Practice Management

CHICAGO – In this age of corporate megamergers, private practice gastroenterologists are increasingly weighing the pros and cons of selling their practices to private equity firms.

It’s becoming more difficult for solo or small group practices to go it alone. While there may be advantages in selling a medical practice to a private equity firm, physicians could be trading a degree of freedom for financial certainty and relief from administrative burdens, according to Klaus Mergener, MD, PhD, MBA, AGAF, a clinical gastroenterologist, affiliate professor of medicine at the University of Washington, Seattle, and chief medical officer of Pentax Medical’s Lifecare Division.

ASGE

“Over the last decades, and ongoing, there have been massive downward pressures on reimbursements and costs are rising. Practices have tried to compensate, and they’ve added ancillary revenue streams, and they’ve tried to cut costs internally. It’s fair to say that depending on the local market, many practices find that one of the last viable options is essentially to spread overhead costs – meaning you have to get larger and you have to merge into larger entities,” he said on May 6 during a presentation at the annual Digestive Diseases Week^® meeting.

The first independent gastroenterology practice was purchased by a private equity firm in 2016. Today, more than 1,000 gastroenterologists have been acquired by private equity firms, which amounts to a total value in excess of $1 billion.

The pace at which private equity firms are buying private medical practices is accelerating. On April 26, Kaiser Permanente – with 39 hospitals and 24,000 physicians – announced that it had acquired Geisinger Health System, a regional health care provider in Pennsylvania with 10 hospitals, forming a new entity called Risant Health.

Dr. Mergener likened the situation to the story of David and Goliath. David famously defeated the much larger and more powerful Goliath, but the metaphor is imperfect, because small private practices are running out of rocks to sling at the big guys.

In some small, rural markets with no significant competition, it may be possible for small practices to survive through mergers, “but in most U.S. markets, it’s fair to say that ... practices have found it hard to merge without external help. There are egos involved, there are many hurdles, and this is where private equity has essentially moved in as catalyst,” Dr. Mergener said.

Employees of large entities

Other physicians, however, say that while acquisition may seem inevitable, private equity is an option for survival.

“I don’t think this means the demise of private practice,“ said Lawrence R. Kosinski, MD, MBA, AGAF , chief medical officer at SonarMD, a Chicago-based company that specializes in facilitating managing the care of patients with chronic conditions.

Capital Digestive Care

Private equity firms sell a bill of goods

“They say, ‘We’re going to improve your services, we’re going to bring you tech, we’re going to negotiate better contracts and do all these things for you.’ Ninety percent of it is a lie, because that’s not what they’re going to do. They’re just going to try to increase the bottom line, bolt down a few more practices, increase the gross revenue, and thereby increase the net profit from where it was before, not necessarily because they’re making better lives for the individual providers. They’re just adding more cows to the field, but every cow is the same as far as they’re concerned. They really don’t care about the production of milk,” Dr. Weinstein said.

A few years ago, his practice considered whether private equity would be a good option. His practice, he said, needed to be bigger and more effective and efficient. Instead, his practice formed a partnership with PE GI Solutions (formerly Physicians Endoscopy), a developer and manager of endoscopic ambulatory surgery centers.

In Dallas, private equity firms have increased reimbursements for Texas Digestive Disease Consultants.

“Our practice went through mergers, acquisitions, and now, with private equity coming onto the scene, it’s completely different,” said Kimberly M. Persley, MD, AGAF, a partner with Texas Digestive Disease Consultants and a member of the GI & Hepatology News board of editors.

Dr. Persley

“We were a five-person independent group negotiating contracts, getting cut every other year by some payer because they negotiated a better price with someone else. And having to go through that process every year when all we really want to do is take care of patients. Private equity adds to our group practice by having someone dedicated to negotiating these contracts, and getting reimbursed far more than we ever did prior to our involvement with private equity,” she said.
 

How it works

In the typical model, a private equity partner purchases the practice and creates a management services organization (MSO), which provides nonclinical services to the practice, theoretically freeing the physicians from the administrative burdens of day-to-day practice.

The practice then becomes the care center managed by the MSO, and the physicians in the practice at the time of the acquisition get stock in the MSO. “They sell a portion of their annual income, so going forward they’re making less money initially, until some of that is being recovered by higher efficiencies. They get an upfront check at a multiple of the income they just sold, and that provides the initial incentive. Then the entity is grown by adding other practices through the same mechanism,” Dr. Mergener said.

After about 5 years, the private equity partner typically sells the MSO to another, probably even larger buyer, and the cycle starts again.

In addition to the upfront incentive that makes practice mergers and consolidation work, the arrangement gives the GI practice access to top-notch administrators, as well as access to capital for investments such as information technology infrastructure, digital health, and data analytics.

He cautioned that it’s crucial for practices to enter the marriage with eyes wide open and be very careful in choosing the private equity partner.

“The goal is to find a partner that has values and a vision that matches the practice’s. In theory, they should be pulling on the same side of the rope, because if it’s a high-quality practice and efficiencies are being improved, more practices should be more likely to join,” which will benefit physicians, patients, and the private equity partner alike, Dr. Mergener said.

Although the private equity construct has been successful in the short term for many practices, it’s less clear what will happen long-term. There is a risk that after 5 years there won’t be a buyer for the MSO at the expected price, which may result in complex financial transactions that could leave the MSO in debt. In such a scenario, physician employees would not be personally liable, but might suffer the consequences of a failing or unsuccessful operation, Dr. Mergener said.

Dr. Mergener’s talk was presented as part of a an ASGE Presidential Plenary held during DDW 2023. He disclosed consulting, honoraria, advisory board activity or stock options from various corporations, but reported having no relationships with private equity.

DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).

CHICAGO – In this age of corporate megamergers, private practice gastroenterologists are increasingly weighing the pros and cons of selling their practices to private equity firms.

It’s becoming more difficult for solo or small group practices to go it alone. While there may be advantages in selling a medical practice to a private equity firm, physicians could be trading a degree of freedom for financial certainty and relief from administrative burdens, according to Klaus Mergener, MD, PhD, MBA, AGAF, a clinical gastroenterologist, affiliate professor of medicine at the University of Washington, Seattle, and chief medical officer of Pentax Medical’s Lifecare Division.

ASGE

“Over the last decades, and ongoing, there have been massive downward pressures on reimbursements and costs are rising. Practices have tried to compensate, and they’ve added ancillary revenue streams, and they’ve tried to cut costs internally. It’s fair to say that depending on the local market, many practices find that one of the last viable options is essentially to spread overhead costs – meaning you have to get larger and you have to merge into larger entities,” he said on May 6 during a presentation at the annual Digestive Diseases Week^® meeting.

The first independent gastroenterology practice was purchased by a private equity firm in 2016. Today, more than 1,000 gastroenterologists have been acquired by private equity firms, which amounts to a total value in excess of $1 billion.

The pace at which private equity firms are buying private medical practices is accelerating. On April 26, Kaiser Permanente – with 39 hospitals and 24,000 physicians – announced that it had acquired Geisinger Health System, a regional health care provider in Pennsylvania with 10 hospitals, forming a new entity called Risant Health.

Dr. Mergener likened the situation to the story of David and Goliath. David famously defeated the much larger and more powerful Goliath, but the metaphor is imperfect, because small private practices are running out of rocks to sling at the big guys.

In some small, rural markets with no significant competition, it may be possible for small practices to survive through mergers, “but in most U.S. markets, it’s fair to say that ... practices have found it hard to merge without external help. There are egos involved, there are many hurdles, and this is where private equity has essentially moved in as catalyst,” Dr. Mergener said.

Employees of large entities

Other physicians, however, say that while acquisition may seem inevitable, private equity is an option for survival.

“I don’t think this means the demise of private practice,“ said Lawrence R. Kosinski, MD, MBA, AGAF , chief medical officer at SonarMD, a Chicago-based company that specializes in facilitating managing the care of patients with chronic conditions.

Capital Digestive Care

Private equity firms sell a bill of goods

“They say, ‘We’re going to improve your services, we’re going to bring you tech, we’re going to negotiate better contracts and do all these things for you.’ Ninety percent of it is a lie, because that’s not what they’re going to do. They’re just going to try to increase the bottom line, bolt down a few more practices, increase the gross revenue, and thereby increase the net profit from where it was before, not necessarily because they’re making better lives for the individual providers. They’re just adding more cows to the field, but every cow is the same as far as they’re concerned. They really don’t care about the production of milk,” Dr. Weinstein said.

A few years ago, his practice considered whether private equity would be a good option. His practice, he said, needed to be bigger and more effective and efficient. Instead, his practice formed a partnership with PE GI Solutions (formerly Physicians Endoscopy), a developer and manager of endoscopic ambulatory surgery centers.

In Dallas, private equity firms have increased reimbursements for Texas Digestive Disease Consultants.

“Our practice went through mergers, acquisitions, and now, with private equity coming onto the scene, it’s completely different,” said Kimberly M. Persley, MD, AGAF, a partner with Texas Digestive Disease Consultants and a member of the GI & Hepatology News board of editors.

Dr. Persley

“We were a five-person independent group negotiating contracts, getting cut every other year by some payer because they negotiated a better price with someone else. And having to go through that process every year when all we really want to do is take care of patients. Private equity adds to our group practice by having someone dedicated to negotiating these contracts, and getting reimbursed far more than we ever did prior to our involvement with private equity,” she said.
 

How it works

In the typical model, a private equity partner purchases the practice and creates a management services organization (MSO), which provides nonclinical services to the practice, theoretically freeing the physicians from the administrative burdens of day-to-day practice.

The practice then becomes the care center managed by the MSO, and the physicians in the practice at the time of the acquisition get stock in the MSO. “They sell a portion of their annual income, so going forward they’re making less money initially, until some of that is being recovered by higher efficiencies. They get an upfront check at a multiple of the income they just sold, and that provides the initial incentive. Then the entity is grown by adding other practices through the same mechanism,” Dr. Mergener said.

After about 5 years, the private equity partner typically sells the MSO to another, probably even larger buyer, and the cycle starts again.

In addition to the upfront incentive that makes practice mergers and consolidation work, the arrangement gives the GI practice access to top-notch administrators, as well as access to capital for investments such as information technology infrastructure, digital health, and data analytics.

He cautioned that it’s crucial for practices to enter the marriage with eyes wide open and be very careful in choosing the private equity partner.

“The goal is to find a partner that has values and a vision that matches the practice’s. In theory, they should be pulling on the same side of the rope, because if it’s a high-quality practice and efficiencies are being improved, more practices should be more likely to join,” which will benefit physicians, patients, and the private equity partner alike, Dr. Mergener said.

Although the private equity construct has been successful in the short term for many practices, it’s less clear what will happen long-term. There is a risk that after 5 years there won’t be a buyer for the MSO at the expected price, which may result in complex financial transactions that could leave the MSO in debt. In such a scenario, physician employees would not be personally liable, but might suffer the consequences of a failing or unsuccessful operation, Dr. Mergener said.

Dr. Mergener’s talk was presented as part of a an ASGE Presidential Plenary held during DDW 2023. He disclosed consulting, honoraria, advisory board activity or stock options from various corporations, but reported having no relationships with private equity.

DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).

CHICAGO – In this age of corporate megamergers, private practice gastroenterologists are increasingly weighing the pros and cons of selling their practices to private equity firms.

It’s becoming more difficult for solo or small group practices to go it alone. While there may be advantages in selling a medical practice to a private equity firm, physicians could be trading a degree of freedom for financial certainty and relief from administrative burdens, according to Klaus Mergener, MD, PhD, MBA, AGAF, a clinical gastroenterologist, affiliate professor of medicine at the University of Washington, Seattle, and chief medical officer of Pentax Medical’s Lifecare Division.

ASGE

“Over the last decades, and ongoing, there have been massive downward pressures on reimbursements and costs are rising. Practices have tried to compensate, and they’ve added ancillary revenue streams, and they’ve tried to cut costs internally. It’s fair to say that depending on the local market, many practices find that one of the last viable options is essentially to spread overhead costs – meaning you have to get larger and you have to merge into larger entities,” he said on May 6 during a presentation at the annual Digestive Diseases Week^® meeting.

The first independent gastroenterology practice was purchased by a private equity firm in 2016. Today, more than 1,000 gastroenterologists have been acquired by private equity firms, which amounts to a total value in excess of $1 billion.

The pace at which private equity firms are buying private medical practices is accelerating. On April 26, Kaiser Permanente – with 39 hospitals and 24,000 physicians – announced that it had acquired Geisinger Health System, a regional health care provider in Pennsylvania with 10 hospitals, forming a new entity called Risant Health.

Dr. Mergener likened the situation to the story of David and Goliath. David famously defeated the much larger and more powerful Goliath, but the metaphor is imperfect, because small private practices are running out of rocks to sling at the big guys.

In some small, rural markets with no significant competition, it may be possible for small practices to survive through mergers, “but in most U.S. markets, it’s fair to say that ... practices have found it hard to merge without external help. There are egos involved, there are many hurdles, and this is where private equity has essentially moved in as catalyst,” Dr. Mergener said.

Employees of large entities

Other physicians, however, say that while acquisition may seem inevitable, private equity is an option for survival.

“I don’t think this means the demise of private practice,“ said Lawrence R. Kosinski, MD, MBA, AGAF , chief medical officer at SonarMD, a Chicago-based company that specializes in facilitating managing the care of patients with chronic conditions.

Capital Digestive Care

Private equity firms sell a bill of goods

“They say, ‘We’re going to improve your services, we’re going to bring you tech, we’re going to negotiate better contracts and do all these things for you.’ Ninety percent of it is a lie, because that’s not what they’re going to do. They’re just going to try to increase the bottom line, bolt down a few more practices, increase the gross revenue, and thereby increase the net profit from where it was before, not necessarily because they’re making better lives for the individual providers. They’re just adding more cows to the field, but every cow is the same as far as they’re concerned. They really don’t care about the production of milk,” Dr. Weinstein said.

A few years ago, his practice considered whether private equity would be a good option. His practice, he said, needed to be bigger and more effective and efficient. Instead, his practice formed a partnership with PE GI Solutions (formerly Physicians Endoscopy), a developer and manager of endoscopic ambulatory surgery centers.

In Dallas, private equity firms have increased reimbursements for Texas Digestive Disease Consultants.

“Our practice went through mergers, acquisitions, and now, with private equity coming onto the scene, it’s completely different,” said Kimberly M. Persley, MD, AGAF, a partner with Texas Digestive Disease Consultants and a member of the GI & Hepatology News board of editors.

Dr. Persley

“We were a five-person independent group negotiating contracts, getting cut every other year by some payer because they negotiated a better price with someone else. And having to go through that process every year when all we really want to do is take care of patients. Private equity adds to our group practice by having someone dedicated to negotiating these contracts, and getting reimbursed far more than we ever did prior to our involvement with private equity,” she said.
 

How it works

In the typical model, a private equity partner purchases the practice and creates a management services organization (MSO), which provides nonclinical services to the practice, theoretically freeing the physicians from the administrative burdens of day-to-day practice.

The practice then becomes the care center managed by the MSO, and the physicians in the practice at the time of the acquisition get stock in the MSO. “They sell a portion of their annual income, so going forward they’re making less money initially, until some of that is being recovered by higher efficiencies. They get an upfront check at a multiple of the income they just sold, and that provides the initial incentive. Then the entity is grown by adding other practices through the same mechanism,” Dr. Mergener said.

After about 5 years, the private equity partner typically sells the MSO to another, probably even larger buyer, and the cycle starts again.

In addition to the upfront incentive that makes practice mergers and consolidation work, the arrangement gives the GI practice access to top-notch administrators, as well as access to capital for investments such as information technology infrastructure, digital health, and data analytics.

He cautioned that it’s crucial for practices to enter the marriage with eyes wide open and be very careful in choosing the private equity partner.

“The goal is to find a partner that has values and a vision that matches the practice’s. In theory, they should be pulling on the same side of the rope, because if it’s a high-quality practice and efficiencies are being improved, more practices should be more likely to join,” which will benefit physicians, patients, and the private equity partner alike, Dr. Mergener said.

Although the private equity construct has been successful in the short term for many practices, it’s less clear what will happen long-term. There is a risk that after 5 years there won’t be a buyer for the MSO at the expected price, which may result in complex financial transactions that could leave the MSO in debt. In such a scenario, physician employees would not be personally liable, but might suffer the consequences of a failing or unsuccessful operation, Dr. Mergener said.

Dr. Mergener’s talk was presented as part of a an ASGE Presidential Plenary held during DDW 2023. He disclosed consulting, honoraria, advisory board activity or stock options from various corporations, but reported having no relationships with private equity.

DDW is sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and The Society for Surgery of the Alimentary Tract (SSAT).

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

Since May, physicians in 21 states are no longer being asked broad mental health or substance abuse questions when they apply for a medical license. That’s a major shift that could ease doctors’ concerns about seeking treatment, according to the Dr. Lorna Breen Heroes› Foundation, a physician burnout prevention group that tracks such changes.

The foundation was named in honor of Lorna Breen, MD, an emergency medicine physician in New York City who died by suicide in April 2020 as the pandemic unfolded. The rate of suicide among physicians is twice that of the general population.

“The issue is not whether a physician may have had a serious or a mild mental illness ... but whether they have any disabilities that may affect their current work,” said Peter Yellowlees, MD, distinguished professor of psychiatry at the University of California, Davis. “Asking about any past mental illness episodes, which may have occurred years previously ... is simply discriminatory and is an example of the stigma associated with mental disorders.”

The Breen Foundation has been working with state medical boards and hospitals to remove stigmatizing mental health and substance abuse questions from licensing and credentialing applications.

Dr. Breen had told her sister and brother-in-law shortly before her suicide that she was afraid she could lose her license and the career she loved if the medical board found out that she had received inpatient mental health treatment, said J. Corey Feist, JD, MBA, her brother-in-law and cofounder and president of the foundation.

She wasn’t aware that New York was a state that didn’t ask physicians questions about their mental health, said Mr. Feist.

“That’s why we want to make it very clear to physicians which states continue to ask these questions and which ones don’t,” Mr. Feist said.

Many physicians share Dr. Breen’s concern about professional consequences.

Four in 10 physicians said that they did not seek help for burnout or depression because they worried that their employer or state medical board would find out, according to the Medscape ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023.

One Oregon emergency department physician said that informing her state medical board about an episode of mania resulted in public disclosures, a 4-month long investigation, lost income, and poorer work evaluations. Looking back on her decision to be transparent with the board, Susan Haney, MD, said that she was naive. “The board is not your friend.”

Fearing for her career, now-retired ob.gyn. Robyn Alley-Hay, MD, never disclosed on licensing applications that in the 1990s, she had been hospitalized and treated for depression. She stopped practicing medicine in 2014 and now works as a life coach.

“I hated those questions because I felt I could never tell the whole truth,” Dr. Alley-Hay said. “But I could always truthfully answer ‘no’ to questions about impairment. That was a line that I wouldn’t cross – if you’re impaired, you shouldn’t be practicing.”
 

Does the focus on current impairment protect the public?

New York, Texas, California, Montana, Illinois, and North Carolina are among the 21 states that either ask no health-related questions or ask only a single question to address physical and mental health, said Mr. Feist.

Most of these changes align with the 2018 Federation of State Medical Boards recommendations, said Joe Knickrehm, FSMB vice president of communications. “Application questions must focus only on current impairment and not on illness, diagnosis, or previous treatment in order to be compliant with the Americans With Disabilities Act,” states the FSMB.

Mental health questions were often added to licensing and credentialing applications out of a “misplaced desire to protect patients and families from clinicians who might not be fit to give care. Yet there is no evidence they serve that function,” said Mr. Feist.

Marian Hollingsworth, a patient safety advocate in California, says medical boards have a responsibility to ensure that doctors pose no risk or a negligible risk to the public. She questioned whether the medical boards can adequately protect the public if they only ask about medical conditions rather than mental illness or substance abuse.

“There’s a fine line between privacy and right to know for public protection. I would want to see the approving medical board have assurance from a treating professional that this physician is stable and is doing well with continued treatment,” said Ms. Hollingsworth.
 

Legislation requires that mental health questions be removed

In March, Virginia became the first state to enact a law that requires all health care profession regulatory boards, including medical boards, to remove or replace mental health questions on licensing, certification, and registration applications.

The law requires that boards use the following wording if they replace mental health questions: “Do you have any reason to believe you would pose a risk to the safety or well-being of patients?” “Are you able to perform the essential functions of your job with or without reasonable accommodations?”

The Illinois General Assembly passed a more limited bill in May that requires medical boards to remove or replace mental health questions on its licensing applications. Gov. J. B. Pritzker (D) is expected to sign the bill.

The Virginia Healthcare and Hospital Association, which represents more than 100 hospitals and health systems in the state, partnered with the Medical Society of Virginia and the Virginia Nurses Association to advocate for the new legislation.

“The reason that the Virginia coalition pushed for the law was because the state’s medical boards weren’t acting quickly enough. Although state laws vary about what medical boards can do, legislation isn’t necessary in most states to change licensing questions,” said Mr. Feist.

Virginia hospitals began working last year with the foundation to change their mental health questions on credentialing applications. About 20% of Virginia’s hospitals have completed the process, including four large health systems: Inova, UVA Health, Centerra, and Children’s Hospitals of King’s Daughters, said Mr. Feist.

The foundation also challenged Lisa MacLean, MD, a psychiatrist and chief clinical wellness officer at the Henry Ford Medical Group in Detroit, to review their credentialing application for any stigmatizing mental health questions.

Dr. MacLean told the American Medical Association that she had found one question that needed to be changed but that it took time to get through the hospital›s approval process. Ultimately, the wording was changed from “a diagnosis or treatment of a physical, mental, chemical dependency or emotional condition” to “a diagnosis or treatment of any condition which could impair your ability to practice medicine.”
 

National medical organizations back changes

The Joint Commission, which accredits hospitals, has emphasized since 2020 that it doesn’t require hospitals to ask about an applicant’s mental health history.

“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” the Commission said in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”

The Joint Commission said it supports the FSMB recommendations and the AMA’s recommendation that questions about clinicians’ mental health be limited to “conditions that currently impair the clinicians’ ability to perform their job.”

More than 40 professional medical organizations, including the American Academy of Family Physicians and the American Psychiatric Association, signed a joint statement in 2020 calling for changes in disclosure rules about mental health.

“The backing of major organizations is helpful because it’s changing the conversation that occurs within and outside the house of medicine,” said Mr. Feist.
 

Should doctors answer mental health questions?

Many states continue to ask questions about hospitalization and mental health diagnoses or treatment on their licensing and credentialing applications.

Yellowlees advises doctors to “be honest and not lie or deny past mental health problems, as medical boards tend to take a very serious view of physicians who do not tell the truth.”

However, the questions asked by medical boards can vary by state. “If it’s possible, physicians can give accurate but minimal information while trying to focus mainly on their current work capacity,” said Dr. Yellowlees.

He also suggested that physicians who are uncertain about how to respond to mental health questions consider obtaining advice from lawyers accustomed to working with the relevant medical boards.

Physicians who want to get involved in removing licensing and credentialing barriers to mental health care can find resources here and here.

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

It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.

The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.

While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.

AGA

“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.

The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.

AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.

UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”

“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”

However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.

The advance notification policy comes despite immense pressure from physicians, patients, lawmakers, and regulators to crack down on prior authorization policies. “AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
 

How advance notification works

Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.

The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.

Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.

Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.

UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”

The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.

Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.

“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.

For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.

It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.

The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.

While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.

AGA

“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.

The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.

AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.

UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”

“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”

However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.

The advance notification policy comes despite immense pressure from physicians, patients, lawmakers, and regulators to crack down on prior authorization policies. “AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
 

How advance notification works

Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.

The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.

Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.

Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.

UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”

The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.

Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.

“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.

For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.

It’s been just over 1 month since UnitedHealthcare (UHC) launched its advance notification program requiring providers to record nonscreening colonoscopy and other gastroenterology procedures to be eligible for its 2024 Gold Card program.

The program, which will begin next year, may eliminate prior authorization requirements for providers who successfully complete the advance notification program this year. However, there is no guarantee that providers who complete the advance notification program will be enrolled in the Gold Card program, which means they would have to seek prior authorization for nonscreening procedures, according to the American Gastroenterological Association.

While UHC has provided some information about how advance notification works, there are many unanswered questions, said Barbara H. Jung, MD,AGAF, AGA president.

AGA

“UnitedHealthcare’s haphazard approach to rolling out a policy that will ultimately control patient access to critical, often lifesaving medical procedures are the opposite of what should be our common goal of expeditious access to essential care,” she said in a written statement.

The advance notification program was announced on June 1 when UHC said it was dropping its controversial prior authorization program, which was due to go into effect that day.

AGA is concerned that UHC’s advance notification program is merely a delay tactic because prior authorization may be required next year for providers who are not accepted into the Gold Card program. Providers who are not accepted into the program may face delays in administering procedures due to the need for prior authorizations. Thousands of endoscopies and colonoscopies could potentially be disrupted in the first month alone due to canceled procedures because of new prior authorization requirements, they said.

UHC has been trying to rein in health care costs by first considering prior authorizations for most gastrointestinal (GI) endoscopic procedures, except for screening colonoscopy, but ultimately adopting advance notification. Providers, UHC has said, don’t always follow evidence-based medicine treatment recommendations or they overutilize procedures. Their goal, according to a summary document it issued outlining changes to advance notification and prior authorization requirements, is “better care, improved health outcomes, and lower costs.”

“Clinical studies demonstrate overutilization of these procedures and lack of adherence to specialty society–endorsed guidelines and recommendations. Up to one-third of upper GI procedures and almost half of nonscreening colonoscopies performed for common clinical conditions are not consistent with clinical guidelines,” UHC stated in an FAQ. “A UHC review of upper endoscopy and lower endoscopy procedures performed in 2022 revealed two- to fivefold practice-level variation in the use of both procedure types, even after adjusting for member characteristics including age and comorbidities.”

However, according to a statement from the AGA, it has not seen utilization data specific to UHC: “It is clear that UHC does not currently have any data indicating significant overutilization of critical colonoscopy and endoscopy procedures and therefore no justification to impose burdensome barriers like prior authorization.” AGA also pointed to research showing there is an unmet need for colonoscopies in the United States, which suggests there is an underutilization of this crucial procedure.

The advance notification policy comes despite immense pressure from physicians, patients, lawmakers, and regulators to crack down on prior authorization policies. “AGA has expressed its willingness to work collaboratively with UnitedHealthcare to address any concerns and educate physicians, but communication and transparency with the insurer are nearly nonexistent. Instead, the GI community is confronted with a nebulous concept called advance notification, which is not conducive to seamless patient care. Ultimately, it appears advance notification will form the basis of prior authorization, which we know can delay, disrupt, and deny timely care,” Dr. Jung said.
 

How advance notification works

Beginning June 1, providers have been asked to provide advance notification for nonscreening GI endoscopy procedures that include: esophagogastroduodenoscopy, capsule endoscopy, diagnostic colonoscopy and surveillance colonoscopy. The notification can be made by phone (866-889-8054) or through a UHC online portal at UHCprovider.com.

The AGA has said that some GI practices have found the portal to be confusing and it lacks a standard software application raising concerns for high error rates.

Advance notification applies to patients who have UHC commercial plans, including UnitedHealthcare, UnitedHealthcare Plan of the River Valley, Neighborhood Health Partnership, UnitedHealthcare Level Funded, and UnitedHealthcare Oxford Health Plans in all states, except Rhode Island, Kentucky, and New Mexico.

Providers who opt out of participating in advance notification will not be eligible to participate in the Gold Card program in 2024. The program will essentially allow providers to order most GI endoscopy procedures, except for screening colonoscopy, without prior authorization. However, UHC has not released any information about how it will implement its planned Gold Card prior authorization program or how many providers will be accepted into the program.

UHC has assured providers it will not issue medical necessity denials through this process, but it may ask providers to participate in a “comprehensive peer-to-peer discussion with a board-certified gastroenterologist around clinical guidelines.”

The fear for practices is that advance notification will be an onerous process adding burdensome paperwork that practices are not equipped to manage. UHC is the largest health insurer in the country representing 46% of the total market.

Lawrence Kim, MD, AGAF, vice president of AGA and a gastroenterologist practicing in Denver said that each physician in his practice does over 1,000 procedures annually and 25% of their patients carry UHC.

“We are currently completing 30-40 notifications a day, requiring two staff members to comply with this program. UHC is not asking for any clinical information, just procedure and diagnosis codes, and in some cases site of service. Therefore, the advance notification program as it stands will not provide UHC with any additional information beyond what they already have through claims data. This highlights the strain these requirements are putting on providers and practices for repetitive data,” he said.

For more details about UHC’s advance notification program, UHC has prepared this FAQ. To learn more about AGA’s advocacy, visit www.gastro.org/UHC.

Shikha Jain, MD, felt the urgency of the moment.

It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.

The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.

Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.

“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”

The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.

Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.

That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.

But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.

“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”

Her patient received the regimen that evening. He later went into remission.

This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.

Since then, Dr. Jain has confronted a growing onslaught of prior authorization requirements. Her days are often sidelined by prior authorization paperwork and calls.

There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.

There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.

And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.

“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”

For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”

The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.

According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”

“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”

In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”

Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.

“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”

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

Shikha Jain, MD, felt the urgency of the moment.

It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.

The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.

Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.

“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”

The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.

Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.

That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.

But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.

“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”

Her patient received the regimen that evening. He later went into remission.

This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.

Since then, Dr. Jain has confronted a growing onslaught of prior authorization requirements. Her days are often sidelined by prior authorization paperwork and calls.

There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.

There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.

And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.

“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”

For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”

The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.

According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”

“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”

In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”

Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.

“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”

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

Shikha Jain, MD, felt the urgency of the moment.

It was 10:00 AM. A young patient had stepped into her Chicago cancer clinic. His face was red, and he was struggling to breathe.

The man had primary mediastinal B-cell lymphoma, a rare, aggressive form of non-Hodgkin lymphoma. Many cases involve large, fast‐growing masses that expand into the lungs and compress respiratory pathways, sometimes leaving patients breathless.

Dr. Jain rushed to his side and walked him from the clinic to an ICU bed at the hospital nearby.

“He was so sick,” recalled Dr. Jain, currently a tenured associate professor of medicine in the division of hematology and oncology at the University of Illinois Cancer Center, Chicago. “He needed chemotherapy immediately.”

The standard chemotherapy regimen at the time – R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) – required prior authorization.

Dr. Jain’s patient did not have days to wait, so Dr. Jain requested an expedited approval. The insurance company responded quickly, denying the request for treatment.

That evening, after hours on the phone trying to reverse the denial, Dr. Jain was able to arrange a peer-to-peer conversation with the insurer. She explained her patient’s pressing need for chemotherapy: He would die if he continued to wait.

But Dr. Jain’s argument did not move the reviewer. At that point, she had reached her limit.

“I asked for the gentleman’s full name. I told him he would be responsible for this 30-year-old man’s death, and my next call would be to CNN,” Dr. Jain told this news organization. “And that is how I got my patient’s chemotherapy approved.”

Her patient received the regimen that evening. He later went into remission.

This incident occurred almost a decade ago, but it has stayed with Dr. Jain. She knows that her persistence in that moment meant the difference between her patient’s life and death.

Since then, Dr. Jain has confronted a growing onslaught of prior authorization requirements. Her days are often sidelined by prior authorization paperwork and calls.

There was the denial for standard-of-care staging and surveillance imaging – dotatate PET/CT – for her patient with neuroendocrine cancer. “The specific insurance company simply doesn’t approve this imaging, despite being around for years,” she said.

There was the patient with metastatic colon cancer who needed third-line therapy. His insurer took more than a month to reverse its denial for a recently approved drug, and in that time, the man’s disease progressed. “He eventually succumbed to the cancer after receiving the drug, but it’s unclear if his life was cut short by the delay in care,” Dr. Jain said.

And there is the maze of insurance company phone calls and transfers. On one call, Dr. Jain recalled being transferred six times before being connected to the right department to discuss approving standard-of-care chemotherapy for a patient. After being denied approval, Dr. Jain was put on hold to speak with a manager, and the call was abruptly disconnected.

“I have wasted so many hours on prior authorization and have seen months and months of patient care delays,” Dr. Jain said. “It’s easy to see why people just give up.”

For Dr. Jain, prior authorization has begun to “feel like psychological warfare,” she said. “To have everything questioned by people who don’t understand the basics of oncology is demoralizing.”

The growing administrative – and emotional – burden of prior authorization is contributing to physician burnout.

According to Medscape’s ‘I Cry but No One Cares’: Physician Burnout & Depression Report 2023, more than half of oncologists reported feeling burned out this year – the highest percentage in 5 years. When asked what factors led to burnout, most doctors surveyed pointed to an overabundance of bureaucratic tasks, and specifically, “insurance companies telling me how to practice medicine and controlling what the patients can and can’t do.”

“Burnout is a real problem in medicine,” said Kelly Anderson, PhD, MPP, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora. “While there are many factors that contribute to burnout, prior authorization is certainly one.”

In a 2022 survey from the American Medical Association, 88% of respondents reported that the burden associated with prior authorization requirements was “high or extremely high.”

Although insurers argue that prior authorization cuts down on unnecessary and expensive care, physicians in the AMA survey reported that this practice often leads to greater overall use of health care resources, including more emergency department and office visits.

“Insurers are confident that prior authorization is saving money overall, but there’s also no clear evidence of that,” Dr. Anderson noted. “Prior authorization may reduce spending without harming patients in some instances, but in others, it’s adding administrative burden, costs, and may be causing harm to patients.”

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

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

[email protected]

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

[email protected]

“I’ve been hit in the head by a walking stick,” a primary care receptionist reported.

“A mother came in and was screaming and swearing at me because she couldn’t get an appointment for her daughters,” another receptionist reported.

“I’ve had people throw a bag of syringes at me because we don’t accept syringes,” said another.

Reports such as these are part of the literature supporting a review that finds patient aggression against receptionists is a serious safety concern for primary care offices and affects delivery of health care.

The review was published online in the BMJ’s Family Medicine and Community Health journal.

“Receptionists in general practice deserve evidence-based measures to improve their working conditions and well-being,” say the authors, led by Fiona Willer, PhD, of the Centre for Community Health and Wellbeing at the University of Queensland, Brisbane, Australia.

Though the study looked primarily at European and Australian practices, physicians in the United States say the incidences are familiar.
 

Cause often lack of access

Dr. Willer and colleagues point out that the root cause of patient regression is typically related to operational factors, such as inefficient scheduling or lack of access to the medical providers.

“However, reception staff are placed in the unenviable position of having to deal with the aftermath of the poor function of these systems without having the status or autonomy to overhaul them,” the authors note.

Authors analyzed 20 studies on aggression against receptionists.

Among the findings:

• All studies reported that patient hostility and verbal abuse of receptionists “was a frequent, routine, and relatively unavoidable occurrence in general practice.”
• Nine studies reported acts of physical violence toward receptionists, with all reporting that physical abuse occurred much less frequently than verbal abuse.
• Some acts were very severe, including being hit, shaken, held at gunpoint, stalked, and threatened with a razorblade.

The studies also discussed ways to prevent potential aggression or react to it, including:

• Regular staff training for managing patient aggression.
• Designing clinics with “safe rooms” and “cool down” spaces.
• Providing clear acrylic shields between receptionists and patients.
• Developing formal policy/procedure/protocol/action guides relating to management of patients.
•  

Behavior can interrupt health care delivery

Carrie Janiski, DO, regional medical director at Golden Valley Health Centers in California, who was not part of the review, said she has seen the aggressive behavior the authors document in her practice’s lobby, “including yelling, name-calling, and threatening language or physical behavior.”

The instances disrupt health care delivery to the patient, who is often in crisis, and all patients and staff in the clinic, she said.

“The patient needs help and the aggressive way they are seeking it could cause harm to others or prevent them from receiving all the help they need,” she said.

She says in practices she has worked in, some effective mitigation strategies have included open-access scheduling, increased walk-in availability for appointments, de-escalation training for front-line staff, and office and exam room layout designed for safety.

She added that incident review is important and should include a process for patient dismissal from the practice.

Dustin Arnold, DO, an internal medicine specialist and chief medical officer at UnityPoint Health-St. Luke’s Hospital, Cedar Rapids, IA, said he agrees with the authors on the urgency for action.

“This is an urgent concern for practices across the country. Your receptionist is the face of your practice, and you should invest in them,” said Dr. Arnold, who was not part of the review.

He said he has seen “verbal abuse and generalized incivility” from patients against receptionists in practices where he has worked.

He said the measure the authors list that he thinks is most effective is staff de-escalation training.

“However, the best preventative measure is for the physician to be on time and minimize cancellation of appointments,” he said. “These are the two primary triggers of a patient becoming disruptive.”

He said his practice has installed a panic button at the front desk and built an alert into the electronic health record indicating that a patient has shown disruptive behavior in the past.

The authors conclude: “Staff training and protocols to manage patient aggression and ongoing structured staff support should be considered essential in general practice. Evidence-based strategies to prevent, manage, and mitigate the harms of patient aggression towards general practice reception staff are urgently needed.”

The authors and Dr. Janiski and Dr. Arnold declared no relevant financial relationships.

[email protected]

The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

Pediatric nephrologist Bryan Carmody, MD, recalls working alongside an extremely experienced neonatologist during his residency. She had managed a neonatal intensive care unit in her home country of Lithuania, but because she wanted to practice in the United States, it took years of repeat training before she was eligible for a medical license.

“She was very accomplished, and she was wonderful to have as a coresident at the time,” Dr. Carmody said in an interview.

The neonatologist now practices at a U.S. academic medical center, but to obtain that position, she had to complete 3 years of pediatric residency and 3 years of fellowship in the United States, Dr. Carmody said.

Such training for international medical graduates (IMGs) is a routine part of obtaining a U.S. medical license, but a new Tennessee law bypasses these requirements and creates a quicker pathway for IMGs to secure medical licenses in the United States.

The American Medical Association took similar measures at its recent annual meeting, making it easier for IMGs to gain licensure. Because the pandemic and Russia’s invasion of Ukraine disrupted the process by which some IMGs had their licenses verified, the AMA is now encouraging state licensing boards and other credentialing institutions to accept certification from the Educational Commission for Foreign Medical Graduates as verification, rather than requiring documents directly from international medical schools.

When it comes to Tennessee’s new law, signed by Gov. Bill Lee in April, experienced IMGs who have received medical training abroad can skip U.S. residency requirements and obtain a temporary license to practice medicine in Tennessee if they meet certain qualifications.

The international doctors must demonstrate competency, as determined by the state medical board. In addition, they must have completed a 3-year postgraduate training program in the graduate’s licensing country or otherwise have practiced as a medical professional in which they performed the duties of a physician for at least 3 of the past 5 years outside the United States, according to the new law.

To be approved, IMGs must also have received an employment offer from a Tennessee health care provider that has a residency program accredited by the Accreditation Council for Graduate Medical Education.

If physicians remain in good standing for 2 years, the board will grant them a full and unrestricted license to practice in Tennessee.

“The new legislation opens up a lot of doors for international medical graduates and is also a lifeline for a lot of underserved areas in Tennessee,” said Asim Ansari, MD, a Canadian who attended medical school in the Caribbean and is an advocate for IMGs.

Dr. Ansari is participating in a child and adolescent psychiatry fellowship at the University of Kansas Medical Center, Kansas City, until he can apply for the sixth time to a residency program. “This could possibly be a model that other states may want to implement in a few years.”
 

What’s behind the law?

A predicted physician shortage in Tennessee drove the legislation, said Rep. Sabi “Doc” Kumar, MD, vice chair for the Tennessee House Health Committee and a cosponsor of the legislation. Legislators hope the law will mitigate that shortage and boost the number of physicians practicing in underserved areas of the state.

“Considering that one in four physicians in the U.S. are international medical gradates, it was important for us to be able to attract those physicians to Tennessee,” he said.

The Tennessee Board of Medical Examiners will develop administrative rules for the law, which may take up to a year, Rep. Kumar said. He expects the program to be available to IMGs beginning in mid-2024.

Upon completion of the program, IMGs will be able to practice general medicine in Tennessee, not a specialty. Requirements for specialty certification would have to be met through the specialties’ respective boards.

Dr. Carmody, who blogs about medical education, including the new legislation, said in an interview the law will greatly benefit experienced IMGs, who often are bypassed as residency candidates because they graduated years ago. Hospitals also win because they can fill positions that otherwise might sit vacant, he said.

Family physician Sahil Bawa, MD, an IMG from India who recently matched into his specialty, said the Tennessee legislation will help fellow IMGs find U.S. medical jobs.

“It’s very difficult for IMGs to get into residency in the U.S.,” he said. “I’ve seen people with medical degrees from other countries drive Uber or do odd jobs to sustain themselves here. I’ve known a few people who have left and gone back to their home country because they were not accepted into a residency.”
 

Who benefits most?

Dr. Bawa noted that the legislation would not have helped him, as he needed a visa to practice in the United States and the law does not include the sponsoring of visas. The legislation requires IMGs to show evidence of citizenship or evidence that they are legally entitled to live or work in the United States.

U.S. citizen IMGs who haven’t completed residency or who practiced in another country also are left out of the law, Dr. Carmody said.

“This law is designed to take the most accomplished cream of the crop international medical graduates with the most experience and the most sophisticated skill set and send them to Tennessee. I think that’s the intent,” he said. “But many international medical graduates are U.S. citizens who don’t have the opportunity to practice in countries other than United States or do residencies. A lot of these people are sitting on the sidelines, unable to secure residency positions. I’m sure they would be desperate for a program like this.”
 

Questions remain

“Just because the doctor can get a [temporary] license without the training doesn’t mean employers are going to be interested in sponsoring those doctors,” said Adam Cohen, an immigration attorney who practices in Memphis. “What is the inclination of these employers to hire these physicians who have undergone training outside the U.S.? And will there be skepticism on the part of employers about the competence of these doctors?”

“Hospital systems will be able to hire experienced practitioners for a very low cost,” Dr. Ansari said. “So now you have these additional bodies who can do the work of a physician, but you don’t have to pay them as much as a physician for 2 years. And because some are desperate to work, they will take lower pay as long as they have a pathway to full licensure in Tennessee. What are the protections for these physicians? Who will cover their insurance? Who will be responsible for them, the attendees? And will the attendees be willing to put their license on the line for them?”

In addition, Dr. Carmody questions what, if anything, will encourage IMGs to work in underserved areas in Tennessee after their 2 years are up and whether there will be any incentives to guide them. He wonders, too, whether the physicians will be stuck practicing in Tennessee following completion of the program.

“Will these physicians only be able to work in Tennessee?” he asked. “I think that’s probably going to be the case, because they’ll be licensed in Tennessee, but to go to another state, they would be missing the required residency training. So it might be these folks are stuck in Tennessee unless other states develop reciprocal arrangements.”

Other states would have to decide whether to recognize the Tennessee license acquired through this pathway, Rep. Kumar said.

He explained that the sponsoring sites would be responsible for providing work-hour restrictions and liability protections. There are currently no incentives in the legislation for IMGs to practice in rural, underserved areas, but the hospitals and communities there generally offer incentives when recruiting, Rep. Kumar said.

“The law definitely has the potential to be helpful,” Mr. Cohen said, “because there’s an ability to place providers in the state without having to go through the bottleneck of limited residency slots. If other states see a positive effect on Tennessee or are exploring ways to alleviate their own shortages, it’s possible [they] might follow suit.”

Rep. Kumar agreed that other states will be watching Tennessee to weigh the law’s success.

“I think the law will have to prove itself and show that Tennessee has benefited from it and that the results have been good,” he said. “We are providing a pioneering way for attracting medical graduates and making it easier for them to obtain a license. I would think other states would want to do that.”

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

CHICAGO – Clinical trials are so White. Only a small percentage of eligible patients participate in clinical trials in the first place, and very few come from racial and ethnic minority groups.

For example, according to the Food and Drug Administration, in trials that resulted in drug approvals from 2017 to 2020, only 2%-5% of participants were Black patients.

When clinical trials lack diverse patient populations, those who are left out have fewer opportunities to get new therapies. Moreover, the scope of the research is limited by smaller phenotypic and genotypic samples, and the trial results are applicable only to more homogeneous patient groups.

There has been a push to include more underrepresented patients in clinical trials. One group reported its success in doing so here at the annual meeting of the American Society of Clinical Oncology.

Researchers from the Alliance for Clinical Trials in Oncology explained how a multifaceted approach resulted in a 75% relative improvement in trial enrollment from 2014 to 2022, a period that included a pandemic-induced hiatus in clinical trials in general.

Alliance member Electra D. Paskett, PhD, from the College of Public Health at the Ohio State University in Columbus, presented accrual data from 117 trials led by the Alliance from 2014 to 2022.

During this period, accrual of racial and ethnic minority patients increased from 13.6% to 25.3% for cancer treatment trials and from 13% to 21.5% for cancer control trials.

Overall, the recruitment program resulted in an absolute increase from 13.5 % to 23.6% of underrepresented populations, which translated into a relative 74.8% improvement.

“We’re focusing now on monitoring accrual of women, rural populations, younger AYAs [adolescents and young adults] and older patients, and we’ll see what strategies we need to implement,” Dr. Packett told this news organization.

The Alliance has implemented a real-time accrual dashboard on its website that allows individual sites to review accrual by trial and overall for all of the identified underrepresented populations, she noted.
 

Program to increase underrepresented patient accrual

The impetus for the program to increase enrollment of underrepresented patients came from the goal set by Monica M. Bertagnolli, MD, group chair of the Alliance from 2011 to 2022 and currently the director of the U.S. National Cancer Institute.

“Our leader, Dr. Bertagnolli, set out a group-wide goal for accrual of underrepresented minorities to our trials of 20%, and that gave us permission to implement a whole host of new strategies,” Dr. Paskett said in an interview.

“These strategies follow the Accrual of Clinical Trials framework, which essentially says that the interaction between the patient and the provider for going on a clinical trial is not just an interaction between the patient and provider but recognizes, for example, that the provider has coworkers and they have norms and beliefs and attitudes, and the patient comes from a family with their own values. And then there are system-level barriers, and there are community barriers that all relate to this interaction about going on a trial,” Dr. Packett said.
 

What works?

The study was presented as a poster at the meeting. During the poster discussion session, comoderator Victoria S. Blinder, MD, from Memorial Sloan Kettering Cancer Center in New York, asked Dr. Paskett, “If you had a certain amount of money and you really wanted to use that resource to focus on one area, where would you put that resource?”

“I’m going to violate the rules of your question,” Dr. Paskett replied.

“You cannot change this problem by focusing on one thing, and that’s what we showed in our Alliance poster, and what I’ve said is based on over 30 years of work in this area,” she said.

She cited what she considered as the two most important components for improving accrual of underrepresented populations: a commitment by leadership to a recruitment goal, and the development of protocols with specific accrual goals for minority populations.

Still, those are only two components of a comprehensive program that includes the aforementioned accrual goal set by Dr. Bertagnolli, as well as the following:

• Funding of minority junior investigators and research that focuses on issues of concern to underrepresented populations.
• Establishment of work groups that focus on specific populations with the Alliance health disparities committee.
• Translation of informational materials for patients.
• Opening studies at National Cancer Institute Community. Oncology Research Program–designated minority underserved sites.
• Real-time monitoring of accrual demographics by the Alliance and at the trial site.
• Closing protocol enrollment to majority populations.
• Increasing the study sample sizes to enroll additional minority participants and to allow for subgroup analyses.

The study was funded by the National Institutes of Health. Dr. Packett and Dr. Blinder reported no relevant financial relationships.

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

CHICAGO – Clinical trials are so White. Only a small percentage of eligible patients participate in clinical trials in the first place, and very few come from racial and ethnic minority groups.

For example, according to the Food and Drug Administration, in trials that resulted in drug approvals from 2017 to 2020, only 2%-5% of participants were Black patients.

When clinical trials lack diverse patient populations, those who are left out have fewer opportunities to get new therapies. Moreover, the scope of the research is limited by smaller phenotypic and genotypic samples, and the trial results are applicable only to more homogeneous patient groups.

There has been a push to include more underrepresented patients in clinical trials. One group reported its success in doing so here at the annual meeting of the American Society of Clinical Oncology.

Researchers from the Alliance for Clinical Trials in Oncology explained how a multifaceted approach resulted in a 75% relative improvement in trial enrollment from 2014 to 2022, a period that included a pandemic-induced hiatus in clinical trials in general.

Alliance member Electra D. Paskett, PhD, from the College of Public Health at the Ohio State University in Columbus, presented accrual data from 117 trials led by the Alliance from 2014 to 2022.

During this period, accrual of racial and ethnic minority patients increased from 13.6% to 25.3% for cancer treatment trials and from 13% to 21.5% for cancer control trials.

Overall, the recruitment program resulted in an absolute increase from 13.5 % to 23.6% of underrepresented populations, which translated into a relative 74.8% improvement.

“We’re focusing now on monitoring accrual of women, rural populations, younger AYAs [adolescents and young adults] and older patients, and we’ll see what strategies we need to implement,” Dr. Packett told this news organization.

The Alliance has implemented a real-time accrual dashboard on its website that allows individual sites to review accrual by trial and overall for all of the identified underrepresented populations, she noted.
 

Program to increase underrepresented patient accrual

The impetus for the program to increase enrollment of underrepresented patients came from the goal set by Monica M. Bertagnolli, MD, group chair of the Alliance from 2011 to 2022 and currently the director of the U.S. National Cancer Institute.

“Our leader, Dr. Bertagnolli, set out a group-wide goal for accrual of underrepresented minorities to our trials of 20%, and that gave us permission to implement a whole host of new strategies,” Dr. Paskett said in an interview.

“These strategies follow the Accrual of Clinical Trials framework, which essentially says that the interaction between the patient and the provider for going on a clinical trial is not just an interaction between the patient and provider but recognizes, for example, that the provider has coworkers and they have norms and beliefs and attitudes, and the patient comes from a family with their own values. And then there are system-level barriers, and there are community barriers that all relate to this interaction about going on a trial,” Dr. Packett said.
 

What works?

The study was presented as a poster at the meeting. During the poster discussion session, comoderator Victoria S. Blinder, MD, from Memorial Sloan Kettering Cancer Center in New York, asked Dr. Paskett, “If you had a certain amount of money and you really wanted to use that resource to focus on one area, where would you put that resource?”

“I’m going to violate the rules of your question,” Dr. Paskett replied.

“You cannot change this problem by focusing on one thing, and that’s what we showed in our Alliance poster, and what I’ve said is based on over 30 years of work in this area,” she said.

She cited what she considered as the two most important components for improving accrual of underrepresented populations: a commitment by leadership to a recruitment goal, and the development of protocols with specific accrual goals for minority populations.

Still, those are only two components of a comprehensive program that includes the aforementioned accrual goal set by Dr. Bertagnolli, as well as the following:

• Funding of minority junior investigators and research that focuses on issues of concern to underrepresented populations.
• Establishment of work groups that focus on specific populations with the Alliance health disparities committee.
• Translation of informational materials for patients.
• Opening studies at National Cancer Institute Community. Oncology Research Program–designated minority underserved sites.
• Real-time monitoring of accrual demographics by the Alliance and at the trial site.
• Closing protocol enrollment to majority populations.
• Increasing the study sample sizes to enroll additional minority participants and to allow for subgroup analyses.

The study was funded by the National Institutes of Health. Dr. Packett and Dr. Blinder reported no relevant financial relationships.

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

CHICAGO – Clinical trials are so White. Only a small percentage of eligible patients participate in clinical trials in the first place, and very few come from racial and ethnic minority groups.

For example, according to the Food and Drug Administration, in trials that resulted in drug approvals from 2017 to 2020, only 2%-5% of participants were Black patients.

When clinical trials lack diverse patient populations, those who are left out have fewer opportunities to get new therapies. Moreover, the scope of the research is limited by smaller phenotypic and genotypic samples, and the trial results are applicable only to more homogeneous patient groups.

There has been a push to include more underrepresented patients in clinical trials. One group reported its success in doing so here at the annual meeting of the American Society of Clinical Oncology.

Researchers from the Alliance for Clinical Trials in Oncology explained how a multifaceted approach resulted in a 75% relative improvement in trial enrollment from 2014 to 2022, a period that included a pandemic-induced hiatus in clinical trials in general.

Alliance member Electra D. Paskett, PhD, from the College of Public Health at the Ohio State University in Columbus, presented accrual data from 117 trials led by the Alliance from 2014 to 2022.

During this period, accrual of racial and ethnic minority patients increased from 13.6% to 25.3% for cancer treatment trials and from 13% to 21.5% for cancer control trials.

Overall, the recruitment program resulted in an absolute increase from 13.5 % to 23.6% of underrepresented populations, which translated into a relative 74.8% improvement.

“We’re focusing now on monitoring accrual of women, rural populations, younger AYAs [adolescents and young adults] and older patients, and we’ll see what strategies we need to implement,” Dr. Packett told this news organization.

The Alliance has implemented a real-time accrual dashboard on its website that allows individual sites to review accrual by trial and overall for all of the identified underrepresented populations, she noted.
 

Program to increase underrepresented patient accrual

The impetus for the program to increase enrollment of underrepresented patients came from the goal set by Monica M. Bertagnolli, MD, group chair of the Alliance from 2011 to 2022 and currently the director of the U.S. National Cancer Institute.

“Our leader, Dr. Bertagnolli, set out a group-wide goal for accrual of underrepresented minorities to our trials of 20%, and that gave us permission to implement a whole host of new strategies,” Dr. Paskett said in an interview.

“These strategies follow the Accrual of Clinical Trials framework, which essentially says that the interaction between the patient and the provider for going on a clinical trial is not just an interaction between the patient and provider but recognizes, for example, that the provider has coworkers and they have norms and beliefs and attitudes, and the patient comes from a family with their own values. And then there are system-level barriers, and there are community barriers that all relate to this interaction about going on a trial,” Dr. Packett said.
 

What works?

The study was presented as a poster at the meeting. During the poster discussion session, comoderator Victoria S. Blinder, MD, from Memorial Sloan Kettering Cancer Center in New York, asked Dr. Paskett, “If you had a certain amount of money and you really wanted to use that resource to focus on one area, where would you put that resource?”

“I’m going to violate the rules of your question,” Dr. Paskett replied.

“You cannot change this problem by focusing on one thing, and that’s what we showed in our Alliance poster, and what I’ve said is based on over 30 years of work in this area,” she said.

She cited what she considered as the two most important components for improving accrual of underrepresented populations: a commitment by leadership to a recruitment goal, and the development of protocols with specific accrual goals for minority populations.

Still, those are only two components of a comprehensive program that includes the aforementioned accrual goal set by Dr. Bertagnolli, as well as the following:

• Funding of minority junior investigators and research that focuses on issues of concern to underrepresented populations.
• Establishment of work groups that focus on specific populations with the Alliance health disparities committee.
• Translation of informational materials for patients.
• Opening studies at National Cancer Institute Community. Oncology Research Program–designated minority underserved sites.
• Real-time monitoring of accrual demographics by the Alliance and at the trial site.
• Closing protocol enrollment to majority populations.
• Increasing the study sample sizes to enroll additional minority participants and to allow for subgroup analyses.

The study was funded by the National Institutes of Health. Dr. Packett and Dr. Blinder reported no relevant financial relationships.

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

In this video, Dr. David Ramsay of Digestive Health Specialists in Winston Salem, N.C., discusses the different career paths available to fellows and early-career physicians, and why he chose to become a private practice gastroenterologist. Dr. Ramsay shares his insights into different private practice models and what physicians should consider when beginning their careers, as well as what questions to ask when trying to determine if an organization will be a good fit for their future career plans. He has no financial conflicts relative to the topics in this video.

Vidyard Video

In this video, Dr. David Ramsay of Digestive Health Specialists in Winston Salem, N.C., discusses the different career paths available to fellows and early-career physicians, and why he chose to become a private practice gastroenterologist. Dr. Ramsay shares his insights into different private practice models and what physicians should consider when beginning their careers, as well as what questions to ask when trying to determine if an organization will be a good fit for their future career plans. He has no financial conflicts relative to the topics in this video.

Vidyard Video

In this video, Dr. David Ramsay of Digestive Health Specialists in Winston Salem, N.C., discusses the different career paths available to fellows and early-career physicians, and why he chose to become a private practice gastroenterologist. Dr. Ramsay shares his insights into different private practice models and what physicians should consider when beginning their careers, as well as what questions to ask when trying to determine if an organization will be a good fit for their future career plans. He has no financial conflicts relative to the topics in this video.

Vidyard Video

The Food and Drug Administration has approved the oral poly (ADP-ribose) polymerase inhibitor talazoparib (Talzenna, Pfizer) plus enzalutamide (Xtandi) to treat homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer.

Talazoparib is already approved for adults with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. The new approval, granted following priority review, is based on findings from the randomized, placebo-controlled, phase 3 TALAPRO-2 trial, published in The Lancet.

The 399 patients in the study were randomly assigned in a 1:1 ratio to receive either enzalutamide 160 mg daily plus either talazoparib 0.5 mg or placebo daily. Median radiographic progression-free survival (PFS) was not reached in the treatment group; it was 13.8 months in the placebo group (hazard ratio, 0.45). In an exploratory analysis by BRCA mutation status, patients with BRCA-mutated disease who received talazoparib exhibited an even stronger median radiographic PFS (HR, 0.20; not reached vs. 11 months) in comparison with those without BRCA-mutated disease (HR, 0.72; 24.7 vs. 16.7 months).

Serious adverse reactions occurred in 30% of patients who received talazoparib plus enzalutamide. The most common serious adverse reactions, reported in more than 2% of patients, included anemia (9%) and fracture (3%). Discontinuation of talazoparib occurred in 10% of patients, according to a Pfizer statement.

Pfizer also noted that a marketing authorization application for the drug combination has been accepted for review by the European Medicines Agency.

“Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy,” lead investigator Neeraj Agarwal, MD, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, said in a statement. Patients with metastatic castration-resistant prostate cancer harboring HRR genetic alterations have even worse outcomes, and thus the FDA’s approval of the talazoparib and enzalutamide combination “represents a treatment option deserving of excitement and attention.”

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

The Food and Drug Administration has approved the oral poly (ADP-ribose) polymerase inhibitor talazoparib (Talzenna, Pfizer) plus enzalutamide (Xtandi) to treat homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer.

Talazoparib is already approved for adults with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. The new approval, granted following priority review, is based on findings from the randomized, placebo-controlled, phase 3 TALAPRO-2 trial, published in The Lancet.

The 399 patients in the study were randomly assigned in a 1:1 ratio to receive either enzalutamide 160 mg daily plus either talazoparib 0.5 mg or placebo daily. Median radiographic progression-free survival (PFS) was not reached in the treatment group; it was 13.8 months in the placebo group (hazard ratio, 0.45). In an exploratory analysis by BRCA mutation status, patients with BRCA-mutated disease who received talazoparib exhibited an even stronger median radiographic PFS (HR, 0.20; not reached vs. 11 months) in comparison with those without BRCA-mutated disease (HR, 0.72; 24.7 vs. 16.7 months).

Serious adverse reactions occurred in 30% of patients who received talazoparib plus enzalutamide. The most common serious adverse reactions, reported in more than 2% of patients, included anemia (9%) and fracture (3%). Discontinuation of talazoparib occurred in 10% of patients, according to a Pfizer statement.

Pfizer also noted that a marketing authorization application for the drug combination has been accepted for review by the European Medicines Agency.

“Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy,” lead investigator Neeraj Agarwal, MD, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, said in a statement. Patients with metastatic castration-resistant prostate cancer harboring HRR genetic alterations have even worse outcomes, and thus the FDA’s approval of the talazoparib and enzalutamide combination “represents a treatment option deserving of excitement and attention.”

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

The Food and Drug Administration has approved the oral poly (ADP-ribose) polymerase inhibitor talazoparib (Talzenna, Pfizer) plus enzalutamide (Xtandi) to treat homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer.

Talazoparib is already approved for adults with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. The new approval, granted following priority review, is based on findings from the randomized, placebo-controlled, phase 3 TALAPRO-2 trial, published in The Lancet.

The 399 patients in the study were randomly assigned in a 1:1 ratio to receive either enzalutamide 160 mg daily plus either talazoparib 0.5 mg or placebo daily. Median radiographic progression-free survival (PFS) was not reached in the treatment group; it was 13.8 months in the placebo group (hazard ratio, 0.45). In an exploratory analysis by BRCA mutation status, patients with BRCA-mutated disease who received talazoparib exhibited an even stronger median radiographic PFS (HR, 0.20; not reached vs. 11 months) in comparison with those without BRCA-mutated disease (HR, 0.72; 24.7 vs. 16.7 months).

Serious adverse reactions occurred in 30% of patients who received talazoparib plus enzalutamide. The most common serious adverse reactions, reported in more than 2% of patients, included anemia (9%) and fracture (3%). Discontinuation of talazoparib occurred in 10% of patients, according to a Pfizer statement.

Pfizer also noted that a marketing authorization application for the drug combination has been accepted for review by the European Medicines Agency.

“Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy,” lead investigator Neeraj Agarwal, MD, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, said in a statement. Patients with metastatic castration-resistant prostate cancer harboring HRR genetic alterations have even worse outcomes, and thus the FDA’s approval of the talazoparib and enzalutamide combination “represents a treatment option deserving of excitement and attention.”

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