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Medicare will speed nationwide payment decisions for as many as five promising new medical devices a year, a move that could get some products to patients earlier and spare companies from a bureaucratic slog to secure regional clearances.

The Centers for Medicare & Medicaid Services (CMS) in August finalized a long-awaited plan to accelerate coverage decisions on medical devices that have impressed regulators.

The intent is to create a smoother pathway for some devices that earned a “breakthrough” designation from the US Food and Drug Administration (FDA), a label intended for innovative products that significantly advance treatment for serious illness.

“We’ll see how many they actually take on, but it could make a really big difference on how quickly devices make it through the Medicare coverage gauntlet and get to patients,” Emily P. Zeitler, MD, MHS, a cardiologist and assistant professor of medicine at Dartmouth’s Geisel School of Medicine in Hanover, New Hampshire, told this news organization.

Companies selling “breakthrough” devices face tougher challenges in securing Medicare payment than device makers whose products fit into already established niches. Previous Medicare decisions can serve as a path to coverage for those products.

The new CMS Transitional Coverage for Emerging Technologies (TCET) pathway addresses two causes of delay in securing Medicare coverage for newcomer devices:

• CMS delegates many decisions on new device coverage to Medicare Administrative Contractors (MACs). MACs are businesses owned by, or affiliated with, insurers such as Blue Cross plans. Companies sometimes need to work their way through several regional MACs to gain nationwide coverage of their devices.
• Congress sets different mandates for the FDA and CMS regarding medical products. The FDA needs to know a product is safe and effective enough for US sales. Companies sometimes produce enough evidence to show products can meet the FDA’s standard without generating sufficient data to compel Medicare coverage. Medicare covers about 66.7 million people: 59.1 million aged 65 years or older and 7.6 million with disabilities.

“Medicare beneficiaries are often older, have multiple comorbidities, and are often underrepresented or not represented in many clinical studies,” CMS said in its August notice on the TCET pathway.

“Consequently, a device’s potential benefits and harms for older patients with more comorbidities may not be well understood at the time of FDA market authorization,” the agency added.
 

Coverage With Evidence Development (CED) Experience

TCET is meant to help CMS officials clear coverage of breakthrough devices sooner, and on a nationwide basis, while sometimes continuing to study how well these products work for people enrolled in Medicare.

The TCET pathway builds on Medicare’s experience over two decades with its “CED” program. That program allows coverage of well-regarded new devices or treatments whose effects on older patients were not yet well understood.

In the TCET notice, CMS provided details of its plans for using contractors for evidence reviews and evidence development plans as part of its new coverage pathway.

Securing help from these experts outside of CMS, along with perhaps some new arrangements for in-house staff, would help the agency reach its goals for TCET, Dr. Zeitler said. She has published research on the CED process and has participated in cardiac registries associated with CED as both a researcher and a physician who implants devices.

The poster child for the benefits of the CED approach is the transcatheter aortic valve replacement (TAVR) devices, said Ralph Brindis, MD, MPH, a past president of the American College of Cardiology (ACC) and the senior medical officer for external affairs of the ACC’s National Cardiovascular Data Registry (NCDR).

Through the NCDR, ACC members worked with CMS for years in trying to find ways to gather evidence about the best uses of medical devices.

Brindis said this approach to evidence generation involved more tracking of off-label use and analysis of how TAVR devices performed in routine use through the data obtained through a registry, rather than relying solely on clinical trials requiring a much longer time frame for completion and at an increased cost.

This approach allowed cardiovascular surgeons and cardiologists to steer the course of real-world evidence gathering, he said.

“We were able to expand indications for TAVR without relying on industry to fund randomized clinical trials that they may not have had interest or bandwidth or finances” to do, Dr. Brindis said. “And we already had the data in hand.”

The TCET policy is welcomed, although there remain questions about how well CMS will be able to carry out this program due to funding limitations, Dr. Brindis said. Groups such as the ACC may be able to help CMS by encouraging Congress to provide the agency with more money to carry out the TCET plans, Dr. Brindis said.

“The professional societies will work hand in hand with CMS in trying to achieve these goals” with TCET, he said.

AdvaMed, the trade group for makers of medical devices, also called for beefing up the administrative budget for CMS to speed reviews of innovative devices.

“The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources,” AdvaMed CEO Scott Whitaker said in a statement.

Mr. Whitaker also described CMS’ decision to exclude medical tests from the TCET pathway as a disappointment.

The agency said the majority of coverage decisions on diagnostic tests should stay with MACs. In some cases, there may be a need for CMS to use its long-standing processes for considering a national coverage decision for certain tests, the agency said.

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering,” AdvaMed’s Mr. Whitaker said.

Dr. Brindis said he had no relevant financial disclosures. Dr. Zeitler reported having received consulting and speaking fees, travel payments, and research support from Medtronic, Abbott, Biosense Webster, Sanofi, NIH/NIGMS, Element Science, Edwards, Boston Scientific, Philips, and V-Wave.
 

A version of this article appeared on Medscape.com.

Medicare will speed nationwide payment decisions for as many as five promising new medical devices a year, a move that could get some products to patients earlier and spare companies from a bureaucratic slog to secure regional clearances.

The Centers for Medicare & Medicaid Services (CMS) in August finalized a long-awaited plan to accelerate coverage decisions on medical devices that have impressed regulators.

The intent is to create a smoother pathway for some devices that earned a “breakthrough” designation from the US Food and Drug Administration (FDA), a label intended for innovative products that significantly advance treatment for serious illness.

“We’ll see how many they actually take on, but it could make a really big difference on how quickly devices make it through the Medicare coverage gauntlet and get to patients,” Emily P. Zeitler, MD, MHS, a cardiologist and assistant professor of medicine at Dartmouth’s Geisel School of Medicine in Hanover, New Hampshire, told this news organization.

Companies selling “breakthrough” devices face tougher challenges in securing Medicare payment than device makers whose products fit into already established niches. Previous Medicare decisions can serve as a path to coverage for those products.

The new CMS Transitional Coverage for Emerging Technologies (TCET) pathway addresses two causes of delay in securing Medicare coverage for newcomer devices:

• CMS delegates many decisions on new device coverage to Medicare Administrative Contractors (MACs). MACs are businesses owned by, or affiliated with, insurers such as Blue Cross plans. Companies sometimes need to work their way through several regional MACs to gain nationwide coverage of their devices.
• Congress sets different mandates for the FDA and CMS regarding medical products. The FDA needs to know a product is safe and effective enough for US sales. Companies sometimes produce enough evidence to show products can meet the FDA’s standard without generating sufficient data to compel Medicare coverage. Medicare covers about 66.7 million people: 59.1 million aged 65 years or older and 7.6 million with disabilities.

“Medicare beneficiaries are often older, have multiple comorbidities, and are often underrepresented or not represented in many clinical studies,” CMS said in its August notice on the TCET pathway.

“Consequently, a device’s potential benefits and harms for older patients with more comorbidities may not be well understood at the time of FDA market authorization,” the agency added.
 

Coverage With Evidence Development (CED) Experience

TCET is meant to help CMS officials clear coverage of breakthrough devices sooner, and on a nationwide basis, while sometimes continuing to study how well these products work for people enrolled in Medicare.

The TCET pathway builds on Medicare’s experience over two decades with its “CED” program. That program allows coverage of well-regarded new devices or treatments whose effects on older patients were not yet well understood.

In the TCET notice, CMS provided details of its plans for using contractors for evidence reviews and evidence development plans as part of its new coverage pathway.

Securing help from these experts outside of CMS, along with perhaps some new arrangements for in-house staff, would help the agency reach its goals for TCET, Dr. Zeitler said. She has published research on the CED process and has participated in cardiac registries associated with CED as both a researcher and a physician who implants devices.

The poster child for the benefits of the CED approach is the transcatheter aortic valve replacement (TAVR) devices, said Ralph Brindis, MD, MPH, a past president of the American College of Cardiology (ACC) and the senior medical officer for external affairs of the ACC’s National Cardiovascular Data Registry (NCDR).

Through the NCDR, ACC members worked with CMS for years in trying to find ways to gather evidence about the best uses of medical devices.

Brindis said this approach to evidence generation involved more tracking of off-label use and analysis of how TAVR devices performed in routine use through the data obtained through a registry, rather than relying solely on clinical trials requiring a much longer time frame for completion and at an increased cost.

This approach allowed cardiovascular surgeons and cardiologists to steer the course of real-world evidence gathering, he said.

“We were able to expand indications for TAVR without relying on industry to fund randomized clinical trials that they may not have had interest or bandwidth or finances” to do, Dr. Brindis said. “And we already had the data in hand.”

The TCET policy is welcomed, although there remain questions about how well CMS will be able to carry out this program due to funding limitations, Dr. Brindis said. Groups such as the ACC may be able to help CMS by encouraging Congress to provide the agency with more money to carry out the TCET plans, Dr. Brindis said.

“The professional societies will work hand in hand with CMS in trying to achieve these goals” with TCET, he said.

AdvaMed, the trade group for makers of medical devices, also called for beefing up the administrative budget for CMS to speed reviews of innovative devices.

“The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources,” AdvaMed CEO Scott Whitaker said in a statement.

Mr. Whitaker also described CMS’ decision to exclude medical tests from the TCET pathway as a disappointment.

The agency said the majority of coverage decisions on diagnostic tests should stay with MACs. In some cases, there may be a need for CMS to use its long-standing processes for considering a national coverage decision for certain tests, the agency said.

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering,” AdvaMed’s Mr. Whitaker said.

Dr. Brindis said he had no relevant financial disclosures. Dr. Zeitler reported having received consulting and speaking fees, travel payments, and research support from Medtronic, Abbott, Biosense Webster, Sanofi, NIH/NIGMS, Element Science, Edwards, Boston Scientific, Philips, and V-Wave.
 

A version of this article appeared on Medscape.com.

Medicare will speed nationwide payment decisions for as many as five promising new medical devices a year, a move that could get some products to patients earlier and spare companies from a bureaucratic slog to secure regional clearances.

The Centers for Medicare & Medicaid Services (CMS) in August finalized a long-awaited plan to accelerate coverage decisions on medical devices that have impressed regulators.

The intent is to create a smoother pathway for some devices that earned a “breakthrough” designation from the US Food and Drug Administration (FDA), a label intended for innovative products that significantly advance treatment for serious illness.

“We’ll see how many they actually take on, but it could make a really big difference on how quickly devices make it through the Medicare coverage gauntlet and get to patients,” Emily P. Zeitler, MD, MHS, a cardiologist and assistant professor of medicine at Dartmouth’s Geisel School of Medicine in Hanover, New Hampshire, told this news organization.

Companies selling “breakthrough” devices face tougher challenges in securing Medicare payment than device makers whose products fit into already established niches. Previous Medicare decisions can serve as a path to coverage for those products.

The new CMS Transitional Coverage for Emerging Technologies (TCET) pathway addresses two causes of delay in securing Medicare coverage for newcomer devices:

• CMS delegates many decisions on new device coverage to Medicare Administrative Contractors (MACs). MACs are businesses owned by, or affiliated with, insurers such as Blue Cross plans. Companies sometimes need to work their way through several regional MACs to gain nationwide coverage of their devices.
• Congress sets different mandates for the FDA and CMS regarding medical products. The FDA needs to know a product is safe and effective enough for US sales. Companies sometimes produce enough evidence to show products can meet the FDA’s standard without generating sufficient data to compel Medicare coverage. Medicare covers about 66.7 million people: 59.1 million aged 65 years or older and 7.6 million with disabilities.

“Medicare beneficiaries are often older, have multiple comorbidities, and are often underrepresented or not represented in many clinical studies,” CMS said in its August notice on the TCET pathway.

“Consequently, a device’s potential benefits and harms for older patients with more comorbidities may not be well understood at the time of FDA market authorization,” the agency added.
 

Coverage With Evidence Development (CED) Experience

TCET is meant to help CMS officials clear coverage of breakthrough devices sooner, and on a nationwide basis, while sometimes continuing to study how well these products work for people enrolled in Medicare.

The TCET pathway builds on Medicare’s experience over two decades with its “CED” program. That program allows coverage of well-regarded new devices or treatments whose effects on older patients were not yet well understood.

In the TCET notice, CMS provided details of its plans for using contractors for evidence reviews and evidence development plans as part of its new coverage pathway.

Securing help from these experts outside of CMS, along with perhaps some new arrangements for in-house staff, would help the agency reach its goals for TCET, Dr. Zeitler said. She has published research on the CED process and has participated in cardiac registries associated with CED as both a researcher and a physician who implants devices.

The poster child for the benefits of the CED approach is the transcatheter aortic valve replacement (TAVR) devices, said Ralph Brindis, MD, MPH, a past president of the American College of Cardiology (ACC) and the senior medical officer for external affairs of the ACC’s National Cardiovascular Data Registry (NCDR).

Through the NCDR, ACC members worked with CMS for years in trying to find ways to gather evidence about the best uses of medical devices.

Brindis said this approach to evidence generation involved more tracking of off-label use and analysis of how TAVR devices performed in routine use through the data obtained through a registry, rather than relying solely on clinical trials requiring a much longer time frame for completion and at an increased cost.

This approach allowed cardiovascular surgeons and cardiologists to steer the course of real-world evidence gathering, he said.

“We were able to expand indications for TAVR without relying on industry to fund randomized clinical trials that they may not have had interest or bandwidth or finances” to do, Dr. Brindis said. “And we already had the data in hand.”

The TCET policy is welcomed, although there remain questions about how well CMS will be able to carry out this program due to funding limitations, Dr. Brindis said. Groups such as the ACC may be able to help CMS by encouraging Congress to provide the agency with more money to carry out the TCET plans, Dr. Brindis said.

“The professional societies will work hand in hand with CMS in trying to achieve these goals” with TCET, he said.

AdvaMed, the trade group for makers of medical devices, also called for beefing up the administrative budget for CMS to speed reviews of innovative devices.

“The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources,” AdvaMed CEO Scott Whitaker said in a statement.

Mr. Whitaker also described CMS’ decision to exclude medical tests from the TCET pathway as a disappointment.

The agency said the majority of coverage decisions on diagnostic tests should stay with MACs. In some cases, there may be a need for CMS to use its long-standing processes for considering a national coverage decision for certain tests, the agency said.

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering,” AdvaMed’s Mr. Whitaker said.

Dr. Brindis said he had no relevant financial disclosures. Dr. Zeitler reported having received consulting and speaking fees, travel payments, and research support from Medtronic, Abbott, Biosense Webster, Sanofi, NIH/NIGMS, Element Science, Edwards, Boston Scientific, Philips, and V-Wave.
 

A version of this article appeared on Medscape.com.

More women are enrolling into higher-paid physician specialty fields, especially surgery, but they still have a way to go before reaching parity with their male counterparts, an analysis found.

Rising Interest in Surgical Specialties

Among 490,188 students to “pipeline” specialties from 2008 to 2022 (47.4% women), the proportion of women entering higher-paid specialties grew from 32.7% to 40.8% (P = .003), powered by increased interest in surgical jobs, reported Karina Pereira-Lima, PhD, MSc, of the University of Michigan, Ann Arbor, Michigan, and colleagues in JAMA.

“It was exciting to see the proportion of women entering high-compensation surgical specialties jump from 28.8% in 2008 to 42.4% in 2022,” Dr. Pereira-Lima told this news organization. “At the same time, the proportion of women entering high-compensation nonsurgical specialties didn’t change much over time, and we even saw a decrease in female applicants to those fields.”

The researchers launched the analysis to better understand the career choices of medical students. “We’ve been seeing a national trend where more women are entering the medical profession, with women now making up more than half of medical school students. At the same time, most of the highest compensation specialties have traditionally been dominated by men,” Dr. Pereira-Lima said. “Tracking changes in the proportion of women entering these programs over time can give us insight into whether we’re making progress toward more equitable gender representation in these high-compensation specialties.”
 

Highest vs Lowest Compensated Specialties

The researchers analyzed 2008-2022 data from students and applicants to Accreditation Council for Graduate Medical Education–accredited residency programs in “pipeline” specialties, defined as those that lead to primary board certification.

Specialties defined as having the highest compensation, based on data from Doximity, were the surgical fields of neurosurgery, ophthalmology, orthopedic surgery, otorhinolaryngology, plastic surgery (integrated), surgery (general), thoracic surgery (integrated), urology, and vascular surgery (integrated) and the nonsurgical fields of anesthesiology, dermatology, nuclear medicine, radiation oncology, and radiology (diagnostic).

The lowest-compensated fields were all nonsurgical: Child neurology, emergency medicine, family medicine, internal medicine, internal medicine/pediatrics, medical genetics and genomics, neurology, nuclear medicine, obstetrics and gynecology, pathology, pediatrics, physical medicine and rehabilitation, and psychiatry.

The proportion of women entering lower-compensated specialties stayed steady from 2008 to 2022 (53.0% vs 53.3%, respectively; P = .44), as did the percentage entering nonsurgical specialties (37.6% vs 38.7%, respectively; P = .55).

Meanwhile, the proportion of women applicants to high-compensation nonsurgical specialties fell from 36.8% in 2009 to 34.3% in 2022 (P = .001), whereas the number grew in high-compensation surgical specialties from 28.1% in 2009 to 37.6% in 2022 (P < .001).
 

Implications for Future Representation

The findings suggest that “the issue of women’s underrepresentation isn’t just limited to surgical specialties,” Dr. Pereira-Lima said. “It’s affecting many of the highest-compensated specialties overall. Moving forward, it’ll be important to investigate what’s driving the increase in women entering these highly compensated surgical specialties and see if those same factors can be applied to other fields where women are still underrepresented.”

She added that it will take time for the dominance of women among medical students to translate into more representation in the physician workforce. Also, “studies show that female physicians have higher attrition rates than men. To achieve a more balanced gender representation in medicine, it’s crucial not just to have more women entering the profession, but to focus on addressing the barriers that hinder their career advancement.”

Shikha Jain, MD, University of Illinois College of Medicine, Chicago, an oncologist who’s studied gender representation in medicine, told this news organization that the rise in women entering surgical fields may be due to an increased focus on gender disparity. “It’s nice to see that we’re actually seeing some movement there,” she said, especially in light of findings that female surgeons have better outcomes than male surgeons.

However, research has shown that women in surgical specialties aren’t as highly compensated as men, she said. “Bullying, harassment, micro- and macro-aggressions, and gaslighting are all huge problems that continue to persist in healthcare. They’re a huge part of the reason many women weren’t in these specialties. With the increase in women entering these fields, I hope we see a real concerted effort to address these challenges so we can continue to see these trends moving forward.”

Dr. Pereira-Lima is supported by the National Institutes of Health, and another author is supported by the National Institute of Mental Health. No author disclosures were reported. Dr. Jain had no disclosures.
 

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

More women are enrolling into higher-paid physician specialty fields, especially surgery, but they still have a way to go before reaching parity with their male counterparts, an analysis found.

Rising Interest in Surgical Specialties

Among 490,188 students to “pipeline” specialties from 2008 to 2022 (47.4% women), the proportion of women entering higher-paid specialties grew from 32.7% to 40.8% (P = .003), powered by increased interest in surgical jobs, reported Karina Pereira-Lima, PhD, MSc, of the University of Michigan, Ann Arbor, Michigan, and colleagues in JAMA.

“It was exciting to see the proportion of women entering high-compensation surgical specialties jump from 28.8% in 2008 to 42.4% in 2022,” Dr. Pereira-Lima told this news organization. “At the same time, the proportion of women entering high-compensation nonsurgical specialties didn’t change much over time, and we even saw a decrease in female applicants to those fields.”

The researchers launched the analysis to better understand the career choices of medical students. “We’ve been seeing a national trend where more women are entering the medical profession, with women now making up more than half of medical school students. At the same time, most of the highest compensation specialties have traditionally been dominated by men,” Dr. Pereira-Lima said. “Tracking changes in the proportion of women entering these programs over time can give us insight into whether we’re making progress toward more equitable gender representation in these high-compensation specialties.”
 

Highest vs Lowest Compensated Specialties

The researchers analyzed 2008-2022 data from students and applicants to Accreditation Council for Graduate Medical Education–accredited residency programs in “pipeline” specialties, defined as those that lead to primary board certification.

Specialties defined as having the highest compensation, based on data from Doximity, were the surgical fields of neurosurgery, ophthalmology, orthopedic surgery, otorhinolaryngology, plastic surgery (integrated), surgery (general), thoracic surgery (integrated), urology, and vascular surgery (integrated) and the nonsurgical fields of anesthesiology, dermatology, nuclear medicine, radiation oncology, and radiology (diagnostic).

The lowest-compensated fields were all nonsurgical: Child neurology, emergency medicine, family medicine, internal medicine, internal medicine/pediatrics, medical genetics and genomics, neurology, nuclear medicine, obstetrics and gynecology, pathology, pediatrics, physical medicine and rehabilitation, and psychiatry.

The proportion of women entering lower-compensated specialties stayed steady from 2008 to 2022 (53.0% vs 53.3%, respectively; P = .44), as did the percentage entering nonsurgical specialties (37.6% vs 38.7%, respectively; P = .55).

Meanwhile, the proportion of women applicants to high-compensation nonsurgical specialties fell from 36.8% in 2009 to 34.3% in 2022 (P = .001), whereas the number grew in high-compensation surgical specialties from 28.1% in 2009 to 37.6% in 2022 (P < .001).
 

Implications for Future Representation

The findings suggest that “the issue of women’s underrepresentation isn’t just limited to surgical specialties,” Dr. Pereira-Lima said. “It’s affecting many of the highest-compensated specialties overall. Moving forward, it’ll be important to investigate what’s driving the increase in women entering these highly compensated surgical specialties and see if those same factors can be applied to other fields where women are still underrepresented.”

She added that it will take time for the dominance of women among medical students to translate into more representation in the physician workforce. Also, “studies show that female physicians have higher attrition rates than men. To achieve a more balanced gender representation in medicine, it’s crucial not just to have more women entering the profession, but to focus on addressing the barriers that hinder their career advancement.”

Shikha Jain, MD, University of Illinois College of Medicine, Chicago, an oncologist who’s studied gender representation in medicine, told this news organization that the rise in women entering surgical fields may be due to an increased focus on gender disparity. “It’s nice to see that we’re actually seeing some movement there,” she said, especially in light of findings that female surgeons have better outcomes than male surgeons.

However, research has shown that women in surgical specialties aren’t as highly compensated as men, she said. “Bullying, harassment, micro- and macro-aggressions, and gaslighting are all huge problems that continue to persist in healthcare. They’re a huge part of the reason many women weren’t in these specialties. With the increase in women entering these fields, I hope we see a real concerted effort to address these challenges so we can continue to see these trends moving forward.”

Dr. Pereira-Lima is supported by the National Institutes of Health, and another author is supported by the National Institute of Mental Health. No author disclosures were reported. Dr. Jain had no disclosures.
 

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

More women are enrolling into higher-paid physician specialty fields, especially surgery, but they still have a way to go before reaching parity with their male counterparts, an analysis found.

Rising Interest in Surgical Specialties

Among 490,188 students to “pipeline” specialties from 2008 to 2022 (47.4% women), the proportion of women entering higher-paid specialties grew from 32.7% to 40.8% (P = .003), powered by increased interest in surgical jobs, reported Karina Pereira-Lima, PhD, MSc, of the University of Michigan, Ann Arbor, Michigan, and colleagues in JAMA.

“It was exciting to see the proportion of women entering high-compensation surgical specialties jump from 28.8% in 2008 to 42.4% in 2022,” Dr. Pereira-Lima told this news organization. “At the same time, the proportion of women entering high-compensation nonsurgical specialties didn’t change much over time, and we even saw a decrease in female applicants to those fields.”

The researchers launched the analysis to better understand the career choices of medical students. “We’ve been seeing a national trend where more women are entering the medical profession, with women now making up more than half of medical school students. At the same time, most of the highest compensation specialties have traditionally been dominated by men,” Dr. Pereira-Lima said. “Tracking changes in the proportion of women entering these programs over time can give us insight into whether we’re making progress toward more equitable gender representation in these high-compensation specialties.”
 

Highest vs Lowest Compensated Specialties

The researchers analyzed 2008-2022 data from students and applicants to Accreditation Council for Graduate Medical Education–accredited residency programs in “pipeline” specialties, defined as those that lead to primary board certification.

Specialties defined as having the highest compensation, based on data from Doximity, were the surgical fields of neurosurgery, ophthalmology, orthopedic surgery, otorhinolaryngology, plastic surgery (integrated), surgery (general), thoracic surgery (integrated), urology, and vascular surgery (integrated) and the nonsurgical fields of anesthesiology, dermatology, nuclear medicine, radiation oncology, and radiology (diagnostic).

The lowest-compensated fields were all nonsurgical: Child neurology, emergency medicine, family medicine, internal medicine, internal medicine/pediatrics, medical genetics and genomics, neurology, nuclear medicine, obstetrics and gynecology, pathology, pediatrics, physical medicine and rehabilitation, and psychiatry.

The proportion of women entering lower-compensated specialties stayed steady from 2008 to 2022 (53.0% vs 53.3%, respectively; P = .44), as did the percentage entering nonsurgical specialties (37.6% vs 38.7%, respectively; P = .55).

Meanwhile, the proportion of women applicants to high-compensation nonsurgical specialties fell from 36.8% in 2009 to 34.3% in 2022 (P = .001), whereas the number grew in high-compensation surgical specialties from 28.1% in 2009 to 37.6% in 2022 (P < .001).
 

Implications for Future Representation

The findings suggest that “the issue of women’s underrepresentation isn’t just limited to surgical specialties,” Dr. Pereira-Lima said. “It’s affecting many of the highest-compensated specialties overall. Moving forward, it’ll be important to investigate what’s driving the increase in women entering these highly compensated surgical specialties and see if those same factors can be applied to other fields where women are still underrepresented.”

She added that it will take time for the dominance of women among medical students to translate into more representation in the physician workforce. Also, “studies show that female physicians have higher attrition rates than men. To achieve a more balanced gender representation in medicine, it’s crucial not just to have more women entering the profession, but to focus on addressing the barriers that hinder their career advancement.”

Shikha Jain, MD, University of Illinois College of Medicine, Chicago, an oncologist who’s studied gender representation in medicine, told this news organization that the rise in women entering surgical fields may be due to an increased focus on gender disparity. “It’s nice to see that we’re actually seeing some movement there,” she said, especially in light of findings that female surgeons have better outcomes than male surgeons.

However, research has shown that women in surgical specialties aren’t as highly compensated as men, she said. “Bullying, harassment, micro- and macro-aggressions, and gaslighting are all huge problems that continue to persist in healthcare. They’re a huge part of the reason many women weren’t in these specialties. With the increase in women entering these fields, I hope we see a real concerted effort to address these challenges so we can continue to see these trends moving forward.”

Dr. Pereira-Lima is supported by the National Institutes of Health, and another author is supported by the National Institute of Mental Health. No author disclosures were reported. Dr. Jain had no disclosures.
 

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

Neoadjuvant concurrent chemoradiotherapy significantly improves survival outcomes over adjuvant sequential chemoradiotherapy (ASCRT) in patients with locally advanced esophageal squamous cell carcinoma, confirmed the first randomized trial to directly compare the two approaches.

Yaoyao Zhu, MD, Department of Radiation Oncology, Shanghai Pulmonary Hospital, Shanghai, China, presented the new research at the annual World Conference on Lung Cancer on September 10.

Based on the findings, neoadjuvant concurrent chemoradiotherapy (NCCRT) followed by surgical resection “should be regarded as the standard of care for patients with locally advanced esophageal squamous cell carcinoma (ESCC) in the Chinese population,” Dr. Zhu said.
 

Different Approaches in ESCC

Dr. Zhu began her presentation by underscoring that in Western countries, NCCRT followed by surgery has been the standard treatment for locally advanced, resectable esophageal cancer since the publication of the CROSS trial in 2012, which compared neoadjuvant therapy plus surgery with surgery alone.

This demonstrated that preoperative chemoradiotherapy improved survival by 34% in patients with potentially curable esophageal or esophagogastric junction cancer, while adverse event rates were deemed “acceptable.”

In contrast, in most centers in China, clinicians opt for performing surgery followed by ASCRT.

Dr. Zhu pointed out that as previous randomized controlled trials have used surgery alone as the comparator arm, it has not been shown definitively that NCCRT plus surgery is superior to surgery followed by ASCRT.

The researchers, therefore, conducted the NEOTERIC trial, which enrolled patients with clinically resectable, locally advanced ESCC, defined as clinical stage T1-2N1M0 or T3-4N0-1M0.

They were randomized to one of two arms. The NCCRT arm involved 6 weeks of carboplatin plus paclitaxel chemotherapy alongside radiotherapy delivered as 50.4 Gy over 28 fractions. After an interval of 4-6 weeks, the patients underwent surgery, followed by an optional two cycles of carboplatin plus paclitaxel 4-6 weeks later.

In the ASCRT arm, patients underwent surgery straightaway, waited for 4-6 weeks, then had two cycles of carboplatin plus paclitaxel 3 weeks apart, followed by the same radiotherapy regimen as in the first arm. About 2-4 weeks later, patients could then undergo another two cycles of carboplatin plus paclitaxel.
 

More Than Doubling of Survival Outcomes

One hundred patients were assigned to NCCRT and 104 to ASCRT. There were no significant differences between the groups in terms of their baseline characteristics.

The vast majority of patients were men, just over two thirds were smokers, and the median age was around 60 years. The median tumor length was approximately 5 cm, and around half of tumors were located in the middle third of the esophagus.

Median disease-free survival was markedly longer with NCCRT, at 51.0 months vs 14.0 months in the ASCRT arm (P = .01). Similarly, median overall survival was far longer with neoadjuvant therapy, at 79.0 months, vs 38.0 months when waiting until after surgery to provide chemoradiotherapy (P = .025).

There were no significant differences in postsurgical complications between the two arms, and no significant differences in rates of grade 3-4 hematologic and nonhematologic toxicities. There were also no chemoradiotherapy-related deaths.

The most common toxicities across the two study arms were esophagitis, neutropenia, thrombocytopenia, and leukopenia.

Overall, the rates of recurrence were significantly lower with NCCRT than with ASCRT (58.0% vs 66.3%; P = .020). This included significant reductions in both locoregional (P = .012) and distant recurrence (P = .009).

Jaffer A. Ajani, MD, University of Texas MD Anderson Cancer Center, Houston, underlined that the experimental arm of the trial, with neoadjuvant chemoradiotherapy, “has been the standard of care in the United States for a long time, particularly for squamous carcinoma.”

However, he said in an interview that it is not a standard of care in China and clinicians continue with adjuvant therapy. This is despite a recent study conducted in Hong Kong that concluded that patients should not be given any treatment after surgery “because they do worse” than those given neoadjuvant therapy, he continued.

While Dr. Ajani noted that the current analysis is underpowered to provide a definitive conclusion, it remains “an important study for Chinese patients.

“Hopefully, it will be well advertised in China, and all the providers switch [to NCCRT]. This could push them to abandon what in the West was considered harmful.”

Dr. Ajani explained the reason neoadjuvant therapy performs better than adjuvant chemoradiotherapy is it “may be mopping up some of the micro metastatic disease, which is difficult to do after surgery,” especially as many patients cannot tolerate postoperative treatment.

“It may be that the majority of patients don’t even get [adjuvant therapy], and those who get it don’t seem to benefit.”

Vishwanath Sathyanarayanan, MD, PhD, Senior Consultant, Professor and Academic Advisor, Department of Medical Oncology, Apollo Cancer Centers, Bangalore, India, agreed that the study reinforces that “NCCRT continues to remain the standard of care in locally advanced resectable esophageal squamous cell carcinoma.”

Consequently, there are “no implications for clinical practice” for providers in the West from these study results, “particularly as NCCRT significantly improves outcomes vs ASCRT with a similar toxicity profile,” he said in an interview.

No funding was declared. Dr. Zhu declared no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Neoadjuvant concurrent chemoradiotherapy significantly improves survival outcomes over adjuvant sequential chemoradiotherapy (ASCRT) in patients with locally advanced esophageal squamous cell carcinoma, confirmed the first randomized trial to directly compare the two approaches.

Yaoyao Zhu, MD, Department of Radiation Oncology, Shanghai Pulmonary Hospital, Shanghai, China, presented the new research at the annual World Conference on Lung Cancer on September 10.

Based on the findings, neoadjuvant concurrent chemoradiotherapy (NCCRT) followed by surgical resection “should be regarded as the standard of care for patients with locally advanced esophageal squamous cell carcinoma (ESCC) in the Chinese population,” Dr. Zhu said.
 

Different Approaches in ESCC

Dr. Zhu began her presentation by underscoring that in Western countries, NCCRT followed by surgery has been the standard treatment for locally advanced, resectable esophageal cancer since the publication of the CROSS trial in 2012, which compared neoadjuvant therapy plus surgery with surgery alone.

This demonstrated that preoperative chemoradiotherapy improved survival by 34% in patients with potentially curable esophageal or esophagogastric junction cancer, while adverse event rates were deemed “acceptable.”

In contrast, in most centers in China, clinicians opt for performing surgery followed by ASCRT.

Dr. Zhu pointed out that as previous randomized controlled trials have used surgery alone as the comparator arm, it has not been shown definitively that NCCRT plus surgery is superior to surgery followed by ASCRT.

The researchers, therefore, conducted the NEOTERIC trial, which enrolled patients with clinically resectable, locally advanced ESCC, defined as clinical stage T1-2N1M0 or T3-4N0-1M0.

They were randomized to one of two arms. The NCCRT arm involved 6 weeks of carboplatin plus paclitaxel chemotherapy alongside radiotherapy delivered as 50.4 Gy over 28 fractions. After an interval of 4-6 weeks, the patients underwent surgery, followed by an optional two cycles of carboplatin plus paclitaxel 4-6 weeks later.

In the ASCRT arm, patients underwent surgery straightaway, waited for 4-6 weeks, then had two cycles of carboplatin plus paclitaxel 3 weeks apart, followed by the same radiotherapy regimen as in the first arm. About 2-4 weeks later, patients could then undergo another two cycles of carboplatin plus paclitaxel.
 

More Than Doubling of Survival Outcomes

One hundred patients were assigned to NCCRT and 104 to ASCRT. There were no significant differences between the groups in terms of their baseline characteristics.

The vast majority of patients were men, just over two thirds were smokers, and the median age was around 60 years. The median tumor length was approximately 5 cm, and around half of tumors were located in the middle third of the esophagus.

Median disease-free survival was markedly longer with NCCRT, at 51.0 months vs 14.0 months in the ASCRT arm (P = .01). Similarly, median overall survival was far longer with neoadjuvant therapy, at 79.0 months, vs 38.0 months when waiting until after surgery to provide chemoradiotherapy (P = .025).

There were no significant differences in postsurgical complications between the two arms, and no significant differences in rates of grade 3-4 hematologic and nonhematologic toxicities. There were also no chemoradiotherapy-related deaths.

The most common toxicities across the two study arms were esophagitis, neutropenia, thrombocytopenia, and leukopenia.

Overall, the rates of recurrence were significantly lower with NCCRT than with ASCRT (58.0% vs 66.3%; P = .020). This included significant reductions in both locoregional (P = .012) and distant recurrence (P = .009).

Jaffer A. Ajani, MD, University of Texas MD Anderson Cancer Center, Houston, underlined that the experimental arm of the trial, with neoadjuvant chemoradiotherapy, “has been the standard of care in the United States for a long time, particularly for squamous carcinoma.”

However, he said in an interview that it is not a standard of care in China and clinicians continue with adjuvant therapy. This is despite a recent study conducted in Hong Kong that concluded that patients should not be given any treatment after surgery “because they do worse” than those given neoadjuvant therapy, he continued.

While Dr. Ajani noted that the current analysis is underpowered to provide a definitive conclusion, it remains “an important study for Chinese patients.

“Hopefully, it will be well advertised in China, and all the providers switch [to NCCRT]. This could push them to abandon what in the West was considered harmful.”

Dr. Ajani explained the reason neoadjuvant therapy performs better than adjuvant chemoradiotherapy is it “may be mopping up some of the micro metastatic disease, which is difficult to do after surgery,” especially as many patients cannot tolerate postoperative treatment.

“It may be that the majority of patients don’t even get [adjuvant therapy], and those who get it don’t seem to benefit.”

Vishwanath Sathyanarayanan, MD, PhD, Senior Consultant, Professor and Academic Advisor, Department of Medical Oncology, Apollo Cancer Centers, Bangalore, India, agreed that the study reinforces that “NCCRT continues to remain the standard of care in locally advanced resectable esophageal squamous cell carcinoma.”

Consequently, there are “no implications for clinical practice” for providers in the West from these study results, “particularly as NCCRT significantly improves outcomes vs ASCRT with a similar toxicity profile,” he said in an interview.

No funding was declared. Dr. Zhu declared no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Neoadjuvant concurrent chemoradiotherapy significantly improves survival outcomes over adjuvant sequential chemoradiotherapy (ASCRT) in patients with locally advanced esophageal squamous cell carcinoma, confirmed the first randomized trial to directly compare the two approaches.

Yaoyao Zhu, MD, Department of Radiation Oncology, Shanghai Pulmonary Hospital, Shanghai, China, presented the new research at the annual World Conference on Lung Cancer on September 10.

Based on the findings, neoadjuvant concurrent chemoradiotherapy (NCCRT) followed by surgical resection “should be regarded as the standard of care for patients with locally advanced esophageal squamous cell carcinoma (ESCC) in the Chinese population,” Dr. Zhu said.
 

Different Approaches in ESCC

Dr. Zhu began her presentation by underscoring that in Western countries, NCCRT followed by surgery has been the standard treatment for locally advanced, resectable esophageal cancer since the publication of the CROSS trial in 2012, which compared neoadjuvant therapy plus surgery with surgery alone.

This demonstrated that preoperative chemoradiotherapy improved survival by 34% in patients with potentially curable esophageal or esophagogastric junction cancer, while adverse event rates were deemed “acceptable.”

In contrast, in most centers in China, clinicians opt for performing surgery followed by ASCRT.

Dr. Zhu pointed out that as previous randomized controlled trials have used surgery alone as the comparator arm, it has not been shown definitively that NCCRT plus surgery is superior to surgery followed by ASCRT.

The researchers, therefore, conducted the NEOTERIC trial, which enrolled patients with clinically resectable, locally advanced ESCC, defined as clinical stage T1-2N1M0 or T3-4N0-1M0.

They were randomized to one of two arms. The NCCRT arm involved 6 weeks of carboplatin plus paclitaxel chemotherapy alongside radiotherapy delivered as 50.4 Gy over 28 fractions. After an interval of 4-6 weeks, the patients underwent surgery, followed by an optional two cycles of carboplatin plus paclitaxel 4-6 weeks later.

In the ASCRT arm, patients underwent surgery straightaway, waited for 4-6 weeks, then had two cycles of carboplatin plus paclitaxel 3 weeks apart, followed by the same radiotherapy regimen as in the first arm. About 2-4 weeks later, patients could then undergo another two cycles of carboplatin plus paclitaxel.
 

More Than Doubling of Survival Outcomes

One hundred patients were assigned to NCCRT and 104 to ASCRT. There were no significant differences between the groups in terms of their baseline characteristics.

The vast majority of patients were men, just over two thirds were smokers, and the median age was around 60 years. The median tumor length was approximately 5 cm, and around half of tumors were located in the middle third of the esophagus.

Median disease-free survival was markedly longer with NCCRT, at 51.0 months vs 14.0 months in the ASCRT arm (P = .01). Similarly, median overall survival was far longer with neoadjuvant therapy, at 79.0 months, vs 38.0 months when waiting until after surgery to provide chemoradiotherapy (P = .025).

There were no significant differences in postsurgical complications between the two arms, and no significant differences in rates of grade 3-4 hematologic and nonhematologic toxicities. There were also no chemoradiotherapy-related deaths.

The most common toxicities across the two study arms were esophagitis, neutropenia, thrombocytopenia, and leukopenia.

Overall, the rates of recurrence were significantly lower with NCCRT than with ASCRT (58.0% vs 66.3%; P = .020). This included significant reductions in both locoregional (P = .012) and distant recurrence (P = .009).

Jaffer A. Ajani, MD, University of Texas MD Anderson Cancer Center, Houston, underlined that the experimental arm of the trial, with neoadjuvant chemoradiotherapy, “has been the standard of care in the United States for a long time, particularly for squamous carcinoma.”

However, he said in an interview that it is not a standard of care in China and clinicians continue with adjuvant therapy. This is despite a recent study conducted in Hong Kong that concluded that patients should not be given any treatment after surgery “because they do worse” than those given neoadjuvant therapy, he continued.

While Dr. Ajani noted that the current analysis is underpowered to provide a definitive conclusion, it remains “an important study for Chinese patients.

“Hopefully, it will be well advertised in China, and all the providers switch [to NCCRT]. This could push them to abandon what in the West was considered harmful.”

Dr. Ajani explained the reason neoadjuvant therapy performs better than adjuvant chemoradiotherapy is it “may be mopping up some of the micro metastatic disease, which is difficult to do after surgery,” especially as many patients cannot tolerate postoperative treatment.

“It may be that the majority of patients don’t even get [adjuvant therapy], and those who get it don’t seem to benefit.”

Vishwanath Sathyanarayanan, MD, PhD, Senior Consultant, Professor and Academic Advisor, Department of Medical Oncology, Apollo Cancer Centers, Bangalore, India, agreed that the study reinforces that “NCCRT continues to remain the standard of care in locally advanced resectable esophageal squamous cell carcinoma.”

Consequently, there are “no implications for clinical practice” for providers in the West from these study results, “particularly as NCCRT significantly improves outcomes vs ASCRT with a similar toxicity profile,” he said in an interview.

No funding was declared. Dr. Zhu declared no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Salaries for millennial physicians are slightly increasing, but clinicians still face pay disparities across location, practice type, and gender.

Medscape Medical News reviewed survey data from more than 1200 practicing doctors under age 40 across 29 specialties over a 4-month period starting in October 2023.

The average annual total compensation (including any bonuses) for young clinicians rose from $326,000 to $338,000, about 4%, between 2022 and 2023. Among millennials, primary care physicians saw a 5% increase. But a large pay gap exists between fields: Specialists under age 40 earned an average of $357,000 in 2023, compared with the average primary care clinician salary of $271,000.

“Procedures are reimbursed too high, while very little value is placed on primary care,” one survey respondent complained.

The type of practice plays a major part in compensation. Millennial doctors in office-based, single-specialty group practices earned an average of $358,000 per year, followed by those in office-based multispecialty group practices at 355,000 per year. Those in outpatient clinics earned $278,000 per year.

“I believe the practice situation is a huge portion of compensation,” said Tiffany Di Pietro, DO, a cardiologist and internal medicine physician in Fort Lauderdale, Florida. “Owning your own private practice is generally more lucrative (if you have good business sense), but it is also quite a bit more time-consuming, whereas employed physicians usually make less but have fewer concerns with staffing and overhead.”

Like in previous years, a gender pay gap equated to men outearning women. Female physicians under age 40 of any kind earned about $302,000 per year, 24% less than their male counterparts, on average.

Millennial doctors in the Midwest brought home the biggest earnings, with an average salary of $343,000 vs $332,000 on the West Coast.

Millennial physicians also reported higher levels of dissatisfaction. In the 2022 report, 46% said they were not paid fairly. That figure rose to 49%. Just 68% of millennial doctors would choose medicine again if they could do things over, down from 76% in the 2021 report.

“Doctors go through multiple years of school and then have to act like we are working at Dunkin’ Donuts — like we’re on an assembly line,” one survey respondent said. “We should not have to be paid per patient seen but valued for 8-9 years of training.”

Despite these complaints, close to 7 out of 10 millennial respondents said pay was not a major factor in what area of medicine they chose, with 29% saying it played no role at all in their decision.

Psychiatrists and anesthesiologists were the happiest with their earnings, with 61% of both specialties reporting that they felt fairly paid. They were followed by dermatologists and emergency medicine doctors, both of whom 60% reported fair earnings.

Many millennial doctors are finding ways to make money outside of their practice, with 18% securing other medical-related work, 15% doing medical moonlighting, and 5% taking on non–medical-related work.

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

Salaries for millennial physicians are slightly increasing, but clinicians still face pay disparities across location, practice type, and gender.

Medscape Medical News reviewed survey data from more than 1200 practicing doctors under age 40 across 29 specialties over a 4-month period starting in October 2023.

The average annual total compensation (including any bonuses) for young clinicians rose from $326,000 to $338,000, about 4%, between 2022 and 2023. Among millennials, primary care physicians saw a 5% increase. But a large pay gap exists between fields: Specialists under age 40 earned an average of $357,000 in 2023, compared with the average primary care clinician salary of $271,000.

“Procedures are reimbursed too high, while very little value is placed on primary care,” one survey respondent complained.

The type of practice plays a major part in compensation. Millennial doctors in office-based, single-specialty group practices earned an average of $358,000 per year, followed by those in office-based multispecialty group practices at 355,000 per year. Those in outpatient clinics earned $278,000 per year.

“I believe the practice situation is a huge portion of compensation,” said Tiffany Di Pietro, DO, a cardiologist and internal medicine physician in Fort Lauderdale, Florida. “Owning your own private practice is generally more lucrative (if you have good business sense), but it is also quite a bit more time-consuming, whereas employed physicians usually make less but have fewer concerns with staffing and overhead.”

Like in previous years, a gender pay gap equated to men outearning women. Female physicians under age 40 of any kind earned about $302,000 per year, 24% less than their male counterparts, on average.

Millennial doctors in the Midwest brought home the biggest earnings, with an average salary of $343,000 vs $332,000 on the West Coast.

Millennial physicians also reported higher levels of dissatisfaction. In the 2022 report, 46% said they were not paid fairly. That figure rose to 49%. Just 68% of millennial doctors would choose medicine again if they could do things over, down from 76% in the 2021 report.

“Doctors go through multiple years of school and then have to act like we are working at Dunkin’ Donuts — like we’re on an assembly line,” one survey respondent said. “We should not have to be paid per patient seen but valued for 8-9 years of training.”

Despite these complaints, close to 7 out of 10 millennial respondents said pay was not a major factor in what area of medicine they chose, with 29% saying it played no role at all in their decision.

Psychiatrists and anesthesiologists were the happiest with their earnings, with 61% of both specialties reporting that they felt fairly paid. They were followed by dermatologists and emergency medicine doctors, both of whom 60% reported fair earnings.

Many millennial doctors are finding ways to make money outside of their practice, with 18% securing other medical-related work, 15% doing medical moonlighting, and 5% taking on non–medical-related work.

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

Salaries for millennial physicians are slightly increasing, but clinicians still face pay disparities across location, practice type, and gender.

Medscape Medical News reviewed survey data from more than 1200 practicing doctors under age 40 across 29 specialties over a 4-month period starting in October 2023.

The average annual total compensation (including any bonuses) for young clinicians rose from $326,000 to $338,000, about 4%, between 2022 and 2023. Among millennials, primary care physicians saw a 5% increase. But a large pay gap exists between fields: Specialists under age 40 earned an average of $357,000 in 2023, compared with the average primary care clinician salary of $271,000.

“Procedures are reimbursed too high, while very little value is placed on primary care,” one survey respondent complained.

The type of practice plays a major part in compensation. Millennial doctors in office-based, single-specialty group practices earned an average of $358,000 per year, followed by those in office-based multispecialty group practices at 355,000 per year. Those in outpatient clinics earned $278,000 per year.

“I believe the practice situation is a huge portion of compensation,” said Tiffany Di Pietro, DO, a cardiologist and internal medicine physician in Fort Lauderdale, Florida. “Owning your own private practice is generally more lucrative (if you have good business sense), but it is also quite a bit more time-consuming, whereas employed physicians usually make less but have fewer concerns with staffing and overhead.”

Like in previous years, a gender pay gap equated to men outearning women. Female physicians under age 40 of any kind earned about $302,000 per year, 24% less than their male counterparts, on average.

Millennial doctors in the Midwest brought home the biggest earnings, with an average salary of $343,000 vs $332,000 on the West Coast.

Millennial physicians also reported higher levels of dissatisfaction. In the 2022 report, 46% said they were not paid fairly. That figure rose to 49%. Just 68% of millennial doctors would choose medicine again if they could do things over, down from 76% in the 2021 report.

“Doctors go through multiple years of school and then have to act like we are working at Dunkin’ Donuts — like we’re on an assembly line,” one survey respondent said. “We should not have to be paid per patient seen but valued for 8-9 years of training.”

Despite these complaints, close to 7 out of 10 millennial respondents said pay was not a major factor in what area of medicine they chose, with 29% saying it played no role at all in their decision.

Psychiatrists and anesthesiologists were the happiest with their earnings, with 61% of both specialties reporting that they felt fairly paid. They were followed by dermatologists and emergency medicine doctors, both of whom 60% reported fair earnings.

Many millennial doctors are finding ways to make money outside of their practice, with 18% securing other medical-related work, 15% doing medical moonlighting, and 5% taking on non–medical-related work.

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

Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

Residency programs across the country may have a few more slots for incoming residents due to a recent bump in Medicare funding.

Case in point: The University of Alabama at Birmingham (UAB). The state has one of the top stroke rates in the country, and yet UAB has the only hospital in the state training future doctors to help stroke patients recover. “Our hospital cares for Alabama’s sickest patients, many who need rehabilitation services,” said Craig Hoesley, MD, senior associate dean for medical education, who oversees graduate medical education (GME) or residency programs.

After decades of stagnant support, a recent bump in Medicare funding will allow UAB to add two more physical medicine and rehabilitation residents to the four residencies already receiving such funding.

Medicare also awarded UAB more funding last year to add an addiction medicine fellowship, one of two such training programs in the state for the specialty that helps treat patients fighting addiction.

UAB is among healthcare systems and hospitals nationwide benefiting from a recent hike in Medicare funding for residency programs after some 25 years at the same level of federal support. Medicare is the largest funder of training positions. Otherwise, hospitals finance training through means such as state support.

The latest round of funding, which went into effect in July, adds 200 positions to the doctor pipeline, creating more openings for residents seeking positions after medical school.

In the next few months, the Centers for Medicare & Medicaid Services (CMS) will notify teaching hospitals whether they’ll receive the next round of Medicare funding for more residency positions. At that time, CMS will have awarded nearly half of the 1200 residency training slots Congress approved in the past few years. In 2020 — for the first time since 1996 — Congress approved adding 1000 residency slots at teaching hospitals nationwide. CMS awards the money for 200 slots each year for 5 years.

More than half of the initial round of funding focused on training primary care specialists, with other slots designated for mental health specialists. Last year, Congress also approved a separate allocation of 200 more Medicare-funded residency positions, with at least half designated for psychiatry and related subspecialty residencies to help meet the growing need for more mental health specialists. On August 1, CMS announced it would distribute the funds next year, effective in 2026.

The additional Medicare funding attempts to address the shortage of healthcare providers and ensure future access to care, including in rural and underserved communities. The Association of American Medical Colleges (AAMC) estimates the nation will face a shortage of up to 86,000 physicians by 2036, including primary care doctors and specialists.

In addition, more than 100 million Americans, nearly a third of the nation, don’t have access to primary care due to the physician shortages in their communities, according to the National Association of Community Health Centers.

Major medical organizations, medical schools, and hospital groups have been pushing for years for increased Medicare funding to train new doctors to keep up with the demand for healthcare services and offset the physician shortage. As a cost-saving measure, Medicare set its cap in 1996 for how much it will reimburse each hospital offering GME training. However, according to the medical groups that continue to advocate to Congress for more funding, the funding hasn’t kept pace with the growing healthcare needs or rising medical school enrollment.
 

Adding Residency Spots

In April, Dr. Hoesley of UAB spoke at a Congressional briefing among health systems and hospitals that benefited from the additional funding. He told Congressional leaders how the increased number of GME positions affects UAB Medicine and its ability to care for rural areas.

“We have entire counties in Alabama that don’t have physicians. One way to address the physician shortage is to grow the GME programs. The funding we received will help us grow these programs and care for residents in our state.”

Still, the Medicare funding is only a drop in the bucket, Dr. Hoesley said. “We rely on Medicare funding alongside other funding partners to train residents and expand our care across the state.” He said many UAB residency programs are over their Medicare funding cap and would like to grow, but they can’t without more funding.

Mount Sinai Health System in New York City also will be able to expand its residency program after receiving Medicare support in the latest round of funding. The health system will use the federal funds to train an additional vascular surgeon. Mount Sinai currently receives CMS funding to train three residents in the specialty.

Over a 5-year program, that means CMS funding will help train 20 residents in the specialty that treats blood vessel blockages and diseases of the veins and arteries generally associated with aging.

“The funding is amazing,” said Peter L. Faries, MD, a surgery professor and system chief of vascular surgery at the Icahn School of Medicine at Mount Sinai, New York City, who directs the residency program.

“We don’t have the capacity to provide an individual training program without the funding. It’s not economically feasible.”

The need for more vascular surgeons increases as the population continues to age, he said. Mount Sinai treats patients throughout New York, including underserved areas in Harlem, the Bronx, Washington Heights, Brooklyn, and Queens. “These individuals might not receive an appropriate level of vascular care if we don’t have clinicians to treat them.”

Of the recent funding, Dr. Faries said it’s taken the residency program 15 years of advocacy to increase by two slots. “It’s a long process to get funding.” Vascular training programs can remain very selective with Medicare funding, typically receiving two applicants for every position,” said Dr. Faries.
 

Pushing for More Funds

Nearly 98,000 students enrolled in medical school this year, according to the National Resident Matching Program. A total of 44,853 applicants vied for the 38,494 first-year residency positions and 3009 second-year slots, leaving 3350 medical school graduates without a match.

“There are not enough spots to meet the growing demand,” said Jesse M. Ehrenfeld, MD, MPH, immediate past president of the American Medical Association. “Graduate medical education funding has not kept up.”

Despite the increase in medical school graduates over the past two decades, Medicare-supported training opportunities remained frozen at the 1996 level. A limited number of training positions meant residency programs couldn’t expand the physician pipeline to offset an aging workforce, contributing to the shortage. “The way to solve this is to expand GME,” Dr. Ehrenfeld said. “We continue to advocate to remove the cap.”

Dr. Ehrenfeld also told this news organization that he doesn’t mind that Congress recently designated GME funding to certain specialties, such as psychiatry, because he believes the need is great for residency spots across the board. “The good news is people recognize it’s challenging to get much through Congress.” He’s optimistic, though, about recent legislative efforts to increase funding.

AAMC, representing about a third of the nation’s 1100 teaching hospitals and health systems, feels the same. Congress “acknowledges and continues to recognize that the shortage is not getting better, and one way to address it is to increase Medicare-supported GME positions,” said Leonard Marquez, senior director of government relations and legislative advocacy.

Still, he said that the Medicare funding bump is only making a small dent in the need. AAMC estimates the average cost to train residents is $23 billion annually, and Medicare only funds 20% of that, or $5 billion. “Our members are at the point where they say: We already can’t add new training positions,” Mr. Marquez said. He added that without increasing residency slots, patient care will suffer. “We have to do anything possible we can to increase access to care.”

Mr. Marquez also believes Medicare funding should increase residency positions across the specialty spectrum, not just for psychiatry and primary care. He said that the targeted funding may prevent some teaching hospitals from applying for residency positions if they need other types of specialists based on their community’s needs.

Among the current proposals before Congress, the Resident Physician Shortage Reduction Act of 2023 would add 14,000 Medicare-supported residency slots over 7 years. Mr. Marquez said it may be more realistic to expect fewer new slots. A decision on potential legislation is expected at the end of the year. He said that if the medical groups aren’t pleased with the decision, they’ll advocate again in 2025.
 

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

Nasal Staphylococcus aureus (SA) carriage is associated with SA surgical site and bloodstream infections following a surgical procedure, according to findings from a new prospective, multicenter clinical study published in the August issue of Open Forum Infectious Diseases.

“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.

The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.

There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.

Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).

A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.

The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.

However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.

He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”

The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.

The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.

She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.

Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.

The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.

Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.

Nasal Staphylococcus aureus (SA) carriage is associated with SA surgical site and bloodstream infections following a surgical procedure, according to findings from a new prospective, multicenter clinical study published in the August issue of Open Forum Infectious Diseases.

“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.

The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.

There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.

Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).

A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.

The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.

However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.

He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”

The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.

The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.

She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.

Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.

The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.

Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.

Nasal Staphylococcus aureus (SA) carriage is associated with SA surgical site and bloodstream infections following a surgical procedure, according to findings from a new prospective, multicenter clinical study published in the August issue of Open Forum Infectious Diseases.

“This was a pan-European study with many hospitals, many different clinical settings, and as far as I’m aware, it hasn’t been done before. [The new study] covers a lot of European countries and a lot of surgical specialties,” said lead author Jan Kluytmans, MD. The study also captures the current state of preventive strategies in surgery, such as changes in air flow, dress, and skin preparation, he added.

The study included 5004 patients from 33 hospitals in ten European countries, of whom 67.3% were found to be SA carriers. The median age was 65 years, and 49.8% of patients were male. Open cardiac, and knee and hip prosthesis surgeries made up the largest fraction, but there were 12 types of surgery included in the study.

There were 100 SA surgical site or blood infections. The researchers found an association between surgical site or blood infection and SA carriage at any site (adjusted hazard ratio [aHR], 4.6; 95% CI, 2.1-10.0) and nasal SA carriage (aHR, 4.2; 95% CI, 2.0-8.6). Extranasal SA carriage was not associated with an increased infection risk.

Each 1-unit increase in nasal bacteria was associated with an increase in infection risk (aHR, 1.23; 95% CI, 1.05-1.43).

A strength of the study is that it is the largest prospective study yet conducted on SA carriage in surgical patients, but the researchers were unable to do a subgroup of methicillin-resistant SA (MRSA) due to small numbers of infections.

The study confirms the value of the decolonization strategy, which the World Health Organization has endorsed with the highest level of scientific evidence that is available in preventive strategies in surgery. WHO strongly recommends decolonization for cardiothoracic and orthopedic surgery using intranasal applications of mupirocin 2% ointment with or without a combination of chlorhexidine gluconate body wash. It has a conditional recommendation for a similar procedure before other types of surgery.

However, “It is not widely practiced, and although that was not a surprise to me, I think it’s really disappointing to see that proven effective strategies are not being practiced,” said Dr. Kluytmans, professor of medical microbiology at University Medical Center Utrecht, Utrecht University, the Netherlands. “If I would come into surgery being a carrier, and not be decolonized, I would really be quite angry because it puts you at risk, which is preventable. I think that’s something we owe to our patients,” he said.

He said that some may have concerns about the potential for decolonization to contribute to antibiotic resistance, but the short-term prophylaxis — typically a few days — should not foster resistance, according to Dr. Kluytmans. “If you use it short term, just before surgery, it has been shown in many studies that resistance isn’t a big problem and it can be monitored.”

The link specifically to SA nasal carriage is a mystery, according to Dr. Kluytmans. “It puzzles me still how it gets from the nares to the wound during surgery. So that’s my million-dollar question that I would like to resolve. We would like to study it, but we haven’t quite a bright idea how to do that,” he said.

The results are compelling, according to Heather Evans, MD, who was asked for comment. “On the face of it, this looks like a no-brainer. We should be decolonizing all patients that go to the operating room, and it’s not a terribly unpleasant thing for a patient to undergo to have decolonization done. Particularly for patients who are at higher risk for having a severe complication, like someone that has an operation that’s involving an implant, for example, I think it really makes a lot of sense to do this low-cost intervention for those patients,” said Dr. Evans, professor of medicine at The Medical University of South Carolina as well as the president of the Surgical Infection Society.

She noted that many facilities test for methicillin-resistant SA, but usual not SA more broadly. “This is a very interesting and compelling study that makes us rethink that, and maybe it isn’t even worth testing to see if you have staph aureus, maybe we should just be putting Betadine in everyone’s nostrils when they come to the operating room. It just seems like it would be a pretty low-cost intervention and something that could potentially have a big impact,” said Dr. Evans.

Although she was impressed by the study, Dr. Evans noted that the researchers tested for carriage at sites unrelated to the surgical site. “It really made me wonder if it would have added even more credibility to the study if there had been a sample taken after surgical prep was done to demonstrate that there is actually no staph aureus present on the skin at the time that the wound was made,” she said.

The question ties into the recent “Trojan horse” hypothesis, which suggests that endemic carriage of bacteria is responsible for most surgical site infections, rather than the long-held belief that operating room contamination is to blame. “That would sort of fly with this study, that the patient is walking around with Staph aureus and not necessarily on their skin or at their surgical site, but it’s endemic in their body,” said Dr. Evans.

Dr. Kluytmans and Dr. Evans have no relevant financial disclosures.

The turf war between two types of anesthesia providers is escalating: The American Society of Anesthesiologists (ASA) has filed a trademark complaint against the recently renamed American Association of Nurse Anesthesiology (AANA), alleging its use of the word “anesthesiology” is “deceptively misdescriptive.”

At issue: Who can be called an anesthesiologist?

In its complaint, filed in June 2024 with the US Trademark Trial and Appeal Board, the 54,000-member physician society seeks to deny the nurse group the registration of its trademark. If ASA wins, it could sue AANA in federal court.

AANA denied the physicians’ allegations in its recent response to the complaint.

The dispute between the two associations comes at a time when physicians are facing challenges from providers such as nurse practitioners and physician assistants who seek new titles and more autonomy in medical decision-making.
 

A Controversial Name Change

In 2021, the 61,000-member AANA changed its name from the American Association of Nurse Anesthetists, saying the change “clarifies” the role of its members.

The ASA declared it was “gravely concerned” by the name change, which “confuses patients and creates discord in the care setting, ultimately risking patient safety.

“ ’Anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from nonphysicians, including nurse anesthetists,” the physicians’ group said in a news release.

Chicago Intellectual Property Attorney Laura M. Schaefer, who represents AANA, told this news organization that certified registered nurse anesthetists (CRNAs) — “also known as nurse anesthesiologists or nurse anesthetists — have a 150-year track record of administering safe, effective anesthesia to patients in need of care. Not only are CRNAs highly trained and capable, they also use the exact same techniques to provide anesthesia as other anesthesiology professionals.”

Ms. Schaefer declined to comment further, and ASA declined to comment at all, citing pending litigation.

The scope of practice of nurse anesthetists has long been disputed. In mid-September, California health officials clarified what nurse anesthetists can do on the job after complaints about lack of oversight, The Modesto Bee reported.

According to nursing education site NurseJournal.org, CRNAs and anesthesiologists “perform many of the same duties,” although CRNAs are in more demand. Also, the site says some states require CRNAs to be supervised by anesthesiologists.

“It is possible that scope of practice debates are increasing in prominence due to the increase in demand for healthcare services, coupled with workforce shortages in certain areas,” Alice Chen, PhD, MBA, vice dean for research at the USC Sol Price School of Public Policy in Los Angeles, told this news organization. “For example, during COVID, the federal government temporarily expanded scope of practice to help address healthcare needs.”

She added her group’s research has shown that despite the large stakes perceived by both sides of the debate, changes in practice behavior were actually quite small in states that allowed CRNAs to practice without supervision.

“In fact, we found only modest reduction in anesthesiologist billing for supervision, and we did not find an increase in the supply of anesthesia care,” she noted.

Trademark law specialists told this news organization that they couldn’t predict which way the board will rule. However, they noted potential weaknesses of the ASA’s case.

Rebecca Tushnet, JD, a professor at Harvard Law School, Cambridge, Massachusetts, explained that a trademark “can’t misrepresent those goods or services in a way that deceives consumers.” However, if insurers, doctors, and hospitals are considered the “consumers” — and not patients — “then confusion is probably less likely because they will have relevant expertise to distinguish among groups.”

Christine Farley, JD, LLM, JSD, professor at American University Washington College of Law, said attacking the AANA’s trademark as deceptive may be one of the ASA’s strongest arguments. The suggestion, she said, is that “nurse anesthesiologist” is an oxymoron, like “jumbo shrimp.”

On the other hand, she said it’s not clear that people will miss the word “nurse” in AANA’s name and say, “ ’Well, obviously these people are doctors.’ So that that’s an uphill battle.”

What happens now? The Trademark Trial and Appeal Board will decide whether AANA’s trademark application should be granted or denied, said Kayla Jimenez, JD, a San Diego trademark attorney and adjunct law professor at the University of San Diego. The entire process can take 2-3 years, she said.

The board “cannot award attorneys’ fees or force a party to stop using a trademark,” she said. “You would have to go file a lawsuit in federal court if that is your endgame.” Also, she said, the board’s ultimate decision can be appealed in federal court.

Eric Goldman, JD, MBA, associate dean for research and professor at Santa Clara University School of Law, Santa Clara, California, doesn’t expect the trademark case will spell the end of this dispute.

“ASA is signaling that it will challenge AANA’s use of the term in multiple battlegrounds,” he said. “I see this as a move by ASA to contest AANA in every potentially relevant venue, even if neither side can score a knockout blow in the Trademark Trial and Appeal Board.”

Dr. Chen, Ms. Farley, Ms. Jimenez, and Mr. Goldman had no disclosures. 
 

A version of this article appeared on Medscape.com.

The turf war between two types of anesthesia providers is escalating: The American Society of Anesthesiologists (ASA) has filed a trademark complaint against the recently renamed American Association of Nurse Anesthesiology (AANA), alleging its use of the word “anesthesiology” is “deceptively misdescriptive.”

At issue: Who can be called an anesthesiologist?

In its complaint, filed in June 2024 with the US Trademark Trial and Appeal Board, the 54,000-member physician society seeks to deny the nurse group the registration of its trademark. If ASA wins, it could sue AANA in federal court.

AANA denied the physicians’ allegations in its recent response to the complaint.

The dispute between the two associations comes at a time when physicians are facing challenges from providers such as nurse practitioners and physician assistants who seek new titles and more autonomy in medical decision-making.
 

A Controversial Name Change

In 2021, the 61,000-member AANA changed its name from the American Association of Nurse Anesthetists, saying the change “clarifies” the role of its members.

The ASA declared it was “gravely concerned” by the name change, which “confuses patients and creates discord in the care setting, ultimately risking patient safety.

“ ’Anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from nonphysicians, including nurse anesthetists,” the physicians’ group said in a news release.

Chicago Intellectual Property Attorney Laura M. Schaefer, who represents AANA, told this news organization that certified registered nurse anesthetists (CRNAs) — “also known as nurse anesthesiologists or nurse anesthetists — have a 150-year track record of administering safe, effective anesthesia to patients in need of care. Not only are CRNAs highly trained and capable, they also use the exact same techniques to provide anesthesia as other anesthesiology professionals.”

Ms. Schaefer declined to comment further, and ASA declined to comment at all, citing pending litigation.

The scope of practice of nurse anesthetists has long been disputed. In mid-September, California health officials clarified what nurse anesthetists can do on the job after complaints about lack of oversight, The Modesto Bee reported.

According to nursing education site NurseJournal.org, CRNAs and anesthesiologists “perform many of the same duties,” although CRNAs are in more demand. Also, the site says some states require CRNAs to be supervised by anesthesiologists.

“It is possible that scope of practice debates are increasing in prominence due to the increase in demand for healthcare services, coupled with workforce shortages in certain areas,” Alice Chen, PhD, MBA, vice dean for research at the USC Sol Price School of Public Policy in Los Angeles, told this news organization. “For example, during COVID, the federal government temporarily expanded scope of practice to help address healthcare needs.”

She added her group’s research has shown that despite the large stakes perceived by both sides of the debate, changes in practice behavior were actually quite small in states that allowed CRNAs to practice without supervision.

“In fact, we found only modest reduction in anesthesiologist billing for supervision, and we did not find an increase in the supply of anesthesia care,” she noted.

Trademark law specialists told this news organization that they couldn’t predict which way the board will rule. However, they noted potential weaknesses of the ASA’s case.

Rebecca Tushnet, JD, a professor at Harvard Law School, Cambridge, Massachusetts, explained that a trademark “can’t misrepresent those goods or services in a way that deceives consumers.” However, if insurers, doctors, and hospitals are considered the “consumers” — and not patients — “then confusion is probably less likely because they will have relevant expertise to distinguish among groups.”

Christine Farley, JD, LLM, JSD, professor at American University Washington College of Law, said attacking the AANA’s trademark as deceptive may be one of the ASA’s strongest arguments. The suggestion, she said, is that “nurse anesthesiologist” is an oxymoron, like “jumbo shrimp.”

On the other hand, she said it’s not clear that people will miss the word “nurse” in AANA’s name and say, “ ’Well, obviously these people are doctors.’ So that that’s an uphill battle.”

What happens now? The Trademark Trial and Appeal Board will decide whether AANA’s trademark application should be granted or denied, said Kayla Jimenez, JD, a San Diego trademark attorney and adjunct law professor at the University of San Diego. The entire process can take 2-3 years, she said.

The board “cannot award attorneys’ fees or force a party to stop using a trademark,” she said. “You would have to go file a lawsuit in federal court if that is your endgame.” Also, she said, the board’s ultimate decision can be appealed in federal court.

Eric Goldman, JD, MBA, associate dean for research and professor at Santa Clara University School of Law, Santa Clara, California, doesn’t expect the trademark case will spell the end of this dispute.

“ASA is signaling that it will challenge AANA’s use of the term in multiple battlegrounds,” he said. “I see this as a move by ASA to contest AANA in every potentially relevant venue, even if neither side can score a knockout blow in the Trademark Trial and Appeal Board.”

Dr. Chen, Ms. Farley, Ms. Jimenez, and Mr. Goldman had no disclosures. 
 

A version of this article appeared on Medscape.com.

The turf war between two types of anesthesia providers is escalating: The American Society of Anesthesiologists (ASA) has filed a trademark complaint against the recently renamed American Association of Nurse Anesthesiology (AANA), alleging its use of the word “anesthesiology” is “deceptively misdescriptive.”

At issue: Who can be called an anesthesiologist?

In its complaint, filed in June 2024 with the US Trademark Trial and Appeal Board, the 54,000-member physician society seeks to deny the nurse group the registration of its trademark. If ASA wins, it could sue AANA in federal court.

AANA denied the physicians’ allegations in its recent response to the complaint.

The dispute between the two associations comes at a time when physicians are facing challenges from providers such as nurse practitioners and physician assistants who seek new titles and more autonomy in medical decision-making.
 

A Controversial Name Change

In 2021, the 61,000-member AANA changed its name from the American Association of Nurse Anesthetists, saying the change “clarifies” the role of its members.

The ASA declared it was “gravely concerned” by the name change, which “confuses patients and creates discord in the care setting, ultimately risking patient safety.

“ ’Anesthesiologist’ has always been used to differentiate physicians trained in the science and study of anesthesiology from nonphysicians, including nurse anesthetists,” the physicians’ group said in a news release.

Chicago Intellectual Property Attorney Laura M. Schaefer, who represents AANA, told this news organization that certified registered nurse anesthetists (CRNAs) — “also known as nurse anesthesiologists or nurse anesthetists — have a 150-year track record of administering safe, effective anesthesia to patients in need of care. Not only are CRNAs highly trained and capable, they also use the exact same techniques to provide anesthesia as other anesthesiology professionals.”

Ms. Schaefer declined to comment further, and ASA declined to comment at all, citing pending litigation.

The scope of practice of nurse anesthetists has long been disputed. In mid-September, California health officials clarified what nurse anesthetists can do on the job after complaints about lack of oversight, The Modesto Bee reported.

According to nursing education site NurseJournal.org, CRNAs and anesthesiologists “perform many of the same duties,” although CRNAs are in more demand. Also, the site says some states require CRNAs to be supervised by anesthesiologists.

“It is possible that scope of practice debates are increasing in prominence due to the increase in demand for healthcare services, coupled with workforce shortages in certain areas,” Alice Chen, PhD, MBA, vice dean for research at the USC Sol Price School of Public Policy in Los Angeles, told this news organization. “For example, during COVID, the federal government temporarily expanded scope of practice to help address healthcare needs.”

She added her group’s research has shown that despite the large stakes perceived by both sides of the debate, changes in practice behavior were actually quite small in states that allowed CRNAs to practice without supervision.

“In fact, we found only modest reduction in anesthesiologist billing for supervision, and we did not find an increase in the supply of anesthesia care,” she noted.

Trademark law specialists told this news organization that they couldn’t predict which way the board will rule. However, they noted potential weaknesses of the ASA’s case.

Rebecca Tushnet, JD, a professor at Harvard Law School, Cambridge, Massachusetts, explained that a trademark “can’t misrepresent those goods or services in a way that deceives consumers.” However, if insurers, doctors, and hospitals are considered the “consumers” — and not patients — “then confusion is probably less likely because they will have relevant expertise to distinguish among groups.”

Christine Farley, JD, LLM, JSD, professor at American University Washington College of Law, said attacking the AANA’s trademark as deceptive may be one of the ASA’s strongest arguments. The suggestion, she said, is that “nurse anesthesiologist” is an oxymoron, like “jumbo shrimp.”

On the other hand, she said it’s not clear that people will miss the word “nurse” in AANA’s name and say, “ ’Well, obviously these people are doctors.’ So that that’s an uphill battle.”

What happens now? The Trademark Trial and Appeal Board will decide whether AANA’s trademark application should be granted or denied, said Kayla Jimenez, JD, a San Diego trademark attorney and adjunct law professor at the University of San Diego. The entire process can take 2-3 years, she said.

The board “cannot award attorneys’ fees or force a party to stop using a trademark,” she said. “You would have to go file a lawsuit in federal court if that is your endgame.” Also, she said, the board’s ultimate decision can be appealed in federal court.

Eric Goldman, JD, MBA, associate dean for research and professor at Santa Clara University School of Law, Santa Clara, California, doesn’t expect the trademark case will spell the end of this dispute.

“ASA is signaling that it will challenge AANA’s use of the term in multiple battlegrounds,” he said. “I see this as a move by ASA to contest AANA in every potentially relevant venue, even if neither side can score a knockout blow in the Trademark Trial and Appeal Board.”

Dr. Chen, Ms. Farley, Ms. Jimenez, and Mr. Goldman had no disclosures. 
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) plans to scrutinize the safety and efficacy of lab-developed tests — those designed, manufactured, and used in a single laboratory — far more thoroughly in the future.

Under a rule finalized in April, the FDA will treat facilities that develop and use lab tests as manufacturers and regulate tests as medical devices. That means that most lab tests will need an FDA review before going on sale.

The FDA will also impose new quality standards, requiring test manufacturers to report adverse events and create a registry of lab tests under the new rule, which will be phased in over 4 years.

FDA officials have been concerned for years about the reliability of commercial lab tests, which have ballooned into a multibillion-dollar industry.

Consumer groups have long urged the FDA to regulate lab tests more strictly, arguing that the lack of scrutiny allows doctors and patients to be exploited by bad actors such as Theranos, which falsely claimed that its tests could diagnose multiple diseases with a single drop of blood.

“When it comes to some of these tests that doctors are recommending for patients, many doctors are just crossing their fingers and relying on the representation of the company because nobody is checking” to verify a manufacturer’s claims, said Joshua Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
 

Nearly 12,000 Labs Making Medical Tests

Although the FDA estimates there are nearly 12,000 labs manufacturing medical tests, agency officials said they don’t know how many tests are being marketed. The FDA already requires that home test kits marketed directly to consumers, such as those used to detect COVID-19, get clearance from the agency before being sold.

“There’s plenty of time for industry to get its act together to develop the data that it might need to make a premarket application,” said Peter Lurie, MD, PhD, a former associate commissioner at the FDA. In 2015, Dr. Lurie led a report outlining some of the dangers of unregulated lab tests.

For the average physician who orders lab tests, nothing is going to immediately change because of the final rule, said Dr. Lurie, now president of the Center for Science in the Public Interest, a nonprofit consumer watchdog.

“Tomorrow, this will look just the same as it does today,” Dr. Lurie said. “For the next 3 years, the companies will be scurrying behind the scenes to comply with the early stages of implementation. But most of that will be invisible to the average practitioner.”

Dr. Lurie predicted the FDA will focus its scrutiny on tests that pose the greatest potential risk to patients, such as ones used to diagnose serious diseases or guide treatment for life-threatening conditions. “The least significant tests will likely get very limited, if any, scrutiny,” said Dr. Lurie, adding that the FDA will likely issue guidance about how it plans to define low- and high-risk tests. “My suspicion is that it will be probably a small minority of products that are subject to full premarket approval.”
 

Lab Industry Groups Push Back

But imposing new rules with the potential to affect an industry’s bottom line is no easy task.

The American Clinical Laboratory Association, which represents the lab industry, said in a statement that the FDA rule will “limit access to scores of critical tests, increase healthcare costs, and undermine innovation in new diagnostics.” Another industry group, the Association for Molecular Pathology, has warned of “significant and harmful disruption to laboratory medicine.”

The two associations have filed separate lawsuits, charging that the FDA overstepped the authority granted by Congress. In their lawsuits, groups claim that lab tests are professional services, not manufactured products. The groups noted that the Centers for Medicare & Medicaid Services (CMS) already inspects lab facilities. CMS does not assess the tests’ quality or reliability.

A recent Supreme Court decision could make those lawsuits more likely to succeed, said David Simon, JD, LLM, PhD, an assistant professor of law at the Northeastern University School of Law, Boston, Massachusetts.

In the case of Loper Bright Enterprises v. Raimondo, decided in June, justices overturned a long-standing precedent known as Chevron deference, which required courts to defer to federal agencies when interpreting ambiguous laws. That means that courts no longer have to accept the FDA’s definition of a device, Dr. Simon said.

“Because judges may have more active roles in defining agency authority, federal agencies may have correspondingly less robust roles in policymaking,” Dr. Simon wrote in an editorial coauthored with Michael J. Young, MD, MPhil, of Harvard Medical School, Boston.

The Supreme Court ruling could pressure Congress to more clearly define FDA’s ruling in regulating lab tests, Dr. Simon and Dr. Young wrote.

Members of Congress first introduced a bill to clarify the FDA’s role in regulating lab tests, called the VALID Act, in 2020. The bill stalled and, despite efforts to revive it, still hasn’t passed.

FDA officials have said they remain “open to working with Congress,” noting that any future legislation about lab-developed tests would supersede their current policy.

In an interview, Dr. Simon noted the FDA significantly narrowed the scope of the final rule in response to comments from critics who objected to an earlier version of the policy proposed in 2023. The final rule carves out several categories of tests that won’t need to apply for “premarket review.”

Notably, a “grandfather clause” will allow some lab tests already on the market to continue being sold without undergoing FDA’s premarket review process. In explaining the exemption, FDA officials said they did not want doctors and patients to lose access to tests on which they rely. But Dr. Lurie noted that because the FDA views all these tests as under its jurisdiction, the agency could opt to take a closer look “at a very old device that is causing a problem today.”

The FDA also will exempt tests approved by New York State’s Clinical Laboratory Evaluation Program, which conducts its own stringent reviews. And the FDA will continue to allow hospitals to develop tests for patients within their healthcare system without going through the FDA approval process, if no FDA-approved tests are available.

Hospital-based tests play a critical role in treating infectious diseases, said Amesh Adalja, MD, an infectious diseases specialist and senior scholar at the Johns Hopkins Center for Health Security. For example, a large research hospital treating a patient with cytomegalovirus may need to develop its own test to determine whether the infection is resistant to antiviral drugs, Dr. Adalja said.

“With novel infectious disease outbreaks, researchers are able to move quickly to make diagnostic tests months and months before commercial laboratories are able to get through regulatory processes,” Dr. Adalja said.

To help scientists respond quickly to emergencies, the FDA published special guidance for labs that develop unauthorized lab tests for disease outbreaks.

Medical groups such as the American Hospital Association and Infectious Diseases Society of America remain concerned about the burden of complying with new regulations.

“Many vital tests developed in hospitals and health systems may be subjected to unnecessary and costly paperwork,” said Stacey Hughes, executive vice president of the American Hospital Association, in a statement.

Other groups, such as the American Society of Clinical Oncology, praised the new FDA policy. In comments submitted to the FDA in 2023, the cancer group said it “emphatically supports” requiring lab tests to undergo FDA review.

“We appreciate FDA action to modernize oversight of these tests and are hopeful this rule will increase focus on the need to balance rapid diagnostic innovation with patient safety and access” Everett Vokes, MD, the group’s board chair, said in a statement released after the FDA’s final rule was published.

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

The Food and Drug Administration (FDA) plans to scrutinize the safety and efficacy of lab-developed tests — those designed, manufactured, and used in a single laboratory — far more thoroughly in the future.

Under a rule finalized in April, the FDA will treat facilities that develop and use lab tests as manufacturers and regulate tests as medical devices. That means that most lab tests will need an FDA review before going on sale.

The FDA will also impose new quality standards, requiring test manufacturers to report adverse events and create a registry of lab tests under the new rule, which will be phased in over 4 years.

FDA officials have been concerned for years about the reliability of commercial lab tests, which have ballooned into a multibillion-dollar industry.

Consumer groups have long urged the FDA to regulate lab tests more strictly, arguing that the lack of scrutiny allows doctors and patients to be exploited by bad actors such as Theranos, which falsely claimed that its tests could diagnose multiple diseases with a single drop of blood.

“When it comes to some of these tests that doctors are recommending for patients, many doctors are just crossing their fingers and relying on the representation of the company because nobody is checking” to verify a manufacturer’s claims, said Joshua Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
 

Nearly 12,000 Labs Making Medical Tests

Although the FDA estimates there are nearly 12,000 labs manufacturing medical tests, agency officials said they don’t know how many tests are being marketed. The FDA already requires that home test kits marketed directly to consumers, such as those used to detect COVID-19, get clearance from the agency before being sold.

“There’s plenty of time for industry to get its act together to develop the data that it might need to make a premarket application,” said Peter Lurie, MD, PhD, a former associate commissioner at the FDA. In 2015, Dr. Lurie led a report outlining some of the dangers of unregulated lab tests.

For the average physician who orders lab tests, nothing is going to immediately change because of the final rule, said Dr. Lurie, now president of the Center for Science in the Public Interest, a nonprofit consumer watchdog.

“Tomorrow, this will look just the same as it does today,” Dr. Lurie said. “For the next 3 years, the companies will be scurrying behind the scenes to comply with the early stages of implementation. But most of that will be invisible to the average practitioner.”

Dr. Lurie predicted the FDA will focus its scrutiny on tests that pose the greatest potential risk to patients, such as ones used to diagnose serious diseases or guide treatment for life-threatening conditions. “The least significant tests will likely get very limited, if any, scrutiny,” said Dr. Lurie, adding that the FDA will likely issue guidance about how it plans to define low- and high-risk tests. “My suspicion is that it will be probably a small minority of products that are subject to full premarket approval.”
 

Lab Industry Groups Push Back

But imposing new rules with the potential to affect an industry’s bottom line is no easy task.

The American Clinical Laboratory Association, which represents the lab industry, said in a statement that the FDA rule will “limit access to scores of critical tests, increase healthcare costs, and undermine innovation in new diagnostics.” Another industry group, the Association for Molecular Pathology, has warned of “significant and harmful disruption to laboratory medicine.”

The two associations have filed separate lawsuits, charging that the FDA overstepped the authority granted by Congress. In their lawsuits, groups claim that lab tests are professional services, not manufactured products. The groups noted that the Centers for Medicare & Medicaid Services (CMS) already inspects lab facilities. CMS does not assess the tests’ quality or reliability.

A recent Supreme Court decision could make those lawsuits more likely to succeed, said David Simon, JD, LLM, PhD, an assistant professor of law at the Northeastern University School of Law, Boston, Massachusetts.

In the case of Loper Bright Enterprises v. Raimondo, decided in June, justices overturned a long-standing precedent known as Chevron deference, which required courts to defer to federal agencies when interpreting ambiguous laws. That means that courts no longer have to accept the FDA’s definition of a device, Dr. Simon said.

“Because judges may have more active roles in defining agency authority, federal agencies may have correspondingly less robust roles in policymaking,” Dr. Simon wrote in an editorial coauthored with Michael J. Young, MD, MPhil, of Harvard Medical School, Boston.

The Supreme Court ruling could pressure Congress to more clearly define FDA’s ruling in regulating lab tests, Dr. Simon and Dr. Young wrote.

Members of Congress first introduced a bill to clarify the FDA’s role in regulating lab tests, called the VALID Act, in 2020. The bill stalled and, despite efforts to revive it, still hasn’t passed.

FDA officials have said they remain “open to working with Congress,” noting that any future legislation about lab-developed tests would supersede their current policy.

In an interview, Dr. Simon noted the FDA significantly narrowed the scope of the final rule in response to comments from critics who objected to an earlier version of the policy proposed in 2023. The final rule carves out several categories of tests that won’t need to apply for “premarket review.”

Notably, a “grandfather clause” will allow some lab tests already on the market to continue being sold without undergoing FDA’s premarket review process. In explaining the exemption, FDA officials said they did not want doctors and patients to lose access to tests on which they rely. But Dr. Lurie noted that because the FDA views all these tests as under its jurisdiction, the agency could opt to take a closer look “at a very old device that is causing a problem today.”

The FDA also will exempt tests approved by New York State’s Clinical Laboratory Evaluation Program, which conducts its own stringent reviews. And the FDA will continue to allow hospitals to develop tests for patients within their healthcare system without going through the FDA approval process, if no FDA-approved tests are available.

Hospital-based tests play a critical role in treating infectious diseases, said Amesh Adalja, MD, an infectious diseases specialist and senior scholar at the Johns Hopkins Center for Health Security. For example, a large research hospital treating a patient with cytomegalovirus may need to develop its own test to determine whether the infection is resistant to antiviral drugs, Dr. Adalja said.

“With novel infectious disease outbreaks, researchers are able to move quickly to make diagnostic tests months and months before commercial laboratories are able to get through regulatory processes,” Dr. Adalja said.

To help scientists respond quickly to emergencies, the FDA published special guidance for labs that develop unauthorized lab tests for disease outbreaks.

Medical groups such as the American Hospital Association and Infectious Diseases Society of America remain concerned about the burden of complying with new regulations.

“Many vital tests developed in hospitals and health systems may be subjected to unnecessary and costly paperwork,” said Stacey Hughes, executive vice president of the American Hospital Association, in a statement.

Other groups, such as the American Society of Clinical Oncology, praised the new FDA policy. In comments submitted to the FDA in 2023, the cancer group said it “emphatically supports” requiring lab tests to undergo FDA review.

“We appreciate FDA action to modernize oversight of these tests and are hopeful this rule will increase focus on the need to balance rapid diagnostic innovation with patient safety and access” Everett Vokes, MD, the group’s board chair, said in a statement released after the FDA’s final rule was published.

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

The Food and Drug Administration (FDA) plans to scrutinize the safety and efficacy of lab-developed tests — those designed, manufactured, and used in a single laboratory — far more thoroughly in the future.

Under a rule finalized in April, the FDA will treat facilities that develop and use lab tests as manufacturers and regulate tests as medical devices. That means that most lab tests will need an FDA review before going on sale.

The FDA will also impose new quality standards, requiring test manufacturers to report adverse events and create a registry of lab tests under the new rule, which will be phased in over 4 years.

FDA officials have been concerned for years about the reliability of commercial lab tests, which have ballooned into a multibillion-dollar industry.

Consumer groups have long urged the FDA to regulate lab tests more strictly, arguing that the lack of scrutiny allows doctors and patients to be exploited by bad actors such as Theranos, which falsely claimed that its tests could diagnose multiple diseases with a single drop of blood.

“When it comes to some of these tests that doctors are recommending for patients, many doctors are just crossing their fingers and relying on the representation of the company because nobody is checking” to verify a manufacturer’s claims, said Joshua Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
 

Nearly 12,000 Labs Making Medical Tests

Although the FDA estimates there are nearly 12,000 labs manufacturing medical tests, agency officials said they don’t know how many tests are being marketed. The FDA already requires that home test kits marketed directly to consumers, such as those used to detect COVID-19, get clearance from the agency before being sold.

“There’s plenty of time for industry to get its act together to develop the data that it might need to make a premarket application,” said Peter Lurie, MD, PhD, a former associate commissioner at the FDA. In 2015, Dr. Lurie led a report outlining some of the dangers of unregulated lab tests.

For the average physician who orders lab tests, nothing is going to immediately change because of the final rule, said Dr. Lurie, now president of the Center for Science in the Public Interest, a nonprofit consumer watchdog.

“Tomorrow, this will look just the same as it does today,” Dr. Lurie said. “For the next 3 years, the companies will be scurrying behind the scenes to comply with the early stages of implementation. But most of that will be invisible to the average practitioner.”

Dr. Lurie predicted the FDA will focus its scrutiny on tests that pose the greatest potential risk to patients, such as ones used to diagnose serious diseases or guide treatment for life-threatening conditions. “The least significant tests will likely get very limited, if any, scrutiny,” said Dr. Lurie, adding that the FDA will likely issue guidance about how it plans to define low- and high-risk tests. “My suspicion is that it will be probably a small minority of products that are subject to full premarket approval.”
 

Lab Industry Groups Push Back

But imposing new rules with the potential to affect an industry’s bottom line is no easy task.

The American Clinical Laboratory Association, which represents the lab industry, said in a statement that the FDA rule will “limit access to scores of critical tests, increase healthcare costs, and undermine innovation in new diagnostics.” Another industry group, the Association for Molecular Pathology, has warned of “significant and harmful disruption to laboratory medicine.”

The two associations have filed separate lawsuits, charging that the FDA overstepped the authority granted by Congress. In their lawsuits, groups claim that lab tests are professional services, not manufactured products. The groups noted that the Centers for Medicare & Medicaid Services (CMS) already inspects lab facilities. CMS does not assess the tests’ quality or reliability.

A recent Supreme Court decision could make those lawsuits more likely to succeed, said David Simon, JD, LLM, PhD, an assistant professor of law at the Northeastern University School of Law, Boston, Massachusetts.

In the case of Loper Bright Enterprises v. Raimondo, decided in June, justices overturned a long-standing precedent known as Chevron deference, which required courts to defer to federal agencies when interpreting ambiguous laws. That means that courts no longer have to accept the FDA’s definition of a device, Dr. Simon said.

“Because judges may have more active roles in defining agency authority, federal agencies may have correspondingly less robust roles in policymaking,” Dr. Simon wrote in an editorial coauthored with Michael J. Young, MD, MPhil, of Harvard Medical School, Boston.

The Supreme Court ruling could pressure Congress to more clearly define FDA’s ruling in regulating lab tests, Dr. Simon and Dr. Young wrote.

Members of Congress first introduced a bill to clarify the FDA’s role in regulating lab tests, called the VALID Act, in 2020. The bill stalled and, despite efforts to revive it, still hasn’t passed.

FDA officials have said they remain “open to working with Congress,” noting that any future legislation about lab-developed tests would supersede their current policy.

In an interview, Dr. Simon noted the FDA significantly narrowed the scope of the final rule in response to comments from critics who objected to an earlier version of the policy proposed in 2023. The final rule carves out several categories of tests that won’t need to apply for “premarket review.”

Notably, a “grandfather clause” will allow some lab tests already on the market to continue being sold without undergoing FDA’s premarket review process. In explaining the exemption, FDA officials said they did not want doctors and patients to lose access to tests on which they rely. But Dr. Lurie noted that because the FDA views all these tests as under its jurisdiction, the agency could opt to take a closer look “at a very old device that is causing a problem today.”

The FDA also will exempt tests approved by New York State’s Clinical Laboratory Evaluation Program, which conducts its own stringent reviews. And the FDA will continue to allow hospitals to develop tests for patients within their healthcare system without going through the FDA approval process, if no FDA-approved tests are available.

Hospital-based tests play a critical role in treating infectious diseases, said Amesh Adalja, MD, an infectious diseases specialist and senior scholar at the Johns Hopkins Center for Health Security. For example, a large research hospital treating a patient with cytomegalovirus may need to develop its own test to determine whether the infection is resistant to antiviral drugs, Dr. Adalja said.

“With novel infectious disease outbreaks, researchers are able to move quickly to make diagnostic tests months and months before commercial laboratories are able to get through regulatory processes,” Dr. Adalja said.

To help scientists respond quickly to emergencies, the FDA published special guidance for labs that develop unauthorized lab tests for disease outbreaks.

Medical groups such as the American Hospital Association and Infectious Diseases Society of America remain concerned about the burden of complying with new regulations.

“Many vital tests developed in hospitals and health systems may be subjected to unnecessary and costly paperwork,” said Stacey Hughes, executive vice president of the American Hospital Association, in a statement.

Other groups, such as the American Society of Clinical Oncology, praised the new FDA policy. In comments submitted to the FDA in 2023, the cancer group said it “emphatically supports” requiring lab tests to undergo FDA review.

“We appreciate FDA action to modernize oversight of these tests and are hopeful this rule will increase focus on the need to balance rapid diagnostic innovation with patient safety and access” Everett Vokes, MD, the group’s board chair, said in a statement released after the FDA’s final rule was published.

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

You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.

An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.

But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?

Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.

This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.

Issues dividing defendant physicians, their insurers, and insurance company lawyers who represent them often arise from conflicting perspectives on risk, financial considerations, and reputation damage. Disagreements might include:

• Choice of expert witnesses
• Tactical decisions related to trial strategy
• Public relations considerations
• Admissions of liability
• Allocation of resources

To Settle or Not?

One of the most challenging — and common — disagreements is whether to settle the case.

Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
 

The Underlying Medical Malpractice Case

Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.

Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.

The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.

The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.

The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.

Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.

A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.

“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”

The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.

Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.

Meanwhile the case inched closer to trial.

The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.

Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.

A committee at the insurance company had decided to proceed with the trial rather than settle.

The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.

Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
 

The Follow-up

Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.

Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.

The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
 

Protecting Yourself

The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.

The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:

• You disagree with your insurer on how to proceed in a case.
• You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
• Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.

Retaining independent counsel protects your interests, not those of your insurance company.

Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.

Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.

The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.

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

You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.

An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.

But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?

Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.

This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.

Issues dividing defendant physicians, their insurers, and insurance company lawyers who represent them often arise from conflicting perspectives on risk, financial considerations, and reputation damage. Disagreements might include:

• Choice of expert witnesses
• Tactical decisions related to trial strategy
• Public relations considerations
• Admissions of liability
• Allocation of resources

To Settle or Not?

One of the most challenging — and common — disagreements is whether to settle the case.

Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
 

The Underlying Medical Malpractice Case

Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.

Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.

The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.

The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.

The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.

Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.

A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.

“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”

The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.

Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.

Meanwhile the case inched closer to trial.

The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.

Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.

A committee at the insurance company had decided to proceed with the trial rather than settle.

The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.

Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
 

The Follow-up

Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.

Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.

The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
 

Protecting Yourself

The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.

The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:

• You disagree with your insurer on how to proceed in a case.
• You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
• Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.

Retaining independent counsel protects your interests, not those of your insurance company.

Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.

Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.

The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.

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

You’ve been sued for medical malpractice. If you are a physician in the United States, that is not an unlikely scenario.

An analysis by the American Medical Association shows that almost half of all physicians are sued by the time they reach 54. In some specialties, such as ob.gyn., one is almost guaranteed to be sued at some point.

But that’s what medical malpractice insurance is for, right? Your medical malpractice insurer will assign an attorney to take care of you and help you through this situation. Won’t they?

Maybe so, but the attorney and the claims representative your insurer assigns to your case may have a different idea about how to proceed than you do. Though the defense attorney assigned to you represents you, he or she gets paid by the insurance carrier.

This can create a conflict when your defense counsel and your insurance claims representative aim to take your case in a direction you don’t like.

Issues dividing defendant physicians, their insurers, and insurance company lawyers who represent them often arise from conflicting perspectives on risk, financial considerations, and reputation damage. Disagreements might include:

• Choice of expert witnesses
• Tactical decisions related to trial strategy
• Public relations considerations
• Admissions of liability
• Allocation of resources

To Settle or Not?

One of the most challenging — and common — disagreements is whether to settle the case.

Sometimes a malpractice insurer wants to settle the case against the defendant doctor’s wishes. Or the doctor wants to settle but is pushed into going to trial. In the following case, one doctor had to face the consequences of a decision he didn’t even make.
 

The Underlying Medical Malpractice Case

Dr. D was sued by a patient who had allegedly called Dr. D’s office six times in 2 days complaining of intermittent chest pain.

Dr. D had been swamped with patients and couldn’t squeeze this patient in for an office visit, but he did call back. The patient later claimed that during the call he told the doctor he was suffering from chest pain. The doctor recalled that the patient had complained of abdominal discomfort that began after he had exercised.

The physician wrote a prescription for an ECG at the local hospital and called to ensure that the patient could just walk in. The ECG was allegedly abnormal but was not read as representing an impending or current heart attack. Later that evening, however, the patient went to the emergency department of another hospital where it was confirmed that he had suffered a heart attack. The patient underwent cardiac catheterization and stent placement to address a blockage in his left anterior descending artery.

The patient subsequently sued Dr. D and the hospital where he had the original ECG. Dr. D contacted his medical malpractice insurance company. The insurance company assigned an attorney to represent Dr. D. Discovery in the case began.

The plaintiff’s own medical expert testified in a deposition that there was no way for the heart attack to have been prevented and that the treatment would have been the same either way. But Dr. D could not find a record of the phone calls with the patient, and he had not noted his conversation the patient in their medical records.

Dr. D held a policy for $1 million, and his state had a fund that would kick in an additional $1 million. But the plaintiffs demanded $4 million to settle.

A month before trial, the plaintiff’s attorney sent a threatening letter to Dr. D’s attorney warning him that Dr. D was underinsured and suggesting that it would be in the physician’s best interests to settle.

“I want to stress to you that it is not my desire to harm your client’s reputation or to destroy his business,” wrote the plaintiff’s attorney. “However, now is the time to avoid consequences such as these by making a good faith effort to get this case resolved.”

The letter went on to note that the defense attorney should give Dr. D a copy of the letter so that everyone would be aware of the potential consequences of an award against Dr. D in excess of his limits of insurance coverage. The plaintiff’s attorney even suggested that Dr. D should retain personal counsel.

Dr. D’s defense attorney downplayed the letter and assured him that there was no reason to worry.

Meanwhile the case inched closer to trial.

The codefendant hospital settled with the plaintiff on the night before jury selection, leaving Dr. D in the uncomfortable position of being the only defendant in the case. At this point, Dr. D decided he would like to settle, and he sent his attorney an email telling him so. But the attorney instead referred him to an insurance company claims.

Just days before the trial was to start, Dr. D repeatedly told the claims representative assigned to his claim that he did not want to go to trial but rather wanted to settle. The representative told Dr. D that he had no choice in whether the action settled.

A committee at the insurance company had decided to proceed with the trial rather than settle.

The trial proved a painful debacle for Dr. D. His attorney’s idea of showing a “gotcha” video of the allegedly permanently injured plaintiff carrying a large, heavy box backfired when the jury was shown by the plaintiff that the box actually contained ice cream cones and weighed very little.

Prior to trial, the plaintiff offered to settle for $1 million. On the first day of trial, they lowered that amount to $750,000, yet the defense attorney did not settle the case, and it proceeded to a jury verdict. The jury awarded the plaintiff over $4 million — well in excess of Dr. D’s policy limits.
 

The Follow-up

Dr. D was horrified, but the insurance company claims representative said the insurer would promptly offer $2 million in available insurance coverage to settle the case post verdict. This did not happen. Instead, the insurer chose to appeal the verdict against Dr. D’s wishes.

Ultimately, Dr. D was forced to hire his own lawyer. He ultimately sued the insurance company for breach of contract and bad faith.

The insurance company eventually attempted to settle with the plaintiffs’ counsel, but the plaintiff refused to accept the available insurance coverage. The insurance carrier still has not posted the entire appeal bond. The case is still pending.
 

Protecting Yourself

The lesson from Dr. D’s experience: Understand that the insurance company is not your friend. It’s a business looking out for its own interests.

The plaintiff’s attorney was absolutely correct in suggesting that Dr. D retain his own attorney to represent his own interests. You should hire your own lawyer when:

• You disagree with your insurer on how to proceed in a case.
• You receive a demand that exceeds your available insurance coverage or for damages that may not be covered by your policy, such as punitive damages.
• Your insurance carrier attempts to deny insurance coverage for your claim or sends you a letter stating that it is “reserving its rights” not to cover or to limit coverage for your claim.

Retaining independent counsel protects your interests, not those of your insurance company.

Independent counsel can give you a second opinion on the strengths and weaknesses of your claim, help you prepare for your deposition, and attend court dates with you to ensure that you are completely protected.

Independent counsel can challenge your insurance company’s decision to deny or limit your insurance coverage and ensure that you receive all of the benefits to which you are entitled under your insurance policy. Some policies may include an independent lawyer to be paid for by your insurance carrier in case of a conflicts.

The most important takeaway? Your medical malpractice insurance carrier is not your friend, so act accordingly in times of conflict.

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

In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.

The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.

The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.

The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.

Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.

The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.

“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.

The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.

The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.

Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.

The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.

The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.

The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.

Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.

The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.

“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.

The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.

The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.

Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

In a groundbreaking procedure, a team of surgeons from New York University Langone Health successfully performed the first combined face and eye transplant on a patient with extensive craniofacial tissue loss after an electrical accident.

The highly complex surgery lasted for 21 hours and involved more than 140 surgeons, nurses, and other healthcare professionals under the leadership of Eduardo D. Rodriguez. MD. It not only restored the patient’s facial features, but also integrated a functional eyeball, potentially setting a new standard for future treatments in similar cases.

The transplant took place in May 2023, and the case report was published on September 5 this year in JAMA.

The 46-year-old man lost a large part of his craniofacial tissue and his left eyeball. The approach was highly specialized. Advanced microsurgical techniques such as anastomoses of microscopic vessels and delicate suturing techniques were crucial for the transplant’s success.

Moreover, customized surgical devices, specific implants, and tissue manipulation tools were developed specifically for this case, thus ensuring the viability of the transplant and adequate perfusion of the transplanted ocular tissue.

The initial results are encouraging. Retinal arterial perfusion has been maintained, and retinal architecture has been preserved, as demonstrated by optical coherence tomography. Electroretinography confirmed retinal responses to light, suggesting that the transplanted eye may eventually contribute to the patient’s visual perception. These results are comparable to those of previous facial tissue transplants, but with the significant addition of ocular functionality, which is a notable advance.

“The successful revascularization of the transplanted eye achieved in this study may serve as a step toward the goal of globe transplant for restoration of vision,” wrote the authors.

The complexity of the combined transplant required a deep understanding of facial and ocular anatomy, as well as tissue preservation techniques. The surgical team reported significant challenges, including the need to align delicate anatomical structures and ensure immunological compatibility between the donor and recipient. Meticulous planning from donor selection to postoperative follow-up was considered essential to maximize the likelihood of success and minimize the risk for allograft rejection.

The patient will now be continuously monitored and receive treatment with immunosuppressants such as tacrolimus and prednisone, adjusted according to his response to the transplant. According to the researchers, further studies will be needed to assess the long-term functionality of the transplanted eye and its integration with the central nervous system.

Despite being the fifth facial transplant surgery performed under Dr. Rodriguez’s leadership, this is the first record of a whole-eye transplant. “The mere fact that we have successfully performed the first whole-eye transplant along with a face transplant is a tremendous achievement that many believed to be impossible,” the doctor said in a statement. “We have taken a giant step forward and paved the way for the next chapter in vision restoration.”
 

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.