MDedge Surgery

A study from the University of Texas demonstrates the feasibility of using robotic single-port laparoscopy in nipple-sparing mastectomy (NSM), a type of conservative mastectomy preserving the skin and nipple-areola complex. The new findings potentially expand the application of robotic surgery to a larger patient population but doubts about the safety of this approach linger.

Robotic Mastectomy

The first surgeries involving the Da Vinci robotic surgeon for breast removal date to 2015. Multiport robotic surgery faces significant obstacles in this field, however. Feasibility studies have primarily focused on women with small breasts, corresponding to cup size C or smaller.

In the study that was published in JAMA Surgery, surgeons used the more cost-effective single-port platform for bilateral NSM procedures. Among the 20 patients included in the analysis (age, 29-63 years), 11 underwent prophylactic mastectomy (for a high risk for cancer) and 9 had mastectomy for breast tumors. Breast sizes ranged from A cup to D cup.

The duration of the procedure, from skin incision to suture for both breasts, ranged from 205 to 351 minutes (median, 277 minutes). No immediate operative complications (eg, hematoma) occurred, and there was no need for conversion to open surgery in any case. Over the 36-month follow-up, there were no recurrences. About 95% of patients retained skin sensitivity and 55% retained nipple sensitivity.
 

Unanswered Questions

In an accompanying article, Monica Morrow, MD, director of surgical breast oncology at the Memorial Sloan-Kettering Cancer Center in New York, acknowledged that the new evidence confirms the surgical approach’s feasibility but deems it insufficient to adopt it lightly. “At this point, the issue is not whether robotic mastectomy can be done but whether there is sufficient information about its oncologic safety that it should be done,” she wrote.

In a 2019 statement that was updated in 2021, the US Food and Drug Administration stated, “The safety and effectiveness of using robotically assisted surgical devices in mastectomy procedures or in the prevention or treatment of breast cancer have not been established.” The significance of this caution is underscored by the experience with laparoscopic and robotic radical hysterectomies. These procedures were widely adopted until a randomized prospective study demonstrated lower disease-free and overall survival for the minimally invasive approach compared with open surgery.

The University of Texas surgeons stated that acceptable safety and oncological outcomes for robotic NSM compared with conventional NSM had been demonstrated. They cited two trials with 238 cases and a median follow-up of less than 3 years. Dr. Morrow wrote, “While these reports provide reassurance that gross residual tumor is not being left behind, they do not address the issue of failure to remove all of the breast tissue due to thick skin flaps, with the potential for development of late recurrence or new cancers.” It is worth noting that even with the traditional surgical approach, the 5-year local recurrence rate after NSM is approximately double when observed with shorter follow-ups.

According to Dr. Morrow, the high rate of sensory preservation observed with robotic surgery, a desirable outcome for patients, is also a cause for concern. “While this may be due to incision placement or minimal skin flap retraction, as suggested by the authors, it is equally plausible that this could be due to thick skin flaps with preservation of the terminal branches of the fourth intercostal nerve.”

Therefore, more information on long-term oncological outcomes in a large number of patients will be necessary to confirm the safety of the procedure. In addition, measuring patient-reported outcomes will be useful in demonstrating that the benefits of the procedure outweigh increased operating times and costs. 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

A study from the University of Texas demonstrates the feasibility of using robotic single-port laparoscopy in nipple-sparing mastectomy (NSM), a type of conservative mastectomy preserving the skin and nipple-areola complex. The new findings potentially expand the application of robotic surgery to a larger patient population but doubts about the safety of this approach linger.

Robotic Mastectomy

The first surgeries involving the Da Vinci robotic surgeon for breast removal date to 2015. Multiport robotic surgery faces significant obstacles in this field, however. Feasibility studies have primarily focused on women with small breasts, corresponding to cup size C or smaller.

In the study that was published in JAMA Surgery, surgeons used the more cost-effective single-port platform for bilateral NSM procedures. Among the 20 patients included in the analysis (age, 29-63 years), 11 underwent prophylactic mastectomy (for a high risk for cancer) and 9 had mastectomy for breast tumors. Breast sizes ranged from A cup to D cup.

The duration of the procedure, from skin incision to suture for both breasts, ranged from 205 to 351 minutes (median, 277 minutes). No immediate operative complications (eg, hematoma) occurred, and there was no need for conversion to open surgery in any case. Over the 36-month follow-up, there were no recurrences. About 95% of patients retained skin sensitivity and 55% retained nipple sensitivity.
 

Unanswered Questions

In an accompanying article, Monica Morrow, MD, director of surgical breast oncology at the Memorial Sloan-Kettering Cancer Center in New York, acknowledged that the new evidence confirms the surgical approach’s feasibility but deems it insufficient to adopt it lightly. “At this point, the issue is not whether robotic mastectomy can be done but whether there is sufficient information about its oncologic safety that it should be done,” she wrote.

In a 2019 statement that was updated in 2021, the US Food and Drug Administration stated, “The safety and effectiveness of using robotically assisted surgical devices in mastectomy procedures or in the prevention or treatment of breast cancer have not been established.” The significance of this caution is underscored by the experience with laparoscopic and robotic radical hysterectomies. These procedures were widely adopted until a randomized prospective study demonstrated lower disease-free and overall survival for the minimally invasive approach compared with open surgery.

The University of Texas surgeons stated that acceptable safety and oncological outcomes for robotic NSM compared with conventional NSM had been demonstrated. They cited two trials with 238 cases and a median follow-up of less than 3 years. Dr. Morrow wrote, “While these reports provide reassurance that gross residual tumor is not being left behind, they do not address the issue of failure to remove all of the breast tissue due to thick skin flaps, with the potential for development of late recurrence or new cancers.” It is worth noting that even with the traditional surgical approach, the 5-year local recurrence rate after NSM is approximately double when observed with shorter follow-ups.

According to Dr. Morrow, the high rate of sensory preservation observed with robotic surgery, a desirable outcome for patients, is also a cause for concern. “While this may be due to incision placement or minimal skin flap retraction, as suggested by the authors, it is equally plausible that this could be due to thick skin flaps with preservation of the terminal branches of the fourth intercostal nerve.”

Therefore, more information on long-term oncological outcomes in a large number of patients will be necessary to confirm the safety of the procedure. In addition, measuring patient-reported outcomes will be useful in demonstrating that the benefits of the procedure outweigh increased operating times and costs. 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

A study from the University of Texas demonstrates the feasibility of using robotic single-port laparoscopy in nipple-sparing mastectomy (NSM), a type of conservative mastectomy preserving the skin and nipple-areola complex. The new findings potentially expand the application of robotic surgery to a larger patient population but doubts about the safety of this approach linger.

Robotic Mastectomy

The first surgeries involving the Da Vinci robotic surgeon for breast removal date to 2015. Multiport robotic surgery faces significant obstacles in this field, however. Feasibility studies have primarily focused on women with small breasts, corresponding to cup size C or smaller.

In the study that was published in JAMA Surgery, surgeons used the more cost-effective single-port platform for bilateral NSM procedures. Among the 20 patients included in the analysis (age, 29-63 years), 11 underwent prophylactic mastectomy (for a high risk for cancer) and 9 had mastectomy for breast tumors. Breast sizes ranged from A cup to D cup.

The duration of the procedure, from skin incision to suture for both breasts, ranged from 205 to 351 minutes (median, 277 minutes). No immediate operative complications (eg, hematoma) occurred, and there was no need for conversion to open surgery in any case. Over the 36-month follow-up, there were no recurrences. About 95% of patients retained skin sensitivity and 55% retained nipple sensitivity.
 

Unanswered Questions

In an accompanying article, Monica Morrow, MD, director of surgical breast oncology at the Memorial Sloan-Kettering Cancer Center in New York, acknowledged that the new evidence confirms the surgical approach’s feasibility but deems it insufficient to adopt it lightly. “At this point, the issue is not whether robotic mastectomy can be done but whether there is sufficient information about its oncologic safety that it should be done,” she wrote.

In a 2019 statement that was updated in 2021, the US Food and Drug Administration stated, “The safety and effectiveness of using robotically assisted surgical devices in mastectomy procedures or in the prevention or treatment of breast cancer have not been established.” The significance of this caution is underscored by the experience with laparoscopic and robotic radical hysterectomies. These procedures were widely adopted until a randomized prospective study demonstrated lower disease-free and overall survival for the minimally invasive approach compared with open surgery.

The University of Texas surgeons stated that acceptable safety and oncological outcomes for robotic NSM compared with conventional NSM had been demonstrated. They cited two trials with 238 cases and a median follow-up of less than 3 years. Dr. Morrow wrote, “While these reports provide reassurance that gross residual tumor is not being left behind, they do not address the issue of failure to remove all of the breast tissue due to thick skin flaps, with the potential for development of late recurrence or new cancers.” It is worth noting that even with the traditional surgical approach, the 5-year local recurrence rate after NSM is approximately double when observed with shorter follow-ups.

According to Dr. Morrow, the high rate of sensory preservation observed with robotic surgery, a desirable outcome for patients, is also a cause for concern. “While this may be due to incision placement or minimal skin flap retraction, as suggested by the authors, it is equally plausible that this could be due to thick skin flaps with preservation of the terminal branches of the fourth intercostal nerve.”

Therefore, more information on long-term oncological outcomes in a large number of patients will be necessary to confirm the safety of the procedure. In addition, measuring patient-reported outcomes will be useful in demonstrating that the benefits of the procedure outweigh increased operating times and costs. 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

TOPLINE:

Tumor regrowth predicts distant metastases in patients with rectal cancer undergoing surveillance after complete clinical responses to neoadjuvant therapy.

METHODOLOGY:

• “Watch and wait” is generally offered to patients with rectal cancer who have a complete clinical response to neoadjuvant therapy.
• Up to 30% of tumors regrow within 3 years, and about 5% of patients develop distant metastases.
• To get a better handle on the risk factors, investigators identified 508 watch-and-wait patients from the International Watch & Wait database who had a local regrowth and underwent resection.
• The team compared them with 893 patients from a Spanish registry who had total mesorectal excisions after neoadjuvant therapy and who were found to have had a nearly complete response to neoadjuvant therapy, meaning that 90% or more of their tumor was gone.

TAKEAWAY:

• Three-year distant metastasis–free survival was 75% in the watch-and-wait/regrowth group vs 87% in the upfront surgery arm (P = .001); the results held when the two groups were stratified by pathological T stage and nodal status.
• Patients with local regrowth also had a higher risk of developing distant metastasis (22.8% vs 10.2% at 3 years).
• Local regrowth was an independent risk factor for distant metastasis, along with higher pathological T stage and positive nodal status on the resected regrowth specimen.
• Baseline clinical T stage and nodal status were not significantly associated with risk.

IN PRACTICE:

“Leaving the primary undetectable tumor in situ until development of local regrowth may result in worse oncological outcomes ... Efforts should be made to minimize the risk of local regrowth among patients undergoing watch and wait by the use of very stringent criteria for the identification of a clinical complete response.” There may be a role for ctDNA to improve patient selection for watch and wait.

SOURCE:

The study was led by Laura Melina Fernandez of the Champalimaud Foundation in Lisbon, Portugal, and presented on January 20, 2024, at the ASCO Gastrointestinal Cancers Symposium.

LIMITATIONS:

The definition of “complete clinical response” and selection of patients for watch and wait varied across International Watch & Wait database institutions. Recruitment occurred before implementation of total neoadjuvant therapy regimens.

DISCLOSURES:

There was no external funding for the work. The lead investigator didn’t have any disclosures.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Tumor regrowth predicts distant metastases in patients with rectal cancer undergoing surveillance after complete clinical responses to neoadjuvant therapy.

METHODOLOGY:

• “Watch and wait” is generally offered to patients with rectal cancer who have a complete clinical response to neoadjuvant therapy.
• Up to 30% of tumors regrow within 3 years, and about 5% of patients develop distant metastases.
• To get a better handle on the risk factors, investigators identified 508 watch-and-wait patients from the International Watch & Wait database who had a local regrowth and underwent resection.
• The team compared them with 893 patients from a Spanish registry who had total mesorectal excisions after neoadjuvant therapy and who were found to have had a nearly complete response to neoadjuvant therapy, meaning that 90% or more of their tumor was gone.

TAKEAWAY:

• Three-year distant metastasis–free survival was 75% in the watch-and-wait/regrowth group vs 87% in the upfront surgery arm (P = .001); the results held when the two groups were stratified by pathological T stage and nodal status.
• Patients with local regrowth also had a higher risk of developing distant metastasis (22.8% vs 10.2% at 3 years).
• Local regrowth was an independent risk factor for distant metastasis, along with higher pathological T stage and positive nodal status on the resected regrowth specimen.
• Baseline clinical T stage and nodal status were not significantly associated with risk.

IN PRACTICE:

“Leaving the primary undetectable tumor in situ until development of local regrowth may result in worse oncological outcomes ... Efforts should be made to minimize the risk of local regrowth among patients undergoing watch and wait by the use of very stringent criteria for the identification of a clinical complete response.” There may be a role for ctDNA to improve patient selection for watch and wait.

SOURCE:

The study was led by Laura Melina Fernandez of the Champalimaud Foundation in Lisbon, Portugal, and presented on January 20, 2024, at the ASCO Gastrointestinal Cancers Symposium.

LIMITATIONS:

The definition of “complete clinical response” and selection of patients for watch and wait varied across International Watch & Wait database institutions. Recruitment occurred before implementation of total neoadjuvant therapy regimens.

DISCLOSURES:

There was no external funding for the work. The lead investigator didn’t have any disclosures.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Tumor regrowth predicts distant metastases in patients with rectal cancer undergoing surveillance after complete clinical responses to neoadjuvant therapy.

METHODOLOGY:

• “Watch and wait” is generally offered to patients with rectal cancer who have a complete clinical response to neoadjuvant therapy.
• Up to 30% of tumors regrow within 3 years, and about 5% of patients develop distant metastases.
• To get a better handle on the risk factors, investigators identified 508 watch-and-wait patients from the International Watch & Wait database who had a local regrowth and underwent resection.
• The team compared them with 893 patients from a Spanish registry who had total mesorectal excisions after neoadjuvant therapy and who were found to have had a nearly complete response to neoadjuvant therapy, meaning that 90% or more of their tumor was gone.

TAKEAWAY:

• Three-year distant metastasis–free survival was 75% in the watch-and-wait/regrowth group vs 87% in the upfront surgery arm (P = .001); the results held when the two groups were stratified by pathological T stage and nodal status.
• Patients with local regrowth also had a higher risk of developing distant metastasis (22.8% vs 10.2% at 3 years).
• Local regrowth was an independent risk factor for distant metastasis, along with higher pathological T stage and positive nodal status on the resected regrowth specimen.
• Baseline clinical T stage and nodal status were not significantly associated with risk.

IN PRACTICE:

“Leaving the primary undetectable tumor in situ until development of local regrowth may result in worse oncological outcomes ... Efforts should be made to minimize the risk of local regrowth among patients undergoing watch and wait by the use of very stringent criteria for the identification of a clinical complete response.” There may be a role for ctDNA to improve patient selection for watch and wait.

SOURCE:

The study was led by Laura Melina Fernandez of the Champalimaud Foundation in Lisbon, Portugal, and presented on January 20, 2024, at the ASCO Gastrointestinal Cancers Symposium.

LIMITATIONS:

The definition of “complete clinical response” and selection of patients for watch and wait varied across International Watch & Wait database institutions. Recruitment occurred before implementation of total neoadjuvant therapy regimens.

DISCLOSURES:

There was no external funding for the work. The lead investigator didn’t have any disclosures.
 

A version of this article appeared on Medscape.com.

For adults with obesity and uncontrolled hypertension, bariatric surgery is an effective and durable strategy to control high blood pressure (BP), final, 5-year follow-up data from the GATEWAY trial suggested.

In the trial, those who underwent bariatric surgery had lower body mass index (BMI) and were on fewer antihypertensive medications after 5 years while maintaining normal BP than those who only used antihypertensive medications.

The results show that “bariatric and metabolic surgery can be very effective in the treatment of patients with obesity and hypertension in the long term,” chief investigator Carlos Aurelio Schiavon, MD, with the Research Institute, Heart Hospital, São Paulo, Brazil, told this news organization. 

“The most important clinical implication of this trial is that we must treat obesity to accomplish success when treating patients with cardiovascular diseases, such as hypertension and obesity,” Dr. Schiavon said.

The study was published online on February 5, 2024, in the Journal of the American College of Cardiology. 
 

A Gateway to Lasting BP Control

GATEWAY enrolled 100 adults (76% women) with grade 1/2 obesity (BMI, 30 to < 40 kg/m²; mean, 37 kg/m²) who were on at least two antihypertensive medications at maximum doses at baseline.

Half were randomly allocated to laparoscopic Roux-en-Y gastric-bypass surgery (RYGB) plus medications and half to medication alone. The primary outcome was at least a 30% reduction of antihypertensive medications while maintaining BP < 140/90 mm Hg. Five-year results were based on 37 patients in the surgery group and 32 in the medication only group. 

After 5 years, BMI was 28.01 kg/m² for those who had surgery vs 36.40 kg/m² for those on medication alone (P < .001).

Patients who underwent RYGB had an 80.7% reduction in the number of antihypertensive medications they were taking while maintaining BP < 140/90 mm Hg compared with a 13.7% reduction in those on medication alone.

After 5 years, surgery patients were taking a mean of 0.80 antihypertensive medications vs 2.97 in the medication only group to control BP at or below the target. 

Despite using less antihypertensive medications in the RYGB, ambulatory BP monitoring data revealed similar 24-hour, daytime, and nighttime BP profiles compared with medication alone. 

The rate of hypertension remission (controlled BP without medication) was nearly 20-fold higher in the surgery group than in the medication only group (46.9% vs 2.4%; P < .001).

In addition, the rate of apparent resistant hypertension was lower with than without surgery (0% vs 15.2%). The surgery group also showed evidence of less atrial remodeling. 

The 5-year results were consistent with the 1-year GATEWAY results Dr. Schiavon presented at the American Heart Association 2017 scientific sessions, as reported by this news organization. They also mirrored the results reported at 3 years. 

Limitations of the study include its single-center, open-label design with a small sample size and loss of follow-up in some patients.

“Taken together, these results support the long-term effective role of bariatric surgery in reducing the burden of hypertension and related polypharmacy, which is frequently observed in patients with obesity and is a cause of concern for them,” the authors wrote. 

“In clinical practice, obesity is an overlooked condition. As a consequence, there is a frequent failure in approaching obesity as a crucial step for mitigating the risk of important cardiovascular risk factors including hypertension. Our results underscore the importance of approaching obesity in reducing hypertension rates,” they added. 
 

Important Data, Lingering Questions 

The coauthors of an accompanying editorial said this study provides “important long-term data on the benefits of gastric bypass on weight loss and blood pressure control, but questions remain.”

Yet, Michael Hall, MD, MSc, with University of Mississippi Medical Center in Jackson, and coauthors noted that the study only included patients undergoing RYGB; it remains unclear if other bariatric surgery procedures would have the same long-term results.

“Sleeve gastrectomy has become more common than RYGB because it is less complex and has earlier recovery and similar effectiveness for treating obesity and type 2 diabetes,” they pointed out. “Further comparative randomized controlled trials are needed to determine whether sleeve gastrectomy is as effective as RYGB for long-term BP control.”

As reported previously by this news organization, in SLEEVEPASS, there was greater weight loss and higher likelihood of hypertension remission with RYGB than with sleeve gastrectomy (24% vs 8%; P = .04), although BP control was not the primary outcome. 

The GATEWAY study was supported by a grant from Ethicon. Dr. Schiavon received a research grant from Ethicon and has received lecture fees from Ethicon and Medtronic. The editorial writers had no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

For adults with obesity and uncontrolled hypertension, bariatric surgery is an effective and durable strategy to control high blood pressure (BP), final, 5-year follow-up data from the GATEWAY trial suggested.

In the trial, those who underwent bariatric surgery had lower body mass index (BMI) and were on fewer antihypertensive medications after 5 years while maintaining normal BP than those who only used antihypertensive medications.

The results show that “bariatric and metabolic surgery can be very effective in the treatment of patients with obesity and hypertension in the long term,” chief investigator Carlos Aurelio Schiavon, MD, with the Research Institute, Heart Hospital, São Paulo, Brazil, told this news organization. 

“The most important clinical implication of this trial is that we must treat obesity to accomplish success when treating patients with cardiovascular diseases, such as hypertension and obesity,” Dr. Schiavon said.

The study was published online on February 5, 2024, in the Journal of the American College of Cardiology. 
 

A Gateway to Lasting BP Control

GATEWAY enrolled 100 adults (76% women) with grade 1/2 obesity (BMI, 30 to < 40 kg/m²; mean, 37 kg/m²) who were on at least two antihypertensive medications at maximum doses at baseline.

Half were randomly allocated to laparoscopic Roux-en-Y gastric-bypass surgery (RYGB) plus medications and half to medication alone. The primary outcome was at least a 30% reduction of antihypertensive medications while maintaining BP < 140/90 mm Hg. Five-year results were based on 37 patients in the surgery group and 32 in the medication only group. 

After 5 years, BMI was 28.01 kg/m² for those who had surgery vs 36.40 kg/m² for those on medication alone (P < .001).

Patients who underwent RYGB had an 80.7% reduction in the number of antihypertensive medications they were taking while maintaining BP < 140/90 mm Hg compared with a 13.7% reduction in those on medication alone.

After 5 years, surgery patients were taking a mean of 0.80 antihypertensive medications vs 2.97 in the medication only group to control BP at or below the target. 

Despite using less antihypertensive medications in the RYGB, ambulatory BP monitoring data revealed similar 24-hour, daytime, and nighttime BP profiles compared with medication alone. 

The rate of hypertension remission (controlled BP without medication) was nearly 20-fold higher in the surgery group than in the medication only group (46.9% vs 2.4%; P < .001).

In addition, the rate of apparent resistant hypertension was lower with than without surgery (0% vs 15.2%). The surgery group also showed evidence of less atrial remodeling. 

The 5-year results were consistent with the 1-year GATEWAY results Dr. Schiavon presented at the American Heart Association 2017 scientific sessions, as reported by this news organization. They also mirrored the results reported at 3 years. 

Limitations of the study include its single-center, open-label design with a small sample size and loss of follow-up in some patients.

“Taken together, these results support the long-term effective role of bariatric surgery in reducing the burden of hypertension and related polypharmacy, which is frequently observed in patients with obesity and is a cause of concern for them,” the authors wrote. 

“In clinical practice, obesity is an overlooked condition. As a consequence, there is a frequent failure in approaching obesity as a crucial step for mitigating the risk of important cardiovascular risk factors including hypertension. Our results underscore the importance of approaching obesity in reducing hypertension rates,” they added. 
 

Important Data, Lingering Questions 

The coauthors of an accompanying editorial said this study provides “important long-term data on the benefits of gastric bypass on weight loss and blood pressure control, but questions remain.”

Yet, Michael Hall, MD, MSc, with University of Mississippi Medical Center in Jackson, and coauthors noted that the study only included patients undergoing RYGB; it remains unclear if other bariatric surgery procedures would have the same long-term results.

“Sleeve gastrectomy has become more common than RYGB because it is less complex and has earlier recovery and similar effectiveness for treating obesity and type 2 diabetes,” they pointed out. “Further comparative randomized controlled trials are needed to determine whether sleeve gastrectomy is as effective as RYGB for long-term BP control.”

As reported previously by this news organization, in SLEEVEPASS, there was greater weight loss and higher likelihood of hypertension remission with RYGB than with sleeve gastrectomy (24% vs 8%; P = .04), although BP control was not the primary outcome. 

The GATEWAY study was supported by a grant from Ethicon. Dr. Schiavon received a research grant from Ethicon and has received lecture fees from Ethicon and Medtronic. The editorial writers had no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

For adults with obesity and uncontrolled hypertension, bariatric surgery is an effective and durable strategy to control high blood pressure (BP), final, 5-year follow-up data from the GATEWAY trial suggested.

In the trial, those who underwent bariatric surgery had lower body mass index (BMI) and were on fewer antihypertensive medications after 5 years while maintaining normal BP than those who only used antihypertensive medications.

The results show that “bariatric and metabolic surgery can be very effective in the treatment of patients with obesity and hypertension in the long term,” chief investigator Carlos Aurelio Schiavon, MD, with the Research Institute, Heart Hospital, São Paulo, Brazil, told this news organization. 

“The most important clinical implication of this trial is that we must treat obesity to accomplish success when treating patients with cardiovascular diseases, such as hypertension and obesity,” Dr. Schiavon said.

The study was published online on February 5, 2024, in the Journal of the American College of Cardiology. 
 

A Gateway to Lasting BP Control

GATEWAY enrolled 100 adults (76% women) with grade 1/2 obesity (BMI, 30 to < 40 kg/m²; mean, 37 kg/m²) who were on at least two antihypertensive medications at maximum doses at baseline.

Half were randomly allocated to laparoscopic Roux-en-Y gastric-bypass surgery (RYGB) plus medications and half to medication alone. The primary outcome was at least a 30% reduction of antihypertensive medications while maintaining BP < 140/90 mm Hg. Five-year results were based on 37 patients in the surgery group and 32 in the medication only group. 

After 5 years, BMI was 28.01 kg/m² for those who had surgery vs 36.40 kg/m² for those on medication alone (P < .001).

Patients who underwent RYGB had an 80.7% reduction in the number of antihypertensive medications they were taking while maintaining BP < 140/90 mm Hg compared with a 13.7% reduction in those on medication alone.

After 5 years, surgery patients were taking a mean of 0.80 antihypertensive medications vs 2.97 in the medication only group to control BP at or below the target. 

Despite using less antihypertensive medications in the RYGB, ambulatory BP monitoring data revealed similar 24-hour, daytime, and nighttime BP profiles compared with medication alone. 

The rate of hypertension remission (controlled BP without medication) was nearly 20-fold higher in the surgery group than in the medication only group (46.9% vs 2.4%; P < .001).

In addition, the rate of apparent resistant hypertension was lower with than without surgery (0% vs 15.2%). The surgery group also showed evidence of less atrial remodeling. 

The 5-year results were consistent with the 1-year GATEWAY results Dr. Schiavon presented at the American Heart Association 2017 scientific sessions, as reported by this news organization. They also mirrored the results reported at 3 years. 

Limitations of the study include its single-center, open-label design with a small sample size and loss of follow-up in some patients.

“Taken together, these results support the long-term effective role of bariatric surgery in reducing the burden of hypertension and related polypharmacy, which is frequently observed in patients with obesity and is a cause of concern for them,” the authors wrote. 

“In clinical practice, obesity is an overlooked condition. As a consequence, there is a frequent failure in approaching obesity as a crucial step for mitigating the risk of important cardiovascular risk factors including hypertension. Our results underscore the importance of approaching obesity in reducing hypertension rates,” they added. 
 

Important Data, Lingering Questions 

The coauthors of an accompanying editorial said this study provides “important long-term data on the benefits of gastric bypass on weight loss and blood pressure control, but questions remain.”

Yet, Michael Hall, MD, MSc, with University of Mississippi Medical Center in Jackson, and coauthors noted that the study only included patients undergoing RYGB; it remains unclear if other bariatric surgery procedures would have the same long-term results.

“Sleeve gastrectomy has become more common than RYGB because it is less complex and has earlier recovery and similar effectiveness for treating obesity and type 2 diabetes,” they pointed out. “Further comparative randomized controlled trials are needed to determine whether sleeve gastrectomy is as effective as RYGB for long-term BP control.”

As reported previously by this news organization, in SLEEVEPASS, there was greater weight loss and higher likelihood of hypertension remission with RYGB than with sleeve gastrectomy (24% vs 8%; P = .04), although BP control was not the primary outcome. 

The GATEWAY study was supported by a grant from Ethicon. Dr. Schiavon received a research grant from Ethicon and has received lecture fees from Ethicon and Medtronic. The editorial writers had no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.

A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.

Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.

“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe. “If we look at the 50 largest verdicts in 2023 and average them out, we have a higher monetary amount than any other year.”

In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.

From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.

While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.

A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.

“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”

Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.

And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.

“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.

Why Are Juries Awarding Higher Verdicts?

There’s no single reason for the rise in nuclear verdicts, Mr. Henderson said.

One theory is that plaintiffs’ attorneys held back on resolving high-dollar cases during the COVID pandemic and let loose with high-demand claims when courts returned to normal, he said.

Another theory is that people emerged from the pandemic angrier.

“Whether it was political dynamics, masking [mandates], or differences in opinions, people came out of it angry, and generally speaking, you don’t want an angry jury,” Mr. Henderson said. “For a while, there was the halo effect, where health professionals were seen as heroes. That went away, and all of a sudden [they] became ‘the bad guys.’ ”

“People are angry at the healthcare system, and this anger manifests itself in [liability] suits,” added Bill Burns, vice president of research for the Medical Professional Liability Association, an industry group for medical liability insurers.

Hospital and medical group consolidation also reduces the personal connection juries may have with healthcare providers, Mr. Burns said.

“Healthcare has become a big business, and the corporatization of medicine now puts companies on the stand and not your local community hospital or your family doctor that you have known since birth,” he said.

Plaintiffs’ attorneys also deploy tactics that can prompt higher verdicts, Mr. White said. They may tell a jury that the provider or hospital is a threat to the community and that awarding a large verdict will deter others in the healthcare community from repeating the same actions.

Juries may then want to punish the defendant in addition to assessing damages for economic harm or pain and suffering, Mr. White said.

“I am concerned that jurors are trying to right social wrongs rather than judging cases on the facts presented to them,” added Mike Stinson, vice president for policy and legal affairs for the Medical Professional Liability Association.

Third-party litigation financing also can lead to mega verdicts. That’s an emerging practice in which companies unrelated to a lawsuit provide capital to plaintiffs in return for a portion of any financial award. The firms essentially “invest” in the litigation.

“What this does is provide an additional financial backdrop for plaintiffs,” Mr. Henderson said. “It allows them to dig in harder on cases. They can hold out for higher numbers, and if nothing else, it can prolong litigation.”

Do High Awards Actually Stick?

Multimillion-dollar verdicts may grab headlines, but do plaintiffs actually receive them?

Rarely, said TransRe, which tracks the final outcomes of verdicts. In many cases, large verdicts are reduced on appeal.

In the Maya case, which involved child protection authorities, a judge later lowered the damages against Johns Hopkins All Children’s Hospital by $47.5 million.

A federal judge in October, for example, rejected a record $110 million medical malpractice award in Minnesota, reducing it to $10 million. The district judge ruled the award was “shockingly excessive” and that the plaintiff should either accept the $10 million award or retry the case.

After a verdict is awarded, the defendant typically challenges the award, and the case goes through the appellate pipeline, Mr. Henderson explained. A judge may reduce some elements of the verdict, he said, but more often, the plaintiff and defendant agree on a compromised figure.

Seattle medical liability defense attorney Jennifer Crisera has experienced this firsthand. She recalled a recent case where a plaintiff’s attorney demanded what she describes as an unreasonable amount to settle a claim. Ms. Crisera did not want to give exact numbers but said the plaintiff made an 8-figure demand and the defense offered a low 7-figure range.

“My impression was that plaintiff’s counsel believed that they could get a nuclear verdict from the jury, so they kept their settlement demand artificially high,” she said. “The division between the numbers was way too high. Ultimately, we had to let a jury decide the value.”

The plaintiff won the case, and the verdict was much less than the settlement demand, she said. Even so, the defense incurred trial costs, and the health provider was forced to endure the emotional stress of a trial that could have been avoided, Ms. Crisera said.

Higher medical malpractice premiums are another consequence of massive awards.

Premium rates are associated with how much insurers pay on average for cases and how frequently they are making payouts, Mr. White said.

Medical liability insurance premiums for physicians have steadily increased since 2019, according to data from the Medical Liability Monitor, a national publication that analyzes liability insurance premiums. The Monitor studies insurance premium data from insurers that cover internists, general surgeons, and obstetrician-gynecologists.

From 2019 to 2023, average premium rates for physicians increased between 1.1% and 3% each year in states without patient compensation funds, according to Monitor data.

“Nuclear verdicts are a real driver of the industry’s underwriting losses and remain top of mind for every malpractice insurance company,” said Michael Matray, editor for the Medical Liability Monitor. “Responses to this year’s rate survey questionnaire indicate that most responding companies have experienced an increase in claims greater than $1 million and claims greater than $5 million during the past 2 years.”

However, increases vary widely by region and among counties. In Montgomery County, Alabama, for instance, premiums for internists rose by 24% from 2022 to 2023, from $8,231 to $10,240. Premiums for Montgomery County general surgeons rose by 11.9% from 2022 to 2023, from $30,761 to $34,426, according to survey data.

In several counties in Illinois (Adams, Knox, Peoria, and Rock Island), premiums for some internists rose by 15% from $24,041 to $27,783, and premiums for some surgeons increased by 27% from $60,202 to $76,461, according to survey data. Some internists in Catoosa County, Georgia, meanwhile, paid $17,831 in 2023, up from $16,313 in 2022. Some surgeons in Catoosa County paid $65,616 in 2023, up from $60,032 in 2022. Inflation could be one factor behind higher liability premium rates. Claim severity is a key driver of higher premium rates, Mr. White added.

“We have not seen stability in claims severity,” he said. “It is continuing to go up and, in all likelihood, it will drive [premium] rates up further from this point.”
 

A version of this article appeared on Medscape.com.

In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.

A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.

Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.

“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe. “If we look at the 50 largest verdicts in 2023 and average them out, we have a higher monetary amount than any other year.”

In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.

From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.

While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.

A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.

“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”

Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.

And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.

“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.

Why Are Juries Awarding Higher Verdicts?

There’s no single reason for the rise in nuclear verdicts, Mr. Henderson said.

One theory is that plaintiffs’ attorneys held back on resolving high-dollar cases during the COVID pandemic and let loose with high-demand claims when courts returned to normal, he said.

Another theory is that people emerged from the pandemic angrier.

“Whether it was political dynamics, masking [mandates], or differences in opinions, people came out of it angry, and generally speaking, you don’t want an angry jury,” Mr. Henderson said. “For a while, there was the halo effect, where health professionals were seen as heroes. That went away, and all of a sudden [they] became ‘the bad guys.’ ”

“People are angry at the healthcare system, and this anger manifests itself in [liability] suits,” added Bill Burns, vice president of research for the Medical Professional Liability Association, an industry group for medical liability insurers.

Hospital and medical group consolidation also reduces the personal connection juries may have with healthcare providers, Mr. Burns said.

“Healthcare has become a big business, and the corporatization of medicine now puts companies on the stand and not your local community hospital or your family doctor that you have known since birth,” he said.

Plaintiffs’ attorneys also deploy tactics that can prompt higher verdicts, Mr. White said. They may tell a jury that the provider or hospital is a threat to the community and that awarding a large verdict will deter others in the healthcare community from repeating the same actions.

Juries may then want to punish the defendant in addition to assessing damages for economic harm or pain and suffering, Mr. White said.

“I am concerned that jurors are trying to right social wrongs rather than judging cases on the facts presented to them,” added Mike Stinson, vice president for policy and legal affairs for the Medical Professional Liability Association.

Third-party litigation financing also can lead to mega verdicts. That’s an emerging practice in which companies unrelated to a lawsuit provide capital to plaintiffs in return for a portion of any financial award. The firms essentially “invest” in the litigation.

“What this does is provide an additional financial backdrop for plaintiffs,” Mr. Henderson said. “It allows them to dig in harder on cases. They can hold out for higher numbers, and if nothing else, it can prolong litigation.”

Do High Awards Actually Stick?

Multimillion-dollar verdicts may grab headlines, but do plaintiffs actually receive them?

Rarely, said TransRe, which tracks the final outcomes of verdicts. In many cases, large verdicts are reduced on appeal.

In the Maya case, which involved child protection authorities, a judge later lowered the damages against Johns Hopkins All Children’s Hospital by $47.5 million.

A federal judge in October, for example, rejected a record $110 million medical malpractice award in Minnesota, reducing it to $10 million. The district judge ruled the award was “shockingly excessive” and that the plaintiff should either accept the $10 million award or retry the case.

After a verdict is awarded, the defendant typically challenges the award, and the case goes through the appellate pipeline, Mr. Henderson explained. A judge may reduce some elements of the verdict, he said, but more often, the plaintiff and defendant agree on a compromised figure.

Seattle medical liability defense attorney Jennifer Crisera has experienced this firsthand. She recalled a recent case where a plaintiff’s attorney demanded what she describes as an unreasonable amount to settle a claim. Ms. Crisera did not want to give exact numbers but said the plaintiff made an 8-figure demand and the defense offered a low 7-figure range.

“My impression was that plaintiff’s counsel believed that they could get a nuclear verdict from the jury, so they kept their settlement demand artificially high,” she said. “The division between the numbers was way too high. Ultimately, we had to let a jury decide the value.”

The plaintiff won the case, and the verdict was much less than the settlement demand, she said. Even so, the defense incurred trial costs, and the health provider was forced to endure the emotional stress of a trial that could have been avoided, Ms. Crisera said.

Higher medical malpractice premiums are another consequence of massive awards.

Premium rates are associated with how much insurers pay on average for cases and how frequently they are making payouts, Mr. White said.

Medical liability insurance premiums for physicians have steadily increased since 2019, according to data from the Medical Liability Monitor, a national publication that analyzes liability insurance premiums. The Monitor studies insurance premium data from insurers that cover internists, general surgeons, and obstetrician-gynecologists.

From 2019 to 2023, average premium rates for physicians increased between 1.1% and 3% each year in states without patient compensation funds, according to Monitor data.

“Nuclear verdicts are a real driver of the industry’s underwriting losses and remain top of mind for every malpractice insurance company,” said Michael Matray, editor for the Medical Liability Monitor. “Responses to this year’s rate survey questionnaire indicate that most responding companies have experienced an increase in claims greater than $1 million and claims greater than $5 million during the past 2 years.”

However, increases vary widely by region and among counties. In Montgomery County, Alabama, for instance, premiums for internists rose by 24% from 2022 to 2023, from $8,231 to $10,240. Premiums for Montgomery County general surgeons rose by 11.9% from 2022 to 2023, from $30,761 to $34,426, according to survey data.

In several counties in Illinois (Adams, Knox, Peoria, and Rock Island), premiums for some internists rose by 15% from $24,041 to $27,783, and premiums for some surgeons increased by 27% from $60,202 to $76,461, according to survey data. Some internists in Catoosa County, Georgia, meanwhile, paid $17,831 in 2023, up from $16,313 in 2022. Some surgeons in Catoosa County paid $65,616 in 2023, up from $60,032 in 2022. Inflation could be one factor behind higher liability premium rates. Claim severity is a key driver of higher premium rates, Mr. White added.

“We have not seen stability in claims severity,” he said. “It is continuing to go up and, in all likelihood, it will drive [premium] rates up further from this point.”
 

A version of this article appeared on Medscape.com.

In December, in what’s known as the “Take Care of Maya” case, a Florida jury returned a record $261 million verdict against Johns Hopkins All Children’s Hospital, St. Petersburg, Florida, for its treatment of a young patient and her family after an emergency room visit.

A month earlier, in New York, a jury ordered Westchester Medical Center Health Network to pay $120 million to a patient and his family following delayed stroke care that resulted in brain damage.

Mega malpractice awards like these are rising against physicians and hospitals around the country, according to new data from TransRe, an international reinsurance company that tracks large verdicts.

“2023 blew away every record previously set among high medical malpractice verdicts,” said Richard Henderson, senior vice president for TransRe. “If we look at the 50 largest verdicts in 2023 and average them out, we have a higher monetary amount than any other year.”

In 2023, there were 57 medical malpractice verdicts of $10 million or more in the United States, the data showed. Slightly more than half of those reached $25 million or more.

From 2012 to 2022, verdicts of $10 million or more ranged from 34 in 2013 to 52 in 2022, TransRe research found.

While New York, Illinois, and Florida typically saw the highest dollar verdicts in previous years, so-called “nuclear” verdicts now occur in states like Utah and Georgia where they once were uncommon, said Robert E. White Jr., president of TDC Group and The Doctors Company, a national medical liability insurer for physicians.

A rollback of tort reforms across the country is one contributor, he said. For example, Georgia’s cap on noneconomic damages is among those that have been ruled unconstitutional by courts. Utah’s cap on noneconomic damages still stands, but the limit was deemed unconstitutional in wrongful death cases. In 2019, a portion of Utah›s pre-litigation panel process was also struck down by the state’s Supreme Court.

“We used to be able to predict where these high verdicts would occur,” Mr. White said. “We can’t predict it anymore.”

Research shows a majority of malpractice cases are dropped or settled before trial, and claims that go before juries usually end in doctors’ favor. Plaintiffs’ attorneys cite large jury verdicts in similar cases to induce settlements and higher payouts, Mr. White said.

And while mega verdicts rarely stick, they can have lasting effects on future claims. The awards lead to larger settlement demands from plaintiffs and drive up the cost to resolve claims, according to Mr. Henderson and Mr. White.

“Verdicts are the yardstick by which all settlements are measured,” Mr. White said. “That’s where the damage is done.” The prospect of a mega verdict can make insurers leery of fighting some malpractice cases and motivate them to offer bigger settlements to stay out of the courtroom, he added.

Why Are Juries Awarding Higher Verdicts?

There’s no single reason for the rise in nuclear verdicts, Mr. Henderson said.

One theory is that plaintiffs’ attorneys held back on resolving high-dollar cases during the COVID pandemic and let loose with high-demand claims when courts returned to normal, he said.

Another theory is that people emerged from the pandemic angrier.

“Whether it was political dynamics, masking [mandates], or differences in opinions, people came out of it angry, and generally speaking, you don’t want an angry jury,” Mr. Henderson said. “For a while, there was the halo effect, where health professionals were seen as heroes. That went away, and all of a sudden [they] became ‘the bad guys.’ ”

“People are angry at the healthcare system, and this anger manifests itself in [liability] suits,” added Bill Burns, vice president of research for the Medical Professional Liability Association, an industry group for medical liability insurers.

Hospital and medical group consolidation also reduces the personal connection juries may have with healthcare providers, Mr. Burns said.

“Healthcare has become a big business, and the corporatization of medicine now puts companies on the stand and not your local community hospital or your family doctor that you have known since birth,” he said.

Plaintiffs’ attorneys also deploy tactics that can prompt higher verdicts, Mr. White said. They may tell a jury that the provider or hospital is a threat to the community and that awarding a large verdict will deter others in the healthcare community from repeating the same actions.

Juries may then want to punish the defendant in addition to assessing damages for economic harm or pain and suffering, Mr. White said.

“I am concerned that jurors are trying to right social wrongs rather than judging cases on the facts presented to them,” added Mike Stinson, vice president for policy and legal affairs for the Medical Professional Liability Association.

Third-party litigation financing also can lead to mega verdicts. That’s an emerging practice in which companies unrelated to a lawsuit provide capital to plaintiffs in return for a portion of any financial award. The firms essentially “invest” in the litigation.

“What this does is provide an additional financial backdrop for plaintiffs,” Mr. Henderson said. “It allows them to dig in harder on cases. They can hold out for higher numbers, and if nothing else, it can prolong litigation.”

Do High Awards Actually Stick?

Multimillion-dollar verdicts may grab headlines, but do plaintiffs actually receive them?

Rarely, said TransRe, which tracks the final outcomes of verdicts. In many cases, large verdicts are reduced on appeal.

In the Maya case, which involved child protection authorities, a judge later lowered the damages against Johns Hopkins All Children’s Hospital by $47.5 million.

A federal judge in October, for example, rejected a record $110 million medical malpractice award in Minnesota, reducing it to $10 million. The district judge ruled the award was “shockingly excessive” and that the plaintiff should either accept the $10 million award or retry the case.

After a verdict is awarded, the defendant typically challenges the award, and the case goes through the appellate pipeline, Mr. Henderson explained. A judge may reduce some elements of the verdict, he said, but more often, the plaintiff and defendant agree on a compromised figure.

Seattle medical liability defense attorney Jennifer Crisera has experienced this firsthand. She recalled a recent case where a plaintiff’s attorney demanded what she describes as an unreasonable amount to settle a claim. Ms. Crisera did not want to give exact numbers but said the plaintiff made an 8-figure demand and the defense offered a low 7-figure range.

“My impression was that plaintiff’s counsel believed that they could get a nuclear verdict from the jury, so they kept their settlement demand artificially high,” she said. “The division between the numbers was way too high. Ultimately, we had to let a jury decide the value.”

The plaintiff won the case, and the verdict was much less than the settlement demand, she said. Even so, the defense incurred trial costs, and the health provider was forced to endure the emotional stress of a trial that could have been avoided, Ms. Crisera said.

Higher medical malpractice premiums are another consequence of massive awards.

Premium rates are associated with how much insurers pay on average for cases and how frequently they are making payouts, Mr. White said.

Medical liability insurance premiums for physicians have steadily increased since 2019, according to data from the Medical Liability Monitor, a national publication that analyzes liability insurance premiums. The Monitor studies insurance premium data from insurers that cover internists, general surgeons, and obstetrician-gynecologists.

From 2019 to 2023, average premium rates for physicians increased between 1.1% and 3% each year in states without patient compensation funds, according to Monitor data.

“Nuclear verdicts are a real driver of the industry’s underwriting losses and remain top of mind for every malpractice insurance company,” said Michael Matray, editor for the Medical Liability Monitor. “Responses to this year’s rate survey questionnaire indicate that most responding companies have experienced an increase in claims greater than $1 million and claims greater than $5 million during the past 2 years.”

However, increases vary widely by region and among counties. In Montgomery County, Alabama, for instance, premiums for internists rose by 24% from 2022 to 2023, from $8,231 to $10,240. Premiums for Montgomery County general surgeons rose by 11.9% from 2022 to 2023, from $30,761 to $34,426, according to survey data.

In several counties in Illinois (Adams, Knox, Peoria, and Rock Island), premiums for some internists rose by 15% from $24,041 to $27,783, and premiums for some surgeons increased by 27% from $60,202 to $76,461, according to survey data. Some internists in Catoosa County, Georgia, meanwhile, paid $17,831 in 2023, up from $16,313 in 2022. Some surgeons in Catoosa County paid $65,616 in 2023, up from $60,032 in 2022. Inflation could be one factor behind higher liability premium rates. Claim severity is a key driver of higher premium rates, Mr. White added.

“We have not seen stability in claims severity,” he said. “It is continuing to go up and, in all likelihood, it will drive [premium] rates up further from this point.”
 

A version of this article appeared on Medscape.com.

A new Senate bill would require Medicare to test two tools routinely used by credit card companies to prevent fraud: Artificial intelligence (AI)-trained algorithms to detect suspicious activity and a system to quickly alert Medicare patients on whose behalf payment is being sought.

Senator Mike Braun (R-IN) recently introduced the Medicare Transaction Fraud Prevention Act, which calls for a 2-year test of this approach.

The experiment, targeted to start in 2025, would focus on durable medical equipment and clinical diagnostic laboratory tests and cover Medicare beneficiaries who receive electronic notices about claims.

The legislation would direct the Center for Medicare and Medicaid Services (CMS) to test the use of predictive risk-scoring algorithms in finding fraud. The program would be modeled on the systems that credit card companies already use. Transactions could be scored from 1 (least risky) to 99 (most risky).

CMS would then check directly by email or phone call with selected Medicare enrollees about transactions considered to present a high risk for fraud.

Many consumers have benefited from this approach when used to check for fraud on their credit cards, Braun noted during a November hearing of the Senate Special Committee on Aging. Credit card companies often can intervene before a fraudulent transaction is cleared.

“There’s no reason we wouldn’t want to minimally at least mimic that,” Braun said at the hearing.

Asking Medicare enrollees to verify certain purchases could give CMS increased access to vital predictive data, test proof of concept, and save hundreds of millions of dollars, Braun said.

Concerns Raised

So far, Braun has only one cosponsor for the bill, Senator Bill Cassidy, MD (R-LA), and the bill has drawn some criticism.

Brett Meeks, executive director of the Health Innovation Alliance, a trade group representing technology companies, insurers, and consumer organizations, objected to requiring Medicare enrollees to verify flagged orders. CMS should internally root out fraud through technology, not burden seniors, Meeks told this news organization.

Meeks said he has been following the discussion about the use of AI in addressing Medicare fraud. Had a bill broadly targeted Medicare fraud through AI, his alliance might have backed it, he said. But the current proposed legislation has a narrower focus.

Focusing on durable medical equipment, for example, could have unintended consequences like denying power wheelchairs to people with debilitating conditions like multiple sclerosis, Meeks said.

But Braun’s bill won a quick nod of approval from a researcher who studies the use of AI to detect Medicare fraud. Taghi M. Khoshgoftaar, PhD, director of the Data Mining and Machine Learning Lab at Florida Atlantic University, Boca Raton, Florida, said he sees an advantage to Braun’s approach of involving Medicare enrollees in the protection of their benefits.

The bill does not authorize funding for the pilot project, and it’s unclear what it would cost.

Detecting Medicare Fraud

The federal government has stepped up Medicare fraud investigations in recent years, and more doctors are getting caught.

A study published in 2018 examined cases of physicians excluded from Medicare using data from the US Office of Inspector General (OIG) at the Department of Health and Human Services.

The OIG has the right to exclude clinicians from Medicare for fraud or other reasons. Chen and coauthors looked at Medicare physician exclusions from 2007 to 2017. They found that exclusions due to fraud increased an estimated 14% per year on average from a base level of 139 exclusions in 2007.

In 2019, CMS sought feedback on new ways to use AI to detect fraud. In a public request for information, the agency said Medicare scrutinizes fewer claims for payment than commercial insurers do.

About 99.7% of Medicare fee-for-service claims are processed and paid within 17 days without any medical review, CMS said at the time.

A version of this article appeared on Medscape.com .

A new Senate bill would require Medicare to test two tools routinely used by credit card companies to prevent fraud: Artificial intelligence (AI)-trained algorithms to detect suspicious activity and a system to quickly alert Medicare patients on whose behalf payment is being sought.

Senator Mike Braun (R-IN) recently introduced the Medicare Transaction Fraud Prevention Act, which calls for a 2-year test of this approach.

The experiment, targeted to start in 2025, would focus on durable medical equipment and clinical diagnostic laboratory tests and cover Medicare beneficiaries who receive electronic notices about claims.

The legislation would direct the Center for Medicare and Medicaid Services (CMS) to test the use of predictive risk-scoring algorithms in finding fraud. The program would be modeled on the systems that credit card companies already use. Transactions could be scored from 1 (least risky) to 99 (most risky).

CMS would then check directly by email or phone call with selected Medicare enrollees about transactions considered to present a high risk for fraud.

Many consumers have benefited from this approach when used to check for fraud on their credit cards, Braun noted during a November hearing of the Senate Special Committee on Aging. Credit card companies often can intervene before a fraudulent transaction is cleared.

“There’s no reason we wouldn’t want to minimally at least mimic that,” Braun said at the hearing.

Asking Medicare enrollees to verify certain purchases could give CMS increased access to vital predictive data, test proof of concept, and save hundreds of millions of dollars, Braun said.

Concerns Raised

So far, Braun has only one cosponsor for the bill, Senator Bill Cassidy, MD (R-LA), and the bill has drawn some criticism.

Brett Meeks, executive director of the Health Innovation Alliance, a trade group representing technology companies, insurers, and consumer organizations, objected to requiring Medicare enrollees to verify flagged orders. CMS should internally root out fraud through technology, not burden seniors, Meeks told this news organization.

Meeks said he has been following the discussion about the use of AI in addressing Medicare fraud. Had a bill broadly targeted Medicare fraud through AI, his alliance might have backed it, he said. But the current proposed legislation has a narrower focus.

Focusing on durable medical equipment, for example, could have unintended consequences like denying power wheelchairs to people with debilitating conditions like multiple sclerosis, Meeks said.

But Braun’s bill won a quick nod of approval from a researcher who studies the use of AI to detect Medicare fraud. Taghi M. Khoshgoftaar, PhD, director of the Data Mining and Machine Learning Lab at Florida Atlantic University, Boca Raton, Florida, said he sees an advantage to Braun’s approach of involving Medicare enrollees in the protection of their benefits.

The bill does not authorize funding for the pilot project, and it’s unclear what it would cost.

Detecting Medicare Fraud

The federal government has stepped up Medicare fraud investigations in recent years, and more doctors are getting caught.

A study published in 2018 examined cases of physicians excluded from Medicare using data from the US Office of Inspector General (OIG) at the Department of Health and Human Services.

The OIG has the right to exclude clinicians from Medicare for fraud or other reasons. Chen and coauthors looked at Medicare physician exclusions from 2007 to 2017. They found that exclusions due to fraud increased an estimated 14% per year on average from a base level of 139 exclusions in 2007.

In 2019, CMS sought feedback on new ways to use AI to detect fraud. In a public request for information, the agency said Medicare scrutinizes fewer claims for payment than commercial insurers do.

About 99.7% of Medicare fee-for-service claims are processed and paid within 17 days without any medical review, CMS said at the time.

A version of this article appeared on Medscape.com .

A new Senate bill would require Medicare to test two tools routinely used by credit card companies to prevent fraud: Artificial intelligence (AI)-trained algorithms to detect suspicious activity and a system to quickly alert Medicare patients on whose behalf payment is being sought.

Senator Mike Braun (R-IN) recently introduced the Medicare Transaction Fraud Prevention Act, which calls for a 2-year test of this approach.

The experiment, targeted to start in 2025, would focus on durable medical equipment and clinical diagnostic laboratory tests and cover Medicare beneficiaries who receive electronic notices about claims.

The legislation would direct the Center for Medicare and Medicaid Services (CMS) to test the use of predictive risk-scoring algorithms in finding fraud. The program would be modeled on the systems that credit card companies already use. Transactions could be scored from 1 (least risky) to 99 (most risky).

CMS would then check directly by email or phone call with selected Medicare enrollees about transactions considered to present a high risk for fraud.

Many consumers have benefited from this approach when used to check for fraud on their credit cards, Braun noted during a November hearing of the Senate Special Committee on Aging. Credit card companies often can intervene before a fraudulent transaction is cleared.

“There’s no reason we wouldn’t want to minimally at least mimic that,” Braun said at the hearing.

Asking Medicare enrollees to verify certain purchases could give CMS increased access to vital predictive data, test proof of concept, and save hundreds of millions of dollars, Braun said.

Concerns Raised

So far, Braun has only one cosponsor for the bill, Senator Bill Cassidy, MD (R-LA), and the bill has drawn some criticism.

Brett Meeks, executive director of the Health Innovation Alliance, a trade group representing technology companies, insurers, and consumer organizations, objected to requiring Medicare enrollees to verify flagged orders. CMS should internally root out fraud through technology, not burden seniors, Meeks told this news organization.

Meeks said he has been following the discussion about the use of AI in addressing Medicare fraud. Had a bill broadly targeted Medicare fraud through AI, his alliance might have backed it, he said. But the current proposed legislation has a narrower focus.

Focusing on durable medical equipment, for example, could have unintended consequences like denying power wheelchairs to people with debilitating conditions like multiple sclerosis, Meeks said.

But Braun’s bill won a quick nod of approval from a researcher who studies the use of AI to detect Medicare fraud. Taghi M. Khoshgoftaar, PhD, director of the Data Mining and Machine Learning Lab at Florida Atlantic University, Boca Raton, Florida, said he sees an advantage to Braun’s approach of involving Medicare enrollees in the protection of their benefits.

The bill does not authorize funding for the pilot project, and it’s unclear what it would cost.

Detecting Medicare Fraud

The federal government has stepped up Medicare fraud investigations in recent years, and more doctors are getting caught.

A study published in 2018 examined cases of physicians excluded from Medicare using data from the US Office of Inspector General (OIG) at the Department of Health and Human Services.

The OIG has the right to exclude clinicians from Medicare for fraud or other reasons. Chen and coauthors looked at Medicare physician exclusions from 2007 to 2017. They found that exclusions due to fraud increased an estimated 14% per year on average from a base level of 139 exclusions in 2007.

In 2019, CMS sought feedback on new ways to use AI to detect fraud. In a public request for information, the agency said Medicare scrutinizes fewer claims for payment than commercial insurers do.

About 99.7% of Medicare fee-for-service claims are processed and paid within 17 days without any medical review, CMS said at the time.

A version of this article appeared on Medscape.com .

Modern technology for recording deep-brain activity involves sharp metal electrodes that penetrate the tissue, causing damage that can compromise the signal and limiting how often they can be used. 

A rapidly growing area in materials science and engineering aims to fix the problem by designing electrodes that are softer, smaller, and flexible — safer for use inside the delicate tissues of the brain. On January 17, researchers from the University of California, San Diego, reported the development of a thin, flexible electrode that can be inserted deep within the brain and communicate with sensors on the surface. 

But what if you could record detailed deep-brain activity without piercing the brain? 

A team of researchers (as it happens, also from UC San Diego) have developed a thin, flexible implant that “resides on the brain’s surface” and “can infer neural activity from deeper layers,” said Duygu Kuzum, PhD, a professor of electrical and computer engineering, who led the research. 

By combining electrical and optical imaging methods, and artificial intelligence, the researchers used the device — a polymer strip packed with graphene electrodes — to predict deep calcium activity from surface signals, according to a proof-of-concept study published this month in Nature Nanotechnology. 

“Almost everything we know about how neurons behave in living brains comes from data collected with either electrophysiology or two-photon imaging,” said neuroscientist Joshua H. Siegle, PhD, of the Allen Institute for Neural Dynamics in Seattle , who not involved in the study. “ Until now, these two methods have rarely been used simultaneously.”

The technology, which has been tested in mice, could help advance our knowledge of how the brain works and may lead to new minimally invasive treatments for neurologic disorders. 
 

Multimodal Neurotech: The Power of 2-in-1

Electrical and optical methods for recording brain activity have been crucial in advancing neurophysiologic science, but each technique has its limits. Electrical recordings provide high “temporal resolution”; they reveal when activation is happening, but not really where. Optical imaging, on the other hand, offers high “spatial resolution,” showing which area of the brain is lighting up, but its measurements may not correspond with the activity’s timing. 

Research over the past decade has explored how to combine and harness the strengths of both methods. One potential solution is to use electrodes made of transparent materials such as graphene, allowing a clear field of view for a microscope during imaging. Recently, University of Pennsylvania scientists used graphene electrodes to illuminate the neural dynamics of seizures. 

But there are challenges. If graphene electrodes are very small — in this case, 20 µm in diameter — they become more resistant to the flow of electricity. Dr. Kuzum and colleagues addressed this by adding tiny platinum particles to improve electrical conductivity. Long graphene wires connect electrodes to the circuit board, but defects in graphene can interrupt the signal, so they made each wire with two layers; any defects in one wire could be hidden by the other.

By combining the two methods (microelectrode arrays and two-photon imaging), the researchers could see both when brain activity was happening and where, including in deeper layers. They discovered a correlation between electrical responses on the surface and cellular calcium activity deeper down. The team used these data to create a neural network (a type of artificial intelligence that learns to recognize patterns) that predicts deep calcium activity from surface-level readings.

The tech could help scientists study brain activity “in a way not possible with current single-function tools,” said Luyao Lu, PhD, professor of biomedical engineering at George Washington University in Washington, DC, who was not involved in the study. It could shed light on interactions between vascular and electrical activity, or explain how place cells (neurons in the hippocampus) are so efficient at creating spatial memory. 

It could also pave the way for minimally invasive neural prosthetics or targeted treatments for neurologic disorders, the researchers say. Implanting the device would be a “straightforward process” similar to placing electrocorticography grids in patients with epilepsy, said Dr. Kuzum. 

But first, the team plans to do more studies in animal models before testing the tech in clinical settings, Dr. Kuzum added.

A version of this article appeared on Medscape.com.

Modern technology for recording deep-brain activity involves sharp metal electrodes that penetrate the tissue, causing damage that can compromise the signal and limiting how often they can be used. 

A rapidly growing area in materials science and engineering aims to fix the problem by designing electrodes that are softer, smaller, and flexible — safer for use inside the delicate tissues of the brain. On January 17, researchers from the University of California, San Diego, reported the development of a thin, flexible electrode that can be inserted deep within the brain and communicate with sensors on the surface. 

But what if you could record detailed deep-brain activity without piercing the brain? 

A team of researchers (as it happens, also from UC San Diego) have developed a thin, flexible implant that “resides on the brain’s surface” and “can infer neural activity from deeper layers,” said Duygu Kuzum, PhD, a professor of electrical and computer engineering, who led the research. 

By combining electrical and optical imaging methods, and artificial intelligence, the researchers used the device — a polymer strip packed with graphene electrodes — to predict deep calcium activity from surface signals, according to a proof-of-concept study published this month in Nature Nanotechnology. 

“Almost everything we know about how neurons behave in living brains comes from data collected with either electrophysiology or two-photon imaging,” said neuroscientist Joshua H. Siegle, PhD, of the Allen Institute for Neural Dynamics in Seattle , who not involved in the study. “ Until now, these two methods have rarely been used simultaneously.”

The technology, which has been tested in mice, could help advance our knowledge of how the brain works and may lead to new minimally invasive treatments for neurologic disorders. 
 

Multimodal Neurotech: The Power of 2-in-1

Electrical and optical methods for recording brain activity have been crucial in advancing neurophysiologic science, but each technique has its limits. Electrical recordings provide high “temporal resolution”; they reveal when activation is happening, but not really where. Optical imaging, on the other hand, offers high “spatial resolution,” showing which area of the brain is lighting up, but its measurements may not correspond with the activity’s timing. 

Research over the past decade has explored how to combine and harness the strengths of both methods. One potential solution is to use electrodes made of transparent materials such as graphene, allowing a clear field of view for a microscope during imaging. Recently, University of Pennsylvania scientists used graphene electrodes to illuminate the neural dynamics of seizures. 

But there are challenges. If graphene electrodes are very small — in this case, 20 µm in diameter — they become more resistant to the flow of electricity. Dr. Kuzum and colleagues addressed this by adding tiny platinum particles to improve electrical conductivity. Long graphene wires connect electrodes to the circuit board, but defects in graphene can interrupt the signal, so they made each wire with two layers; any defects in one wire could be hidden by the other.

By combining the two methods (microelectrode arrays and two-photon imaging), the researchers could see both when brain activity was happening and where, including in deeper layers. They discovered a correlation between electrical responses on the surface and cellular calcium activity deeper down. The team used these data to create a neural network (a type of artificial intelligence that learns to recognize patterns) that predicts deep calcium activity from surface-level readings.

The tech could help scientists study brain activity “in a way not possible with current single-function tools,” said Luyao Lu, PhD, professor of biomedical engineering at George Washington University in Washington, DC, who was not involved in the study. It could shed light on interactions between vascular and electrical activity, or explain how place cells (neurons in the hippocampus) are so efficient at creating spatial memory. 

It could also pave the way for minimally invasive neural prosthetics or targeted treatments for neurologic disorders, the researchers say. Implanting the device would be a “straightforward process” similar to placing electrocorticography grids in patients with epilepsy, said Dr. Kuzum. 

But first, the team plans to do more studies in animal models before testing the tech in clinical settings, Dr. Kuzum added.

A version of this article appeared on Medscape.com.

Modern technology for recording deep-brain activity involves sharp metal electrodes that penetrate the tissue, causing damage that can compromise the signal and limiting how often they can be used. 

A rapidly growing area in materials science and engineering aims to fix the problem by designing electrodes that are softer, smaller, and flexible — safer for use inside the delicate tissues of the brain. On January 17, researchers from the University of California, San Diego, reported the development of a thin, flexible electrode that can be inserted deep within the brain and communicate with sensors on the surface. 

But what if you could record detailed deep-brain activity without piercing the brain? 

A team of researchers (as it happens, also from UC San Diego) have developed a thin, flexible implant that “resides on the brain’s surface” and “can infer neural activity from deeper layers,” said Duygu Kuzum, PhD, a professor of electrical and computer engineering, who led the research. 

By combining electrical and optical imaging methods, and artificial intelligence, the researchers used the device — a polymer strip packed with graphene electrodes — to predict deep calcium activity from surface signals, according to a proof-of-concept study published this month in Nature Nanotechnology. 

“Almost everything we know about how neurons behave in living brains comes from data collected with either electrophysiology or two-photon imaging,” said neuroscientist Joshua H. Siegle, PhD, of the Allen Institute for Neural Dynamics in Seattle , who not involved in the study. “ Until now, these two methods have rarely been used simultaneously.”

The technology, which has been tested in mice, could help advance our knowledge of how the brain works and may lead to new minimally invasive treatments for neurologic disorders. 
 

Multimodal Neurotech: The Power of 2-in-1

Electrical and optical methods for recording brain activity have been crucial in advancing neurophysiologic science, but each technique has its limits. Electrical recordings provide high “temporal resolution”; they reveal when activation is happening, but not really where. Optical imaging, on the other hand, offers high “spatial resolution,” showing which area of the brain is lighting up, but its measurements may not correspond with the activity’s timing. 

Research over the past decade has explored how to combine and harness the strengths of both methods. One potential solution is to use electrodes made of transparent materials such as graphene, allowing a clear field of view for a microscope during imaging. Recently, University of Pennsylvania scientists used graphene electrodes to illuminate the neural dynamics of seizures. 

But there are challenges. If graphene electrodes are very small — in this case, 20 µm in diameter — they become more resistant to the flow of electricity. Dr. Kuzum and colleagues addressed this by adding tiny platinum particles to improve electrical conductivity. Long graphene wires connect electrodes to the circuit board, but defects in graphene can interrupt the signal, so they made each wire with two layers; any defects in one wire could be hidden by the other.

By combining the two methods (microelectrode arrays and two-photon imaging), the researchers could see both when brain activity was happening and where, including in deeper layers. They discovered a correlation between electrical responses on the surface and cellular calcium activity deeper down. The team used these data to create a neural network (a type of artificial intelligence that learns to recognize patterns) that predicts deep calcium activity from surface-level readings.

The tech could help scientists study brain activity “in a way not possible with current single-function tools,” said Luyao Lu, PhD, professor of biomedical engineering at George Washington University in Washington, DC, who was not involved in the study. It could shed light on interactions between vascular and electrical activity, or explain how place cells (neurons in the hippocampus) are so efficient at creating spatial memory. 

It could also pave the way for minimally invasive neural prosthetics or targeted treatments for neurologic disorders, the researchers say. Implanting the device would be a “straightforward process” similar to placing electrocorticography grids in patients with epilepsy, said Dr. Kuzum. 

But first, the team plans to do more studies in animal models before testing the tech in clinical settings, Dr. Kuzum added.

A version of this article appeared on Medscape.com.

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

A week earlier I’d had a heart surgery and was heading out for a post-op appointment when I saw it: I had a flat tire. It didn’t make sense. The tire was brand new, and there was no puncture. But it was flat.

I swapped out the flat for the spare and went off base to a tire shop. While I was there, my surgeon’s office called and rescheduled my appointment for a couple of hours later. That was lucky because by the time the tire was fixed, I had just enough time to get there.

The hospital is right near I-35 in San Antonio, Texas. I got off the freeway and onto the access road and paused to turn into the parking lot. That’s when I heard an enormous crash.

I saw a big poof of white smoke, and a car barreled off the freeway and came rolling down the embankment.

When the car hit the access road, I saw a woman ejected through the windshield. She bounced and landed in the road about 25 feet in front of me.

I put my car in park, grabbed my face mask and gloves, and started running toward her. But another vehicle — a truck towing a trailer — came from behind to drive around me. The driver didn’t realize what had happened and couldn’t stop in time…

The trailer ran over her.

I didn’t know if anyone could’ve survived that, but I went to her. I saw several other bystanders, but they were frozen in shock. I was praying, dear God, if she’s alive, let me do whatever I need to do to save her life.

It was a horrible scene. This poor lady was in a bloody heap in the middle of the road. Her right arm was twisted up under her neck so tightly, she was choking herself. So, the first thing I did was straighten her arm out to protect her airway.

I started yelling at people, “Call 9-1-1! Run to the hospital! Let them know there’s an accident out here, and I need help!”

The woman had a pulse, but it was super rapid. On first glance, she clearly had multiple fractures and a bad head bleed. With the sheer number of times she’d been injured, I didn’t know what was going on internally, but it was bad. She was gargling on her own blood and spitting it up. She was drowning.

A couple of technicians from the hospital came and brought me a tiny emergency kit. It had a blood pressure cuff and an oral airway. All the vital signs indicated the lady was going into shock. She’d lost a lot of blood on the pavement.

I was able to get the oral airway in. A few minutes later, a fire chief showed up. By now, the traffic had backed up so badly, the emergency vehicles couldn’t get in. But he managed to get there another way and gave me a cervical collar (C collar) and an Ambu bag.

I was hyper-focused on what I could do at that moment and what I needed to do next. Her stats were going down, but she still had a pulse. If she lost the pulse or went into a lethal rhythm, I’d have to start cardiopulmonary resuscitation (CPR). I asked the other people, but nobody else knew CPR, so I wouldn’t have help.

I could tell the lady had a pelvic fracture, and we needed to stabilize her. I directed people how to hold her neck safely and log-roll her flat on the ground. I also needed to put pressure on the back of her head because of all the bleeding. I got people to give me their clothes and tried to do that as I was bagging her.

The windows of her vehicle had all been blown out. I asked somebody to go find her purse with her ID. Then I noticed something …

My heart jumped into my stomach.

A car seat. There was an empty child’s car seat in the back of the car.

I started yelling at everyone, “Look for a baby! Go up and down the embankment and across the road. There might have been a baby in the car!”

But there wasn’t. Thank God. She hadn’t been driving with her child.

At that point, a paramedic came running from behind all the traffic. We did life support together until the ambulance finally arrived.

Emergency medical services got an intravenous line in and used medical anti-shock trousers. Thankfully, I already had the C collar on, and we’d been bagging her, so they could load her very quickly.

I got rid of my bloody gloves. I told a police officer I would come back. And then I went to my doctor’s appointment.

The window at my doctor’s office faced the access road, so the people there had seen all the traffic. They asked me what happened, and I said, “It was me. I saw it happen. I tried to help.” I was a little frazzled.

When I got back to the scene, the police and the fire chief kept thanking me for stopping. Why wouldn’t I stop? It was astounding to realize that they imagined somebody wouldn’t stop in a situation like this.

They told me the lady was alive. She was in the intensive care unit in critical condition, but she had survived. At that moment, I had this overwhelming feeling: God had put me in this exact place at the exact time to save her life.

Looking back, I think about how God ordered my steps. Without the mysterious flat tire, I would’ve gone to the hospital earlier. If my appointment hadn’t been rescheduled, I wouldn’t have been on the access road. All those events brought me there.

Several months later, the woman’s family contacted me and asked if we could meet. I found out more about her injuries. She’d had multiple skull fractures, facial fractures, and a broken jaw. Her upper arm was broken in three places. Her clavicle was broken. She had internal bleeding, a pelvic fracture, and a broken leg. She was 28 years old.

She’d had multiple surgeries, spent 2 months in the ICU, and another 3 months in intensive rehab. But she survived. It was incredible.

We all met up at a McDonald’s. First, her little son — who was the baby I thought might have been in the car — ran up to me and said, “Thank you for saving my mommy’s life.”

Then I turned, and there she was — a beautiful lady looking at me with awe and crying, saying, “It’s me.”

She obviously had gone through a transformation from all the injuries and the medications. She had a little bit of a speech delay, but mentally, she was there. She could walk.

She said, “You’re my angel. God put you there to save my life.” Her family all came up and hugged me. It was so beautiful.

She told me about the accident. She’d been speeding that day, zigzagging through lanes to get around the traffic. And she didn’t have her seatbelt on. She’d driven onto the shoulder to try to pass everyone, but it started narrowing. She clipped somebody’s bumper, went into a tailspin, and collided with a second vehicle, which caused her to flip over and down the embankment.

“God’s given me a new lease on life,” she said, “a fresh start. I will forever wear my seatbelt. And I’m going to do whatever I can to give back to other people because I don’t even feel like I deserve this.”

I just cried.

I’ve been a nurse for 29 years, first on the civilian side and later in the military. I’ve led codes and responded to trauma in a hospital setting or a deployed environment. I was well prepared to do what I did. But doing it under such stress with adrenaline bombarding me ... I’m amazed. I just think God’s hand was on me.

At that time, I was personally going through some things. After my heart surgery, I was in an emotional place where I didn’t feel loved or valued. But when I had that realization — when I knew that I was meant to be there to save her life, I also got the very clear message that I was valued and loved so much.

I know I have a very strong purpose. That day changed my life.
 

US Air Force Lt. Col. Anne Staley is the officer in charge of the Military Training Network, a division of the Defense Health Agency Education and Training Directorate in San Antonio, Texas.

A version of this article appeared on Medscape.com.

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

A week earlier I’d had a heart surgery and was heading out for a post-op appointment when I saw it: I had a flat tire. It didn’t make sense. The tire was brand new, and there was no puncture. But it was flat.

I swapped out the flat for the spare and went off base to a tire shop. While I was there, my surgeon’s office called and rescheduled my appointment for a couple of hours later. That was lucky because by the time the tire was fixed, I had just enough time to get there.

The hospital is right near I-35 in San Antonio, Texas. I got off the freeway and onto the access road and paused to turn into the parking lot. That’s when I heard an enormous crash.

I saw a big poof of white smoke, and a car barreled off the freeway and came rolling down the embankment.

When the car hit the access road, I saw a woman ejected through the windshield. She bounced and landed in the road about 25 feet in front of me.

I put my car in park, grabbed my face mask and gloves, and started running toward her. But another vehicle — a truck towing a trailer — came from behind to drive around me. The driver didn’t realize what had happened and couldn’t stop in time…

The trailer ran over her.

I didn’t know if anyone could’ve survived that, but I went to her. I saw several other bystanders, but they were frozen in shock. I was praying, dear God, if she’s alive, let me do whatever I need to do to save her life.

It was a horrible scene. This poor lady was in a bloody heap in the middle of the road. Her right arm was twisted up under her neck so tightly, she was choking herself. So, the first thing I did was straighten her arm out to protect her airway.

I started yelling at people, “Call 9-1-1! Run to the hospital! Let them know there’s an accident out here, and I need help!”

The woman had a pulse, but it was super rapid. On first glance, she clearly had multiple fractures and a bad head bleed. With the sheer number of times she’d been injured, I didn’t know what was going on internally, but it was bad. She was gargling on her own blood and spitting it up. She was drowning.

A couple of technicians from the hospital came and brought me a tiny emergency kit. It had a blood pressure cuff and an oral airway. All the vital signs indicated the lady was going into shock. She’d lost a lot of blood on the pavement.

I was able to get the oral airway in. A few minutes later, a fire chief showed up. By now, the traffic had backed up so badly, the emergency vehicles couldn’t get in. But he managed to get there another way and gave me a cervical collar (C collar) and an Ambu bag.

I was hyper-focused on what I could do at that moment and what I needed to do next. Her stats were going down, but she still had a pulse. If she lost the pulse or went into a lethal rhythm, I’d have to start cardiopulmonary resuscitation (CPR). I asked the other people, but nobody else knew CPR, so I wouldn’t have help.

I could tell the lady had a pelvic fracture, and we needed to stabilize her. I directed people how to hold her neck safely and log-roll her flat on the ground. I also needed to put pressure on the back of her head because of all the bleeding. I got people to give me their clothes and tried to do that as I was bagging her.

The windows of her vehicle had all been blown out. I asked somebody to go find her purse with her ID. Then I noticed something …

My heart jumped into my stomach.

A car seat. There was an empty child’s car seat in the back of the car.

I started yelling at everyone, “Look for a baby! Go up and down the embankment and across the road. There might have been a baby in the car!”

But there wasn’t. Thank God. She hadn’t been driving with her child.

At that point, a paramedic came running from behind all the traffic. We did life support together until the ambulance finally arrived.

Emergency medical services got an intravenous line in and used medical anti-shock trousers. Thankfully, I already had the C collar on, and we’d been bagging her, so they could load her very quickly.

I got rid of my bloody gloves. I told a police officer I would come back. And then I went to my doctor’s appointment.

The window at my doctor’s office faced the access road, so the people there had seen all the traffic. They asked me what happened, and I said, “It was me. I saw it happen. I tried to help.” I was a little frazzled.

When I got back to the scene, the police and the fire chief kept thanking me for stopping. Why wouldn’t I stop? It was astounding to realize that they imagined somebody wouldn’t stop in a situation like this.

They told me the lady was alive. She was in the intensive care unit in critical condition, but she had survived. At that moment, I had this overwhelming feeling: God had put me in this exact place at the exact time to save her life.

Looking back, I think about how God ordered my steps. Without the mysterious flat tire, I would’ve gone to the hospital earlier. If my appointment hadn’t been rescheduled, I wouldn’t have been on the access road. All those events brought me there.

Several months later, the woman’s family contacted me and asked if we could meet. I found out more about her injuries. She’d had multiple skull fractures, facial fractures, and a broken jaw. Her upper arm was broken in three places. Her clavicle was broken. She had internal bleeding, a pelvic fracture, and a broken leg. She was 28 years old.

She’d had multiple surgeries, spent 2 months in the ICU, and another 3 months in intensive rehab. But she survived. It was incredible.

We all met up at a McDonald’s. First, her little son — who was the baby I thought might have been in the car — ran up to me and said, “Thank you for saving my mommy’s life.”

Then I turned, and there she was — a beautiful lady looking at me with awe and crying, saying, “It’s me.”

She obviously had gone through a transformation from all the injuries and the medications. She had a little bit of a speech delay, but mentally, she was there. She could walk.

She said, “You’re my angel. God put you there to save my life.” Her family all came up and hugged me. It was so beautiful.

She told me about the accident. She’d been speeding that day, zigzagging through lanes to get around the traffic. And she didn’t have her seatbelt on. She’d driven onto the shoulder to try to pass everyone, but it started narrowing. She clipped somebody’s bumper, went into a tailspin, and collided with a second vehicle, which caused her to flip over and down the embankment.

“God’s given me a new lease on life,” she said, “a fresh start. I will forever wear my seatbelt. And I’m going to do whatever I can to give back to other people because I don’t even feel like I deserve this.”

I just cried.

I’ve been a nurse for 29 years, first on the civilian side and later in the military. I’ve led codes and responded to trauma in a hospital setting or a deployed environment. I was well prepared to do what I did. But doing it under such stress with adrenaline bombarding me ... I’m amazed. I just think God’s hand was on me.

At that time, I was personally going through some things. After my heart surgery, I was in an emotional place where I didn’t feel loved or valued. But when I had that realization — when I knew that I was meant to be there to save her life, I also got the very clear message that I was valued and loved so much.

I know I have a very strong purpose. That day changed my life.
 

US Air Force Lt. Col. Anne Staley is the officer in charge of the Military Training Network, a division of the Defense Health Agency Education and Training Directorate in San Antonio, Texas.

A version of this article appeared on Medscape.com.

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.

A week earlier I’d had a heart surgery and was heading out for a post-op appointment when I saw it: I had a flat tire. It didn’t make sense. The tire was brand new, and there was no puncture. But it was flat.

I swapped out the flat for the spare and went off base to a tire shop. While I was there, my surgeon’s office called and rescheduled my appointment for a couple of hours later. That was lucky because by the time the tire was fixed, I had just enough time to get there.

The hospital is right near I-35 in San Antonio, Texas. I got off the freeway and onto the access road and paused to turn into the parking lot. That’s when I heard an enormous crash.

I saw a big poof of white smoke, and a car barreled off the freeway and came rolling down the embankment.

When the car hit the access road, I saw a woman ejected through the windshield. She bounced and landed in the road about 25 feet in front of me.

I put my car in park, grabbed my face mask and gloves, and started running toward her. But another vehicle — a truck towing a trailer — came from behind to drive around me. The driver didn’t realize what had happened and couldn’t stop in time…

The trailer ran over her.

I didn’t know if anyone could’ve survived that, but I went to her. I saw several other bystanders, but they were frozen in shock. I was praying, dear God, if she’s alive, let me do whatever I need to do to save her life.

It was a horrible scene. This poor lady was in a bloody heap in the middle of the road. Her right arm was twisted up under her neck so tightly, she was choking herself. So, the first thing I did was straighten her arm out to protect her airway.

I started yelling at people, “Call 9-1-1! Run to the hospital! Let them know there’s an accident out here, and I need help!”

The woman had a pulse, but it was super rapid. On first glance, she clearly had multiple fractures and a bad head bleed. With the sheer number of times she’d been injured, I didn’t know what was going on internally, but it was bad. She was gargling on her own blood and spitting it up. She was drowning.

A couple of technicians from the hospital came and brought me a tiny emergency kit. It had a blood pressure cuff and an oral airway. All the vital signs indicated the lady was going into shock. She’d lost a lot of blood on the pavement.

I was able to get the oral airway in. A few minutes later, a fire chief showed up. By now, the traffic had backed up so badly, the emergency vehicles couldn’t get in. But he managed to get there another way and gave me a cervical collar (C collar) and an Ambu bag.

I was hyper-focused on what I could do at that moment and what I needed to do next. Her stats were going down, but she still had a pulse. If she lost the pulse or went into a lethal rhythm, I’d have to start cardiopulmonary resuscitation (CPR). I asked the other people, but nobody else knew CPR, so I wouldn’t have help.

I could tell the lady had a pelvic fracture, and we needed to stabilize her. I directed people how to hold her neck safely and log-roll her flat on the ground. I also needed to put pressure on the back of her head because of all the bleeding. I got people to give me their clothes and tried to do that as I was bagging her.

The windows of her vehicle had all been blown out. I asked somebody to go find her purse with her ID. Then I noticed something …

My heart jumped into my stomach.

A car seat. There was an empty child’s car seat in the back of the car.

I started yelling at everyone, “Look for a baby! Go up and down the embankment and across the road. There might have been a baby in the car!”

But there wasn’t. Thank God. She hadn’t been driving with her child.

At that point, a paramedic came running from behind all the traffic. We did life support together until the ambulance finally arrived.

Emergency medical services got an intravenous line in and used medical anti-shock trousers. Thankfully, I already had the C collar on, and we’d been bagging her, so they could load her very quickly.

I got rid of my bloody gloves. I told a police officer I would come back. And then I went to my doctor’s appointment.

The window at my doctor’s office faced the access road, so the people there had seen all the traffic. They asked me what happened, and I said, “It was me. I saw it happen. I tried to help.” I was a little frazzled.

When I got back to the scene, the police and the fire chief kept thanking me for stopping. Why wouldn’t I stop? It was astounding to realize that they imagined somebody wouldn’t stop in a situation like this.

They told me the lady was alive. She was in the intensive care unit in critical condition, but she had survived. At that moment, I had this overwhelming feeling: God had put me in this exact place at the exact time to save her life.

Looking back, I think about how God ordered my steps. Without the mysterious flat tire, I would’ve gone to the hospital earlier. If my appointment hadn’t been rescheduled, I wouldn’t have been on the access road. All those events brought me there.

Several months later, the woman’s family contacted me and asked if we could meet. I found out more about her injuries. She’d had multiple skull fractures, facial fractures, and a broken jaw. Her upper arm was broken in three places. Her clavicle was broken. She had internal bleeding, a pelvic fracture, and a broken leg. She was 28 years old.

She’d had multiple surgeries, spent 2 months in the ICU, and another 3 months in intensive rehab. But she survived. It was incredible.

We all met up at a McDonald’s. First, her little son — who was the baby I thought might have been in the car — ran up to me and said, “Thank you for saving my mommy’s life.”

Then I turned, and there she was — a beautiful lady looking at me with awe and crying, saying, “It’s me.”

She obviously had gone through a transformation from all the injuries and the medications. She had a little bit of a speech delay, but mentally, she was there. She could walk.

She said, “You’re my angel. God put you there to save my life.” Her family all came up and hugged me. It was so beautiful.

She told me about the accident. She’d been speeding that day, zigzagging through lanes to get around the traffic. And she didn’t have her seatbelt on. She’d driven onto the shoulder to try to pass everyone, but it started narrowing. She clipped somebody’s bumper, went into a tailspin, and collided with a second vehicle, which caused her to flip over and down the embankment.

“God’s given me a new lease on life,” she said, “a fresh start. I will forever wear my seatbelt. And I’m going to do whatever I can to give back to other people because I don’t even feel like I deserve this.”

I just cried.

I’ve been a nurse for 29 years, first on the civilian side and later in the military. I’ve led codes and responded to trauma in a hospital setting or a deployed environment. I was well prepared to do what I did. But doing it under such stress with adrenaline bombarding me ... I’m amazed. I just think God’s hand was on me.

At that time, I was personally going through some things. After my heart surgery, I was in an emotional place where I didn’t feel loved or valued. But when I had that realization — when I knew that I was meant to be there to save her life, I also got the very clear message that I was valued and loved so much.

I know I have a very strong purpose. That day changed my life.
 

US Air Force Lt. Col. Anne Staley is the officer in charge of the Military Training Network, a division of the Defense Health Agency Education and Training Directorate in San Antonio, Texas.

A version of this article appeared on Medscape.com.

Kidney stones afflict approximately one in nine individuals, causing intense pain and serious infections. With over 1.3 million emergency room visits and healthcare expenditures exceeding $5 billion annually in the United States, they pose a significant health burden. Laser fragmentation through ureteroscopy is the most common treatment, but success rates in eliminating stones range from 60% to 75%. Small, hard-to-extract fragments are often left behind, risking natural elimination. While technologies like focused ultrasound, fragment adhesion with biopolymers, and negative pressure aspiration have been explored, they face limitations, especially with standard ureteroscope channel sizes.
 

Magnetizing Renal Calculus Fragments

A published study introduced the Magnetic System for Total Nephrolith Extraction, a system designed to enhance the efficiency of renal calculus fragment removal. In this system, the stones are coated with a magnetic hydrogel and retrieved using a magnetic guidewire compatible with standard ureteroscopes.

In vitro, laser-obtained renal calculus fragments were separated by size and coated with either ferumoxytol alone or combined with chitosan (Hydrogel CF). Treated fragments were then subjected to a magnetic wire for fragment removal assessment. Additional tests included scanning electron microscopy and cell culture with human urothelial cells to evaluate the cytotoxicity of the magnetic hydrogel components. The hydrogel and its components underwent safety and efficacy evaluations in in vitro studies, human tissue samples, and murine models to assess their impact on urothelium and antibacterial properties.
 

Safe Fragment Removal

The Hydrogel CF, composed of ferumoxytol and chitosan, demonstrated 100% effectiveness in eliminating all tested fragments, even those measuring up to 4 mm, across various stone compositions. Particle tracing simulations indicated that small-sized stones (1 and 3 mm) could be captured several millimeters away. Scanning electron microscopy confirmed the binding of ferumoxytol and Hydrogel CF to the surface of calcium oxalate stones.

The components of Hydrogel CF did not induce significant cytotoxicity on human urothelial cells, even after a 4-hour exposure. Moreover, live mouse studies showed that Hydrogel CF caused less bladder urothelium exfoliation compared with chitosan, and the urothelium returned to normal within 12 hours. In addition, these components exhibited antibacterial properties, inhibiting the growth of uropathogenic bacteria such as Escherichia coli and Proteus mirabilis, comparable to that of ciprofloxacin.

The ability to eliminate lithiasic fragments, the absence of significant urothelial toxicity, and antibacterial activity suggest that the use of magnetic hydrogel could be integrated into laser treatments for renal stones through ureteroscopy without immediate complications. The antibacterial properties could offer potential postoperative benefits while reducing procedural time. Further animal studies are underway to assess the safety of Hydrogel CF before proceeding to human clinical trials.
 

This article was translated from JIM, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Kidney stones afflict approximately one in nine individuals, causing intense pain and serious infections. With over 1.3 million emergency room visits and healthcare expenditures exceeding $5 billion annually in the United States, they pose a significant health burden. Laser fragmentation through ureteroscopy is the most common treatment, but success rates in eliminating stones range from 60% to 75%. Small, hard-to-extract fragments are often left behind, risking natural elimination. While technologies like focused ultrasound, fragment adhesion with biopolymers, and negative pressure aspiration have been explored, they face limitations, especially with standard ureteroscope channel sizes.
 

Magnetizing Renal Calculus Fragments

A published study introduced the Magnetic System for Total Nephrolith Extraction, a system designed to enhance the efficiency of renal calculus fragment removal. In this system, the stones are coated with a magnetic hydrogel and retrieved using a magnetic guidewire compatible with standard ureteroscopes.

In vitro, laser-obtained renal calculus fragments were separated by size and coated with either ferumoxytol alone or combined with chitosan (Hydrogel CF). Treated fragments were then subjected to a magnetic wire for fragment removal assessment. Additional tests included scanning electron microscopy and cell culture with human urothelial cells to evaluate the cytotoxicity of the magnetic hydrogel components. The hydrogel and its components underwent safety and efficacy evaluations in in vitro studies, human tissue samples, and murine models to assess their impact on urothelium and antibacterial properties.
 

Safe Fragment Removal

The Hydrogel CF, composed of ferumoxytol and chitosan, demonstrated 100% effectiveness in eliminating all tested fragments, even those measuring up to 4 mm, across various stone compositions. Particle tracing simulations indicated that small-sized stones (1 and 3 mm) could be captured several millimeters away. Scanning electron microscopy confirmed the binding of ferumoxytol and Hydrogel CF to the surface of calcium oxalate stones.

The components of Hydrogel CF did not induce significant cytotoxicity on human urothelial cells, even after a 4-hour exposure. Moreover, live mouse studies showed that Hydrogel CF caused less bladder urothelium exfoliation compared with chitosan, and the urothelium returned to normal within 12 hours. In addition, these components exhibited antibacterial properties, inhibiting the growth of uropathogenic bacteria such as Escherichia coli and Proteus mirabilis, comparable to that of ciprofloxacin.

The ability to eliminate lithiasic fragments, the absence of significant urothelial toxicity, and antibacterial activity suggest that the use of magnetic hydrogel could be integrated into laser treatments for renal stones through ureteroscopy without immediate complications. The antibacterial properties could offer potential postoperative benefits while reducing procedural time. Further animal studies are underway to assess the safety of Hydrogel CF before proceeding to human clinical trials.
 

This article was translated from JIM, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Kidney stones afflict approximately one in nine individuals, causing intense pain and serious infections. With over 1.3 million emergency room visits and healthcare expenditures exceeding $5 billion annually in the United States, they pose a significant health burden. Laser fragmentation through ureteroscopy is the most common treatment, but success rates in eliminating stones range from 60% to 75%. Small, hard-to-extract fragments are often left behind, risking natural elimination. While technologies like focused ultrasound, fragment adhesion with biopolymers, and negative pressure aspiration have been explored, they face limitations, especially with standard ureteroscope channel sizes.
 

Magnetizing Renal Calculus Fragments

A published study introduced the Magnetic System for Total Nephrolith Extraction, a system designed to enhance the efficiency of renal calculus fragment removal. In this system, the stones are coated with a magnetic hydrogel and retrieved using a magnetic guidewire compatible with standard ureteroscopes.

In vitro, laser-obtained renal calculus fragments were separated by size and coated with either ferumoxytol alone or combined with chitosan (Hydrogel CF). Treated fragments were then subjected to a magnetic wire for fragment removal assessment. Additional tests included scanning electron microscopy and cell culture with human urothelial cells to evaluate the cytotoxicity of the magnetic hydrogel components. The hydrogel and its components underwent safety and efficacy evaluations in in vitro studies, human tissue samples, and murine models to assess their impact on urothelium and antibacterial properties.
 

Safe Fragment Removal

The Hydrogel CF, composed of ferumoxytol and chitosan, demonstrated 100% effectiveness in eliminating all tested fragments, even those measuring up to 4 mm, across various stone compositions. Particle tracing simulations indicated that small-sized stones (1 and 3 mm) could be captured several millimeters away. Scanning electron microscopy confirmed the binding of ferumoxytol and Hydrogel CF to the surface of calcium oxalate stones.

The components of Hydrogel CF did not induce significant cytotoxicity on human urothelial cells, even after a 4-hour exposure. Moreover, live mouse studies showed that Hydrogel CF caused less bladder urothelium exfoliation compared with chitosan, and the urothelium returned to normal within 12 hours. In addition, these components exhibited antibacterial properties, inhibiting the growth of uropathogenic bacteria such as Escherichia coli and Proteus mirabilis, comparable to that of ciprofloxacin.

The ability to eliminate lithiasic fragments, the absence of significant urothelial toxicity, and antibacterial activity suggest that the use of magnetic hydrogel could be integrated into laser treatments for renal stones through ureteroscopy without immediate complications. The antibacterial properties could offer potential postoperative benefits while reducing procedural time. Further animal studies are underway to assess the safety of Hydrogel CF before proceeding to human clinical trials.
 

This article was translated from JIM, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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

Physicians groups on January 17 hailed a new federal rule requiring health insurers to streamline and disclose more information about their prior authorization processes, saying it will improve patient care and reduce doctors’ administrative burden.

Health insurers participating in federal programs, including Medicare Advantage and Medicaid, must now respond to expedited prior authorization requests within 72 hours and other requests within 7 days under the long-awaited final rule, released on January 17 by the Centers for Medicare & Medicaid Services (CMS). 

Insurers also must include their reasons for denying a prior authorization request and will be required to publicly release data on denial and approval rates for medical treatment. They’ll also need to give patients more information about their decisions to deny care. Insurers must comply with some of the rule’s provisions by January 2026 and others by January 2027. 

The final rule “is an important step forward” toward the Medical Group Management Association’s goal of reducing the overall volume of prior authorization requests, said Anders Gilberg, the group’s senior vice president for government affairs, in a statement. 

“Only then will medical groups find meaningful reprieve from these onerous, ill-intentioned administrative requirements that dangerously impede patient care,” Mr. Gilberg said.

Health insurers have long lobbied against increased regulation of prior authorization, arguing that it’s needed to rein in healthcare costs and prevent unnecessary treatment. 

“We appreciate CMS’s announcement of enforcement discretion that will permit plans to use one standard, rather than mixing and matching, to reduce costs and speed implementation,” said America’s Health Insurance Plans, an insurers’ lobbying group, in an unsigned statement. “However, we must remember that the CMS rule is only half the picture; the Office of the Coordinator for Health Information Technology (ONC) should swiftly require vendors to build electronic prior authorization capabilities into the electronic health record so that providers can do their part, or plans will build a bridge to nowhere.” 

The rule comes as health insurers have increasingly been criticized for onerous and time-consuming prior authorization procedures that physicians say unfairly delay or deny the medical treatment that their patients need. With federal legislation to rein in prior authorization overuse at a standstill, 30 states have introduced their own bills to address the problem. Regulators and lawsuits also have called attention to insurers’ increasing use of artificial intelligence and algorithms to deny claims without human review.

“Family physicians know firsthand how prior authorizations divert valuable time and resources away from direct patient care. We also know that these types of administrative requirements are driving physicians away from the workforce and worsening physician shortages,” said Steven P. Furr, MD, president of the American Academy of Family Physicians, in a statement praising the new rule. 

Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, called the final rule “ a major win” for patients and physicians, adding that its requirements for health insurers to integrate their prior authorization procedures into physicians’ electronic health records systems will also help make “the current time-consuming, manual workflow” more efficient.

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