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Federal Bill Seeks AI Tools to Stop Medicare Fraud
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 .
Etrasimod Appears Effective in Eosinophilic Esophagitis: Phase 2 Study
Etrasimod, an investigational, oral selective sphingosine-1-phosphate (S1P)–receptor modulator, also improved endoscopic features of EoE, overall symptom severity, and dysphagia in some patients, researchers reported.
“These results support further investigation of etrasimod in EoE,” said Evan S. Dellon, MD, MPH, AGAF, of the University of North Carolina at Chapel Hill.
Dr. Dellon presented the results from the phase 2 study at the October 2023 annual scientific meeting of the American College of Gastroenterology in Vancouver, Canada.
VOYAGE Study
In the VOYAGE study, 108 adults were included, with about half female and an average EoE diagnosis for nearly 5 years.
The patients were randomized to once-daily doses of etrasimod 2 mg, etrasimod 1 mg, or placebo for 24 weeks, followed by a 28-week still-ongoing extension period investigating the efficacy and safety of daily oral etrasimod 1 mg and 2 mg, compared with placebo.
After 24 weeks of treatment, there was a 52.4% reduction in peak eosinophil count (PEC) in the group of patients who were given a 2-mg daily dose of etrasimod compared to placebo, Dr. Dellon said.
Among patients given a 1-mg daily dose of etrasimod, there was a 27.4% reduction in PEC.
Meanwhile, there was a 61% increase in PEC for people who were given placebo.
Etrasimod also bested placebo on secondary outcomes in the VOYAGE study, including:
- Comprehensive histologic severity and extent scores, with a change of -0.2 in both etrasimod groups (P < .0001), compared with a slight increase for the placebo group.
- Endoscopic features (EREFS), with a decline of 1.3 for the 2-mg–dose etrasimod group (P = .0303), compared with a slight decline for the placebo group. There was a decline of 1.0 in the 1-mg–dose etrasimod group, but this was not statistically significant.
Higher Dose Arm, Better Results
In the email exchange with GI & Hepatology News, Dr. Dellon said this appears to be “a dose-response where the 2-mg dose is needed to see more prominent response, but the EREFS response is in the right direction with the 1-mg dose.”
The study found a statistically significant decrease in only one segment of the trial participants, those who took the 2-mg dose and had a history of dilation, as measured by the Dysphagia Symptom Questionnaire (DSQ). In that group, there was a reported decrease of 21.6 points from baseline.
“The average scores at baseline are in the low 30s. The range for DSQ (which is a composite score of daily measurements over 14 days) is from 0 to 84,” Dr. Dellon wrote. “A score in the 30s over 2 weeks is quite symptomatic, so a decrease of 21.6 points is substantial.”
Dr. Dellon and co-authors said etrasimod appeared to be well tolerated with a safety profile consistent with use of the drug in patients with ulcerative colitis.
In treatment-emergent adverse events, elevation of liver transaminases was reported among 4 of 39 patients (10.3%) in the 1-mg etrasimod group and 3 of the 41 patients (7.3%) in the 2-mg etrasimod group, compared with none in the placebo group.
Bilirubin elevation was reported in 2 patients (5.1%) in the 1-mg etrasimod group and none in the 2-mg etrasimod or placebo groups.
Prospect of Another EoE Treatment
In an interview with GI & Hepatology News, Scott Gabbard, MD, a gastroenterologist at Cleveland Clinic, said, “For so many years, there was no FDA approved therapy [for EoE]. Now, we do have an FDA approved therapy.”
The FDA approved the first treatment for EoE — dupilumab (Dupixent) — last year.
“It’s exciting to suddenly have the prospect of more options for patients with EoE. We can see multiple other options for our patients who sorely need therapy coming down the pipeline,” Dr. Gabbard said.
The data support further investigation, with only about one potential concern drawing attention during the presentation, he added.
“Overall, there were no serious adverse events,” Dr. Gabbard said. “There was clearly a change in baseline and overall symptom scores.”
In an email exchange with GI & Hepatology News, Jennifer Horsley-Silva, MD, of the Mayo Clinic, said the VOYAGE study was important because it serves as a proof of concept that targeting S1P receptors can affect EoE.
“A limitation of the study is it was conducted in a specific group of patients with EoE: a substantial number were refractory to corticosteroids, and over half had prior esophageal dilations,” she wrote.
Pfizer sponsored the VOYAGE trial. Dr. Dellon indicated no relevant financial relationships. Dr. Horsley Silva has research funding from Regeneron/Sanofi, Allakos, Celgene, Bristol Myers Squibb, and has participated in an advisory board for Sanofi Genzyme. No disclosures were included for Dr. Gabbard and no recent paper is available in PubMed for Dr. Horsley-Silva.
Etrasimod, an investigational, oral selective sphingosine-1-phosphate (S1P)–receptor modulator, also improved endoscopic features of EoE, overall symptom severity, and dysphagia in some patients, researchers reported.
“These results support further investigation of etrasimod in EoE,” said Evan S. Dellon, MD, MPH, AGAF, of the University of North Carolina at Chapel Hill.
Dr. Dellon presented the results from the phase 2 study at the October 2023 annual scientific meeting of the American College of Gastroenterology in Vancouver, Canada.
VOYAGE Study
In the VOYAGE study, 108 adults were included, with about half female and an average EoE diagnosis for nearly 5 years.
The patients were randomized to once-daily doses of etrasimod 2 mg, etrasimod 1 mg, or placebo for 24 weeks, followed by a 28-week still-ongoing extension period investigating the efficacy and safety of daily oral etrasimod 1 mg and 2 mg, compared with placebo.
After 24 weeks of treatment, there was a 52.4% reduction in peak eosinophil count (PEC) in the group of patients who were given a 2-mg daily dose of etrasimod compared to placebo, Dr. Dellon said.
Among patients given a 1-mg daily dose of etrasimod, there was a 27.4% reduction in PEC.
Meanwhile, there was a 61% increase in PEC for people who were given placebo.
Etrasimod also bested placebo on secondary outcomes in the VOYAGE study, including:
- Comprehensive histologic severity and extent scores, with a change of -0.2 in both etrasimod groups (P < .0001), compared with a slight increase for the placebo group.
- Endoscopic features (EREFS), with a decline of 1.3 for the 2-mg–dose etrasimod group (P = .0303), compared with a slight decline for the placebo group. There was a decline of 1.0 in the 1-mg–dose etrasimod group, but this was not statistically significant.
Higher Dose Arm, Better Results
In the email exchange with GI & Hepatology News, Dr. Dellon said this appears to be “a dose-response where the 2-mg dose is needed to see more prominent response, but the EREFS response is in the right direction with the 1-mg dose.”
The study found a statistically significant decrease in only one segment of the trial participants, those who took the 2-mg dose and had a history of dilation, as measured by the Dysphagia Symptom Questionnaire (DSQ). In that group, there was a reported decrease of 21.6 points from baseline.
“The average scores at baseline are in the low 30s. The range for DSQ (which is a composite score of daily measurements over 14 days) is from 0 to 84,” Dr. Dellon wrote. “A score in the 30s over 2 weeks is quite symptomatic, so a decrease of 21.6 points is substantial.”
Dr. Dellon and co-authors said etrasimod appeared to be well tolerated with a safety profile consistent with use of the drug in patients with ulcerative colitis.
In treatment-emergent adverse events, elevation of liver transaminases was reported among 4 of 39 patients (10.3%) in the 1-mg etrasimod group and 3 of the 41 patients (7.3%) in the 2-mg etrasimod group, compared with none in the placebo group.
Bilirubin elevation was reported in 2 patients (5.1%) in the 1-mg etrasimod group and none in the 2-mg etrasimod or placebo groups.
Prospect of Another EoE Treatment
In an interview with GI & Hepatology News, Scott Gabbard, MD, a gastroenterologist at Cleveland Clinic, said, “For so many years, there was no FDA approved therapy [for EoE]. Now, we do have an FDA approved therapy.”
The FDA approved the first treatment for EoE — dupilumab (Dupixent) — last year.
“It’s exciting to suddenly have the prospect of more options for patients with EoE. We can see multiple other options for our patients who sorely need therapy coming down the pipeline,” Dr. Gabbard said.
The data support further investigation, with only about one potential concern drawing attention during the presentation, he added.
“Overall, there were no serious adverse events,” Dr. Gabbard said. “There was clearly a change in baseline and overall symptom scores.”
In an email exchange with GI & Hepatology News, Jennifer Horsley-Silva, MD, of the Mayo Clinic, said the VOYAGE study was important because it serves as a proof of concept that targeting S1P receptors can affect EoE.
“A limitation of the study is it was conducted in a specific group of patients with EoE: a substantial number were refractory to corticosteroids, and over half had prior esophageal dilations,” she wrote.
Pfizer sponsored the VOYAGE trial. Dr. Dellon indicated no relevant financial relationships. Dr. Horsley Silva has research funding from Regeneron/Sanofi, Allakos, Celgene, Bristol Myers Squibb, and has participated in an advisory board for Sanofi Genzyme. No disclosures were included for Dr. Gabbard and no recent paper is available in PubMed for Dr. Horsley-Silva.
Etrasimod, an investigational, oral selective sphingosine-1-phosphate (S1P)–receptor modulator, also improved endoscopic features of EoE, overall symptom severity, and dysphagia in some patients, researchers reported.
“These results support further investigation of etrasimod in EoE,” said Evan S. Dellon, MD, MPH, AGAF, of the University of North Carolina at Chapel Hill.
Dr. Dellon presented the results from the phase 2 study at the October 2023 annual scientific meeting of the American College of Gastroenterology in Vancouver, Canada.
VOYAGE Study
In the VOYAGE study, 108 adults were included, with about half female and an average EoE diagnosis for nearly 5 years.
The patients were randomized to once-daily doses of etrasimod 2 mg, etrasimod 1 mg, or placebo for 24 weeks, followed by a 28-week still-ongoing extension period investigating the efficacy and safety of daily oral etrasimod 1 mg and 2 mg, compared with placebo.
After 24 weeks of treatment, there was a 52.4% reduction in peak eosinophil count (PEC) in the group of patients who were given a 2-mg daily dose of etrasimod compared to placebo, Dr. Dellon said.
Among patients given a 1-mg daily dose of etrasimod, there was a 27.4% reduction in PEC.
Meanwhile, there was a 61% increase in PEC for people who were given placebo.
Etrasimod also bested placebo on secondary outcomes in the VOYAGE study, including:
- Comprehensive histologic severity and extent scores, with a change of -0.2 in both etrasimod groups (P < .0001), compared with a slight increase for the placebo group.
- Endoscopic features (EREFS), with a decline of 1.3 for the 2-mg–dose etrasimod group (P = .0303), compared with a slight decline for the placebo group. There was a decline of 1.0 in the 1-mg–dose etrasimod group, but this was not statistically significant.
Higher Dose Arm, Better Results
In the email exchange with GI & Hepatology News, Dr. Dellon said this appears to be “a dose-response where the 2-mg dose is needed to see more prominent response, but the EREFS response is in the right direction with the 1-mg dose.”
The study found a statistically significant decrease in only one segment of the trial participants, those who took the 2-mg dose and had a history of dilation, as measured by the Dysphagia Symptom Questionnaire (DSQ). In that group, there was a reported decrease of 21.6 points from baseline.
“The average scores at baseline are in the low 30s. The range for DSQ (which is a composite score of daily measurements over 14 days) is from 0 to 84,” Dr. Dellon wrote. “A score in the 30s over 2 weeks is quite symptomatic, so a decrease of 21.6 points is substantial.”
Dr. Dellon and co-authors said etrasimod appeared to be well tolerated with a safety profile consistent with use of the drug in patients with ulcerative colitis.
In treatment-emergent adverse events, elevation of liver transaminases was reported among 4 of 39 patients (10.3%) in the 1-mg etrasimod group and 3 of the 41 patients (7.3%) in the 2-mg etrasimod group, compared with none in the placebo group.
Bilirubin elevation was reported in 2 patients (5.1%) in the 1-mg etrasimod group and none in the 2-mg etrasimod or placebo groups.
Prospect of Another EoE Treatment
In an interview with GI & Hepatology News, Scott Gabbard, MD, a gastroenterologist at Cleveland Clinic, said, “For so many years, there was no FDA approved therapy [for EoE]. Now, we do have an FDA approved therapy.”
The FDA approved the first treatment for EoE — dupilumab (Dupixent) — last year.
“It’s exciting to suddenly have the prospect of more options for patients with EoE. We can see multiple other options for our patients who sorely need therapy coming down the pipeline,” Dr. Gabbard said.
The data support further investigation, with only about one potential concern drawing attention during the presentation, he added.
“Overall, there were no serious adverse events,” Dr. Gabbard said. “There was clearly a change in baseline and overall symptom scores.”
In an email exchange with GI & Hepatology News, Jennifer Horsley-Silva, MD, of the Mayo Clinic, said the VOYAGE study was important because it serves as a proof of concept that targeting S1P receptors can affect EoE.
“A limitation of the study is it was conducted in a specific group of patients with EoE: a substantial number were refractory to corticosteroids, and over half had prior esophageal dilations,” she wrote.
Pfizer sponsored the VOYAGE trial. Dr. Dellon indicated no relevant financial relationships. Dr. Horsley Silva has research funding from Regeneron/Sanofi, Allakos, Celgene, Bristol Myers Squibb, and has participated in an advisory board for Sanofi Genzyme. No disclosures were included for Dr. Gabbard and no recent paper is available in PubMed for Dr. Horsley-Silva.
FROM ACG 2023
Ultrasound Monitoring of IBD May Prompt Faster Treatment Change
, according to a small retrospective analysis.
“Current disease monitoring tools have significant limitations,” said Noa Krugliak Cleveland, MD, director of the intestinal ultrasound program at the University of Chicago. “Intestinal ultrasound is an innovative technology that enables point-of-care assessment.”
Dr. Cleveland presented the findings at the October 2023 American College of Gastroenterology’s annual scientific meeting in Vancouver, Canada.
The analysis was based on 30 patients with IBD in an ongoing real-world prospective study of upadacitinib (Rinvoq, Abbvie) who were not in clinical remission at week 8. For 11 patients, routine clinical care included IUS; the other 19 patients were monitored using a conventional approach.
In the study, both groups were almost evenly split in terms of diagnosis. In the IUS group, four patients had Crohn’s disease and five had ulcerative colitis. In the conventional management group, six had Crohn’s disease and five had ulcerative colitis.
The primary endpoint was time to treatment change.
For the secondary endpoint, the researchers defined clinical remission as a Simple Clinical Colitis Activity Index ≤ 2, or Harvey-Bradshaw Index ≤ 4, and by IUS as bowel wall thickness ≤ 3 mm in the colon or terminal ileum and no hyperemia by color Doppler signal.
The average time to treatment change in the IUS group was 1.1 days, compared with 16.6 days for the conventional management group, Dr. Cleveland reported.
The average time to clinical remission was 26.8 days for the IUS group, compared with 55.3 days for the conventional management group.
The delays in treatment change in the conventional management group were attributed to awaiting test results and endoscopy procedures, as well as communications among clinical team members.
Strength of this research project included its prospective data collection and the experienced sonographers who participated, Dr. Cleveland and colleagues said. Limitations included retrospective analysis, a small number of patients on a single therapy, and the potential for bias in patient selection. Studies of other therapies and a prospective trial are underway.
During the presentation, Dr. Cleveland commented about what kinds of treatment changes were made for patients in the study. They commonly involved extending the induction time, and, in some cases, patients were switched to another treatment, she said.
In an interview, Michael Dolinger, MD, of the Icahn School of Medicine at Mount Sinai in New York, said more research needs to be done to show whether IUS will improve outcomes.
“They’re showing that they make more changes sooner,” he said. “Does that actually affect and improve outcomes? That’s the big question.”
Dr. Dolinger said the concept for using IUS is that it helps physicians catch disease flares earlier and respond faster with changes to the treatment plan, thus preventing the buildup of chronic bowel damage.
“That’s the concept, but that concept is actually not so proven in reality” yet, he said. “But I do believe that they’re on the right path.”
In Dr. Dolinger’s view, adding ultrasound provides a more patient-centric approach to care of people with IBD. With more traditional approaches, patients often are waiting for results of tests done outside of the visit, such as MRI.
“With ultrasound, I am walking them through the results as it’s happening in real time during the clinic visit,” Dr. Dolinger said. ”I am showing them on the screen, allowing them to ask questions. They’re telling me about their symptoms, as I’m putting the probe on where it may hurt, as I’m showing them inflammation or healing. And that changes the whole conversation.”
The study received support from the Mutchnik Family Foundation. Dr. Cleveland reported financial relationships with Bristol Myers Squibb, Neurologica, and Takeda. Her coauthors reported financial relationships with multiple drug and device makers. Dr. Dolinger said he is a consultant for Samsung’s Neurologica Corp., which makes ultrasound equipment.
, according to a small retrospective analysis.
“Current disease monitoring tools have significant limitations,” said Noa Krugliak Cleveland, MD, director of the intestinal ultrasound program at the University of Chicago. “Intestinal ultrasound is an innovative technology that enables point-of-care assessment.”
Dr. Cleveland presented the findings at the October 2023 American College of Gastroenterology’s annual scientific meeting in Vancouver, Canada.
The analysis was based on 30 patients with IBD in an ongoing real-world prospective study of upadacitinib (Rinvoq, Abbvie) who were not in clinical remission at week 8. For 11 patients, routine clinical care included IUS; the other 19 patients were monitored using a conventional approach.
In the study, both groups were almost evenly split in terms of diagnosis. In the IUS group, four patients had Crohn’s disease and five had ulcerative colitis. In the conventional management group, six had Crohn’s disease and five had ulcerative colitis.
The primary endpoint was time to treatment change.
For the secondary endpoint, the researchers defined clinical remission as a Simple Clinical Colitis Activity Index ≤ 2, or Harvey-Bradshaw Index ≤ 4, and by IUS as bowel wall thickness ≤ 3 mm in the colon or terminal ileum and no hyperemia by color Doppler signal.
The average time to treatment change in the IUS group was 1.1 days, compared with 16.6 days for the conventional management group, Dr. Cleveland reported.
The average time to clinical remission was 26.8 days for the IUS group, compared with 55.3 days for the conventional management group.
The delays in treatment change in the conventional management group were attributed to awaiting test results and endoscopy procedures, as well as communications among clinical team members.
Strength of this research project included its prospective data collection and the experienced sonographers who participated, Dr. Cleveland and colleagues said. Limitations included retrospective analysis, a small number of patients on a single therapy, and the potential for bias in patient selection. Studies of other therapies and a prospective trial are underway.
During the presentation, Dr. Cleveland commented about what kinds of treatment changes were made for patients in the study. They commonly involved extending the induction time, and, in some cases, patients were switched to another treatment, she said.
In an interview, Michael Dolinger, MD, of the Icahn School of Medicine at Mount Sinai in New York, said more research needs to be done to show whether IUS will improve outcomes.
“They’re showing that they make more changes sooner,” he said. “Does that actually affect and improve outcomes? That’s the big question.”
Dr. Dolinger said the concept for using IUS is that it helps physicians catch disease flares earlier and respond faster with changes to the treatment plan, thus preventing the buildup of chronic bowel damage.
“That’s the concept, but that concept is actually not so proven in reality” yet, he said. “But I do believe that they’re on the right path.”
In Dr. Dolinger’s view, adding ultrasound provides a more patient-centric approach to care of people with IBD. With more traditional approaches, patients often are waiting for results of tests done outside of the visit, such as MRI.
“With ultrasound, I am walking them through the results as it’s happening in real time during the clinic visit,” Dr. Dolinger said. ”I am showing them on the screen, allowing them to ask questions. They’re telling me about their symptoms, as I’m putting the probe on where it may hurt, as I’m showing them inflammation or healing. And that changes the whole conversation.”
The study received support from the Mutchnik Family Foundation. Dr. Cleveland reported financial relationships with Bristol Myers Squibb, Neurologica, and Takeda. Her coauthors reported financial relationships with multiple drug and device makers. Dr. Dolinger said he is a consultant for Samsung’s Neurologica Corp., which makes ultrasound equipment.
, according to a small retrospective analysis.
“Current disease monitoring tools have significant limitations,” said Noa Krugliak Cleveland, MD, director of the intestinal ultrasound program at the University of Chicago. “Intestinal ultrasound is an innovative technology that enables point-of-care assessment.”
Dr. Cleveland presented the findings at the October 2023 American College of Gastroenterology’s annual scientific meeting in Vancouver, Canada.
The analysis was based on 30 patients with IBD in an ongoing real-world prospective study of upadacitinib (Rinvoq, Abbvie) who were not in clinical remission at week 8. For 11 patients, routine clinical care included IUS; the other 19 patients were monitored using a conventional approach.
In the study, both groups were almost evenly split in terms of diagnosis. In the IUS group, four patients had Crohn’s disease and five had ulcerative colitis. In the conventional management group, six had Crohn’s disease and five had ulcerative colitis.
The primary endpoint was time to treatment change.
For the secondary endpoint, the researchers defined clinical remission as a Simple Clinical Colitis Activity Index ≤ 2, or Harvey-Bradshaw Index ≤ 4, and by IUS as bowel wall thickness ≤ 3 mm in the colon or terminal ileum and no hyperemia by color Doppler signal.
The average time to treatment change in the IUS group was 1.1 days, compared with 16.6 days for the conventional management group, Dr. Cleveland reported.
The average time to clinical remission was 26.8 days for the IUS group, compared with 55.3 days for the conventional management group.
The delays in treatment change in the conventional management group were attributed to awaiting test results and endoscopy procedures, as well as communications among clinical team members.
Strength of this research project included its prospective data collection and the experienced sonographers who participated, Dr. Cleveland and colleagues said. Limitations included retrospective analysis, a small number of patients on a single therapy, and the potential for bias in patient selection. Studies of other therapies and a prospective trial are underway.
During the presentation, Dr. Cleveland commented about what kinds of treatment changes were made for patients in the study. They commonly involved extending the induction time, and, in some cases, patients were switched to another treatment, she said.
In an interview, Michael Dolinger, MD, of the Icahn School of Medicine at Mount Sinai in New York, said more research needs to be done to show whether IUS will improve outcomes.
“They’re showing that they make more changes sooner,” he said. “Does that actually affect and improve outcomes? That’s the big question.”
Dr. Dolinger said the concept for using IUS is that it helps physicians catch disease flares earlier and respond faster with changes to the treatment plan, thus preventing the buildup of chronic bowel damage.
“That’s the concept, but that concept is actually not so proven in reality” yet, he said. “But I do believe that they’re on the right path.”
In Dr. Dolinger’s view, adding ultrasound provides a more patient-centric approach to care of people with IBD. With more traditional approaches, patients often are waiting for results of tests done outside of the visit, such as MRI.
“With ultrasound, I am walking them through the results as it’s happening in real time during the clinic visit,” Dr. Dolinger said. ”I am showing them on the screen, allowing them to ask questions. They’re telling me about their symptoms, as I’m putting the probe on where it may hurt, as I’m showing them inflammation or healing. And that changes the whole conversation.”
The study received support from the Mutchnik Family Foundation. Dr. Cleveland reported financial relationships with Bristol Myers Squibb, Neurologica, and Takeda. Her coauthors reported financial relationships with multiple drug and device makers. Dr. Dolinger said he is a consultant for Samsung’s Neurologica Corp., which makes ultrasound equipment.
FROM ACG 2023
Tenapanor Shows Response in IBS-C Within Weeks: Pooled Data Analysis
“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.
Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.
Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.
Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.
The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.
Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.
“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.
Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.
This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.
They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.
The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.
The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.
“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.
In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.
The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.
“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.
Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.
Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.
Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.
The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.
“It also reinforces for clinicians not to be impatient,” he said.
Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.
“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.
Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.
Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.
Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.
The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.
Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.
“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.
Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.
This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.
They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.
The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.
The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.
“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.
In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.
The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.
“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.
Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.
Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.
Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.
The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.
“It also reinforces for clinicians not to be impatient,” he said.
Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.
“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.
Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.
Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.
Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.
The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.
Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.
“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.
Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.
This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.
They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.
The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.
The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.
“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.
In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.
The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.
“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.
Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.
Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.
Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.
The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.
“It also reinforces for clinicians not to be impatient,” he said.
Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.
FROM ACG 2023
Panel Recommends Small Bump in 2025 Medicare Physician Pay
An influential panel is seeking an increase in Medicare’s 2025 payments for clinicians, adding to pressure on Congress to reconsider how the largest US purchaser of health services pays for office visits and related care of the nation’s older citizens and those with disabilities.
The Medicare Payment Advisory Commission (MedPAC) on Thursday voted unanimously in favor of a two-part recommendation on changes to the 2025 physician fee schedule:
- An increase in the base rate equal to half of the projected change in the Medicare Economic Index (MEI). Recent estimates have projected a 2.6% increase in MEI for 2025, which is intended to show how inflation affects the costs of running a medical practice.
- The creation of a safety-net add-on payment under the physician fee schedule to cover care of people with low incomes.
These recommendations echo the calls MedPAC made in a 2023 report to Congress.
Lawmakers and the Centers for Medicare and Medicaid Services (CMS) rely on MedPAC’s work in deciding how much to pay for services. About 1.3 million clinicians bill Medicare for their work, including about 670,000 physicians.
Thursday’s MedPAC vote comes amid continuing uncertainty about how much the federal government will actually pay clinicians this year through the physician fee schedule.
There are serious efforts underway to undo cuts already demanded by previously passed federal law. In an email, Rep. Larry Buchson, MD, (R-IN) said he remains committed to “eliminating the full 3.37% cut this year while also working toward a permanent solution to halt the downward spiral of physician reimbursement.”
“The Medicare payment cut to physicians will impede patients’ access to care and further accelerate the current path toward consolidation, physician burnout, and closure of medical practices,” Buchson told this news organization. “It’s past time that Congress provides much needed and deserved stability for America’s doctors.”
Congress this month is attempting to complete overdue budget legislation needed to fund federal operations for fiscal 2024, which began October 1, 2023. The pending expiration of a short-term stopgap continuing resolution could provide a vehicle that could also carry legislation that would address the physician fee schedule.
In a Thursday statement, Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, commended MedPAC for its recommendations and urged lawmakers to act.
“Long-term reforms from Congress are overdue to close the unsustainable gap between what Medicare pays physicians and the actual costs of delivering high-quality care,” Dr. Ehrenfeld said. “When adjusted for inflation in practice costs, Medicare physician pay declined 26% from 2001 to 2023.”
Continual Struggles
Congress has struggled for years in its attempts to set Medicare payments for office visits and other services covered by the physician fee schedule. A 1990s budget law set the stage for what proved to be untenable reductions in payment through the sustainable growth rate mechanism.
Between 2003 through April 2014, lawmakers passed “doc-fix” legislation 17 times to block the slated cuts, according to the Congressional Research Service. In 2015, Congress passed an intended overhaul of the physician fee schedule through the Medicare Access and CHIP Reauthorization Act (MACRA). As part of this law, Congress eliminated a base automatic inflation adjuster for the physician fee schedule.
In recent years, Congress has acted repeatedly to address MACRA’s mandates for flat base pay. MedPAC and members of both parties in Congress have called for a broad new look at how Medicare pays physicians.
At Thursday’s meeting, MedPAC member Lawrence Casalino, MD, PhD, MPH, noted that the struggles to keep up with inflation and the “unpredictability of what the payment rates are going to be from year to year really do affect physician morale.”
A version of this article appeared on Medscape.com.
An influential panel is seeking an increase in Medicare’s 2025 payments for clinicians, adding to pressure on Congress to reconsider how the largest US purchaser of health services pays for office visits and related care of the nation’s older citizens and those with disabilities.
The Medicare Payment Advisory Commission (MedPAC) on Thursday voted unanimously in favor of a two-part recommendation on changes to the 2025 physician fee schedule:
- An increase in the base rate equal to half of the projected change in the Medicare Economic Index (MEI). Recent estimates have projected a 2.6% increase in MEI for 2025, which is intended to show how inflation affects the costs of running a medical practice.
- The creation of a safety-net add-on payment under the physician fee schedule to cover care of people with low incomes.
These recommendations echo the calls MedPAC made in a 2023 report to Congress.
Lawmakers and the Centers for Medicare and Medicaid Services (CMS) rely on MedPAC’s work in deciding how much to pay for services. About 1.3 million clinicians bill Medicare for their work, including about 670,000 physicians.
Thursday’s MedPAC vote comes amid continuing uncertainty about how much the federal government will actually pay clinicians this year through the physician fee schedule.
There are serious efforts underway to undo cuts already demanded by previously passed federal law. In an email, Rep. Larry Buchson, MD, (R-IN) said he remains committed to “eliminating the full 3.37% cut this year while also working toward a permanent solution to halt the downward spiral of physician reimbursement.”
“The Medicare payment cut to physicians will impede patients’ access to care and further accelerate the current path toward consolidation, physician burnout, and closure of medical practices,” Buchson told this news organization. “It’s past time that Congress provides much needed and deserved stability for America’s doctors.”
Congress this month is attempting to complete overdue budget legislation needed to fund federal operations for fiscal 2024, which began October 1, 2023. The pending expiration of a short-term stopgap continuing resolution could provide a vehicle that could also carry legislation that would address the physician fee schedule.
In a Thursday statement, Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, commended MedPAC for its recommendations and urged lawmakers to act.
“Long-term reforms from Congress are overdue to close the unsustainable gap between what Medicare pays physicians and the actual costs of delivering high-quality care,” Dr. Ehrenfeld said. “When adjusted for inflation in practice costs, Medicare physician pay declined 26% from 2001 to 2023.”
Continual Struggles
Congress has struggled for years in its attempts to set Medicare payments for office visits and other services covered by the physician fee schedule. A 1990s budget law set the stage for what proved to be untenable reductions in payment through the sustainable growth rate mechanism.
Between 2003 through April 2014, lawmakers passed “doc-fix” legislation 17 times to block the slated cuts, according to the Congressional Research Service. In 2015, Congress passed an intended overhaul of the physician fee schedule through the Medicare Access and CHIP Reauthorization Act (MACRA). As part of this law, Congress eliminated a base automatic inflation adjuster for the physician fee schedule.
In recent years, Congress has acted repeatedly to address MACRA’s mandates for flat base pay. MedPAC and members of both parties in Congress have called for a broad new look at how Medicare pays physicians.
At Thursday’s meeting, MedPAC member Lawrence Casalino, MD, PhD, MPH, noted that the struggles to keep up with inflation and the “unpredictability of what the payment rates are going to be from year to year really do affect physician morale.”
A version of this article appeared on Medscape.com.
An influential panel is seeking an increase in Medicare’s 2025 payments for clinicians, adding to pressure on Congress to reconsider how the largest US purchaser of health services pays for office visits and related care of the nation’s older citizens and those with disabilities.
The Medicare Payment Advisory Commission (MedPAC) on Thursday voted unanimously in favor of a two-part recommendation on changes to the 2025 physician fee schedule:
- An increase in the base rate equal to half of the projected change in the Medicare Economic Index (MEI). Recent estimates have projected a 2.6% increase in MEI for 2025, which is intended to show how inflation affects the costs of running a medical practice.
- The creation of a safety-net add-on payment under the physician fee schedule to cover care of people with low incomes.
These recommendations echo the calls MedPAC made in a 2023 report to Congress.
Lawmakers and the Centers for Medicare and Medicaid Services (CMS) rely on MedPAC’s work in deciding how much to pay for services. About 1.3 million clinicians bill Medicare for their work, including about 670,000 physicians.
Thursday’s MedPAC vote comes amid continuing uncertainty about how much the federal government will actually pay clinicians this year through the physician fee schedule.
There are serious efforts underway to undo cuts already demanded by previously passed federal law. In an email, Rep. Larry Buchson, MD, (R-IN) said he remains committed to “eliminating the full 3.37% cut this year while also working toward a permanent solution to halt the downward spiral of physician reimbursement.”
“The Medicare payment cut to physicians will impede patients’ access to care and further accelerate the current path toward consolidation, physician burnout, and closure of medical practices,” Buchson told this news organization. “It’s past time that Congress provides much needed and deserved stability for America’s doctors.”
Congress this month is attempting to complete overdue budget legislation needed to fund federal operations for fiscal 2024, which began October 1, 2023. The pending expiration of a short-term stopgap continuing resolution could provide a vehicle that could also carry legislation that would address the physician fee schedule.
In a Thursday statement, Jesse M. Ehrenfeld, MD, MPH, president of the American Medical Association, commended MedPAC for its recommendations and urged lawmakers to act.
“Long-term reforms from Congress are overdue to close the unsustainable gap between what Medicare pays physicians and the actual costs of delivering high-quality care,” Dr. Ehrenfeld said. “When adjusted for inflation in practice costs, Medicare physician pay declined 26% from 2001 to 2023.”
Continual Struggles
Congress has struggled for years in its attempts to set Medicare payments for office visits and other services covered by the physician fee schedule. A 1990s budget law set the stage for what proved to be untenable reductions in payment through the sustainable growth rate mechanism.
Between 2003 through April 2014, lawmakers passed “doc-fix” legislation 17 times to block the slated cuts, according to the Congressional Research Service. In 2015, Congress passed an intended overhaul of the physician fee schedule through the Medicare Access and CHIP Reauthorization Act (MACRA). As part of this law, Congress eliminated a base automatic inflation adjuster for the physician fee schedule.
In recent years, Congress has acted repeatedly to address MACRA’s mandates for flat base pay. MedPAC and members of both parties in Congress have called for a broad new look at how Medicare pays physicians.
At Thursday’s meeting, MedPAC member Lawrence Casalino, MD, PhD, MPH, noted that the struggles to keep up with inflation and the “unpredictability of what the payment rates are going to be from year to year really do affect physician morale.”
A version of this article appeared on Medscape.com.
Which Therapies Reduce Daytime Symptoms of Insomnia?
Zolpidem and behavior therapy significantly reduce daytime symptoms of insomnia such as fatigue, functional impairments, and depressive symptoms, data suggested.
In a randomized clinical trial of more than 200 patients with chronic insomnia, behavioral therapy was associated with a 4.7-point reduction in Multidimensional Fatigue Inventory (MFI) score. Zolpidem was associated with a 5.2-point reduction in this score.
“There may be some advantage to starting with behavioral intervention,” study author Charles Morin, PhD, Canada research chair in sleeping disorders at Laval University in Quebec City, told this news organization. “But by the same token, because it takes a bit more time to produce benefits, some patients quit too quickly. So, even if we want to minimize the use of medications because of potential side effects, there may be times where we need to use it.”
The results were published in JAMA Network Open.
‘Different Treatment Options’
There is growing awareness that sleep is a critical pillar of good health that is just as important as good nutrition and exercise, said Dr. Morin. Clinicians thus need to pay more attention to the toll of poor sleep on physical and mental health, he added.
For the current study, the investigators randomly assigned 211 adults with chronic insomnia to behavioral therapy, which included sleep restriction and stimulus control procedures, or zolpidem (5-10 mg nightly) for 6 weeks. Participants who achieved insomnia remission by that point were followed for 12 months. Participants who did not achieve remission were randomly assigned to a second-stage psychological therapy or medication therapy (zolpidem or trazodone).
The outcome measures were daytime functional outcomes such as mood disturbances, fatigue, functional impairments of insomnia, and physical and mental health. The researchers assessed these outcomes at baseline, 6 weeks, the end of second-stage therapy, and 3- and 12-month follow-up visits.
Both initial treatments were associated with significant and equivalent reductions in depressive symptoms, fatigue, and functional impairments. Mean change in the Beck Depression Inventory-II was −3.5 for patients in the behavioral therapy arm and −4.3 for patients in the zolpidem arm. Mean change in the MFI score was −4.7 among patients who received behavioral therapy and −5.2 among those who received zolpidem. Mean change in the Work and Social Adjustment Scale, which measured functional impairments, was −5.0 for the behavioral therapy arm and −5.1 for the zolpidem arm.
In addition, both treatments were associated with improvements in mental health, as measured by the Short-Form Health Survey (SF-36). Mean change in the mental health subscale of SF-36 was 3.5 points in the behavioral therapy arm and 2.5 points in the zolpidem arm.
Second-stage treatments were associated with further improvements, and these benefits were maintained throughout the 12 months of follow-up. These findings support adding a second treatment of insomnia as part of efforts to address daytime function, the authors wrote.
“If the first treatment doesn’t work, we should not stop there. There are different treatment options,” said Dr. Morin.
“Future developments of insomnia treatment strategies should take into account the daytime consequences of insomnia,” wrote the investigators. “Additional studies are needed to further investigate the potential benefits of switching treatment modalities and incorporating a therapeutic component that can address psychological and mood disturbances.”
The authors acknowledged that the study was limited by the lack of a control condition and by relatively small sample sizes for each treatment group, which may reduce the statistical power to detect more significant group differences. They also noted that only patients who did not achieve insomnia remission received second-stage therapy, but those who did achieve remission can still have residual daytime impairments (eg, fatigue and mood disturbances) that are associated with future relapse.
Compliance Needed
Commenting on the findings for this news organization, Jocelyn Y. Cheng, MD, vice chair of the public safety committee of the American Academy of Sleep Medicine (AASM) and a researcher at the pharmaceutical firm Eisai, said that the research was designed well and used established and practical assessment tools. Cheng did not participate in the study.
In 2020, AASM published a clinical practice guideline on chronic insomnia disorder that strongly recommended cognitive behavioral therapy (CBT). Some of the guideline’s authors, such as Dr. Morin, conducted the present study.
The current results offer reassurance about cases in which patients may prefer options other than CBT, said Cheng. Therapy and medication each appear to help reduce daytime outcomes of insomnia such as anxiety, she said.
Some patients are reluctant to try CBT, and others may not be able to find or participate in this kind of therapy because of other medical conditions such as traumatic brain injury. CBT “does require compliance and somebody willing to participate and also somebody able to participate,” said Cheng. “So, in that case, medication might be the better way to go [for the] first line.”
This study was funded by the National Institute of Mental Health. Dr. Morin reported receiving grants and personal fees from Eisai and Idorsia, grants from Lallemand Health, and royalties from Mapi Research Trust outside the submitted work. A coauthor reported receiving grants from Janssen Pharmaceuticals, Axsome Pharmaceutics, Attune, Harmony, Neurocrine Biosciences, Reveal Biosensors, the Ray and Dagmar Dolby Family Fund, and the National Institutes of Health; personal fees from Axsome Therapeutics, Big Health, Eisai, Evecxia, Harmony Biosciences, Idorsia, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Millenium Pharmaceuticals, Merck, Neurocrine Biosciences, Neurawell, Pernix, Otsuka Pharmaceuticals, Sage, and Takeda; and stock options from Big Health and Neurawell outside the submitted work. Cheng reported no relevant financial relationships other than her employment by Eisai.
A version of this article appeared on Medscape.com.
Zolpidem and behavior therapy significantly reduce daytime symptoms of insomnia such as fatigue, functional impairments, and depressive symptoms, data suggested.
In a randomized clinical trial of more than 200 patients with chronic insomnia, behavioral therapy was associated with a 4.7-point reduction in Multidimensional Fatigue Inventory (MFI) score. Zolpidem was associated with a 5.2-point reduction in this score.
“There may be some advantage to starting with behavioral intervention,” study author Charles Morin, PhD, Canada research chair in sleeping disorders at Laval University in Quebec City, told this news organization. “But by the same token, because it takes a bit more time to produce benefits, some patients quit too quickly. So, even if we want to minimize the use of medications because of potential side effects, there may be times where we need to use it.”
The results were published in JAMA Network Open.
‘Different Treatment Options’
There is growing awareness that sleep is a critical pillar of good health that is just as important as good nutrition and exercise, said Dr. Morin. Clinicians thus need to pay more attention to the toll of poor sleep on physical and mental health, he added.
For the current study, the investigators randomly assigned 211 adults with chronic insomnia to behavioral therapy, which included sleep restriction and stimulus control procedures, or zolpidem (5-10 mg nightly) for 6 weeks. Participants who achieved insomnia remission by that point were followed for 12 months. Participants who did not achieve remission were randomly assigned to a second-stage psychological therapy or medication therapy (zolpidem or trazodone).
The outcome measures were daytime functional outcomes such as mood disturbances, fatigue, functional impairments of insomnia, and physical and mental health. The researchers assessed these outcomes at baseline, 6 weeks, the end of second-stage therapy, and 3- and 12-month follow-up visits.
Both initial treatments were associated with significant and equivalent reductions in depressive symptoms, fatigue, and functional impairments. Mean change in the Beck Depression Inventory-II was −3.5 for patients in the behavioral therapy arm and −4.3 for patients in the zolpidem arm. Mean change in the MFI score was −4.7 among patients who received behavioral therapy and −5.2 among those who received zolpidem. Mean change in the Work and Social Adjustment Scale, which measured functional impairments, was −5.0 for the behavioral therapy arm and −5.1 for the zolpidem arm.
In addition, both treatments were associated with improvements in mental health, as measured by the Short-Form Health Survey (SF-36). Mean change in the mental health subscale of SF-36 was 3.5 points in the behavioral therapy arm and 2.5 points in the zolpidem arm.
Second-stage treatments were associated with further improvements, and these benefits were maintained throughout the 12 months of follow-up. These findings support adding a second treatment of insomnia as part of efforts to address daytime function, the authors wrote.
“If the first treatment doesn’t work, we should not stop there. There are different treatment options,” said Dr. Morin.
“Future developments of insomnia treatment strategies should take into account the daytime consequences of insomnia,” wrote the investigators. “Additional studies are needed to further investigate the potential benefits of switching treatment modalities and incorporating a therapeutic component that can address psychological and mood disturbances.”
The authors acknowledged that the study was limited by the lack of a control condition and by relatively small sample sizes for each treatment group, which may reduce the statistical power to detect more significant group differences. They also noted that only patients who did not achieve insomnia remission received second-stage therapy, but those who did achieve remission can still have residual daytime impairments (eg, fatigue and mood disturbances) that are associated with future relapse.
Compliance Needed
Commenting on the findings for this news organization, Jocelyn Y. Cheng, MD, vice chair of the public safety committee of the American Academy of Sleep Medicine (AASM) and a researcher at the pharmaceutical firm Eisai, said that the research was designed well and used established and practical assessment tools. Cheng did not participate in the study.
In 2020, AASM published a clinical practice guideline on chronic insomnia disorder that strongly recommended cognitive behavioral therapy (CBT). Some of the guideline’s authors, such as Dr. Morin, conducted the present study.
The current results offer reassurance about cases in which patients may prefer options other than CBT, said Cheng. Therapy and medication each appear to help reduce daytime outcomes of insomnia such as anxiety, she said.
Some patients are reluctant to try CBT, and others may not be able to find or participate in this kind of therapy because of other medical conditions such as traumatic brain injury. CBT “does require compliance and somebody willing to participate and also somebody able to participate,” said Cheng. “So, in that case, medication might be the better way to go [for the] first line.”
This study was funded by the National Institute of Mental Health. Dr. Morin reported receiving grants and personal fees from Eisai and Idorsia, grants from Lallemand Health, and royalties from Mapi Research Trust outside the submitted work. A coauthor reported receiving grants from Janssen Pharmaceuticals, Axsome Pharmaceutics, Attune, Harmony, Neurocrine Biosciences, Reveal Biosensors, the Ray and Dagmar Dolby Family Fund, and the National Institutes of Health; personal fees from Axsome Therapeutics, Big Health, Eisai, Evecxia, Harmony Biosciences, Idorsia, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Millenium Pharmaceuticals, Merck, Neurocrine Biosciences, Neurawell, Pernix, Otsuka Pharmaceuticals, Sage, and Takeda; and stock options from Big Health and Neurawell outside the submitted work. Cheng reported no relevant financial relationships other than her employment by Eisai.
A version of this article appeared on Medscape.com.
Zolpidem and behavior therapy significantly reduce daytime symptoms of insomnia such as fatigue, functional impairments, and depressive symptoms, data suggested.
In a randomized clinical trial of more than 200 patients with chronic insomnia, behavioral therapy was associated with a 4.7-point reduction in Multidimensional Fatigue Inventory (MFI) score. Zolpidem was associated with a 5.2-point reduction in this score.
“There may be some advantage to starting with behavioral intervention,” study author Charles Morin, PhD, Canada research chair in sleeping disorders at Laval University in Quebec City, told this news organization. “But by the same token, because it takes a bit more time to produce benefits, some patients quit too quickly. So, even if we want to minimize the use of medications because of potential side effects, there may be times where we need to use it.”
The results were published in JAMA Network Open.
‘Different Treatment Options’
There is growing awareness that sleep is a critical pillar of good health that is just as important as good nutrition and exercise, said Dr. Morin. Clinicians thus need to pay more attention to the toll of poor sleep on physical and mental health, he added.
For the current study, the investigators randomly assigned 211 adults with chronic insomnia to behavioral therapy, which included sleep restriction and stimulus control procedures, or zolpidem (5-10 mg nightly) for 6 weeks. Participants who achieved insomnia remission by that point were followed for 12 months. Participants who did not achieve remission were randomly assigned to a second-stage psychological therapy or medication therapy (zolpidem or trazodone).
The outcome measures were daytime functional outcomes such as mood disturbances, fatigue, functional impairments of insomnia, and physical and mental health. The researchers assessed these outcomes at baseline, 6 weeks, the end of second-stage therapy, and 3- and 12-month follow-up visits.
Both initial treatments were associated with significant and equivalent reductions in depressive symptoms, fatigue, and functional impairments. Mean change in the Beck Depression Inventory-II was −3.5 for patients in the behavioral therapy arm and −4.3 for patients in the zolpidem arm. Mean change in the MFI score was −4.7 among patients who received behavioral therapy and −5.2 among those who received zolpidem. Mean change in the Work and Social Adjustment Scale, which measured functional impairments, was −5.0 for the behavioral therapy arm and −5.1 for the zolpidem arm.
In addition, both treatments were associated with improvements in mental health, as measured by the Short-Form Health Survey (SF-36). Mean change in the mental health subscale of SF-36 was 3.5 points in the behavioral therapy arm and 2.5 points in the zolpidem arm.
Second-stage treatments were associated with further improvements, and these benefits were maintained throughout the 12 months of follow-up. These findings support adding a second treatment of insomnia as part of efforts to address daytime function, the authors wrote.
“If the first treatment doesn’t work, we should not stop there. There are different treatment options,” said Dr. Morin.
“Future developments of insomnia treatment strategies should take into account the daytime consequences of insomnia,” wrote the investigators. “Additional studies are needed to further investigate the potential benefits of switching treatment modalities and incorporating a therapeutic component that can address psychological and mood disturbances.”
The authors acknowledged that the study was limited by the lack of a control condition and by relatively small sample sizes for each treatment group, which may reduce the statistical power to detect more significant group differences. They also noted that only patients who did not achieve insomnia remission received second-stage therapy, but those who did achieve remission can still have residual daytime impairments (eg, fatigue and mood disturbances) that are associated with future relapse.
Compliance Needed
Commenting on the findings for this news organization, Jocelyn Y. Cheng, MD, vice chair of the public safety committee of the American Academy of Sleep Medicine (AASM) and a researcher at the pharmaceutical firm Eisai, said that the research was designed well and used established and practical assessment tools. Cheng did not participate in the study.
In 2020, AASM published a clinical practice guideline on chronic insomnia disorder that strongly recommended cognitive behavioral therapy (CBT). Some of the guideline’s authors, such as Dr. Morin, conducted the present study.
The current results offer reassurance about cases in which patients may prefer options other than CBT, said Cheng. Therapy and medication each appear to help reduce daytime outcomes of insomnia such as anxiety, she said.
Some patients are reluctant to try CBT, and others may not be able to find or participate in this kind of therapy because of other medical conditions such as traumatic brain injury. CBT “does require compliance and somebody willing to participate and also somebody able to participate,” said Cheng. “So, in that case, medication might be the better way to go [for the] first line.”
This study was funded by the National Institute of Mental Health. Dr. Morin reported receiving grants and personal fees from Eisai and Idorsia, grants from Lallemand Health, and royalties from Mapi Research Trust outside the submitted work. A coauthor reported receiving grants from Janssen Pharmaceuticals, Axsome Pharmaceutics, Attune, Harmony, Neurocrine Biosciences, Reveal Biosensors, the Ray and Dagmar Dolby Family Fund, and the National Institutes of Health; personal fees from Axsome Therapeutics, Big Health, Eisai, Evecxia, Harmony Biosciences, Idorsia, Janssen Pharmaceuticals, Jazz Pharmaceuticals, Millenium Pharmaceuticals, Merck, Neurocrine Biosciences, Neurawell, Pernix, Otsuka Pharmaceuticals, Sage, and Takeda; and stock options from Big Health and Neurawell outside the submitted work. Cheng reported no relevant financial relationships other than her employment by Eisai.
A version of this article appeared on Medscape.com.
The Struggle to Provide Gender-Affirming Care to Youth
Pediatrician Michelle Collins-Ogle, MD, already has a busy practice helping young people address questions about their gender identity. She has treated more than 230 patients over the past 2 years at Children’s Hospital at Montefiore in the Bronx, New York.
Dr. Collins-Ogle specializes in adolescent medicine in New York, a state without the restrictions on such care that have been enacted in roughly half the country.
On December 13, 2023, Ohio lawmakers passed a bill banning gender-affirming medical care to minors which Gov. Mike DeWine vetoed on December 29. Another 26 states have similar restrictions in place, according to a tally provided to this news organization by the Human Rights Campaign, which tracks this issue.
Clinicians like Dr. Collins-Ogle are feeling the impact. In her practice, Dr. Collins-Ogle met a couple that moved from Texas to New York to allow their child to access gender-affirming medical care.
“They wanted their child to be able to receive medical care, but they also were afraid for their own safety, of having their child taken from them, and being locked up,” Dr. Collins-Ogle told this news organization.
With patients have also come protestors and harassment. In fact, many physicians are reluctant to speak on this topic amid a recent spate of threats. Psychiatric News reported that conservative pundits and high-profile social media accounts have targeted physicians who provide gender-affirming medical care, spurring harassment campaigns against clinics in cities such as Akron, Boston, and Nashville. “The attackers asserted that the clinics were mutilating children and giving them ‘chemical castration drugs,’ among other claims,” the Psychiatric News reported.
This news organization contacted more than a half dozen organizations that provide gender-affirming care for adolescents and teens seeking interviews about the effects of these restrictions.
All but Montefiore’s Dr. Collins-Ogle turned down the request.
“If my kids are brave enough to come see me, I can’t cower,” Dr. Collins-Ogle said.
But Dr. Collins-Ogle emphasized she understands why many fellow physicians are concerned about speaking publicly about gender-affirming medical care.
Dissenters Spread Misinformation and Threats
Recent years have seen increasing politicization of this issue, often due to inaccurate depictions of gender-affirming medical care circulating on social media.
In 2022, the American Medical Association (AMA), the American Academy of Pediatrics (AAP), and the Children’s Hospital Association asked the Justice Department to investigate what they called “increasing threats of violence against physicians, hospitals, and families of children for providing and seeking evidence-based gender-affirming care.”
The three organizations also called on X (formerly known as Twitter), TikTok, and Meta, which owns Facebook and Instagram, to do more to address coordinated campaigns of disinformation.
“We cannot stand by as threats of violence against our members and their patients proliferate with little consequence,” said Moira Szilagyi, MD, PhD, then AAP president in a statement.
Medical Groups Defend Care to Prevent Suicide
The AAP, AMA, and other influential medical associations are banding together to fight new legal restrictions on gender-affirming medical care for teens and adolescents. (These briefs do not discuss surgeries typically available for adults.)
Since 2022, these medical organizations have filed amicus briefs in cases challenging new restrictions put in place in Arkansas, Alabama, Florida, Georgia, Idaho, Indiana, Kentucky, North Dakota, Oklahoma, Tennessee, and Texas.
Other signers to the amicus briefs:
- Academic Pediatric Association
- American Academy of Child & Adolescent Psychiatry
- American Academy of Family Physicians
- American Academy of Nursing
- GLMA: Health Professionals Advancing LGBTQ+ Equality
- American College of Obstetricians and Gynecologists
- American College of Osteopathic Pediatricians
- The American College of Physicians
- American Pediatric Society
- Association of Medical School Pediatric Department Chairs, Inc.
- Endocrine Society
- National Association of Pediatric Nurse Practitioners
- The Pediatric Endocrine Society, Societies for Pediatric Urology
- Society for Adolescent Health and Medicine
- Society for Pediatric Research
- The Society of Pediatric Nurses
- World Professional Association for Transgender Health
In these amicus briefs, the medical groups argue that evidence-based guidelines support the use of medication in treating gender dysphoria. The amicus briefs in particular cite an Endocrine Society guideline and the standards of care developed by the World Professional Association for Transgender Health (WPATH).
Research shows that adolescents with gender dysphoria who receive puberty blockers and other medications experience less depression, anxiety, and suicidal ideation, the groups have said.
“In light of this evidence supporting the connection between lack of access to gender-affirming care and lifetime suicide risk, banning such care can put patients’ lives at risk,” the AAP and other groups said.
Debate Over Source of Gender Identity Concerns
Having doubts and concerns about one’s gender remains a relatively rare phenomena, although it appears more common among younger people.
Among US adults, 0.5% or about 1.3 million people identify as transgender whereas about 1.4% or about 300,000 people in the 13-17–year-old group do so, according to a report issued in 2022 by the Williams Institute of the UCLA School of Law.
Questionable Diagnosis Drives Bans on Care
The term “rapid-onset gender dysphoria,” referring to young people who suddenly question their gender as part of peer group dynamics, persists in political debates. The conservative Heritage Foundation has used the term as well as “social contagion” in its effort to seek restrictions on gender-affirming care for young people.
Ohio Rep. Gary Click, a Republican, said at an April 2023 hearing that his Save Adolescents from Experimentation (SAFE) bill would prevent teens from being harmed due to “social contagion” or “ rapid-onset gender dysphoria.”
The bill, which the Ohio legislature cleared in December, would block physicians from starting new patients on puberty blockers. (It also bars surgeries as part of gender-affirming medical care, although hospital officials and physicians told lawmakers these are not done in Ohio.)
Among the groups opposing Click’s bill were the Ohio chapter of the AAP, the Ohio State Medical Association and several hospitals and hospital groups as well as physicians speaking independently.
Gender-Affirming Care ‘Buys Time’ to Avoid Impulsive Decisions
Kate Krueck, MD, a pediatrician with a practice in the Columbus area, testified about her experience as the mother of a transgender child who once attempted suicide.
“It wasn’t always easy to reconstruct my vision of a baby with a vagina into the adolescent before me with a new name and changed pronouns, but they were still the same incredible person,” Krueck said.
She urged lawmakers to understand how puberty blockers can “buy time” for teens to cope with a body at odds with their vision of themselves, noting that many of the effects of these medications are largely reversible. The side effects that are not reversible, such as facial hair growth and the growth of Adam’s Apple, are certainly outweighed by the risks of withholding treatment, she said.
Bad Patient Experience Drives Detractor Activist
Arguing against that point was Chloe Cole, a detransitioner activist who had returned to a female identity. At the Ohio legislative hearings, Ms. Cole spoke of her experience in California as a teen treated for gender dysphoria.
“I was fast-tracked by medical butchers starting at 13 when I was given cross sex hormones, and they took my breasts away from me at 15 years old,” she said.
Ms. Cole appears frequently to testify in favor of bans on gender-affirming medical care. In 2022, she told the Ohio lawmakers about her experience of attending a class with about a dozen other young people in the midst of female-to-male transitions. She now sees that class as having inadvertently helped reinforce her decision to have her breasts removed.
“Despite all these consultations and classes, I don’t feel like I understood all the ramifications that came with any of the medical decisions I was making,” Ms. Cole said. “I didn’t realize how traumatic the recovery would be, and it wasn’t until I was almost a year post-op that I realized I may want to breastfeed my future children; I will never be able to do that.”
Ms. Cole also spoke in July before the US House subcommittee on the Constitution and Limited Government.
“I look in the mirror sometimes, and I feel like a monster,” Ms. Cole said at the House hearing, which was titled “ The Dangers and Due Process Violations of ‘Gender-Affirming Care’.”
During the hearing, Shannon Minter, legal director of the National Center for Lesbian Rights (NCLR), who also made a gender transition, thanked Ms. Cole but noted that her case is an exception.
A 2022 Lancet Child and Adolescent Health article reported that 704 (98%) people in the Netherlands who had started gender-affirming medical treatment in adolescence continued to use gender-affirming hormones at follow-up. Ms. Minter credits this high rate of continuation to clinicians taking their duties to adolescents seriously.
State legislatures and medical boards oversee the regulation of medical practice in the US. But a few Republicans in both chambers of the US Congress have shown an interest in enacting a federal ban restricting physicians’ ability to provide gender-affirming medical care.
They include Rep. Mike Johnson of Louisiana, who in October 2023 became Speaker of the House. He chaired the July hearing at which Ms. Cole spoke. He’s also a sponsor of a House bill introduced by Rep. Marjorie Taylor Greene (R-GA).
This measure, which has the support of 45 House Republicans, would make it a felony to perform any gender-affirming care on a minor, and it permits a minor on whom such care is performed to bring a civil action against each individual who provided the care. Sen. JD Vance (R-OH) introduced the companion Senate measure.
Reality of Gender-Affirming Care
The drive to pass laws like those in Ohio and Arkansas stem from a lack of knowledge about gender-affirming treatments, including a false idea that doctors prescribe medications at teens’ requests, Montefiore’s Dr. Collins-Ogle said.
“There’s a misperception that young people will say ‘I’m transgender’ and that those of us who provide care are just giving them hormones or whatever they want. It’s not true, and it doesn’t happen that way,” Dr. Collins-Ogle said.
At the Children’s Hospital at Montefiore, Dr. Collins-Ogle said her work with patients wrestling with gender identity issues begins with questions.
“What’s your understanding of dysphoria? Where’s the incongruence between the gender you were assigned at birth and what you’re feeling now? You have to be able to verbalize that” before the treatment proceeds, she said.
Sometimes teens leave after an initial conversation and then return later when they have a more clearly defined sense of what dysphoria means.
“There are other kids who clearly, clearly understand that the gender they were assigned at birth is not who they are,” she said.
Children now wrestle with added concerns that their parents could be put at risk for trying to help them, she said.
“These kids go through so much. And we have these people in powerful positions telling them that they don’t matter and telling them, ‘We’re going to cut off your access to healthcare, Medicaid; if your parents tried to seek out this care for you, we’re going to put them in jail,’” she said.
“It’s the biggest factor in fear mongering,” she said.
Dr. Collins-Ogle said she wonders why legislators who lack medical training are trying to dictate how physicians can practice.
“I took a Hippocratic oath to do no harm. I have a medical board that I answer to,” she said. “I don’t understand how legislators can get away with legislating about something they know nothing about.”
A version of this article appeared on Medscape.com.
Pediatrician Michelle Collins-Ogle, MD, already has a busy practice helping young people address questions about their gender identity. She has treated more than 230 patients over the past 2 years at Children’s Hospital at Montefiore in the Bronx, New York.
Dr. Collins-Ogle specializes in adolescent medicine in New York, a state without the restrictions on such care that have been enacted in roughly half the country.
On December 13, 2023, Ohio lawmakers passed a bill banning gender-affirming medical care to minors which Gov. Mike DeWine vetoed on December 29. Another 26 states have similar restrictions in place, according to a tally provided to this news organization by the Human Rights Campaign, which tracks this issue.
Clinicians like Dr. Collins-Ogle are feeling the impact. In her practice, Dr. Collins-Ogle met a couple that moved from Texas to New York to allow their child to access gender-affirming medical care.
“They wanted their child to be able to receive medical care, but they also were afraid for their own safety, of having their child taken from them, and being locked up,” Dr. Collins-Ogle told this news organization.
With patients have also come protestors and harassment. In fact, many physicians are reluctant to speak on this topic amid a recent spate of threats. Psychiatric News reported that conservative pundits and high-profile social media accounts have targeted physicians who provide gender-affirming medical care, spurring harassment campaigns against clinics in cities such as Akron, Boston, and Nashville. “The attackers asserted that the clinics were mutilating children and giving them ‘chemical castration drugs,’ among other claims,” the Psychiatric News reported.
This news organization contacted more than a half dozen organizations that provide gender-affirming care for adolescents and teens seeking interviews about the effects of these restrictions.
All but Montefiore’s Dr. Collins-Ogle turned down the request.
“If my kids are brave enough to come see me, I can’t cower,” Dr. Collins-Ogle said.
But Dr. Collins-Ogle emphasized she understands why many fellow physicians are concerned about speaking publicly about gender-affirming medical care.
Dissenters Spread Misinformation and Threats
Recent years have seen increasing politicization of this issue, often due to inaccurate depictions of gender-affirming medical care circulating on social media.
In 2022, the American Medical Association (AMA), the American Academy of Pediatrics (AAP), and the Children’s Hospital Association asked the Justice Department to investigate what they called “increasing threats of violence against physicians, hospitals, and families of children for providing and seeking evidence-based gender-affirming care.”
The three organizations also called on X (formerly known as Twitter), TikTok, and Meta, which owns Facebook and Instagram, to do more to address coordinated campaigns of disinformation.
“We cannot stand by as threats of violence against our members and their patients proliferate with little consequence,” said Moira Szilagyi, MD, PhD, then AAP president in a statement.
Medical Groups Defend Care to Prevent Suicide
The AAP, AMA, and other influential medical associations are banding together to fight new legal restrictions on gender-affirming medical care for teens and adolescents. (These briefs do not discuss surgeries typically available for adults.)
Since 2022, these medical organizations have filed amicus briefs in cases challenging new restrictions put in place in Arkansas, Alabama, Florida, Georgia, Idaho, Indiana, Kentucky, North Dakota, Oklahoma, Tennessee, and Texas.
Other signers to the amicus briefs:
- Academic Pediatric Association
- American Academy of Child & Adolescent Psychiatry
- American Academy of Family Physicians
- American Academy of Nursing
- GLMA: Health Professionals Advancing LGBTQ+ Equality
- American College of Obstetricians and Gynecologists
- American College of Osteopathic Pediatricians
- The American College of Physicians
- American Pediatric Society
- Association of Medical School Pediatric Department Chairs, Inc.
- Endocrine Society
- National Association of Pediatric Nurse Practitioners
- The Pediatric Endocrine Society, Societies for Pediatric Urology
- Society for Adolescent Health and Medicine
- Society for Pediatric Research
- The Society of Pediatric Nurses
- World Professional Association for Transgender Health
In these amicus briefs, the medical groups argue that evidence-based guidelines support the use of medication in treating gender dysphoria. The amicus briefs in particular cite an Endocrine Society guideline and the standards of care developed by the World Professional Association for Transgender Health (WPATH).
Research shows that adolescents with gender dysphoria who receive puberty blockers and other medications experience less depression, anxiety, and suicidal ideation, the groups have said.
“In light of this evidence supporting the connection between lack of access to gender-affirming care and lifetime suicide risk, banning such care can put patients’ lives at risk,” the AAP and other groups said.
Debate Over Source of Gender Identity Concerns
Having doubts and concerns about one’s gender remains a relatively rare phenomena, although it appears more common among younger people.
Among US adults, 0.5% or about 1.3 million people identify as transgender whereas about 1.4% or about 300,000 people in the 13-17–year-old group do so, according to a report issued in 2022 by the Williams Institute of the UCLA School of Law.
Questionable Diagnosis Drives Bans on Care
The term “rapid-onset gender dysphoria,” referring to young people who suddenly question their gender as part of peer group dynamics, persists in political debates. The conservative Heritage Foundation has used the term as well as “social contagion” in its effort to seek restrictions on gender-affirming care for young people.
Ohio Rep. Gary Click, a Republican, said at an April 2023 hearing that his Save Adolescents from Experimentation (SAFE) bill would prevent teens from being harmed due to “social contagion” or “ rapid-onset gender dysphoria.”
The bill, which the Ohio legislature cleared in December, would block physicians from starting new patients on puberty blockers. (It also bars surgeries as part of gender-affirming medical care, although hospital officials and physicians told lawmakers these are not done in Ohio.)
Among the groups opposing Click’s bill were the Ohio chapter of the AAP, the Ohio State Medical Association and several hospitals and hospital groups as well as physicians speaking independently.
Gender-Affirming Care ‘Buys Time’ to Avoid Impulsive Decisions
Kate Krueck, MD, a pediatrician with a practice in the Columbus area, testified about her experience as the mother of a transgender child who once attempted suicide.
“It wasn’t always easy to reconstruct my vision of a baby with a vagina into the adolescent before me with a new name and changed pronouns, but they were still the same incredible person,” Krueck said.
She urged lawmakers to understand how puberty blockers can “buy time” for teens to cope with a body at odds with their vision of themselves, noting that many of the effects of these medications are largely reversible. The side effects that are not reversible, such as facial hair growth and the growth of Adam’s Apple, are certainly outweighed by the risks of withholding treatment, she said.
Bad Patient Experience Drives Detractor Activist
Arguing against that point was Chloe Cole, a detransitioner activist who had returned to a female identity. At the Ohio legislative hearings, Ms. Cole spoke of her experience in California as a teen treated for gender dysphoria.
“I was fast-tracked by medical butchers starting at 13 when I was given cross sex hormones, and they took my breasts away from me at 15 years old,” she said.
Ms. Cole appears frequently to testify in favor of bans on gender-affirming medical care. In 2022, she told the Ohio lawmakers about her experience of attending a class with about a dozen other young people in the midst of female-to-male transitions. She now sees that class as having inadvertently helped reinforce her decision to have her breasts removed.
“Despite all these consultations and classes, I don’t feel like I understood all the ramifications that came with any of the medical decisions I was making,” Ms. Cole said. “I didn’t realize how traumatic the recovery would be, and it wasn’t until I was almost a year post-op that I realized I may want to breastfeed my future children; I will never be able to do that.”
Ms. Cole also spoke in July before the US House subcommittee on the Constitution and Limited Government.
“I look in the mirror sometimes, and I feel like a monster,” Ms. Cole said at the House hearing, which was titled “ The Dangers and Due Process Violations of ‘Gender-Affirming Care’.”
During the hearing, Shannon Minter, legal director of the National Center for Lesbian Rights (NCLR), who also made a gender transition, thanked Ms. Cole but noted that her case is an exception.
A 2022 Lancet Child and Adolescent Health article reported that 704 (98%) people in the Netherlands who had started gender-affirming medical treatment in adolescence continued to use gender-affirming hormones at follow-up. Ms. Minter credits this high rate of continuation to clinicians taking their duties to adolescents seriously.
State legislatures and medical boards oversee the regulation of medical practice in the US. But a few Republicans in both chambers of the US Congress have shown an interest in enacting a federal ban restricting physicians’ ability to provide gender-affirming medical care.
They include Rep. Mike Johnson of Louisiana, who in October 2023 became Speaker of the House. He chaired the July hearing at which Ms. Cole spoke. He’s also a sponsor of a House bill introduced by Rep. Marjorie Taylor Greene (R-GA).
This measure, which has the support of 45 House Republicans, would make it a felony to perform any gender-affirming care on a minor, and it permits a minor on whom such care is performed to bring a civil action against each individual who provided the care. Sen. JD Vance (R-OH) introduced the companion Senate measure.
Reality of Gender-Affirming Care
The drive to pass laws like those in Ohio and Arkansas stem from a lack of knowledge about gender-affirming treatments, including a false idea that doctors prescribe medications at teens’ requests, Montefiore’s Dr. Collins-Ogle said.
“There’s a misperception that young people will say ‘I’m transgender’ and that those of us who provide care are just giving them hormones or whatever they want. It’s not true, and it doesn’t happen that way,” Dr. Collins-Ogle said.
At the Children’s Hospital at Montefiore, Dr. Collins-Ogle said her work with patients wrestling with gender identity issues begins with questions.
“What’s your understanding of dysphoria? Where’s the incongruence between the gender you were assigned at birth and what you’re feeling now? You have to be able to verbalize that” before the treatment proceeds, she said.
Sometimes teens leave after an initial conversation and then return later when they have a more clearly defined sense of what dysphoria means.
“There are other kids who clearly, clearly understand that the gender they were assigned at birth is not who they are,” she said.
Children now wrestle with added concerns that their parents could be put at risk for trying to help them, she said.
“These kids go through so much. And we have these people in powerful positions telling them that they don’t matter and telling them, ‘We’re going to cut off your access to healthcare, Medicaid; if your parents tried to seek out this care for you, we’re going to put them in jail,’” she said.
“It’s the biggest factor in fear mongering,” she said.
Dr. Collins-Ogle said she wonders why legislators who lack medical training are trying to dictate how physicians can practice.
“I took a Hippocratic oath to do no harm. I have a medical board that I answer to,” she said. “I don’t understand how legislators can get away with legislating about something they know nothing about.”
A version of this article appeared on Medscape.com.
Pediatrician Michelle Collins-Ogle, MD, already has a busy practice helping young people address questions about their gender identity. She has treated more than 230 patients over the past 2 years at Children’s Hospital at Montefiore in the Bronx, New York.
Dr. Collins-Ogle specializes in adolescent medicine in New York, a state without the restrictions on such care that have been enacted in roughly half the country.
On December 13, 2023, Ohio lawmakers passed a bill banning gender-affirming medical care to minors which Gov. Mike DeWine vetoed on December 29. Another 26 states have similar restrictions in place, according to a tally provided to this news organization by the Human Rights Campaign, which tracks this issue.
Clinicians like Dr. Collins-Ogle are feeling the impact. In her practice, Dr. Collins-Ogle met a couple that moved from Texas to New York to allow their child to access gender-affirming medical care.
“They wanted their child to be able to receive medical care, but they also were afraid for their own safety, of having their child taken from them, and being locked up,” Dr. Collins-Ogle told this news organization.
With patients have also come protestors and harassment. In fact, many physicians are reluctant to speak on this topic amid a recent spate of threats. Psychiatric News reported that conservative pundits and high-profile social media accounts have targeted physicians who provide gender-affirming medical care, spurring harassment campaigns against clinics in cities such as Akron, Boston, and Nashville. “The attackers asserted that the clinics were mutilating children and giving them ‘chemical castration drugs,’ among other claims,” the Psychiatric News reported.
This news organization contacted more than a half dozen organizations that provide gender-affirming care for adolescents and teens seeking interviews about the effects of these restrictions.
All but Montefiore’s Dr. Collins-Ogle turned down the request.
“If my kids are brave enough to come see me, I can’t cower,” Dr. Collins-Ogle said.
But Dr. Collins-Ogle emphasized she understands why many fellow physicians are concerned about speaking publicly about gender-affirming medical care.
Dissenters Spread Misinformation and Threats
Recent years have seen increasing politicization of this issue, often due to inaccurate depictions of gender-affirming medical care circulating on social media.
In 2022, the American Medical Association (AMA), the American Academy of Pediatrics (AAP), and the Children’s Hospital Association asked the Justice Department to investigate what they called “increasing threats of violence against physicians, hospitals, and families of children for providing and seeking evidence-based gender-affirming care.”
The three organizations also called on X (formerly known as Twitter), TikTok, and Meta, which owns Facebook and Instagram, to do more to address coordinated campaigns of disinformation.
“We cannot stand by as threats of violence against our members and their patients proliferate with little consequence,” said Moira Szilagyi, MD, PhD, then AAP president in a statement.
Medical Groups Defend Care to Prevent Suicide
The AAP, AMA, and other influential medical associations are banding together to fight new legal restrictions on gender-affirming medical care for teens and adolescents. (These briefs do not discuss surgeries typically available for adults.)
Since 2022, these medical organizations have filed amicus briefs in cases challenging new restrictions put in place in Arkansas, Alabama, Florida, Georgia, Idaho, Indiana, Kentucky, North Dakota, Oklahoma, Tennessee, and Texas.
Other signers to the amicus briefs:
- Academic Pediatric Association
- American Academy of Child & Adolescent Psychiatry
- American Academy of Family Physicians
- American Academy of Nursing
- GLMA: Health Professionals Advancing LGBTQ+ Equality
- American College of Obstetricians and Gynecologists
- American College of Osteopathic Pediatricians
- The American College of Physicians
- American Pediatric Society
- Association of Medical School Pediatric Department Chairs, Inc.
- Endocrine Society
- National Association of Pediatric Nurse Practitioners
- The Pediatric Endocrine Society, Societies for Pediatric Urology
- Society for Adolescent Health and Medicine
- Society for Pediatric Research
- The Society of Pediatric Nurses
- World Professional Association for Transgender Health
In these amicus briefs, the medical groups argue that evidence-based guidelines support the use of medication in treating gender dysphoria. The amicus briefs in particular cite an Endocrine Society guideline and the standards of care developed by the World Professional Association for Transgender Health (WPATH).
Research shows that adolescents with gender dysphoria who receive puberty blockers and other medications experience less depression, anxiety, and suicidal ideation, the groups have said.
“In light of this evidence supporting the connection between lack of access to gender-affirming care and lifetime suicide risk, banning such care can put patients’ lives at risk,” the AAP and other groups said.
Debate Over Source of Gender Identity Concerns
Having doubts and concerns about one’s gender remains a relatively rare phenomena, although it appears more common among younger people.
Among US adults, 0.5% or about 1.3 million people identify as transgender whereas about 1.4% or about 300,000 people in the 13-17–year-old group do so, according to a report issued in 2022 by the Williams Institute of the UCLA School of Law.
Questionable Diagnosis Drives Bans on Care
The term “rapid-onset gender dysphoria,” referring to young people who suddenly question their gender as part of peer group dynamics, persists in political debates. The conservative Heritage Foundation has used the term as well as “social contagion” in its effort to seek restrictions on gender-affirming care for young people.
Ohio Rep. Gary Click, a Republican, said at an April 2023 hearing that his Save Adolescents from Experimentation (SAFE) bill would prevent teens from being harmed due to “social contagion” or “ rapid-onset gender dysphoria.”
The bill, which the Ohio legislature cleared in December, would block physicians from starting new patients on puberty blockers. (It also bars surgeries as part of gender-affirming medical care, although hospital officials and physicians told lawmakers these are not done in Ohio.)
Among the groups opposing Click’s bill were the Ohio chapter of the AAP, the Ohio State Medical Association and several hospitals and hospital groups as well as physicians speaking independently.
Gender-Affirming Care ‘Buys Time’ to Avoid Impulsive Decisions
Kate Krueck, MD, a pediatrician with a practice in the Columbus area, testified about her experience as the mother of a transgender child who once attempted suicide.
“It wasn’t always easy to reconstruct my vision of a baby with a vagina into the adolescent before me with a new name and changed pronouns, but they were still the same incredible person,” Krueck said.
She urged lawmakers to understand how puberty blockers can “buy time” for teens to cope with a body at odds with their vision of themselves, noting that many of the effects of these medications are largely reversible. The side effects that are not reversible, such as facial hair growth and the growth of Adam’s Apple, are certainly outweighed by the risks of withholding treatment, she said.
Bad Patient Experience Drives Detractor Activist
Arguing against that point was Chloe Cole, a detransitioner activist who had returned to a female identity. At the Ohio legislative hearings, Ms. Cole spoke of her experience in California as a teen treated for gender dysphoria.
“I was fast-tracked by medical butchers starting at 13 when I was given cross sex hormones, and they took my breasts away from me at 15 years old,” she said.
Ms. Cole appears frequently to testify in favor of bans on gender-affirming medical care. In 2022, she told the Ohio lawmakers about her experience of attending a class with about a dozen other young people in the midst of female-to-male transitions. She now sees that class as having inadvertently helped reinforce her decision to have her breasts removed.
“Despite all these consultations and classes, I don’t feel like I understood all the ramifications that came with any of the medical decisions I was making,” Ms. Cole said. “I didn’t realize how traumatic the recovery would be, and it wasn’t until I was almost a year post-op that I realized I may want to breastfeed my future children; I will never be able to do that.”
Ms. Cole also spoke in July before the US House subcommittee on the Constitution and Limited Government.
“I look in the mirror sometimes, and I feel like a monster,” Ms. Cole said at the House hearing, which was titled “ The Dangers and Due Process Violations of ‘Gender-Affirming Care’.”
During the hearing, Shannon Minter, legal director of the National Center for Lesbian Rights (NCLR), who also made a gender transition, thanked Ms. Cole but noted that her case is an exception.
A 2022 Lancet Child and Adolescent Health article reported that 704 (98%) people in the Netherlands who had started gender-affirming medical treatment in adolescence continued to use gender-affirming hormones at follow-up. Ms. Minter credits this high rate of continuation to clinicians taking their duties to adolescents seriously.
State legislatures and medical boards oversee the regulation of medical practice in the US. But a few Republicans in both chambers of the US Congress have shown an interest in enacting a federal ban restricting physicians’ ability to provide gender-affirming medical care.
They include Rep. Mike Johnson of Louisiana, who in October 2023 became Speaker of the House. He chaired the July hearing at which Ms. Cole spoke. He’s also a sponsor of a House bill introduced by Rep. Marjorie Taylor Greene (R-GA).
This measure, which has the support of 45 House Republicans, would make it a felony to perform any gender-affirming care on a minor, and it permits a minor on whom such care is performed to bring a civil action against each individual who provided the care. Sen. JD Vance (R-OH) introduced the companion Senate measure.
Reality of Gender-Affirming Care
The drive to pass laws like those in Ohio and Arkansas stem from a lack of knowledge about gender-affirming treatments, including a false idea that doctors prescribe medications at teens’ requests, Montefiore’s Dr. Collins-Ogle said.
“There’s a misperception that young people will say ‘I’m transgender’ and that those of us who provide care are just giving them hormones or whatever they want. It’s not true, and it doesn’t happen that way,” Dr. Collins-Ogle said.
At the Children’s Hospital at Montefiore, Dr. Collins-Ogle said her work with patients wrestling with gender identity issues begins with questions.
“What’s your understanding of dysphoria? Where’s the incongruence between the gender you were assigned at birth and what you’re feeling now? You have to be able to verbalize that” before the treatment proceeds, she said.
Sometimes teens leave after an initial conversation and then return later when they have a more clearly defined sense of what dysphoria means.
“There are other kids who clearly, clearly understand that the gender they were assigned at birth is not who they are,” she said.
Children now wrestle with added concerns that their parents could be put at risk for trying to help them, she said.
“These kids go through so much. And we have these people in powerful positions telling them that they don’t matter and telling them, ‘We’re going to cut off your access to healthcare, Medicaid; if your parents tried to seek out this care for you, we’re going to put them in jail,’” she said.
“It’s the biggest factor in fear mongering,” she said.
Dr. Collins-Ogle said she wonders why legislators who lack medical training are trying to dictate how physicians can practice.
“I took a Hippocratic oath to do no harm. I have a medical board that I answer to,” she said. “I don’t understand how legislators can get away with legislating about something they know nothing about.”
A version of this article appeared on Medscape.com.
Debate grows over facility fees as lawmakers urge greater transparency
Can the US healthcare system learn something about how to operate from car dealerships? Lawrence Kosinski, MD, MBA, a governing board member of American Gastroenterological Association (AGA), believes so.
There’s growing concern in the United States about the lack of clarity surrounding facility fees, which are intended to cover costs of maintaining medical facilities. Dr. Kosinski thinks that Congress should look into the transparency mandate it created for car prices as a model for how to address this.
A 1958 federal law set the stage for the consumer-friendly breakdown of costs and relevant performance data that anyone who has bought a new vehicle in the United States would recognize.
“You look at that and you know exactly what you are paying for,” Dr. Kosinski told this news organization. “In healthcare, we need something like that.”
Novel solutions like Dr. Kosinski’s will be increasingly necessary, as lawmakers on the state and federal level have begun to set their sights on tackling this issue.
The Biden administration in July expressed concern about an increased use of facility fees for healthcare provided at doctors’ offices, saying these additional costs often surprise consumers. House Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-WA) also raised this issue several times this year, including at a May meeting about pending legislation on price transparency for health services, where she mentioned the case of a man who underwent eye surgery in Maine.
“His bill included three separate facility fees totaling $7800 and professional fees totaling $6200,” Ms. Rodgers said. “Why are three facility fees necessary for 1 hour of surgery in one O.R.?”
AGA’s Dr. Kosinski said facility fees cover the additional costs hospitals and clinics face in providing even routine treatments for some patients. For example, colonoscopy for a patient with a body mass index of 50 would pose special challenges for the anesthesiologist.
These factors need to be considered in setting policies on facility fees, he said. But there is no reason hospitals and other sites of medical care can’t make the information about facility fees easy for patients to find and understand, Dr. Kosinski said.
“I’m struggling to see a reason why we can’t be more transparent,” he said.
Big Battles Ahead
There are two connected battles ahead regarding facility fees: Efforts to restrict these additional charges for many medical services and fights over the need for greater transparency in general about health costs.
Senate Health, Education, Labor and Pensions Chairman Bernie Sanders (I-VT) is seeking to broadly restrict facility fees through his pending Primary Care and Health Workforce Act (S. 2840). The measure would block hospitals from charging health plans facility fees for many evaluation, management, and telehealth services.
The American Hospital Association (AHA) opposes it. They argue that the current payment approach rightly accounts for the added costs incurred when hospitals treat patients who are more likely to be ill or have chronic conditions than those seen in independent practices.
AHA said hospitals also need to maintain standby capacity for natural and man-made disasters, public health emergencies, and unexpected traumatic events. In September, AHA launched a television ad campaign to oppose any drive toward site-neutral policies. AHA says reducing the extra payments could cause more hospitals to shut their doors.
But there’s persistent interest in site-neutral payment, the term describing when the same reimbursement is given for care regardless of setting. This would lower pay for hospitals.
Among those pressing for change is an umbrella group of medical organizations known as the Alliance for Site Neutral Payment Reform. Its members include the American Academy of Family Physicians, American Academy of Orthopaedic Surgeons, American College of Physicians, Community Oncology Alliance, and Digestive Health Physicians Association.
And on November 9, Sen. Maggie Hassan (D-NH) argued for eventually including a site-neutral Medicare provision to a major healthcare package that the Senate Finance Committee is putting together.
Sen. Hassan is seeking to end what she called the “the practice of charging patients unfair hospital facility fees for care provided in the off-campus outpatient setting, like at a regular doctor’s office.”
Senate Finance Chairman Ron Wyden (D-OR) and the ranking Republican on the committee, Sen. Mike Crapo (R-ID), told Sen. Hassan they intended to work with her to see if this issue could be addressed in the pending legislative package.
A 2015 budget deal marked the last time Congress took a major step to address the higher cost of services provided in hospital-owned facilities.
Lawmakers then were scrambling to find cuts to offset spending in what became the 2015 Bipartisan Budget Act. This law established site-neutral payments under Medicare for services received at off-campus outpatient departments but exempted hospitals that already ran these kinds of operations or had advanced plans to create them.
Lawmakers are well aware of the potential savings from site-neutral policies and could look in time again to use them as part of a future budget deal.
In fact, in June, Sen. Hassan and Sens. Mike Braun (R-IN) and John Kennedy (R-LA) introduced a bill meant to basically end the exemption given in the 2015 deal to existing hospital outpatient departments, which has allowed higher Medicare payments. In a press release, Braun estimated that their proposed site-neutral change could save taxpayers $40 billion over a decade.
As Debate Continues, States Are Moving Ahead With Changes
Consumer activists have won a few battles this year at the state level about facility fees.
In July, Maine Gov. Janet Mills, a Democrat, signed a law that requires medical organizations to report facility fees to the state, which will share them publicly. Facility fees can pop up after a patient has received an insurance company estimate of the out-of-pocket costs for care.
“Patients receive bills bloated by healthcare providers that overcharge for services and insurance companies that deny claims without explanation,” the Portland Press Herald reported in a 2022 story. “And with little clout to fight back or even negotiate, feeling helpless, they often give up and pay, worn down by a system that is as time-consuming as it is obtuse.”
In May, Colorado enacted a law that will require patient notification about facility fees at many hospitals in the state.
In June, Connecticut expanded its law regarding facility fees and prohibited them for certain routine outpatient healthcare services. A statement from Gov. Ned Lamont’s office said the original intent of these facility fees was to ensure hospitals could maintain the around-the-clock care needed for inpatient and emergency care.
“However, these fees have been increasingly applied to services such as diagnostic testing and other routine services,” the statement said.
But there have been setbacks as well for those seeking to curb facilities.
The Texas Hospital Association (THA) in May said its advocacy defeated a pair of state bills, House bill 1692 and Senate bill 1275, that sought to limit facility fees for outpatient services.
In rallying opposition to these bills, THA said the loss of facility fees would threaten care for patients. Facility fees help cover costs “beyond the doctor’s bill,” such as “lab technicians, interpreters, medical records, security personnel, janitorial staff, and others,” THA said.
More Patients Shopping?
It’s unclear when — or if — Congress and other states will take major steps to reduce additional payments to hospitals for outpatient care.
But the increased use of high deductibles in health plans is driving more consumers to try to understand all of the costs of medical procedures ahead of time and, thus, drawing attention to facility fees, said Charlie Byrge, the chief operating officer of MDsave.
The average annual deductible levels for an individual increased by 3.0% to $2004 from 2020 to 2021 and for a family plan by 3.9% to $3868, according to a federal report. Some people have higher deductibles, exceeding $5000, Mr. Byrge said.
“That’s creating an opportunity for firms that can connect physicians directly with patients who will pay part or all of the costs of a treatment out of pocket,” he told this news organization.
Doctors and hospitals work with MDsave to charge preset prices for certain services, such as colonoscopies and mammograms. Consumers then can shop online to see if they can save. For example, in Nashville, Tennessee, where MDsave is based, the cost of a colonoscopy through MDsave is $2334, about half of the $4714 national average, according to the firm’s website.
This model for pricing routine medical care is akin to those used for other products and services, where companies decide ahead of time what to charge, he said.
“You don’t buy an airline ticket from Southwest or United or Delta and then there’s a bill after the fact because the price of gas went up a little bit on your flight,” Mr. Byrge said.
This will drive more competition among hospitals and clinics, in places where there are several sites of care in a region, Mr. Byrge said. But there are advantages for physicians and hospitals from the MDsave approach, he said.
“They know they’re getting paid upfront. They’re not going through the delays and headaches of the insurance reimbursement process. There are no denials. It’s just an upfront payment, and I think that’s what we’re starting to see the market really moving toward,” he said.
A version of this article appeared on Medscape.com.
Can the US healthcare system learn something about how to operate from car dealerships? Lawrence Kosinski, MD, MBA, a governing board member of American Gastroenterological Association (AGA), believes so.
There’s growing concern in the United States about the lack of clarity surrounding facility fees, which are intended to cover costs of maintaining medical facilities. Dr. Kosinski thinks that Congress should look into the transparency mandate it created for car prices as a model for how to address this.
A 1958 federal law set the stage for the consumer-friendly breakdown of costs and relevant performance data that anyone who has bought a new vehicle in the United States would recognize.
“You look at that and you know exactly what you are paying for,” Dr. Kosinski told this news organization. “In healthcare, we need something like that.”
Novel solutions like Dr. Kosinski’s will be increasingly necessary, as lawmakers on the state and federal level have begun to set their sights on tackling this issue.
The Biden administration in July expressed concern about an increased use of facility fees for healthcare provided at doctors’ offices, saying these additional costs often surprise consumers. House Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-WA) also raised this issue several times this year, including at a May meeting about pending legislation on price transparency for health services, where she mentioned the case of a man who underwent eye surgery in Maine.
“His bill included three separate facility fees totaling $7800 and professional fees totaling $6200,” Ms. Rodgers said. “Why are three facility fees necessary for 1 hour of surgery in one O.R.?”
AGA’s Dr. Kosinski said facility fees cover the additional costs hospitals and clinics face in providing even routine treatments for some patients. For example, colonoscopy for a patient with a body mass index of 50 would pose special challenges for the anesthesiologist.
These factors need to be considered in setting policies on facility fees, he said. But there is no reason hospitals and other sites of medical care can’t make the information about facility fees easy for patients to find and understand, Dr. Kosinski said.
“I’m struggling to see a reason why we can’t be more transparent,” he said.
Big Battles Ahead
There are two connected battles ahead regarding facility fees: Efforts to restrict these additional charges for many medical services and fights over the need for greater transparency in general about health costs.
Senate Health, Education, Labor and Pensions Chairman Bernie Sanders (I-VT) is seeking to broadly restrict facility fees through his pending Primary Care and Health Workforce Act (S. 2840). The measure would block hospitals from charging health plans facility fees for many evaluation, management, and telehealth services.
The American Hospital Association (AHA) opposes it. They argue that the current payment approach rightly accounts for the added costs incurred when hospitals treat patients who are more likely to be ill or have chronic conditions than those seen in independent practices.
AHA said hospitals also need to maintain standby capacity for natural and man-made disasters, public health emergencies, and unexpected traumatic events. In September, AHA launched a television ad campaign to oppose any drive toward site-neutral policies. AHA says reducing the extra payments could cause more hospitals to shut their doors.
But there’s persistent interest in site-neutral payment, the term describing when the same reimbursement is given for care regardless of setting. This would lower pay for hospitals.
Among those pressing for change is an umbrella group of medical organizations known as the Alliance for Site Neutral Payment Reform. Its members include the American Academy of Family Physicians, American Academy of Orthopaedic Surgeons, American College of Physicians, Community Oncology Alliance, and Digestive Health Physicians Association.
And on November 9, Sen. Maggie Hassan (D-NH) argued for eventually including a site-neutral Medicare provision to a major healthcare package that the Senate Finance Committee is putting together.
Sen. Hassan is seeking to end what she called the “the practice of charging patients unfair hospital facility fees for care provided in the off-campus outpatient setting, like at a regular doctor’s office.”
Senate Finance Chairman Ron Wyden (D-OR) and the ranking Republican on the committee, Sen. Mike Crapo (R-ID), told Sen. Hassan they intended to work with her to see if this issue could be addressed in the pending legislative package.
A 2015 budget deal marked the last time Congress took a major step to address the higher cost of services provided in hospital-owned facilities.
Lawmakers then were scrambling to find cuts to offset spending in what became the 2015 Bipartisan Budget Act. This law established site-neutral payments under Medicare for services received at off-campus outpatient departments but exempted hospitals that already ran these kinds of operations or had advanced plans to create them.
Lawmakers are well aware of the potential savings from site-neutral policies and could look in time again to use them as part of a future budget deal.
In fact, in June, Sen. Hassan and Sens. Mike Braun (R-IN) and John Kennedy (R-LA) introduced a bill meant to basically end the exemption given in the 2015 deal to existing hospital outpatient departments, which has allowed higher Medicare payments. In a press release, Braun estimated that their proposed site-neutral change could save taxpayers $40 billion over a decade.
As Debate Continues, States Are Moving Ahead With Changes
Consumer activists have won a few battles this year at the state level about facility fees.
In July, Maine Gov. Janet Mills, a Democrat, signed a law that requires medical organizations to report facility fees to the state, which will share them publicly. Facility fees can pop up after a patient has received an insurance company estimate of the out-of-pocket costs for care.
“Patients receive bills bloated by healthcare providers that overcharge for services and insurance companies that deny claims without explanation,” the Portland Press Herald reported in a 2022 story. “And with little clout to fight back or even negotiate, feeling helpless, they often give up and pay, worn down by a system that is as time-consuming as it is obtuse.”
In May, Colorado enacted a law that will require patient notification about facility fees at many hospitals in the state.
In June, Connecticut expanded its law regarding facility fees and prohibited them for certain routine outpatient healthcare services. A statement from Gov. Ned Lamont’s office said the original intent of these facility fees was to ensure hospitals could maintain the around-the-clock care needed for inpatient and emergency care.
“However, these fees have been increasingly applied to services such as diagnostic testing and other routine services,” the statement said.
But there have been setbacks as well for those seeking to curb facilities.
The Texas Hospital Association (THA) in May said its advocacy defeated a pair of state bills, House bill 1692 and Senate bill 1275, that sought to limit facility fees for outpatient services.
In rallying opposition to these bills, THA said the loss of facility fees would threaten care for patients. Facility fees help cover costs “beyond the doctor’s bill,” such as “lab technicians, interpreters, medical records, security personnel, janitorial staff, and others,” THA said.
More Patients Shopping?
It’s unclear when — or if — Congress and other states will take major steps to reduce additional payments to hospitals for outpatient care.
But the increased use of high deductibles in health plans is driving more consumers to try to understand all of the costs of medical procedures ahead of time and, thus, drawing attention to facility fees, said Charlie Byrge, the chief operating officer of MDsave.
The average annual deductible levels for an individual increased by 3.0% to $2004 from 2020 to 2021 and for a family plan by 3.9% to $3868, according to a federal report. Some people have higher deductibles, exceeding $5000, Mr. Byrge said.
“That’s creating an opportunity for firms that can connect physicians directly with patients who will pay part or all of the costs of a treatment out of pocket,” he told this news organization.
Doctors and hospitals work with MDsave to charge preset prices for certain services, such as colonoscopies and mammograms. Consumers then can shop online to see if they can save. For example, in Nashville, Tennessee, where MDsave is based, the cost of a colonoscopy through MDsave is $2334, about half of the $4714 national average, according to the firm’s website.
This model for pricing routine medical care is akin to those used for other products and services, where companies decide ahead of time what to charge, he said.
“You don’t buy an airline ticket from Southwest or United or Delta and then there’s a bill after the fact because the price of gas went up a little bit on your flight,” Mr. Byrge said.
This will drive more competition among hospitals and clinics, in places where there are several sites of care in a region, Mr. Byrge said. But there are advantages for physicians and hospitals from the MDsave approach, he said.
“They know they’re getting paid upfront. They’re not going through the delays and headaches of the insurance reimbursement process. There are no denials. It’s just an upfront payment, and I think that’s what we’re starting to see the market really moving toward,” he said.
A version of this article appeared on Medscape.com.
Can the US healthcare system learn something about how to operate from car dealerships? Lawrence Kosinski, MD, MBA, a governing board member of American Gastroenterological Association (AGA), believes so.
There’s growing concern in the United States about the lack of clarity surrounding facility fees, which are intended to cover costs of maintaining medical facilities. Dr. Kosinski thinks that Congress should look into the transparency mandate it created for car prices as a model for how to address this.
A 1958 federal law set the stage for the consumer-friendly breakdown of costs and relevant performance data that anyone who has bought a new vehicle in the United States would recognize.
“You look at that and you know exactly what you are paying for,” Dr. Kosinski told this news organization. “In healthcare, we need something like that.”
Novel solutions like Dr. Kosinski’s will be increasingly necessary, as lawmakers on the state and federal level have begun to set their sights on tackling this issue.
The Biden administration in July expressed concern about an increased use of facility fees for healthcare provided at doctors’ offices, saying these additional costs often surprise consumers. House Energy and Commerce Chairwoman Cathy McMorris Rodgers (R-WA) also raised this issue several times this year, including at a May meeting about pending legislation on price transparency for health services, where she mentioned the case of a man who underwent eye surgery in Maine.
“His bill included three separate facility fees totaling $7800 and professional fees totaling $6200,” Ms. Rodgers said. “Why are three facility fees necessary for 1 hour of surgery in one O.R.?”
AGA’s Dr. Kosinski said facility fees cover the additional costs hospitals and clinics face in providing even routine treatments for some patients. For example, colonoscopy for a patient with a body mass index of 50 would pose special challenges for the anesthesiologist.
These factors need to be considered in setting policies on facility fees, he said. But there is no reason hospitals and other sites of medical care can’t make the information about facility fees easy for patients to find and understand, Dr. Kosinski said.
“I’m struggling to see a reason why we can’t be more transparent,” he said.
Big Battles Ahead
There are two connected battles ahead regarding facility fees: Efforts to restrict these additional charges for many medical services and fights over the need for greater transparency in general about health costs.
Senate Health, Education, Labor and Pensions Chairman Bernie Sanders (I-VT) is seeking to broadly restrict facility fees through his pending Primary Care and Health Workforce Act (S. 2840). The measure would block hospitals from charging health plans facility fees for many evaluation, management, and telehealth services.
The American Hospital Association (AHA) opposes it. They argue that the current payment approach rightly accounts for the added costs incurred when hospitals treat patients who are more likely to be ill or have chronic conditions than those seen in independent practices.
AHA said hospitals also need to maintain standby capacity for natural and man-made disasters, public health emergencies, and unexpected traumatic events. In September, AHA launched a television ad campaign to oppose any drive toward site-neutral policies. AHA says reducing the extra payments could cause more hospitals to shut their doors.
But there’s persistent interest in site-neutral payment, the term describing when the same reimbursement is given for care regardless of setting. This would lower pay for hospitals.
Among those pressing for change is an umbrella group of medical organizations known as the Alliance for Site Neutral Payment Reform. Its members include the American Academy of Family Physicians, American Academy of Orthopaedic Surgeons, American College of Physicians, Community Oncology Alliance, and Digestive Health Physicians Association.
And on November 9, Sen. Maggie Hassan (D-NH) argued for eventually including a site-neutral Medicare provision to a major healthcare package that the Senate Finance Committee is putting together.
Sen. Hassan is seeking to end what she called the “the practice of charging patients unfair hospital facility fees for care provided in the off-campus outpatient setting, like at a regular doctor’s office.”
Senate Finance Chairman Ron Wyden (D-OR) and the ranking Republican on the committee, Sen. Mike Crapo (R-ID), told Sen. Hassan they intended to work with her to see if this issue could be addressed in the pending legislative package.
A 2015 budget deal marked the last time Congress took a major step to address the higher cost of services provided in hospital-owned facilities.
Lawmakers then were scrambling to find cuts to offset spending in what became the 2015 Bipartisan Budget Act. This law established site-neutral payments under Medicare for services received at off-campus outpatient departments but exempted hospitals that already ran these kinds of operations or had advanced plans to create them.
Lawmakers are well aware of the potential savings from site-neutral policies and could look in time again to use them as part of a future budget deal.
In fact, in June, Sen. Hassan and Sens. Mike Braun (R-IN) and John Kennedy (R-LA) introduced a bill meant to basically end the exemption given in the 2015 deal to existing hospital outpatient departments, which has allowed higher Medicare payments. In a press release, Braun estimated that their proposed site-neutral change could save taxpayers $40 billion over a decade.
As Debate Continues, States Are Moving Ahead With Changes
Consumer activists have won a few battles this year at the state level about facility fees.
In July, Maine Gov. Janet Mills, a Democrat, signed a law that requires medical organizations to report facility fees to the state, which will share them publicly. Facility fees can pop up after a patient has received an insurance company estimate of the out-of-pocket costs for care.
“Patients receive bills bloated by healthcare providers that overcharge for services and insurance companies that deny claims without explanation,” the Portland Press Herald reported in a 2022 story. “And with little clout to fight back or even negotiate, feeling helpless, they often give up and pay, worn down by a system that is as time-consuming as it is obtuse.”
In May, Colorado enacted a law that will require patient notification about facility fees at many hospitals in the state.
In June, Connecticut expanded its law regarding facility fees and prohibited them for certain routine outpatient healthcare services. A statement from Gov. Ned Lamont’s office said the original intent of these facility fees was to ensure hospitals could maintain the around-the-clock care needed for inpatient and emergency care.
“However, these fees have been increasingly applied to services such as diagnostic testing and other routine services,” the statement said.
But there have been setbacks as well for those seeking to curb facilities.
The Texas Hospital Association (THA) in May said its advocacy defeated a pair of state bills, House bill 1692 and Senate bill 1275, that sought to limit facility fees for outpatient services.
In rallying opposition to these bills, THA said the loss of facility fees would threaten care for patients. Facility fees help cover costs “beyond the doctor’s bill,” such as “lab technicians, interpreters, medical records, security personnel, janitorial staff, and others,” THA said.
More Patients Shopping?
It’s unclear when — or if — Congress and other states will take major steps to reduce additional payments to hospitals for outpatient care.
But the increased use of high deductibles in health plans is driving more consumers to try to understand all of the costs of medical procedures ahead of time and, thus, drawing attention to facility fees, said Charlie Byrge, the chief operating officer of MDsave.
The average annual deductible levels for an individual increased by 3.0% to $2004 from 2020 to 2021 and for a family plan by 3.9% to $3868, according to a federal report. Some people have higher deductibles, exceeding $5000, Mr. Byrge said.
“That’s creating an opportunity for firms that can connect physicians directly with patients who will pay part or all of the costs of a treatment out of pocket,” he told this news organization.
Doctors and hospitals work with MDsave to charge preset prices for certain services, such as colonoscopies and mammograms. Consumers then can shop online to see if they can save. For example, in Nashville, Tennessee, where MDsave is based, the cost of a colonoscopy through MDsave is $2334, about half of the $4714 national average, according to the firm’s website.
This model for pricing routine medical care is akin to those used for other products and services, where companies decide ahead of time what to charge, he said.
“You don’t buy an airline ticket from Southwest or United or Delta and then there’s a bill after the fact because the price of gas went up a little bit on your flight,” Mr. Byrge said.
This will drive more competition among hospitals and clinics, in places where there are several sites of care in a region, Mr. Byrge said. But there are advantages for physicians and hospitals from the MDsave approach, he said.
“They know they’re getting paid upfront. They’re not going through the delays and headaches of the insurance reimbursement process. There are no denials. It’s just an upfront payment, and I think that’s what we’re starting to see the market really moving toward,” he said.
A version of this article appeared on Medscape.com.
FDA panel voices concerns over 2 lymphoma accelerated approvals
At a Nov. 16 meeting, the Oncologic Drugs Advisory Committee of the Food and Drug Administration reviewed the reasons for delays in confirmatory trials for pralatrexate (Folotyn) and belinostat (Beleodaq), both now owned by East Windsor, N.J.–based Acrotech. The FDA granted accelerated approval for pralatrexate in 2009 and belinostat in 2014.
“The consensus of the advisory committee is that we have significant concerns about the very prolonged delay and getting these confirmatory studies underway,” said Andy Chen, MD, PhD, of Oregon Health & Science University, Portland, who served as acting ODAC chair for the meeting.
Corporate ownership changes were among the reasons Acrotech cited for the long delays in producing the confirmatory research on pralatrexate and belinostat. Allos Therapeutics won the FDA approval of pralatrexate in 2009. In 2012, Spectrum Pharmaceuticals acquired Acrotech. Spectrum won approval of belinostat in 2014. Acrotech acquired Spectrum in 2019.
The FDA didn’t ask ODAC to take votes on any questions at the meeting. Instead, the FDA sought its expert feedback about how to address the prolonged delays with pralatrexate and belinostat research and, in general, how to promote more timely completion of confirmatory trials for drugs cleared by accelerated approval.
Pralatrexate and belinostat are both used to treat relapsed or refractory peripheral T-cell lymphoma, a rare and aggressive disease affecting about 10,000-15,000 people annually in the United States.
Through the accelerated approval process, the FDA seeks to speed medicines to people with fatal and serious conditions based on promising signs in clinical testing.
The initial pralatrexate and belinostat were based on phase 2, single-arm, monotherapy studies, with about 109 evaluable patients in the key pralatrexate study and 120 evaluable patients in the belinostat study. As is common, these phase 2 tests used measurements of cancer progression, known as the overall response rate.
The FDA then expects companies to show through more extensive testing that medicines cleared with accelerated approvals can deliver significant benefits, such as extending lives. When there are delays in confirmatory trials, patients can be exposed to medicines, often with significant side effects, that are unlikely to benefit them.
For example, the FDA granted an accelerated approval in 2011 for romidepsin for this use for peripheral T-cell lymphoma, the same condition for which pralatrexate and belinostat are used. But in 2021, Bristol-Myers Squibb withdrew the approval for that use of romidepsin when a confirmatory trial failed to meet the primary efficacy endpoint of progression free survival.
At the meeting, Richard Pazdur, MD, who leads oncology medicine at the FDA, urged Acrotech to shorten the time needed to determine whether its medicines deliver significant benefits to patients and thus merit full approval, or whether they too may fall short.
“We’re really in a situation where patients are caught in the middle here,” Dr. Pazdur said. “I feel very bad for that situation and very bad for the patients that they don’t have this information.”
‘Dangerous precedent’
The FDA in recent years has stepped up its efforts to get companies to complete their required studies on drugs cleared by accelerated approvals. The FDA has granted a total of 187 accelerated approvals for cancer drugs. Many of these cover new uses of established drugs and others serve to allow the introduction of new medicines.
For more than half of these cases, 96 of 187, the FDA already has learned that it made the right call in allowing early access to medicines. Companies have presented study results that confirmed the benefit of drugs and thus been able to convert accelerated approvals to traditional approvals.
But 27 of the 187 oncology accelerated approvals have been withdrawn. In these cases, subsequent research failed to establish the expected benefits of these cancer drugs.
And in 95 cases, the FDA and companies are still waiting for the results of studies to confirm the expected benefit of drugs granted accelerated approvals. The FDA classifies these as ongoing accelerated approvals. About 85% of these ongoing approvals were granted in the past 5 years, in contrast to 14 years for pralatrexate and 9 for belinostat.
“It sets a dangerous precedent for the other sponsors and drug companies to have such outliers from the same company,” said ODAC member Toni K. Choueiri, MD, of Harvard Medical School and the Dana-Farber Cancer Institute, both in Boston.
The current agreement between the FDA and Acrotech focuses on a phase 3 trial, SPI-BEL-301 as the confirmatory study. Acrotech’s plan is to start with dose optimization studies in part 1 of the trial, with part 2 meant to see if its medicines provide a significant benefit as measured by progression-free survival.
The plan is to compare treatments. One group of patients would get belinostat plus a common cancer regimen known as CHOP, another group would get pralatrexate plus the COP cancer regimen, which is CHOP without doxorubicin, and a third group would get CHOP.
Acrotech’s current time line is for part 1, which began in October, to finish by December 2025. Then the part 2 timeline would run from 2026 to 2030, with interim progression-free survival possible by 2028.
ODAC member Ashley Rosko, MD, a hematologist from Ohio State University, Columbus, asked Acrotech what steps it will take to try to speed recruitment for the study.
“We are going to implement many strategies,” including what’s called digital amplification, replied Ashish Anvekar, president of Acrotech. This will help identify patients and channel them toward participating clinical sites.
Alexander A. Vinks, PhD, PharmD, who served as a temporary member of ODAC for the Nov. 16 meeting, said many clinicians will not be excited about enrolling patients in this kind of large, traditionally designed study.
Dr. Vinks, who is professor emeritus at Cincinnati Children’s Hospital Medical Center and University of Cincinnati, now works with consultant group NDA, a firm that advises companies on developing drugs.
Dr. Vinks advised Acrotech should try “to pin down what is most likely a smaller study that could be simpler, but still give robust, informative data.”
At a Nov. 16 meeting, the Oncologic Drugs Advisory Committee of the Food and Drug Administration reviewed the reasons for delays in confirmatory trials for pralatrexate (Folotyn) and belinostat (Beleodaq), both now owned by East Windsor, N.J.–based Acrotech. The FDA granted accelerated approval for pralatrexate in 2009 and belinostat in 2014.
“The consensus of the advisory committee is that we have significant concerns about the very prolonged delay and getting these confirmatory studies underway,” said Andy Chen, MD, PhD, of Oregon Health & Science University, Portland, who served as acting ODAC chair for the meeting.
Corporate ownership changes were among the reasons Acrotech cited for the long delays in producing the confirmatory research on pralatrexate and belinostat. Allos Therapeutics won the FDA approval of pralatrexate in 2009. In 2012, Spectrum Pharmaceuticals acquired Acrotech. Spectrum won approval of belinostat in 2014. Acrotech acquired Spectrum in 2019.
The FDA didn’t ask ODAC to take votes on any questions at the meeting. Instead, the FDA sought its expert feedback about how to address the prolonged delays with pralatrexate and belinostat research and, in general, how to promote more timely completion of confirmatory trials for drugs cleared by accelerated approval.
Pralatrexate and belinostat are both used to treat relapsed or refractory peripheral T-cell lymphoma, a rare and aggressive disease affecting about 10,000-15,000 people annually in the United States.
Through the accelerated approval process, the FDA seeks to speed medicines to people with fatal and serious conditions based on promising signs in clinical testing.
The initial pralatrexate and belinostat were based on phase 2, single-arm, monotherapy studies, with about 109 evaluable patients in the key pralatrexate study and 120 evaluable patients in the belinostat study. As is common, these phase 2 tests used measurements of cancer progression, known as the overall response rate.
The FDA then expects companies to show through more extensive testing that medicines cleared with accelerated approvals can deliver significant benefits, such as extending lives. When there are delays in confirmatory trials, patients can be exposed to medicines, often with significant side effects, that are unlikely to benefit them.
For example, the FDA granted an accelerated approval in 2011 for romidepsin for this use for peripheral T-cell lymphoma, the same condition for which pralatrexate and belinostat are used. But in 2021, Bristol-Myers Squibb withdrew the approval for that use of romidepsin when a confirmatory trial failed to meet the primary efficacy endpoint of progression free survival.
At the meeting, Richard Pazdur, MD, who leads oncology medicine at the FDA, urged Acrotech to shorten the time needed to determine whether its medicines deliver significant benefits to patients and thus merit full approval, or whether they too may fall short.
“We’re really in a situation where patients are caught in the middle here,” Dr. Pazdur said. “I feel very bad for that situation and very bad for the patients that they don’t have this information.”
‘Dangerous precedent’
The FDA in recent years has stepped up its efforts to get companies to complete their required studies on drugs cleared by accelerated approvals. The FDA has granted a total of 187 accelerated approvals for cancer drugs. Many of these cover new uses of established drugs and others serve to allow the introduction of new medicines.
For more than half of these cases, 96 of 187, the FDA already has learned that it made the right call in allowing early access to medicines. Companies have presented study results that confirmed the benefit of drugs and thus been able to convert accelerated approvals to traditional approvals.
But 27 of the 187 oncology accelerated approvals have been withdrawn. In these cases, subsequent research failed to establish the expected benefits of these cancer drugs.
And in 95 cases, the FDA and companies are still waiting for the results of studies to confirm the expected benefit of drugs granted accelerated approvals. The FDA classifies these as ongoing accelerated approvals. About 85% of these ongoing approvals were granted in the past 5 years, in contrast to 14 years for pralatrexate and 9 for belinostat.
“It sets a dangerous precedent for the other sponsors and drug companies to have such outliers from the same company,” said ODAC member Toni K. Choueiri, MD, of Harvard Medical School and the Dana-Farber Cancer Institute, both in Boston.
The current agreement between the FDA and Acrotech focuses on a phase 3 trial, SPI-BEL-301 as the confirmatory study. Acrotech’s plan is to start with dose optimization studies in part 1 of the trial, with part 2 meant to see if its medicines provide a significant benefit as measured by progression-free survival.
The plan is to compare treatments. One group of patients would get belinostat plus a common cancer regimen known as CHOP, another group would get pralatrexate plus the COP cancer regimen, which is CHOP without doxorubicin, and a third group would get CHOP.
Acrotech’s current time line is for part 1, which began in October, to finish by December 2025. Then the part 2 timeline would run from 2026 to 2030, with interim progression-free survival possible by 2028.
ODAC member Ashley Rosko, MD, a hematologist from Ohio State University, Columbus, asked Acrotech what steps it will take to try to speed recruitment for the study.
“We are going to implement many strategies,” including what’s called digital amplification, replied Ashish Anvekar, president of Acrotech. This will help identify patients and channel them toward participating clinical sites.
Alexander A. Vinks, PhD, PharmD, who served as a temporary member of ODAC for the Nov. 16 meeting, said many clinicians will not be excited about enrolling patients in this kind of large, traditionally designed study.
Dr. Vinks, who is professor emeritus at Cincinnati Children’s Hospital Medical Center and University of Cincinnati, now works with consultant group NDA, a firm that advises companies on developing drugs.
Dr. Vinks advised Acrotech should try “to pin down what is most likely a smaller study that could be simpler, but still give robust, informative data.”
At a Nov. 16 meeting, the Oncologic Drugs Advisory Committee of the Food and Drug Administration reviewed the reasons for delays in confirmatory trials for pralatrexate (Folotyn) and belinostat (Beleodaq), both now owned by East Windsor, N.J.–based Acrotech. The FDA granted accelerated approval for pralatrexate in 2009 and belinostat in 2014.
“The consensus of the advisory committee is that we have significant concerns about the very prolonged delay and getting these confirmatory studies underway,” said Andy Chen, MD, PhD, of Oregon Health & Science University, Portland, who served as acting ODAC chair for the meeting.
Corporate ownership changes were among the reasons Acrotech cited for the long delays in producing the confirmatory research on pralatrexate and belinostat. Allos Therapeutics won the FDA approval of pralatrexate in 2009. In 2012, Spectrum Pharmaceuticals acquired Acrotech. Spectrum won approval of belinostat in 2014. Acrotech acquired Spectrum in 2019.
The FDA didn’t ask ODAC to take votes on any questions at the meeting. Instead, the FDA sought its expert feedback about how to address the prolonged delays with pralatrexate and belinostat research and, in general, how to promote more timely completion of confirmatory trials for drugs cleared by accelerated approval.
Pralatrexate and belinostat are both used to treat relapsed or refractory peripheral T-cell lymphoma, a rare and aggressive disease affecting about 10,000-15,000 people annually in the United States.
Through the accelerated approval process, the FDA seeks to speed medicines to people with fatal and serious conditions based on promising signs in clinical testing.
The initial pralatrexate and belinostat were based on phase 2, single-arm, monotherapy studies, with about 109 evaluable patients in the key pralatrexate study and 120 evaluable patients in the belinostat study. As is common, these phase 2 tests used measurements of cancer progression, known as the overall response rate.
The FDA then expects companies to show through more extensive testing that medicines cleared with accelerated approvals can deliver significant benefits, such as extending lives. When there are delays in confirmatory trials, patients can be exposed to medicines, often with significant side effects, that are unlikely to benefit them.
For example, the FDA granted an accelerated approval in 2011 for romidepsin for this use for peripheral T-cell lymphoma, the same condition for which pralatrexate and belinostat are used. But in 2021, Bristol-Myers Squibb withdrew the approval for that use of romidepsin when a confirmatory trial failed to meet the primary efficacy endpoint of progression free survival.
At the meeting, Richard Pazdur, MD, who leads oncology medicine at the FDA, urged Acrotech to shorten the time needed to determine whether its medicines deliver significant benefits to patients and thus merit full approval, or whether they too may fall short.
“We’re really in a situation where patients are caught in the middle here,” Dr. Pazdur said. “I feel very bad for that situation and very bad for the patients that they don’t have this information.”
‘Dangerous precedent’
The FDA in recent years has stepped up its efforts to get companies to complete their required studies on drugs cleared by accelerated approvals. The FDA has granted a total of 187 accelerated approvals for cancer drugs. Many of these cover new uses of established drugs and others serve to allow the introduction of new medicines.
For more than half of these cases, 96 of 187, the FDA already has learned that it made the right call in allowing early access to medicines. Companies have presented study results that confirmed the benefit of drugs and thus been able to convert accelerated approvals to traditional approvals.
But 27 of the 187 oncology accelerated approvals have been withdrawn. In these cases, subsequent research failed to establish the expected benefits of these cancer drugs.
And in 95 cases, the FDA and companies are still waiting for the results of studies to confirm the expected benefit of drugs granted accelerated approvals. The FDA classifies these as ongoing accelerated approvals. About 85% of these ongoing approvals were granted in the past 5 years, in contrast to 14 years for pralatrexate and 9 for belinostat.
“It sets a dangerous precedent for the other sponsors and drug companies to have such outliers from the same company,” said ODAC member Toni K. Choueiri, MD, of Harvard Medical School and the Dana-Farber Cancer Institute, both in Boston.
The current agreement between the FDA and Acrotech focuses on a phase 3 trial, SPI-BEL-301 as the confirmatory study. Acrotech’s plan is to start with dose optimization studies in part 1 of the trial, with part 2 meant to see if its medicines provide a significant benefit as measured by progression-free survival.
The plan is to compare treatments. One group of patients would get belinostat plus a common cancer regimen known as CHOP, another group would get pralatrexate plus the COP cancer regimen, which is CHOP without doxorubicin, and a third group would get CHOP.
Acrotech’s current time line is for part 1, which began in October, to finish by December 2025. Then the part 2 timeline would run from 2026 to 2030, with interim progression-free survival possible by 2028.
ODAC member Ashley Rosko, MD, a hematologist from Ohio State University, Columbus, asked Acrotech what steps it will take to try to speed recruitment for the study.
“We are going to implement many strategies,” including what’s called digital amplification, replied Ashish Anvekar, president of Acrotech. This will help identify patients and channel them toward participating clinical sites.
Alexander A. Vinks, PhD, PharmD, who served as a temporary member of ODAC for the Nov. 16 meeting, said many clinicians will not be excited about enrolling patients in this kind of large, traditionally designed study.
Dr. Vinks, who is professor emeritus at Cincinnati Children’s Hospital Medical Center and University of Cincinnati, now works with consultant group NDA, a firm that advises companies on developing drugs.
Dr. Vinks advised Acrotech should try “to pin down what is most likely a smaller study that could be simpler, but still give robust, informative data.”
Study eases fears: Knee surgery surge not linked to premature intervention
“Both the total number [of surgeons performing primary TKA] and the number of surgeons per capita have been generally increasing,” wrote Peter Dust, MD, of McGill University, Montreal, and coauthors. “Reassuringly, however, our results suggest that despite the increasing number of surgeons, the indications for surgery are not being eroded by operating on healthier patients to fill operating room time.”
The study was published in the Canadian Journal of Surgery.
Rising demand
In the paper, Dr. Dust and colleagues noted that there was a 162% increase in volume of total knee arthroplasties among people enrolled in the Medicare program between 1991 and 2010.
Unrelated to the study, the Canadian Institute for Health Information (CIHI) has reported similar trends. In 2018-2019, about 75,000 knee replacements were performed in Canada; an increase of 22.5% over the previous 5 years. The numbers dropped in 2020-2021 during the pandemic because of limited access to medical facilities during that time, but then rebounded between April and September 2022 to close to prepandemic numbers. However, about 50% of patients were waiting longer during that time than the recommended 6 months (182 days) for their surgery.
So, what’s happening?
The trends for rising numbers of knee surgeries cannot be fully explained by population growth and increasing rates of obesity, Dr. Dust and colleagues wrote. That led them to ask whether some patients were undergoing surgery with a higher level of preoperative function compared with the past.
They conducted a systematic review and meta-analysis of the MEDLINE, Embase, and Cochrane databases with the aim of determining the effect of time, age, and sex on preoperative functional status. A total of 149 studies were ultimately included in the study, with data from 257 independent groups and 57,844 patients recruited from 1991 to 2015.
The analysis revealed that patients are undergoing TKA with a level of preoperative function similar to that in the past. Also, patient age, sex, and location did not influence the functional status at which patients were considered for surgery.
Jasvinder Singh, MD, professor of medicine and epidemiology at University of Alabama at Birmingham, who was not involved with the research, offered another suggestion to explain the trend: People today are more familiar with knee replacement surgery and thus find it a less daunting option.
“Everybody knows somebody who has had a knee done or a hip done,” Singh said in an interview.”People are a lot more familiar with these things than they were 30 years ago.”
Subjective criteria persists
In the paper, Dr. Dust said that he and his colleagues had hoped this study might reveal a target physical component summary (PCS) score, used to assess functional status, based on which patients could be considered for surgery. Their findings, however, did not enable such a recommendation to be made.
In an interview, Claudette M. Lajam, MD, a spokesperson for the American Academy of Orthopedic Surgeons (AAOS), agreed that there does not appear to be a trend toward earlier intervention. Also, a precise number or score that can be used to determine when patients should undergo TKA still does not exist. Dr. Lajam is professor of orthopedic surgery and system chief for orthopedic quality and risk at NYU Langone Health, New York.
The “sweet spot time” for TKA is still not clear based on available metrics, Dr. Lajam said. Physicians need to consider not only patient level of function before surgery, but also when to intervene so they will get the most benefit from these procedures.
The knee has to be “bad enough to justify major surgery,” she said, while waiting too long might lead to inferior outcomes.
In time, she thinks artificial intelligence (AI) could help in identifying when primary care clinicians should advise patients to seek specialist care for ailing knees.
AI could allow physicians and researchers to search for clues about the best timing for surgery by combing through millions of x-rays, a variety of functional scores used in assessing patients, and other sources of information, she explained. At this time, the PCS used by Dr. Dust and colleagues is just one of many measures used to assess patient level of function. AI might be able to bring these data together for scientists to review.
“AI can see patterns that I can’t see right now,” Dr. Lajam said.
But she emphasized that any AI application would be an aid to physicians in counseling patients. Evaluation by an experienced surgeon, together with guidance from any AI tool, could provide a greater understanding of how TKA could help patients with arthritis of the knee.
“The physician sees intangibles that AI would not see because we actually talk to the patient,” she explained.
Dr. Dust said there was no outside funding for the study and the authors and Dr. Lajam reported no relevant financial relationships. Dr. Singh said he has received consulting fees from AstraZeneca and institutional research support from Zimmer Biomet Holdings. He has received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America, and owns stock options in Atai Life Sciences. He is a member of the executive committee of Outcome Measures in Rheumatology (OMERACT), an organization that receives arms-length funding from eight companies.
A version of this article appeared on Medscape.com.
“Both the total number [of surgeons performing primary TKA] and the number of surgeons per capita have been generally increasing,” wrote Peter Dust, MD, of McGill University, Montreal, and coauthors. “Reassuringly, however, our results suggest that despite the increasing number of surgeons, the indications for surgery are not being eroded by operating on healthier patients to fill operating room time.”
The study was published in the Canadian Journal of Surgery.
Rising demand
In the paper, Dr. Dust and colleagues noted that there was a 162% increase in volume of total knee arthroplasties among people enrolled in the Medicare program between 1991 and 2010.
Unrelated to the study, the Canadian Institute for Health Information (CIHI) has reported similar trends. In 2018-2019, about 75,000 knee replacements were performed in Canada; an increase of 22.5% over the previous 5 years. The numbers dropped in 2020-2021 during the pandemic because of limited access to medical facilities during that time, but then rebounded between April and September 2022 to close to prepandemic numbers. However, about 50% of patients were waiting longer during that time than the recommended 6 months (182 days) for their surgery.
So, what’s happening?
The trends for rising numbers of knee surgeries cannot be fully explained by population growth and increasing rates of obesity, Dr. Dust and colleagues wrote. That led them to ask whether some patients were undergoing surgery with a higher level of preoperative function compared with the past.
They conducted a systematic review and meta-analysis of the MEDLINE, Embase, and Cochrane databases with the aim of determining the effect of time, age, and sex on preoperative functional status. A total of 149 studies were ultimately included in the study, with data from 257 independent groups and 57,844 patients recruited from 1991 to 2015.
The analysis revealed that patients are undergoing TKA with a level of preoperative function similar to that in the past. Also, patient age, sex, and location did not influence the functional status at which patients were considered for surgery.
Jasvinder Singh, MD, professor of medicine and epidemiology at University of Alabama at Birmingham, who was not involved with the research, offered another suggestion to explain the trend: People today are more familiar with knee replacement surgery and thus find it a less daunting option.
“Everybody knows somebody who has had a knee done or a hip done,” Singh said in an interview.”People are a lot more familiar with these things than they were 30 years ago.”
Subjective criteria persists
In the paper, Dr. Dust said that he and his colleagues had hoped this study might reveal a target physical component summary (PCS) score, used to assess functional status, based on which patients could be considered for surgery. Their findings, however, did not enable such a recommendation to be made.
In an interview, Claudette M. Lajam, MD, a spokesperson for the American Academy of Orthopedic Surgeons (AAOS), agreed that there does not appear to be a trend toward earlier intervention. Also, a precise number or score that can be used to determine when patients should undergo TKA still does not exist. Dr. Lajam is professor of orthopedic surgery and system chief for orthopedic quality and risk at NYU Langone Health, New York.
The “sweet spot time” for TKA is still not clear based on available metrics, Dr. Lajam said. Physicians need to consider not only patient level of function before surgery, but also when to intervene so they will get the most benefit from these procedures.
The knee has to be “bad enough to justify major surgery,” she said, while waiting too long might lead to inferior outcomes.
In time, she thinks artificial intelligence (AI) could help in identifying when primary care clinicians should advise patients to seek specialist care for ailing knees.
AI could allow physicians and researchers to search for clues about the best timing for surgery by combing through millions of x-rays, a variety of functional scores used in assessing patients, and other sources of information, she explained. At this time, the PCS used by Dr. Dust and colleagues is just one of many measures used to assess patient level of function. AI might be able to bring these data together for scientists to review.
“AI can see patterns that I can’t see right now,” Dr. Lajam said.
But she emphasized that any AI application would be an aid to physicians in counseling patients. Evaluation by an experienced surgeon, together with guidance from any AI tool, could provide a greater understanding of how TKA could help patients with arthritis of the knee.
“The physician sees intangibles that AI would not see because we actually talk to the patient,” she explained.
Dr. Dust said there was no outside funding for the study and the authors and Dr. Lajam reported no relevant financial relationships. Dr. Singh said he has received consulting fees from AstraZeneca and institutional research support from Zimmer Biomet Holdings. He has received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America, and owns stock options in Atai Life Sciences. He is a member of the executive committee of Outcome Measures in Rheumatology (OMERACT), an organization that receives arms-length funding from eight companies.
A version of this article appeared on Medscape.com.
“Both the total number [of surgeons performing primary TKA] and the number of surgeons per capita have been generally increasing,” wrote Peter Dust, MD, of McGill University, Montreal, and coauthors. “Reassuringly, however, our results suggest that despite the increasing number of surgeons, the indications for surgery are not being eroded by operating on healthier patients to fill operating room time.”
The study was published in the Canadian Journal of Surgery.
Rising demand
In the paper, Dr. Dust and colleagues noted that there was a 162% increase in volume of total knee arthroplasties among people enrolled in the Medicare program between 1991 and 2010.
Unrelated to the study, the Canadian Institute for Health Information (CIHI) has reported similar trends. In 2018-2019, about 75,000 knee replacements were performed in Canada; an increase of 22.5% over the previous 5 years. The numbers dropped in 2020-2021 during the pandemic because of limited access to medical facilities during that time, but then rebounded between April and September 2022 to close to prepandemic numbers. However, about 50% of patients were waiting longer during that time than the recommended 6 months (182 days) for their surgery.
So, what’s happening?
The trends for rising numbers of knee surgeries cannot be fully explained by population growth and increasing rates of obesity, Dr. Dust and colleagues wrote. That led them to ask whether some patients were undergoing surgery with a higher level of preoperative function compared with the past.
They conducted a systematic review and meta-analysis of the MEDLINE, Embase, and Cochrane databases with the aim of determining the effect of time, age, and sex on preoperative functional status. A total of 149 studies were ultimately included in the study, with data from 257 independent groups and 57,844 patients recruited from 1991 to 2015.
The analysis revealed that patients are undergoing TKA with a level of preoperative function similar to that in the past. Also, patient age, sex, and location did not influence the functional status at which patients were considered for surgery.
Jasvinder Singh, MD, professor of medicine and epidemiology at University of Alabama at Birmingham, who was not involved with the research, offered another suggestion to explain the trend: People today are more familiar with knee replacement surgery and thus find it a less daunting option.
“Everybody knows somebody who has had a knee done or a hip done,” Singh said in an interview.”People are a lot more familiar with these things than they were 30 years ago.”
Subjective criteria persists
In the paper, Dr. Dust said that he and his colleagues had hoped this study might reveal a target physical component summary (PCS) score, used to assess functional status, based on which patients could be considered for surgery. Their findings, however, did not enable such a recommendation to be made.
In an interview, Claudette M. Lajam, MD, a spokesperson for the American Academy of Orthopedic Surgeons (AAOS), agreed that there does not appear to be a trend toward earlier intervention. Also, a precise number or score that can be used to determine when patients should undergo TKA still does not exist. Dr. Lajam is professor of orthopedic surgery and system chief for orthopedic quality and risk at NYU Langone Health, New York.
The “sweet spot time” for TKA is still not clear based on available metrics, Dr. Lajam said. Physicians need to consider not only patient level of function before surgery, but also when to intervene so they will get the most benefit from these procedures.
The knee has to be “bad enough to justify major surgery,” she said, while waiting too long might lead to inferior outcomes.
In time, she thinks artificial intelligence (AI) could help in identifying when primary care clinicians should advise patients to seek specialist care for ailing knees.
AI could allow physicians and researchers to search for clues about the best timing for surgery by combing through millions of x-rays, a variety of functional scores used in assessing patients, and other sources of information, she explained. At this time, the PCS used by Dr. Dust and colleagues is just one of many measures used to assess patient level of function. AI might be able to bring these data together for scientists to review.
“AI can see patterns that I can’t see right now,” Dr. Lajam said.
But she emphasized that any AI application would be an aid to physicians in counseling patients. Evaluation by an experienced surgeon, together with guidance from any AI tool, could provide a greater understanding of how TKA could help patients with arthritis of the knee.
“The physician sees intangibles that AI would not see because we actually talk to the patient,” she explained.
Dr. Dust said there was no outside funding for the study and the authors and Dr. Lajam reported no relevant financial relationships. Dr. Singh said he has received consulting fees from AstraZeneca and institutional research support from Zimmer Biomet Holdings. He has received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America, and owns stock options in Atai Life Sciences. He is a member of the executive committee of Outcome Measures in Rheumatology (OMERACT), an organization that receives arms-length funding from eight companies.
A version of this article appeared on Medscape.com.