MDedge Endocrinology

An insurance industry lobbying campaign persuaded federal officials to allow insurers to charge physicians fees for the privilege of being paid electronically, even though it can cost more to mail paper checks, according to a new investigation by the nonprofit news organization ProPublica. 

The Affordable Care Act requires that health plans give providers the option of being paid electronically to improve efficiency and save money. In 2017, the Centers for Medicare & Medicaid Services issued guidance that prohibited insurers and their payment processing vendors from “engaging in unfair business practices that do not support an efficient healthcare system,” according to a recent Medical Group Management Association position paper.

But that guidance, which appeared to forbid requiring fees to receive payments online, disappeared from the CMS site 6 months later.

According to ProPublica’s reporting, the change was the result of a quiet insurance industry lobbying campaign led by Matthew Albright, a former CMS employee who left government service to work for Zelis, a payment processing company co-owned by private equity giant Bain Capital.

The details of the lobbying effort were discovered by Alex Shteynshlyuger, a New York urologist, who through public records requests received the email correspondence between Mr. Albright and CMS and shared that material with ProPublica.

Mr. Albright had been able to influence CMS policy to protect what ProPublica called a “crucial revenue stream” for payment processors. The fee notice was removed just 3 days after Mr. Albright requested the change, ProPublica found.

When CMS resisted further changes, including eliminating guidance forbidding insurers and payment processors from charging excess fees for online payments, Mr. Albright brought in a law firm. The threat of a lawsuit by deep-pocketed Zelis was enough to bring CMS in line, ProPublica reported. Today, these fees can cost larger medical practices more than $1 million a year, according to the MGMA report.

“It took less than a decade for a new industry of middlemen, owned by private equity funds and giant conglomerates like UnitedHealth Group, to cash in,” writes Cezary Podkul, the author of the ProPublica report.
 

Predatory practices

It might seem that avoiding the fees would be as simple as requesting to be paid by check. However, a 2021 poll by the MGMA found that 57% of doctors were being charged these fees when they hadn’t agreed to them. According to the ProPublica report, physicians who have requested to be paid by check often find themselves being bounced back to electronic fund transfer (EFT) payments, where they are again charged fees.

In October 2021, more than 90 physician organizations, including the American Medical Association and the MGMA, signed a letter calling on the Biden administration to reinstate guidance to protect physicians’ right to receive EFT payments without paying fees. The letter describes the practice as “outrageous” and analogous to “an employee being required to enroll in a program that would deduct a percentage of each paycheck to receive direct deposit payments from an employer.”

So far, however, the situation remains unchanged. The language on the CMS site has changed, though. In 2022, the guidelines were adjusted to clarify that EFT fees are allowed.

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

An insurance industry lobbying campaign persuaded federal officials to allow insurers to charge physicians fees for the privilege of being paid electronically, even though it can cost more to mail paper checks, according to a new investigation by the nonprofit news organization ProPublica. 

The Affordable Care Act requires that health plans give providers the option of being paid electronically to improve efficiency and save money. In 2017, the Centers for Medicare & Medicaid Services issued guidance that prohibited insurers and their payment processing vendors from “engaging in unfair business practices that do not support an efficient healthcare system,” according to a recent Medical Group Management Association position paper.

But that guidance, which appeared to forbid requiring fees to receive payments online, disappeared from the CMS site 6 months later.

According to ProPublica’s reporting, the change was the result of a quiet insurance industry lobbying campaign led by Matthew Albright, a former CMS employee who left government service to work for Zelis, a payment processing company co-owned by private equity giant Bain Capital.

The details of the lobbying effort were discovered by Alex Shteynshlyuger, a New York urologist, who through public records requests received the email correspondence between Mr. Albright and CMS and shared that material with ProPublica.

Mr. Albright had been able to influence CMS policy to protect what ProPublica called a “crucial revenue stream” for payment processors. The fee notice was removed just 3 days after Mr. Albright requested the change, ProPublica found.

When CMS resisted further changes, including eliminating guidance forbidding insurers and payment processors from charging excess fees for online payments, Mr. Albright brought in a law firm. The threat of a lawsuit by deep-pocketed Zelis was enough to bring CMS in line, ProPublica reported. Today, these fees can cost larger medical practices more than $1 million a year, according to the MGMA report.

“It took less than a decade for a new industry of middlemen, owned by private equity funds and giant conglomerates like UnitedHealth Group, to cash in,” writes Cezary Podkul, the author of the ProPublica report.
 

Predatory practices

It might seem that avoiding the fees would be as simple as requesting to be paid by check. However, a 2021 poll by the MGMA found that 57% of doctors were being charged these fees when they hadn’t agreed to them. According to the ProPublica report, physicians who have requested to be paid by check often find themselves being bounced back to electronic fund transfer (EFT) payments, where they are again charged fees.

In October 2021, more than 90 physician organizations, including the American Medical Association and the MGMA, signed a letter calling on the Biden administration to reinstate guidance to protect physicians’ right to receive EFT payments without paying fees. The letter describes the practice as “outrageous” and analogous to “an employee being required to enroll in a program that would deduct a percentage of each paycheck to receive direct deposit payments from an employer.”

So far, however, the situation remains unchanged. The language on the CMS site has changed, though. In 2022, the guidelines were adjusted to clarify that EFT fees are allowed.

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

An insurance industry lobbying campaign persuaded federal officials to allow insurers to charge physicians fees for the privilege of being paid electronically, even though it can cost more to mail paper checks, according to a new investigation by the nonprofit news organization ProPublica. 

The Affordable Care Act requires that health plans give providers the option of being paid electronically to improve efficiency and save money. In 2017, the Centers for Medicare & Medicaid Services issued guidance that prohibited insurers and their payment processing vendors from “engaging in unfair business practices that do not support an efficient healthcare system,” according to a recent Medical Group Management Association position paper.

But that guidance, which appeared to forbid requiring fees to receive payments online, disappeared from the CMS site 6 months later.

According to ProPublica’s reporting, the change was the result of a quiet insurance industry lobbying campaign led by Matthew Albright, a former CMS employee who left government service to work for Zelis, a payment processing company co-owned by private equity giant Bain Capital.

The details of the lobbying effort were discovered by Alex Shteynshlyuger, a New York urologist, who through public records requests received the email correspondence between Mr. Albright and CMS and shared that material with ProPublica.

Mr. Albright had been able to influence CMS policy to protect what ProPublica called a “crucial revenue stream” for payment processors. The fee notice was removed just 3 days after Mr. Albright requested the change, ProPublica found.

When CMS resisted further changes, including eliminating guidance forbidding insurers and payment processors from charging excess fees for online payments, Mr. Albright brought in a law firm. The threat of a lawsuit by deep-pocketed Zelis was enough to bring CMS in line, ProPublica reported. Today, these fees can cost larger medical practices more than $1 million a year, according to the MGMA report.

“It took less than a decade for a new industry of middlemen, owned by private equity funds and giant conglomerates like UnitedHealth Group, to cash in,” writes Cezary Podkul, the author of the ProPublica report.
 

Predatory practices

It might seem that avoiding the fees would be as simple as requesting to be paid by check. However, a 2021 poll by the MGMA found that 57% of doctors were being charged these fees when they hadn’t agreed to them. According to the ProPublica report, physicians who have requested to be paid by check often find themselves being bounced back to electronic fund transfer (EFT) payments, where they are again charged fees.

In October 2021, more than 90 physician organizations, including the American Medical Association and the MGMA, signed a letter calling on the Biden administration to reinstate guidance to protect physicians’ right to receive EFT payments without paying fees. The letter describes the practice as “outrageous” and analogous to “an employee being required to enroll in a program that would deduct a percentage of each paycheck to receive direct deposit payments from an employer.”

So far, however, the situation remains unchanged. The language on the CMS site has changed, though. In 2022, the guidelines were adjusted to clarify that EFT fees are allowed.

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

Measuring four circulating biomarkers through a simple blood test in patients with type 2 diabetes and kidney disease may predict their risk of heart and kidney disease progression, suggests an analysis of the CREDENCE trial.

The research, published online in the journal Circulation, also revealed that patients treated with the sodium-glucose cotransporter-2 inhibitor canagliflozin (Invokana, Invokamet) had lower levels of the biomarkers after 1 year compared with those given placebo.

Examination of biomarker levels in more than 2,600 patients from CREDENCE showed that high baseline concentrations of the individual biomarkers were able to predict the future risk for a composite endpoint of renal and heart outcomes.

The combination of all four biomarkers into a single panel revealed that patients with the highest levels were more than four times as likely to experience the composite endpoint than were those with the lowest levels.

As two of the biomarkers used in the study have yet to have established prognostic thresholds, the results remain exploratory.

Lead author James L. Januzzi, MD, director of the Heart Failure and Biomarker Trials at the Baim Institute for Clinical Research, Boston, said that further study will help refine the predictive value of the panel.

“Given that the American Heart Association/American College of Cardiology and the American Diabetes Association now all recommend measurement of biomarkers to enhance the ability to predict risk in persons with type 2 diabetes, these results may considerably extend the reach of biomarker-based testing, refining accuracy even further,” he said in a press release.

In an interview, Dr. Januzzi said that “three out of the four biomarkers are already clinically and commercially available,” while the fourth, for insulin-like growth factor binding protein 7 (IGFBP7), is “on the near horizon.”

He stressed that the “future for multiple biomarker testing, however, will be less about ordering each individual test, and ultimately will revolve around panels of blood work that are ordered as a single test.”

Dr. Januzzi added that “rather than using the rather primitive approach that we took” of looking at the individual biomarkers in adjusted models, the next stage “will be to utilize algorithms to combine the results into a single value.

“A clinician will not have to struggle with looking at individual results but will just receive one aggregated test result that informs them whether a patient is at low, medium or higher risk,” he explained.

However, this will require determining the relative importance of each biomarker and weighting them in the final model.

Consequently, the current results “set the foundation for identifying some very powerful individual tests that may ultimately, in aggregate, help us to help our patients with diabetes avoid a major complication,” Dr. Januzzi said.

By revealing that some individuals with both type 2 diabetes and kidney disease are at higher risk than others, he also hopes the findings can be leveraged to treat patients with “varying degrees of intensity with proven therapies, including weight loss, dietary adjustment, and pharmacologic intervention.”

Dr. Januzzi added: “Diabetes affects a dramatic, and growing, percentage of our population, and this type of personalized strategy to reduce the major complications of this rather common disease is an important step forward.”

The authors noted that there is a “bidirectional relationship” between cardiovascular disease and chronic kidney disease (CKD), such that either diagnosis may increase the risk of, or exacerbate, the other. 

Individuals with type 2 diabetes and CKD albuminuria, they added, are at particularly high risk for major cardiovascular events, and studies have shown that several circulating cardiorenal stress biomarkers may predict the onset and progression of CKD in type 2 diabetes, as well as predict cardiovascular events.
 

Several biomarkers associated with myocardial stress and necrosis

The recent CANVAS trial revealed that, among individuals with type 2 diabetes with and without CKD, several biomarkers were associated with myocardial stress and necrosis, and renal tubular injury, predicting the progression of CKD with albuminuria, and the risk for heart failure events.

Taking inspiration from those findings, the current researchers studied a panel of similar cardiac and renal biomarkers among participants from the CREDENCE trial, for which 4,401 patients with type 2 diabetes and CKD at high risk of progression were randomly assigned to canagliflozin or placebo.

The current analysis involved 2,627 participants who had baseline plasma samples available for analysis of four circulating biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), growth differentiation factor-15 (GDF-15), and IGFBP7.

Among those, 2,385 participants also had year 1 plasma samples available for analysis, while year 3 plasma samples were available for 895 individuals.

The results showed that, in general, median baseline concentrations of each biomarker in both treatment groups were elevated compared with healthy reference populations.

Baseline log-transformed concentrations of each biomarker were also strongly predictive of cardiac and renal outcomes, including heart failure and progression of CKD.

For example, each unit increase in baseline NT-proBNP concentrations was associated with a hazard ratio of 1.35 for the primary composite endpoint of end-stage kidney disease, doubling of serum creatinine levels, renal death, or cardiovascular disease (P < .001).

For each unit increase in hs-cTnT levels, the hazard ratio for the primary composite was 1.73 (P < .001), for GDF-15 it was 1.84 (P < .0001), and for IGFBP7 the hazard ratio was 3.14 (P < .001).

Combining the four biomarkers into a single multimarker panel revealed that, compared with individuals with a low-risk score, those with a high-risk score had a hazard ratio for the primary outcome of 4.01, whereas those with a moderate risk score had a hazard ratio of 2.39 (P < .001 for both).

For the individual outcome of heart failure hospitalization, the effect was even greater. A high-risk score was associated with a hazard ratio vs. a low-risk score of 6.04 (P < .001), whereas patients with a moderate risk score had a hazard ratio of 2.45 (P = .04).

The researchers also reported that, between baseline and year 1, concentrations of all four biomarkers rose from 6% to 29% in the placebo group, but from 3% to just 10% in those treated with canagliflozin.

“It was reassuring to discover that canagliflozin helped reduce risks the most in people with the highest chances for complications,” said Dr. Januzzi.

The CREDENCE trial and the current analysis were funded by Janssen Research & Development LLC. NT-proBNP, hs-cTnT, GDF-15, and IGFBP7 reagents were provided by Roche Diagnostics. Dr. Januzzi is funded in part by the Hutter Family Professorship. Dr. Januzzi declared relationships with Imbria Pharmaceuticals, Jana Care, Abbott, Applied Therapeutics, HeartFlow, Innolife, Roche Diagnostics, Beckman, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Merck, Novartis, Pfizer, Siemens, Abbott, AbbVie, CVRx, Intercept, and Takeda.


 

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

Measuring four circulating biomarkers through a simple blood test in patients with type 2 diabetes and kidney disease may predict their risk of heart and kidney disease progression, suggests an analysis of the CREDENCE trial.

The research, published online in the journal Circulation, also revealed that patients treated with the sodium-glucose cotransporter-2 inhibitor canagliflozin (Invokana, Invokamet) had lower levels of the biomarkers after 1 year compared with those given placebo.

Examination of biomarker levels in more than 2,600 patients from CREDENCE showed that high baseline concentrations of the individual biomarkers were able to predict the future risk for a composite endpoint of renal and heart outcomes.

The combination of all four biomarkers into a single panel revealed that patients with the highest levels were more than four times as likely to experience the composite endpoint than were those with the lowest levels.

As two of the biomarkers used in the study have yet to have established prognostic thresholds, the results remain exploratory.

Lead author James L. Januzzi, MD, director of the Heart Failure and Biomarker Trials at the Baim Institute for Clinical Research, Boston, said that further study will help refine the predictive value of the panel.

“Given that the American Heart Association/American College of Cardiology and the American Diabetes Association now all recommend measurement of biomarkers to enhance the ability to predict risk in persons with type 2 diabetes, these results may considerably extend the reach of biomarker-based testing, refining accuracy even further,” he said in a press release.

In an interview, Dr. Januzzi said that “three out of the four biomarkers are already clinically and commercially available,” while the fourth, for insulin-like growth factor binding protein 7 (IGFBP7), is “on the near horizon.”

He stressed that the “future for multiple biomarker testing, however, will be less about ordering each individual test, and ultimately will revolve around panels of blood work that are ordered as a single test.”

Dr. Januzzi added that “rather than using the rather primitive approach that we took” of looking at the individual biomarkers in adjusted models, the next stage “will be to utilize algorithms to combine the results into a single value.

“A clinician will not have to struggle with looking at individual results but will just receive one aggregated test result that informs them whether a patient is at low, medium or higher risk,” he explained.

However, this will require determining the relative importance of each biomarker and weighting them in the final model.

Consequently, the current results “set the foundation for identifying some very powerful individual tests that may ultimately, in aggregate, help us to help our patients with diabetes avoid a major complication,” Dr. Januzzi said.

By revealing that some individuals with both type 2 diabetes and kidney disease are at higher risk than others, he also hopes the findings can be leveraged to treat patients with “varying degrees of intensity with proven therapies, including weight loss, dietary adjustment, and pharmacologic intervention.”

Dr. Januzzi added: “Diabetes affects a dramatic, and growing, percentage of our population, and this type of personalized strategy to reduce the major complications of this rather common disease is an important step forward.”

The authors noted that there is a “bidirectional relationship” between cardiovascular disease and chronic kidney disease (CKD), such that either diagnosis may increase the risk of, or exacerbate, the other. 

Individuals with type 2 diabetes and CKD albuminuria, they added, are at particularly high risk for major cardiovascular events, and studies have shown that several circulating cardiorenal stress biomarkers may predict the onset and progression of CKD in type 2 diabetes, as well as predict cardiovascular events.
 

Several biomarkers associated with myocardial stress and necrosis

The recent CANVAS trial revealed that, among individuals with type 2 diabetes with and without CKD, several biomarkers were associated with myocardial stress and necrosis, and renal tubular injury, predicting the progression of CKD with albuminuria, and the risk for heart failure events.

Taking inspiration from those findings, the current researchers studied a panel of similar cardiac and renal biomarkers among participants from the CREDENCE trial, for which 4,401 patients with type 2 diabetes and CKD at high risk of progression were randomly assigned to canagliflozin or placebo.

The current analysis involved 2,627 participants who had baseline plasma samples available for analysis of four circulating biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), growth differentiation factor-15 (GDF-15), and IGFBP7.

Among those, 2,385 participants also had year 1 plasma samples available for analysis, while year 3 plasma samples were available for 895 individuals.

The results showed that, in general, median baseline concentrations of each biomarker in both treatment groups were elevated compared with healthy reference populations.

Baseline log-transformed concentrations of each biomarker were also strongly predictive of cardiac and renal outcomes, including heart failure and progression of CKD.

For example, each unit increase in baseline NT-proBNP concentrations was associated with a hazard ratio of 1.35 for the primary composite endpoint of end-stage kidney disease, doubling of serum creatinine levels, renal death, or cardiovascular disease (P < .001).

For each unit increase in hs-cTnT levels, the hazard ratio for the primary composite was 1.73 (P < .001), for GDF-15 it was 1.84 (P < .0001), and for IGFBP7 the hazard ratio was 3.14 (P < .001).

Combining the four biomarkers into a single multimarker panel revealed that, compared with individuals with a low-risk score, those with a high-risk score had a hazard ratio for the primary outcome of 4.01, whereas those with a moderate risk score had a hazard ratio of 2.39 (P < .001 for both).

For the individual outcome of heart failure hospitalization, the effect was even greater. A high-risk score was associated with a hazard ratio vs. a low-risk score of 6.04 (P < .001), whereas patients with a moderate risk score had a hazard ratio of 2.45 (P = .04).

The researchers also reported that, between baseline and year 1, concentrations of all four biomarkers rose from 6% to 29% in the placebo group, but from 3% to just 10% in those treated with canagliflozin.

“It was reassuring to discover that canagliflozin helped reduce risks the most in people with the highest chances for complications,” said Dr. Januzzi.

The CREDENCE trial and the current analysis were funded by Janssen Research & Development LLC. NT-proBNP, hs-cTnT, GDF-15, and IGFBP7 reagents were provided by Roche Diagnostics. Dr. Januzzi is funded in part by the Hutter Family Professorship. Dr. Januzzi declared relationships with Imbria Pharmaceuticals, Jana Care, Abbott, Applied Therapeutics, HeartFlow, Innolife, Roche Diagnostics, Beckman, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Merck, Novartis, Pfizer, Siemens, Abbott, AbbVie, CVRx, Intercept, and Takeda.


 

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

Measuring four circulating biomarkers through a simple blood test in patients with type 2 diabetes and kidney disease may predict their risk of heart and kidney disease progression, suggests an analysis of the CREDENCE trial.

The research, published online in the journal Circulation, also revealed that patients treated with the sodium-glucose cotransporter-2 inhibitor canagliflozin (Invokana, Invokamet) had lower levels of the biomarkers after 1 year compared with those given placebo.

Examination of biomarker levels in more than 2,600 patients from CREDENCE showed that high baseline concentrations of the individual biomarkers were able to predict the future risk for a composite endpoint of renal and heart outcomes.

The combination of all four biomarkers into a single panel revealed that patients with the highest levels were more than four times as likely to experience the composite endpoint than were those with the lowest levels.

As two of the biomarkers used in the study have yet to have established prognostic thresholds, the results remain exploratory.

Lead author James L. Januzzi, MD, director of the Heart Failure and Biomarker Trials at the Baim Institute for Clinical Research, Boston, said that further study will help refine the predictive value of the panel.

“Given that the American Heart Association/American College of Cardiology and the American Diabetes Association now all recommend measurement of biomarkers to enhance the ability to predict risk in persons with type 2 diabetes, these results may considerably extend the reach of biomarker-based testing, refining accuracy even further,” he said in a press release.

In an interview, Dr. Januzzi said that “three out of the four biomarkers are already clinically and commercially available,” while the fourth, for insulin-like growth factor binding protein 7 (IGFBP7), is “on the near horizon.”

He stressed that the “future for multiple biomarker testing, however, will be less about ordering each individual test, and ultimately will revolve around panels of blood work that are ordered as a single test.”

Dr. Januzzi added that “rather than using the rather primitive approach that we took” of looking at the individual biomarkers in adjusted models, the next stage “will be to utilize algorithms to combine the results into a single value.

“A clinician will not have to struggle with looking at individual results but will just receive one aggregated test result that informs them whether a patient is at low, medium or higher risk,” he explained.

However, this will require determining the relative importance of each biomarker and weighting them in the final model.

Consequently, the current results “set the foundation for identifying some very powerful individual tests that may ultimately, in aggregate, help us to help our patients with diabetes avoid a major complication,” Dr. Januzzi said.

By revealing that some individuals with both type 2 diabetes and kidney disease are at higher risk than others, he also hopes the findings can be leveraged to treat patients with “varying degrees of intensity with proven therapies, including weight loss, dietary adjustment, and pharmacologic intervention.”

Dr. Januzzi added: “Diabetes affects a dramatic, and growing, percentage of our population, and this type of personalized strategy to reduce the major complications of this rather common disease is an important step forward.”

The authors noted that there is a “bidirectional relationship” between cardiovascular disease and chronic kidney disease (CKD), such that either diagnosis may increase the risk of, or exacerbate, the other. 

Individuals with type 2 diabetes and CKD albuminuria, they added, are at particularly high risk for major cardiovascular events, and studies have shown that several circulating cardiorenal stress biomarkers may predict the onset and progression of CKD in type 2 diabetes, as well as predict cardiovascular events.
 

Several biomarkers associated with myocardial stress and necrosis

The recent CANVAS trial revealed that, among individuals with type 2 diabetes with and without CKD, several biomarkers were associated with myocardial stress and necrosis, and renal tubular injury, predicting the progression of CKD with albuminuria, and the risk for heart failure events.

Taking inspiration from those findings, the current researchers studied a panel of similar cardiac and renal biomarkers among participants from the CREDENCE trial, for which 4,401 patients with type 2 diabetes and CKD at high risk of progression were randomly assigned to canagliflozin or placebo.

The current analysis involved 2,627 participants who had baseline plasma samples available for analysis of four circulating biomarkers: N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), growth differentiation factor-15 (GDF-15), and IGFBP7.

Among those, 2,385 participants also had year 1 plasma samples available for analysis, while year 3 plasma samples were available for 895 individuals.

The results showed that, in general, median baseline concentrations of each biomarker in both treatment groups were elevated compared with healthy reference populations.

Baseline log-transformed concentrations of each biomarker were also strongly predictive of cardiac and renal outcomes, including heart failure and progression of CKD.

For example, each unit increase in baseline NT-proBNP concentrations was associated with a hazard ratio of 1.35 for the primary composite endpoint of end-stage kidney disease, doubling of serum creatinine levels, renal death, or cardiovascular disease (P < .001).

For each unit increase in hs-cTnT levels, the hazard ratio for the primary composite was 1.73 (P < .001), for GDF-15 it was 1.84 (P < .0001), and for IGFBP7 the hazard ratio was 3.14 (P < .001).

Combining the four biomarkers into a single multimarker panel revealed that, compared with individuals with a low-risk score, those with a high-risk score had a hazard ratio for the primary outcome of 4.01, whereas those with a moderate risk score had a hazard ratio of 2.39 (P < .001 for both).

For the individual outcome of heart failure hospitalization, the effect was even greater. A high-risk score was associated with a hazard ratio vs. a low-risk score of 6.04 (P < .001), whereas patients with a moderate risk score had a hazard ratio of 2.45 (P = .04).

The researchers also reported that, between baseline and year 1, concentrations of all four biomarkers rose from 6% to 29% in the placebo group, but from 3% to just 10% in those treated with canagliflozin.

“It was reassuring to discover that canagliflozin helped reduce risks the most in people with the highest chances for complications,” said Dr. Januzzi.

The CREDENCE trial and the current analysis were funded by Janssen Research & Development LLC. NT-proBNP, hs-cTnT, GDF-15, and IGFBP7 reagents were provided by Roche Diagnostics. Dr. Januzzi is funded in part by the Hutter Family Professorship. Dr. Januzzi declared relationships with Imbria Pharmaceuticals, Jana Care, Abbott, Applied Therapeutics, HeartFlow, Innolife, Roche Diagnostics, Beckman, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, Merck, Novartis, Pfizer, Siemens, Abbott, AbbVie, CVRx, Intercept, and Takeda.


 

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

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

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

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

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

You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.

Professional liability insurance

According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.

And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.

Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.

But it is what the policies don’t pay for that should be of most interest to practitioners.
 

Exclusions to medical malpractice insurance

All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:

• Reckless or intentional acts.
• Illegal/criminal activities, including theft.
• Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
• Practicing under the influence of alcohol or drugs.
• Altering patient or hospital records.
• Sexual misconduct.
• Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.

It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.

Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
 

The case

Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.

The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.

However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.

The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.

The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.

A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.

After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
 

Court and jury decide

In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.

The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.

However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.

The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.

While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
 

Protecting yourself

The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.

Other ways to protect yourself:

• Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
• Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
• Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
• Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
• The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.

The future

In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.

The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.

In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”

Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
 

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

When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.

When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.

When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.

“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.

Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.

He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”

The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.

Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.

More than half of the respondents not using AI said they first want more evidence that the technology works as intended.

“None of them work as advertised,” said one respondent.

MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.

Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.

Doctors may also be skeptical of AI based on their experience with EHRs, she said.

“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
 

Drawing the line at patient care

Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.

“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.

Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:

• Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
• Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
• Improving billing operations and predictive analytics.

Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.

They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
 

Is regulation needed?

Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.

“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.

In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.

Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.

In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.

There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
 

What should doctors do?

Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.

There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.

“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.

Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
 

A version of this article appeared on Medscape.com.

After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.

“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”

Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.

“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”

Blackstone and Ascension St. John did not respond to this news organization’s request for comment.

TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.

Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”

Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.

Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
 

What should you expect after PE acquisition?

Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.

Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.

“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”

Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.

“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”

When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.

Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.

In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.

PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.

On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.

“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”

Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.

The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.

“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
 

How to prepare for and cope with PE partnerships

If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.

“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.

When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.

“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”

Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.

“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”

“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”

For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.

Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.

Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.

In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.

She advises physicians who are unhappy after acquisitions to speak up and stick together.

“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
 

Why is PE so attracted to health care?

PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.

These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.

When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.

At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.

Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.

Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.

A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.

“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.

Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.

“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.

PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.

A version of this article appeared on Medscape.com.

After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.

“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”

Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.

“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”

Blackstone and Ascension St. John did not respond to this news organization’s request for comment.

TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.

Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”

Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.

Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
 

What should you expect after PE acquisition?

Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.

Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.

“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”

Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.

“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”

When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.

Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.

In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.

PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.

On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.

“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”

Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.

The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.

“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
 

How to prepare for and cope with PE partnerships

If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.

“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.

When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.

“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”

Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.

“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”

“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”

For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.

Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.

Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.

In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.

She advises physicians who are unhappy after acquisitions to speak up and stick together.

“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
 

Why is PE so attracted to health care?

PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.

These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.

When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.

At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.

Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.

Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.

A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.

“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.

Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.

“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.

PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.

A version of this article appeared on Medscape.com.

After her emergency medicine group was acquired by a staffing firm backed by a large private equity (PE) firm, Michelle Wiener, MD, said the workflow changes came swiftly.

“Our staffing has been greatly reduced,” the Detroit physician said. “At this point, we have no say in anything. We have no say in the scheduling. We aren’t allowed to see what is billed under our name. The morale has really gone down.”

Dr. Wiener, who practices at Ascension St. John Hospital, said she and fellow physicians have repeatedly brought their concerns to TeamHealth, which in 2015 took over St. John Emergency Services PC. TeamHealth is owned by PE giant Blackstone.

“It’s very frustrating,” Dr. Wiener said. “We’re taking it from all sides.”

Blackstone and Ascension St. John did not respond to this news organization’s request for comment.

TeamHealth would not respond directly to questions about the Ascension St. John Hospital physicians or their concerns.

Spokesman Josh Hopson provided only a general statement: “TeamHealth is committed to making sure that clinicians have the resources and support needed to provide first-class care to patients, particularly with regard to staffing and compensation. TeamHealth has and will always put patient care first, and that is not impacted by its ownership model.”

Acquisitions of medical practices and hospitals by PE firms are rapidly growing, with more than 1,400 PE deals in health care in 2021 totaling upwards of $208 billion, according to PitchBook Data Inc., a Seattle-based firm that tracks mergers and acquisitions.

Some physicians praise the partnerships as an opportunity to improve technology and efficiency, whereas others decry them as raising patient costs and lowering the quality of care. A recent UC Berkeley study found that PE ownership of medical practices was linked to consumer price increases for 8 of 10 specialties, most notably oncology and gastroenterology.
 

What should you expect after PE acquisition?

Since his practice partnered with a PE firm in 2020, Milwaukee-based otolaryngologist Madan Kandula, MD, said he has found the changes positive. The practice has grown and improved operations in finance, accounting, compliance, and information technology, said Dr. Kandula, founder and CEO of Advent, an ENT practice with 15 clinics in four Midwestern states.

Dr. Kandula said his group already had a sound business practice, and that the goal of partnering with a PE firm wasn’t to change day-to-day operations but to propel the organization forward.

“From patient load to visit time to how we staff our clinics, there has been no change,” he said. “My private equity firm does not, [and] cannot, impose their will on our clinical decisions.”

Experts say the impact of PE acquisitions on individual physicians often depends on where a doctor ranks in the organization, what stage they are in their career, and how much control they had over the deal.

“It’s the older physicians who are usually selling the practice and getting the big payout,” said Anjali Dooley, a St. Louis–based health law attorney who counsels physicians about PE deals. “The younger doctors are usually not part of the deal, as they may still be employees. They don’t have any negotiating power. Hopefully, there is some transparency, but sometimes there is not, and they are blindsided by the deal.”

When it comes to workload, most PE-owned groups are put on a production-based model, such as a wRVU-based model, said Roger Strode, a Chicago-based health law attorney who focuses on health care mergers and acquisitions. Most already operate under such a model, but there might be some changes after a buyout.

Staffing may also change, added Ms. Dooley. The PE firms may want to add partners or companies already in their portfolios to create efficiencies, causing training or workflow changes.

In a hospital buyout, changes may depend on whether a department is a significant revenue generator for the hospital, Ms. Dooley noted.

PE firms frequently favor higher revenue–generating specialties, such as neurosurgery, cardiology, orthopedics, gastroenterology, and plastic surgery. They closely scrutinize departments said that make less money, such as the emergency department or primary care, Ms. Dooley said. Physicians or teams that don’t fit the firm’s cost-efficiency plans may be terminated or replaced.

On the other hand, Mr. Strode said physicians may see improved electronic health records and collections.

“Some of your overall overhead costs may be reduced, because they’re better at it,” Mr. Strode said. “When you’ve got more scale, the cost per patient, the cost per hour, the cost per procedure, goes down, and the cost that’s applied against your production will go down. As [practices grow], they have more bargaining power with payers and you can potentially get better rates. At least, that’s the promise.”

Analysts note that PE health care acquisitions show no signs of slowing and that it pays for physicians to know what to expect and how to cope if their practice or hospital is acquired. Whether physicians have some control over a buyout or are blindsided by the transition, it’s critical to know what to consider, how workloads might change, and your options for settling in or settling up.

The PE industry has about $2 trillion lined up for potential investments in 2023, said Ms. Dooley.

“PE firms are looking at health care to expend some of this dry powder,” Ms. Dooley continued. “If done correctly, PE firms that are aware of health care regulations, compliance, and patient care issues can ... remove redundant services and improve ... efficiencies, but the bad is when that doesn’t happen, and the quality of care goes down or there are patient safety risks.”
 

How to prepare for and cope with PE partnerships

If your practice is considering a PE partnership, it’s important to explore the terms and conditions and carefully weigh the pros and cons, said Gary Herschman, a Newark, N.J.–based attorney who advises PE-owned physician groups.

“My recommendation is that physicians at a minimum conduct due diligence on all potential strategic options for their groups, and then make an informed decision regarding whether a partnership transaction is right for their group, as it’s not right for every group,” he said.

When Texas cardiologist Rick Snyder, MD, was considering PE partnerships, he spoke with physicians who made similar deals to determine whether they were satisfied years later, he said. In April, Snyder’s practice, HeartPlace, the largest physician-owned cardiology practice in Texas, was acquired by US Heart & Vascular, a practice management platform backed by PE firm Ares Management.

“I called every group that I knew that had done private equity for any meaningful amount of time,” Dr. Snyder said. “For the first year or two, everybody is in the honeymoon period. If the model is going to succeed or break down, it’s not going to be in the first year or two. So I wanted to talk to groups that had done this for a longer amount of time and find out what their pitfalls were. What would they have done differently? Has it been a productive relationship? Did they grow?”

Dr. Snyder, president of the Texas Medical Association, said his practice met with seven or eight firms before choosing one that best met their needs. His group wanted a platform that preserved their clinical autonomy, governance, and culture, he said. They also wanted to ensure they were not entering into a “buy and flip” scenario, but rather a “buy and build” plan.

“Thus, financial capital was not sufficient, they also had to have intellectual capital and relationship capital on their bench,” he said. “When we found the partner that embraced all of these factors as well as a history of buying and long-term building, we pulled the trigger and partnered with Ares and US Heart & Vascular Management. The partner we chose did not offer us the most money. We put a premium on these other criteria.”

“I always tell docs, know the culture of your group and your vision,” he said. “Before you go down that route, ask yourself what you want to accomplish and if it makes sense having a private equity partner to accomplish that vision with.”

For younger physicians or those with little control over buyouts, experts recommend they review their contracts and consider consulting with an attorney to better understand how the deal may affect their earnings and career prospects.

Those who have a much longer career runway need to weigh whether they want to work for a PE-linked practice, Mr. Strode said. For some, it’s time to check when their noncompete agreements end and find a position elsewhere.

Also, physicians should know their rights and the laws in their states regarding the corporate practice of medicine. Statutes vary by state, and knowing the provisions in your state helps doctors recognize their legal rights, learn possible exceptions to the requirements, and know the penalties for violations.

In Michigan, a group of physicians and other health professionals at Ascension St. John has voted to unionize. Doctors hope that the union, which includes advanced practice clinicians, nurse practitioners, and physician assistants, will help improve patient care and protect working conditions for staff, Dr. Wiener said.

She advises physicians who are unhappy after acquisitions to speak up and stick together.

“That’s the biggest thing I think physicians should start doing,” she said. “Support each other and stand up. You are stronger together.”
 

Why is PE so attracted to health care?

PE firms typically buy practices or hospitals, work to make the entities more profitable, and then sell them, with the goal of doubling or tripling their investment over a short period. In general, PE firms aim for annual returns exceeding 20% after 3-7 years.

These firms know that health care is relatively recession-proof, that providers have third-party payers, and that the industry is fragmented and requires more efficiency, Ms. Dooley said.

When PE practice acquisitions started gaining momentum about 12 years ago, traditional hospital-based specialties such as anesthesiology and radiology were prime targets, said Mr. Strode.

At the same time, increasing challenges in private practice, such as declining compensation from payers, pressure to participate in value-based care programs, and rising regional competitors have fueled more physician groups to partner with PE firms, Mr. Herschman noted.

Physicians who partner with PE firms often benefit by having new access to capital to grow their practices, cost savings through group purchasing, and the ability to compete with larger health groups, Mr. Herschman said.

Questions remain, however, about how PE involvement affects health care use and spending. An April 2023 JAMA Viewpoint article called out the lack of oversight and regulation in the health care/PE space, suggesting that a stronger framework for regulation and transparency is needed.

A 2022 study in JAMA Health Forum that examined changes in prices and utilization associated with the PE acquisitions of 578 dermatology, gastroenterology, and ophthalmology physician practices from 2016 to 2020 found that prices increased by an average of 11%, and volume rose by 16%, after acquisition.

“We found that acquisitions were associated with increases in health care spending and utilization, as well as some other patterns of care like potential upcoding,” said Jane M. Zhu, MD, an author of the study and assistant professor at Oregon Health & Science University in Portland.

Another recent study that Dr. Zhu coauthored, published in Health Affairs, found that physician practices acquired by PE firms experience greater staff turnover and rely more heavily on advanced practice professionals than doctors.

“To the extent that that turnover indicates physicians are dissatisfied after private equity comes in, that’s really important to investigate further,” Dr. Zhu said.

PE firms owned 4% of U.S. hospitals in 2021 and 11% of nursing homes, according to a Medicare Payment Advisory Commission (MedPAC) report. The report does not include 2021 data on medical practices but notes that from 2013 to 2016, PE firms acquired at least 2% of physician practices. Estimates of PE deals are probably lower than actual numbers because of the lack of comprehensive information sources, according to the MedPAC report.

A version of this article appeared on Medscape.com.

Men and women with prediabetes, undiagnosed diabetes, and, notably, diagnosed diabetes were at higher risk of incident cardiovascular disease (CVD), whereas those with low-normal A1c were at lower risk of this in a large, 12-year observational study of UK Biobank data.

The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.

The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.

“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.

After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.

Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).

“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
 

“The lower the better”

“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.

Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.

The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.

“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.

However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”

“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.

“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.

“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
 

More than 400,000 men, women

The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).

The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).

The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.

Few participants (5%) had any of these outcomes prior to study enrollment.

During the follow-up, there were 51,288 incident CVD events.

After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).

Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).

After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.

Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).

The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
 

A version of this article appeared on Medscape.com.

Men and women with prediabetes, undiagnosed diabetes, and, notably, diagnosed diabetes were at higher risk of incident cardiovascular disease (CVD), whereas those with low-normal A1c were at lower risk of this in a large, 12-year observational study of UK Biobank data.

The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.

The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.

“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.

After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.

Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).

“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
 

“The lower the better”

“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.

Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.

The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.

“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.

However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”

“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.

“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.

“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
 

More than 400,000 men, women

The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).

The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).

The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.

Few participants (5%) had any of these outcomes prior to study enrollment.

During the follow-up, there were 51,288 incident CVD events.

After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).

Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).

After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.

Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).

The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
 

A version of this article appeared on Medscape.com.

Men and women with prediabetes, undiagnosed diabetes, and, notably, diagnosed diabetes were at higher risk of incident cardiovascular disease (CVD), whereas those with low-normal A1c were at lower risk of this in a large, 12-year observational study of UK Biobank data.

The results highlight “the need for strategies to reduce risk of CVD across the [glycemic] spectrum,” Christopher T. Rentsch, MPH, PhD, and colleagues wrote in their study, which was published in the The Lancet Regional Health – Europe.

The findings suggest “that excess [CVD] risks in both men and women were largely explained by modifiable factors and could be ameliorated by attention to weight reduction strategies and greater use of antihypertensive and statin medications.

“Addressing these risk factors could reduce sex disparities in [glycemia]-related risks of CVD,” according to the researchers.

After the researchers accounted for age, the absolute rate of CVD events was higher among men than women (16.9 vs. 9.1 events per 1,000 person-years); however, the relative risk was higher among women than men.

Compared with men, women were more likely to have obesity (63% vs. 53%) and were less likely to be using antihypertensive medications (64% vs. 69%) or a statin (71% vs. 75%).

“This is the largest study to date to investigate sex differences in the risk of CVD across the glycemic spectrum,” the researchers noted.
 

“The lower the better”

“We uncovered compelling evidence that for blood sugar levels within the ‘normal’ range, it was a case of ‘the lower the better’ in protecting against heart disease,” Dr. Rentsch, assistant professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, told this news organization.

Compared with people with normal blood glucose levels, those with lower than normal levels were at 10% lower risk of developing any form of heart disease, he noted.

The study findings “support women being proactive in asking about medications like statins and antihypertensives as an option to help lower their [CVD] risk, if clinically appropriate,” Dr. Rentsch added.

“We found that men and women with diagnosed diabetes remained at elevated risk for three types of heart disease – coronary artery disease, stroke, and heart failure – even after accounting for a large number of sociodemographic, lifestyle, and clinical characteristics,” he pointed out.

However, “total cholesterol, family history of CVD, estimated glomerular filtration rate, and C-reactive protein had relatively little impact on explaining the risk of heart disease associated with blood sugar.”

“It is well established that being overweight can lead to higher blood sugar levels as well as higher blood pressure, these being factors that contribute to higher risk of heart attack and stroke,” Robert Storey, DM, professor of cardiology, University of Sheffield (England), told the UK Science Media Centre.

“This very large UK Biobank study,” he said, “shows that the higher heart risk associated with blood sugar can be detected at a very early stage along the path towards the abnormally high blood sugar levels associated with diabetes.

“The study provides support for a strategy of assessing cardiovascular risk in people who are overweight, including assessment of blood sugar, cholesterol, and blood pressure levels, all of which can be effectively managed to markedly reduce the risk of future heart attack and stroke,” according to Dr. Storey.
 

More than 400,000 men, women

The researchers enrolled men and women aged 40-69 between 2006 to 2010 who were living in England, Scotland, and Wales. After excluding people with type 1 diabetes or those whose A1c data were missing, the current study included 427,435 people (46% of whom were men).

The participants were classified as having low-normal A1c (< 35 mmol/mol or < 5.5%), normal A1c (35-41 mmol/mol or 5.5%-5.9%), prediabetes (42-47 mmol/mol or 6.0%-6.4%), undiagnosed diabetes (≥ 48 mmol/mol or ≥ 6.5%), or diagnosed type 2 diabetes (medical history and in receipt of glucose-lowering medication).

The researchers determined the incidence of six CVD outcomes during a median 11.8-year follow-up: coronary artery disease, atrial fibrillation, deep vein thrombosis, pulmonary embolism, stroke, and heart failure.

Few participants (5%) had any of these outcomes prior to study enrollment.

During the follow-up, there were 51,288 incident CVD events.

After adjustment for age, compared to having normal A1c, having prediabetes or undiagnosed diabetes was associated with an increased risk of CVD for women and men (hazard ratio [HR], 1.30-1.47).

Among individuals with diagnosed type 2 diabetes, the age-adjusted risk of CVD was greater for women (HR, 2.00) than for men (HR, 1.55).

After further adjustment for clinical and lifestyle factors, especially obesity and antihypertensive or statin use, the risk of CVD decreased and became similar among men and women. The fully adjusted HR for CVD was 1.17 for women and 1.06 for men with diagnosed diabetes.

Compared with having normal A1c, women and men with low-normal A1c were at decreased risk of CVD (HR, 0.86 for both).

The study was funded by Diabetes UK and the British Heart Foundation. Dr. Rentsch and Dr. Storey have disclosed no relevant financial relationships. The disclosures of the other study authors are listed in the original article.
 

A version of this article appeared on Medscape.com.

Every 4 years, an interprofessional panel of experts from the American Geriatrics Society provides updated guidelines on safe prescribing of medications in older adults, known as the Beers Criteria. A 2023 update was released in May 2023 after panel review of more 1,500 clinical trials and research studies published since the last update.

Anticoagulants

Notable changes to the 2023 guidelines include updated recommendations for anticoagulation. Warfarin should be avoided as initial therapy for venous thromboembolism or nonvalvular atrial fibrillation unless there are contraindications to direct oral anticoagulants (DOACs) or other substantial barriers to use.

Rivaroxaban should also be avoided, and dabigatran used with caution in favor of apixaban, which is felt to have a better safety profile in older adults. Rivaroxaban may be considered if once daily dosing is deemed to be more clinically appropriate. Financial barriers regarding drug coverage and formulary options were acknowledged as a significant barrier to equitable access to preferred direct oral anticoagulants in older adults.
 

Diabetes medication

Regarding diabetes management, short-acting sulfonylureas should be avoided in addition to long-acting sulfonylureas, because of the increased risk of hypoglycemia, and cardiovascular and all-cause mortality in older adults. Sodium-glucose cotransporter 2 inhibitors as an entire class are recommended to be used with caution, as older adults are at higher risk of euglycemic ketoacidosis and urogenital infections, particularly in women in the first month of initiating treatment.

Like DOACs, the panel acknowledged that financial considerations may lead to limited options for oral diabetic treatment. In circumstances where a sulfonylurea is used, short-acting forms are preferred over long acting to reduce the risk of prolonged hypoglycemia.
 

Aspirin for primary prevention

Alongside the U.S. Preventive Services Task Force guideline update in 2022 regarding aspirin for primary prevention of cardiovascular disease and stroke, the Beer’s Criteria recommend against initiation of aspirin for primary prevention in older adults. Ticagrelor and prasugrel should be used with caution because of the increased risk of major bleeding in older adults over the age of 75, compared with clopidogrel. If prasugrel is used, a lower dose of 5 mg is recommended, in line with guidelines by the American College of Cardiology and American Heart Association.

Pain medication

For pain management, the Beer’s Criteria updated recommendations to avoid NSAIDs, particularly when used in combination with steroids or anticoagulants. The panel highlights that even short-term use of NSAIDs is high risk when used in combination with steroids or anticoagulants. If no other alternatives are possible, patients should be placed on a proton pump inhibitor or misoprostol while taking NSAIDs.

Baclofen should be avoided in older adults with renal insufficiency (estimated glomerular filtration rate < 60 mL/min per 1.73 m²) because of the increased risk of encephalopathy, and when used, should be given at the lowest effective dose with close monitoring for mental status changes.
 

Androgen and estrogen replacement therapy

For androgen replacement therapy, the panel notes that testosterone supplementation should be avoided because of cardiovascular risks unless there is confirmed hypogonadism. The panel revised their recommendation on the basis of emerging data that a history of prostate cancer is not an absolute contraindication for exogenous testosterone. A risk versus benefit discussion about exogenous testosterone should be had with a medical oncologist or urologist in those with a history of prostate cancer.

Regarding estrogen, systemic formulations should not be initiated in women over the age of 60 because of increased risk of cardiovascular events, venous thromboembolism, and dementia. In women with a history of breast cancer, vaginal estrogens are generally felt to be safe to use at low doses, such as less than 25 mcg twice weekly.

Dr. Wang is a geriatrician and general internist at Harborview Medical Center, Seattle.

Every 4 years, an interprofessional panel of experts from the American Geriatrics Society provides updated guidelines on safe prescribing of medications in older adults, known as the Beers Criteria. A 2023 update was released in May 2023 after panel review of more 1,500 clinical trials and research studies published since the last update.

Anticoagulants

Notable changes to the 2023 guidelines include updated recommendations for anticoagulation. Warfarin should be avoided as initial therapy for venous thromboembolism or nonvalvular atrial fibrillation unless there are contraindications to direct oral anticoagulants (DOACs) or other substantial barriers to use.

Rivaroxaban should also be avoided, and dabigatran used with caution in favor of apixaban, which is felt to have a better safety profile in older adults. Rivaroxaban may be considered if once daily dosing is deemed to be more clinically appropriate. Financial barriers regarding drug coverage and formulary options were acknowledged as a significant barrier to equitable access to preferred direct oral anticoagulants in older adults.
 

Diabetes medication

Regarding diabetes management, short-acting sulfonylureas should be avoided in addition to long-acting sulfonylureas, because of the increased risk of hypoglycemia, and cardiovascular and all-cause mortality in older adults. Sodium-glucose cotransporter 2 inhibitors as an entire class are recommended to be used with caution, as older adults are at higher risk of euglycemic ketoacidosis and urogenital infections, particularly in women in the first month of initiating treatment.

Like DOACs, the panel acknowledged that financial considerations may lead to limited options for oral diabetic treatment. In circumstances where a sulfonylurea is used, short-acting forms are preferred over long acting to reduce the risk of prolonged hypoglycemia.
 

Aspirin for primary prevention

Alongside the U.S. Preventive Services Task Force guideline update in 2022 regarding aspirin for primary prevention of cardiovascular disease and stroke, the Beer’s Criteria recommend against initiation of aspirin for primary prevention in older adults. Ticagrelor and prasugrel should be used with caution because of the increased risk of major bleeding in older adults over the age of 75, compared with clopidogrel. If prasugrel is used, a lower dose of 5 mg is recommended, in line with guidelines by the American College of Cardiology and American Heart Association.

Pain medication

For pain management, the Beer’s Criteria updated recommendations to avoid NSAIDs, particularly when used in combination with steroids or anticoagulants. The panel highlights that even short-term use of NSAIDs is high risk when used in combination with steroids or anticoagulants. If no other alternatives are possible, patients should be placed on a proton pump inhibitor or misoprostol while taking NSAIDs.

Baclofen should be avoided in older adults with renal insufficiency (estimated glomerular filtration rate < 60 mL/min per 1.73 m²) because of the increased risk of encephalopathy, and when used, should be given at the lowest effective dose with close monitoring for mental status changes.
 

Androgen and estrogen replacement therapy

For androgen replacement therapy, the panel notes that testosterone supplementation should be avoided because of cardiovascular risks unless there is confirmed hypogonadism. The panel revised their recommendation on the basis of emerging data that a history of prostate cancer is not an absolute contraindication for exogenous testosterone. A risk versus benefit discussion about exogenous testosterone should be had with a medical oncologist or urologist in those with a history of prostate cancer.

Regarding estrogen, systemic formulations should not be initiated in women over the age of 60 because of increased risk of cardiovascular events, venous thromboembolism, and dementia. In women with a history of breast cancer, vaginal estrogens are generally felt to be safe to use at low doses, such as less than 25 mcg twice weekly.

Dr. Wang is a geriatrician and general internist at Harborview Medical Center, Seattle.

Every 4 years, an interprofessional panel of experts from the American Geriatrics Society provides updated guidelines on safe prescribing of medications in older adults, known as the Beers Criteria. A 2023 update was released in May 2023 after panel review of more 1,500 clinical trials and research studies published since the last update.

Anticoagulants

Notable changes to the 2023 guidelines include updated recommendations for anticoagulation. Warfarin should be avoided as initial therapy for venous thromboembolism or nonvalvular atrial fibrillation unless there are contraindications to direct oral anticoagulants (DOACs) or other substantial barriers to use.

Rivaroxaban should also be avoided, and dabigatran used with caution in favor of apixaban, which is felt to have a better safety profile in older adults. Rivaroxaban may be considered if once daily dosing is deemed to be more clinically appropriate. Financial barriers regarding drug coverage and formulary options were acknowledged as a significant barrier to equitable access to preferred direct oral anticoagulants in older adults.
 

Diabetes medication

Regarding diabetes management, short-acting sulfonylureas should be avoided in addition to long-acting sulfonylureas, because of the increased risk of hypoglycemia, and cardiovascular and all-cause mortality in older adults. Sodium-glucose cotransporter 2 inhibitors as an entire class are recommended to be used with caution, as older adults are at higher risk of euglycemic ketoacidosis and urogenital infections, particularly in women in the first month of initiating treatment.

Like DOACs, the panel acknowledged that financial considerations may lead to limited options for oral diabetic treatment. In circumstances where a sulfonylurea is used, short-acting forms are preferred over long acting to reduce the risk of prolonged hypoglycemia.
 

Aspirin for primary prevention

Alongside the U.S. Preventive Services Task Force guideline update in 2022 regarding aspirin for primary prevention of cardiovascular disease and stroke, the Beer’s Criteria recommend against initiation of aspirin for primary prevention in older adults. Ticagrelor and prasugrel should be used with caution because of the increased risk of major bleeding in older adults over the age of 75, compared with clopidogrel. If prasugrel is used, a lower dose of 5 mg is recommended, in line with guidelines by the American College of Cardiology and American Heart Association.

Pain medication

For pain management, the Beer’s Criteria updated recommendations to avoid NSAIDs, particularly when used in combination with steroids or anticoagulants. The panel highlights that even short-term use of NSAIDs is high risk when used in combination with steroids or anticoagulants. If no other alternatives are possible, patients should be placed on a proton pump inhibitor or misoprostol while taking NSAIDs.

Baclofen should be avoided in older adults with renal insufficiency (estimated glomerular filtration rate < 60 mL/min per 1.73 m²) because of the increased risk of encephalopathy, and when used, should be given at the lowest effective dose with close monitoring for mental status changes.
 

Androgen and estrogen replacement therapy

For androgen replacement therapy, the panel notes that testosterone supplementation should be avoided because of cardiovascular risks unless there is confirmed hypogonadism. The panel revised their recommendation on the basis of emerging data that a history of prostate cancer is not an absolute contraindication for exogenous testosterone. A risk versus benefit discussion about exogenous testosterone should be had with a medical oncologist or urologist in those with a history of prostate cancer.

Regarding estrogen, systemic formulations should not be initiated in women over the age of 60 because of increased risk of cardiovascular events, venous thromboembolism, and dementia. In women with a history of breast cancer, vaginal estrogens are generally felt to be safe to use at low doses, such as less than 25 mcg twice weekly.

Dr. Wang is a geriatrician and general internist at Harborview Medical Center, Seattle.

Should we be exercising in the morning or afternoon? Before a meal or after a meal?

Popular media outlets, researchers, and clinicians seem to love these debates. I hate them. For me, it’s a false dichotomy. A false dichotomy is when people argue two sides as if only one option exists. A winner must be crowned, and a loser exists. But in reality, a gray zone exists, and/or a number of options are available. For me, exercise at any point of the day is a win.

Some but not all research suggests that morning fasted exercise may be the best time of day and condition to work out for weight control and training adaptations. Morning exercise may be a bit better for logistical reasons if you like to get up early. Some of us are indeed early chronotypes who rise early, get as much done as we can, including all our fitness and work-related activities, and then head to bed early (for me that is about 10 PM). Getting an early morning workout seems to fit with our schedules as morning larks.

But if you are a late-day chronotype, early exercise may not be in sync with your low morning energy levels or your preference for leisure-time activities later in the day. And lots of people with diabetes prefer to eat and then exercise. Late chronotypes are less physically active in general, compared with early chronotypes, and those who train in the morning tend to have better training adherence and expend more energy overall throughout the day. According to Dr. Normand Boulé from the University of Alberta, Edmonton, who presented on the topic of exercise time of day at the recent scientific sessions of the American Diabetes Association in San Diego, morning exercise in the fasted state tends to be associated with higher rates of fat oxidation, better weight control, and better skeletal muscle adaptations over time, compared with exercise performed later in the day. Dr Boulé also proposed that fasted exercise might be superior for training adaptations and long-term glycemia if you have type 2 diabetes.

But the argument for morning-only exercise falls short when we look specifically at postmeal glycemia, according to Dr. Jenna Gillen from the University of Toronto, who faced off against Dr. Boulé at a debate at the meeting and also publishes on the topic. She pointed out that mild to moderate intensity exercising done soon after meals typically results in fewer glucose spikes after meals in people with diabetes, and her argument is supported by at least one recent meta-analysis where postmeal walking was best for improving glycemia in those with prediabetes and type 2 diabetes.

The notion that postmeal or afternoon exercise is best for people with type 2 diabetes is also supported by a recent reexamination of the original Look AHEAD Trial of over 2,400 adults with type 2 diabetes, wherein the role of lifestyle intervention on cardiovascular outcomes was the original goal. In this recent secondary analysis of the Look AHEAD Trial, those most active in the afternoon (between 1:43 p.m. and 5:00 p.m.) had the greatest improvements in their overall glucose control after 1 year of the intensive lifestyle intervention, compared with exercise at other times of day. Afternoon exercisers were also more likely to have complete “remission” of their diabetes, as defined by no longer needing any glucose-lowering agents to control their glucose levels. But this was not a study that was designed for determining whether exercise time of day matters for glycemia because the participants were not randomly assigned to a set time of day for their activity, and glycemic control was not the primary endpoint (cardiovascular events were).

But hold on a minute. I said this was a false-dichotomy argument. It is. Just because it may or may not be “better” for your glucose to exercise in the morning vs. afternoon, if you have diabetes, it doesn’t mean you have to choose one or the other. You could choose neither (okay, that’s bad), both, or you could alternate between the two. For me this argument is like saying; “There only one time of day to save money”; “to tell a joke”; “to eat a meal” (okay, that’s another useless debate); or “do my laundry” (my mother once told me it’s technically cheaper after 6 p.m.!).

I live with diabetes, and I take insulin. I like how morning exercise in the form of a run with my dog wakes me up, sets me up for the day with positive thoughts, helps generate lots of creative ideas, and perhaps more importantly for me, it tends not to result in hypoglycemia because my insulin on board is lowest then.

Exercise later in the day is tricky when taking insulin because it tends to result in a higher insulin “potency effect” with prandial insulins. However, I still like midday activity and late-day exercise. For example, taking an activity break after lunch blunts the rise in my glucose and breaks up my prolonged sitting time in the office. After-dinner exercise allows me to spend a little more time with my wife, dog, or friends outdoors as the hot summer day begins to cool off. On Monday nights, I play basketball because that’s the only time we can book the gymnasium and that may not end until 9:45 p.m. (15 minutes before I want to go to bed; if you remember, I am a lark). That can result in two frustrating things related to my diabetes: It can cause an immediate rise in my glucose because of a competitive stress response and then a drop in my glucose overnight when I’m sleeping. But I still do it. I know that the training I’m doing at any point of the day will benefit me in lots of little ways, and I think we all need to take as many opportunities to be physically active as we possibly can. My kids and I coin this our daily “fitness opportunities,” and it does not matter to me if its morning, noon, or night!

It’s time to make the headlines and arguments stop. There is no wrong time of day to exercise. At least not in my opinion.
 

Dr. Riddle is a full professor in the school of kinesiology and health science at York University and senior scientist at LMC Diabetes & Endocrinology, both in Toronto. He has disclosed financial relationships with Dexcom, Eli Lilly, Indigo Diabetes, Insulet, Novo Nordisk, Sanofi, Supersapiens, and Zucara Therapeutics.

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

Should we be exercising in the morning or afternoon? Before a meal or after a meal?

Popular media outlets, researchers, and clinicians seem to love these debates. I hate them. For me, it’s a false dichotomy. A false dichotomy is when people argue two sides as if only one option exists. A winner must be crowned, and a loser exists. But in reality, a gray zone exists, and/or a number of options are available. For me, exercise at any point of the day is a win.

Some but not all research suggests that morning fasted exercise may be the best time of day and condition to work out for weight control and training adaptations. Morning exercise may be a bit better for logistical reasons if you like to get up early. Some of us are indeed early chronotypes who rise early, get as much done as we can, including all our fitness and work-related activities, and then head to bed early (for me that is about 10 PM). Getting an early morning workout seems to fit with our schedules as morning larks.

But if you are a late-day chronotype, early exercise may not be in sync with your low morning energy levels or your preference for leisure-time activities later in the day. And lots of people with diabetes prefer to eat and then exercise. Late chronotypes are less physically active in general, compared with early chronotypes, and those who train in the morning tend to have better training adherence and expend more energy overall throughout the day. According to Dr. Normand Boulé from the University of Alberta, Edmonton, who presented on the topic of exercise time of day at the recent scientific sessions of the American Diabetes Association in San Diego, morning exercise in the fasted state tends to be associated with higher rates of fat oxidation, better weight control, and better skeletal muscle adaptations over time, compared with exercise performed later in the day. Dr Boulé also proposed that fasted exercise might be superior for training adaptations and long-term glycemia if you have type 2 diabetes.

But the argument for morning-only exercise falls short when we look specifically at postmeal glycemia, according to Dr. Jenna Gillen from the University of Toronto, who faced off against Dr. Boulé at a debate at the meeting and also publishes on the topic. She pointed out that mild to moderate intensity exercising done soon after meals typically results in fewer glucose spikes after meals in people with diabetes, and her argument is supported by at least one recent meta-analysis where postmeal walking was best for improving glycemia in those with prediabetes and type 2 diabetes.

The notion that postmeal or afternoon exercise is best for people with type 2 diabetes is also supported by a recent reexamination of the original Look AHEAD Trial of over 2,400 adults with type 2 diabetes, wherein the role of lifestyle intervention on cardiovascular outcomes was the original goal. In this recent secondary analysis of the Look AHEAD Trial, those most active in the afternoon (between 1:43 p.m. and 5:00 p.m.) had the greatest improvements in their overall glucose control after 1 year of the intensive lifestyle intervention, compared with exercise at other times of day. Afternoon exercisers were also more likely to have complete “remission” of their diabetes, as defined by no longer needing any glucose-lowering agents to control their glucose levels. But this was not a study that was designed for determining whether exercise time of day matters for glycemia because the participants were not randomly assigned to a set time of day for their activity, and glycemic control was not the primary endpoint (cardiovascular events were).

But hold on a minute. I said this was a false-dichotomy argument. It is. Just because it may or may not be “better” for your glucose to exercise in the morning vs. afternoon, if you have diabetes, it doesn’t mean you have to choose one or the other. You could choose neither (okay, that’s bad), both, or you could alternate between the two. For me this argument is like saying; “There only one time of day to save money”; “to tell a joke”; “to eat a meal” (okay, that’s another useless debate); or “do my laundry” (my mother once told me it’s technically cheaper after 6 p.m.!).

I live with diabetes, and I take insulin. I like how morning exercise in the form of a run with my dog wakes me up, sets me up for the day with positive thoughts, helps generate lots of creative ideas, and perhaps more importantly for me, it tends not to result in hypoglycemia because my insulin on board is lowest then.

Exercise later in the day is tricky when taking insulin because it tends to result in a higher insulin “potency effect” with prandial insulins. However, I still like midday activity and late-day exercise. For example, taking an activity break after lunch blunts the rise in my glucose and breaks up my prolonged sitting time in the office. After-dinner exercise allows me to spend a little more time with my wife, dog, or friends outdoors as the hot summer day begins to cool off. On Monday nights, I play basketball because that’s the only time we can book the gymnasium and that may not end until 9:45 p.m. (15 minutes before I want to go to bed; if you remember, I am a lark). That can result in two frustrating things related to my diabetes: It can cause an immediate rise in my glucose because of a competitive stress response and then a drop in my glucose overnight when I’m sleeping. But I still do it. I know that the training I’m doing at any point of the day will benefit me in lots of little ways, and I think we all need to take as many opportunities to be physically active as we possibly can. My kids and I coin this our daily “fitness opportunities,” and it does not matter to me if its morning, noon, or night!

It’s time to make the headlines and arguments stop. There is no wrong time of day to exercise. At least not in my opinion.
 

Dr. Riddle is a full professor in the school of kinesiology and health science at York University and senior scientist at LMC Diabetes & Endocrinology, both in Toronto. He has disclosed financial relationships with Dexcom, Eli Lilly, Indigo Diabetes, Insulet, Novo Nordisk, Sanofi, Supersapiens, and Zucara Therapeutics.

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

Should we be exercising in the morning or afternoon? Before a meal or after a meal?

Popular media outlets, researchers, and clinicians seem to love these debates. I hate them. For me, it’s a false dichotomy. A false dichotomy is when people argue two sides as if only one option exists. A winner must be crowned, and a loser exists. But in reality, a gray zone exists, and/or a number of options are available. For me, exercise at any point of the day is a win.

Some but not all research suggests that morning fasted exercise may be the best time of day and condition to work out for weight control and training adaptations. Morning exercise may be a bit better for logistical reasons if you like to get up early. Some of us are indeed early chronotypes who rise early, get as much done as we can, including all our fitness and work-related activities, and then head to bed early (for me that is about 10 PM). Getting an early morning workout seems to fit with our schedules as morning larks.

But if you are a late-day chronotype, early exercise may not be in sync with your low morning energy levels or your preference for leisure-time activities later in the day. And lots of people with diabetes prefer to eat and then exercise. Late chronotypes are less physically active in general, compared with early chronotypes, and those who train in the morning tend to have better training adherence and expend more energy overall throughout the day. According to Dr. Normand Boulé from the University of Alberta, Edmonton, who presented on the topic of exercise time of day at the recent scientific sessions of the American Diabetes Association in San Diego, morning exercise in the fasted state tends to be associated with higher rates of fat oxidation, better weight control, and better skeletal muscle adaptations over time, compared with exercise performed later in the day. Dr Boulé also proposed that fasted exercise might be superior for training adaptations and long-term glycemia if you have type 2 diabetes.

But the argument for morning-only exercise falls short when we look specifically at postmeal glycemia, according to Dr. Jenna Gillen from the University of Toronto, who faced off against Dr. Boulé at a debate at the meeting and also publishes on the topic. She pointed out that mild to moderate intensity exercising done soon after meals typically results in fewer glucose spikes after meals in people with diabetes, and her argument is supported by at least one recent meta-analysis where postmeal walking was best for improving glycemia in those with prediabetes and type 2 diabetes.

The notion that postmeal or afternoon exercise is best for people with type 2 diabetes is also supported by a recent reexamination of the original Look AHEAD Trial of over 2,400 adults with type 2 diabetes, wherein the role of lifestyle intervention on cardiovascular outcomes was the original goal. In this recent secondary analysis of the Look AHEAD Trial, those most active in the afternoon (between 1:43 p.m. and 5:00 p.m.) had the greatest improvements in their overall glucose control after 1 year of the intensive lifestyle intervention, compared with exercise at other times of day. Afternoon exercisers were also more likely to have complete “remission” of their diabetes, as defined by no longer needing any glucose-lowering agents to control their glucose levels. But this was not a study that was designed for determining whether exercise time of day matters for glycemia because the participants were not randomly assigned to a set time of day for their activity, and glycemic control was not the primary endpoint (cardiovascular events were).

But hold on a minute. I said this was a false-dichotomy argument. It is. Just because it may or may not be “better” for your glucose to exercise in the morning vs. afternoon, if you have diabetes, it doesn’t mean you have to choose one or the other. You could choose neither (okay, that’s bad), both, or you could alternate between the two. For me this argument is like saying; “There only one time of day to save money”; “to tell a joke”; “to eat a meal” (okay, that’s another useless debate); or “do my laundry” (my mother once told me it’s technically cheaper after 6 p.m.!).

I live with diabetes, and I take insulin. I like how morning exercise in the form of a run with my dog wakes me up, sets me up for the day with positive thoughts, helps generate lots of creative ideas, and perhaps more importantly for me, it tends not to result in hypoglycemia because my insulin on board is lowest then.

Exercise later in the day is tricky when taking insulin because it tends to result in a higher insulin “potency effect” with prandial insulins. However, I still like midday activity and late-day exercise. For example, taking an activity break after lunch blunts the rise in my glucose and breaks up my prolonged sitting time in the office. After-dinner exercise allows me to spend a little more time with my wife, dog, or friends outdoors as the hot summer day begins to cool off. On Monday nights, I play basketball because that’s the only time we can book the gymnasium and that may not end until 9:45 p.m. (15 minutes before I want to go to bed; if you remember, I am a lark). That can result in two frustrating things related to my diabetes: It can cause an immediate rise in my glucose because of a competitive stress response and then a drop in my glucose overnight when I’m sleeping. But I still do it. I know that the training I’m doing at any point of the day will benefit me in lots of little ways, and I think we all need to take as many opportunities to be physically active as we possibly can. My kids and I coin this our daily “fitness opportunities,” and it does not matter to me if its morning, noon, or night!

It’s time to make the headlines and arguments stop. There is no wrong time of day to exercise. At least not in my opinion.
 

Dr. Riddle is a full professor in the school of kinesiology and health science at York University and senior scientist at LMC Diabetes & Endocrinology, both in Toronto. He has disclosed financial relationships with Dexcom, Eli Lilly, Indigo Diabetes, Insulet, Novo Nordisk, Sanofi, Supersapiens, and Zucara Therapeutics.

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

“We were all of us cogs in a great machine which sometimes rolled forward, nobody knew where, sometimes backwards, nobody knew why.” – Ernst Toller

A nice feature of the Apple watch is the stopwatch. With it, I can discreetly click the timer and watch seconds tick away. Tap. There’s one lap. Tap. Two. Tap. That was a quick visit, 6 minutes and 42 seconds. Tap. Under 2 minutes to close the chart. Let’s see if I can beat it. Tap. Tap. What if I moved my Mayo stand over to this side of the room? How about a sign, “All patients must have clothes off if you want a skin exam.” You think ob.gyns. are quick from skin to baby in a stat C-section? You should see how fast I can go from alcohol wipe to Drysol on a biopsy. Seconds. Tick, tick, tap.

Every day I look for ways to go faster. This is not so I can be out the door by 3. Rather, it’s simply to make it through the day without having to log on after we put the kids to bed at night.

Speaking of bedtimes, another nice feature of the Apple watch is the timer. With it, I can set a timer and a lovely chimey alarm will go off. This comes in handy with 3-year-olds. “Sloan, in two minutes we are going to brush your teeth.” Ding. “Sloan, you have one minute to get your pajamas on.” Ding. “Sloanie, I’ll give you 3 more minutes to put the kitties away, then get into bed.” Ding, ding, ding ...

As you can see, using the stopwatch to time a bedtime routine would be demoralizing. If you’ve tried to put a toddler to bed in summer you know. They explore every option to avoid sleeping: one more book (that would make 3), “accidentally” putting their pajamas on backwards, offering to brush their teeth a second time. And once the light is off, “Papa, I have to potty.” No, bedtime routines cannot be standardized. They resist being made efficient.

In contrast, we think of seeing patients as a standardizable process; work to be optimized. This idea that work should be as efficient as possible came from the father of business management, Frederick Taylor. Taylor, a mechanical engineer, observed inefficiencies on the factory floor. His work was seminal in the development of the second industrial revolution. Before then no one had applied scientific rigor to productivity. His book, “The Principles of Scientific Management,” written in 1909, is considered the most influential management book of the 20th century. He was the first to use stopwatches to perform time studies, noting how long each task took with the belief that there was one best way. The worker was an extension of the machine, tuned by management such that he was as efficient as possible.

PublicDomain/commons.wikimedia.org/wiki/File:Ford_assembly_line_-_1913.jpg

A more insidious downside on the drive to efficiency lies in the nature of what we do. We aren’t factory workers punching out widgets, we’re physicians caring for people and people cannot be standardized. In this way, seeing patients is more like putting a toddler to bed than like assembling an iPhone. There will always be by-the-ways, basal cells hiding behind the ear, traffic jams, and bags of products that they want to review. Not sure how to use your fluorouracil? Let’s go over it again. Need to talk more about why you have granuloma annulare? Let me explain. Despite Taylor’s vision, some work simply cannot be optimized. And shouldn’t.

“Where’s my 11:30 patient who checked in half an hour ago?!” I asked my medical assistant. “Oh, she had to go to the bathroom.” Tap.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

“We were all of us cogs in a great machine which sometimes rolled forward, nobody knew where, sometimes backwards, nobody knew why.” – Ernst Toller

A nice feature of the Apple watch is the stopwatch. With it, I can discreetly click the timer and watch seconds tick away. Tap. There’s one lap. Tap. Two. Tap. That was a quick visit, 6 minutes and 42 seconds. Tap. Under 2 minutes to close the chart. Let’s see if I can beat it. Tap. Tap. What if I moved my Mayo stand over to this side of the room? How about a sign, “All patients must have clothes off if you want a skin exam.” You think ob.gyns. are quick from skin to baby in a stat C-section? You should see how fast I can go from alcohol wipe to Drysol on a biopsy. Seconds. Tick, tick, tap.

Every day I look for ways to go faster. This is not so I can be out the door by 3. Rather, it’s simply to make it through the day without having to log on after we put the kids to bed at night.

Speaking of bedtimes, another nice feature of the Apple watch is the timer. With it, I can set a timer and a lovely chimey alarm will go off. This comes in handy with 3-year-olds. “Sloan, in two minutes we are going to brush your teeth.” Ding. “Sloan, you have one minute to get your pajamas on.” Ding. “Sloanie, I’ll give you 3 more minutes to put the kitties away, then get into bed.” Ding, ding, ding ...

As you can see, using the stopwatch to time a bedtime routine would be demoralizing. If you’ve tried to put a toddler to bed in summer you know. They explore every option to avoid sleeping: one more book (that would make 3), “accidentally” putting their pajamas on backwards, offering to brush their teeth a second time. And once the light is off, “Papa, I have to potty.” No, bedtime routines cannot be standardized. They resist being made efficient.

In contrast, we think of seeing patients as a standardizable process; work to be optimized. This idea that work should be as efficient as possible came from the father of business management, Frederick Taylor. Taylor, a mechanical engineer, observed inefficiencies on the factory floor. His work was seminal in the development of the second industrial revolution. Before then no one had applied scientific rigor to productivity. His book, “The Principles of Scientific Management,” written in 1909, is considered the most influential management book of the 20th century. He was the first to use stopwatches to perform time studies, noting how long each task took with the belief that there was one best way. The worker was an extension of the machine, tuned by management such that he was as efficient as possible.

PublicDomain/commons.wikimedia.org/wiki/File:Ford_assembly_line_-_1913.jpg

A more insidious downside on the drive to efficiency lies in the nature of what we do. We aren’t factory workers punching out widgets, we’re physicians caring for people and people cannot be standardized. In this way, seeing patients is more like putting a toddler to bed than like assembling an iPhone. There will always be by-the-ways, basal cells hiding behind the ear, traffic jams, and bags of products that they want to review. Not sure how to use your fluorouracil? Let’s go over it again. Need to talk more about why you have granuloma annulare? Let me explain. Despite Taylor’s vision, some work simply cannot be optimized. And shouldn’t.

“Where’s my 11:30 patient who checked in half an hour ago?!” I asked my medical assistant. “Oh, she had to go to the bathroom.” Tap.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

“We were all of us cogs in a great machine which sometimes rolled forward, nobody knew where, sometimes backwards, nobody knew why.” – Ernst Toller

A nice feature of the Apple watch is the stopwatch. With it, I can discreetly click the timer and watch seconds tick away. Tap. There’s one lap. Tap. Two. Tap. That was a quick visit, 6 minutes and 42 seconds. Tap. Under 2 minutes to close the chart. Let’s see if I can beat it. Tap. Tap. What if I moved my Mayo stand over to this side of the room? How about a sign, “All patients must have clothes off if you want a skin exam.” You think ob.gyns. are quick from skin to baby in a stat C-section? You should see how fast I can go from alcohol wipe to Drysol on a biopsy. Seconds. Tick, tick, tap.

Every day I look for ways to go faster. This is not so I can be out the door by 3. Rather, it’s simply to make it through the day without having to log on after we put the kids to bed at night.

Speaking of bedtimes, another nice feature of the Apple watch is the timer. With it, I can set a timer and a lovely chimey alarm will go off. This comes in handy with 3-year-olds. “Sloan, in two minutes we are going to brush your teeth.” Ding. “Sloan, you have one minute to get your pajamas on.” Ding. “Sloanie, I’ll give you 3 more minutes to put the kitties away, then get into bed.” Ding, ding, ding ...

As you can see, using the stopwatch to time a bedtime routine would be demoralizing. If you’ve tried to put a toddler to bed in summer you know. They explore every option to avoid sleeping: one more book (that would make 3), “accidentally” putting their pajamas on backwards, offering to brush their teeth a second time. And once the light is off, “Papa, I have to potty.” No, bedtime routines cannot be standardized. They resist being made efficient.

In contrast, we think of seeing patients as a standardizable process; work to be optimized. This idea that work should be as efficient as possible came from the father of business management, Frederick Taylor. Taylor, a mechanical engineer, observed inefficiencies on the factory floor. His work was seminal in the development of the second industrial revolution. Before then no one had applied scientific rigor to productivity. His book, “The Principles of Scientific Management,” written in 1909, is considered the most influential management book of the 20th century. He was the first to use stopwatches to perform time studies, noting how long each task took with the belief that there was one best way. The worker was an extension of the machine, tuned by management such that he was as efficient as possible.

PublicDomain/commons.wikimedia.org/wiki/File:Ford_assembly_line_-_1913.jpg

A more insidious downside on the drive to efficiency lies in the nature of what we do. We aren’t factory workers punching out widgets, we’re physicians caring for people and people cannot be standardized. In this way, seeing patients is more like putting a toddler to bed than like assembling an iPhone. There will always be by-the-ways, basal cells hiding behind the ear, traffic jams, and bags of products that they want to review. Not sure how to use your fluorouracil? Let’s go over it again. Need to talk more about why you have granuloma annulare? Let me explain. Despite Taylor’s vision, some work simply cannot be optimized. And shouldn’t.

“Where’s my 11:30 patient who checked in half an hour ago?!” I asked my medical assistant. “Oh, she had to go to the bathroom.” Tap.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

The Food and Drug Administration has approved palovarotene (Sohonos), the first-ever treatment for people with the rare and severely disabling bone condition fibrodysplasia ossificans progressiva (FOP).

Affecting roughly 400 people in the United States and 900 worldwide, FOP is an autosomal dominant condition in which bone develops in soft connective tissue areas of the body where it isn’t normally present (heterotopic ossification), such as the ligaments, tendons, and skeletal muscles. This leads to severe restriction in mobility and function, to the point that people lose the ability to feed or care for themselves. Most are completely disabled by age 30 years and median life expectancy is 56 years, with death often caused by bone formation around the rib cage restricting respiration.

Olivier Le Moal/Getty Images

“As a clinician caring for patients with FOP, I personally see the daily challenges and stresses that our patients and their families must contend with ... since the accumulation of heterotopic ossification in FOP is progressive, irreversible, and life altering. This medication is an important treatment option for our FOP community,” said endocrinologist Edward Hsiao, MD, professor of medicine at the University of California, San Francisco, in a statement from Ipsen.

Taken orally, palovarotene selectively targets the gamma subtype of retinoic acid receptors that regulate skeletal development and ectopic bone in the retinoid signaling pathway. The drug mediates interactions between these receptors, growth factors, and proteins within that pathway to reduce new abnormal bone formation.

It is now FDA approved for the treatment of FOP in female patients aged 8 years or older and male patients aged 10 years or older. The recommended dosing is 5 mg daily or weight-based equivalent for pediatric patients under 14 years of age, which can be modified or increased for flare-up symptoms. It is contraindicated during pregnancy.

The FDA approval was based on 18-month data from the phase 3, multicenter, open-label MOVE trial that included 107 adult and pediatric patients, over 10% of the world’s population with FOP. All received oral palovarotene and were compared with untreated individuals from a prior natural history study of the condition. The drug reduced annualized heterotopic ossification volume by 54%.

Side effects were typical of those seen with other systemic retinoid drugs, including mucocutaneous events such as dryness of the skin and mucous membranes, alopecia, drug eruption, rash, and pruritus, and musculoskeletal events, such as arthralgia and premature growth plate closure in growing children.

According to Dr. Hsiao, who was a MOVE investigator, the study “showed that Sohonos can decrease new heterotopic ossification, and that palovarotene can be tolerated by many patients with FOP. Sohonos is not for everyone. As with all medicines there are risks in this case especially for young children who may develop early growth plate closure. In addition, Sohonos has the same side effects as other retinoids.”

The FDA approval of palovarotene follows its rejection for marketing authorization in the European Union in July 2023.

Reached for comment, an Ipsen spokesperson said in an interview: “We reached the end of the regulatory process in the European Union for Sohonos and are disappointed the European Commission decided not to approved palovarotene for people with FOP in Europe.”

The company is developing another drug, fidrisertib, for treating FOP. A pivotal phase 2 trial for that drug is now recruiting patients. Asked where Ipsen might try to market fidrisertib, the spokesperson replied:“At this point, our focus is on the completion of the pivotal trial.”

Meanwhile, in the United States, the FOP community is celebrating the palovarotene approval. In a statement, Michelle Davis, executive director of the International Fibrodysplasia Ossificans Progressiva Association, said: “FOP is life altering to the individuals diagnosed and their families. There’s not a day that goes by where those impacted don’t worry about the debilitating physical pain of muscle that is replaced by bone, another joint locking, or the relentless emotional toll of losing the ability to do an activity they love, or hold a loved one close. ... The first treatment for FOP has been proven to reduce the volume of new abnormal bone growth, which may result in better health outcomes for people living with FOP.”

Ipsen is offering a patient support program to assist with education, coverage, and reimbursement (1-866-435-5677).

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved palovarotene (Sohonos), the first-ever treatment for people with the rare and severely disabling bone condition fibrodysplasia ossificans progressiva (FOP).

Affecting roughly 400 people in the United States and 900 worldwide, FOP is an autosomal dominant condition in which bone develops in soft connective tissue areas of the body where it isn’t normally present (heterotopic ossification), such as the ligaments, tendons, and skeletal muscles. This leads to severe restriction in mobility and function, to the point that people lose the ability to feed or care for themselves. Most are completely disabled by age 30 years and median life expectancy is 56 years, with death often caused by bone formation around the rib cage restricting respiration.

Olivier Le Moal/Getty Images

“As a clinician caring for patients with FOP, I personally see the daily challenges and stresses that our patients and their families must contend with ... since the accumulation of heterotopic ossification in FOP is progressive, irreversible, and life altering. This medication is an important treatment option for our FOP community,” said endocrinologist Edward Hsiao, MD, professor of medicine at the University of California, San Francisco, in a statement from Ipsen.

Taken orally, palovarotene selectively targets the gamma subtype of retinoic acid receptors that regulate skeletal development and ectopic bone in the retinoid signaling pathway. The drug mediates interactions between these receptors, growth factors, and proteins within that pathway to reduce new abnormal bone formation.

It is now FDA approved for the treatment of FOP in female patients aged 8 years or older and male patients aged 10 years or older. The recommended dosing is 5 mg daily or weight-based equivalent for pediatric patients under 14 years of age, which can be modified or increased for flare-up symptoms. It is contraindicated during pregnancy.

The FDA approval was based on 18-month data from the phase 3, multicenter, open-label MOVE trial that included 107 adult and pediatric patients, over 10% of the world’s population with FOP. All received oral palovarotene and were compared with untreated individuals from a prior natural history study of the condition. The drug reduced annualized heterotopic ossification volume by 54%.

Side effects were typical of those seen with other systemic retinoid drugs, including mucocutaneous events such as dryness of the skin and mucous membranes, alopecia, drug eruption, rash, and pruritus, and musculoskeletal events, such as arthralgia and premature growth plate closure in growing children.

According to Dr. Hsiao, who was a MOVE investigator, the study “showed that Sohonos can decrease new heterotopic ossification, and that palovarotene can be tolerated by many patients with FOP. Sohonos is not for everyone. As with all medicines there are risks in this case especially for young children who may develop early growth plate closure. In addition, Sohonos has the same side effects as other retinoids.”

The FDA approval of palovarotene follows its rejection for marketing authorization in the European Union in July 2023.

Reached for comment, an Ipsen spokesperson said in an interview: “We reached the end of the regulatory process in the European Union for Sohonos and are disappointed the European Commission decided not to approved palovarotene for people with FOP in Europe.”

The company is developing another drug, fidrisertib, for treating FOP. A pivotal phase 2 trial for that drug is now recruiting patients. Asked where Ipsen might try to market fidrisertib, the spokesperson replied:“At this point, our focus is on the completion of the pivotal trial.”

Meanwhile, in the United States, the FOP community is celebrating the palovarotene approval. In a statement, Michelle Davis, executive director of the International Fibrodysplasia Ossificans Progressiva Association, said: “FOP is life altering to the individuals diagnosed and their families. There’s not a day that goes by where those impacted don’t worry about the debilitating physical pain of muscle that is replaced by bone, another joint locking, or the relentless emotional toll of losing the ability to do an activity they love, or hold a loved one close. ... The first treatment for FOP has been proven to reduce the volume of new abnormal bone growth, which may result in better health outcomes for people living with FOP.”

Ipsen is offering a patient support program to assist with education, coverage, and reimbursement (1-866-435-5677).

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved palovarotene (Sohonos), the first-ever treatment for people with the rare and severely disabling bone condition fibrodysplasia ossificans progressiva (FOP).

Affecting roughly 400 people in the United States and 900 worldwide, FOP is an autosomal dominant condition in which bone develops in soft connective tissue areas of the body where it isn’t normally present (heterotopic ossification), such as the ligaments, tendons, and skeletal muscles. This leads to severe restriction in mobility and function, to the point that people lose the ability to feed or care for themselves. Most are completely disabled by age 30 years and median life expectancy is 56 years, with death often caused by bone formation around the rib cage restricting respiration.

Olivier Le Moal/Getty Images

“As a clinician caring for patients with FOP, I personally see the daily challenges and stresses that our patients and their families must contend with ... since the accumulation of heterotopic ossification in FOP is progressive, irreversible, and life altering. This medication is an important treatment option for our FOP community,” said endocrinologist Edward Hsiao, MD, professor of medicine at the University of California, San Francisco, in a statement from Ipsen.

Taken orally, palovarotene selectively targets the gamma subtype of retinoic acid receptors that regulate skeletal development and ectopic bone in the retinoid signaling pathway. The drug mediates interactions between these receptors, growth factors, and proteins within that pathway to reduce new abnormal bone formation.

It is now FDA approved for the treatment of FOP in female patients aged 8 years or older and male patients aged 10 years or older. The recommended dosing is 5 mg daily or weight-based equivalent for pediatric patients under 14 years of age, which can be modified or increased for flare-up symptoms. It is contraindicated during pregnancy.

The FDA approval was based on 18-month data from the phase 3, multicenter, open-label MOVE trial that included 107 adult and pediatric patients, over 10% of the world’s population with FOP. All received oral palovarotene and were compared with untreated individuals from a prior natural history study of the condition. The drug reduced annualized heterotopic ossification volume by 54%.

Side effects were typical of those seen with other systemic retinoid drugs, including mucocutaneous events such as dryness of the skin and mucous membranes, alopecia, drug eruption, rash, and pruritus, and musculoskeletal events, such as arthralgia and premature growth plate closure in growing children.

According to Dr. Hsiao, who was a MOVE investigator, the study “showed that Sohonos can decrease new heterotopic ossification, and that palovarotene can be tolerated by many patients with FOP. Sohonos is not for everyone. As with all medicines there are risks in this case especially for young children who may develop early growth plate closure. In addition, Sohonos has the same side effects as other retinoids.”

The FDA approval of palovarotene follows its rejection for marketing authorization in the European Union in July 2023.

Reached for comment, an Ipsen spokesperson said in an interview: “We reached the end of the regulatory process in the European Union for Sohonos and are disappointed the European Commission decided not to approved palovarotene for people with FOP in Europe.”

The company is developing another drug, fidrisertib, for treating FOP. A pivotal phase 2 trial for that drug is now recruiting patients. Asked where Ipsen might try to market fidrisertib, the spokesperson replied:“At this point, our focus is on the completion of the pivotal trial.”

Meanwhile, in the United States, the FOP community is celebrating the palovarotene approval. In a statement, Michelle Davis, executive director of the International Fibrodysplasia Ossificans Progressiva Association, said: “FOP is life altering to the individuals diagnosed and their families. There’s not a day that goes by where those impacted don’t worry about the debilitating physical pain of muscle that is replaced by bone, another joint locking, or the relentless emotional toll of losing the ability to do an activity they love, or hold a loved one close. ... The first treatment for FOP has been proven to reduce the volume of new abnormal bone growth, which may result in better health outcomes for people living with FOP.”

Ipsen is offering a patient support program to assist with education, coverage, and reimbursement (1-866-435-5677).

A version of this article appeared on Medscape.com.