User login
Physician Compensation: Gains Small, Gaps Large
Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that despite dissatisfaction, more than three-quarters of physicians polled said, paradoxically, they would still choose to enter their embattled profession.
“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”
Based on some 230,000 responses over six years, including those from more than 37,000 U.S. physicians in 2024 alone, as well as more than 1,100 physicians polled in 2025, the digital platform’s most recent report also incorporates thousands of responses to other recent surveys, as well as data from Doximity’s tech-enabled Talent Solutions, which support both permanent and locum tenens healthcare staffing.
Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.
Compensation Lag May Impact Care
A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.
In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity.
Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.
Narrowing the Gap for Primary Care?
Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.
“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”
Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.
The Specialties
This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.
By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. This is higher than the average physician compensation, at $537,870, while neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.
The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.
The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.
Practice Setting and Location
Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.
The Gender Effect
With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to it’s 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.
Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.
Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.
According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News.
The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.
Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?
Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.
Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”
In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.
Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.
Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”
Abreu reported no conflicts of interest in regard to her comments.
Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that despite dissatisfaction, more than three-quarters of physicians polled said, paradoxically, they would still choose to enter their embattled profession.
“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”
Based on some 230,000 responses over six years, including those from more than 37,000 U.S. physicians in 2024 alone, as well as more than 1,100 physicians polled in 2025, the digital platform’s most recent report also incorporates thousands of responses to other recent surveys, as well as data from Doximity’s tech-enabled Talent Solutions, which support both permanent and locum tenens healthcare staffing.
Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.
Compensation Lag May Impact Care
A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.
In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity.
Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.
Narrowing the Gap for Primary Care?
Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.
“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”
Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.
The Specialties
This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.
By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. This is higher than the average physician compensation, at $537,870, while neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.
The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.
The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.
Practice Setting and Location
Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.
The Gender Effect
With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to it’s 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.
Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.
Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.
According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News.
The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.
Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?
Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.
Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”
In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.
Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.
Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”
Abreu reported no conflicts of interest in regard to her comments.
Few would deny that physicians today face many challenges: a growing and aging patient population, personnel shortages, mounting paperwork, regulatory and reimbursement pressures, and personal burnout. Collectively these could work to worsen patient access to care. Yet despite these headwinds, Doximity’s survey-based Physician Compensation Report 2025 found that despite dissatisfaction, more than three-quarters of physicians polled said, paradoxically, they would still choose to enter their embattled profession.
“Physician burnout isn’t new. It’s been a persistent problem over the past decade,” said Amit Phull, MD, chief clinical experience officer at Doximity. “In a Doximity poll of nearly 2,000 physicians conducted in May 2025, 85% reported they feel overworked, up from 73% just four years ago. As a result, about 68% of physicians said they are looking for an employment change or considering early retirement.”
Based on some 230,000 responses over six years, including those from more than 37,000 U.S. physicians in 2024 alone, as well as more than 1,100 physicians polled in 2025, the digital platform’s most recent report also incorporates thousands of responses to other recent surveys, as well as data from Doximity’s tech-enabled Talent Solutions, which support both permanent and locum tenens healthcare staffing.
Greater awareness of contemporary trends may help physicians make more-informed career decisions and more effectively advocate for both themselves and the patients who need them, the report’s authors stated.
Compensation Lag May Impact Care
A small overall average compensation increase of 3.7% from 2023 to 2024 – a slightly lower increase than the 5.9% in the prior year – has done little to close existing pay gaps across the profession.
In 2024, average compensation for men rose 5.7% over 2023, compared with just 1.7% for women – widening the gender pay gap to 26% vs 23% in 2023 and matching the gender gap seen in 2022. And significant disparities persist between physicians caring for adults vs children. In some specialties, the pay gap between pediatric and adult specialists exceeded 80% despite practitioners’ similar levels of training and clinical complexity.
Nearly 60% of respondents said reimbursement pressures could affect their ability to serve Medicare or Medicaid patients in the next year. Additionally, 81% reported that reimbursement policies have significantly contributed to the decline of private practices, and more than a third said they could stifle practice growth with compensation concerns forcing them to delay or cancel hiring or expansion plans. Almost 90% reported an adverse impact from physician shortages, with more citing an inability or limited ability to accept new patients.
Narrowing the Gap for Primary Care?
Over the past three years, the percent pay gap between primary care and specialist medicine declined modestly, the report noted. In 2024, surgical specialists earned 87% more than primary care physicians, down from 100% in 2022. Non-surgical specialists, emergency medicine physicians, and Ob/Gyns also continued to earn significantly more than primary care physicians, though the gaps have narrowed slightly.
“These trends come at a time when primary care remains critical to meeting high patient demand, especially amid ongoing physician shortages,” the report stated. “Primary care physicians continue to earn considerably less than many of their medical colleagues despite their essential role in the healthcare system.”
Significantly, many physicians believe that current reimbursement policies have contributed to the steady decline of independent practices in their fields. According to the American Medical Association, the share of physicians working in private practices dropped by 18 percentage points from 60.1% to 42.2% from 2012 to 2024.
The Specialties
This year’s review found that among 20 specialties, the highest average compensation occurred in surgical and procedural specialties, while the lowest paid were, as mentioned, pediatric medicine and primary care. Pediatric nephrology saw the largest average compensation growth in 2024 at 15.6%, yet compensation still lagged behind adult nephrology with a 40% pay gap.
By medical discipline, gastroenterologists ranked 13th overall in average annual compensation. Gastroenterology remained in the top 20 compensated specialties, with average annual compensation of $537,870 – an increase from $514,208 in 2024, representing a 4.5% growth rate over 2023. This is higher than the average physician compensation, at $537,870, while neurosurgeons topped the list at $749,140, followed by thoracic surgeons at $689,969 and orthopedic surgeons at $679,517.
The three lowest-paid branches were all pediatric: endocrinology at $230,426, rheumatology at $231,574, and infectious diseases at $248,322. Pediatric gastroenterology paid somewhat higher at $298,457.
The largest disparities were seen in hematology and oncology, where adult specialists earned 93% more than their pediatric peers. Pediatric gastroenterology showed an 80% pay gap. There were also substantial pay differences across cardiology, pulmonology, and rheumatology. “These gaps appear to reflect a systemic lag in pay for pediatric specialty care, even as demand for pediatric subspecialists continues to rise,” the report stated.
Practice Setting and Location
Where a doctor practices impacts the bottom line, too: in 2024 the highest compensation reported for a metro area was in Rochester, Minnesota (the Mayo Clinic effect?), at $495,532, while the lowest reported was in Durham-Chapel Hill, North Carolina, at $368,782. St. Louis, Missouri ($484,883) and Los Angeles, California ($470,198) were 2nd and 3rd at the top of the list. Rochester, Minnesota, also emerged as best for annual compensation after cost-of-living adjustment, while Boston, Massachusetts, occupied the bottom rung.
The Gender Effect
With a women’s pay increase in 2024 of just 1.7%, the gender gap returned to it’s 2022-level disparity of 26%, with women physicians earning an average of $120,917 less than men after adjusting for specialty, location, and years of experience.
Doximity’s analysis of data from 2014 to 2019 estimated that on average men make at least $2 million more than women over the course of a 40-year career. This gap is often attributed to the fewer hours worked by female physician with their generally heavier familial responsibilities, “but Doximity’s gender wage gap analysis controls for the number of hours worked and career stage, along with specialty, work type, employment status, region, and credentials,” Phull said.
Women physicians had lower average earnings than men physicians across all specialties, a trend consistent with prior years. As a percentage of pay, the largest gender disparity was seen in pediatric nephrology (16.5%), a specialty that in fact saw the largest annual growth in physician pay. Neurosurgery had the smallest gender gap at 11.3%, while infectious diseases came in at 11.5% and oncology at 12%.
According to Maria T. Abreu, MD, AGAF, executive director of the F. Widjaja Inflammatory Bowel Disease Institute at Cedars-Sinai Medical Center in Los Angeles and past president of AGA, the remuneration gender gap in gastroenterology is being taken seriously by AGA and several other GI societies. “The discrepancies in pay start from the beginning and therefore are magnified over time. We are helping to empower women to negotiate better as well as to gather data on the roots of inequity, she told GI & Hepatology News.
The AGA Women’s Committee has developed a project to support the advancement of women in gastroenterology, Abreu said. The initiative, which includes the AGA Gender Equity Framework and Gender Equity Road Map. focuses attention on disparities in the workplace and promotes opportunities for women’s leadership, career advancement, mentorship and physician health and wellness, she added.
Are these disparities due mainly to the “motherhood penalty,” with career interruption and time lost to maternity leave and fewer hours worked owing to the greater parenting burden of physician mothers? Or are they due to the systemic effects of gender expectations around compensation?
Hours worked appear to be a factor. A 2017 study of dual physician couples found that among childless respondents men worked an average of 57 hours and women 52 hours weekly. Compared with childless men, men with children worked similar numbers of hours weekly. However, compared with childless physicians, mothers worked significantly fewer hours – roughly 40 to 43 hours weekly – depending on the age of their youngest child.
Abreu pushed back on this stereotype. “Most women physicians, including gastroenterologists, do not take the maternity leave they are allowed because they are concerned about burdening their colleagues,” she said. “Thus, it is unlikely to explain the disparities. Many systemic issues remain challenging, but we want women to be empowered to advocate for themselves at the time of hiring and along the arc of their career paths.”
In Abreu’s view, having women assume more leadership roles in the field of gastroenterology provides an opportunity to focus on reducing the disparities in compensation.
Regardless of gender, among all physicians surveyed, autonomy and work-life balance appeared to be a high priority: 77% of doctors said they would be willing to accept or have already accepted lower pay for more autonomy or work-life balance. “Overwork appears to be especially prevalent among women physicians,” said Phull, noting that 91% of women respondents reported being overworked compared with 80% of men. “This overwork has compelled 74% of women to consider making a career change, compared with 62% of men.” Differences emerged among specialties as well: 90% of primary care physicians said they are overworked compared with 84% of surgeons and 83% of non-surgical specialists.
Looking ahead, the report raised an important question. Are we relying too heavily on physicians rather than addressing the underlying need for policies that support a healthier, more sustainable future for all? “Building that future will take more than physician dedication alone,” Phull said. “It will require meaningful collaboration across the entire health care ecosystem – including health systems, hospitals, payors, and policymakers. And physicians must not only have a voice in shaping the path forward; they must have a seat at the table.”
Abreu reported no conflicts of interest in regard to her comments.
Medicolegal Concerns in Contemporary Private GI Practice
The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.
, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.
“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.”
Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.”
Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”
Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.
From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).
Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”
These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.
Update Details
Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.
Stark Law on Self-Referrals
Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.
For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.
Ambulatory Surgery Centers
Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.
A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.
Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.
“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.
The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.
Private-Equity Investment
With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.
Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.
“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.
Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.
“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”
Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”
Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”
The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.
Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.
This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.
A version of this article appeared on Medscape.com.
The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.
, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.
“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.”
Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.”
Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”
Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.
From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).
Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”
These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.
Update Details
Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.
Stark Law on Self-Referrals
Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.
For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.
Ambulatory Surgery Centers
Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.
A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.
Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.
“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.
The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.
Private-Equity Investment
With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.
Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.
“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.
Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.
“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”
Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”
Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”
The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.
Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.
This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.
A version of this article appeared on Medscape.com.
The need for gastroenterology (GI) services is on the rise in the US, with growing rates of colonoscopy, earlier-onset colon cancer, and inflammatory bowel disease. This increase is taking place in the context of a changing regulatory landscape.
, and to that end, a recent educational practice management update was published in Clinical Gastroenterology and Hepatology by Erin Smith Aebel, JD, a health law specialist with Trenam Law in Tampa, Florida. Aebel has been a speaker at several national GI conferences and has addressed GI trainees on these issues in medical schools.
“Healthcare regulation continues to evolve and it’s a complicated area,” Aebel told GI & Hepatology News. “Some physician investors in healthcare ventures see the potential profits but are not fully aware of how a physician’s license and livelihood could be affected by noncompliance.”
Aebel has seen some medical business owners and institutions pushing physicians to their limits in order to maximize profits. “They’re failing to allow them the meaningful things that allow for a long-term productive and successful practice that provides great patient care,” she said. “A current issue I’m dealing with is employers’ taking away physicians’ administrative time and not respecting the work that is necessary for the physician to be efficient and provide great care,” she said. “If too many physicians get squeezed in this manner, they will eventually walk away from big employers to something they can better control.”
Aebel noted that private-equity acquisitions of medical practices — a fast-growing US trend — are often targeted at quick profits and quick exits, which can be inconsistent with quality long-term patient care. “A question to be asked by physicians and patients is who is benefiting from this transaction?” she said. “Sometimes retired physicians can see a great benefit in private equity, but newer physicians can get tied up with a strong noncompete agreement. The best deals are ones that try to find wins for all involved, including patients.”
Many independent gastroenterologists focusing on the demands of daily practice are less aware than they should be of the legal and business administration sides. “I often get clients who come to me complaining about their contracts after they’ve signed them. I don’t have leverage to do as much for them,” she admitted.
From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control. These could relate to compensation and bonuses, as well as opportunities to invest in the practice, the practice management company, and possibly real estate or ambulatory surgery centers (ASCs).
Aebel’s overarching messages to gastroenterologists are as follows: “Be aware. Learn basic health law. Read your contracts before you sign them. And invest in good counsel before you sign agreements,” she said. “In addition, GI practitioners need to have a working knowledge of the federal Anti-Kickback Statute and the federal Stark Law and how they could be commonly applied in their practices.”
These are designed to protect government-funded patient care from monetary influence. The False Claims Act is another federal buttress against fraud and abuse, she said.
Update Details
Though not intended to be legal advice, Aebel’s update touches on several important medicolegal areas.
Stark Law on Self-Referrals
Gastroenterologists should be familiar with this federal law, a self-referral civil penalty statute regulating how physicians can pay themselves in practices that provide designated health services covered by federal healthcare programs such as Medicare or Medicaid.
For a Stark penalty to apply, there must be a physician referral to an entity (eg, lab, hospital, nutrition service, physiotherapy or radiotherapy center) in which the physician or a close family member has a financial interest.
Ambulatory Surgery Centers
Another common area vulnerable to federal fraud and abuse regulation is investment in ASCs. “Generally speaking, it is a felony to pay or be paid anything of value for Medicare or Medicaid business referrals,” Aebel wrote. This provision relates to the general restriction of the federal AKB statute.
A gastroenterologist referring Medicare patients to a center where that physician has an investment could technically violate this law because the physician will receive profit distributions from the referral. In addition to constituting a felony with potential jail time, violation of this statute is grounds for substantial civil monetary penalties and/or exclusion from the government coverage program.
Fortunately, Aebel noted, legal safe harbors cover many financial relationships, including investment in an ASC. The financial arrangement is protected from prosecution if it meets five safe harbor requirements, including nondiscriminatory treatment of government-insured patients and physician investment unrelated to a center’s volume or the value of referrals. If even one aspect is not met, that will automatically constitute a crime.
“However, the government will look at facts and circumstances to determine whether there was an intent to pay for a referral,” Aebel wrote.
The safe harbor designates requirements for four types of ASCs: surgeon-owned, single-specialty, multispecialty, and hospital/physician ASCs.
Private-Equity Investment
With mergers and acquisitions of US medical practices and networks by private-equity firms becoming more common, gastroenterologists need to be aware of the legal issues involved in such investment.
Most states abide by corporate practice of medicine doctrines, which prohibit unlicensed people from direct ownership in a medical practice. These doctrines vary by state, but their primary goal is to ensure that medical decisions are made solely based on patient care and not influenced by corporate interests. The aim is to shield the physician-patient relationship from commercial influence.
“Accordingly, this creates additional complicated structures necessary for private-equity investment in gastroenterology practices,” Aebel wrote. Usually, such investors will invest in a management services organization (MSO), which takes much of the practice’s value via management fees. Gastroenterologists may or may not have an opportunity to invest in the practice and the MSO in this scenario.
Under corporate practice of medicine doctrine, physicians must control the clinical aspects of patient care. Therefore, some states may have restrictions on private-equity companies’ control of the use of medical devices, pricing, medical protocols, or other issues of patient care.
“This needs to be considered when reviewing the investment documents and structural documents proposed by private equity companies,” the advisory stated. From a business standpoint, gastroenterologists need to understand where they can negotiate for financial gain and control over their clinical practice. “This could relate to their compensation, bonuses, and investment opportunities in the practice, the practice management company, and possibly real estate or ASCs.”
Offering a gastroenterologist’s perspective on the paper, Camille Thélin, MD, MSc, an associate professor in the Division of Digestive Diseases and Health at the University of South Florida, Tampa, Florida, who also practices privately, said, that “what Erin Aebel reminds us is that the business side of GI can be just as tricky as the clinical side. Ancillary services like capsule studies or office labs fall under strict Stark rules, ASC ownership has Anti-Kickback Law restrictions, and private-equity deals may affect both your paycheck and your autonomy.”
Thélin’s main takeaway advice is that business opportunities can be valuable but carry real legal risks if not structured correctly. “This isn’t just abstract compliance law — it’s about protecting one’s ability to practice medicine, earn fairly, and avoid devastating penalties,” she told GI & Hepatology News. “This article reinforces the need for proactive legal review and careful structuring of business arrangements so physicians can focus on patient care without stumbling into avoidable legal pitfalls. With the right legal structure, ancillaries, ASCs, and private equity can strengthen your GI practice without risking compliance.”
The bottom line, said Aebel, is that gastroenterologists already in private practice or considering entering one must navigate a complex landscape of compliance and regulatory requirements — particularly when providing ancillary services, investing in ASCs, or engaging with private equity.
Understanding the Stark law, the AKB statute, and the intricacies of private-equity investment is essential to mitigate risks and avoid severe penalties, the advisory stressed. By proactively seeking expert legal and business guidance, gastroenterologists can structure their financial and ownership arrangements in a compliant manner, safeguarding their practices while capitalizing on growth opportunities.
This paper listed no external funding. Neither Aebel nor Thélin had any relevant conflicts of interest.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
IBD 101: Intensive Course for GI Fellows Boosts Clinical Confidence
Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.
The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.
“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.
“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”
The Program
The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.
The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.
The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.
In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.
In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.
Among the specific survey findings:
- 100% said the course had improved their ability to effectively treat and manage patients
- A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08)
- A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
- 98% reported increased interest in exploring IBD during fellowship
- 100% noted improved understanding of supplemental opportunities to learn about IBD
- 96% would strongly recommend this course to future GI fellows
Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.
Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”
And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”
In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.
This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.
A version of this article appeared on Medscape.com.
Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.
The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.
“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.
“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”
The Program
The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.
The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.
The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.
In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.
In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.
Among the specific survey findings:
- 100% said the course had improved their ability to effectively treat and manage patients
- A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08)
- A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
- 98% reported increased interest in exploring IBD during fellowship
- 100% noted improved understanding of supplemental opportunities to learn about IBD
- 96% would strongly recommend this course to future GI fellows
Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.
Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”
And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”
In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.
This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.
A version of this article appeared on Medscape.com.
Results from the initial pilot program in 2019, called “IBD 101: Physicians and Patients Providing Pearls and Perspectives” are outlined in Inflammatory Bowel Diseases by Lisa Malter, MD, AGAF, a professor of medicine in the Division of Gastroenterology at NYU Langone Grossman School of Medicine, New York City, and colleagues.
The course, conducted by Malter at NYU Langone’s simulation center, was designed to increase fellows’ early exposure to the complexities of IBD and its diagnosis and management in the context of rapidly changing therapies and variability across US GI training programs. The authors reported that the 2019 program was well received, with attendees showing “increased comfort and sustained benefit” in discussing IBD management with patients. Notably, participants’ increased comfort levels in broaching IBD topics persisted 3 years after the course compared with that of nonparticipating peers, pointing to potential improved patient care after completion of training.
“At this point, 1 in every 100 GI patients has IBD. It’s one of the more complex GI conditions and its incidence and prevalence are increasing globally,” Malter told GI & Hepatology News. Prevalence rates in the US are reportedly as high as 464.5 per 100,000 persons.
“In addition, its management has become more complicated with newer medications and treatments coming on stream,” she said. “An educational gap exists.”
The Program
The course provided an intimate, interactive format with national experts in the field serving as faculty. Course objectives included basic, introductory information on the diagnosis, treatment, and management of IBD; early exposure to IBD as a subspecialty to allow registrants to make informed career decisions; and information about other educational opportunities.
The course was designed to raise participants’ comfort levels in discussing seven topics with patients, including the need for surgery, IBD in pregnancy, treatment escalation in different disease scenarios, and lack of treatment response.
The three-part course, featuring case scenarios, was offered in person to 60 fellows selected by regional GI fellowship program directors and course faculty, which consisted of a director, three codirectors, and 14 local and national IBD experts. A half-day training session for faculty was held immediately before the course.
In September 2019, the first 32 fellows from Accreditation Council for Graduate Medical Education-accredited programs participated in IBD 101. A total of 49 (89%) of 55 participants completed presession and immediate postsession surveys.
In the 3-year follow-up survey, among 36 fellows, of whom 21 (58%) attended IBD 101 and 15 (42%) did not, attendees reported overall IBD confidence and equivalent or higher levels of comfort in discussing each of seven topics.
Among the specific survey findings:
- 100% said the course had improved their ability to effectively treat and manage patients
- A higher proportion of attendees strongly agreed with having comfort in discussing pregnancy in IBD (43% vs 13%; P = .08)
- A statistically significant proportion strongly agreed with having comfort in discussing loss of response to biologics (62% vs 27%; P = .049)
- 98% reported increased interest in exploring IBD during fellowship
- 100% noted improved understanding of supplemental opportunities to learn about IBD
- 96% would strongly recommend this course to future GI fellows
Further testimony to the effectiveness of the ongoing course, said Malter, is that the version offered in 2024 attracted 425 GI fellows from across the country. “That’s about 90% of US GI fellows,” she said.
Offering an outsider’s perspective on the results of the course, Ashwin N. Ananthakrishnan, MBBS, MPH, AGAF, a director or the Crohn’s and Colitis Center at Massachusetts General Hospital in Boston, said, “It’s a useful update. It’s always good to see benefits from educational courses.” He expressed caution, however, “in that a small subset of GI fellows always selects toward those with greater IBD interest. Consequently, they likely have participated in several other IBD education activities in the intervening 3 years — so one can’t attribute benefit to this course alone.”
And while one effect of such courses may to increase the number of IBD-interested trainees, their role in providing IBD education to gastroenterologists who will not specialize in IBD is more important, Ananthakrishnan added. “These general gastroenterologists are going to be managing a lot of the IBD in the community, so in my opinion, ensuring they are comfortable with caring for IBD patients optimally is more important than training IBD specialists, who have many opportunities for education.”
In collaboration with the American College of Gastroenterology, the course is open to all first-year GI fellows training in North America. The most recent program was held on September 13, 2025.
This paper received no specific funding. The IBD course has been supported by unrestricted educational grants from Pfizer and Takeda Pharmaceuticals and sponsorships from AbbVie, Janssen, and Prometheus Labs.Malter reported receiving educational grants from AbbVie, Janssen, Pfizer, and Takeda; serving as a consultant for Abbvie and Pharmacosmos; and serving on the advisory boards for AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Merck, and Takeda. Multiple coauthors disclosed similar relationships with numerous private-sector companies.
A version of this article appeared on Medscape.com.
SGLT2 Inhibition Promising for Patients With Cirrhosis and on Diuretics
, a large cohort study of more than 10,000 patients found.
Reporting in JAMA Network Open, Dian J. Chiang, MD, MPH, a section head of Hepatology at the Cleveland Clinic in Cleveland looked at the impact of these antihyperglycemic agents, also known as gliflozins, used in diabetes and kidney disease to block the reabsorption of glucose in the kidneys and causing more glucose to be excreted in the urine.
“Patients with cirrhosis were previously not included in SGLT2 inhibition clinical trials, and there is no large real-world evidence on the safety and effectiveness of this class of medication in patients with cirrhosis. Therefore, we decided to conduct the study to assess its safety and effectiveness,” Chiang told GI & Hepatology News.
The study’s primary endpoint was a composite of serious hepatic events, defined as ascites, varices, hyponatremia, and all-cause mortality. Secondary outcomes included variceal bleeding, paracentesis, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome, liver carcinoma, hypoglycemia, and all-cause hospitalizations.
The cohort consisted of 10,660 propensity-matched adult patients with cirrhosis from more than 120 healthcare organizations in the TriNetX database who were receiving furosemide and spironolactone from January 2013 to July 2021. Those also receiving SGLT2 inhibitors (n = 5330) were compared with a matched control group receiving diuretics only (n = 5330). The mean age of participants was 63.8 years, 57.8% were men, 66.3% were White individuals, and all were followed for 3 years.
The SGLT2 inhibitor group had a 32% lower incidence of serious liver events than the control group, for a hazard ratio (HR) of 0.68 (95% CI, 0.66-0.71; P < .001).
Secondary risk reductions in the intervention group were as follows:
- Hepatorenal syndrome: HR, 0.47 (95% CI, 0.40-0.56)
- Spontaneous bacterial peritonitis: HR, 0.55 (95% CI, 0.46-0.65)
- Paracentesis: HR, 0.54 (95% CI, 0.50-0.60)
- Variceal bleeding: HR, 0.79 (95% CI, 0.73-0.84)
- Hypoglycemia: HR, 0.75 (95% CI, 0.62-0.91)
- All-cause hospitalizations: HR, 0.67 (95% CI, 0.63-0.71)
The authors conjectured that SGLT2 inhibition might also benefit patients with other stages of liver disease. They pointed to a 2020 study in patients with diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD), and high baseline fibrosis that revealed a significant reduction in fibrosis after 12 months’ SGLT2 inhibition.
The study findings also align with those of another large propensity-matched cohort in which patients with type 2 diabetes and cirrhosis receiving metformin plus SGLT2 inhibition showed significantly lower 5-year mortality, decreased incidence of decompensated cirrhosis, and reduced hepatocellular carcinoma incidence compared with those taking metformin alone.
Prospective trials are needed to further evaluate safety and efficacy, however, the authors stressed. Future studies should specifically examine changes in sodium levels following SGLT2 inhibitor initiation, as well as the incidence of recurrent urinary tract infections and euglycemic diabetic ketoacidosis, given that these are known adverse effects of this drug class. Additionally, research comparing different types and dosing regimens would provide valuable insights into optimizing treatment.
Commenting on the analysis but not participating in it, Karn Wijarnpreecha, MD, MPH, a hepatologist at College of Medicine, The University of Arizona, Phoenix, said the study was interesting but did not show the adjusted HR for all-cause mortality separately from other serious liver events, “so we do not know if SGLT2 inhibitor group was associated with lower mortality.”
It would be premature to conclude that using SGLT2 inhibitors in patients with cirrhosis and ascites and on diuretics will decrease the need for liver transplant or significantly improve liver-related outcomes based on this study, Wijarnpreecha told GI & Hepatology News. “Moreover, we do not know the dose of diuretics or specific drugs and doses for SGLT2 inhibitors that were used in the study. Indications for using SGLT2 inhibitors are mainly from diabetes and heart failure, so this may not apply to those with cirrhosis without these two conditions as well.”
In addition, the etiology of cirrhosis in this database study is unknown. “Is it mainly from MASLD or alcohol or other conditions such as viral hepatitis or autoimmmunity? We need more thorough study to answer this question.” He also pointed out that the authors urged caution in using SGLT2 inhibitors in the context of hepatic encephalopathy (HE), which could be worsened with these agents. “This should be taken into consideration before starting medication in decompensated cirrhosis with HE,” Wijarnpreecha said.
In an accompanying commentary, Mohamed I. Elsaid, PhD, MPH, a biomedical informatics researcher and assistant professor at The Ohio State University in Columbus, Ohio, said that if confirmed, the findings could substantially improve cirrhosis care. “The signal is exciting but needs strong confirmation from large observational studies and prospective trials,” he wrote. “To turn promise into practice, the next wave of observational studies must embrace the target-trial emulation framework for bolstering firm causal conclusions and doubly robust learners that tease apart who benefits, who does not, and why.”
He added that head-to-head comparisons with the type 2 diabetes drugs known as incretin mimetics will clarify the best antihyperglycemic agents for different patient phenotypes. “With these advanced causal-inference approaches, repurposed type 2 diabetes therapies could shift cirrhosis management from reactive to proactive, improving quality of life and bending the mortality curve,” Elsaid wrote.
For Wijarnpreecha, important pending questions include the benefits of SGLT2 inhibition in cirrhosis without diabetes or heart failure “Can it be used to prevent cirrhosis in MASLD if we start at the early fibrosis stage in F0-F3?”
Chiang conceded that the study had limitations as it relied on 10th revision of the International Classification of Diseases codes to define outcomes, which may not have captured the complexity of cirrhotic complications. “And the retrospective design may have introduced confounding, selection, and information bias, which could have impacted the results,” he said. “Future prospective studies may help confirm our findings.”
No specific funding was reported for this study. The study authors and Wijarnpreecha had no relevant conflicts of interest to declare. Elsaid reported receiving research funding from Genentech and AstraZeneca outside of the submitted work.
A version of this article first appeared on Medscape.com.
, a large cohort study of more than 10,000 patients found.
Reporting in JAMA Network Open, Dian J. Chiang, MD, MPH, a section head of Hepatology at the Cleveland Clinic in Cleveland looked at the impact of these antihyperglycemic agents, also known as gliflozins, used in diabetes and kidney disease to block the reabsorption of glucose in the kidneys and causing more glucose to be excreted in the urine.
“Patients with cirrhosis were previously not included in SGLT2 inhibition clinical trials, and there is no large real-world evidence on the safety and effectiveness of this class of medication in patients with cirrhosis. Therefore, we decided to conduct the study to assess its safety and effectiveness,” Chiang told GI & Hepatology News.
The study’s primary endpoint was a composite of serious hepatic events, defined as ascites, varices, hyponatremia, and all-cause mortality. Secondary outcomes included variceal bleeding, paracentesis, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome, liver carcinoma, hypoglycemia, and all-cause hospitalizations.
The cohort consisted of 10,660 propensity-matched adult patients with cirrhosis from more than 120 healthcare organizations in the TriNetX database who were receiving furosemide and spironolactone from January 2013 to July 2021. Those also receiving SGLT2 inhibitors (n = 5330) were compared with a matched control group receiving diuretics only (n = 5330). The mean age of participants was 63.8 years, 57.8% were men, 66.3% were White individuals, and all were followed for 3 years.
The SGLT2 inhibitor group had a 32% lower incidence of serious liver events than the control group, for a hazard ratio (HR) of 0.68 (95% CI, 0.66-0.71; P < .001).
Secondary risk reductions in the intervention group were as follows:
- Hepatorenal syndrome: HR, 0.47 (95% CI, 0.40-0.56)
- Spontaneous bacterial peritonitis: HR, 0.55 (95% CI, 0.46-0.65)
- Paracentesis: HR, 0.54 (95% CI, 0.50-0.60)
- Variceal bleeding: HR, 0.79 (95% CI, 0.73-0.84)
- Hypoglycemia: HR, 0.75 (95% CI, 0.62-0.91)
- All-cause hospitalizations: HR, 0.67 (95% CI, 0.63-0.71)
The authors conjectured that SGLT2 inhibition might also benefit patients with other stages of liver disease. They pointed to a 2020 study in patients with diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD), and high baseline fibrosis that revealed a significant reduction in fibrosis after 12 months’ SGLT2 inhibition.
The study findings also align with those of another large propensity-matched cohort in which patients with type 2 diabetes and cirrhosis receiving metformin plus SGLT2 inhibition showed significantly lower 5-year mortality, decreased incidence of decompensated cirrhosis, and reduced hepatocellular carcinoma incidence compared with those taking metformin alone.
Prospective trials are needed to further evaluate safety and efficacy, however, the authors stressed. Future studies should specifically examine changes in sodium levels following SGLT2 inhibitor initiation, as well as the incidence of recurrent urinary tract infections and euglycemic diabetic ketoacidosis, given that these are known adverse effects of this drug class. Additionally, research comparing different types and dosing regimens would provide valuable insights into optimizing treatment.
Commenting on the analysis but not participating in it, Karn Wijarnpreecha, MD, MPH, a hepatologist at College of Medicine, The University of Arizona, Phoenix, said the study was interesting but did not show the adjusted HR for all-cause mortality separately from other serious liver events, “so we do not know if SGLT2 inhibitor group was associated with lower mortality.”
It would be premature to conclude that using SGLT2 inhibitors in patients with cirrhosis and ascites and on diuretics will decrease the need for liver transplant or significantly improve liver-related outcomes based on this study, Wijarnpreecha told GI & Hepatology News. “Moreover, we do not know the dose of diuretics or specific drugs and doses for SGLT2 inhibitors that were used in the study. Indications for using SGLT2 inhibitors are mainly from diabetes and heart failure, so this may not apply to those with cirrhosis without these two conditions as well.”
In addition, the etiology of cirrhosis in this database study is unknown. “Is it mainly from MASLD or alcohol or other conditions such as viral hepatitis or autoimmmunity? We need more thorough study to answer this question.” He also pointed out that the authors urged caution in using SGLT2 inhibitors in the context of hepatic encephalopathy (HE), which could be worsened with these agents. “This should be taken into consideration before starting medication in decompensated cirrhosis with HE,” Wijarnpreecha said.
In an accompanying commentary, Mohamed I. Elsaid, PhD, MPH, a biomedical informatics researcher and assistant professor at The Ohio State University in Columbus, Ohio, said that if confirmed, the findings could substantially improve cirrhosis care. “The signal is exciting but needs strong confirmation from large observational studies and prospective trials,” he wrote. “To turn promise into practice, the next wave of observational studies must embrace the target-trial emulation framework for bolstering firm causal conclusions and doubly robust learners that tease apart who benefits, who does not, and why.”
He added that head-to-head comparisons with the type 2 diabetes drugs known as incretin mimetics will clarify the best antihyperglycemic agents for different patient phenotypes. “With these advanced causal-inference approaches, repurposed type 2 diabetes therapies could shift cirrhosis management from reactive to proactive, improving quality of life and bending the mortality curve,” Elsaid wrote.
For Wijarnpreecha, important pending questions include the benefits of SGLT2 inhibition in cirrhosis without diabetes or heart failure “Can it be used to prevent cirrhosis in MASLD if we start at the early fibrosis stage in F0-F3?”
Chiang conceded that the study had limitations as it relied on 10th revision of the International Classification of Diseases codes to define outcomes, which may not have captured the complexity of cirrhotic complications. “And the retrospective design may have introduced confounding, selection, and information bias, which could have impacted the results,” he said. “Future prospective studies may help confirm our findings.”
No specific funding was reported for this study. The study authors and Wijarnpreecha had no relevant conflicts of interest to declare. Elsaid reported receiving research funding from Genentech and AstraZeneca outside of the submitted work.
A version of this article first appeared on Medscape.com.
, a large cohort study of more than 10,000 patients found.
Reporting in JAMA Network Open, Dian J. Chiang, MD, MPH, a section head of Hepatology at the Cleveland Clinic in Cleveland looked at the impact of these antihyperglycemic agents, also known as gliflozins, used in diabetes and kidney disease to block the reabsorption of glucose in the kidneys and causing more glucose to be excreted in the urine.
“Patients with cirrhosis were previously not included in SGLT2 inhibition clinical trials, and there is no large real-world evidence on the safety and effectiveness of this class of medication in patients with cirrhosis. Therefore, we decided to conduct the study to assess its safety and effectiveness,” Chiang told GI & Hepatology News.
The study’s primary endpoint was a composite of serious hepatic events, defined as ascites, varices, hyponatremia, and all-cause mortality. Secondary outcomes included variceal bleeding, paracentesis, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome, liver carcinoma, hypoglycemia, and all-cause hospitalizations.
The cohort consisted of 10,660 propensity-matched adult patients with cirrhosis from more than 120 healthcare organizations in the TriNetX database who were receiving furosemide and spironolactone from January 2013 to July 2021. Those also receiving SGLT2 inhibitors (n = 5330) were compared with a matched control group receiving diuretics only (n = 5330). The mean age of participants was 63.8 years, 57.8% were men, 66.3% were White individuals, and all were followed for 3 years.
The SGLT2 inhibitor group had a 32% lower incidence of serious liver events than the control group, for a hazard ratio (HR) of 0.68 (95% CI, 0.66-0.71; P < .001).
Secondary risk reductions in the intervention group were as follows:
- Hepatorenal syndrome: HR, 0.47 (95% CI, 0.40-0.56)
- Spontaneous bacterial peritonitis: HR, 0.55 (95% CI, 0.46-0.65)
- Paracentesis: HR, 0.54 (95% CI, 0.50-0.60)
- Variceal bleeding: HR, 0.79 (95% CI, 0.73-0.84)
- Hypoglycemia: HR, 0.75 (95% CI, 0.62-0.91)
- All-cause hospitalizations: HR, 0.67 (95% CI, 0.63-0.71)
The authors conjectured that SGLT2 inhibition might also benefit patients with other stages of liver disease. They pointed to a 2020 study in patients with diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD), and high baseline fibrosis that revealed a significant reduction in fibrosis after 12 months’ SGLT2 inhibition.
The study findings also align with those of another large propensity-matched cohort in which patients with type 2 diabetes and cirrhosis receiving metformin plus SGLT2 inhibition showed significantly lower 5-year mortality, decreased incidence of decompensated cirrhosis, and reduced hepatocellular carcinoma incidence compared with those taking metformin alone.
Prospective trials are needed to further evaluate safety and efficacy, however, the authors stressed. Future studies should specifically examine changes in sodium levels following SGLT2 inhibitor initiation, as well as the incidence of recurrent urinary tract infections and euglycemic diabetic ketoacidosis, given that these are known adverse effects of this drug class. Additionally, research comparing different types and dosing regimens would provide valuable insights into optimizing treatment.
Commenting on the analysis but not participating in it, Karn Wijarnpreecha, MD, MPH, a hepatologist at College of Medicine, The University of Arizona, Phoenix, said the study was interesting but did not show the adjusted HR for all-cause mortality separately from other serious liver events, “so we do not know if SGLT2 inhibitor group was associated with lower mortality.”
It would be premature to conclude that using SGLT2 inhibitors in patients with cirrhosis and ascites and on diuretics will decrease the need for liver transplant or significantly improve liver-related outcomes based on this study, Wijarnpreecha told GI & Hepatology News. “Moreover, we do not know the dose of diuretics or specific drugs and doses for SGLT2 inhibitors that were used in the study. Indications for using SGLT2 inhibitors are mainly from diabetes and heart failure, so this may not apply to those with cirrhosis without these two conditions as well.”
In addition, the etiology of cirrhosis in this database study is unknown. “Is it mainly from MASLD or alcohol or other conditions such as viral hepatitis or autoimmmunity? We need more thorough study to answer this question.” He also pointed out that the authors urged caution in using SGLT2 inhibitors in the context of hepatic encephalopathy (HE), which could be worsened with these agents. “This should be taken into consideration before starting medication in decompensated cirrhosis with HE,” Wijarnpreecha said.
In an accompanying commentary, Mohamed I. Elsaid, PhD, MPH, a biomedical informatics researcher and assistant professor at The Ohio State University in Columbus, Ohio, said that if confirmed, the findings could substantially improve cirrhosis care. “The signal is exciting but needs strong confirmation from large observational studies and prospective trials,” he wrote. “To turn promise into practice, the next wave of observational studies must embrace the target-trial emulation framework for bolstering firm causal conclusions and doubly robust learners that tease apart who benefits, who does not, and why.”
He added that head-to-head comparisons with the type 2 diabetes drugs known as incretin mimetics will clarify the best antihyperglycemic agents for different patient phenotypes. “With these advanced causal-inference approaches, repurposed type 2 diabetes therapies could shift cirrhosis management from reactive to proactive, improving quality of life and bending the mortality curve,” Elsaid wrote.
For Wijarnpreecha, important pending questions include the benefits of SGLT2 inhibition in cirrhosis without diabetes or heart failure “Can it be used to prevent cirrhosis in MASLD if we start at the early fibrosis stage in F0-F3?”
Chiang conceded that the study had limitations as it relied on 10th revision of the International Classification of Diseases codes to define outcomes, which may not have captured the complexity of cirrhotic complications. “And the retrospective design may have introduced confounding, selection, and information bias, which could have impacted the results,” he said. “Future prospective studies may help confirm our findings.”
No specific funding was reported for this study. The study authors and Wijarnpreecha had no relevant conflicts of interest to declare. Elsaid reported receiving research funding from Genentech and AstraZeneca outside of the submitted work.
A version of this article first appeared on Medscape.com.
Forceps Assistance Improves Outcomes in Difficult ERCP Cannulations
The results emerged from the small, single-center SOCCER trial of 152 patients recruited from March 2022 to October 2024 and are published in The American Journal of Gastroenterology.
Both groups had a slightly higher number of female participants, and the mean ages of the participants were 61.9 years in the forceps group and 68.3 years in the no forceps group.
First author Steven M. Hadley Jr, an MD candidate at Northwestern Feinberg School of Medicine in Chicago, and colleagues reported that forceps assistance in difficult cannulations yielded significantly higher success rates than no forceps assistance (100% vs 83.9%; P < .001).
The investigators noted that difficult cannulations during ERCP have a frequency of 42%. Cannulation failure is associated with increased morbidity — including longer hospitalization, increased ICU admissions, readmissions, and increased financial cost — as well as mortality rates of up to 10%.
SOCCER defined difficult cannulation as a papilla in or on the rim of a diverticulum, five or more attempts, attempts lasting 5 or more minutes, or two or more unintended pancreatic duct wire passages. Other features were redundant tissue overlaying the papilla or a type 2, 3, or 4 papilla.
The study found forceps assistance also had a nonstatistically significant lower rate of difficult cannulations than no forceps (57.1% vs 69.1%; P = .132). The rate of post-ERCP pancreatitis (PEP) was similarly low in both groups: 5.7% with forceps vs 3.7% without forceps (P = .705). The no forceps group had significantly more cannulation attempts after randomization than the forceps group (14 vs 8.3; P = .026).
Patients who crossed over to forceps assistance all had successful cannulations.
The technique has long been used to overcome cannulation difficulties, said Timothy B. Gardner, MD, MS, a gastroenterologist at the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, and a coauthor of the study. “It was particularly effective for cannulations with redundant tissue limiting access to the papilla,” Gardner told GI & Hepatology News. “We decided to design a randomized trial to determine the extent to which this technique worked. We believed our study would answer an important question that would hopefully lead to an improvement in endoscopy practice.”
While a few case reports and video demos had described the technique, no trials had assessed its effectiveness, Hadley added. “We found the technique to be effective based on our experience, but it was exciting to see that a rigorously designed randomized trial proved that it is indeed a very effective technique to facilitate cannulation.”
Hadley noted the technique does not increase PEP incidence, unlike the commonly used precut sphincterotomy and the double-wire method for difficult cannulations. “As a result, the forceps-assisted technique may be an effective first-line option and may reduce the need for additional, more invasive procedures including surgery and repeat ERCP to obtain the therapeutic intent of the original ERCP.”
The paper outlines the technique’s methodology, he added, “so we believe endoscopists who read the manuscript will be able to start implementing the technique into their practice.”
Commenting on the paper but not involved in it, Christopher J. DiMaio, MD, regional director of Endoscopy for Northwell Health Physician Partners Gastroenterology and a gastroenterologist in Greenlawn, New York, called it potentially helpful but aimed at a niche group of expert practitioners. “The technique appears safe and very effective, which is the number one concern, and I would definitely keep it in my back pocket,” he said. “I expect it will be used more commonly now because of this study.”
He added that although expert endoscopists are familiar with the approach, they use more time-tested and sometimes more aggressive maneuvers to cope with difficult cannulations. “But this is a simple technique using a device that should be available to most high-volume endoscopists.”
DiMaio also noted that he would have liked to see an actual decrease in PEP incidence in the intervention group.
Looking ahead, Hadley said it would be interesting to compare the effectiveness of the double-wire technique against forceps-assisted cannulation in a randomized context. “A study we’re already looking into is seeing whether physician experience with the technique impacts outcomes.”
This study was supported by the American College of Gastroenterology. The authors and DiMaio reported having no relevant competing interests.
A version of this article first appeared on Medscape.com.
The results emerged from the small, single-center SOCCER trial of 152 patients recruited from March 2022 to October 2024 and are published in The American Journal of Gastroenterology.
Both groups had a slightly higher number of female participants, and the mean ages of the participants were 61.9 years in the forceps group and 68.3 years in the no forceps group.
First author Steven M. Hadley Jr, an MD candidate at Northwestern Feinberg School of Medicine in Chicago, and colleagues reported that forceps assistance in difficult cannulations yielded significantly higher success rates than no forceps assistance (100% vs 83.9%; P < .001).
The investigators noted that difficult cannulations during ERCP have a frequency of 42%. Cannulation failure is associated with increased morbidity — including longer hospitalization, increased ICU admissions, readmissions, and increased financial cost — as well as mortality rates of up to 10%.
SOCCER defined difficult cannulation as a papilla in or on the rim of a diverticulum, five or more attempts, attempts lasting 5 or more minutes, or two or more unintended pancreatic duct wire passages. Other features were redundant tissue overlaying the papilla or a type 2, 3, or 4 papilla.
The study found forceps assistance also had a nonstatistically significant lower rate of difficult cannulations than no forceps (57.1% vs 69.1%; P = .132). The rate of post-ERCP pancreatitis (PEP) was similarly low in both groups: 5.7% with forceps vs 3.7% without forceps (P = .705). The no forceps group had significantly more cannulation attempts after randomization than the forceps group (14 vs 8.3; P = .026).
Patients who crossed over to forceps assistance all had successful cannulations.
The technique has long been used to overcome cannulation difficulties, said Timothy B. Gardner, MD, MS, a gastroenterologist at the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, and a coauthor of the study. “It was particularly effective for cannulations with redundant tissue limiting access to the papilla,” Gardner told GI & Hepatology News. “We decided to design a randomized trial to determine the extent to which this technique worked. We believed our study would answer an important question that would hopefully lead to an improvement in endoscopy practice.”
While a few case reports and video demos had described the technique, no trials had assessed its effectiveness, Hadley added. “We found the technique to be effective based on our experience, but it was exciting to see that a rigorously designed randomized trial proved that it is indeed a very effective technique to facilitate cannulation.”
Hadley noted the technique does not increase PEP incidence, unlike the commonly used precut sphincterotomy and the double-wire method for difficult cannulations. “As a result, the forceps-assisted technique may be an effective first-line option and may reduce the need for additional, more invasive procedures including surgery and repeat ERCP to obtain the therapeutic intent of the original ERCP.”
The paper outlines the technique’s methodology, he added, “so we believe endoscopists who read the manuscript will be able to start implementing the technique into their practice.”
Commenting on the paper but not involved in it, Christopher J. DiMaio, MD, regional director of Endoscopy for Northwell Health Physician Partners Gastroenterology and a gastroenterologist in Greenlawn, New York, called it potentially helpful but aimed at a niche group of expert practitioners. “The technique appears safe and very effective, which is the number one concern, and I would definitely keep it in my back pocket,” he said. “I expect it will be used more commonly now because of this study.”
He added that although expert endoscopists are familiar with the approach, they use more time-tested and sometimes more aggressive maneuvers to cope with difficult cannulations. “But this is a simple technique using a device that should be available to most high-volume endoscopists.”
DiMaio also noted that he would have liked to see an actual decrease in PEP incidence in the intervention group.
Looking ahead, Hadley said it would be interesting to compare the effectiveness of the double-wire technique against forceps-assisted cannulation in a randomized context. “A study we’re already looking into is seeing whether physician experience with the technique impacts outcomes.”
This study was supported by the American College of Gastroenterology. The authors and DiMaio reported having no relevant competing interests.
A version of this article first appeared on Medscape.com.
The results emerged from the small, single-center SOCCER trial of 152 patients recruited from March 2022 to October 2024 and are published in The American Journal of Gastroenterology.
Both groups had a slightly higher number of female participants, and the mean ages of the participants were 61.9 years in the forceps group and 68.3 years in the no forceps group.
First author Steven M. Hadley Jr, an MD candidate at Northwestern Feinberg School of Medicine in Chicago, and colleagues reported that forceps assistance in difficult cannulations yielded significantly higher success rates than no forceps assistance (100% vs 83.9%; P < .001).
The investigators noted that difficult cannulations during ERCP have a frequency of 42%. Cannulation failure is associated with increased morbidity — including longer hospitalization, increased ICU admissions, readmissions, and increased financial cost — as well as mortality rates of up to 10%.
SOCCER defined difficult cannulation as a papilla in or on the rim of a diverticulum, five or more attempts, attempts lasting 5 or more minutes, or two or more unintended pancreatic duct wire passages. Other features were redundant tissue overlaying the papilla or a type 2, 3, or 4 papilla.
The study found forceps assistance also had a nonstatistically significant lower rate of difficult cannulations than no forceps (57.1% vs 69.1%; P = .132). The rate of post-ERCP pancreatitis (PEP) was similarly low in both groups: 5.7% with forceps vs 3.7% without forceps (P = .705). The no forceps group had significantly more cannulation attempts after randomization than the forceps group (14 vs 8.3; P = .026).
Patients who crossed over to forceps assistance all had successful cannulations.
The technique has long been used to overcome cannulation difficulties, said Timothy B. Gardner, MD, MS, a gastroenterologist at the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, and a coauthor of the study. “It was particularly effective for cannulations with redundant tissue limiting access to the papilla,” Gardner told GI & Hepatology News. “We decided to design a randomized trial to determine the extent to which this technique worked. We believed our study would answer an important question that would hopefully lead to an improvement in endoscopy practice.”
While a few case reports and video demos had described the technique, no trials had assessed its effectiveness, Hadley added. “We found the technique to be effective based on our experience, but it was exciting to see that a rigorously designed randomized trial proved that it is indeed a very effective technique to facilitate cannulation.”
Hadley noted the technique does not increase PEP incidence, unlike the commonly used precut sphincterotomy and the double-wire method for difficult cannulations. “As a result, the forceps-assisted technique may be an effective first-line option and may reduce the need for additional, more invasive procedures including surgery and repeat ERCP to obtain the therapeutic intent of the original ERCP.”
The paper outlines the technique’s methodology, he added, “so we believe endoscopists who read the manuscript will be able to start implementing the technique into their practice.”
Commenting on the paper but not involved in it, Christopher J. DiMaio, MD, regional director of Endoscopy for Northwell Health Physician Partners Gastroenterology and a gastroenterologist in Greenlawn, New York, called it potentially helpful but aimed at a niche group of expert practitioners. “The technique appears safe and very effective, which is the number one concern, and I would definitely keep it in my back pocket,” he said. “I expect it will be used more commonly now because of this study.”
He added that although expert endoscopists are familiar with the approach, they use more time-tested and sometimes more aggressive maneuvers to cope with difficult cannulations. “But this is a simple technique using a device that should be available to most high-volume endoscopists.”
DiMaio also noted that he would have liked to see an actual decrease in PEP incidence in the intervention group.
Looking ahead, Hadley said it would be interesting to compare the effectiveness of the double-wire technique against forceps-assisted cannulation in a randomized context. “A study we’re already looking into is seeing whether physician experience with the technique impacts outcomes.”
This study was supported by the American College of Gastroenterology. The authors and DiMaio reported having no relevant competing interests.
A version of this article first appeared on Medscape.com.
Intestinal Methanogen Overgrowth Fosters More Constipation, Less Diarrhea
, according to a systematic review and meta-analysis published in Clinical Gastroenterology and Hepatology.
“The distinct phenotype of patients with IMO should be incorporated in patient-reported outcome measures and further correlated with mechanistic microbiome studies,” wrote investigators led by gastroenterologist Ali Rezaie, MD, MSc, medical director of the GI Motility Program at Cedars-Sinai Medical Center and director of biotechnology in the center’s Medically Associated Science and Technology (MAST) Program. Recognizing specific GI symptom profiles can improve diagnosis and treatment strategies, facilitating further clinical trials and targeted microbiome studies to optimize patient care.
Excessive luminal loads of methanogenic archaea – archaea being bacteria-like prokaryotes and one of the main three domains of the tree of life – have been implicated in the pathophysiology of various diseases, including constipation.
The Study
To elucidate the phenotypical presentation of IMO in patients, Rezaie’s group compared the prevalence and severity of gastrointestinal (GI) symptoms in individuals who had IMO with those who did not have IMO. IMO was based on excess levels of this gaseous GI byproduct in exhaled breath tests.
Searching electronic databases from inception to September 2023, the researchers identified 19 eligible studies from diverse geographical regions with 1293 IMO patients and 3208 controls. Eleven studies were performed in the United States; the other studies were conducted in France (n = 2), India (n = 2), New Zealand (n = 1), South Korea (n = 1), Italy (n = 1), and the United Kingdom (n = 1). Thirteen studies were of high quality, as defined by a Newcastle-Ottawa Assessment Scale score of 6.
Patients with IMO were found to exhibit a range of GI symptoms, including bloating (78%), constipation (51%), diarrhea (33%), abdominal pain (65%), nausea (30%), and flatulence (56%).
In other findings:
- Patients with IMO had a significantly higher prevalence of constipation vs controls: 47% vs 38% (odds ratio [OR], 2.04, 95% confidence interval [CI], 1.48-2.83, P < .0001).
- They had a lower prevalence of diarrhea: 37% vs 52% (OR .58, 95% CI, .37-.90, P = .01); and nausea: 32% vs 45%; (OR, .75; 95% CI, .60-.94, P = .01).
- Patients with IMO had more severe constipation: standard mean deviation [SMD], .77 (95% CI, .11-1.43, P = .02) and a lower severity of diarrhea: SMD, –.71 (95% CI, –1.39 to –.03, P = .04). Significant heterogeneity of effect, however, was detected.
- Constipation was more prevalent in IMO diagnosed with the lactulose breath test and the glucose breath test and constipation was particularly prevalent in Europe and the United States.
Mechanism of Action
The findings on constipation and diarrhea corroborate methane’s slowing physiologic effects on motility, the authors noted. It has been consistently found to delay gut transit, both small bowel and colonic transit.
Mechanistically, methane reduces small intestinal peristaltic velocity while augmenting non-propagating contraction amplitude, suggesting that reduction of intestinal transit time is mediated through promotion of non-propulsive contractions.
“This study further consolidates methane’s causal role in constipation and paves the way to establish validated disease-specific patient-reported outcomes,” Rezaie and associates wrote, calling for longitudinal and mechanistic studies assessing the archaeome in order to advance understanding of IMO.
This study was funded in part by Nancy Stark and Stanley Lezman in support of the MAST Program’s Innovation Project at Cedars-Sinai.
Rezaie serves as a consultant/speaker for Bausch Health. Cedars-Sinai Medical Center has a licensing agreement with Gemelli Biotech, in which Rezaie and coauthor Pimentel have equity. They also hold equity in Good LIFE. Pimentel consults for and has received grant support from Bausch Health.
, according to a systematic review and meta-analysis published in Clinical Gastroenterology and Hepatology.
“The distinct phenotype of patients with IMO should be incorporated in patient-reported outcome measures and further correlated with mechanistic microbiome studies,” wrote investigators led by gastroenterologist Ali Rezaie, MD, MSc, medical director of the GI Motility Program at Cedars-Sinai Medical Center and director of biotechnology in the center’s Medically Associated Science and Technology (MAST) Program. Recognizing specific GI symptom profiles can improve diagnosis and treatment strategies, facilitating further clinical trials and targeted microbiome studies to optimize patient care.
Excessive luminal loads of methanogenic archaea – archaea being bacteria-like prokaryotes and one of the main three domains of the tree of life – have been implicated in the pathophysiology of various diseases, including constipation.
The Study
To elucidate the phenotypical presentation of IMO in patients, Rezaie’s group compared the prevalence and severity of gastrointestinal (GI) symptoms in individuals who had IMO with those who did not have IMO. IMO was based on excess levels of this gaseous GI byproduct in exhaled breath tests.
Searching electronic databases from inception to September 2023, the researchers identified 19 eligible studies from diverse geographical regions with 1293 IMO patients and 3208 controls. Eleven studies were performed in the United States; the other studies were conducted in France (n = 2), India (n = 2), New Zealand (n = 1), South Korea (n = 1), Italy (n = 1), and the United Kingdom (n = 1). Thirteen studies were of high quality, as defined by a Newcastle-Ottawa Assessment Scale score of 6.
Patients with IMO were found to exhibit a range of GI symptoms, including bloating (78%), constipation (51%), diarrhea (33%), abdominal pain (65%), nausea (30%), and flatulence (56%).
In other findings:
- Patients with IMO had a significantly higher prevalence of constipation vs controls: 47% vs 38% (odds ratio [OR], 2.04, 95% confidence interval [CI], 1.48-2.83, P < .0001).
- They had a lower prevalence of diarrhea: 37% vs 52% (OR .58, 95% CI, .37-.90, P = .01); and nausea: 32% vs 45%; (OR, .75; 95% CI, .60-.94, P = .01).
- Patients with IMO had more severe constipation: standard mean deviation [SMD], .77 (95% CI, .11-1.43, P = .02) and a lower severity of diarrhea: SMD, –.71 (95% CI, –1.39 to –.03, P = .04). Significant heterogeneity of effect, however, was detected.
- Constipation was more prevalent in IMO diagnosed with the lactulose breath test and the glucose breath test and constipation was particularly prevalent in Europe and the United States.
Mechanism of Action
The findings on constipation and diarrhea corroborate methane’s slowing physiologic effects on motility, the authors noted. It has been consistently found to delay gut transit, both small bowel and colonic transit.
Mechanistically, methane reduces small intestinal peristaltic velocity while augmenting non-propagating contraction amplitude, suggesting that reduction of intestinal transit time is mediated through promotion of non-propulsive contractions.
“This study further consolidates methane’s causal role in constipation and paves the way to establish validated disease-specific patient-reported outcomes,” Rezaie and associates wrote, calling for longitudinal and mechanistic studies assessing the archaeome in order to advance understanding of IMO.
This study was funded in part by Nancy Stark and Stanley Lezman in support of the MAST Program’s Innovation Project at Cedars-Sinai.
Rezaie serves as a consultant/speaker for Bausch Health. Cedars-Sinai Medical Center has a licensing agreement with Gemelli Biotech, in which Rezaie and coauthor Pimentel have equity. They also hold equity in Good LIFE. Pimentel consults for and has received grant support from Bausch Health.
, according to a systematic review and meta-analysis published in Clinical Gastroenterology and Hepatology.
“The distinct phenotype of patients with IMO should be incorporated in patient-reported outcome measures and further correlated with mechanistic microbiome studies,” wrote investigators led by gastroenterologist Ali Rezaie, MD, MSc, medical director of the GI Motility Program at Cedars-Sinai Medical Center and director of biotechnology in the center’s Medically Associated Science and Technology (MAST) Program. Recognizing specific GI symptom profiles can improve diagnosis and treatment strategies, facilitating further clinical trials and targeted microbiome studies to optimize patient care.
Excessive luminal loads of methanogenic archaea – archaea being bacteria-like prokaryotes and one of the main three domains of the tree of life – have been implicated in the pathophysiology of various diseases, including constipation.
The Study
To elucidate the phenotypical presentation of IMO in patients, Rezaie’s group compared the prevalence and severity of gastrointestinal (GI) symptoms in individuals who had IMO with those who did not have IMO. IMO was based on excess levels of this gaseous GI byproduct in exhaled breath tests.
Searching electronic databases from inception to September 2023, the researchers identified 19 eligible studies from diverse geographical regions with 1293 IMO patients and 3208 controls. Eleven studies were performed in the United States; the other studies were conducted in France (n = 2), India (n = 2), New Zealand (n = 1), South Korea (n = 1), Italy (n = 1), and the United Kingdom (n = 1). Thirteen studies were of high quality, as defined by a Newcastle-Ottawa Assessment Scale score of 6.
Patients with IMO were found to exhibit a range of GI symptoms, including bloating (78%), constipation (51%), diarrhea (33%), abdominal pain (65%), nausea (30%), and flatulence (56%).
In other findings:
- Patients with IMO had a significantly higher prevalence of constipation vs controls: 47% vs 38% (odds ratio [OR], 2.04, 95% confidence interval [CI], 1.48-2.83, P < .0001).
- They had a lower prevalence of diarrhea: 37% vs 52% (OR .58, 95% CI, .37-.90, P = .01); and nausea: 32% vs 45%; (OR, .75; 95% CI, .60-.94, P = .01).
- Patients with IMO had more severe constipation: standard mean deviation [SMD], .77 (95% CI, .11-1.43, P = .02) and a lower severity of diarrhea: SMD, –.71 (95% CI, –1.39 to –.03, P = .04). Significant heterogeneity of effect, however, was detected.
- Constipation was more prevalent in IMO diagnosed with the lactulose breath test and the glucose breath test and constipation was particularly prevalent in Europe and the United States.
Mechanism of Action
The findings on constipation and diarrhea corroborate methane’s slowing physiologic effects on motility, the authors noted. It has been consistently found to delay gut transit, both small bowel and colonic transit.
Mechanistically, methane reduces small intestinal peristaltic velocity while augmenting non-propagating contraction amplitude, suggesting that reduction of intestinal transit time is mediated through promotion of non-propulsive contractions.
“This study further consolidates methane’s causal role in constipation and paves the way to establish validated disease-specific patient-reported outcomes,” Rezaie and associates wrote, calling for longitudinal and mechanistic studies assessing the archaeome in order to advance understanding of IMO.
This study was funded in part by Nancy Stark and Stanley Lezman in support of the MAST Program’s Innovation Project at Cedars-Sinai.
Rezaie serves as a consultant/speaker for Bausch Health. Cedars-Sinai Medical Center has a licensing agreement with Gemelli Biotech, in which Rezaie and coauthor Pimentel have equity. They also hold equity in Good LIFE. Pimentel consults for and has received grant support from Bausch Health.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Common Medications Do Not Raise Microscopic Colitis Risk in Seniors
“Sensitivity analyses suggest that previously reported associations and persistent association with SSRI [selective serotonin reuptake inhibitor] initiation may be due to surveillance bias,” wrote gastroenterologist Hamed Khalili, MD, MPH, of Massachusetts General Hospital, Boston, and colleagues in Annals of Internal Medicine, advising clinicians to carefully balance the benefits of these medication classes against the very low likelihood of a causal relationship with MC.
While two smaller studies had challenged the belief that these medications can cause MC, Khalili told GI & Hepatology News, “the quality of the data that supported or refuted this hypothesis were low. Nevertheless, most in the field consider MC to be largely related to medications so we thought it was important to systematically answer this question.”
While most medications thought to trigger MC were found not to be causally linked, he added, “we did observe a marginal association with SSRIs but could not rule out the possibility that the association is related to residual bias.”
The authors noted that the incidence of MC in older persons is rising rapidly and is thought to account for more than 30% of chronic diarrhea cases in this group.
Despite weak evidence in the literature, the treatment guidelines of several societies, including the American Gastroenterological Association, recommend discontinuing potential pharmacologic triggers as first-line prevention or as an adjunct therapy, particularly in recurrent or refractory MC. But this approach may be ineffective in patients with established disease and could lead to inappropriate discontinuation of medication such as antihypertensives, the authors argued.
As to proposed mechanisms of action, said Khalili, “for PPIs [proton-pump inhibitors,] people thought it was related to changes in the gut microbiome. For NSAIDs [nonsteroidal anti-inflammatory drugs], people thought it could be related to changes in the gut barrier function. But overall, not a single mechanism would have explained all the prior associations that were observed.”
While medications such as PPIs and SSRIs can cause diarrhea in a small subset of users, Khalili added, “most patients generally catch these side effects very quickly and realize that stopping these medications will improve their diarrhea. This is very different than most patients we as gastroenterologists see with a new diagnosis of MC. Many of them may have been on these medications for a long time. We believe that stopping medications in these patients is unnecessary.”
Study Details
The investigators looked at eligible residents in Sweden age 65 years or older in the years 2006 to 2017 (n = 191,482 to 2,634,777). Participants had no history of inflammatory bowel disease and different cohorts were examined for various common medications from calcium channel blockers to statins.
With a primary outcome of biopsy-verified MC, dates of diagnosis were obtained from Sweden’s national histopathology cohort ESPRESSO (Epidemiology Strengthened by Histopathology Reports in Sweden). Among the findings:
- The 12- and 24-month cumulative incidences of MC were less than 0.05% under all treatment strategies.
- Estimated 12-month risk differences were close to null under angiotensin-converting enzyme vs calcium-channel blocker (CCB) initiation, angiotensin-receptor blocker vs CCB initiation, NSAID initiation vs noninitiation, PPI inhibitor initiation vs noninitiation, and statin initiation vs noninitiation.
- The estimated 12-month risk difference was 0.04% (95% CI, 0.03%-0.05%) for SSRIs vs mirtazapine.
- Results were similar for 24-month risk differences. Several medications such as SSRIs were also associated with increased risk for undergoing colonoscopy with a normal colorectal mucosa biopsy result.
“We think it’s unlikely that stopping these medications will improve symptoms of MC,” Khalili said.
Commenting on the paper but not involved in it, Jordan E. Axelrad, MD, MPH, codirector of the Inflammatory Bowel Disease Center at NYU Langone Health in New York City, said, “This study strengthens the argument that MC is an immune-mediated disease, not primarily driven by drug exposures. But future studies in diverse cohorts are required to validate these findings.” He said the study nevertheless provides reassurance that previously reported associations may have been overstated or confounded by factors such as reverse causation and increased healthcare utilization preceding the MC diagnosis.
In the meantime, Axelrad added, the findings “may reduce the inclination to promptly discontinue medications historically associated with MC in newly diagnosed cases. Also, these data help shift the clinical focus away from medication cessation alone and toward a needed and broader MC management strategy. US-based validation would likely highlight these changes in our patients.”
Despite concerns about the study’s unmeasured confounding because of differential healthcare utilization or surveillance, the modest association observed between SSRI and MC is supported by literature linking catecholamine and serotonin to gut innate immunity and microbiota, Khalili’s group wrote. “However, this finding may also be confounded by other factors including persisting surveillance and protopathic bias, especially since an association was also seen for risk for receipt of a colonoscopy with normal mucosa.”
Khalili believes the Swedish results are applicable even to the more diverse US population. He noted that lack of primary care data limited measurement of and adjustment for symptoms and medical diagnoses that increase risk. But according to Axelrad, MC is more prevalent in White, older patients, who are well-represented in Swedish cohorts but to a lesser extent in US populations. “Additionally, environmental factors and medication use patterns differ between Sweden and the US, particularly in regard to over-the-counter medication access.”
The findings have implications for future research in pharmacoepidemiologic studies of gastrointestinal-related outcomes. Since many routinely prescribed medications such as SSRIs were associated with an apparent increased risk for colonoscopies with normal colorectal biopsy results, future studies that examine gastrointestinal-specific adverse events should carefully consider potential surveillance bias.
In the meantime, Khalili stressed, it’s important to highlight that while some of these medications cause diarrhea in a small subset of patients, stopping medications in these patients is unnecessary.
This study was supported by the National Institutes of Health (NIH) and the Swedish Research Council. Khalili disclosed grants from the Crohn’s & Coiltis Foundation, the NIH and the Helmsley CharitableTrust, as well as stock ownership in Cylinder Health. One coauthor is employed by Massachusetts General Hospital. Axelrad had no relevant competing interests.
“Sensitivity analyses suggest that previously reported associations and persistent association with SSRI [selective serotonin reuptake inhibitor] initiation may be due to surveillance bias,” wrote gastroenterologist Hamed Khalili, MD, MPH, of Massachusetts General Hospital, Boston, and colleagues in Annals of Internal Medicine, advising clinicians to carefully balance the benefits of these medication classes against the very low likelihood of a causal relationship with MC.
While two smaller studies had challenged the belief that these medications can cause MC, Khalili told GI & Hepatology News, “the quality of the data that supported or refuted this hypothesis were low. Nevertheless, most in the field consider MC to be largely related to medications so we thought it was important to systematically answer this question.”
While most medications thought to trigger MC were found not to be causally linked, he added, “we did observe a marginal association with SSRIs but could not rule out the possibility that the association is related to residual bias.”
The authors noted that the incidence of MC in older persons is rising rapidly and is thought to account for more than 30% of chronic diarrhea cases in this group.
Despite weak evidence in the literature, the treatment guidelines of several societies, including the American Gastroenterological Association, recommend discontinuing potential pharmacologic triggers as first-line prevention or as an adjunct therapy, particularly in recurrent or refractory MC. But this approach may be ineffective in patients with established disease and could lead to inappropriate discontinuation of medication such as antihypertensives, the authors argued.
As to proposed mechanisms of action, said Khalili, “for PPIs [proton-pump inhibitors,] people thought it was related to changes in the gut microbiome. For NSAIDs [nonsteroidal anti-inflammatory drugs], people thought it could be related to changes in the gut barrier function. But overall, not a single mechanism would have explained all the prior associations that were observed.”
While medications such as PPIs and SSRIs can cause diarrhea in a small subset of users, Khalili added, “most patients generally catch these side effects very quickly and realize that stopping these medications will improve their diarrhea. This is very different than most patients we as gastroenterologists see with a new diagnosis of MC. Many of them may have been on these medications for a long time. We believe that stopping medications in these patients is unnecessary.”
Study Details
The investigators looked at eligible residents in Sweden age 65 years or older in the years 2006 to 2017 (n = 191,482 to 2,634,777). Participants had no history of inflammatory bowel disease and different cohorts were examined for various common medications from calcium channel blockers to statins.
With a primary outcome of biopsy-verified MC, dates of diagnosis were obtained from Sweden’s national histopathology cohort ESPRESSO (Epidemiology Strengthened by Histopathology Reports in Sweden). Among the findings:
- The 12- and 24-month cumulative incidences of MC were less than 0.05% under all treatment strategies.
- Estimated 12-month risk differences were close to null under angiotensin-converting enzyme vs calcium-channel blocker (CCB) initiation, angiotensin-receptor blocker vs CCB initiation, NSAID initiation vs noninitiation, PPI inhibitor initiation vs noninitiation, and statin initiation vs noninitiation.
- The estimated 12-month risk difference was 0.04% (95% CI, 0.03%-0.05%) for SSRIs vs mirtazapine.
- Results were similar for 24-month risk differences. Several medications such as SSRIs were also associated with increased risk for undergoing colonoscopy with a normal colorectal mucosa biopsy result.
“We think it’s unlikely that stopping these medications will improve symptoms of MC,” Khalili said.
Commenting on the paper but not involved in it, Jordan E. Axelrad, MD, MPH, codirector of the Inflammatory Bowel Disease Center at NYU Langone Health in New York City, said, “This study strengthens the argument that MC is an immune-mediated disease, not primarily driven by drug exposures. But future studies in diverse cohorts are required to validate these findings.” He said the study nevertheless provides reassurance that previously reported associations may have been overstated or confounded by factors such as reverse causation and increased healthcare utilization preceding the MC diagnosis.
In the meantime, Axelrad added, the findings “may reduce the inclination to promptly discontinue medications historically associated with MC in newly diagnosed cases. Also, these data help shift the clinical focus away from medication cessation alone and toward a needed and broader MC management strategy. US-based validation would likely highlight these changes in our patients.”
Despite concerns about the study’s unmeasured confounding because of differential healthcare utilization or surveillance, the modest association observed between SSRI and MC is supported by literature linking catecholamine and serotonin to gut innate immunity and microbiota, Khalili’s group wrote. “However, this finding may also be confounded by other factors including persisting surveillance and protopathic bias, especially since an association was also seen for risk for receipt of a colonoscopy with normal mucosa.”
Khalili believes the Swedish results are applicable even to the more diverse US population. He noted that lack of primary care data limited measurement of and adjustment for symptoms and medical diagnoses that increase risk. But according to Axelrad, MC is more prevalent in White, older patients, who are well-represented in Swedish cohorts but to a lesser extent in US populations. “Additionally, environmental factors and medication use patterns differ between Sweden and the US, particularly in regard to over-the-counter medication access.”
The findings have implications for future research in pharmacoepidemiologic studies of gastrointestinal-related outcomes. Since many routinely prescribed medications such as SSRIs were associated with an apparent increased risk for colonoscopies with normal colorectal biopsy results, future studies that examine gastrointestinal-specific adverse events should carefully consider potential surveillance bias.
In the meantime, Khalili stressed, it’s important to highlight that while some of these medications cause diarrhea in a small subset of patients, stopping medications in these patients is unnecessary.
This study was supported by the National Institutes of Health (NIH) and the Swedish Research Council. Khalili disclosed grants from the Crohn’s & Coiltis Foundation, the NIH and the Helmsley CharitableTrust, as well as stock ownership in Cylinder Health. One coauthor is employed by Massachusetts General Hospital. Axelrad had no relevant competing interests.
“Sensitivity analyses suggest that previously reported associations and persistent association with SSRI [selective serotonin reuptake inhibitor] initiation may be due to surveillance bias,” wrote gastroenterologist Hamed Khalili, MD, MPH, of Massachusetts General Hospital, Boston, and colleagues in Annals of Internal Medicine, advising clinicians to carefully balance the benefits of these medication classes against the very low likelihood of a causal relationship with MC.
While two smaller studies had challenged the belief that these medications can cause MC, Khalili told GI & Hepatology News, “the quality of the data that supported or refuted this hypothesis were low. Nevertheless, most in the field consider MC to be largely related to medications so we thought it was important to systematically answer this question.”
While most medications thought to trigger MC were found not to be causally linked, he added, “we did observe a marginal association with SSRIs but could not rule out the possibility that the association is related to residual bias.”
The authors noted that the incidence of MC in older persons is rising rapidly and is thought to account for more than 30% of chronic diarrhea cases in this group.
Despite weak evidence in the literature, the treatment guidelines of several societies, including the American Gastroenterological Association, recommend discontinuing potential pharmacologic triggers as first-line prevention or as an adjunct therapy, particularly in recurrent or refractory MC. But this approach may be ineffective in patients with established disease and could lead to inappropriate discontinuation of medication such as antihypertensives, the authors argued.
As to proposed mechanisms of action, said Khalili, “for PPIs [proton-pump inhibitors,] people thought it was related to changes in the gut microbiome. For NSAIDs [nonsteroidal anti-inflammatory drugs], people thought it could be related to changes in the gut barrier function. But overall, not a single mechanism would have explained all the prior associations that were observed.”
While medications such as PPIs and SSRIs can cause diarrhea in a small subset of users, Khalili added, “most patients generally catch these side effects very quickly and realize that stopping these medications will improve their diarrhea. This is very different than most patients we as gastroenterologists see with a new diagnosis of MC. Many of them may have been on these medications for a long time. We believe that stopping medications in these patients is unnecessary.”
Study Details
The investigators looked at eligible residents in Sweden age 65 years or older in the years 2006 to 2017 (n = 191,482 to 2,634,777). Participants had no history of inflammatory bowel disease and different cohorts were examined for various common medications from calcium channel blockers to statins.
With a primary outcome of biopsy-verified MC, dates of diagnosis were obtained from Sweden’s national histopathology cohort ESPRESSO (Epidemiology Strengthened by Histopathology Reports in Sweden). Among the findings:
- The 12- and 24-month cumulative incidences of MC were less than 0.05% under all treatment strategies.
- Estimated 12-month risk differences were close to null under angiotensin-converting enzyme vs calcium-channel blocker (CCB) initiation, angiotensin-receptor blocker vs CCB initiation, NSAID initiation vs noninitiation, PPI inhibitor initiation vs noninitiation, and statin initiation vs noninitiation.
- The estimated 12-month risk difference was 0.04% (95% CI, 0.03%-0.05%) for SSRIs vs mirtazapine.
- Results were similar for 24-month risk differences. Several medications such as SSRIs were also associated with increased risk for undergoing colonoscopy with a normal colorectal mucosa biopsy result.
“We think it’s unlikely that stopping these medications will improve symptoms of MC,” Khalili said.
Commenting on the paper but not involved in it, Jordan E. Axelrad, MD, MPH, codirector of the Inflammatory Bowel Disease Center at NYU Langone Health in New York City, said, “This study strengthens the argument that MC is an immune-mediated disease, not primarily driven by drug exposures. But future studies in diverse cohorts are required to validate these findings.” He said the study nevertheless provides reassurance that previously reported associations may have been overstated or confounded by factors such as reverse causation and increased healthcare utilization preceding the MC diagnosis.
In the meantime, Axelrad added, the findings “may reduce the inclination to promptly discontinue medications historically associated with MC in newly diagnosed cases. Also, these data help shift the clinical focus away from medication cessation alone and toward a needed and broader MC management strategy. US-based validation would likely highlight these changes in our patients.”
Despite concerns about the study’s unmeasured confounding because of differential healthcare utilization or surveillance, the modest association observed between SSRI and MC is supported by literature linking catecholamine and serotonin to gut innate immunity and microbiota, Khalili’s group wrote. “However, this finding may also be confounded by other factors including persisting surveillance and protopathic bias, especially since an association was also seen for risk for receipt of a colonoscopy with normal mucosa.”
Khalili believes the Swedish results are applicable even to the more diverse US population. He noted that lack of primary care data limited measurement of and adjustment for symptoms and medical diagnoses that increase risk. But according to Axelrad, MC is more prevalent in White, older patients, who are well-represented in Swedish cohorts but to a lesser extent in US populations. “Additionally, environmental factors and medication use patterns differ between Sweden and the US, particularly in regard to over-the-counter medication access.”
The findings have implications for future research in pharmacoepidemiologic studies of gastrointestinal-related outcomes. Since many routinely prescribed medications such as SSRIs were associated with an apparent increased risk for colonoscopies with normal colorectal biopsy results, future studies that examine gastrointestinal-specific adverse events should carefully consider potential surveillance bias.
In the meantime, Khalili stressed, it’s important to highlight that while some of these medications cause diarrhea in a small subset of patients, stopping medications in these patients is unnecessary.
This study was supported by the National Institutes of Health (NIH) and the Swedish Research Council. Khalili disclosed grants from the Crohn’s & Coiltis Foundation, the NIH and the Helmsley CharitableTrust, as well as stock ownership in Cylinder Health. One coauthor is employed by Massachusetts General Hospital. Axelrad had no relevant competing interests.
Elevated Serologic Markers Insufficient to Diagnose Celiac Disease
, a large pediatric cohort study in North America found.
Because tTG-IgA assay performance varied widely across labs, diagnostic confirmation by a specialist is essential before gluten-targeted dietary changes are made, according to Denis Chang, MD, MS, of the Division of Gastroenterology and Nutrition at Boston Children’s Hospital in Boston, and colleagues reported in Pediatrics.
“Currently, small intestinal biopsy is the gold standard for diagnosing pediatric celiac disease, but recent European diagnostic criteria allow a nonbiopsy pathway for serologic diagnosis,” Chang told GI & Heaptology News. The European guidelines allow this pathway when a very high tTG-IgA is confirmed by a positive endomysial IgA antibody (EMA) in a second blood sample.
Those guidelines have not been adopted on this continent, however, so Chang’s group assessed the positive predictive value (PPV) of the North American tTG-IgA assay to identify histologic findings of celiac disease.
Another issue is the absence of a universal standard threshold across labs for a high antibody value. “Common assays used in North America differ in performance, and there are not many large multicenter studies looking at this issue. Hopefully, a standard will be developed in the near future. Before this serologic pathway can enter into our guidelines, this question needs to be addressed.”
Study Details
The multicenter retrospective study by Dr. Chang’s team looked at patients younger than 18 years from three pediatric hospitals in Canada and nine in the US who had an elevated tTG-IgA within 6 months of an esophagogastroduodenoscopy from January 2016 to December 2021. Biopsy-confirmed celiac disease was determined by the presence of intraepithelial lymphocytosis and villous atrophy. The primary outcomes were the PPV of an elevated tTG-IgA and a tTG-IgA at least 10 times the upper limit of normal (10x ULN).
The study cohort included 4019 children (63.3% female, 9% with type 1 diabetes, and 2% with Down syndrome). Histologic findings were consistent with celiac disease for 3321 children, for a PPV of 82.6% (95% CI, 81.4%-83.8%).
Among the 1739 (43.2%) children with tTG-IgA of at least 10x ULN, 1651 had biopsy-confirmed celiac disease, for a PPV 10x ULN of 94.9% (95% CI, 93.8%-95.9%). About 5% (n = 88) of positive-testing children did not have histologic findings of celiac disease, including 2% (n = 41) with normal histology.
Diagnostic accuracy of tTG-IgA varied widely among the assays used in North America, with a PPV range of 71.5%-88.8% and a PPV 10x ULN range of 89.3%-97.3%. Assays did not perform as well in children with type 1 diabetes: PPV 10x ULN of 89% (95% CI, 83.5%-92.8%).
In other notable findings, the EMA blood test only marginally improved specificity, as 76% of children without celiac disease, but with a tTG-IgA of at least 10x ULN had a positive EMA in the same sample.
While the study lends credence to the notion that a highly positive tTG-IgA correlates with enteropathy in most children, the 1 in 20 with a tTG-IgA greater than 10x ULN who did not have histologic findings diagnostic of celiac disease cannot be ignored. “This included 2% who had normal small intestinal biopsies on a gluten-containing unrestricted diet, highlighting the limitations of making a celiac disease diagnosis based solely upon a single, highly positive tTG-IgA level,” Chang and colleagues wrote.
Does this mean that substantial numbers of children with suspected celiac disease are being unnecessarily placed on gluten-restricted diets to no avail? “That’s a good question, but our retrospective data do not provide an answer to that,” Chang said. And what causes elevated autoantibodies in children who are not diagnosed with celiac disease? “That is also a question that will require further research,” he said.
Commenting on the study but not involved in it, Supriya Nair, MD, a pediatric gastroenterologist at UTHealth Houston, called it “very interesting because it highlights for primary care physicians that we may need endoscopic evaluation more than we thought.” This is particularly true given the lack of standardized laboratory values noted in the study.
Nair said that some children with high seromarker levels but no discernible lesions may develop celiac disease later. “It may be that the markers are not yet causing inflammation in the bowel. These patients must be monitored to see if levels stay high or come down.”
In her practice, she has seen some children who have been put on gluten-free diets prematurely. “But it’s very important to get an accurate, official confirmation with endoscopy because of the ramifications of a celiac diagnosis,” she said. “This is a lifelong condition, and the diet is not easy to follow, especially in North America.” And for children, especially, there are restrictive social impacts and the constant need to be aware of what they’re eating and the danger of cross-contamination in foods, she said.
Chang hopes these data will be pivotal in helping medical societies develop new North American guidelines. In the meantime, pediatricians and primary doctors need to be aware that a high number on a tTG-IgA test does not always mean the presence of celiac disease, although it could be a harbinger of its future development. “Further confirmation by a specialist is essential.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Chang and Nair reported having no competing interests. Several study authors reported receiving research support from and serving as consultants or members of data safety monitoring boards for pharmaceutical companies.
A version of this article appeared on Medscape.com.
, a large pediatric cohort study in North America found.
Because tTG-IgA assay performance varied widely across labs, diagnostic confirmation by a specialist is essential before gluten-targeted dietary changes are made, according to Denis Chang, MD, MS, of the Division of Gastroenterology and Nutrition at Boston Children’s Hospital in Boston, and colleagues reported in Pediatrics.
“Currently, small intestinal biopsy is the gold standard for diagnosing pediatric celiac disease, but recent European diagnostic criteria allow a nonbiopsy pathway for serologic diagnosis,” Chang told GI & Heaptology News. The European guidelines allow this pathway when a very high tTG-IgA is confirmed by a positive endomysial IgA antibody (EMA) in a second blood sample.
Those guidelines have not been adopted on this continent, however, so Chang’s group assessed the positive predictive value (PPV) of the North American tTG-IgA assay to identify histologic findings of celiac disease.
Another issue is the absence of a universal standard threshold across labs for a high antibody value. “Common assays used in North America differ in performance, and there are not many large multicenter studies looking at this issue. Hopefully, a standard will be developed in the near future. Before this serologic pathway can enter into our guidelines, this question needs to be addressed.”
Study Details
The multicenter retrospective study by Dr. Chang’s team looked at patients younger than 18 years from three pediatric hospitals in Canada and nine in the US who had an elevated tTG-IgA within 6 months of an esophagogastroduodenoscopy from January 2016 to December 2021. Biopsy-confirmed celiac disease was determined by the presence of intraepithelial lymphocytosis and villous atrophy. The primary outcomes were the PPV of an elevated tTG-IgA and a tTG-IgA at least 10 times the upper limit of normal (10x ULN).
The study cohort included 4019 children (63.3% female, 9% with type 1 diabetes, and 2% with Down syndrome). Histologic findings were consistent with celiac disease for 3321 children, for a PPV of 82.6% (95% CI, 81.4%-83.8%).
Among the 1739 (43.2%) children with tTG-IgA of at least 10x ULN, 1651 had biopsy-confirmed celiac disease, for a PPV 10x ULN of 94.9% (95% CI, 93.8%-95.9%). About 5% (n = 88) of positive-testing children did not have histologic findings of celiac disease, including 2% (n = 41) with normal histology.
Diagnostic accuracy of tTG-IgA varied widely among the assays used in North America, with a PPV range of 71.5%-88.8% and a PPV 10x ULN range of 89.3%-97.3%. Assays did not perform as well in children with type 1 diabetes: PPV 10x ULN of 89% (95% CI, 83.5%-92.8%).
In other notable findings, the EMA blood test only marginally improved specificity, as 76% of children without celiac disease, but with a tTG-IgA of at least 10x ULN had a positive EMA in the same sample.
While the study lends credence to the notion that a highly positive tTG-IgA correlates with enteropathy in most children, the 1 in 20 with a tTG-IgA greater than 10x ULN who did not have histologic findings diagnostic of celiac disease cannot be ignored. “This included 2% who had normal small intestinal biopsies on a gluten-containing unrestricted diet, highlighting the limitations of making a celiac disease diagnosis based solely upon a single, highly positive tTG-IgA level,” Chang and colleagues wrote.
Does this mean that substantial numbers of children with suspected celiac disease are being unnecessarily placed on gluten-restricted diets to no avail? “That’s a good question, but our retrospective data do not provide an answer to that,” Chang said. And what causes elevated autoantibodies in children who are not diagnosed with celiac disease? “That is also a question that will require further research,” he said.
Commenting on the study but not involved in it, Supriya Nair, MD, a pediatric gastroenterologist at UTHealth Houston, called it “very interesting because it highlights for primary care physicians that we may need endoscopic evaluation more than we thought.” This is particularly true given the lack of standardized laboratory values noted in the study.
Nair said that some children with high seromarker levels but no discernible lesions may develop celiac disease later. “It may be that the markers are not yet causing inflammation in the bowel. These patients must be monitored to see if levels stay high or come down.”
In her practice, she has seen some children who have been put on gluten-free diets prematurely. “But it’s very important to get an accurate, official confirmation with endoscopy because of the ramifications of a celiac diagnosis,” she said. “This is a lifelong condition, and the diet is not easy to follow, especially in North America.” And for children, especially, there are restrictive social impacts and the constant need to be aware of what they’re eating and the danger of cross-contamination in foods, she said.
Chang hopes these data will be pivotal in helping medical societies develop new North American guidelines. In the meantime, pediatricians and primary doctors need to be aware that a high number on a tTG-IgA test does not always mean the presence of celiac disease, although it could be a harbinger of its future development. “Further confirmation by a specialist is essential.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Chang and Nair reported having no competing interests. Several study authors reported receiving research support from and serving as consultants or members of data safety monitoring boards for pharmaceutical companies.
A version of this article appeared on Medscape.com.
, a large pediatric cohort study in North America found.
Because tTG-IgA assay performance varied widely across labs, diagnostic confirmation by a specialist is essential before gluten-targeted dietary changes are made, according to Denis Chang, MD, MS, of the Division of Gastroenterology and Nutrition at Boston Children’s Hospital in Boston, and colleagues reported in Pediatrics.
“Currently, small intestinal biopsy is the gold standard for diagnosing pediatric celiac disease, but recent European diagnostic criteria allow a nonbiopsy pathway for serologic diagnosis,” Chang told GI & Heaptology News. The European guidelines allow this pathway when a very high tTG-IgA is confirmed by a positive endomysial IgA antibody (EMA) in a second blood sample.
Those guidelines have not been adopted on this continent, however, so Chang’s group assessed the positive predictive value (PPV) of the North American tTG-IgA assay to identify histologic findings of celiac disease.
Another issue is the absence of a universal standard threshold across labs for a high antibody value. “Common assays used in North America differ in performance, and there are not many large multicenter studies looking at this issue. Hopefully, a standard will be developed in the near future. Before this serologic pathway can enter into our guidelines, this question needs to be addressed.”
Study Details
The multicenter retrospective study by Dr. Chang’s team looked at patients younger than 18 years from three pediatric hospitals in Canada and nine in the US who had an elevated tTG-IgA within 6 months of an esophagogastroduodenoscopy from January 2016 to December 2021. Biopsy-confirmed celiac disease was determined by the presence of intraepithelial lymphocytosis and villous atrophy. The primary outcomes were the PPV of an elevated tTG-IgA and a tTG-IgA at least 10 times the upper limit of normal (10x ULN).
The study cohort included 4019 children (63.3% female, 9% with type 1 diabetes, and 2% with Down syndrome). Histologic findings were consistent with celiac disease for 3321 children, for a PPV of 82.6% (95% CI, 81.4%-83.8%).
Among the 1739 (43.2%) children with tTG-IgA of at least 10x ULN, 1651 had biopsy-confirmed celiac disease, for a PPV 10x ULN of 94.9% (95% CI, 93.8%-95.9%). About 5% (n = 88) of positive-testing children did not have histologic findings of celiac disease, including 2% (n = 41) with normal histology.
Diagnostic accuracy of tTG-IgA varied widely among the assays used in North America, with a PPV range of 71.5%-88.8% and a PPV 10x ULN range of 89.3%-97.3%. Assays did not perform as well in children with type 1 diabetes: PPV 10x ULN of 89% (95% CI, 83.5%-92.8%).
In other notable findings, the EMA blood test only marginally improved specificity, as 76% of children without celiac disease, but with a tTG-IgA of at least 10x ULN had a positive EMA in the same sample.
While the study lends credence to the notion that a highly positive tTG-IgA correlates with enteropathy in most children, the 1 in 20 with a tTG-IgA greater than 10x ULN who did not have histologic findings diagnostic of celiac disease cannot be ignored. “This included 2% who had normal small intestinal biopsies on a gluten-containing unrestricted diet, highlighting the limitations of making a celiac disease diagnosis based solely upon a single, highly positive tTG-IgA level,” Chang and colleagues wrote.
Does this mean that substantial numbers of children with suspected celiac disease are being unnecessarily placed on gluten-restricted diets to no avail? “That’s a good question, but our retrospective data do not provide an answer to that,” Chang said. And what causes elevated autoantibodies in children who are not diagnosed with celiac disease? “That is also a question that will require further research,” he said.
Commenting on the study but not involved in it, Supriya Nair, MD, a pediatric gastroenterologist at UTHealth Houston, called it “very interesting because it highlights for primary care physicians that we may need endoscopic evaluation more than we thought.” This is particularly true given the lack of standardized laboratory values noted in the study.
Nair said that some children with high seromarker levels but no discernible lesions may develop celiac disease later. “It may be that the markers are not yet causing inflammation in the bowel. These patients must be monitored to see if levels stay high or come down.”
In her practice, she has seen some children who have been put on gluten-free diets prematurely. “But it’s very important to get an accurate, official confirmation with endoscopy because of the ramifications of a celiac diagnosis,” she said. “This is a lifelong condition, and the diet is not easy to follow, especially in North America.” And for children, especially, there are restrictive social impacts and the constant need to be aware of what they’re eating and the danger of cross-contamination in foods, she said.
Chang hopes these data will be pivotal in helping medical societies develop new North American guidelines. In the meantime, pediatricians and primary doctors need to be aware that a high number on a tTG-IgA test does not always mean the presence of celiac disease, although it could be a harbinger of its future development. “Further confirmation by a specialist is essential.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Chang and Nair reported having no competing interests. Several study authors reported receiving research support from and serving as consultants or members of data safety monitoring boards for pharmaceutical companies.
A version of this article appeared on Medscape.com.
Out-of-Pocket Prep Costs Reduce Screening Colonoscopy Uptake, Especially in Vulnerable Populations
, a large insurance-claims analysis in Gastroenterology reported.
Moreover, this cost-sharing contravenes the preventive-care provisions for bowel preparation mandated by the Affordable Care Act (ACA).
Led by Gastroenterologist Eric D. Shah, MD, MBA, a clinical associate professor at the University of Michigan in Ann Arbor, Michigan, the study found a significant proportion of prescribed bowel preparation claims — 53% for commercial plans and 83% for Medicare — still involve patient cost-sharing, indicating noncompliance with ACA guidelines. Although expense-sharing was less prevalent among Medicaid claims (just 27%), it was not eliminated, suggesting room for improvement in coverage enforcement across the board.
“Colon cancer is unique in that it can be prevented with colonoscopy, but where are the patients? Bowel prep is a major reason that patients defer screening,” Shah told GI & Hepatology News. He said his group was quite surprised that the majority in the study cohort were paying something out of pocket when these costs should have been covered. “Primary care doctors may not think to ask about bowel prep costs when they order screening colonoscopies.”
The findings emerged from an analysis of 2,593,079 prescription drug claims: 52.9% from commercial plans, 35% from Medicare Part D plans, and 8.3% from Medicaid plans.
“These patient costs of $30 or $50 are a real not a theoretical deterrent,” said Whitney Jones, MD, a gastroenterologist, adjunct clinical professor at the University of Louisville in Louisville, Kentucky, and founder of the nonprofit Colon Cancer Prevention Project. Jones was not involved in the analysis. “Some insurers require prior patient authorization for the low-dose preps, but gastroenterologists are doing so many colonoscopies they don’t always have time to get a PA [prior authorization] on everyone.”
With the increasing use of blood and stool-based CRC testing, he added, “when you get a positive result, it’s really important to have the procedure quickly.” And appropriate bowel preparation is a small, cost-effective portion of the total costs of colonoscopy, a procedure that ultimately saves insurers significant money in treatment costs.
The authors noted that while CRC is the second-leading cause of cancer-related deaths in the US, screening rates remain low, with only 59% of adults aged 45 years or older up to date with screening. Screening rates are particularly low among racial and ethnic minority groups as compared with White individuals, a disparity that highlights the need to address existing barriers and enhance screening efforts.
In the current study, shared costs by bowel preparation volume also varied. Low-volume formulations had consistently higher out-of-pocket costs: a median of $60 for low-volume vs $10 for high-volume in commercial plans. In Medicare, 75% of high-volume claims had shared costs compared with 90% for their low-volume counterparts. The cost-sharing difference was slightly narrower with Medicaid: 27% of high-volume claims vs 30% of low-volume claims.
This is concerning, as low-volume options, which are preferred by patients for their better tolerability, can enhance uptake and adherence and improve colonoscopy outcomes. Shah advises physicians to consider prescribing low-volume preparations. “Let patients know about the potential out-of-pocket cost and about copay cards and assistance programs and use high-volume preps as an alternative rather than a go-to,” he said.
As to costs across insurance types, among commercial plans, the median nonzero out-of-pocket cost was $10 for high-volume and $60 for low-volume product claims. For Medicare, the median nonzero out-of-pocket cost was $8 for high-volume and $55.99 for low-volume products.
Under the ACA, CRC screening is classified as a recommended preventive service, requiring health plans to cover it without cost-sharing. Although the Centers for Medicare & Medicaid Services previously tried to enforce this mandate in 2015 and 2016, stating that colonoscopy preparation medications should be covered at no cost, many health plans are still not compliant.
At the nonfederal level, Jones noted, Kentucky, which has a significant high-risk population, recently became the first state to pass legislation requiring health benefit plans to cover all guideline-recommended CRC exams and lab tests.
For its part, AGA has also called on payers to eliminate all cost-sharing barriers across the CRC screening continuum.
Of note, the study authors said, the higher compliance with the ACA mandate in commercial and Medicaid plans than in Medicare highlights disparities that may disproportionately affect vulnerable older adults. While nearly half of commercial patients and nearly three quarters of Medicaid patients incurred zero out-of-pocket costs, fewer than 17% of Medicare beneficiaries, or 1 in 6, did so.
Although these costs may be low relative to the colonoscopy, they nevertheless can deter uptake of preventive screenings, potentially leading to higher CRC incidence and mortality. “While some patients may be willing to pay modest out-of-pocket costs, any required payment, however small, can serve as a barrier to preventative care, particularly in underserved populations,” they wrote. “These financial barriers will continue to contribute to widening disparities and hinder progress toward equitable screening outcomes.”
In the meantime, said Shah, “Physicians should advocate now to their representatives in Congress that bowel prep costs should already be covered as part of the ACA.”
This study was funded by Sebela Pharmaceuticals, maker of SUFLAVE preparation. The authors had no conflicts of interest to declare. Jones is a speaker and consultant for Grail LLC.
A version of this article appeared on Medscape.com.
, a large insurance-claims analysis in Gastroenterology reported.
Moreover, this cost-sharing contravenes the preventive-care provisions for bowel preparation mandated by the Affordable Care Act (ACA).
Led by Gastroenterologist Eric D. Shah, MD, MBA, a clinical associate professor at the University of Michigan in Ann Arbor, Michigan, the study found a significant proportion of prescribed bowel preparation claims — 53% for commercial plans and 83% for Medicare — still involve patient cost-sharing, indicating noncompliance with ACA guidelines. Although expense-sharing was less prevalent among Medicaid claims (just 27%), it was not eliminated, suggesting room for improvement in coverage enforcement across the board.
“Colon cancer is unique in that it can be prevented with colonoscopy, but where are the patients? Bowel prep is a major reason that patients defer screening,” Shah told GI & Hepatology News. He said his group was quite surprised that the majority in the study cohort were paying something out of pocket when these costs should have been covered. “Primary care doctors may not think to ask about bowel prep costs when they order screening colonoscopies.”
The findings emerged from an analysis of 2,593,079 prescription drug claims: 52.9% from commercial plans, 35% from Medicare Part D plans, and 8.3% from Medicaid plans.
“These patient costs of $30 or $50 are a real not a theoretical deterrent,” said Whitney Jones, MD, a gastroenterologist, adjunct clinical professor at the University of Louisville in Louisville, Kentucky, and founder of the nonprofit Colon Cancer Prevention Project. Jones was not involved in the analysis. “Some insurers require prior patient authorization for the low-dose preps, but gastroenterologists are doing so many colonoscopies they don’t always have time to get a PA [prior authorization] on everyone.”
With the increasing use of blood and stool-based CRC testing, he added, “when you get a positive result, it’s really important to have the procedure quickly.” And appropriate bowel preparation is a small, cost-effective portion of the total costs of colonoscopy, a procedure that ultimately saves insurers significant money in treatment costs.
The authors noted that while CRC is the second-leading cause of cancer-related deaths in the US, screening rates remain low, with only 59% of adults aged 45 years or older up to date with screening. Screening rates are particularly low among racial and ethnic minority groups as compared with White individuals, a disparity that highlights the need to address existing barriers and enhance screening efforts.
In the current study, shared costs by bowel preparation volume also varied. Low-volume formulations had consistently higher out-of-pocket costs: a median of $60 for low-volume vs $10 for high-volume in commercial plans. In Medicare, 75% of high-volume claims had shared costs compared with 90% for their low-volume counterparts. The cost-sharing difference was slightly narrower with Medicaid: 27% of high-volume claims vs 30% of low-volume claims.
This is concerning, as low-volume options, which are preferred by patients for their better tolerability, can enhance uptake and adherence and improve colonoscopy outcomes. Shah advises physicians to consider prescribing low-volume preparations. “Let patients know about the potential out-of-pocket cost and about copay cards and assistance programs and use high-volume preps as an alternative rather than a go-to,” he said.
As to costs across insurance types, among commercial plans, the median nonzero out-of-pocket cost was $10 for high-volume and $60 for low-volume product claims. For Medicare, the median nonzero out-of-pocket cost was $8 for high-volume and $55.99 for low-volume products.
Under the ACA, CRC screening is classified as a recommended preventive service, requiring health plans to cover it without cost-sharing. Although the Centers for Medicare & Medicaid Services previously tried to enforce this mandate in 2015 and 2016, stating that colonoscopy preparation medications should be covered at no cost, many health plans are still not compliant.
At the nonfederal level, Jones noted, Kentucky, which has a significant high-risk population, recently became the first state to pass legislation requiring health benefit plans to cover all guideline-recommended CRC exams and lab tests.
For its part, AGA has also called on payers to eliminate all cost-sharing barriers across the CRC screening continuum.
Of note, the study authors said, the higher compliance with the ACA mandate in commercial and Medicaid plans than in Medicare highlights disparities that may disproportionately affect vulnerable older adults. While nearly half of commercial patients and nearly three quarters of Medicaid patients incurred zero out-of-pocket costs, fewer than 17% of Medicare beneficiaries, or 1 in 6, did so.
Although these costs may be low relative to the colonoscopy, they nevertheless can deter uptake of preventive screenings, potentially leading to higher CRC incidence and mortality. “While some patients may be willing to pay modest out-of-pocket costs, any required payment, however small, can serve as a barrier to preventative care, particularly in underserved populations,” they wrote. “These financial barriers will continue to contribute to widening disparities and hinder progress toward equitable screening outcomes.”
In the meantime, said Shah, “Physicians should advocate now to their representatives in Congress that bowel prep costs should already be covered as part of the ACA.”
This study was funded by Sebela Pharmaceuticals, maker of SUFLAVE preparation. The authors had no conflicts of interest to declare. Jones is a speaker and consultant for Grail LLC.
A version of this article appeared on Medscape.com.
, a large insurance-claims analysis in Gastroenterology reported.
Moreover, this cost-sharing contravenes the preventive-care provisions for bowel preparation mandated by the Affordable Care Act (ACA).
Led by Gastroenterologist Eric D. Shah, MD, MBA, a clinical associate professor at the University of Michigan in Ann Arbor, Michigan, the study found a significant proportion of prescribed bowel preparation claims — 53% for commercial plans and 83% for Medicare — still involve patient cost-sharing, indicating noncompliance with ACA guidelines. Although expense-sharing was less prevalent among Medicaid claims (just 27%), it was not eliminated, suggesting room for improvement in coverage enforcement across the board.
“Colon cancer is unique in that it can be prevented with colonoscopy, but where are the patients? Bowel prep is a major reason that patients defer screening,” Shah told GI & Hepatology News. He said his group was quite surprised that the majority in the study cohort were paying something out of pocket when these costs should have been covered. “Primary care doctors may not think to ask about bowel prep costs when they order screening colonoscopies.”
The findings emerged from an analysis of 2,593,079 prescription drug claims: 52.9% from commercial plans, 35% from Medicare Part D plans, and 8.3% from Medicaid plans.
“These patient costs of $30 or $50 are a real not a theoretical deterrent,” said Whitney Jones, MD, a gastroenterologist, adjunct clinical professor at the University of Louisville in Louisville, Kentucky, and founder of the nonprofit Colon Cancer Prevention Project. Jones was not involved in the analysis. “Some insurers require prior patient authorization for the low-dose preps, but gastroenterologists are doing so many colonoscopies they don’t always have time to get a PA [prior authorization] on everyone.”
With the increasing use of blood and stool-based CRC testing, he added, “when you get a positive result, it’s really important to have the procedure quickly.” And appropriate bowel preparation is a small, cost-effective portion of the total costs of colonoscopy, a procedure that ultimately saves insurers significant money in treatment costs.
The authors noted that while CRC is the second-leading cause of cancer-related deaths in the US, screening rates remain low, with only 59% of adults aged 45 years or older up to date with screening. Screening rates are particularly low among racial and ethnic minority groups as compared with White individuals, a disparity that highlights the need to address existing barriers and enhance screening efforts.
In the current study, shared costs by bowel preparation volume also varied. Low-volume formulations had consistently higher out-of-pocket costs: a median of $60 for low-volume vs $10 for high-volume in commercial plans. In Medicare, 75% of high-volume claims had shared costs compared with 90% for their low-volume counterparts. The cost-sharing difference was slightly narrower with Medicaid: 27% of high-volume claims vs 30% of low-volume claims.
This is concerning, as low-volume options, which are preferred by patients for their better tolerability, can enhance uptake and adherence and improve colonoscopy outcomes. Shah advises physicians to consider prescribing low-volume preparations. “Let patients know about the potential out-of-pocket cost and about copay cards and assistance programs and use high-volume preps as an alternative rather than a go-to,” he said.
As to costs across insurance types, among commercial plans, the median nonzero out-of-pocket cost was $10 for high-volume and $60 for low-volume product claims. For Medicare, the median nonzero out-of-pocket cost was $8 for high-volume and $55.99 for low-volume products.
Under the ACA, CRC screening is classified as a recommended preventive service, requiring health plans to cover it without cost-sharing. Although the Centers for Medicare & Medicaid Services previously tried to enforce this mandate in 2015 and 2016, stating that colonoscopy preparation medications should be covered at no cost, many health plans are still not compliant.
At the nonfederal level, Jones noted, Kentucky, which has a significant high-risk population, recently became the first state to pass legislation requiring health benefit plans to cover all guideline-recommended CRC exams and lab tests.
For its part, AGA has also called on payers to eliminate all cost-sharing barriers across the CRC screening continuum.
Of note, the study authors said, the higher compliance with the ACA mandate in commercial and Medicaid plans than in Medicare highlights disparities that may disproportionately affect vulnerable older adults. While nearly half of commercial patients and nearly three quarters of Medicaid patients incurred zero out-of-pocket costs, fewer than 17% of Medicare beneficiaries, or 1 in 6, did so.
Although these costs may be low relative to the colonoscopy, they nevertheless can deter uptake of preventive screenings, potentially leading to higher CRC incidence and mortality. “While some patients may be willing to pay modest out-of-pocket costs, any required payment, however small, can serve as a barrier to preventative care, particularly in underserved populations,” they wrote. “These financial barriers will continue to contribute to widening disparities and hinder progress toward equitable screening outcomes.”
In the meantime, said Shah, “Physicians should advocate now to their representatives in Congress that bowel prep costs should already be covered as part of the ACA.”
This study was funded by Sebela Pharmaceuticals, maker of SUFLAVE preparation. The authors had no conflicts of interest to declare. Jones is a speaker and consultant for Grail LLC.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Colonoscopy Costs Rise When Private Equity Acquires GI Practices, but Quality Does Not
Price increases ranged from about 5% to about 7%.
In view of the growing trend to such acquisitions, policy makers should monitor the impact of PE investment in medical practices, according to researchers led by health economist Daniel R. Arnold, PhD, of the Department of Health Services, Policy & Practice in the School of Public Health at Brown University in Providence, Rhode Island. “In a previous study of ours, gastroenterology stood out as a particularly attractive specialty to private equity,” Arnold told GI & Hepatology News.
Published in JAMA Health Forum, the economic evaluation of more than 1.1 million patients and 1.3 million colonoscopies concluded that PE acquisitions of GI sites are difficult to justify.
The Study
This difference-in-differences event study and economic evaluation analyzed data from US GI practices acquired by PE firms from 2015 to 2021. Commercial insurance claims covering more than 50 million enrollees were used to calculate price, spending, utilization, and quality measures from 2012 to 2021, with all data analyzed from April to September 2024.
The main outcomes were price, spending per physician, number of colonoscopies per physician, number of unique patients per physician, and quality, as defined by polyp detection, incomplete colonoscopies, and four adverse event measures: cardiovascular, serious and nonserious GI events, and any other adverse events.
The mean age of patients was 47.1 years, and 47.8% were men. The sample included 718, 851 colonoscopies conducted by 1494 physicians in 590, 900 patients across 1240 PE-acquired practice sites and 637, 990 control colonoscopies conducted by 2550 physicians in 527,380 patients across 2657 independent practice sites.
Among the findings:
- Colonoscopy prices at PE-acquired sites increased by 4.5% (95% CI, 2.5-6.6; P < .001) vs independent practices. That increase was much lower than that reported by Singh and colleagues for .
- The estimated price increase was 6.7% (95% CI, 4.2-9.3; P < .001) when only colonoscopies at PE practices with market shares above the 75th percentile (24.4%) in 2021 were considered. Both increases were in line with other research, Arnold said.
- Colonoscopy spending per physician increased by 16.0% (95% CI, 8.4%-24.0%; P < .001), while the number of colonoscopies and the number of unique patients per physician increased by 12.1% (95% CI, 5.3-19.4; P < .001) and 11.3% (95% CI, 4.4%-18.5%; P < .001), respectively. These measures, however, were already increasing before PE acquisition.
- No statistically significant associations were detected for the six quality measures analyzed.
Could such cost-raising acquisitions potentially be blocked by concerned regulators?
“No. Generally the purchases are at prices below what would require notification to federal authorities,” Arnold said. “The Department of Justice/Federal Trade Commission hinted at being willing to look at serial acquisitions in their 2023 Merger Guidelines, but until that happens, these will likely continue to fly under the radar.”
Still, as evidence of PE-associated poorer quality outcomes as well as clinician burnout continues to emerge, Arnold added, “I would advise physicians who get buyout offers from PE to educate themselves on what could happen to patients and staff if they choose to sell.”
Offering an outsider’s perspective on the study, health economist Atul Gupta, PhD, an assistant professor of healthcare management in the Wharton School at the University of Pennsylvania in Philadelphia, called it an “excellent addition to the developing literature examining the effects of private equity ownership of healthcare providers.” Very few studies have examined the effects on prices and quality for the same set of deals and providers. “This is important because we want to be able to do an apples-to-apples comparison of the effects on both outcomes before judging PE ownership,” he told GI & Hepatology News.
In an accompanying editorial , primary care physician Jane M. Zhu, MD, an associate professor of medicine at Oregon Health & Science University in Portland, Oregon, and not involved in the commercial-insurance-based study, said one interpretation of the findings may be that PE acquisition focuses on reducing inefficiencies, improving access by expanding practice capacity, and increasing throughput. “Another interpretation may be that PE acquisition is focused on the strategic exploitation of market and pricing power. The latter may have less of an impact on clinical measures like quality of care, but potentially, both strategies could be at play.”
Since this analysis focused on the commercial population, understanding how patient demographics may change after PE acquisition is a future avenue for exploration. “For instance, a potential explanation for both the price and utilization shifts might be if payer mix shifted toward more commercially insured patients at the expense of Medicaid or Medicare patients,” she wrote.
Zhu added that the impact of PE on prices and spending, by now replicated across different settings and specialties, is far clearer than the effect of PE on access and quality. “The analysis by Arnold et al is a welcome addition to the literature, generating important questions for future study and transparent monitoring as investor-owners become increasingly influential in healthcare.”
Going forward, said Gupta, an open question is whether the harmful effects of PE ownership of practices are differentially worse than those of other corporate entities such as insurers and hospital systems.
“There are reasons to believe that PE could be worse in theory. For example, their short-term investment horizon may force them to take measures that others will not as well as avoid investing into capital improvements that have a long-run payoff,” he said. “Their uniquely high dependence on debt and unbundling of real estate can severely hurt financial solvency of providers.” But high-quality evidence is lacking to compare the effects from these two distinct forms of corporatization.
The trend away from individual private practice is a reality, Arnold said. “The administrative burden on solo docs is becoming too much and physicians just seem to want to treat patients and not deal with it. So the options at this point really become selling to a hospital system or private equity.”
This study was funded by a grant from the philanthropic foundation Arnold Ventures (no family relation to Daniel Arnold).
Arnold reported receiving grants from Arnold Ventures during the conduct of the study. Gupta had no competing interests to declare. Zhu reported receiving grants from the Agency for Healthcare Research and Quality during the submitted work and from the National Institutes of Health, National Institute for Health Care Management Foundation, and American Psychological Association, as well as personal fees from Cambia outside the submitted work.
A version of this article appeared on Medscape.com.
Price increases ranged from about 5% to about 7%.
In view of the growing trend to such acquisitions, policy makers should monitor the impact of PE investment in medical practices, according to researchers led by health economist Daniel R. Arnold, PhD, of the Department of Health Services, Policy & Practice in the School of Public Health at Brown University in Providence, Rhode Island. “In a previous study of ours, gastroenterology stood out as a particularly attractive specialty to private equity,” Arnold told GI & Hepatology News.
Published in JAMA Health Forum, the economic evaluation of more than 1.1 million patients and 1.3 million colonoscopies concluded that PE acquisitions of GI sites are difficult to justify.
The Study
This difference-in-differences event study and economic evaluation analyzed data from US GI practices acquired by PE firms from 2015 to 2021. Commercial insurance claims covering more than 50 million enrollees were used to calculate price, spending, utilization, and quality measures from 2012 to 2021, with all data analyzed from April to September 2024.
The main outcomes were price, spending per physician, number of colonoscopies per physician, number of unique patients per physician, and quality, as defined by polyp detection, incomplete colonoscopies, and four adverse event measures: cardiovascular, serious and nonserious GI events, and any other adverse events.
The mean age of patients was 47.1 years, and 47.8% were men. The sample included 718, 851 colonoscopies conducted by 1494 physicians in 590, 900 patients across 1240 PE-acquired practice sites and 637, 990 control colonoscopies conducted by 2550 physicians in 527,380 patients across 2657 independent practice sites.
Among the findings:
- Colonoscopy prices at PE-acquired sites increased by 4.5% (95% CI, 2.5-6.6; P < .001) vs independent practices. That increase was much lower than that reported by Singh and colleagues for .
- The estimated price increase was 6.7% (95% CI, 4.2-9.3; P < .001) when only colonoscopies at PE practices with market shares above the 75th percentile (24.4%) in 2021 were considered. Both increases were in line with other research, Arnold said.
- Colonoscopy spending per physician increased by 16.0% (95% CI, 8.4%-24.0%; P < .001), while the number of colonoscopies and the number of unique patients per physician increased by 12.1% (95% CI, 5.3-19.4; P < .001) and 11.3% (95% CI, 4.4%-18.5%; P < .001), respectively. These measures, however, were already increasing before PE acquisition.
- No statistically significant associations were detected for the six quality measures analyzed.
Could such cost-raising acquisitions potentially be blocked by concerned regulators?
“No. Generally the purchases are at prices below what would require notification to federal authorities,” Arnold said. “The Department of Justice/Federal Trade Commission hinted at being willing to look at serial acquisitions in their 2023 Merger Guidelines, but until that happens, these will likely continue to fly under the radar.”
Still, as evidence of PE-associated poorer quality outcomes as well as clinician burnout continues to emerge, Arnold added, “I would advise physicians who get buyout offers from PE to educate themselves on what could happen to patients and staff if they choose to sell.”
Offering an outsider’s perspective on the study, health economist Atul Gupta, PhD, an assistant professor of healthcare management in the Wharton School at the University of Pennsylvania in Philadelphia, called it an “excellent addition to the developing literature examining the effects of private equity ownership of healthcare providers.” Very few studies have examined the effects on prices and quality for the same set of deals and providers. “This is important because we want to be able to do an apples-to-apples comparison of the effects on both outcomes before judging PE ownership,” he told GI & Hepatology News.
In an accompanying editorial , primary care physician Jane M. Zhu, MD, an associate professor of medicine at Oregon Health & Science University in Portland, Oregon, and not involved in the commercial-insurance-based study, said one interpretation of the findings may be that PE acquisition focuses on reducing inefficiencies, improving access by expanding practice capacity, and increasing throughput. “Another interpretation may be that PE acquisition is focused on the strategic exploitation of market and pricing power. The latter may have less of an impact on clinical measures like quality of care, but potentially, both strategies could be at play.”
Since this analysis focused on the commercial population, understanding how patient demographics may change after PE acquisition is a future avenue for exploration. “For instance, a potential explanation for both the price and utilization shifts might be if payer mix shifted toward more commercially insured patients at the expense of Medicaid or Medicare patients,” she wrote.
Zhu added that the impact of PE on prices and spending, by now replicated across different settings and specialties, is far clearer than the effect of PE on access and quality. “The analysis by Arnold et al is a welcome addition to the literature, generating important questions for future study and transparent monitoring as investor-owners become increasingly influential in healthcare.”
Going forward, said Gupta, an open question is whether the harmful effects of PE ownership of practices are differentially worse than those of other corporate entities such as insurers and hospital systems.
“There are reasons to believe that PE could be worse in theory. For example, their short-term investment horizon may force them to take measures that others will not as well as avoid investing into capital improvements that have a long-run payoff,” he said. “Their uniquely high dependence on debt and unbundling of real estate can severely hurt financial solvency of providers.” But high-quality evidence is lacking to compare the effects from these two distinct forms of corporatization.
The trend away from individual private practice is a reality, Arnold said. “The administrative burden on solo docs is becoming too much and physicians just seem to want to treat patients and not deal with it. So the options at this point really become selling to a hospital system or private equity.”
This study was funded by a grant from the philanthropic foundation Arnold Ventures (no family relation to Daniel Arnold).
Arnold reported receiving grants from Arnold Ventures during the conduct of the study. Gupta had no competing interests to declare. Zhu reported receiving grants from the Agency for Healthcare Research and Quality during the submitted work and from the National Institutes of Health, National Institute for Health Care Management Foundation, and American Psychological Association, as well as personal fees from Cambia outside the submitted work.
A version of this article appeared on Medscape.com.
Price increases ranged from about 5% to about 7%.
In view of the growing trend to such acquisitions, policy makers should monitor the impact of PE investment in medical practices, according to researchers led by health economist Daniel R. Arnold, PhD, of the Department of Health Services, Policy & Practice in the School of Public Health at Brown University in Providence, Rhode Island. “In a previous study of ours, gastroenterology stood out as a particularly attractive specialty to private equity,” Arnold told GI & Hepatology News.
Published in JAMA Health Forum, the economic evaluation of more than 1.1 million patients and 1.3 million colonoscopies concluded that PE acquisitions of GI sites are difficult to justify.
The Study
This difference-in-differences event study and economic evaluation analyzed data from US GI practices acquired by PE firms from 2015 to 2021. Commercial insurance claims covering more than 50 million enrollees were used to calculate price, spending, utilization, and quality measures from 2012 to 2021, with all data analyzed from April to September 2024.
The main outcomes were price, spending per physician, number of colonoscopies per physician, number of unique patients per physician, and quality, as defined by polyp detection, incomplete colonoscopies, and four adverse event measures: cardiovascular, serious and nonserious GI events, and any other adverse events.
The mean age of patients was 47.1 years, and 47.8% were men. The sample included 718, 851 colonoscopies conducted by 1494 physicians in 590, 900 patients across 1240 PE-acquired practice sites and 637, 990 control colonoscopies conducted by 2550 physicians in 527,380 patients across 2657 independent practice sites.
Among the findings:
- Colonoscopy prices at PE-acquired sites increased by 4.5% (95% CI, 2.5-6.6; P < .001) vs independent practices. That increase was much lower than that reported by Singh and colleagues for .
- The estimated price increase was 6.7% (95% CI, 4.2-9.3; P < .001) when only colonoscopies at PE practices with market shares above the 75th percentile (24.4%) in 2021 were considered. Both increases were in line with other research, Arnold said.
- Colonoscopy spending per physician increased by 16.0% (95% CI, 8.4%-24.0%; P < .001), while the number of colonoscopies and the number of unique patients per physician increased by 12.1% (95% CI, 5.3-19.4; P < .001) and 11.3% (95% CI, 4.4%-18.5%; P < .001), respectively. These measures, however, were already increasing before PE acquisition.
- No statistically significant associations were detected for the six quality measures analyzed.
Could such cost-raising acquisitions potentially be blocked by concerned regulators?
“No. Generally the purchases are at prices below what would require notification to federal authorities,” Arnold said. “The Department of Justice/Federal Trade Commission hinted at being willing to look at serial acquisitions in their 2023 Merger Guidelines, but until that happens, these will likely continue to fly under the radar.”
Still, as evidence of PE-associated poorer quality outcomes as well as clinician burnout continues to emerge, Arnold added, “I would advise physicians who get buyout offers from PE to educate themselves on what could happen to patients and staff if they choose to sell.”
Offering an outsider’s perspective on the study, health economist Atul Gupta, PhD, an assistant professor of healthcare management in the Wharton School at the University of Pennsylvania in Philadelphia, called it an “excellent addition to the developing literature examining the effects of private equity ownership of healthcare providers.” Very few studies have examined the effects on prices and quality for the same set of deals and providers. “This is important because we want to be able to do an apples-to-apples comparison of the effects on both outcomes before judging PE ownership,” he told GI & Hepatology News.
In an accompanying editorial , primary care physician Jane M. Zhu, MD, an associate professor of medicine at Oregon Health & Science University in Portland, Oregon, and not involved in the commercial-insurance-based study, said one interpretation of the findings may be that PE acquisition focuses on reducing inefficiencies, improving access by expanding practice capacity, and increasing throughput. “Another interpretation may be that PE acquisition is focused on the strategic exploitation of market and pricing power. The latter may have less of an impact on clinical measures like quality of care, but potentially, both strategies could be at play.”
Since this analysis focused on the commercial population, understanding how patient demographics may change after PE acquisition is a future avenue for exploration. “For instance, a potential explanation for both the price and utilization shifts might be if payer mix shifted toward more commercially insured patients at the expense of Medicaid or Medicare patients,” she wrote.
Zhu added that the impact of PE on prices and spending, by now replicated across different settings and specialties, is far clearer than the effect of PE on access and quality. “The analysis by Arnold et al is a welcome addition to the literature, generating important questions for future study and transparent monitoring as investor-owners become increasingly influential in healthcare.”
Going forward, said Gupta, an open question is whether the harmful effects of PE ownership of practices are differentially worse than those of other corporate entities such as insurers and hospital systems.
“There are reasons to believe that PE could be worse in theory. For example, their short-term investment horizon may force them to take measures that others will not as well as avoid investing into capital improvements that have a long-run payoff,” he said. “Their uniquely high dependence on debt and unbundling of real estate can severely hurt financial solvency of providers.” But high-quality evidence is lacking to compare the effects from these two distinct forms of corporatization.
The trend away from individual private practice is a reality, Arnold said. “The administrative burden on solo docs is becoming too much and physicians just seem to want to treat patients and not deal with it. So the options at this point really become selling to a hospital system or private equity.”
This study was funded by a grant from the philanthropic foundation Arnold Ventures (no family relation to Daniel Arnold).
Arnold reported receiving grants from Arnold Ventures during the conduct of the study. Gupta had no competing interests to declare. Zhu reported receiving grants from the Agency for Healthcare Research and Quality during the submitted work and from the National Institutes of Health, National Institute for Health Care Management Foundation, and American Psychological Association, as well as personal fees from Cambia outside the submitted work.
A version of this article appeared on Medscape.com.