and that’s where Moms on Call was born,” Ms. Walker said.
A few decades later, Ms. Walker and Ms. Hunter turned that experience, empathy, and expertise into a thriving business. Moms on Call is often referred to as the “instruction manual for babies,” and the two nurses have consulted with more than 10,000 families. Along the way, they’ve sold more than a million copies of multiple books, created a deep well of online resources, and trained others in their techniques.
So how did they do it?
A Folder, a Swaddle, and a Mission
Ms. Walker and Ms. Hunter literally wrote the book on helping people in the trenches of new parenthood. But it wasn’t quite a book at first. “It was a folder we printed off the computer with those questions coming in,” Ms. Hunter recalled. The nurses developed a way to approach each call with a specific outline of protocols they had designed.
“What if we just go to the [patient’s] house and help them figure that out?” Ms. Walker remembered one of the pediatricians she worked with suggesting in 2002. For example, Ms. Hunter’s swaddle technique that calmed even the fussiest babies worked much better if it was demonstrated in person.
The two embarked on home visits with new parents. But their advice would be practical, not medical. Because they were not classified as traveling nurses, they drew a “definitive line” that they wouldn’t be discussing “major medical issues.”
“Going into the homes here in Atlanta, taking that folder, clipping nails, doing baths, discussing feeding — whether you were doing bottles or breastfeeding — we were going to help parents where they were,” Ms. Hunter said.
The physicians they worked with began recommending their services. Ms. Walker jokes that they didn’t know what they were doing at first; they considered giving their first client their money back. But parents needed what they were delivering, which was advice, validation, and confidence in their parenting.
Just 6-8 weeks into their initiative, other practices started to inquire about whether the nurses could do the same thing for them.
It was a solution to the problem of the 15-minute office visit. “We were helping with those questions so that when [babies] came in for their well visits, those questions were already answered. Not only did we go into their homes, but we supported them in the months after we left,” Ms. Hunter said.
The Ripple Effect
The outcomes were astonishing. “Babies were sleeping through the night. Parents were more confident. We didn’t expect the results, and we were shocked at how consistent it was,” Ms. Walker said. “Laura and I used to call each other in disbelief after we would put these basic principles in place and partner with parents.”
Local pediatricians were grateful for the help. But for the nurses, it was about walking alongside families. The two have countless stories of desperate parents, marriages “on the brink of disaster,” moments when they realized their work was having a ripple effect.
One military family stands out in Ms. Walker’s memory. “The father was fighting for our country overseas, and his wife was struggling alone at home.”
But support from Moms on Call had a powerful impact. “When [the father] came home, he presented Laura with a flag and a beautiful personal note expressing his gratitude,” Ms. Walker said. “Once his wife had a partner to help and felt confident and well rested, his heart could rest as well. We did what he couldn’t, and it made all the difference. After all, that’s what he was fighting for in the first place.”
The Gambler Calls
After just 1 or 2 years as Moms on Call, Ms. Walker and Ms. Hunter got an unexpected call from none other than celebrity singer Kenny Rogers, who needed help with his twins.
“I was flipping through the folder, and he said: ‘It’s not copyrighted. It’ll be copyrighted tomorrow morning,’ ” Ms. Hunter recalled.
Mr. Rogers’ attorneys called the next day to provide all the information. “He said: ‘Y’all have got something here. Send this folder to a self-publishing company. Throw up a website. It’ll cost you a few thousand bucks,’” said Ms. Hunter. The business was officially born in 2004.
More of Mr. Rogers’ advice: “You can’t hit a bull’s-eye if you don’t throw a few darts. This is worth throwing a few darts at.”
‘They Don’t Teach You That in Nursing School’
The two nurses reimagined their all-knowing folder as a book with a DVD in the back. Because how do you teach parents how to suction noses without showing it? They also wanted to use an outline format — simpler for exhausted parents who just needed to get the information quickly. A few publishers pushed back on these ideas. But the nurses persisted and self-published the first edition.
The original website was basic. Ms. Walker’s Aunt Janet put it together. But grateful clients were Ms. Walker and Ms. Hunter’s best marketing tool, spreading the word to friends and family. The message: Parents know their own children best and can be empowered to help their own kids, rather than leaning on professionals alone.
A community of families also helped them navigate starting a business. A client who was a mergers and acquisitions lawyer helped them form their LLC. “They don’t teach you that in nursing school,” Ms. Walker said.
Ms. Walker added that they made mistakes. “Not everyone that we encountered viewed or felt the same way about growing a business that is primarily focused on helping families. Sometimes that meant offering services at no charge. Or saying no to certain partnerships that didn’t align with our business model.”
Ms. Walker and Ms. Hunter had an eye on equity in creating multiple ways to access their advice at various price points. They started by charging around $75 for an in-home visit. (Now, if one of the CEOs comes out, it’s around $1000.) But the books, app, and online resources support those who can’t access that, as do an additional 10 in-home consultants around the country.
Along the way, moments told them they were going in the right direction and helped them define their purpose. “It is having a client ‘buy’ us as their go-to [baby] shower gift. It is being able to provide and support a clinic in Kenya or military families around the world. It is helping families realize that they can sleep — that they aren’t alone,” Ms. Walker said.
On Call 24/7 in the Car, in the Checkout Line ...
The early days of Moms on Call were also a juggling act. As Ms. Walker and Ms. Hunter balanced work and home with 10 of their own kids between the two of them, they took calls wherever they were. A friend and caller once joked that she could tell Ms. Hunter was checking out at the grocery store while she advised her on her very sick son’s vomiting.
“We were still trying to take care of the kids, run the house, and neither one of us had nannies or night nurses or housekeepers,” Ms. Hunter said. “But being on call allowed us to still be at home.”
Ms. Walker remembers taking calls on the way to ball games with her own kids, who by 8 years old could recite the advice for a baby’s fever from the back of the car. “It was like a family affair, and our kids got to see how that works and see their moms in action,” she said.
Through it all, Ms. Walker and Ms. Hunter’s motivation came from knowing that thousands of parents were begging for help — and they had an answer.
“Our shoulders have absorbed so many tears of parents who were exhausted and hurting, some who had been lied to or told their child would never sleep or had to be raised a certain way. When someone steals that confidence, especially from a brand-new parent overwhelmed by information, it makes us want to shout the truth from every rooftop and digital channel available,” Ms. Walker added.
Do You Have a Business Idea?
“Boots on the ground” healthcare professionals often see new opportunities to serve patients who might be falling through the cracks of the healthcare system. While not all will become a full-blown business, Ms. Hunter encourages them to break down their idea into “bite-sized pieces.” Just have the next conversation.
“Ask the people around you and the people who are brought to you,” Ms. Hunter said. When the two nurses look back, they see how those pieces of the puzzle were meant to come together. “Ask everyone you know,” Ms. Hunter advised. “And talk to the people you are taking care of. It’s possible they have a gift that will help you get to the next bite-sized piece.”
In short — develop a network of people who believe in your idea. Prioritize those relationships and see where they can take you.
The close relationship between Ms. Walker and Ms. Hunter, as business partners and friends, has also been crucial. They joke that they finish each other’s sentences and sandwiches. “You have to fight for that — we prioritize [that relationship]” too, Ms. Walker said.
Finally, remember why you are doing what you do, Ms. Walker said. “These are the people we help: Wonderful people with jobs that serve us all — the airplane pilot, the anesthesiologist, the pediatrician, the single dad. They are all parents who have felt alone and exhausted. In those lonely moments of a parent’s heart where they fear they are doing the wrong thing, we want to be the voice of hope,” she added. “We let them know that if they ever wondered if they were doing it right, well, only good parents wonder that.”
A version of this article appeared on Medscape.com.
FDA Approves Lymphir for R/R Cutaneous T-Cell Lymphoma
The immunotherapy is a reformulation of denileukin diftitox (Ontak), initially approved in 1999 for certain patients with persistent or recurrent cutaneous T-cell lymphoma. In 2014, the original formulation was voluntarily withdrawn from the US market. Citius acquired rights to market a reformulated product outside of Asia in 2021.
This is the first indication for Lymphir, which targets interleukin-2 receptors on malignant T cells.
This approval marks “a significant milestone” for patients with cutaneous T-cell lymphoma, a rare cancer, company CEO Leonard Mazur said in a press release announcing the approval. “The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the [cutaneous T-cell lymphoma] treatment landscape and grow the overall market, currently estimated to be $300-$400 million.”
Approval was based on the single-arm, open-label 302 study in 69 patients who had a median of four prior anticancer therapies. Patients received 9 mcg/kg daily from day 1 to day 5 of 21-day cycles until disease progression or unacceptable toxicity.
The objective response rate was 36.2%, including complete responses in 8.7% of patients. Responses lasted 6 months or longer in 52% of patients. Over 80% of subjects had a decrease in skin tumor burden, and almost a third had clinically significant improvements in pruritus.
Adverse events occurring in 20% or more of patients include increased transaminases, decreased albumin, decreased hemoglobin, nausea, edema, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.
Labeling carries a boxed warning of capillary leak syndrome. Other warnings include visual impairment, infusion reactions, hepatotoxicity, and embryo-fetal toxicity. Citius is under a postmarketing requirement to characterize the risk for visual impairment.
The company expects to launch the agent within 5 months.
A version of this article first appeared on Medscape.com.
The immunotherapy is a reformulation of denileukin diftitox (Ontak), initially approved in 1999 for certain patients with persistent or recurrent cutaneous T-cell lymphoma. In 2014, the original formulation was voluntarily withdrawn from the US market. Citius acquired rights to market a reformulated product outside of Asia in 2021.
This is the first indication for Lymphir, which targets interleukin-2 receptors on malignant T cells.
This approval marks “a significant milestone” for patients with cutaneous T-cell lymphoma, a rare cancer, company CEO Leonard Mazur said in a press release announcing the approval. “The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the [cutaneous T-cell lymphoma] treatment landscape and grow the overall market, currently estimated to be $300-$400 million.”
Approval was based on the single-arm, open-label 302 study in 69 patients who had a median of four prior anticancer therapies. Patients received 9 mcg/kg daily from day 1 to day 5 of 21-day cycles until disease progression or unacceptable toxicity.
The objective response rate was 36.2%, including complete responses in 8.7% of patients. Responses lasted 6 months or longer in 52% of patients. Over 80% of subjects had a decrease in skin tumor burden, and almost a third had clinically significant improvements in pruritus.
Adverse events occurring in 20% or more of patients include increased transaminases, decreased albumin, decreased hemoglobin, nausea, edema, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.
Labeling carries a boxed warning of capillary leak syndrome. Other warnings include visual impairment, infusion reactions, hepatotoxicity, and embryo-fetal toxicity. Citius is under a postmarketing requirement to characterize the risk for visual impairment.
The company expects to launch the agent within 5 months.
A version of this article first appeared on Medscape.com.
The immunotherapy is a reformulation of denileukin diftitox (Ontak), initially approved in 1999 for certain patients with persistent or recurrent cutaneous T-cell lymphoma. In 2014, the original formulation was voluntarily withdrawn from the US market. Citius acquired rights to market a reformulated product outside of Asia in 2021.
This is the first indication for Lymphir, which targets interleukin-2 receptors on malignant T cells.
This approval marks “a significant milestone” for patients with cutaneous T-cell lymphoma, a rare cancer, company CEO Leonard Mazur said in a press release announcing the approval. “The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the [cutaneous T-cell lymphoma] treatment landscape and grow the overall market, currently estimated to be $300-$400 million.”
Approval was based on the single-arm, open-label 302 study in 69 patients who had a median of four prior anticancer therapies. Patients received 9 mcg/kg daily from day 1 to day 5 of 21-day cycles until disease progression or unacceptable toxicity.
The objective response rate was 36.2%, including complete responses in 8.7% of patients. Responses lasted 6 months or longer in 52% of patients. Over 80% of subjects had a decrease in skin tumor burden, and almost a third had clinically significant improvements in pruritus.
Adverse events occurring in 20% or more of patients include increased transaminases, decreased albumin, decreased hemoglobin, nausea, edema, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.
Labeling carries a boxed warning of capillary leak syndrome. Other warnings include visual impairment, infusion reactions, hepatotoxicity, and embryo-fetal toxicity. Citius is under a postmarketing requirement to characterize the risk for visual impairment.
The company expects to launch the agent within 5 months.
A version of this article first appeared on Medscape.com.
More Access to Perinatal Mental Healthcare Needed
Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.
In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.
The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.
The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.
In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).
In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.
Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.
Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.
In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.
The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.
They called for more measures to mitigate the excess burden of PMADs.
This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.
Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.
In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.
The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.
The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.
In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).
In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.
Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.
Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.
In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.
The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.
They called for more measures to mitigate the excess burden of PMADs.
This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.
Despite federal legislation improving healthcare access, concerted efforts are still needed to increase evidence-based treatment for maternal perinatal mental health issues, a large study of commercially insured mothers suggested. It found that federal legislation had variable and suboptimal effect on mental health services use by delivering mothers.
In the cross-sectional study, published in JAMA Network Open, psychotherapy receipt increased somewhat during 2007-2019 among all mothers and among those diagnosed with perinatal mood and anxiety disorders (PMADs). The timeline encompassed periods before and after passage of the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 and the Patient Protection and Affordable Care Act (ACA) of 2010.
The investigators, led by Kara Zivin, PhD, MS, MFA, a professor of psychiatry in the University of Michigan’s School of Public Health at Ann Arbor, found the results varied by policy and between the overall delivering population and the PMAD population. “We did not find a statistically significant immediate change associated with the MHPAEA or ACA in the overall delivering population, except for a steady increase in delivering women who received any psychotherapy after ACA,” Dr. Zivin and colleagues wrote.
The researchers looked at private insurance data for 837,316 deliveries among 716,052 women (64.2% White), ages 15-44 (mean 31.2), to assess changes in psychotherapy visits in the year before and after delivery. They also estimated per-visit out-of-pocket costs for the ACA in 2014 and the MHPAEA in 2010.
In the PMAD population, the MHPAEA was associated with an immediate increase in psychotherapy receipt of 0.72% (95% CI, 0.26%-1.18%; P = .002), followed by a sustained decrease of 0.05% (95% CI, 0.09%-0.02%; P = .001).
In both populations, the ACA was associated with immediate and sustained monthly increases in use of 0.77% (95% CI, 0.26%-1.27%; P = .003) and 0.07% (95% CI, 0.02%-0.12%; P = .005), respectively.
Post MHPAEA, both populations experienced a slight decrease in per-visit monthly out-of-pocket costs, while after the ACA they saw an immediate and steady monthly increase in these.
Although both policies expanded access to any psychotherapy, the greater number of people receiving visits coincided with fewer visits per person, the authors noted. “One hypothesis suggests that the number of available mental health clinicians may not have increased enough to meet the new demand; future research should better characterize this trend,” they wrote.
In addition, a lower standard cost per visit may have dampened the incentive to increase the number of mental health clinicians, they conjectured. These factors could explain why the PMAD group appeared to experience a decrease in the proportion receiving any psychotherapy after the MHPAEA’s implementation.
The findings should be reviewed in the context of the current mental health burden, the authors wrote, in which the shortage of mental health professionals means that less than 30% of mental healthcare needs are being met.
They called for more measures to mitigate the excess burden of PMADs.
This study was funded by the National Institutes of Health. Dr. Zivin had no conflicts of interest. Coauthor Dr. Dalton reported personal fees from Merck, the Society of Family Planning, Up to Date, and The Medical Letter outside of the submitted work.
FROM JAMA NETWORK NEWS
Immunotherapy May Be Overused in Dying Patients With Cancer
Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.
Immunotherapy, however, has been taking its place.
This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.
What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
The N-of-1 Patient
With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.
He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.
The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.
Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”
At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”
This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
Back to Earth
The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.
Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.
Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.
She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.
Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.
Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.
And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.
In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
Prescribing Decisions
Recent research highlights the growing use of immunotherapy at the end of life.
Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.
Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.
Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.
Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.
Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.
More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.
The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.
Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.
To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”
While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.
As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.
Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.
“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.
“Just because something can be done doesn’t always mean it should be done,” he said.
At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.
Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”
Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.
“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”
Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.
Immunotherapy, however, has been taking its place.
This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.
What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
The N-of-1 Patient
With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.
He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.
The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.
Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”
At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”
This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
Back to Earth
The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.
Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.
Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.
She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.
Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.
Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.
And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.
In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
Prescribing Decisions
Recent research highlights the growing use of immunotherapy at the end of life.
Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.
Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.
Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.
Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.
Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.
More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.
The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.
Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.
To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”
While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.
As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.
Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.
“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.
“Just because something can be done doesn’t always mean it should be done,” he said.
At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.
Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”
Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.
“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”
Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Chemotherapy has fallen out of favor for treating cancer toward the end of life. The toxicity is too high, and the benefit, if any, is often too low.
Immunotherapy, however, has been taking its place.
This means “there are patients who are getting immunotherapy who shouldn’t,” said Yale University, New Haven, Connecticut, surgical oncologist Sajid Khan, MD, senior investigator on a recent study that highlighted the growing use of these agents in patients’ last month of life.
What’s driving this trend, and how can oncologists avoid overtreatment with immunotherapy at the end of life?
The N-of-1 Patient
With immunotherapy at the end of life, “each of us has had our N-of-1” where a patient bounces back with a remarkable and durable response, said Don Dizon, MD, a gynecologic oncologist at Brown University, Providence, Rhode Island.
He recalled a patient with sarcoma who did not respond to chemotherapy. But after Dr. Dizon started her on immunotherapy, everything turned around. She has now been in remission for 8 years and counting.
The possibility of an unexpected or remarkable responder is seductive. And the improved safety of immunotherapy over chemotherapy adds to the allure.
Meanwhile, patients are often desperate. It’s rare for someone to be ready to stop treatment, Dr. Dizon said. Everybody “hopes that they’re going to be the exceptional responder.”
At the end of the day, the question often becomes: “Why not try immunotherapy? What’s there to lose?”
This thinking may be prompting broader use of immunotherapy in late-stage disease, even in instances with no Food and Drug Administration indication and virtually no supportive data, such as for metastatic ovarian cancer, Dr. Dizon said.
Back to Earth
The problem with the hopeful approach is that end-of-life turnarounds with immunotherapy are rare, and there’s no way at the moment to predict who will have one, said Laura Petrillo, MD, a palliative care physician at Massachusetts General Hospital, Boston.
Even though immunotherapy generally comes with fewer adverse events than chemotherapy, catastrophic side effects are still possible.
Dr. Petrillo recalled a 95-year-old woman with metastatic cancer who was largely asymptomatic.
She had a qualifying mutation for a checkpoint inhibitor, so her oncologist started her on one. The patient never bounced back from the severe colitis the agent caused, and she died of complications in the hospital.
Although such reactions with immunotherapy are uncommon, less serious problems caused by the agents can still have a major impact on a person’s quality of life. Low-grade diarrhea, for instance, may not sound too bad, but in a patient’s daily life, it can translate to six or more episodes a day.
Even with no side effects, prescribing immunotherapy can mean that patients with limited time left spend a good portion of it at an infusion clinic instead of at home. These patients are also less likely to be referred to hospice and more likely to be admitted to and die in the hospital.
And with treatments that can cost $20,000 per dose, financial toxicity becomes a big concern.
In short, some of the reasons why chemotherapy is not recommended at the end of life also apply to immunotherapy, Dr. Petrillo said.
Prescribing Decisions
Recent research highlights the growing use of immunotherapy at the end of life.
Dr. Khan’s retrospective study found, for instance, that the percentage of patients starting immunotherapy in the last 30 days of life increased by about fourfold to fivefold over the study period for the three cancers analyzed — stage IV melanoma, lung, and kidney cancers.
Among the population that died within 30 days, the percentage receiving immunotherapy increased over the study periods — 0.8%-4.3% for melanoma, 0.9%-3.2% for NSCLC, and 0.5%-2.6% for kidney cell carcinoma — prompting the conclusion that immunotherapy prescriptions in the last month of life are on the rise.
Prescribing immunotherapy in patients who ultimately died within 1 month occurred more frequently at low-volume, nonacademic centers than at academic or high-volume centers, and outcomes varied by practice setting.
Patients had better survival outcomes overall when receiving immunotherapy at academic or high-volume centers — a finding Dr. Khan said is worth investigating further. Possible explanations include better management of severe immune-related side effects at larger centers and more caution when prescribing immunotherapy to “borderline” candidates, such as those with several comorbidities.
Importantly, given the retrospective design, Dr. Khan and colleagues already knew which patients prescribed immunotherapy died within 30 days of initiating treatment.
More specifically, 5192 of 71,204 patients who received immunotherapy (7.3%) died within a month of initiating therapy, while 66,012 (92.7%) lived beyond that point.
The study, however, did not assess how the remaining 92.7% who lived beyond 30 days fared on immunotherapy and the differences between those who lived less than 30 days and those who survived longer.
Knowing the outcome of patients at the outset of the analysis still leaves open the question of when immunotherapy can extend life and when it can’t for the patient in front of you.
To avoid overtreating at the end of life, it’s important to have “the same standard that you have for giving chemotherapy. You have to treat it with the same respect,” said Moshe Chasky, MD, a community medical oncologist with Alliance Cancer Specialists in Philadelphia, Pennsylvania. “You can’t just be throwing” immunotherapy around “at the end of life.”
While there are no clear predictors of risk and benefit, there are some factors to help guide decisions.
As with chemotherapy, Dr. Petrillo said performance status is key. Dr. Petrillo and colleagues found that median overall survival with immune checkpoint inhibitors for advanced non–small cell lung cancer was 14.3 months in patients with an Eastern Cooperative Oncology Group performance score of 0-1 but only 4.5 months with scores of ≥ 2.
Dr. Khan also found that immunotherapy survival is, unsurprisingly, worse in patients with high metastatic burdens and more comorbidities.
“You should still consider immunotherapy for metastatic melanoma, non–small cell lung cancer, and renal cell carcinoma,” Dr. Khan said. The message here is to “think twice before using” it, especially in comorbid patients with widespread metastases.
“Just because something can be done doesn’t always mean it should be done,” he said.
At Yale, when Dr. Khan works, immunotherapy decisions are considered by a multidisciplinary tumor board. At Mass General, immunotherapy has generally moved to the frontline setting, and the hospital no longer prescribes checkpoint inhibitors to hospitalized patients because the cost is too high relative to the potential benefit, Dr. Petrillo explained.
Still, with all the uncertainties about risk and benefit, counseling patients is a challenge. Dr. Dizon called it “the epitome of shared decision-making.”
Dr. Petrillo noted that it’s critical not to counsel patients based solely on the anecdotal patients who do surprisingly well.
“It’s hard to mention that and not have that be what somebody anchors on,” she said. But that speaks to “how desperate people can feel, how hopeful they can be.”
Dr. Khan, Dr. Petrillo, and Dr. Chasky all reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Free Med School Alone Won’t Boost Diversity
This transcript has been edited for clarity.
We need more diverse students — more students from disadvantaged and underrepresented backgrounds in medical school. That is not a controversial take. That’s not even a new thought.
What is a hot take, however, is that free medical school alone is not going to accomplish this goal. In fact, based on data and what people think and are saying, that’s just reality.
I recently chatted about whether or not free medical school would motivate more students to pursue primary care. That was New York University’s (NYU’s) goal. If you haven’t seen that video, check it out. Now I want to explore whether free medical school would actually create a more diverse medical student body.
This topic is especially important now because, in 2023, the Supreme Court ended affirmative action for college admissions, and this naturally has a downstream effect when it comes to getting into medical school. Right now, about 6% of US physicians are Black or Hispanic/Latina, and around 0.1%-0.3% identify as Indigenous Americans, Native Hawaiians, or Pacific Islanders.
Is free medical school the answer? Well, that’s based on a huge assumption that the cost of medical school — incoming debt — is the single greatest barrier for students from diverse backgrounds, as if every single student from every background had the same level of resources in the same opportunity and were all equally competitive prior to applying, and just the prospect of debt is what caused the disparity. I don’t know if that’s reality. Let’s take a look at NYU.
After the free tuition announcement, total applications to the medical school went up nearly 50%. And from underrepresented groups, it was 100%. In 2019, the associate dean for admissions said, “A key driver was to remove a financial disincentive that dissuades people from pursuing a path in medicine.” But the acceptance rate stayed under 3%, and the average Medical College Admission Test (MCAT) and grade point average (GPA) to get in went up. Basically, the school just became more competitive.
I will always commend anyone, anywhere, who is making medical school more affordable and more accessible. With NYU, it seems a tuition gift just made it harder for students from disadvantaged backgrounds to actually get in. I mean, congratulations, you got more applications. This probably helped in ratings, and you got mentioned in news headlines, but are you actually achieving your mission?
At NYU, over the last few years, Black students made up about 11% of the medical school class, which is actually down from 2017 before the tuition gift. Students from low-income backgrounds, whom this would really benefit, used to make up around 12% of the class prior to the free tuition announcement, and now it’s around 3%-7%.
According to students from underrepresented backgrounds, the outreach and the equal opportunity need to start way earlier. The K-12 process needs to be addressed, as do mentorship opportunities and guidance throughout college, MCAT prep, resources for interviews, research opportunities, and so much more.
The following quote is from an interview with an interventional cardiology fellow who came here as a refugee: “For me, growing up, basic necessities like a quiet study space, high-speed internet, healthy meals and proper sleep were luxuries of which I could only dream. After resettling in the US as a political refugee, I lived in circumstances where such comforts were out of reach, and my path to medical school seemed insurmountable.”
I also spoke to a friend in pediatric cancer, Michael Galvez, MD, who was outspoken about the need to improve representation in medicine, about what he thought would actually work to diversify medical schools. He mentioned adversity scores or looking at the distance traveled for applicants, as well as efforts to recruit from local, state, and community colleges, which often reflect local underserved populations.
Dr. Galvez also agreed that although such metrics as GPA and MCAT are important, medical schools should also consider the impact applicants may have had for local, underserved communities and life experiences that may represent significant potential contributions applicants can make for public health.
The effort needs to start early. If we take a look at one of the most diverse medical schools in the country, UC Davis, we can see how this makes a difference. At UC Davis, in the class of 2026, about half of the 133 students come from underrepresented backgrounds in medicine. I’m taking a look at their website from the Office of Student and Resident Diversity, and it lists:
- K-12 outreach programs
- Undergraduate and community college programs
- Specific plans for postbaccalaureate students
- Support systems
- Resources for students that extend far beyond just premedical students
My home institution, Stanford School of Medicine, has similar programs as well, with similar ways for students from underrepresented backgrounds to find support and mentorship. This all makes a huge difference.
Regarding the actual admissions process for medical school, I’ll highlight the Johns Hopkins School of Medicine and the adaptions they’ve made to create a more fair and holistic process. It includes:
- A clear mission statement about diversity enhancement
- Anonymous voting
- A larger group to avoid bias
- Not showing academic metrics to interviewers
- Implicit association tests and trainings
- Removing photos from applications
- Appointing women, minorities, and young people with less implicit bias to the committees
Does this seem like a lot? It is, because a comprehensive approach is what it takes to build a more diverse US physician workforce, which will provide more culturally competent care, empower future generations, break down barriers and disparities in health care, and ultimately improve public health. Free tuition is awesome. I’m jealous. But on its own to solve these problems? This all feels like a misguided attempt.
Dr. Patel is clinical instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons, and pediatric hospitalist at Morgan Stanley Children’s Hospital of NewYork-Presbyterian, New York, and Benioff Children’s Hospital, University of California, San Francisco. He disclosed ties with Medumo Inc.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
We need more diverse students — more students from disadvantaged and underrepresented backgrounds in medical school. That is not a controversial take. That’s not even a new thought.
What is a hot take, however, is that free medical school alone is not going to accomplish this goal. In fact, based on data and what people think and are saying, that’s just reality.
I recently chatted about whether or not free medical school would motivate more students to pursue primary care. That was New York University’s (NYU’s) goal. If you haven’t seen that video, check it out. Now I want to explore whether free medical school would actually create a more diverse medical student body.
This topic is especially important now because, in 2023, the Supreme Court ended affirmative action for college admissions, and this naturally has a downstream effect when it comes to getting into medical school. Right now, about 6% of US physicians are Black or Hispanic/Latina, and around 0.1%-0.3% identify as Indigenous Americans, Native Hawaiians, or Pacific Islanders.
Is free medical school the answer? Well, that’s based on a huge assumption that the cost of medical school — incoming debt — is the single greatest barrier for students from diverse backgrounds, as if every single student from every background had the same level of resources in the same opportunity and were all equally competitive prior to applying, and just the prospect of debt is what caused the disparity. I don’t know if that’s reality. Let’s take a look at NYU.
After the free tuition announcement, total applications to the medical school went up nearly 50%. And from underrepresented groups, it was 100%. In 2019, the associate dean for admissions said, “A key driver was to remove a financial disincentive that dissuades people from pursuing a path in medicine.” But the acceptance rate stayed under 3%, and the average Medical College Admission Test (MCAT) and grade point average (GPA) to get in went up. Basically, the school just became more competitive.
I will always commend anyone, anywhere, who is making medical school more affordable and more accessible. With NYU, it seems a tuition gift just made it harder for students from disadvantaged backgrounds to actually get in. I mean, congratulations, you got more applications. This probably helped in ratings, and you got mentioned in news headlines, but are you actually achieving your mission?
At NYU, over the last few years, Black students made up about 11% of the medical school class, which is actually down from 2017 before the tuition gift. Students from low-income backgrounds, whom this would really benefit, used to make up around 12% of the class prior to the free tuition announcement, and now it’s around 3%-7%.
According to students from underrepresented backgrounds, the outreach and the equal opportunity need to start way earlier. The K-12 process needs to be addressed, as do mentorship opportunities and guidance throughout college, MCAT prep, resources for interviews, research opportunities, and so much more.
The following quote is from an interview with an interventional cardiology fellow who came here as a refugee: “For me, growing up, basic necessities like a quiet study space, high-speed internet, healthy meals and proper sleep were luxuries of which I could only dream. After resettling in the US as a political refugee, I lived in circumstances where such comforts were out of reach, and my path to medical school seemed insurmountable.”
I also spoke to a friend in pediatric cancer, Michael Galvez, MD, who was outspoken about the need to improve representation in medicine, about what he thought would actually work to diversify medical schools. He mentioned adversity scores or looking at the distance traveled for applicants, as well as efforts to recruit from local, state, and community colleges, which often reflect local underserved populations.
Dr. Galvez also agreed that although such metrics as GPA and MCAT are important, medical schools should also consider the impact applicants may have had for local, underserved communities and life experiences that may represent significant potential contributions applicants can make for public health.
The effort needs to start early. If we take a look at one of the most diverse medical schools in the country, UC Davis, we can see how this makes a difference. At UC Davis, in the class of 2026, about half of the 133 students come from underrepresented backgrounds in medicine. I’m taking a look at their website from the Office of Student and Resident Diversity, and it lists:
- K-12 outreach programs
- Undergraduate and community college programs
- Specific plans for postbaccalaureate students
- Support systems
- Resources for students that extend far beyond just premedical students
My home institution, Stanford School of Medicine, has similar programs as well, with similar ways for students from underrepresented backgrounds to find support and mentorship. This all makes a huge difference.
Regarding the actual admissions process for medical school, I’ll highlight the Johns Hopkins School of Medicine and the adaptions they’ve made to create a more fair and holistic process. It includes:
- A clear mission statement about diversity enhancement
- Anonymous voting
- A larger group to avoid bias
- Not showing academic metrics to interviewers
- Implicit association tests and trainings
- Removing photos from applications
- Appointing women, minorities, and young people with less implicit bias to the committees
Does this seem like a lot? It is, because a comprehensive approach is what it takes to build a more diverse US physician workforce, which will provide more culturally competent care, empower future generations, break down barriers and disparities in health care, and ultimately improve public health. Free tuition is awesome. I’m jealous. But on its own to solve these problems? This all feels like a misguided attempt.
Dr. Patel is clinical instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons, and pediatric hospitalist at Morgan Stanley Children’s Hospital of NewYork-Presbyterian, New York, and Benioff Children’s Hospital, University of California, San Francisco. He disclosed ties with Medumo Inc.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
We need more diverse students — more students from disadvantaged and underrepresented backgrounds in medical school. That is not a controversial take. That’s not even a new thought.
What is a hot take, however, is that free medical school alone is not going to accomplish this goal. In fact, based on data and what people think and are saying, that’s just reality.
I recently chatted about whether or not free medical school would motivate more students to pursue primary care. That was New York University’s (NYU’s) goal. If you haven’t seen that video, check it out. Now I want to explore whether free medical school would actually create a more diverse medical student body.
This topic is especially important now because, in 2023, the Supreme Court ended affirmative action for college admissions, and this naturally has a downstream effect when it comes to getting into medical school. Right now, about 6% of US physicians are Black or Hispanic/Latina, and around 0.1%-0.3% identify as Indigenous Americans, Native Hawaiians, or Pacific Islanders.
Is free medical school the answer? Well, that’s based on a huge assumption that the cost of medical school — incoming debt — is the single greatest barrier for students from diverse backgrounds, as if every single student from every background had the same level of resources in the same opportunity and were all equally competitive prior to applying, and just the prospect of debt is what caused the disparity. I don’t know if that’s reality. Let’s take a look at NYU.
After the free tuition announcement, total applications to the medical school went up nearly 50%. And from underrepresented groups, it was 100%. In 2019, the associate dean for admissions said, “A key driver was to remove a financial disincentive that dissuades people from pursuing a path in medicine.” But the acceptance rate stayed under 3%, and the average Medical College Admission Test (MCAT) and grade point average (GPA) to get in went up. Basically, the school just became more competitive.
I will always commend anyone, anywhere, who is making medical school more affordable and more accessible. With NYU, it seems a tuition gift just made it harder for students from disadvantaged backgrounds to actually get in. I mean, congratulations, you got more applications. This probably helped in ratings, and you got mentioned in news headlines, but are you actually achieving your mission?
At NYU, over the last few years, Black students made up about 11% of the medical school class, which is actually down from 2017 before the tuition gift. Students from low-income backgrounds, whom this would really benefit, used to make up around 12% of the class prior to the free tuition announcement, and now it’s around 3%-7%.
According to students from underrepresented backgrounds, the outreach and the equal opportunity need to start way earlier. The K-12 process needs to be addressed, as do mentorship opportunities and guidance throughout college, MCAT prep, resources for interviews, research opportunities, and so much more.
The following quote is from an interview with an interventional cardiology fellow who came here as a refugee: “For me, growing up, basic necessities like a quiet study space, high-speed internet, healthy meals and proper sleep were luxuries of which I could only dream. After resettling in the US as a political refugee, I lived in circumstances where such comforts were out of reach, and my path to medical school seemed insurmountable.”
I also spoke to a friend in pediatric cancer, Michael Galvez, MD, who was outspoken about the need to improve representation in medicine, about what he thought would actually work to diversify medical schools. He mentioned adversity scores or looking at the distance traveled for applicants, as well as efforts to recruit from local, state, and community colleges, which often reflect local underserved populations.
Dr. Galvez also agreed that although such metrics as GPA and MCAT are important, medical schools should also consider the impact applicants may have had for local, underserved communities and life experiences that may represent significant potential contributions applicants can make for public health.
The effort needs to start early. If we take a look at one of the most diverse medical schools in the country, UC Davis, we can see how this makes a difference. At UC Davis, in the class of 2026, about half of the 133 students come from underrepresented backgrounds in medicine. I’m taking a look at their website from the Office of Student and Resident Diversity, and it lists:
- K-12 outreach programs
- Undergraduate and community college programs
- Specific plans for postbaccalaureate students
- Support systems
- Resources for students that extend far beyond just premedical students
My home institution, Stanford School of Medicine, has similar programs as well, with similar ways for students from underrepresented backgrounds to find support and mentorship. This all makes a huge difference.
Regarding the actual admissions process for medical school, I’ll highlight the Johns Hopkins School of Medicine and the adaptions they’ve made to create a more fair and holistic process. It includes:
- A clear mission statement about diversity enhancement
- Anonymous voting
- A larger group to avoid bias
- Not showing academic metrics to interviewers
- Implicit association tests and trainings
- Removing photos from applications
- Appointing women, minorities, and young people with less implicit bias to the committees
Does this seem like a lot? It is, because a comprehensive approach is what it takes to build a more diverse US physician workforce, which will provide more culturally competent care, empower future generations, break down barriers and disparities in health care, and ultimately improve public health. Free tuition is awesome. I’m jealous. But on its own to solve these problems? This all feels like a misguided attempt.
Dr. Patel is clinical instructor, Department of Pediatrics, Columbia University College of Physicians and Surgeons, and pediatric hospitalist at Morgan Stanley Children’s Hospital of NewYork-Presbyterian, New York, and Benioff Children’s Hospital, University of California, San Francisco. He disclosed ties with Medumo Inc.
A version of this article first appeared on Medscape.com.
Tool Can Help Predict Futile Surgery in Pancreatic Cancer
TOPLINE:
METHODOLOGY:
- Immediate resection is associated with a high incidence of postoperative complications and disease recurrence within a year of surgery in patients with pancreatic ductal adenocarcinoma. Predicting which patients likely won’t benefit from upfront pancreatectomy is important.
- To identify preoperative risk factors for futile pancreatectomy, researchers evaluated 1426 patients (median age, 69 years; 53.2% men) with anatomically resectable pancreatic ductal adenocarcinoma who underwent pancreatic resection between January 2010 and December 2021.
- The patients were divided into derivation (n = 885) and validation (n = 541) cohorts.
- The primary outcome was the rate of futile upfront pancreatectomy, defined as death or disease recurrence within 6 months of surgery. Patients were divided into three risk categories — low, intermediate, and high risk — each with escalating likelihoods of futile resection, worse pathological features, and worse outcomes.
- The secondary endpoint was to develop criteria for surgical candidacy, setting a futility likelihood threshold of < 20%. This threshold corresponds to the lower bound of the 95% confidence interval (CI) for postneoadjuvant resection rates (resection rate, 0.90; 95% CI, 0.80-1.01) from recent meta-analyses.
TAKEAWAY:
- The futility rate for pancreatectomy was 18.9% — 19.2% in the development cohort and 18.6% in the validation cohort. Three independent risk factors for futile resection included American Society of Anesthesiologists (ASA) class (95% CI for coefficients, 0.68-0.87), preoperative cancer antigen 19.9 serum levels (95% CI for coefficients, 0.05-0.75), and radiologic tumor size (95% CI for coefficients, 0.28-0.46).
- Using these independent risk factors, the predictive model demonstrated adequate calibration and discrimination in both the derivation and validation cohorts.
- The researchers then identified three risk groups. In the derivation cohort, the rate of futile pancreatectomy was 9.2% in the low-risk group, 18.0% in the intermediate-risk group, and 28.7% in the high-risk group (P < .001 for trend). In the validation cohort, the futility rate was 10.9% in the low-risk group, 20.2% in the intermediate-risk group, and 29.2% in the high-risk group (P < .001 for trend).
- Researchers identified four conditions associated with a futility likelihood below 20%, where larger tumor size is paired with lower cancer antigen 19.9 levels (defined as cancer antigen 19.9–adjusted-to-size). Patients who met these criteria experienced significantly longer disease-free survival (median 18.4 months vs 11.2 months) and overall survival (38.5 months vs 22.1 months).
IN PRACTICE:
“Although the study provides an easy-to-use calculator for clinical decision-making, there are some methodological limitations,” according to the authors of accompanying commentary. These limitations include failing to accurately describe how ASA class, cancer antigen 19.9 level, and tumor size were chosen for the model. “While we do not think the model is yet ready for standard clinical use, it may prove to be a viable tool if tested in future randomized trials comparing the neoadjuvant approach to upfront surgery in resectable pancreatic cancer,” the editorialists added.
SOURCE:
This study, led by Stefano Crippa, MD, PhD, Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy, and the accompanying commentary were published online in JAMA Surgery.
LIMITATIONS:
In addition to the limitations noted by the editorialists, others include the study’s retrospective design, which could introduce bias. Because preoperative imaging was not revised, the assigned resectability classes could show variability. Institutional differences existed in the selection process for upfront pancreatectomy. The model cannot be applied to cancer antigen 19.9 nonsecretors and was not externally validated.
DISCLOSURES:
The Italian Association for Cancer Research Special Program in Metastatic Disease and Italian Ministry of Health/Italian Foundation for the Research of Pancreatic Diseases supported the study in the form of a grant. Two authors reported receiving personal fees outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Immediate resection is associated with a high incidence of postoperative complications and disease recurrence within a year of surgery in patients with pancreatic ductal adenocarcinoma. Predicting which patients likely won’t benefit from upfront pancreatectomy is important.
- To identify preoperative risk factors for futile pancreatectomy, researchers evaluated 1426 patients (median age, 69 years; 53.2% men) with anatomically resectable pancreatic ductal adenocarcinoma who underwent pancreatic resection between January 2010 and December 2021.
- The patients were divided into derivation (n = 885) and validation (n = 541) cohorts.
- The primary outcome was the rate of futile upfront pancreatectomy, defined as death or disease recurrence within 6 months of surgery. Patients were divided into three risk categories — low, intermediate, and high risk — each with escalating likelihoods of futile resection, worse pathological features, and worse outcomes.
- The secondary endpoint was to develop criteria for surgical candidacy, setting a futility likelihood threshold of < 20%. This threshold corresponds to the lower bound of the 95% confidence interval (CI) for postneoadjuvant resection rates (resection rate, 0.90; 95% CI, 0.80-1.01) from recent meta-analyses.
TAKEAWAY:
- The futility rate for pancreatectomy was 18.9% — 19.2% in the development cohort and 18.6% in the validation cohort. Three independent risk factors for futile resection included American Society of Anesthesiologists (ASA) class (95% CI for coefficients, 0.68-0.87), preoperative cancer antigen 19.9 serum levels (95% CI for coefficients, 0.05-0.75), and radiologic tumor size (95% CI for coefficients, 0.28-0.46).
- Using these independent risk factors, the predictive model demonstrated adequate calibration and discrimination in both the derivation and validation cohorts.
- The researchers then identified three risk groups. In the derivation cohort, the rate of futile pancreatectomy was 9.2% in the low-risk group, 18.0% in the intermediate-risk group, and 28.7% in the high-risk group (P < .001 for trend). In the validation cohort, the futility rate was 10.9% in the low-risk group, 20.2% in the intermediate-risk group, and 29.2% in the high-risk group (P < .001 for trend).
- Researchers identified four conditions associated with a futility likelihood below 20%, where larger tumor size is paired with lower cancer antigen 19.9 levels (defined as cancer antigen 19.9–adjusted-to-size). Patients who met these criteria experienced significantly longer disease-free survival (median 18.4 months vs 11.2 months) and overall survival (38.5 months vs 22.1 months).
IN PRACTICE:
“Although the study provides an easy-to-use calculator for clinical decision-making, there are some methodological limitations,” according to the authors of accompanying commentary. These limitations include failing to accurately describe how ASA class, cancer antigen 19.9 level, and tumor size were chosen for the model. “While we do not think the model is yet ready for standard clinical use, it may prove to be a viable tool if tested in future randomized trials comparing the neoadjuvant approach to upfront surgery in resectable pancreatic cancer,” the editorialists added.
SOURCE:
This study, led by Stefano Crippa, MD, PhD, Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy, and the accompanying commentary were published online in JAMA Surgery.
LIMITATIONS:
In addition to the limitations noted by the editorialists, others include the study’s retrospective design, which could introduce bias. Because preoperative imaging was not revised, the assigned resectability classes could show variability. Institutional differences existed in the selection process for upfront pancreatectomy. The model cannot be applied to cancer antigen 19.9 nonsecretors and was not externally validated.
DISCLOSURES:
The Italian Association for Cancer Research Special Program in Metastatic Disease and Italian Ministry of Health/Italian Foundation for the Research of Pancreatic Diseases supported the study in the form of a grant. Two authors reported receiving personal fees outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Immediate resection is associated with a high incidence of postoperative complications and disease recurrence within a year of surgery in patients with pancreatic ductal adenocarcinoma. Predicting which patients likely won’t benefit from upfront pancreatectomy is important.
- To identify preoperative risk factors for futile pancreatectomy, researchers evaluated 1426 patients (median age, 69 years; 53.2% men) with anatomically resectable pancreatic ductal adenocarcinoma who underwent pancreatic resection between January 2010 and December 2021.
- The patients were divided into derivation (n = 885) and validation (n = 541) cohorts.
- The primary outcome was the rate of futile upfront pancreatectomy, defined as death or disease recurrence within 6 months of surgery. Patients were divided into three risk categories — low, intermediate, and high risk — each with escalating likelihoods of futile resection, worse pathological features, and worse outcomes.
- The secondary endpoint was to develop criteria for surgical candidacy, setting a futility likelihood threshold of < 20%. This threshold corresponds to the lower bound of the 95% confidence interval (CI) for postneoadjuvant resection rates (resection rate, 0.90; 95% CI, 0.80-1.01) from recent meta-analyses.
TAKEAWAY:
- The futility rate for pancreatectomy was 18.9% — 19.2% in the development cohort and 18.6% in the validation cohort. Three independent risk factors for futile resection included American Society of Anesthesiologists (ASA) class (95% CI for coefficients, 0.68-0.87), preoperative cancer antigen 19.9 serum levels (95% CI for coefficients, 0.05-0.75), and radiologic tumor size (95% CI for coefficients, 0.28-0.46).
- Using these independent risk factors, the predictive model demonstrated adequate calibration and discrimination in both the derivation and validation cohorts.
- The researchers then identified three risk groups. In the derivation cohort, the rate of futile pancreatectomy was 9.2% in the low-risk group, 18.0% in the intermediate-risk group, and 28.7% in the high-risk group (P < .001 for trend). In the validation cohort, the futility rate was 10.9% in the low-risk group, 20.2% in the intermediate-risk group, and 29.2% in the high-risk group (P < .001 for trend).
- Researchers identified four conditions associated with a futility likelihood below 20%, where larger tumor size is paired with lower cancer antigen 19.9 levels (defined as cancer antigen 19.9–adjusted-to-size). Patients who met these criteria experienced significantly longer disease-free survival (median 18.4 months vs 11.2 months) and overall survival (38.5 months vs 22.1 months).
IN PRACTICE:
“Although the study provides an easy-to-use calculator for clinical decision-making, there are some methodological limitations,” according to the authors of accompanying commentary. These limitations include failing to accurately describe how ASA class, cancer antigen 19.9 level, and tumor size were chosen for the model. “While we do not think the model is yet ready for standard clinical use, it may prove to be a viable tool if tested in future randomized trials comparing the neoadjuvant approach to upfront surgery in resectable pancreatic cancer,” the editorialists added.
SOURCE:
This study, led by Stefano Crippa, MD, PhD, Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy, and the accompanying commentary were published online in JAMA Surgery.
LIMITATIONS:
In addition to the limitations noted by the editorialists, others include the study’s retrospective design, which could introduce bias. Because preoperative imaging was not revised, the assigned resectability classes could show variability. Institutional differences existed in the selection process for upfront pancreatectomy. The model cannot be applied to cancer antigen 19.9 nonsecretors and was not externally validated.
DISCLOSURES:
The Italian Association for Cancer Research Special Program in Metastatic Disease and Italian Ministry of Health/Italian Foundation for the Research of Pancreatic Diseases supported the study in the form of a grant. Two authors reported receiving personal fees outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Last Call for Alcohol? Probably Not
For most of my formative years in medicine it was taken as gospel that 1-2 drinks/day, particularly red wine, was good for you.
Today though, the pendulum has swung the other way (granted, that could change in a year).
Recent re-analysis of the data now suggests there’s no benefit to any amount of alcohol. Zero. Zip. Nada.
This certainly isn’t the first time in medicine this has happened. It’s amazing how many studies end up getting re-analyzed, and re-re-analyzed, years later, with different conclusions reached.
It makes you wonder how these things happen. Possible explanations include flawed methodologies that either weren’t recognized at the time, confirmation bias, a rush to publish, and, rarely, outright fraud.
All of them, except for the last, are understandable. We all make mistakes. We’re all susceptible to the same statistical and psychological biases. Isn’t that part of the reason we do the peer-review process, so more than one pair of eyes can look for errors?
So, basically, no amount of alcohol is good for you.
Do I really think this is going to change anything? Hell no.
A huge amount of our culture revolves around alcohol. I’m not much of a drinker, but have no desire to give up my 2-3 beers per month, either. Just shopping in the store you see T-shirts, kitchen towels, gift bags, etc., that say things like “wine is just fruit salad” or “1 tequila, 2, tequila, 3 tequila, floor.”
The archaeological record suggests we began making alcoholic beverages 13,000 years ago. That’s a long time, and a pretty hard cultural habit to break. For comparison, tobacco has only been used for 3000 years.
In one of our strangest moments, America launched a 13-year experiment in prohibition, which failed miserably. Think about that. One hundred years ago, in 1924, you couldn’t legally buy alcohol anywhere in the United States. You had to break the law to get a drink, which most people did. Even then it was dangerous —in order to keep industrial ethanol from being sold to the public it was denatured with various toxins. As a result several thousand Americans died from their routine nightcap — with the government’s blessing.
Basically, alcohol isn’t going away. Not now, probably not ever.
There may be some out there who will alter their drinking habits based on the study, but I doubt it. I just don’t see too many people having a glass solely for the same reason they might take Lipitor or a multivitamin.
But I have no issue with correcting the original data. In medicine, and life in general, finding out what works is just as important as learning what doesn’t.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
For most of my formative years in medicine it was taken as gospel that 1-2 drinks/day, particularly red wine, was good for you.
Today though, the pendulum has swung the other way (granted, that could change in a year).
Recent re-analysis of the data now suggests there’s no benefit to any amount of alcohol. Zero. Zip. Nada.
This certainly isn’t the first time in medicine this has happened. It’s amazing how many studies end up getting re-analyzed, and re-re-analyzed, years later, with different conclusions reached.
It makes you wonder how these things happen. Possible explanations include flawed methodologies that either weren’t recognized at the time, confirmation bias, a rush to publish, and, rarely, outright fraud.
All of them, except for the last, are understandable. We all make mistakes. We’re all susceptible to the same statistical and psychological biases. Isn’t that part of the reason we do the peer-review process, so more than one pair of eyes can look for errors?
So, basically, no amount of alcohol is good for you.
Do I really think this is going to change anything? Hell no.
A huge amount of our culture revolves around alcohol. I’m not much of a drinker, but have no desire to give up my 2-3 beers per month, either. Just shopping in the store you see T-shirts, kitchen towels, gift bags, etc., that say things like “wine is just fruit salad” or “1 tequila, 2, tequila, 3 tequila, floor.”
The archaeological record suggests we began making alcoholic beverages 13,000 years ago. That’s a long time, and a pretty hard cultural habit to break. For comparison, tobacco has only been used for 3000 years.
In one of our strangest moments, America launched a 13-year experiment in prohibition, which failed miserably. Think about that. One hundred years ago, in 1924, you couldn’t legally buy alcohol anywhere in the United States. You had to break the law to get a drink, which most people did. Even then it was dangerous —in order to keep industrial ethanol from being sold to the public it was denatured with various toxins. As a result several thousand Americans died from their routine nightcap — with the government’s blessing.
Basically, alcohol isn’t going away. Not now, probably not ever.
There may be some out there who will alter their drinking habits based on the study, but I doubt it. I just don’t see too many people having a glass solely for the same reason they might take Lipitor or a multivitamin.
But I have no issue with correcting the original data. In medicine, and life in general, finding out what works is just as important as learning what doesn’t.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
For most of my formative years in medicine it was taken as gospel that 1-2 drinks/day, particularly red wine, was good for you.
Today though, the pendulum has swung the other way (granted, that could change in a year).
Recent re-analysis of the data now suggests there’s no benefit to any amount of alcohol. Zero. Zip. Nada.
This certainly isn’t the first time in medicine this has happened. It’s amazing how many studies end up getting re-analyzed, and re-re-analyzed, years later, with different conclusions reached.
It makes you wonder how these things happen. Possible explanations include flawed methodologies that either weren’t recognized at the time, confirmation bias, a rush to publish, and, rarely, outright fraud.
All of them, except for the last, are understandable. We all make mistakes. We’re all susceptible to the same statistical and psychological biases. Isn’t that part of the reason we do the peer-review process, so more than one pair of eyes can look for errors?
So, basically, no amount of alcohol is good for you.
Do I really think this is going to change anything? Hell no.
A huge amount of our culture revolves around alcohol. I’m not much of a drinker, but have no desire to give up my 2-3 beers per month, either. Just shopping in the store you see T-shirts, kitchen towels, gift bags, etc., that say things like “wine is just fruit salad” or “1 tequila, 2, tequila, 3 tequila, floor.”
The archaeological record suggests we began making alcoholic beverages 13,000 years ago. That’s a long time, and a pretty hard cultural habit to break. For comparison, tobacco has only been used for 3000 years.
In one of our strangest moments, America launched a 13-year experiment in prohibition, which failed miserably. Think about that. One hundred years ago, in 1924, you couldn’t legally buy alcohol anywhere in the United States. You had to break the law to get a drink, which most people did. Even then it was dangerous —in order to keep industrial ethanol from being sold to the public it was denatured with various toxins. As a result several thousand Americans died from their routine nightcap — with the government’s blessing.
Basically, alcohol isn’t going away. Not now, probably not ever.
There may be some out there who will alter their drinking habits based on the study, but I doubt it. I just don’t see too many people having a glass solely for the same reason they might take Lipitor or a multivitamin.
But I have no issue with correcting the original data. In medicine, and life in general, finding out what works is just as important as learning what doesn’t.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
Government Accuses Health System of Paying Docs Outrageous Salaries for Patient Referrals
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
SUNY Downstate Emergency Medicine Doc Charged With $1.5M Fraud
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
FDA Approves First Engineered Cell Therapy for a Solid Tumor
Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.
The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.
Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities.
“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”
T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors.
The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew.
According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.
“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.
The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.
The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.
The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.
The list price for the one-time therapy is $727,000, according to Fierce Pharma.
A version of this article first appeared on Medscape.com.
Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.
The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.
Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities.
“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”
T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors.
The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew.
According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.
“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.
The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.
The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.
The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.
The list price for the one-time therapy is $727,000, according to Fierce Pharma.
A version of this article first appeared on Medscape.com.
Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.
The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.
Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities.
“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”
T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors.
The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew.
According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.
“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.
The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.
The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.
The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.
The list price for the one-time therapy is $727,000, according to Fierce Pharma.
A version of this article first appeared on Medscape.com.