In a Parallel Universe, “I’d Be a Concert Pianist” Says Tennessee GI

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Whether it’s playing her piano, working on a sewing project or performing a colonoscopy, Stephanie D. Pointer, MD, enjoys working with her hands. She also relishes opportunities to think, to analyze, and solve problems for her patients.

One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.

 

Dr. Pointer
Dr. Stephanie D. Pointer

Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”

In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
 

Q: Why did you choose GI?

I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.

During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures. 
 

Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?

There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.

But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty. 
 

 

 

Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?

I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.

That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly. 
 

Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?

Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.

The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.

It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
 

Q: When you’re not being a GI, how do you spend your free weekend afternoons?

I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.

Lightning Round

Texting or talking?

Talking

Favorite junk food?

Chocolate chip cookies

Cat or dog person?

Cat

Favorite vacation?

Hawaii

How many cups of coffee do you drink per day?

I don’t drink coffee

Favorite ice cream?

Butter pecan

Favorite sport?

I don’t watch sports

Optimist or pessimist?

Optimist

Publications
Topics
Sections

Whether it’s playing her piano, working on a sewing project or performing a colonoscopy, Stephanie D. Pointer, MD, enjoys working with her hands. She also relishes opportunities to think, to analyze, and solve problems for her patients.

One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.

 

Dr. Pointer
Dr. Stephanie D. Pointer

Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”

In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
 

Q: Why did you choose GI?

I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.

During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures. 
 

Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?

There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.

But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty. 
 

 

 

Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?

I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.

That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly. 
 

Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?

Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.

The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.

It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
 

Q: When you’re not being a GI, how do you spend your free weekend afternoons?

I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.

Lightning Round

Texting or talking?

Talking

Favorite junk food?

Chocolate chip cookies

Cat or dog person?

Cat

Favorite vacation?

Hawaii

How many cups of coffee do you drink per day?

I don’t drink coffee

Favorite ice cream?

Butter pecan

Favorite sport?

I don’t watch sports

Optimist or pessimist?

Optimist

Whether it’s playing her piano, working on a sewing project or performing a colonoscopy, Stephanie D. Pointer, MD, enjoys working with her hands. She also relishes opportunities to think, to analyze, and solve problems for her patients.

One of her chief interests is inflammatory bowel disease (IBD). It’s reassuring to focus on a field of work “where I know exactly what’s causing the issue, and I can select a therapeutic approach (medication and lifestyle changes) that help a patient achieve remission,” said Dr. Pointer, co-owner and managing partner of Digestive and Liver Health Specialists in Hendersonville, Tenn. She’s also the medical director and a principal investigator of Quality Medical Research in Nashville, and currently serves as chair of the AGA Trainee and Early Career Committee.

 

Dr. Pointer
Dr. Stephanie D. Pointer

Starting her own practice has been just as challenging and rewarding as going through medical school. Medical training does not prepare you for starting your own practice, Dr. Pointer said, so she and her business partner have had to learn as they go. “But I think we’ve done very well. We’ve taken the ups and downs in stride.”

In an interview, Dr. Pointer spoke more about her work in IBD and the ways in which she’s given back to the community through music and mentoring.
 

Q: Why did you choose GI?

I knew from a very young age that I was going to be a physician. I had always been interested in science. When I got into medical school and became exposed to the different areas, I really liked the cognitive skills where you had to think through a problem or an issue. But I also liked the procedural things as well.

During my internal medicine residency training, I felt that I had a knack for it. As I was looking at different options, I decided on gastroenterology because it combined both cognitive thinking through issues, but also taking it to the next step and intervening through procedures. 
 

Q: During fellowship, your focus was inflammatory bowel disease. What drew your interest to this condition?

There are a lot of different areas within gastroenterology that one can subspecialize in, as we see the full gamut of gastrointestinal and hepatic disorders. But treating some conditions, like functional disorders, means taking more of a ‘trial and error’ approach, and you may not always get the patient a hundred percent better. That’s not to say that we can’t improve a patient’s quality of life, but it’s not always a guarantee.

But inflammatory bowel disease is a little bit different. Because I can point to an exact spot in the intestines that’s causing the problem, it’s very fulfilling for me as a physician to take a patient who is having 10-12 bloody bowel movements a day, to normal form stools and no abdominal pain. They’re able to gain weight and go on about their lives and about their day. So that was why I picked inflammatory bowel disease as my subspecialty. 
 

 

 

Q: Tell me about the gastroenterology elective you developed for family medicine residents and undergraduate students. What’s the status of the program now?

I’ve always been interested in teaching and giving back to the next generations. I feel like I had great mentor opportunities and people who helped me along the way. In my previous hospital position, I was able to work with the family medicine department and create an elective through which residents and even undergraduate students could come and shadow and work with me in the clinic and see me performing procedures.

That elective ended once I left that position, at least as far as I’m aware. But in the private practice that I co-own now, we have numerous shadowing opportunities. I was able to give a lecture at Middle Tennessee State University for some students. And through that lecture, many students have reached out to me to shadow. I have allowed them to come shadow and do clinic work as a medical assistant and watch me perform procedures. I have multiple students working with me weekly. 
 

Q: Years ago, you founded the non-profit Enchanted Fingers Piano Lessons, which gave free piano lessons to underserved youth. What was that experience like?

Piano was one of my first loves. In some parallel universe, there’s a Dr. Pointer who is a classical, concert pianist. I started taking piano lessons when I was in early middle school, and I took to it very quickly. I was able to excel. I just loved it. I enjoyed practicing and I still play.

The impetus for starting Enchanted Fingers Piano lessons was because I wanted to give back again to the community. I came from an underserved community. Oftentimes children and young adults in those communities don’t get exposed to extracurricular activities and they don’t even know what they could potentially have a passion for. And I definitely had a passion for piano. I partnered with a church organization and they allowed me to use their church to host these piano lessons, and it was a phenomenal and rewarding experience. I would definitely like to start it up again one day in the future. It was an amazing experience.

It’s actually how I met my husband. He was one of the young adult students who signed up to take lessons. We both still enjoy playing the piano together.
 

Q: When you’re not being a GI, how do you spend your free weekend afternoons?

I’m a creative at heart. I really enjoy sewing and I’m working on a few sewing projects. I just got a serger. It is a machine that helps you finish a seam. It can also be used to sew entire garments. That has been fun, learning how to thread that machine. When I’m not doing that or just relaxing with my family, I do enjoy curling up with a good book. Stephen King is one of my favorite authors.

Lightning Round

Texting or talking?

Talking

Favorite junk food?

Chocolate chip cookies

Cat or dog person?

Cat

Favorite vacation?

Hawaii

How many cups of coffee do you drink per day?

I don’t drink coffee

Favorite ice cream?

Butter pecan

Favorite sport?

I don’t watch sports

Optimist or pessimist?

Optimist

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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes

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In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.

The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.

A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.

 

Thyme Care
Dr. Samyukta Mullangi

“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.

Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.

The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.

The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.

CMS expects the new navigators may:

  • Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
  • Provide support to accomplish the clinician’s treatment plan.
  • Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.

Peers as Navigators

The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.

“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.

The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.

But those without a definitive diagnosis may also qualify to receive navigator services.

In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.

“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.

Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.

The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.

The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



Gaining a special Medicare payment for these kinds of services will elevate this work, she said.

Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.

Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.

“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
 

 

 

Potential Challenges

Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.

“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.

In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.

While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.

“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.

Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.

Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.

A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.

Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.

The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.

Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
 

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

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In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.

The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.

A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.

 

Thyme Care
Dr. Samyukta Mullangi

“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.

Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.

The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.

The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.

CMS expects the new navigators may:

  • Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
  • Provide support to accomplish the clinician’s treatment plan.
  • Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.

Peers as Navigators

The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.

“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.

The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.

But those without a definitive diagnosis may also qualify to receive navigator services.

In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.

“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.

Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.

The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.

The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



Gaining a special Medicare payment for these kinds of services will elevate this work, she said.

Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.

Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.

“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
 

 

 

Potential Challenges

Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.

“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.

In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.

While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.

“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.

Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.

Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.

A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.

Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.

The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.

Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
 

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

 

In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.

The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.

A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.

 

Thyme Care
Dr. Samyukta Mullangi

“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.

Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.

The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.

The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.

CMS expects the new navigators may:

  • Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
  • Provide support to accomplish the clinician’s treatment plan.
  • Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.

Peers as Navigators

The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.

“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.

The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.

But those without a definitive diagnosis may also qualify to receive navigator services.

In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.

“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.

Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.

The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.

The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



Gaining a special Medicare payment for these kinds of services will elevate this work, she said.

Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.

Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.

“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
 

 

 

Potential Challenges

Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.

“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.

In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.

While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.

“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.

Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.

Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.

A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.

Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.

The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.

Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
 

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

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SVS Now Accepting Abstracts for VAM 2017

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Abstracts for the 2017 Vascular Annual Meeting are now being accepted. The submission site opened Monday, Nov. 14 for the meeting, to be held May 31 to June 3, 2017, in San Diego. Plenary sessions and exhibits will be June 1 to 3.

Participants may submit abstracts into any of 14 categories and a number of presentation types, including videos. In 2016, organizers selected approximately two-thirds of the submitted abstracts, and this year the VAM Program Committee is seeking additional venues for people to present their work in, including more sessions and other presentation formats.

Click here for abstract guidelines and more information. Abstracts themselves may be submitted here.

 

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Abstracts for the 2017 Vascular Annual Meeting are now being accepted. The submission site opened Monday, Nov. 14 for the meeting, to be held May 31 to June 3, 2017, in San Diego. Plenary sessions and exhibits will be June 1 to 3.

Participants may submit abstracts into any of 14 categories and a number of presentation types, including videos. In 2016, organizers selected approximately two-thirds of the submitted abstracts, and this year the VAM Program Committee is seeking additional venues for people to present their work in, including more sessions and other presentation formats.

Click here for abstract guidelines and more information. Abstracts themselves may be submitted here.

 

 

Abstracts for the 2017 Vascular Annual Meeting are now being accepted. The submission site opened Monday, Nov. 14 for the meeting, to be held May 31 to June 3, 2017, in San Diego. Plenary sessions and exhibits will be June 1 to 3.

Participants may submit abstracts into any of 14 categories and a number of presentation types, including videos. In 2016, organizers selected approximately two-thirds of the submitted abstracts, and this year the VAM Program Committee is seeking additional venues for people to present their work in, including more sessions and other presentation formats.

Click here for abstract guidelines and more information. Abstracts themselves may be submitted here.

 

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Atypical Antipsychotics Tied to Adrenal Issues

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NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.

They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.

At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.

Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.

A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.

Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.

However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.

In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.

Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.

 

Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON

 

 

Spotting Adrenal Insufficiency

Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:

Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.

Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.

Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.

Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.

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NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.

They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.

At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.

Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.

A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.

Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.

However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.

In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.

Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.

 

Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON

 

 

Spotting Adrenal Insufficiency

Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:

Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.

Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.

Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.

Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.

 

 

NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.

They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.

At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.

Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.

A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.

Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.

However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.

In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.

Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.

 

Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON

 

 

Spotting Adrenal Insufficiency

Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:

Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.

Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.

Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.

Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.

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Agent Orange Exposure Increases Lymphoma Risk in Million Veteran Program Cohort

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TOPLINE: Agent Orange exposure was associated with a 26% to 71% increased risk for multiple lymphoid cancers in veterans enrolled in the US Department of Veterans Affairs (VA) Million Veterans Program (MVP), while genetic predisposition independently raised risk by 12% to 81% across different lymphoma subtypes. A case-controlled analysis of 255,155 veterans found no significant interaction between genetic risk scores and Agent Orange exposure.

METHODOLOGY:

  • A case-control study included 255,155 non-Hispanic White veterans (median age 67 years, 92.5% male) enrolled in the VA MVP with genotype and Agent Orange exposure data.

  • Researchers analyzed five lymphoid malignant neoplasm subtypes: chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and multiple myeloma diagnosed from January 1965 through June 2024.

  • Agent Orange exposure was determined through self-reported survey responses, while polygenic risk scores were derived from genome-wide association studies of lymphoid malignant neoplasms.

  • Analysis included adjustments for age at enrollment, sex, and the first 10 genetic principal components in logistic regression models evaluating Agent Orange exposure, polygenic risk scores, and their potential interaction.

TAKEAWAY:

  • Agent Orange exposure significantly increased risk for chronic lymphocytic leukemia (odds ratio [OR], 1.61; 95% CI, 1.40-1.84), diffuse large B-cell lymphoma (OR, 1.26; 95% CI, 1.03-1.53), follicular lymphoma (OR, 1.71; 95% CI, 1.39-2.11), and multiple myeloma (OR, 1.58; 95% CI, 1.35-1.86).

  • Polygenic risk scores were independently associated with all lymphoma subtypes, with strongest associations for chronic lymphocytic leukemia (OR, 1.81; 95% CI, 1.70-1.93) and multiple myeloma (OR, 1.41; 95% CI, 1.31-1.52).

  • Analysis in African American participants showed similar associations for multiple myeloma with both Agent Orange exposure (OR, 1.56; 95% CI, 1.18-2.07) and polygenic risk scores (OR, 1.31; 95% CI, 1.15-1.49).

  • According to the researchers, no significant polygenic risk score and Agent Orange exposure interactions were observed for any lymphoma subtype.

IN PRACTICE: "Our study addressed the public health concerns surrounding Agent Orange exposure and lymphoid malignant neoplasms, finding that both Agent Orange exposure and polygenic risk are independently associated with disease, suggesting potentially distinct and additive pathways that merit further investigation," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, Irvine and the Tibor Rubin Veterans Affairs Medical Center, Long Beach, Californiaand was published online on August 13 in JAMA Network Open.

LIMITATIONS: According to the authors, while this represents the largest case-control study of Agent Orange exposure and lymphoid malignant neoplasm risk, the power to detect interaction associations in specific subtypes might be limited. Self-reported Agent Orange exposure data may have introduced survival bias, particularly in aggressive subtypes, as patients with aggressive tumors may have died before joining the MVP. Additionally, about half of the patients were diagnosed with lymphoid malignant neoplasms before self-reporting Agent Orange exposure, potentially introducing recall bias.

DISCLOSURES: The research was supported by a Veterans Affairs Career Development Award Xueyi Teng, PhD, received grants from the George E. Hewitt Foundation for Medical Research Postdoc Fellowship during the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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TOPLINE: Agent Orange exposure was associated with a 26% to 71% increased risk for multiple lymphoid cancers in veterans enrolled in the US Department of Veterans Affairs (VA) Million Veterans Program (MVP), while genetic predisposition independently raised risk by 12% to 81% across different lymphoma subtypes. A case-controlled analysis of 255,155 veterans found no significant interaction between genetic risk scores and Agent Orange exposure.

METHODOLOGY:

  • A case-control study included 255,155 non-Hispanic White veterans (median age 67 years, 92.5% male) enrolled in the VA MVP with genotype and Agent Orange exposure data.

  • Researchers analyzed five lymphoid malignant neoplasm subtypes: chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and multiple myeloma diagnosed from January 1965 through June 2024.

  • Agent Orange exposure was determined through self-reported survey responses, while polygenic risk scores were derived from genome-wide association studies of lymphoid malignant neoplasms.

  • Analysis included adjustments for age at enrollment, sex, and the first 10 genetic principal components in logistic regression models evaluating Agent Orange exposure, polygenic risk scores, and their potential interaction.

TAKEAWAY:

  • Agent Orange exposure significantly increased risk for chronic lymphocytic leukemia (odds ratio [OR], 1.61; 95% CI, 1.40-1.84), diffuse large B-cell lymphoma (OR, 1.26; 95% CI, 1.03-1.53), follicular lymphoma (OR, 1.71; 95% CI, 1.39-2.11), and multiple myeloma (OR, 1.58; 95% CI, 1.35-1.86).

  • Polygenic risk scores were independently associated with all lymphoma subtypes, with strongest associations for chronic lymphocytic leukemia (OR, 1.81; 95% CI, 1.70-1.93) and multiple myeloma (OR, 1.41; 95% CI, 1.31-1.52).

  • Analysis in African American participants showed similar associations for multiple myeloma with both Agent Orange exposure (OR, 1.56; 95% CI, 1.18-2.07) and polygenic risk scores (OR, 1.31; 95% CI, 1.15-1.49).

  • According to the researchers, no significant polygenic risk score and Agent Orange exposure interactions were observed for any lymphoma subtype.

IN PRACTICE: "Our study addressed the public health concerns surrounding Agent Orange exposure and lymphoid malignant neoplasms, finding that both Agent Orange exposure and polygenic risk are independently associated with disease, suggesting potentially distinct and additive pathways that merit further investigation," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, Irvine and the Tibor Rubin Veterans Affairs Medical Center, Long Beach, Californiaand was published online on August 13 in JAMA Network Open.

LIMITATIONS: According to the authors, while this represents the largest case-control study of Agent Orange exposure and lymphoid malignant neoplasm risk, the power to detect interaction associations in specific subtypes might be limited. Self-reported Agent Orange exposure data may have introduced survival bias, particularly in aggressive subtypes, as patients with aggressive tumors may have died before joining the MVP. Additionally, about half of the patients were diagnosed with lymphoid malignant neoplasms before self-reporting Agent Orange exposure, potentially introducing recall bias.

DISCLOSURES: The research was supported by a Veterans Affairs Career Development Award Xueyi Teng, PhD, received grants from the George E. Hewitt Foundation for Medical Research Postdoc Fellowship during the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: Agent Orange exposure was associated with a 26% to 71% increased risk for multiple lymphoid cancers in veterans enrolled in the US Department of Veterans Affairs (VA) Million Veterans Program (MVP), while genetic predisposition independently raised risk by 12% to 81% across different lymphoma subtypes. A case-controlled analysis of 255,155 veterans found no significant interaction between genetic risk scores and Agent Orange exposure.

METHODOLOGY:

  • A case-control study included 255,155 non-Hispanic White veterans (median age 67 years, 92.5% male) enrolled in the VA MVP with genotype and Agent Orange exposure data.

  • Researchers analyzed five lymphoid malignant neoplasm subtypes: chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and multiple myeloma diagnosed from January 1965 through June 2024.

  • Agent Orange exposure was determined through self-reported survey responses, while polygenic risk scores were derived from genome-wide association studies of lymphoid malignant neoplasms.

  • Analysis included adjustments for age at enrollment, sex, and the first 10 genetic principal components in logistic regression models evaluating Agent Orange exposure, polygenic risk scores, and their potential interaction.

TAKEAWAY:

  • Agent Orange exposure significantly increased risk for chronic lymphocytic leukemia (odds ratio [OR], 1.61; 95% CI, 1.40-1.84), diffuse large B-cell lymphoma (OR, 1.26; 95% CI, 1.03-1.53), follicular lymphoma (OR, 1.71; 95% CI, 1.39-2.11), and multiple myeloma (OR, 1.58; 95% CI, 1.35-1.86).

  • Polygenic risk scores were independently associated with all lymphoma subtypes, with strongest associations for chronic lymphocytic leukemia (OR, 1.81; 95% CI, 1.70-1.93) and multiple myeloma (OR, 1.41; 95% CI, 1.31-1.52).

  • Analysis in African American participants showed similar associations for multiple myeloma with both Agent Orange exposure (OR, 1.56; 95% CI, 1.18-2.07) and polygenic risk scores (OR, 1.31; 95% CI, 1.15-1.49).

  • According to the researchers, no significant polygenic risk score and Agent Orange exposure interactions were observed for any lymphoma subtype.

IN PRACTICE: "Our study addressed the public health concerns surrounding Agent Orange exposure and lymphoid malignant neoplasms, finding that both Agent Orange exposure and polygenic risk are independently associated with disease, suggesting potentially distinct and additive pathways that merit further investigation," wrote the authors of the study.

SOURCE: The study was led by researchers at the University of California, Irvine and the Tibor Rubin Veterans Affairs Medical Center, Long Beach, Californiaand was published online on August 13 in JAMA Network Open.

LIMITATIONS: According to the authors, while this represents the largest case-control study of Agent Orange exposure and lymphoid malignant neoplasm risk, the power to detect interaction associations in specific subtypes might be limited. Self-reported Agent Orange exposure data may have introduced survival bias, particularly in aggressive subtypes, as patients with aggressive tumors may have died before joining the MVP. Additionally, about half of the patients were diagnosed with lymphoid malignant neoplasms before self-reporting Agent Orange exposure, potentially introducing recall bias.

DISCLOSURES: The research was supported by a Veterans Affairs Career Development Award Xueyi Teng, PhD, received grants from the George E. Hewitt Foundation for Medical Research Postdoc Fellowship during the study.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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Identical Survival for Abiraterone and Enzalutamide in Vets With Metastatic Hormone-Sensitive Prostate Cancer

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Abiraterone and enzalutamide showed identical survival outcomes when used as first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC), according to a new study using US Department of Veterans Affairs (VA) data. The report represents the first head-to-head clinical analysis of these commonly used androgen receptor inhibitors.

Among 1258 veterans treated with abiraterone and 311 treated with enzalutamide, median overall survival was 36.2 months for both drugs. Patients were followed for a mean of 28.7 months (abiraterone) and 30.8 months (enzalutamide), reported by Martin W. Schoen, MD, MPH, from Saint Louis University School of Medicine and the St. Louis VA Medical Center, in JAMA Network Open

Notably, there was no significant difference in outcomes among Black veterans, who often have poorer outcomes in prostate cancer, and in patients with cardiovascular disease.

“This is the first direct comparison of abiraterone and enzalutamide for mHSPC in a clinical practice setting,” Schoen told Federal Practitioner. “At the population level, there are no differences based on initial treatment choice.”

Abiraterone Is Preferred in the VA Due to Cost

According to Schoen, abiraterone and enzalutamide are the most commonly used androgen receptor inhibitors to treat mHSPC within the VA. A 2025 study by Schoen and colleagues found that 53.7% of veterans with mHSPC in 2022 received androgen receptor inhibitor therapy, up from 16.9% in 2017. 

“In the VA, the preference for most patients is abiraterone since it is the least expensive agent,” he said. A generic version has been available for several years.

Additionally, abiraterone “has been on the market for the longest, and therefore clinicians are familiar with its use,” Schoen said. However, “clinicians have little idea of the comparative efficacy between these 2 agents,” he added.

The authors suggest that the cost and toxicities of the medications should guide clinician decisions, Schoen said. “There is data that abiraterone may worsen diabetes, since it is given with prednisone and could increase the risk of cardiovascular events,” he said.

He added that 2 newer drugs, apalutamide and darolutamide, are also “viable options.” Chemotherapies and certain targeted drugs are also available, “but they are only used in a select group of patients.”

Outside Specialist: Diverse Study Population Is a Plus

Hematologist-oncologist Natalie Reizine, MD, of the University of Illinois College of Medicine, Chicago, who was not involved in the study, told Federal Practitioner that the real-world data are valuable given the limitations of clinical trial populations.

“It’s difficult to compare clinical trials because they enroll different groups of patients,” she said. And, she said, they often exclude patients with significant comorbidities. “If they have bad cardiovascular disease, for instance, or poorly controlled diabetes, they're excluded from the clinical trial. But in real life, many of our patients have other medical problems that we have to manage.”

Reizine also emphasized the significance of the study’s diverse patient population. “Black men are very underrepresented in clinical trials. Many clinical trials that lead to drug approval will have only few or no Black men at all, yet these drugs go on to be widely prescribed to all men with prostate cancer.”

Results Are ‘Reassuring’

Reizine described the overall study findings as “reassuring,” especially in light of “studies that show that abiraterone and prednisone may be associated with worse cardiovascular outcomes. This study showed that in this VA population, even for patients who had cardiovascular disease, there was not a difference in how they did.”

As for choosing between agents, she recommended considering comorbidities and potential drug-drug interactions. “One of the big reasons that you may not be able to safely prescribe enzalutamide, for instance, is if a patient is on an anticoagulant, which is incredibly common in cancer patients. Enzalutamide has more drug-drug interactions than abiraterone and prednisone.” 

Study Demographics and Findings

The study included all patients with mHSPC who initiated abiraterone or enzalutamide between July 2017 and April 2023.

Median ages were 73 (abiraterone) and 74 years (enzalutamide, = .29). Racial distribution was similar between groups: abiraterone (68.1% White, 25.0% Black, 6.9% other/unknown) and enzalutamide (66.6% White, 27.0% Black, 6.4% other/unknown; P = .74). Ethnicity was 89.2% non-Hispanic, 4.4% Hispanic, and 6.4% unknown in the abiraterone group vs 88.4% non-Hispanic, 3.5% Hispanic, and 8.0% unknown in the enzalutamide group (P = .50).

The groups had similar rates of the most common comorbidities: diabetes (40.5% vs 46.3%, respectively, = .07), peripheral vascular disease (40.2% vs 37.6%, respectively, = .44), and chronic pulmonary disease (37.0% vs 40.5%, = .29).

In an inverse probability weighting analysis with abiraterone as reference, weighted median overall survival was comparable across the entire cohort (36.2 months, = .32), Black veterans (39.7 months, = .90), and those with cardiovascular disease (31.5 months, P = .30).

The authors noted limitations such as the observational cohort design and data constraints. 

The study was supported by the American Society of Clinical Oncology Conquer Cancer Foundation, the Prostate Cancer Foundation, and the Blavatnik Family Foundation.

Schoen discloses relationships with the Prostate Cancer Foundation, Astellas, and US Department of Defense. Other authors disclose relationships with the American Society of Clinical Oncology, Pfizer, Exelixis, Eli Lilly, Sanofi, Merck, Seagen, Bellicum, and BMS.

Outside the submitted work. Reizine discloses relationships with the US Department of Defense, Sanofi, Exelexis, Janssen, AstraZeneca, EMD Serono, Janssen, Merck, and Tempus.

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Abiraterone and enzalutamide showed identical survival outcomes when used as first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC), according to a new study using US Department of Veterans Affairs (VA) data. The report represents the first head-to-head clinical analysis of these commonly used androgen receptor inhibitors.

Among 1258 veterans treated with abiraterone and 311 treated with enzalutamide, median overall survival was 36.2 months for both drugs. Patients were followed for a mean of 28.7 months (abiraterone) and 30.8 months (enzalutamide), reported by Martin W. Schoen, MD, MPH, from Saint Louis University School of Medicine and the St. Louis VA Medical Center, in JAMA Network Open

Notably, there was no significant difference in outcomes among Black veterans, who often have poorer outcomes in prostate cancer, and in patients with cardiovascular disease.

“This is the first direct comparison of abiraterone and enzalutamide for mHSPC in a clinical practice setting,” Schoen told Federal Practitioner. “At the population level, there are no differences based on initial treatment choice.”

Abiraterone Is Preferred in the VA Due to Cost

According to Schoen, abiraterone and enzalutamide are the most commonly used androgen receptor inhibitors to treat mHSPC within the VA. A 2025 study by Schoen and colleagues found that 53.7% of veterans with mHSPC in 2022 received androgen receptor inhibitor therapy, up from 16.9% in 2017. 

“In the VA, the preference for most patients is abiraterone since it is the least expensive agent,” he said. A generic version has been available for several years.

Additionally, abiraterone “has been on the market for the longest, and therefore clinicians are familiar with its use,” Schoen said. However, “clinicians have little idea of the comparative efficacy between these 2 agents,” he added.

The authors suggest that the cost and toxicities of the medications should guide clinician decisions, Schoen said. “There is data that abiraterone may worsen diabetes, since it is given with prednisone and could increase the risk of cardiovascular events,” he said.

He added that 2 newer drugs, apalutamide and darolutamide, are also “viable options.” Chemotherapies and certain targeted drugs are also available, “but they are only used in a select group of patients.”

Outside Specialist: Diverse Study Population Is a Plus

Hematologist-oncologist Natalie Reizine, MD, of the University of Illinois College of Medicine, Chicago, who was not involved in the study, told Federal Practitioner that the real-world data are valuable given the limitations of clinical trial populations.

“It’s difficult to compare clinical trials because they enroll different groups of patients,” she said. And, she said, they often exclude patients with significant comorbidities. “If they have bad cardiovascular disease, for instance, or poorly controlled diabetes, they're excluded from the clinical trial. But in real life, many of our patients have other medical problems that we have to manage.”

Reizine also emphasized the significance of the study’s diverse patient population. “Black men are very underrepresented in clinical trials. Many clinical trials that lead to drug approval will have only few or no Black men at all, yet these drugs go on to be widely prescribed to all men with prostate cancer.”

Results Are ‘Reassuring’

Reizine described the overall study findings as “reassuring,” especially in light of “studies that show that abiraterone and prednisone may be associated with worse cardiovascular outcomes. This study showed that in this VA population, even for patients who had cardiovascular disease, there was not a difference in how they did.”

As for choosing between agents, she recommended considering comorbidities and potential drug-drug interactions. “One of the big reasons that you may not be able to safely prescribe enzalutamide, for instance, is if a patient is on an anticoagulant, which is incredibly common in cancer patients. Enzalutamide has more drug-drug interactions than abiraterone and prednisone.” 

Study Demographics and Findings

The study included all patients with mHSPC who initiated abiraterone or enzalutamide between July 2017 and April 2023.

Median ages were 73 (abiraterone) and 74 years (enzalutamide, = .29). Racial distribution was similar between groups: abiraterone (68.1% White, 25.0% Black, 6.9% other/unknown) and enzalutamide (66.6% White, 27.0% Black, 6.4% other/unknown; P = .74). Ethnicity was 89.2% non-Hispanic, 4.4% Hispanic, and 6.4% unknown in the abiraterone group vs 88.4% non-Hispanic, 3.5% Hispanic, and 8.0% unknown in the enzalutamide group (P = .50).

The groups had similar rates of the most common comorbidities: diabetes (40.5% vs 46.3%, respectively, = .07), peripheral vascular disease (40.2% vs 37.6%, respectively, = .44), and chronic pulmonary disease (37.0% vs 40.5%, = .29).

In an inverse probability weighting analysis with abiraterone as reference, weighted median overall survival was comparable across the entire cohort (36.2 months, = .32), Black veterans (39.7 months, = .90), and those with cardiovascular disease (31.5 months, P = .30).

The authors noted limitations such as the observational cohort design and data constraints. 

The study was supported by the American Society of Clinical Oncology Conquer Cancer Foundation, the Prostate Cancer Foundation, and the Blavatnik Family Foundation.

Schoen discloses relationships with the Prostate Cancer Foundation, Astellas, and US Department of Defense. Other authors disclose relationships with the American Society of Clinical Oncology, Pfizer, Exelixis, Eli Lilly, Sanofi, Merck, Seagen, Bellicum, and BMS.

Outside the submitted work. Reizine discloses relationships with the US Department of Defense, Sanofi, Exelexis, Janssen, AstraZeneca, EMD Serono, Janssen, Merck, and Tempus.

Abiraterone and enzalutamide showed identical survival outcomes when used as first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC), according to a new study using US Department of Veterans Affairs (VA) data. The report represents the first head-to-head clinical analysis of these commonly used androgen receptor inhibitors.

Among 1258 veterans treated with abiraterone and 311 treated with enzalutamide, median overall survival was 36.2 months for both drugs. Patients were followed for a mean of 28.7 months (abiraterone) and 30.8 months (enzalutamide), reported by Martin W. Schoen, MD, MPH, from Saint Louis University School of Medicine and the St. Louis VA Medical Center, in JAMA Network Open

Notably, there was no significant difference in outcomes among Black veterans, who often have poorer outcomes in prostate cancer, and in patients with cardiovascular disease.

“This is the first direct comparison of abiraterone and enzalutamide for mHSPC in a clinical practice setting,” Schoen told Federal Practitioner. “At the population level, there are no differences based on initial treatment choice.”

Abiraterone Is Preferred in the VA Due to Cost

According to Schoen, abiraterone and enzalutamide are the most commonly used androgen receptor inhibitors to treat mHSPC within the VA. A 2025 study by Schoen and colleagues found that 53.7% of veterans with mHSPC in 2022 received androgen receptor inhibitor therapy, up from 16.9% in 2017. 

“In the VA, the preference for most patients is abiraterone since it is the least expensive agent,” he said. A generic version has been available for several years.

Additionally, abiraterone “has been on the market for the longest, and therefore clinicians are familiar with its use,” Schoen said. However, “clinicians have little idea of the comparative efficacy between these 2 agents,” he added.

The authors suggest that the cost and toxicities of the medications should guide clinician decisions, Schoen said. “There is data that abiraterone may worsen diabetes, since it is given with prednisone and could increase the risk of cardiovascular events,” he said.

He added that 2 newer drugs, apalutamide and darolutamide, are also “viable options.” Chemotherapies and certain targeted drugs are also available, “but they are only used in a select group of patients.”

Outside Specialist: Diverse Study Population Is a Plus

Hematologist-oncologist Natalie Reizine, MD, of the University of Illinois College of Medicine, Chicago, who was not involved in the study, told Federal Practitioner that the real-world data are valuable given the limitations of clinical trial populations.

“It’s difficult to compare clinical trials because they enroll different groups of patients,” she said. And, she said, they often exclude patients with significant comorbidities. “If they have bad cardiovascular disease, for instance, or poorly controlled diabetes, they're excluded from the clinical trial. But in real life, many of our patients have other medical problems that we have to manage.”

Reizine also emphasized the significance of the study’s diverse patient population. “Black men are very underrepresented in clinical trials. Many clinical trials that lead to drug approval will have only few or no Black men at all, yet these drugs go on to be widely prescribed to all men with prostate cancer.”

Results Are ‘Reassuring’

Reizine described the overall study findings as “reassuring,” especially in light of “studies that show that abiraterone and prednisone may be associated with worse cardiovascular outcomes. This study showed that in this VA population, even for patients who had cardiovascular disease, there was not a difference in how they did.”

As for choosing between agents, she recommended considering comorbidities and potential drug-drug interactions. “One of the big reasons that you may not be able to safely prescribe enzalutamide, for instance, is if a patient is on an anticoagulant, which is incredibly common in cancer patients. Enzalutamide has more drug-drug interactions than abiraterone and prednisone.” 

Study Demographics and Findings

The study included all patients with mHSPC who initiated abiraterone or enzalutamide between July 2017 and April 2023.

Median ages were 73 (abiraterone) and 74 years (enzalutamide, = .29). Racial distribution was similar between groups: abiraterone (68.1% White, 25.0% Black, 6.9% other/unknown) and enzalutamide (66.6% White, 27.0% Black, 6.4% other/unknown; P = .74). Ethnicity was 89.2% non-Hispanic, 4.4% Hispanic, and 6.4% unknown in the abiraterone group vs 88.4% non-Hispanic, 3.5% Hispanic, and 8.0% unknown in the enzalutamide group (P = .50).

The groups had similar rates of the most common comorbidities: diabetes (40.5% vs 46.3%, respectively, = .07), peripheral vascular disease (40.2% vs 37.6%, respectively, = .44), and chronic pulmonary disease (37.0% vs 40.5%, = .29).

In an inverse probability weighting analysis with abiraterone as reference, weighted median overall survival was comparable across the entire cohort (36.2 months, = .32), Black veterans (39.7 months, = .90), and those with cardiovascular disease (31.5 months, P = .30).

The authors noted limitations such as the observational cohort design and data constraints. 

The study was supported by the American Society of Clinical Oncology Conquer Cancer Foundation, the Prostate Cancer Foundation, and the Blavatnik Family Foundation.

Schoen discloses relationships with the Prostate Cancer Foundation, Astellas, and US Department of Defense. Other authors disclose relationships with the American Society of Clinical Oncology, Pfizer, Exelixis, Eli Lilly, Sanofi, Merck, Seagen, Bellicum, and BMS.

Outside the submitted work. Reizine discloses relationships with the US Department of Defense, Sanofi, Exelexis, Janssen, AstraZeneca, EMD Serono, Janssen, Merck, and Tempus.

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Lower Cancer Risk in Veterans With COVID-19 Infection

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TOPLINE: COVID-19 infection is associated with a 25% reduction in cancer risk over 3 years among veterans who survived the initial infection. This protective effect was observed across sexes and racial groups, with stronger benefits seen in older patients and those with mild disease.

METHODOLOGY: 

  • Researchers conducted a retrospective cohort study comparing Veterans who tested positive for COVID-19 between March 15, 2020, and November 30, 2020, to those who tested negative.

  • Analysis included 499,396 veterans, with 88,590 (17.2%) COVID-19 positive and 427,566 (82.8%) COVID-19 negative patients, with mean (SD) ages of 57.9 (16.4) and 59.5 (15.8) years, respectively.

  • Investigators utilized Cox proportional hazard regression models to determine the hazard ratio of new cancer diagnosis within a three-year follow-up period.

  • Patient characteristics included age, race, ethnicity, sex, BMI, smoking status, and various comorbidities as covariates in the analysis.

TAKEAWAY:

  • For patients surviving ≥ 30 days after COVID-19 testing, infection was associated with a 25% reduction in cancer hazard (hazard ratio [HR], 0.75; 95% CI, 0.73-0.77).

  • The reduction in cancer risk was similar across sexes and races, with the exception of Asians, and showed greater decreases with advancing age above 45 years.

  • Patients with mild COVID-19 showed the strongest reduction in cancer risk (adjusted HR, 0.72; 95% CI, 0.70-0.74), while those with moderate COVID-19 showed an 11% reduction (adjusted HR, 0.89; 95% CI, 0.83-0.93), and severe COVID-19 showed no significant reduction in cancer risk.

IN PRACTICE: "Regarding age, the incidence of cancer appeared to decrease with each decade of life in the COVID-19 group com­pared to that in the non-exposed group,” the authors noted. “This is surprising, given that cancer diagnoses typically increase with age.” 

SOURCE: The study was led by researchers at the Miami Veterans Affairs (VA) Healthcare System Geriatric Research, Education, and Clinical Center and was published online on August 25 in PLoS One.

LIMITATIONS: The findings of this retrospective and observational study should be interpreted with caution. Results may not be generalizable beyond the predominantly male, older veteran population. The 3-year follow-up period may be insufficient to fully understand long-term cancer incidence patterns. Researchers could not capture all COVID-19 reinfection cases due to testing occurring outside the Veterans Affairs system, including at-home testing. The impact of vaccination status and reinfection on cancer risk could not be fully assessed, as the initial study cohort was grouped prior to vaccine availability.

DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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TOPLINE: COVID-19 infection is associated with a 25% reduction in cancer risk over 3 years among veterans who survived the initial infection. This protective effect was observed across sexes and racial groups, with stronger benefits seen in older patients and those with mild disease.

METHODOLOGY: 

  • Researchers conducted a retrospective cohort study comparing Veterans who tested positive for COVID-19 between March 15, 2020, and November 30, 2020, to those who tested negative.

  • Analysis included 499,396 veterans, with 88,590 (17.2%) COVID-19 positive and 427,566 (82.8%) COVID-19 negative patients, with mean (SD) ages of 57.9 (16.4) and 59.5 (15.8) years, respectively.

  • Investigators utilized Cox proportional hazard regression models to determine the hazard ratio of new cancer diagnosis within a three-year follow-up period.

  • Patient characteristics included age, race, ethnicity, sex, BMI, smoking status, and various comorbidities as covariates in the analysis.

TAKEAWAY:

  • For patients surviving ≥ 30 days after COVID-19 testing, infection was associated with a 25% reduction in cancer hazard (hazard ratio [HR], 0.75; 95% CI, 0.73-0.77).

  • The reduction in cancer risk was similar across sexes and races, with the exception of Asians, and showed greater decreases with advancing age above 45 years.

  • Patients with mild COVID-19 showed the strongest reduction in cancer risk (adjusted HR, 0.72; 95% CI, 0.70-0.74), while those with moderate COVID-19 showed an 11% reduction (adjusted HR, 0.89; 95% CI, 0.83-0.93), and severe COVID-19 showed no significant reduction in cancer risk.

IN PRACTICE: "Regarding age, the incidence of cancer appeared to decrease with each decade of life in the COVID-19 group com­pared to that in the non-exposed group,” the authors noted. “This is surprising, given that cancer diagnoses typically increase with age.” 

SOURCE: The study was led by researchers at the Miami Veterans Affairs (VA) Healthcare System Geriatric Research, Education, and Clinical Center and was published online on August 25 in PLoS One.

LIMITATIONS: The findings of this retrospective and observational study should be interpreted with caution. Results may not be generalizable beyond the predominantly male, older veteran population. The 3-year follow-up period may be insufficient to fully understand long-term cancer incidence patterns. Researchers could not capture all COVID-19 reinfection cases due to testing occurring outside the Veterans Affairs system, including at-home testing. The impact of vaccination status and reinfection on cancer risk could not be fully assessed, as the initial study cohort was grouped prior to vaccine availability.

DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: COVID-19 infection is associated with a 25% reduction in cancer risk over 3 years among veterans who survived the initial infection. This protective effect was observed across sexes and racial groups, with stronger benefits seen in older patients and those with mild disease.

METHODOLOGY: 

  • Researchers conducted a retrospective cohort study comparing Veterans who tested positive for COVID-19 between March 15, 2020, and November 30, 2020, to those who tested negative.

  • Analysis included 499,396 veterans, with 88,590 (17.2%) COVID-19 positive and 427,566 (82.8%) COVID-19 negative patients, with mean (SD) ages of 57.9 (16.4) and 59.5 (15.8) years, respectively.

  • Investigators utilized Cox proportional hazard regression models to determine the hazard ratio of new cancer diagnosis within a three-year follow-up period.

  • Patient characteristics included age, race, ethnicity, sex, BMI, smoking status, and various comorbidities as covariates in the analysis.

TAKEAWAY:

  • For patients surviving ≥ 30 days after COVID-19 testing, infection was associated with a 25% reduction in cancer hazard (hazard ratio [HR], 0.75; 95% CI, 0.73-0.77).

  • The reduction in cancer risk was similar across sexes and races, with the exception of Asians, and showed greater decreases with advancing age above 45 years.

  • Patients with mild COVID-19 showed the strongest reduction in cancer risk (adjusted HR, 0.72; 95% CI, 0.70-0.74), while those with moderate COVID-19 showed an 11% reduction (adjusted HR, 0.89; 95% CI, 0.83-0.93), and severe COVID-19 showed no significant reduction in cancer risk.

IN PRACTICE: "Regarding age, the incidence of cancer appeared to decrease with each decade of life in the COVID-19 group com­pared to that in the non-exposed group,” the authors noted. “This is surprising, given that cancer diagnoses typically increase with age.” 

SOURCE: The study was led by researchers at the Miami Veterans Affairs (VA) Healthcare System Geriatric Research, Education, and Clinical Center and was published online on August 25 in PLoS One.

LIMITATIONS: The findings of this retrospective and observational study should be interpreted with caution. Results may not be generalizable beyond the predominantly male, older veteran population. The 3-year follow-up period may be insufficient to fully understand long-term cancer incidence patterns. Researchers could not capture all COVID-19 reinfection cases due to testing occurring outside the Veterans Affairs system, including at-home testing. The impact of vaccination status and reinfection on cancer risk could not be fully assessed, as the initial study cohort was grouped prior to vaccine availability.

DISCLOSURES: The authors report no financial support was received for this study and declare no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

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VA Revises Policy For Male Breast Cancer

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Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”

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Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”

Male veterans with breast cancer may have a more difficult time receiving appropriate health care due to a recently revised US Department of Veterans Affairs (VA) policy that requires each individual to prove the disease’s connection to their service to qualify for coverage. 

According to a VA memo obtained by ProPublica, the change is based on a Jan. 1 presidential order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” VA Press Secretary Pete Kasperowicz told ProPublica that the policy was changed because the previous policy “falsely classified male breasts as reproductive organs.” 

In 2024, the VA added male breast cancer (along with urethral cancer and cancer of the paraurethral glands) to its list of presumed service-connected disabilities due to military environmental exposure, such as toxic burn pits. Male breast cancer was added to the category of “reproductive cancer of any type” after experts pointed to the similarity of male and female breast cancers.

Establishing a connection between a variety of cancers and military service has been a years-long fight only resolved recently in the form of the 2022 PACT Act. The VA lists > 20 medical conditions as “presumptive” for service connection, with some caveats, such as area of service. The act reduced the burden of proof needed: The terms “presumptive conditions” and “presumptive-exposure locations” mean veterans only have to provide their military records to show they were in an exposure location to have their care for certain conditions covered. 

Supporters of the PACT Act say the policy change could make it harder for veterans to receive timely care, a serious issue for men with breast cancer who have been “severely underrepresented” in clinical studies and many studies specifically exclude males. The American Cancer Society estimates about 2800 men have been or will be diagnosed with invasive breast cancer in 2025. Less than 1% of breast cancers in the US occur in men, but breast cancer is notably higher among veterans: 11% of 3304 veterans, according to a 2023 study

Breast cancer is more aggressive in men—they’re more often diagnosed at Stage IV and tend to be older—and survival rates have been lower than in women. In a 2019 study of 16,025 male and 1,800,708 female patients with breast cancer, men had 19% higher overall mortality.

Treatment for male breast cancer has lagged. A 2021 study found men were less likely than women to receive radiation therapy. However, that’s changing. Since that study, however, the American Cancer Society claims treatments and survival rates have improved. According to the Surveillance, Epidemiology, and End Results database, 5-year survival rates are 97% for localized, 86% for regional, and 31% for distant; 84% for all stages combined.

Screening and treatment have focused on women. But the VA Breast and Gynecologic Oncology System of Excellence (BGSoE) provides cancer care for all veterans diagnosed with breast malignancies. Male veterans with breast cancer do face additional challenges in addressing a cancer that is most often associated with females. “I must admit, it was awkward every time I went [to the Women’s Health Center for postmastectomy follow-ups]” William K. Lewis, described in his patient perspective on male breast cancer treatment in the VA.

Though the policy has changed, Kasperowicz told ProPublica that veterans who previously qualified for coverage can keep it: “The department grants disability benefits compensation claims for male Veterans with breast cancer on an individual basis and will continue to do so. VA encourages any male Veterans with breast cancer who feel their health may have been impacted by their military service to submit a disability compensation claim.”

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GI Endoscopists Want More Training in Moderate Sedation

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Gastroenterologists want more training in how to safely deliver moderate sedation during endoscopic procedures, and a majority would be interested in providing physician-directed propofol sedation, especially after in-person or online training, according to results from an ongoing survey presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The dwindling supply of anesthesiology professionals in the US puts pressure on endoscopists, Dayna S. Early, MD, professor of medicine in the Gastroenterology Division at the Washington University, director of endoscopy at Barnes-Jewish Hospital, both in St. Louis, and chair of an ACG task force on anesthesia issues, told meeting attendees. However, preliminary results from the survey found that only about 4% of respondents said they used solely endoscopist-directed moderate sedation.

Dr. Dayna S. Early



This could be because — as the survey also showed — GI fellows are not receiving adequate training in moderate sedation, which requires no interventions to maintain a patient airway, she reported. About 80% of program directors and 75% of senior fellows responding to the survey said they received training in moderate/conscious sedation during their fellowship.

These numbers are not impressive, said Early.

The Accreditation Council for Graduate Medical Education (ACGME) requires gastroenterology fellows to demonstrate competence in conscious sedation, along with other core skills, she explained. “What if I substituted training in mucosal biopsy or training in colonoscopy with polypectomy, which are other core requirements? I think you’d be shocked.”

The survey was small, with only 92 of 250 program directors and 33 of 655 fellows responding, but Early said the task force continues to collect responses.

 

Is Existing Training Enough?

Ten percent of fellows who replied to the survey did not participate in any moderate sedation procedures during training. And about a third of program directors said fellows participated in less than 100 such procedures.

“We really don’t know if that’s enough, in this era of competency-based assessment, which really values competency measures over numbers,” said Early.

Of the fellows who did receive training, 37% received hands-on training, a quarter received didactic lecture training, 11% used online modules, and 17% received a combination of the above training methods.

Just two thirds of program directors said they or their fellows were competent in moderate sedation, while close to 70% of fellows judged themselves competent.

While the majority of program directors (80%) knew that training in conscious sedation was a core ACGME requirement, only around a quarter of fellows were aware of the requirement.

Most gastroenterologists rely on anesthesiologists or certified registered nurse anesthetists (CRNAs) to deliver moderate or deep sedation, said Early, citing results from a separate survey sent to practicing clinicians.

 

Ongoing Shortages of CRNAs and Anesthesiologists

Shortages of anesthesiologists and CRNAs will continue to limit endoscopy procedure volume, especially in rural areas of the US, said Early.

The nation is expected to be short by 450,000 CRNAs this year and by 6300 anesthesiologists within a decade, she reported. Anesthesia providers are burned out or nearing retirement age, and there are not enough residency programs to produce new anesthesiologists at the rate needed to meet the demand, she said.

Gastroenterologists have become reliant on anesthesia providers, but adding a clinician is more expensive and “doesn’t appear to resolve and improve safety as compared with endoscopist-directed sedation for routine procedures,” said Early.

When practicing clinicians were asked if they’d be interested in providing physician-directed propofol sedation, 20% said yes, while 35% said no. But 16% said they would want to provide moderate sedation after completing in-person training, and 19% said they would after completing online training.

It may take time for gastroenterologists to get appropriate training and reduce reliance on anesthesia providers, Early said. But she said it may be increasingly possible in states allowing endoscopist-directed, nurse-administered propofol, and with medications such as remimazolam, a rapid-acting benzodiazepine that has shown similar efficacy and lower adverse event rates than propofol.

There will have to be a really deliberate step in order to take back control of endoscopic sedation from anesthesia and start performing more modest sedation, she said.

Early reported having no conflicts.

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

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Gastroenterologists want more training in how to safely deliver moderate sedation during endoscopic procedures, and a majority would be interested in providing physician-directed propofol sedation, especially after in-person or online training, according to results from an ongoing survey presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The dwindling supply of anesthesiology professionals in the US puts pressure on endoscopists, Dayna S. Early, MD, professor of medicine in the Gastroenterology Division at the Washington University, director of endoscopy at Barnes-Jewish Hospital, both in St. Louis, and chair of an ACG task force on anesthesia issues, told meeting attendees. However, preliminary results from the survey found that only about 4% of respondents said they used solely endoscopist-directed moderate sedation.

Dr. Dayna S. Early



This could be because — as the survey also showed — GI fellows are not receiving adequate training in moderate sedation, which requires no interventions to maintain a patient airway, she reported. About 80% of program directors and 75% of senior fellows responding to the survey said they received training in moderate/conscious sedation during their fellowship.

These numbers are not impressive, said Early.

The Accreditation Council for Graduate Medical Education (ACGME) requires gastroenterology fellows to demonstrate competence in conscious sedation, along with other core skills, she explained. “What if I substituted training in mucosal biopsy or training in colonoscopy with polypectomy, which are other core requirements? I think you’d be shocked.”

The survey was small, with only 92 of 250 program directors and 33 of 655 fellows responding, but Early said the task force continues to collect responses.

 

Is Existing Training Enough?

Ten percent of fellows who replied to the survey did not participate in any moderate sedation procedures during training. And about a third of program directors said fellows participated in less than 100 such procedures.

“We really don’t know if that’s enough, in this era of competency-based assessment, which really values competency measures over numbers,” said Early.

Of the fellows who did receive training, 37% received hands-on training, a quarter received didactic lecture training, 11% used online modules, and 17% received a combination of the above training methods.

Just two thirds of program directors said they or their fellows were competent in moderate sedation, while close to 70% of fellows judged themselves competent.

While the majority of program directors (80%) knew that training in conscious sedation was a core ACGME requirement, only around a quarter of fellows were aware of the requirement.

Most gastroenterologists rely on anesthesiologists or certified registered nurse anesthetists (CRNAs) to deliver moderate or deep sedation, said Early, citing results from a separate survey sent to practicing clinicians.

 

Ongoing Shortages of CRNAs and Anesthesiologists

Shortages of anesthesiologists and CRNAs will continue to limit endoscopy procedure volume, especially in rural areas of the US, said Early.

The nation is expected to be short by 450,000 CRNAs this year and by 6300 anesthesiologists within a decade, she reported. Anesthesia providers are burned out or nearing retirement age, and there are not enough residency programs to produce new anesthesiologists at the rate needed to meet the demand, she said.

Gastroenterologists have become reliant on anesthesia providers, but adding a clinician is more expensive and “doesn’t appear to resolve and improve safety as compared with endoscopist-directed sedation for routine procedures,” said Early.

When practicing clinicians were asked if they’d be interested in providing physician-directed propofol sedation, 20% said yes, while 35% said no. But 16% said they would want to provide moderate sedation after completing in-person training, and 19% said they would after completing online training.

It may take time for gastroenterologists to get appropriate training and reduce reliance on anesthesia providers, Early said. But she said it may be increasingly possible in states allowing endoscopist-directed, nurse-administered propofol, and with medications such as remimazolam, a rapid-acting benzodiazepine that has shown similar efficacy and lower adverse event rates than propofol.

There will have to be a really deliberate step in order to take back control of endoscopic sedation from anesthesia and start performing more modest sedation, she said.

Early reported having no conflicts.

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

Gastroenterologists want more training in how to safely deliver moderate sedation during endoscopic procedures, and a majority would be interested in providing physician-directed propofol sedation, especially after in-person or online training, according to results from an ongoing survey presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting.

The dwindling supply of anesthesiology professionals in the US puts pressure on endoscopists, Dayna S. Early, MD, professor of medicine in the Gastroenterology Division at the Washington University, director of endoscopy at Barnes-Jewish Hospital, both in St. Louis, and chair of an ACG task force on anesthesia issues, told meeting attendees. However, preliminary results from the survey found that only about 4% of respondents said they used solely endoscopist-directed moderate sedation.

Dr. Dayna S. Early



This could be because — as the survey also showed — GI fellows are not receiving adequate training in moderate sedation, which requires no interventions to maintain a patient airway, she reported. About 80% of program directors and 75% of senior fellows responding to the survey said they received training in moderate/conscious sedation during their fellowship.

These numbers are not impressive, said Early.

The Accreditation Council for Graduate Medical Education (ACGME) requires gastroenterology fellows to demonstrate competence in conscious sedation, along with other core skills, she explained. “What if I substituted training in mucosal biopsy or training in colonoscopy with polypectomy, which are other core requirements? I think you’d be shocked.”

The survey was small, with only 92 of 250 program directors and 33 of 655 fellows responding, but Early said the task force continues to collect responses.

 

Is Existing Training Enough?

Ten percent of fellows who replied to the survey did not participate in any moderate sedation procedures during training. And about a third of program directors said fellows participated in less than 100 such procedures.

“We really don’t know if that’s enough, in this era of competency-based assessment, which really values competency measures over numbers,” said Early.

Of the fellows who did receive training, 37% received hands-on training, a quarter received didactic lecture training, 11% used online modules, and 17% received a combination of the above training methods.

Just two thirds of program directors said they or their fellows were competent in moderate sedation, while close to 70% of fellows judged themselves competent.

While the majority of program directors (80%) knew that training in conscious sedation was a core ACGME requirement, only around a quarter of fellows were aware of the requirement.

Most gastroenterologists rely on anesthesiologists or certified registered nurse anesthetists (CRNAs) to deliver moderate or deep sedation, said Early, citing results from a separate survey sent to practicing clinicians.

 

Ongoing Shortages of CRNAs and Anesthesiologists

Shortages of anesthesiologists and CRNAs will continue to limit endoscopy procedure volume, especially in rural areas of the US, said Early.

The nation is expected to be short by 450,000 CRNAs this year and by 6300 anesthesiologists within a decade, she reported. Anesthesia providers are burned out or nearing retirement age, and there are not enough residency programs to produce new anesthesiologists at the rate needed to meet the demand, she said.

Gastroenterologists have become reliant on anesthesia providers, but adding a clinician is more expensive and “doesn’t appear to resolve and improve safety as compared with endoscopist-directed sedation for routine procedures,” said Early.

When practicing clinicians were asked if they’d be interested in providing physician-directed propofol sedation, 20% said yes, while 35% said no. But 16% said they would want to provide moderate sedation after completing in-person training, and 19% said they would after completing online training.

It may take time for gastroenterologists to get appropriate training and reduce reliance on anesthesia providers, Early said. But she said it may be increasingly possible in states allowing endoscopist-directed, nurse-administered propofol, and with medications such as remimazolam, a rapid-acting benzodiazepine that has shown similar efficacy and lower adverse event rates than propofol.

There will have to be a really deliberate step in order to take back control of endoscopic sedation from anesthesia and start performing more modest sedation, she said.

Early reported having no conflicts.

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

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FDA OKs Linzess for IBS With Constipation in Kids

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The FDA has approved linaclotide (Linzess) for children aged 7 years or older with irritable bowel syndrome with constipation (IBS-C), making it the first approved treatment for pediatric IBS-C. 

The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.

Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.

IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.

There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval. 

The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.

The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.

The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.

The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.

Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide. 

Full prescribing information is available online.
 

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

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The FDA has approved linaclotide (Linzess) for children aged 7 years or older with irritable bowel syndrome with constipation (IBS-C), making it the first approved treatment for pediatric IBS-C. 

The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.

Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.

IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.

There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval. 

The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.

The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.

The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.

The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.

Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide. 

Full prescribing information is available online.
 

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

The FDA has approved linaclotide (Linzess) for children aged 7 years or older with irritable bowel syndrome with constipation (IBS-C), making it the first approved treatment for pediatric IBS-C. 

The recommended dosage in pediatric patients is 145 mcg/d oral linaclotide.

Linaclotide is already approved in the US for IBS-C in adults, as well as functional constipation in children aged 6 years or older and chronic idiopathic constipation in adults.

IBS-C is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.

There is no known underlying organic cause and there are typically multiple contributing factors, the FDA said in a statement announcing the approval. 

The efficacy of linaclotide to treat IBS-C in children aged 7 years or older was supported by extrapolation of efficacy from studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients aged 7-17 years who met modified Rome III criteria for child/adolescent IBS-C, the FDA noted.

The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two naturally occurring bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period.

The efficacy results in children with IBS-C were consistent with results seen in adults with IBS-C, with no new safety signals.

The most common side effect with linaclotide is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.

Linaclotide is contraindicated in children younger than 2 years. Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide. 

Full prescribing information is available online.
 

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

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