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A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

A radiologist who claims he was forced to resign after requesting to work from home has settled his discrimination lawsuit with a New York hospital.

Although the case was resolved without a definitive win, legal analysts say the complaint raises important questions about whether some physicians have the right to work from home.

Since the pandemic, employers across the country have become more accepting of professionals working remotely. But are some doctors legally entitled to the accommodation? And if so, how do physicians prove the allowance is reasonable for their circumstances?

Richard Heiden, MD, sued New York City Health and Hospitals in 2020, claiming discrimination and retaliation violations under the American with Disabilities Act (ADA) and the New York State Human Rights Law. Dr. Heiden, who has ulcerative colitis, had asked to work off-site during the start of the pandemic, but the hospital denied his accommodation request. Shortly later, administrators accused Dr. Heiden of poor performance and requested he resign or administrators would terminate him, according to his lawsuit.

Attorneys for New York City Health and Hospitals contended that Dr. Heiden was a poorly performing radiologist who was undergoing a performance review at the time of his accommodation request. The radiologist’s departure was related to the results of the review and had nothing to do with his disability or accommodation request, according to the hospital.

The undisclosed settlement ends a 3-year court battle between Dr. Heiden and the hospital corporation.

In an email, Laura Williams, an attorney for the hospital corporation, said that “the settlement was in the best interest of all parties.”

Dr. Heiden and his attorneys also did not respond to requests for comment.

A critical piece to the puzzle is understanding who is protected under the ADA and is therefore entitled to reasonable accommodations, said Doron Dorfman, JSD, an associate professor at Seton Hall University Law School in Newark, N.J., who focuses on disability law.

A common misconception is that only physicians with a physical disability are “disabled,” he said. However, under the law, a disabled individual is anyone with a physical or mental impairment – including mental illness – that limits major life activities; a person with a history of such impairment; or a person who is perceived by others as having an impairment.

“The law is much broader than many people think,” he said. “I think a lot of people don’t think about those with invisible disabilities, such as people with allergies, those who are immunocompromised, those with chronic illnesses. A lot of people don’t see themselves as disabled, and a lot of employers don’t see them as disabled.”

Working from home has not historically been considered a “reasonable accommodation” under the ADA, Mr. Dorfman said. However, that appears to be changing.

“There has been a sea change,” Mr. Dorfman said. “The question is coming before the courts more frequently, and recent legal decisions show judges may be altering their views on the subject.”
 

What led to the doctor’s lawsuit?

Dr. Heiden, a longtime radiologist, had practiced at Lincoln Medical and Mental Health Center for about a year when he requested to work remotely. (Lincoln is operated by New York City Health and Hospitals.) At the time, the governor of New York had ordered a statewide lockdown because of COVID-19, and Dr. Heiden expressed concern that his ulcerative colitis made him a high-risk individual for the virus, according to court documents.

In his March 22, 2020, request, Dr. Heiden said that, except for fluoroscopy, his job could be done entirely from his home, according to a district court summary of the case. He also offered to pay for any costs associated with the remote work setup.

Around the same time, New York City Health and Hospitals permitted its facilities to issue a limited number of workstations to radiologists to facilitate remote work in the event of COVID-related staffing shortages. Administrators were in the process of acquiring remote radiology workstations and determining which radiologists at Lincoln would receive them, according to the case summary.

On March 24, the chair of radiology at Lincoln met with Dr. Heiden to review the results of a recent focused professional practice evaluation (FPPE). An FPPE refers to an intensive review of an expansive selection of patient cases handled by the subject physician. During the meeting, the chair that claimed Dr. Heiden was a poor performer and was accurate in his assessments 93.8% of the time, which was below the hospital’s 97% threshold, according to Dr. Heiden’s lawsuit. Dr. Heiden disagreed with the results, and the two engaged in several more meetings.

Meanwhile, Dr. Heiden’s accommodation request was forwarded to other administrators. In an email introduced into court evidence, the chair indicated he did not support the accommodation, writing that Dr. Heiden’s “skill set does not meet the criteria for the initial installations” of the workstations.

On March 26, 2020, the chair allegedly asked Dr. Heiden to either resign or he would be terminated and reported to the New York State Office of Professional Medical Conduct. Four days later, Dr. Heiden learned that his accommodation request had been denied. He resigned on April 2, 2020.

In his lawsuit, Dr. Heiden claimed that the hospital discriminated against him on the basis of his disability in violation of ADA by denying him equal terms and conditions of employment and failing to provide a reasonable accommodation.

The defendants, who included the radiology chair, did not dispute that Dr. Heiden was asked to resign or that administrators warned termination, but they argued the impetus was his FPPE results and a history of inaccurate interpretations. Other clinicians and physicians had expressed concerns about Dr. Heiden’s “lack of clarity [and] interpretive errors,” according to deposition testimony. The hospital emphasized the FPPE had concluded before Dr. Heiden’s accommodation request was made.

New York City Health and Hospitals requested a federal judge dismiss the lawsuit for lack of valid claims. In January 2023, U.S. District Judge Lewis Liman allowed the case to proceed, ruling that some of Dr. Heiden’s claims had merit.

“Plaintiff has satisfied his obligation to proffer sufficient evidence to create an inference of retaliatory or discriminatory intent,” Judge Liman wrote in his decision. “[The chair] had not always planned to ask for plaintiff’s resignation based on the results of the FPPE completed on March 10, 2020. The decision to ask for that resignation arose shortly after the request for the accommodation. And there is evidence from which the jury could find that [the chair] was not receptive to making the accommodation.”

A jury trial was scheduled for July 2023, but the parties reached a settlement on May 31, 2023.
 

Is working from home reasonable for physicians?

The widespread swing to remote work in recent years has paved a smoother road for physicians who request the accommodation, said Peter Poullos, MD, clinical associate professor of radiology, gastroenterology, and hepatology at Stanford (Calif.) University and founder and cochair of the Stanford Medicine Alliance for Disability Inclusion and Equity.

“There is now a precedent and examples all over that working from home for some is a viable alternative to working in the hospital or a clinic,” Dr. Poullos said. “If a lawyer can point to instances of other people having received the same accommodation, even if the accommodation was given to someone without a disability, it’s much harder for an employer to say: ‘It’s not possible.’ Because clearly, it is.”

A key factor is the employee’s job duties and whether the employee can complete them remotely, said Mr. Dorfman. With physicians, the reasonableness would heavily depend on their specialty.

A radiologist, for example, would probably have a stronger case for performing their duties remotely compared with a surgeon, Dr. Poullos said.

In general, whether an accommodation is reasonable is decided on a case-by-case basis and usually includes reviewing supporting documentation from a medical provider, said Emily Harvey, a Denver-based disability law attorney. Employers are allowed to deny accommodations if they would cause an undue burden to the employer or fundamentally alter the nature or operation of the job or business.

“When it comes to the ADA, and disability rights in general, the analysis is based on the need of the individual,” she said. “Two people with identical diagnoses could need vastly different accommodations to be successful in the same job.”

Mr. Dorfman added that employers are only required to provide an accommodation that is reasonable under the circumstances, whether or not that accommodation meets the preferred request of the employee. For instance, if an immunocompromised physician asked to work from home, but the employer could ensure that all those working around the physician will mask, that could be reasonable enough.

A recent case analysis by Bloomberg Law shows that more courts are siding with employees who request remote work, compared with in past years. Employees who made disability-related remote work requests prevailed in 40% of federal court rulings from 2021 to 2023 versusa success rate of 30% from 2017 to 2019, according to the July 2023 analysis.

The analysis shows that employers still win the majority of the time, but that the gap is closing, Mr. Dorfman said.

In a September 2020 decision, for example, a Massachusetts District Court ruled in favor of an employee with asthma who was precluding from working at home by a behavioral and mental health agency. U.S. Magistrate Judge Katherine Robertson said that the manager was entitled to telework as a reasonable accommodation under the ADA for 60 days or until further notice. The lawsuit was settled in 2021.

“I think judges are much more used to working from home themselves,” Mr. Dorfman said. “That may affect their sense of accepting remote work as a reasonable accommodation. Their personal experience with it [may] actually inform their view of the topic.”
 

Your accommodation request was denied: Now what?

If you are unsure about your rights under the ADA, a first step is understanding the law’s protections and learning the obligations of your employer. 

Keep in mind that not everyone at your workplace may understand the law and what is required, said Dr. Poullos. When making a request to work from home, ensure that you’re using the right words and asking the right people, he advised. Some physicians, for instance, may only discuss the request with their direct supervisor and give up when the request is denied. “The employee might say, ‘I’ve been dealing with some medical issues and I’m really tired and need to adjust my schedule.’ They don’t mention the word ‘disability,’ they don’t mention the ADA, they don’t mention the word ‘accommodation,’ and so that might not trigger the appropriate response.”

Lisa Meeks, PhD, an expert and researcher in disabilities in medical education, encourages physicians and others to follow the appeals process at their institution if they feel their accommodation request has been unjustly denied.

Research shows that physicians who make accommodation requests rarely escalate denials to an appeal, grievance, or complaint, said Dr. Meeks, cohost of the Docs With Disabilities podcast and director of the Docs With Disabilities Initiative. The initiative aims to use research, education, and stories to drive change in perceptions, disability policy, and procedures in health professions and in biomedical and science education.

If an accommodation cannot be agreed on, doctors can reach out the Equal Employment Opportunity Commission and file a discrimination charge. The agency will review the case and provide an opinion on whether the charge has merit. The EEOC’s decision is not binding in court, and even if the agency believes the charge has no merit, employees still have the right to sue, he said.

Ms. Harvey added that the EEOC has many resources on its website, and that most states also have civil rights agencies that have additional resources. Every state and U.S. territory also has a protection and advocacy organization that may be able to help. Physicians can also review their state bar to locate and consult with disability rights attorneys.

Although it may seem like an uphill battle to push for an accommodation, it can be worth it in the end, said Michael Argenyi, MD, an addiction medicine specialist and assistant professor at the University of Massachusetts, Worcester. Dr. Argenyi, who has hearing loss, was featured on the Docs With Disabilities podcast.

“It’s difficult to ‘rock the boat’ and ask for support from the C-suite for employees with disabilities, or to rearrange a small medical office budget to establish a byline just for accommodations,” Dr. Argenyi said. “Yet, the payoff is worthwhile – patients and fellow colleagues notice commitments to diversity building and inclusion.”

A version of this article appeared on Medscape.com.

I’m not the smartest dermatologist in our department. We’re fortunate to have a few super-smarties, you know, the ones who can still recite all the genes in Jean Bolognia’s dermatology textbook and have “Dermpath Bowl Champion” plaques covering their walls. Yet as our chief, I often get requests for a second or third opinion, hoping somehow I’ll discover a diagnosis that others missed. Sometimes they are real diagnostic dilemmas. Oftentimes they’re just itchy.

Kaiser Permanente

Recently an itchy 73-year-old woman came to see me. She had seen several competent dermatologists, had comprehensive workups, and had reasonable, even aggressive, attempts at treating. Not much interesting in her history. Nothing on exam. Cancer workup was negative as was pretty much any autoimmune or allergic cause. Biopsy? Maybe a touch of “dermal hypersensitivity.” She was still upset at being told previously she might have scabies. “Scabies!” she said indignantly. “How could I have scabies? No one has touched this body in nearly 4 years!” That’s interesting, I thought.

The electronic medical record holds a lot of useful information. We spend hours combing through histories, labs, pathology, scans, drugs to search for clues that might help with diagnoses. One tab we hardly visit is demographics. Why should that matter, of course? Age, phone number, and address are typically not contributory. But for this woman there was a bit of data that mattered; I checked right after her remark. Marital status: Widowed. She couldn’t have had scabies because no one touches her. Anymore. As our comprehensive workup did not find a cause nor did treatments mitigate her symptoms, I wondered if loneliness might be a contributing factor. I asked if anyone else was itching, any family, any friends? “No, I live alone. I don’t have anyone.”

Loneliness is a huge health risk. Lacking personal connection has psychological and physical consequences, increasing the risk for depression, cardiovascular disease, and dementia for example. According to the U.S. Surgeon General, it increases the risk for premature death comparable to smoking 15 cigarettes a day. Yet, we rarely (ever?) ask people if they’re lonely. In part because we don’t have good treatments. Remedies for loneliness are mostly societal – reaching out to the widowed, creating spaces that encourage connection, organizing events that bring people together. I cannot type any of these into the EMR orders. However, merely mentioning that a patient could be lonely can be therapeutic. They might not recognize its impact or that they have agency to make it better. They also might not see how their lives still have meaning, an important comorbidity of loneliness.

Not long after her appointment was a 63-year-old man who complained of a burning scrotum. He worked as a knife sharpener, setting up a folding table at local groceries and farmers markets. COVID killed most of his gigs. Like the woman who didn’t have scabies, comprehensive workups turned up nothing. And seemingly nothing, including antibiotics, gabapentin, indomethacin, lidocaine, helped. At his last visit, we talked about his condition. We had also talked about the proper way to sharpen a knife. I came in prepared to offer something dramatic this visit, methotrexate, dupilumab? But before I could speak, he opened a recycled plastic grocery bag and dumped out knives of various sizes. Also a small ax. He then proceeded to show me how each knife has to be sharpened in its own way. Before leaving he handed me a well-worn Arkansas sharpening stone. “For you,” he said. I gave him no additional recommendations or treatments. He hasn’t been back to dermatology since.

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

I’m not the smartest dermatologist in our department. We’re fortunate to have a few super-smarties, you know, the ones who can still recite all the genes in Jean Bolognia’s dermatology textbook and have “Dermpath Bowl Champion” plaques covering their walls. Yet as our chief, I often get requests for a second or third opinion, hoping somehow I’ll discover a diagnosis that others missed. Sometimes they are real diagnostic dilemmas. Oftentimes they’re just itchy.

Kaiser Permanente

Recently an itchy 73-year-old woman came to see me. She had seen several competent dermatologists, had comprehensive workups, and had reasonable, even aggressive, attempts at treating. Not much interesting in her history. Nothing on exam. Cancer workup was negative as was pretty much any autoimmune or allergic cause. Biopsy? Maybe a touch of “dermal hypersensitivity.” She was still upset at being told previously she might have scabies. “Scabies!” she said indignantly. “How could I have scabies? No one has touched this body in nearly 4 years!” That’s interesting, I thought.

The electronic medical record holds a lot of useful information. We spend hours combing through histories, labs, pathology, scans, drugs to search for clues that might help with diagnoses. One tab we hardly visit is demographics. Why should that matter, of course? Age, phone number, and address are typically not contributory. But for this woman there was a bit of data that mattered; I checked right after her remark. Marital status: Widowed. She couldn’t have had scabies because no one touches her. Anymore. As our comprehensive workup did not find a cause nor did treatments mitigate her symptoms, I wondered if loneliness might be a contributing factor. I asked if anyone else was itching, any family, any friends? “No, I live alone. I don’t have anyone.”

Loneliness is a huge health risk. Lacking personal connection has psychological and physical consequences, increasing the risk for depression, cardiovascular disease, and dementia for example. According to the U.S. Surgeon General, it increases the risk for premature death comparable to smoking 15 cigarettes a day. Yet, we rarely (ever?) ask people if they’re lonely. In part because we don’t have good treatments. Remedies for loneliness are mostly societal – reaching out to the widowed, creating spaces that encourage connection, organizing events that bring people together. I cannot type any of these into the EMR orders. However, merely mentioning that a patient could be lonely can be therapeutic. They might not recognize its impact or that they have agency to make it better. They also might not see how their lives still have meaning, an important comorbidity of loneliness.

Not long after her appointment was a 63-year-old man who complained of a burning scrotum. He worked as a knife sharpener, setting up a folding table at local groceries and farmers markets. COVID killed most of his gigs. Like the woman who didn’t have scabies, comprehensive workups turned up nothing. And seemingly nothing, including antibiotics, gabapentin, indomethacin, lidocaine, helped. At his last visit, we talked about his condition. We had also talked about the proper way to sharpen a knife. I came in prepared to offer something dramatic this visit, methotrexate, dupilumab? But before I could speak, he opened a recycled plastic grocery bag and dumped out knives of various sizes. Also a small ax. He then proceeded to show me how each knife has to be sharpened in its own way. Before leaving he handed me a well-worn Arkansas sharpening stone. “For you,” he said. I gave him no additional recommendations or treatments. He hasn’t been back to dermatology since.

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

I’m not the smartest dermatologist in our department. We’re fortunate to have a few super-smarties, you know, the ones who can still recite all the genes in Jean Bolognia’s dermatology textbook and have “Dermpath Bowl Champion” plaques covering their walls. Yet as our chief, I often get requests for a second or third opinion, hoping somehow I’ll discover a diagnosis that others missed. Sometimes they are real diagnostic dilemmas. Oftentimes they’re just itchy.

Kaiser Permanente

Recently an itchy 73-year-old woman came to see me. She had seen several competent dermatologists, had comprehensive workups, and had reasonable, even aggressive, attempts at treating. Not much interesting in her history. Nothing on exam. Cancer workup was negative as was pretty much any autoimmune or allergic cause. Biopsy? Maybe a touch of “dermal hypersensitivity.” She was still upset at being told previously she might have scabies. “Scabies!” she said indignantly. “How could I have scabies? No one has touched this body in nearly 4 years!” That’s interesting, I thought.

The electronic medical record holds a lot of useful information. We spend hours combing through histories, labs, pathology, scans, drugs to search for clues that might help with diagnoses. One tab we hardly visit is demographics. Why should that matter, of course? Age, phone number, and address are typically not contributory. But for this woman there was a bit of data that mattered; I checked right after her remark. Marital status: Widowed. She couldn’t have had scabies because no one touches her. Anymore. As our comprehensive workup did not find a cause nor did treatments mitigate her symptoms, I wondered if loneliness might be a contributing factor. I asked if anyone else was itching, any family, any friends? “No, I live alone. I don’t have anyone.”

Loneliness is a huge health risk. Lacking personal connection has psychological and physical consequences, increasing the risk for depression, cardiovascular disease, and dementia for example. According to the U.S. Surgeon General, it increases the risk for premature death comparable to smoking 15 cigarettes a day. Yet, we rarely (ever?) ask people if they’re lonely. In part because we don’t have good treatments. Remedies for loneliness are mostly societal – reaching out to the widowed, creating spaces that encourage connection, organizing events that bring people together. I cannot type any of these into the EMR orders. However, merely mentioning that a patient could be lonely can be therapeutic. They might not recognize its impact or that they have agency to make it better. They also might not see how their lives still have meaning, an important comorbidity of loneliness.

Not long after her appointment was a 63-year-old man who complained of a burning scrotum. He worked as a knife sharpener, setting up a folding table at local groceries and farmers markets. COVID killed most of his gigs. Like the woman who didn’t have scabies, comprehensive workups turned up nothing. And seemingly nothing, including antibiotics, gabapentin, indomethacin, lidocaine, helped. At his last visit, we talked about his condition. We had also talked about the proper way to sharpen a knife. I came in prepared to offer something dramatic this visit, methotrexate, dupilumab? But before I could speak, he opened a recycled plastic grocery bag and dumped out knives of various sizes. Also a small ax. He then proceeded to show me how each knife has to be sharpened in its own way. Before leaving he handed me a well-worn Arkansas sharpening stone. “For you,” he said. I gave him no additional recommendations or treatments. He hasn’t been back to dermatology since.

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

Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.

“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”

Here’s a look at the seven top tax breaks physician respondents claimed in our tax report, so you can ensure you’re making the most of the tax strategies available to you. To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
 

Contribute to charity

Claimed by 70% of physicians in 2022.

Who’s eligible: Anyone.

How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.

Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
 

Contribute to a pre-tax 401(k) account

Claimed by 60% of physicians in 2022.

Who’s eligible: Those who work for a company that sponsors a 401(k) plan.

How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.

Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.

“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”

If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
 

Deduct interest on a home mortgage

Claimed by 52% of physicians.

Who’s eligible: Most homeowners who have a mortgage.

How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)

Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.

Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
 

Write off eligible business expenses

Claimed by 46% of physicians.

Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.

How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.

“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”

Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.

“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
 

Contribute to a 529 college savings plan

Claimed by 27% of physicians.

Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.

How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.

Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.

“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”

Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
 

Sell investments at a loss

Claimed by 22% of physicians.

Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.

How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.

Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
 

Contribute to a backdoor Roth IRA

Claimed by 20% of physicians.

Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.

How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.

There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.

Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
 

A version of this article appeared on Medscape.com.

Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.

“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”

Here’s a look at the seven top tax breaks physician respondents claimed in our tax report, so you can ensure you’re making the most of the tax strategies available to you. To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
 

Contribute to charity

Claimed by 70% of physicians in 2022.

Who’s eligible: Anyone.

How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.

Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
 

Contribute to a pre-tax 401(k) account

Claimed by 60% of physicians in 2022.

Who’s eligible: Those who work for a company that sponsors a 401(k) plan.

How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.

Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.

“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”

If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
 

Deduct interest on a home mortgage

Claimed by 52% of physicians.

Who’s eligible: Most homeowners who have a mortgage.

How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)

Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.

Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
 

Write off eligible business expenses

Claimed by 46% of physicians.

Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.

How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.

“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”

Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.

“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
 

Contribute to a 529 college savings plan

Claimed by 27% of physicians.

Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.

How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.

Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.

“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”

Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
 

Sell investments at a loss

Claimed by 22% of physicians.

Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.

How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.

Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
 

Contribute to a backdoor Roth IRA

Claimed by 20% of physicians.

Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.

How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.

There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.

Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
 

A version of this article appeared on Medscape.com.

Plenty of perks come along with earning a physician’s salary, but a low tax rate isn’t among them. Medscape’s Physicians and Taxes Report 2023 shows that last year, doctors paid an average of nearly $100,000 in state and federal taxes, and three-quarters of them thought that they were paying too much to Uncle Sam. In most cases, it’s impossible to eliminate that tax bill, but physicians told us they have found ways to minimize it.

“The percentage you have to pay in taxes escalates as you earn more money, and most doctors are at the maximum rate,” says Paul Joseph, a certified public accountant and founder of Joseph & Joseph Tax & Payroll in Williamston, Mich. “So every dollar you can deduct from your income is worth more.”

Here’s a look at the seven top tax breaks physician respondents claimed in our tax report, so you can ensure you’re making the most of the tax strategies available to you. To claim most of these options, you’ll need to itemize your deductions when filing your taxes.
 

Contribute to charity

Claimed by 70% of physicians in 2022.

Who’s eligible: Anyone.

How it works: If you itemize your taxes, you can deduct the value of cash, securities, or property donations to 501(c)(3) organizations. You’ll need a receipt from the charity and a third-party appraisal for any property donations worth more than $5,000.

Pro tip: Donating stocks that have appreciated in value can deliver additional tax benefits: You get to write off both the value of the contribution and avoid capital gains taxes that you’d face for selling the security.
 

Contribute to a pre-tax 401(k) account

Claimed by 60% of physicians in 2022.

Who’s eligible: Those who work for a company that sponsors a 401(k) plan.

How it works: Contributions to a 401(k) or 403(b) account come directly out of your paycheck, pre-tax, and grow tax-free until you withdraw them in retirement. Many companies offer a match on contributions. In 2023, you can contribute up to $22,500 ($30,000 if you’re age 50 or older) to a 401(k) account.

Pro tip: If you’re maxing out your 401(k) account, you can stash money in other tax-advantaged accounts such as a health savings account (if you have a high-deductible health plan) or an individual retirement account (IRA). Although employees with access to a 401(k) may not get the pre-tax advantage of the IRA contributions, the money will grow tax-free through retirement, and you may have access to additional investment options unavailable in your workplace plan.

“You want to maximize your retirement contributions,” says Mark Steber, the chief tax information officer for Jackson Hewitt Tax Services. “If you’re not taking full advantage of them, you’re probably leaving some tax dollars on the table.”

If you’re self-employed and don’t have access to a workplace plan, there are several options for tax-advantaged retirement savings, including a SEP IRA and a solo 401(k).
 

Deduct interest on a home mortgage

Claimed by 52% of physicians.

Who’s eligible: Most homeowners who have a mortgage.

How it works: Homeowners can deduct the interest paid on the first $750,000 of their mortgage. (Those who have had the same mortgage since before December 16, 2007, can deduct interest on the first $1 million of their loan.)

Pro tip: If you purchased a home this year and bought points to reduce the rate, you may be able to deduct the cost of those points on your taxes.

Physicians might also be eligible for other home-related tax benefits, such as for green home improvements under the Inflation Reduction Act or for home equity loans used to improve the value of your home.
 

Write off eligible business expenses

Claimed by 46% of physicians.

Who’s eligible: Physicians who own all or a portion of their practice, as well as those who work as consultants or contractors paid with a 1099.

How it works: Doctors who run their business using an LLC or S corporation can itemize the deductions on their Schedule C. There are dozens of deductions that might qualify, including for office space and supplies, medical equipment, uniforms, staff wages and benefits, and state and local tax payments. Physicians who work as consultants can deduct home office expenses, travel costs, and the price of supplies purchased for the job.

“For business expenses, you want to make sure that you’re tracking those expenses on an ongoing basis, rather than trying to reconstruct something at the end of the year from 8 months ago,” Mr. Joseph says. “You want to have a system in place that’s calculating those expenses every single day.”

Pro tip: The Tax Cuts and Jobs Act of 2017 also allows owners of pass-through businesses to deduct up to 20% of their business income.

“Not all physicians will qualify for that, because they are in a service-based business and many of them make too much money, but it’s always a good idea to look at whether that’s something they’re eligible for and make sure that they claim it,” says Eric Bronnenkant, head of tax at New York–based investment company Betterment.
 

Contribute to a 529 college savings plan

Claimed by 27% of physicians.

Who’s eligible: Those who live in the 37 states that offer a credit or deduction for 529 plan contributions.

How it works: The rules and amounts that qualify vary significantly by state. Most states offer benefits for contributions to in-state accounts only, whereas others offer a tax break for contributions to any 529 account.

Although there is no federal income tax benefit for contributions to a 529 plan, the money grows tax-free until tapped for qualified education expenses, which include both private primary and high school tuition and college costs. Starting in 2024, up to $35,000 in unused funds can roll over into a Roth IRA for the beneficiary.

“It’s not just about the immediate deduction with a 529 account,” says Brian Copeland, partner and director of financial planning with Hightower Wealth Advisors in St. Louis. “It’s not saving you a lot on day one; it’s more about as that account grows, you don’t have to pay taxes on it along the way, so you’re sheltering it from taxes for the 18 years you’re saving for your kids’ college.”

Pro tip: Even if you live in a state without a state income tax or without a tax break for 529 contributions, opening an account can be a smart financial move. Because you don’t need to choose an in-state plan for the tax breaks, look for one that offers low fees and investment options that you like.
 

Sell investments at a loss

Claimed by 22% of physicians.

Who’s eligible: Anyone who has sold stocks, mutual funds, or other investments at a loss.

How it works: After selling a security that has lost value, you can deduct the value of that loss on your taxes to offset capital gains in the same year. If you have more losses than gains, you can use the losses to offset up to $3,000 in ordinary income per year. If you have more than $3,000 in losses, you can carry those losses forward to offset future income or capital gains.

Pro tip: In years with a lot of market volatility, such as this one, there’s potential to engage in “tax loss harvesting” in which you intentionally sell securities that have lost value to realize the losses for the tax benefits. Keep in mind that if you sell a security at a loss, you cannot repurchase the same security within 30 days – the IRS sees that as a “wash sale,” which does not qualify for a capital loss for tax purposes.
 

Contribute to a backdoor Roth IRA

Claimed by 20% of physicians.

Who’s eligible: Anyone who wishes to contribute to a Roth IRA but is not allowed to do so because their income is too high.

How it works: High earners typically don’t qualify for contributions to a Roth IRA, in which contributions go in after taxes but grow tax-free and distributions in retirement are also tax-free. But there are no income requirements for making after-tax contributions to a traditional and then converting it to a Roth IRA.

There are, however, complex tax rules for those who also have a traditional IRA that’s funded with pre-tax dollars. If that’s the case, work with a tax pro or financial advisor to determine whether a backdoor Roth conversion is the most tax-efficient approach for your situation.

Pro tip: A growing number of workplace retirement plans now include an option for Roth contributions. There are no income limits on a Roth 401(k), so contributing to that type of an account could be a smart route for taxpayers for whom a backdoor conversion doesn’t make sense.
 

A version of this article appeared on Medscape.com.

The 2022-2023 Term of the Supreme Court illustrates how important the Court has become to health-related matters, including decisions regarding the selection and training of new professionals, the daily practice of medicine, and the future availability of new drugs. The importance of several cases is reinforced by the fact that major medical organizations filed amicus curiae (“friend of the court”) briefs in those cases.

Amicus briefs are filed by individuals or organizations with something significant to say about a case to the court—most often to present a point of view, make an argument, or provide information that the parties to the case may not have communicated. Amicus briefs are burdensome in terms of the time, energy, and cost of preparing and filing. Thus, they are not undertaken lightly. Medical organizations submitted amicus briefs in the first 3 cases we consider.

Admissions, race, and diversity

The case: Students for Fair Admissions v President and Fellows of Harvard College

The American College of Obstetricians and Gynecologists (ACOG) joined an amici curiae brief in Students for Fair Admissions v President and Fellows of Harvard College (and the University of North Carolina [UNC]).¹ This case challenged the use of racial preferences in college admissions. The Association of American Medical Colleges (AAMC) was the lead organization; nearly 40 other health-related organizations joined the brief.

The legal claim. Those filing the suits asserted that racial preferences by public colleges violate the 14th Amendment’s Equal Protection Clause (“no state shall deny to any person … the equal protection of the law”). That is, if a state university gives racial preferences in selective admissions, it denies some other applicant the equal protection of the law. As for private schools (in this case, Harvard), Title VI of the Civil Rights Act of 1964 has the same standards as the Equal Protection Clause. Thus, the Court consolidated the cases and used the same legal standard in considering public and private colleges (with “colleges” including professional and graduate programs as well as undergraduate institutions).

Background. For nearly 50 years, the Supreme Court has allowed limited racial preferences in college admissions. Those preferences could only operate as a plus, however, and not a negative for applicants and be narrowly tailored. The measure was instituted temporarily; in a 2003 case, the Court said, “We expect that 25 years from now, the use of racial preferences will no longer be necessary.”²

Decision. In a 6-3 decision, the Court held (in the UNC case) that racial preferences generally violate the Constitution, and by a 6-2 decision (in the Harvard case) these preferences violate the Civil Rights Act of 1964. (Justice Jackson was recused in the Harvard case because of a conflict.) The opinion covered 237 pages in the US Reports, so any summary is incomplete.

The majority concluded, “The Harvard and UNC admissions programs cannot be reconciled with the guarantees of the Equal Protection Clause. Both programs lack sufficiently focused and measurable objectives warranting the use of race, unavoidably employ race in a negative manner, involve racial stereotyping, and lack meaningful end points. We have never permitted admissions programs to work in that way, and we will not do so today.”³

There were 3 concurring opinions and 2 dissents in the case. The concurrences reviewed the history of the Equal Protection Clause and the Civil Rights Act, the damage racial preferences can do, and the explicit limits the Court said there must be on racial preferences in higher education. The dissents had a different view of the legal history of the 14th Amendment. They said the majority was turning a blind eye to segregation in society and the race-based gap in America.

As a practical matter, this case means that colleges, including professional schools, cannot use racial preferences. The Court said that universities may consider essays and the like in which applicants describe how their own experiences as an individual (including race) have affected their own lives. However, the Court cautioned that “universities may not simply establish through application essays or other means the regime we hold unlawful today.”³

Continue to: The amici brief...

ACOG joined 40 other health-related organizations in filing an amici brief (multiple “friends”) in Students for Fair Admission. The AAMC led the brief, with the others signing as amici.⁴ The brief made 3 essential points: diversity in medical education “markedly improves health outcomes,” and a loss of diversity “threaten[s] patients’ health; medical schools engage in an intense “holistic” review of applicants for admission; and medical schools must consider applicants’ “full background” (including race) to achieve their educational and professional goals.⁴

A powerful part of the brief described the medical school admissions process, particularly the very “holistic” review that is not entirely dependent on admissions scores. The brief effectively weaves the consideration of race into this process, mentioning race (on page 22) only after discussing many other admissions factors.

Child custody decisions related to the Indian Child Welfare Act

The case: Haaland v Brackeen

The American Medical Association (AMA) and the American Academy of Pediatrics filed a brief in Haaland v Brackeen⁵ involving the constitutionality of the 1978 Indian Child Welfare Act (ICWA). The statute followed a terrible history of Indian children being removed from their families inappropriately, as detailed in a concurring opinion by Justice Gorsuch.⁵ The two purposes of the act were to promote raising Native American children in their culture and stem the downward trend in tribal membership.

The legal claim. The Court consolidated several cases. Essentially, a 10-month-old child (A.L.M.) was placed in foster care with the Brackeens in Texas. After more than 1 year, the Brackeens sought adoption; the biological father, mother, and grandparents all supported it. The Navajo and Cherokee Nations objected and informed the Texas court that they had found alternative placement with (nonrelative) tribal members in New Mexico. The “court-appointed guardian and a psychological expert … described the strong emotional bond between A.L.M. and his foster parents.” The court denied the adoption petition based on ICWA’s preference for tribe custody, and the Brackeens filed a lawsuit. The Court noted that the act “requires a state court to place an Indian child with an Indian caretaker, if one is available, even if the child is already living with a non-Indian family and the state court thinks it in the child’s best interest to stay there.” That is, the ICWA may require a placement that the court believes is not in the child’s best interest.⁵

Decision. The constitutional claim in the case was that Congress lacked the authority to impose these substantial rules on states in making child custody decisions. The Supreme Court, in a 7-2 decision, upheld the constitutionality of the ICWA. The Court found the authority primarily in Article 1, Section 8, giving Congress the power to “regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes.” In addition, the Court suggested that the treaty power and “principles inherent in the Constitution’s structure may empower Congress to act in the field of Indian affairs.”

The amici brief

The joint amici brief of the American Academy of Pediatrics (AAP) and the AMA argued that tribes are “extended families” of Native American children.⁶ It noted the destructive history of removing Native American children from their families and suggested that kinship care improves children’s health. To its credit, the brief also honestly noted the serious mental health and suicide rates in some tribes, which suggest issues that might arise in child custody and adoption cases.

The Court did not, in this case, take up another constitutional issue that the parties raised—whether the strong preference for Native American over non ̶ Native American custody violates the Equal Protection Clause of the 14th Amendment. The Court said the parties to this case did not have standing to raise the issue. Justice Kavanaugh, concurring, said it was a “serious” issue and invited it to be raised in another case.⁵

False Claims Act cases

The case: Costs for SuperValu prescriptions

For physicians and health care organizations, False Claims Act (FCA) cases are an ongoing burden and, some would say, threat. (There are also state FCAs, but here we are discussing the federal act.) The federal government has recovered more than $70 billion since 1986, most from health care entities.⁷The Justice Department identifies “health care fraud” as the largest area of FCA recovery and provides annual details on frauds resulting in liability.⁸

The legal claim. One FCA case this Term involved billings SuperValu made for outpatient prescriptions in Medicare-Medicaid programs. As its “usual and customary” costs, it essentially reported a list price that did not include the substantial discounts it commonly gave.⁹ The charge was that it “knowingly” made a false claim regarding the price of prescriptions. The question was what state of mind, or “scienter,” is required for “knowingly.” Should it be objective (what a reasonable person would know) or subjective (the defendant’s “knowledge and subjective beliefs”)?

Background. Subjective knowledge (what the defendant actually knows) may seem impossible to prove—the defendant could just say, “I did not know I was doing wrong.” Over time the law has developed several ways of demonstrating “knowing.” Justice Thomas, writing for a unanimous Court, held that whistleblowers or the government might prove “knowing” in 3 ways:

1. defendants “actually knew that their reported prices were not their ‘usual and customary’ prices when they reported them”

2. were aware of a substantial risk that their higher, retail prices were not their “usual and customary” prices and intentionally avoided learning whether their reports were accurate

3. were aware of such a substantial and unjustifiable risk but submitted the claims anyway.⁹

Of course, records of the company, information from the whistleblower, and circumstantial evidence may be used to prove any of these; it does not require the company’s admission.

The Court said that if the government or whistleblowers make a showing of any of these 3 things, it is enough.

Decision. The case was returned to the lower court to apply these rules.

The amici brief

The American Hospital Association and America’s Health Insurance Plans filed an amici brief.¹⁰ It reminded the Court that many reimbursement regulations are unclear. Therefore, it is inappropriate to impose FCA liability for guessing incorrectly what the regulations mean. Having to check on every possible ambiguity was unworkable. The Court declined, however, the suggestion that defendants should be able to use any one of many “objectively” reasonable interpretations of regulations.

Continue to: The case: Polansky v Executive Health Resources...

The case: Polansky v Executive Health Resources

Health care providers who dislike the FCA may find solace this Term in this second FCA case.¹¹

The legal claim. Polansky, a physician employed by a medical billing company, became an “intervenor” in a suit claiming the company assisted hospitals in false billing (inpatient claims for outpatient services). The government sought to dismiss the case, but Polansky refused.

Decision. The case eventually reached the Supreme Court, which held that the government may enter an FCA case at any time and move to dismiss the case even over the objection of a whistleblower. The government does not seek to enter a case in order to file dismissal motions often. When it does so, whistleblowers are protected by the fact that the dismissal motion requires a hearing before the federal court.

An important part of this case has escaped much attention. Justices Thomas, Kavanaugh, and Barrett invited litigation to determine if allowing private whistleblowers to represent the government’s interest is consistent with Article II of the Constitution.¹¹ The invitation will likely be accepted. We expect to see cases challenging the place of “intervenors” pursuing claims when the government has declined to take up the case. The private intervenor is a crucial provision of the current FCA, and if such a challenge were successful, it could substantially reduce FCA cases.

Criminal false claims

Another case this Term is cautionary about the consequences of health care misbilling. It resulted in a criminal charge. More importantly, in addition to a basic fraud charge, the government added a charge of aggravated identity theft,¹² which carries a mandatory 2-year prison sentence.

Dubin overbilled Medicaid for psychological testing by saying the testing was done by a licensed psychologist rather than an assistant. The government claimed the “identity theft” was using the patient’s (actual) Medicaid number in submitting the bill.¹² The Court unanimously held the overbilling was not aggravated identity theft as defined in federal law. Dubin could be convicted of fraudulent billing but not aggravated identity theft, thereby avoiding the mandatory prison term.

Patents of “genus” targets

The case: Amgen v Sanofi

This case, which corrected an error of the patent office, received little attention but was likely a turning point in the next generation of pharmaceuticals.¹³

Background. “Genus” patents allow a single pharmaceutical company to patent every antibody that binds to a specific amino acid on a naturally occurring protein. In this case, the patent office had granted a “genus” patent on “all antibodies” that bind to the naturally occurring protein PCSK9 and block it from hindering the body’s mechanism for removing low-density lipoprotein (LDL) cholesterol from the bloodstream,¹³ helping to reduce LDL cholesterol levels. These patents could involve millions of antibodies—and Amgen was claiming a patent on all of them. Amgen and Sanofi marketed their products, each with their own unique amino acid sequence.¹³ Amgen sued Sanofi for violating its patent rights.

Decision. The Court unanimously held that Amgen did not have a valid patent on all antibodies targeting PCSK9, only those that it had explicitly described in its patent application—a ruling based on a 150-year-old technical requirement for receiving a patent. An applicant for a patent must include “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the same.”¹³ Amgen’s patent provided the description for only a few of the antibodies, but from the description in its application others could not “make and use” all of the antibodies targeting PCSK9.

While the decision was vital for future pharmaceuticals, the patent principle on which it was based has an interesting history. The Court noted that it affected the telegraph (Morse lost part of his patent), electric lights (Edison won his case against other inventors), and the glue for wood veneering (Perkins Glue Company lost).¹³

Continue to: Other notable decisions...

Student loans

The Court struck down the Biden Administration’s student loan forgiveness program, which would have cost approximately $430 billion.¹⁴ The central issue was whether the administration had the authority for such massive loan forgiveness; that is, whether Congress had authorized the broad loan forgiveness. The administration claimed authority from the post ̶ 9/11 HEROES Act, which allows the Secretary of Education to “waive or modify” loan provisions during national emergencies. The temporary hold on loan payments during COVID was based on this provision. However, in a 6-3 decision, the Court held that the act did not allow the secretary to cancel $430 billion in loans. “The Act allows the Secretary to ‘waive or modify’ existing statutory or regulatory provisions applicable to financial assistance programs under the Education Act, not to rewrite that statute from the ground up.”¹⁴

Free speech and the wedding web designer

303 Creative v Elenis involved a creative website designer who did not want to be required to create a website for a gay wedding.¹⁵ The designer had strong beliefs against same-sex marriages, but Colorado sought to force her to do so under the state “public accommodations” law. In a 6-3 decision, the Court held that the designer had a “free speech” right. That is, the state could not compel her to undertake speech expressing things she did not believe. This was because the website design was an expressive, creative activity and therefore was “speech” under the First Amendment.

Wetlands and the Clean Water Act

The essential issue in Sackett v Environmental Protection Agency (EPA) was the definitions of waters of the United States and related wetlands. The broad definition the EPA used meant it had jurisdiction to regulate an extraordinary amount of territory. It had, for example, prevented the Sacketts from building a modest house claiming it was part of the “waters of the United States because they were near a ditch that fed into a creek, which fed into Priest Lake, a navigable, intrastate lake.” The Court held that the EPA exceeded its statutory authority to define “wetlands.”¹⁶

The Court held that under the Clean Water Act, for the EPA to establish jurisdiction over adjacent wetlands, it must demonstrate that¹⁶:

1. “the adjacent body of water constitutes waters of the United States (ie, a relatively permanent body of water connected to traditional interstate navigable waters)…”

2. “…the wetland has a continuous surface connection with that water, making it difficult to determine where the water ends, and the wetland begins.”

Under this definition, the Sacketts could build their house. This was a statutory interpretation case. Therefore, Congress can expand or otherwise change the EPA’s authority under the Clean Water Act and other legislation.

Conclusions: A new justice, “shadow docket,” and ethics rules

SCOTUS’ newest member. When the Marshall called the Court into session on October 3, 2022, it had a new member, Justice Ketanji Brown Jackson. She was sworn in on June 30, 2022, when her predecessor (Justice Breyer) officially retired. She had been a law clerk for Justice Breyer in 1999, as well as a district court judge and court of appeals judge. Those who count such things described her as the “chattiest justice.”¹⁷ She spoke more than any other justice—by one count, a total of 75,632 words (an average of 1,300 words in each of the 58 arguments).

A more balanced Court? Most commentators view the Court as more balanced or less conservative than the previous Term. For example, Justice Sotomayor was in the majority 40% last Term but 65% this Term. Justice Thomas was in the majority 75% last Term but 55% this Term. Put another way, this Term in the divided cases, the liberal justices were in the majority 64% of the time, compared with the conservative justices 73%.¹⁸ Of course, these differences may reflect a different set of cases rather than a change in the direction of the Court. There were 11 (or 12, depending on how 1 case is counted) 6-3 cases, but only 5 were considered ideological. That suggests that, in many cases, the coalitions were somewhat fluid.

“Shadow docket” controversy continues.¹⁹ Shadow docket refers to orders the Court makes that do not follow oral arguments and often do not have written opinions. The orders are all publicly available. This Term a close examination of the approximately 30 shadow docket opinions shows that the overwhelming majority were dissents or explanations about denials of certiorari. The Court ordered only a few stays or injunctions via the shadow docket. One shadow docket stay (that prevented a lower court order from going into effect) is particularly noteworthy. A federal judge had ordered the suspension of the distribution of mifepristone while courts considered claims that the US Food and Drug Administration (FDA) had improperly approved the drug. In a shadow docket order, the Court issued the stay to allow mifepristone to be sold while the case challenging its approval was heard.²⁰ The only opinion was a dissent from Justice Alito. But it also demonstrates the importance of the shadow docket. Without this intervention, in at least part of the country, the distribution of mifepristone would have been interrupted pending the outcome of the FDA cases.

In August, the Court delayed a settlement in the Purdue Pharma liability bankruptcy case.²¹ It also stayed an injunction of a lower court, thereby permitting federal “ghost guns” regulations to go into effect at least temporarily.²²

More ethics rules to come? Another area in which the Court faced criticism was formal ethics rules. The justices make financial disclosures, but these are somewhat ambiguous. There is likely to be increasing pressure for a more complete disclosure of non-financial relationships and more formal ethics rules. ●

The 2022-2023 Term of the Supreme Court illustrates how important the Court has become to health-related matters, including decisions regarding the selection and training of new professionals, the daily practice of medicine, and the future availability of new drugs. The importance of several cases is reinforced by the fact that major medical organizations filed amicus curiae (“friend of the court”) briefs in those cases.

Amicus briefs are filed by individuals or organizations with something significant to say about a case to the court—most often to present a point of view, make an argument, or provide information that the parties to the case may not have communicated. Amicus briefs are burdensome in terms of the time, energy, and cost of preparing and filing. Thus, they are not undertaken lightly. Medical organizations submitted amicus briefs in the first 3 cases we consider.

Admissions, race, and diversity

The case: Students for Fair Admissions v President and Fellows of Harvard College

The American College of Obstetricians and Gynecologists (ACOG) joined an amici curiae brief in Students for Fair Admissions v President and Fellows of Harvard College (and the University of North Carolina [UNC]).¹ This case challenged the use of racial preferences in college admissions. The Association of American Medical Colleges (AAMC) was the lead organization; nearly 40 other health-related organizations joined the brief.

The legal claim. Those filing the suits asserted that racial preferences by public colleges violate the 14th Amendment’s Equal Protection Clause (“no state shall deny to any person … the equal protection of the law”). That is, if a state university gives racial preferences in selective admissions, it denies some other applicant the equal protection of the law. As for private schools (in this case, Harvard), Title VI of the Civil Rights Act of 1964 has the same standards as the Equal Protection Clause. Thus, the Court consolidated the cases and used the same legal standard in considering public and private colleges (with “colleges” including professional and graduate programs as well as undergraduate institutions).

Background. For nearly 50 years, the Supreme Court has allowed limited racial preferences in college admissions. Those preferences could only operate as a plus, however, and not a negative for applicants and be narrowly tailored. The measure was instituted temporarily; in a 2003 case, the Court said, “We expect that 25 years from now, the use of racial preferences will no longer be necessary.”²

Decision. In a 6-3 decision, the Court held (in the UNC case) that racial preferences generally violate the Constitution, and by a 6-2 decision (in the Harvard case) these preferences violate the Civil Rights Act of 1964. (Justice Jackson was recused in the Harvard case because of a conflict.) The opinion covered 237 pages in the US Reports, so any summary is incomplete.

The majority concluded, “The Harvard and UNC admissions programs cannot be reconciled with the guarantees of the Equal Protection Clause. Both programs lack sufficiently focused and measurable objectives warranting the use of race, unavoidably employ race in a negative manner, involve racial stereotyping, and lack meaningful end points. We have never permitted admissions programs to work in that way, and we will not do so today.”³

There were 3 concurring opinions and 2 dissents in the case. The concurrences reviewed the history of the Equal Protection Clause and the Civil Rights Act, the damage racial preferences can do, and the explicit limits the Court said there must be on racial preferences in higher education. The dissents had a different view of the legal history of the 14th Amendment. They said the majority was turning a blind eye to segregation in society and the race-based gap in America.

As a practical matter, this case means that colleges, including professional schools, cannot use racial preferences. The Court said that universities may consider essays and the like in which applicants describe how their own experiences as an individual (including race) have affected their own lives. However, the Court cautioned that “universities may not simply establish through application essays or other means the regime we hold unlawful today.”³

Continue to: The amici brief...

ACOG joined 40 other health-related organizations in filing an amici brief (multiple “friends”) in Students for Fair Admission. The AAMC led the brief, with the others signing as amici.⁴ The brief made 3 essential points: diversity in medical education “markedly improves health outcomes,” and a loss of diversity “threaten[s] patients’ health; medical schools engage in an intense “holistic” review of applicants for admission; and medical schools must consider applicants’ “full background” (including race) to achieve their educational and professional goals.⁴

A powerful part of the brief described the medical school admissions process, particularly the very “holistic” review that is not entirely dependent on admissions scores. The brief effectively weaves the consideration of race into this process, mentioning race (on page 22) only after discussing many other admissions factors.

Child custody decisions related to the Indian Child Welfare Act

The case: Haaland v Brackeen

The American Medical Association (AMA) and the American Academy of Pediatrics filed a brief in Haaland v Brackeen⁵ involving the constitutionality of the 1978 Indian Child Welfare Act (ICWA). The statute followed a terrible history of Indian children being removed from their families inappropriately, as detailed in a concurring opinion by Justice Gorsuch.⁵ The two purposes of the act were to promote raising Native American children in their culture and stem the downward trend in tribal membership.

The legal claim. The Court consolidated several cases. Essentially, a 10-month-old child (A.L.M.) was placed in foster care with the Brackeens in Texas. After more than 1 year, the Brackeens sought adoption; the biological father, mother, and grandparents all supported it. The Navajo and Cherokee Nations objected and informed the Texas court that they had found alternative placement with (nonrelative) tribal members in New Mexico. The “court-appointed guardian and a psychological expert … described the strong emotional bond between A.L.M. and his foster parents.” The court denied the adoption petition based on ICWA’s preference for tribe custody, and the Brackeens filed a lawsuit. The Court noted that the act “requires a state court to place an Indian child with an Indian caretaker, if one is available, even if the child is already living with a non-Indian family and the state court thinks it in the child’s best interest to stay there.” That is, the ICWA may require a placement that the court believes is not in the child’s best interest.⁵

Decision. The constitutional claim in the case was that Congress lacked the authority to impose these substantial rules on states in making child custody decisions. The Supreme Court, in a 7-2 decision, upheld the constitutionality of the ICWA. The Court found the authority primarily in Article 1, Section 8, giving Congress the power to “regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes.” In addition, the Court suggested that the treaty power and “principles inherent in the Constitution’s structure may empower Congress to act in the field of Indian affairs.”

The amici brief

The joint amici brief of the American Academy of Pediatrics (AAP) and the AMA argued that tribes are “extended families” of Native American children.⁶ It noted the destructive history of removing Native American children from their families and suggested that kinship care improves children’s health. To its credit, the brief also honestly noted the serious mental health and suicide rates in some tribes, which suggest issues that might arise in child custody and adoption cases.

The Court did not, in this case, take up another constitutional issue that the parties raised—whether the strong preference for Native American over non ̶ Native American custody violates the Equal Protection Clause of the 14th Amendment. The Court said the parties to this case did not have standing to raise the issue. Justice Kavanaugh, concurring, said it was a “serious” issue and invited it to be raised in another case.⁵

False Claims Act cases

The case: Costs for SuperValu prescriptions

For physicians and health care organizations, False Claims Act (FCA) cases are an ongoing burden and, some would say, threat. (There are also state FCAs, but here we are discussing the federal act.) The federal government has recovered more than $70 billion since 1986, most from health care entities.⁷The Justice Department identifies “health care fraud” as the largest area of FCA recovery and provides annual details on frauds resulting in liability.⁸

The legal claim. One FCA case this Term involved billings SuperValu made for outpatient prescriptions in Medicare-Medicaid programs. As its “usual and customary” costs, it essentially reported a list price that did not include the substantial discounts it commonly gave.⁹ The charge was that it “knowingly” made a false claim regarding the price of prescriptions. The question was what state of mind, or “scienter,” is required for “knowingly.” Should it be objective (what a reasonable person would know) or subjective (the defendant’s “knowledge and subjective beliefs”)?

Background. Subjective knowledge (what the defendant actually knows) may seem impossible to prove—the defendant could just say, “I did not know I was doing wrong.” Over time the law has developed several ways of demonstrating “knowing.” Justice Thomas, writing for a unanimous Court, held that whistleblowers or the government might prove “knowing” in 3 ways:

1. defendants “actually knew that their reported prices were not their ‘usual and customary’ prices when they reported them”

2. were aware of a substantial risk that their higher, retail prices were not their “usual and customary” prices and intentionally avoided learning whether their reports were accurate

3. were aware of such a substantial and unjustifiable risk but submitted the claims anyway.⁹

Of course, records of the company, information from the whistleblower, and circumstantial evidence may be used to prove any of these; it does not require the company’s admission.

The Court said that if the government or whistleblowers make a showing of any of these 3 things, it is enough.

Decision. The case was returned to the lower court to apply these rules.

The amici brief

The American Hospital Association and America’s Health Insurance Plans filed an amici brief.¹⁰ It reminded the Court that many reimbursement regulations are unclear. Therefore, it is inappropriate to impose FCA liability for guessing incorrectly what the regulations mean. Having to check on every possible ambiguity was unworkable. The Court declined, however, the suggestion that defendants should be able to use any one of many “objectively” reasonable interpretations of regulations.

Continue to: The case: Polansky v Executive Health Resources...

The case: Polansky v Executive Health Resources

Health care providers who dislike the FCA may find solace this Term in this second FCA case.¹¹

The legal claim. Polansky, a physician employed by a medical billing company, became an “intervenor” in a suit claiming the company assisted hospitals in false billing (inpatient claims for outpatient services). The government sought to dismiss the case, but Polansky refused.

Decision. The case eventually reached the Supreme Court, which held that the government may enter an FCA case at any time and move to dismiss the case even over the objection of a whistleblower. The government does not seek to enter a case in order to file dismissal motions often. When it does so, whistleblowers are protected by the fact that the dismissal motion requires a hearing before the federal court.

An important part of this case has escaped much attention. Justices Thomas, Kavanaugh, and Barrett invited litigation to determine if allowing private whistleblowers to represent the government’s interest is consistent with Article II of the Constitution.¹¹ The invitation will likely be accepted. We expect to see cases challenging the place of “intervenors” pursuing claims when the government has declined to take up the case. The private intervenor is a crucial provision of the current FCA, and if such a challenge were successful, it could substantially reduce FCA cases.

Criminal false claims

Another case this Term is cautionary about the consequences of health care misbilling. It resulted in a criminal charge. More importantly, in addition to a basic fraud charge, the government added a charge of aggravated identity theft,¹² which carries a mandatory 2-year prison sentence.

Dubin overbilled Medicaid for psychological testing by saying the testing was done by a licensed psychologist rather than an assistant. The government claimed the “identity theft” was using the patient’s (actual) Medicaid number in submitting the bill.¹² The Court unanimously held the overbilling was not aggravated identity theft as defined in federal law. Dubin could be convicted of fraudulent billing but not aggravated identity theft, thereby avoiding the mandatory prison term.

Patents of “genus” targets

The case: Amgen v Sanofi

This case, which corrected an error of the patent office, received little attention but was likely a turning point in the next generation of pharmaceuticals.¹³

Background. “Genus” patents allow a single pharmaceutical company to patent every antibody that binds to a specific amino acid on a naturally occurring protein. In this case, the patent office had granted a “genus” patent on “all antibodies” that bind to the naturally occurring protein PCSK9 and block it from hindering the body’s mechanism for removing low-density lipoprotein (LDL) cholesterol from the bloodstream,¹³ helping to reduce LDL cholesterol levels. These patents could involve millions of antibodies—and Amgen was claiming a patent on all of them. Amgen and Sanofi marketed their products, each with their own unique amino acid sequence.¹³ Amgen sued Sanofi for violating its patent rights.

Decision. The Court unanimously held that Amgen did not have a valid patent on all antibodies targeting PCSK9, only those that it had explicitly described in its patent application—a ruling based on a 150-year-old technical requirement for receiving a patent. An applicant for a patent must include “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the same.”¹³ Amgen’s patent provided the description for only a few of the antibodies, but from the description in its application others could not “make and use” all of the antibodies targeting PCSK9.

While the decision was vital for future pharmaceuticals, the patent principle on which it was based has an interesting history. The Court noted that it affected the telegraph (Morse lost part of his patent), electric lights (Edison won his case against other inventors), and the glue for wood veneering (Perkins Glue Company lost).¹³

Continue to: Other notable decisions...

Student loans

The Court struck down the Biden Administration’s student loan forgiveness program, which would have cost approximately $430 billion.¹⁴ The central issue was whether the administration had the authority for such massive loan forgiveness; that is, whether Congress had authorized the broad loan forgiveness. The administration claimed authority from the post ̶ 9/11 HEROES Act, which allows the Secretary of Education to “waive or modify” loan provisions during national emergencies. The temporary hold on loan payments during COVID was based on this provision. However, in a 6-3 decision, the Court held that the act did not allow the secretary to cancel $430 billion in loans. “The Act allows the Secretary to ‘waive or modify’ existing statutory or regulatory provisions applicable to financial assistance programs under the Education Act, not to rewrite that statute from the ground up.”¹⁴

Free speech and the wedding web designer

303 Creative v Elenis involved a creative website designer who did not want to be required to create a website for a gay wedding.¹⁵ The designer had strong beliefs against same-sex marriages, but Colorado sought to force her to do so under the state “public accommodations” law. In a 6-3 decision, the Court held that the designer had a “free speech” right. That is, the state could not compel her to undertake speech expressing things she did not believe. This was because the website design was an expressive, creative activity and therefore was “speech” under the First Amendment.

Wetlands and the Clean Water Act

The essential issue in Sackett v Environmental Protection Agency (EPA) was the definitions of waters of the United States and related wetlands. The broad definition the EPA used meant it had jurisdiction to regulate an extraordinary amount of territory. It had, for example, prevented the Sacketts from building a modest house claiming it was part of the “waters of the United States because they were near a ditch that fed into a creek, which fed into Priest Lake, a navigable, intrastate lake.” The Court held that the EPA exceeded its statutory authority to define “wetlands.”¹⁶

The Court held that under the Clean Water Act, for the EPA to establish jurisdiction over adjacent wetlands, it must demonstrate that¹⁶:

1. “the adjacent body of water constitutes waters of the United States (ie, a relatively permanent body of water connected to traditional interstate navigable waters)…”

2. “…the wetland has a continuous surface connection with that water, making it difficult to determine where the water ends, and the wetland begins.”

Under this definition, the Sacketts could build their house. This was a statutory interpretation case. Therefore, Congress can expand or otherwise change the EPA’s authority under the Clean Water Act and other legislation.

Conclusions: A new justice, “shadow docket,” and ethics rules

SCOTUS’ newest member. When the Marshall called the Court into session on October 3, 2022, it had a new member, Justice Ketanji Brown Jackson. She was sworn in on June 30, 2022, when her predecessor (Justice Breyer) officially retired. She had been a law clerk for Justice Breyer in 1999, as well as a district court judge and court of appeals judge. Those who count such things described her as the “chattiest justice.”¹⁷ She spoke more than any other justice—by one count, a total of 75,632 words (an average of 1,300 words in each of the 58 arguments).

A more balanced Court? Most commentators view the Court as more balanced or less conservative than the previous Term. For example, Justice Sotomayor was in the majority 40% last Term but 65% this Term. Justice Thomas was in the majority 75% last Term but 55% this Term. Put another way, this Term in the divided cases, the liberal justices were in the majority 64% of the time, compared with the conservative justices 73%.¹⁸ Of course, these differences may reflect a different set of cases rather than a change in the direction of the Court. There were 11 (or 12, depending on how 1 case is counted) 6-3 cases, but only 5 were considered ideological. That suggests that, in many cases, the coalitions were somewhat fluid.

“Shadow docket” controversy continues.¹⁹ Shadow docket refers to orders the Court makes that do not follow oral arguments and often do not have written opinions. The orders are all publicly available. This Term a close examination of the approximately 30 shadow docket opinions shows that the overwhelming majority were dissents or explanations about denials of certiorari. The Court ordered only a few stays or injunctions via the shadow docket. One shadow docket stay (that prevented a lower court order from going into effect) is particularly noteworthy. A federal judge had ordered the suspension of the distribution of mifepristone while courts considered claims that the US Food and Drug Administration (FDA) had improperly approved the drug. In a shadow docket order, the Court issued the stay to allow mifepristone to be sold while the case challenging its approval was heard.²⁰ The only opinion was a dissent from Justice Alito. But it also demonstrates the importance of the shadow docket. Without this intervention, in at least part of the country, the distribution of mifepristone would have been interrupted pending the outcome of the FDA cases.

In August, the Court delayed a settlement in the Purdue Pharma liability bankruptcy case.²¹ It also stayed an injunction of a lower court, thereby permitting federal “ghost guns” regulations to go into effect at least temporarily.²²

More ethics rules to come? Another area in which the Court faced criticism was formal ethics rules. The justices make financial disclosures, but these are somewhat ambiguous. There is likely to be increasing pressure for a more complete disclosure of non-financial relationships and more formal ethics rules. ●

The 2022-2023 Term of the Supreme Court illustrates how important the Court has become to health-related matters, including decisions regarding the selection and training of new professionals, the daily practice of medicine, and the future availability of new drugs. The importance of several cases is reinforced by the fact that major medical organizations filed amicus curiae (“friend of the court”) briefs in those cases.

Amicus briefs are filed by individuals or organizations with something significant to say about a case to the court—most often to present a point of view, make an argument, or provide information that the parties to the case may not have communicated. Amicus briefs are burdensome in terms of the time, energy, and cost of preparing and filing. Thus, they are not undertaken lightly. Medical organizations submitted amicus briefs in the first 3 cases we consider.

Admissions, race, and diversity

The case: Students for Fair Admissions v President and Fellows of Harvard College

The American College of Obstetricians and Gynecologists (ACOG) joined an amici curiae brief in Students for Fair Admissions v President and Fellows of Harvard College (and the University of North Carolina [UNC]).¹ This case challenged the use of racial preferences in college admissions. The Association of American Medical Colleges (AAMC) was the lead organization; nearly 40 other health-related organizations joined the brief.

The legal claim. Those filing the suits asserted that racial preferences by public colleges violate the 14th Amendment’s Equal Protection Clause (“no state shall deny to any person … the equal protection of the law”). That is, if a state university gives racial preferences in selective admissions, it denies some other applicant the equal protection of the law. As for private schools (in this case, Harvard), Title VI of the Civil Rights Act of 1964 has the same standards as the Equal Protection Clause. Thus, the Court consolidated the cases and used the same legal standard in considering public and private colleges (with “colleges” including professional and graduate programs as well as undergraduate institutions).

Background. For nearly 50 years, the Supreme Court has allowed limited racial preferences in college admissions. Those preferences could only operate as a plus, however, and not a negative for applicants and be narrowly tailored. The measure was instituted temporarily; in a 2003 case, the Court said, “We expect that 25 years from now, the use of racial preferences will no longer be necessary.”²

Decision. In a 6-3 decision, the Court held (in the UNC case) that racial preferences generally violate the Constitution, and by a 6-2 decision (in the Harvard case) these preferences violate the Civil Rights Act of 1964. (Justice Jackson was recused in the Harvard case because of a conflict.) The opinion covered 237 pages in the US Reports, so any summary is incomplete.

The majority concluded, “The Harvard and UNC admissions programs cannot be reconciled with the guarantees of the Equal Protection Clause. Both programs lack sufficiently focused and measurable objectives warranting the use of race, unavoidably employ race in a negative manner, involve racial stereotyping, and lack meaningful end points. We have never permitted admissions programs to work in that way, and we will not do so today.”³

There were 3 concurring opinions and 2 dissents in the case. The concurrences reviewed the history of the Equal Protection Clause and the Civil Rights Act, the damage racial preferences can do, and the explicit limits the Court said there must be on racial preferences in higher education. The dissents had a different view of the legal history of the 14th Amendment. They said the majority was turning a blind eye to segregation in society and the race-based gap in America.

As a practical matter, this case means that colleges, including professional schools, cannot use racial preferences. The Court said that universities may consider essays and the like in which applicants describe how their own experiences as an individual (including race) have affected their own lives. However, the Court cautioned that “universities may not simply establish through application essays or other means the regime we hold unlawful today.”³

Continue to: The amici brief...

ACOG joined 40 other health-related organizations in filing an amici brief (multiple “friends”) in Students for Fair Admission. The AAMC led the brief, with the others signing as amici.⁴ The brief made 3 essential points: diversity in medical education “markedly improves health outcomes,” and a loss of diversity “threaten[s] patients’ health; medical schools engage in an intense “holistic” review of applicants for admission; and medical schools must consider applicants’ “full background” (including race) to achieve their educational and professional goals.⁴

A powerful part of the brief described the medical school admissions process, particularly the very “holistic” review that is not entirely dependent on admissions scores. The brief effectively weaves the consideration of race into this process, mentioning race (on page 22) only after discussing many other admissions factors.

Child custody decisions related to the Indian Child Welfare Act

The case: Haaland v Brackeen

The American Medical Association (AMA) and the American Academy of Pediatrics filed a brief in Haaland v Brackeen⁵ involving the constitutionality of the 1978 Indian Child Welfare Act (ICWA). The statute followed a terrible history of Indian children being removed from their families inappropriately, as detailed in a concurring opinion by Justice Gorsuch.⁵ The two purposes of the act were to promote raising Native American children in their culture and stem the downward trend in tribal membership.

The legal claim. The Court consolidated several cases. Essentially, a 10-month-old child (A.L.M.) was placed in foster care with the Brackeens in Texas. After more than 1 year, the Brackeens sought adoption; the biological father, mother, and grandparents all supported it. The Navajo and Cherokee Nations objected and informed the Texas court that they had found alternative placement with (nonrelative) tribal members in New Mexico. The “court-appointed guardian and a psychological expert … described the strong emotional bond between A.L.M. and his foster parents.” The court denied the adoption petition based on ICWA’s preference for tribe custody, and the Brackeens filed a lawsuit. The Court noted that the act “requires a state court to place an Indian child with an Indian caretaker, if one is available, even if the child is already living with a non-Indian family and the state court thinks it in the child’s best interest to stay there.” That is, the ICWA may require a placement that the court believes is not in the child’s best interest.⁵

Decision. The constitutional claim in the case was that Congress lacked the authority to impose these substantial rules on states in making child custody decisions. The Supreme Court, in a 7-2 decision, upheld the constitutionality of the ICWA. The Court found the authority primarily in Article 1, Section 8, giving Congress the power to “regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes.” In addition, the Court suggested that the treaty power and “principles inherent in the Constitution’s structure may empower Congress to act in the field of Indian affairs.”

The amici brief

The joint amici brief of the American Academy of Pediatrics (AAP) and the AMA argued that tribes are “extended families” of Native American children.⁶ It noted the destructive history of removing Native American children from their families and suggested that kinship care improves children’s health. To its credit, the brief also honestly noted the serious mental health and suicide rates in some tribes, which suggest issues that might arise in child custody and adoption cases.

The Court did not, in this case, take up another constitutional issue that the parties raised—whether the strong preference for Native American over non ̶ Native American custody violates the Equal Protection Clause of the 14th Amendment. The Court said the parties to this case did not have standing to raise the issue. Justice Kavanaugh, concurring, said it was a “serious” issue and invited it to be raised in another case.⁵

False Claims Act cases

The case: Costs for SuperValu prescriptions

For physicians and health care organizations, False Claims Act (FCA) cases are an ongoing burden and, some would say, threat. (There are also state FCAs, but here we are discussing the federal act.) The federal government has recovered more than $70 billion since 1986, most from health care entities.⁷The Justice Department identifies “health care fraud” as the largest area of FCA recovery and provides annual details on frauds resulting in liability.⁸

The legal claim. One FCA case this Term involved billings SuperValu made for outpatient prescriptions in Medicare-Medicaid programs. As its “usual and customary” costs, it essentially reported a list price that did not include the substantial discounts it commonly gave.⁹ The charge was that it “knowingly” made a false claim regarding the price of prescriptions. The question was what state of mind, or “scienter,” is required for “knowingly.” Should it be objective (what a reasonable person would know) or subjective (the defendant’s “knowledge and subjective beliefs”)?

Background. Subjective knowledge (what the defendant actually knows) may seem impossible to prove—the defendant could just say, “I did not know I was doing wrong.” Over time the law has developed several ways of demonstrating “knowing.” Justice Thomas, writing for a unanimous Court, held that whistleblowers or the government might prove “knowing” in 3 ways:

1. defendants “actually knew that their reported prices were not their ‘usual and customary’ prices when they reported them”

2. were aware of a substantial risk that their higher, retail prices were not their “usual and customary” prices and intentionally avoided learning whether their reports were accurate

3. were aware of such a substantial and unjustifiable risk but submitted the claims anyway.⁹

Of course, records of the company, information from the whistleblower, and circumstantial evidence may be used to prove any of these; it does not require the company’s admission.

The Court said that if the government or whistleblowers make a showing of any of these 3 things, it is enough.

Decision. The case was returned to the lower court to apply these rules.

The amici brief

The American Hospital Association and America’s Health Insurance Plans filed an amici brief.¹⁰ It reminded the Court that many reimbursement regulations are unclear. Therefore, it is inappropriate to impose FCA liability for guessing incorrectly what the regulations mean. Having to check on every possible ambiguity was unworkable. The Court declined, however, the suggestion that defendants should be able to use any one of many “objectively” reasonable interpretations of regulations.

Continue to: The case: Polansky v Executive Health Resources...

The case: Polansky v Executive Health Resources

Health care providers who dislike the FCA may find solace this Term in this second FCA case.¹¹

The legal claim. Polansky, a physician employed by a medical billing company, became an “intervenor” in a suit claiming the company assisted hospitals in false billing (inpatient claims for outpatient services). The government sought to dismiss the case, but Polansky refused.

Decision. The case eventually reached the Supreme Court, which held that the government may enter an FCA case at any time and move to dismiss the case even over the objection of a whistleblower. The government does not seek to enter a case in order to file dismissal motions often. When it does so, whistleblowers are protected by the fact that the dismissal motion requires a hearing before the federal court.

An important part of this case has escaped much attention. Justices Thomas, Kavanaugh, and Barrett invited litigation to determine if allowing private whistleblowers to represent the government’s interest is consistent with Article II of the Constitution.¹¹ The invitation will likely be accepted. We expect to see cases challenging the place of “intervenors” pursuing claims when the government has declined to take up the case. The private intervenor is a crucial provision of the current FCA, and if such a challenge were successful, it could substantially reduce FCA cases.

Criminal false claims

Another case this Term is cautionary about the consequences of health care misbilling. It resulted in a criminal charge. More importantly, in addition to a basic fraud charge, the government added a charge of aggravated identity theft,¹² which carries a mandatory 2-year prison sentence.

Dubin overbilled Medicaid for psychological testing by saying the testing was done by a licensed psychologist rather than an assistant. The government claimed the “identity theft” was using the patient’s (actual) Medicaid number in submitting the bill.¹² The Court unanimously held the overbilling was not aggravated identity theft as defined in federal law. Dubin could be convicted of fraudulent billing but not aggravated identity theft, thereby avoiding the mandatory prison term.

Patents of “genus” targets

The case: Amgen v Sanofi

This case, which corrected an error of the patent office, received little attention but was likely a turning point in the next generation of pharmaceuticals.¹³

Background. “Genus” patents allow a single pharmaceutical company to patent every antibody that binds to a specific amino acid on a naturally occurring protein. In this case, the patent office had granted a “genus” patent on “all antibodies” that bind to the naturally occurring protein PCSK9 and block it from hindering the body’s mechanism for removing low-density lipoprotein (LDL) cholesterol from the bloodstream,¹³ helping to reduce LDL cholesterol levels. These patents could involve millions of antibodies—and Amgen was claiming a patent on all of them. Amgen and Sanofi marketed their products, each with their own unique amino acid sequence.¹³ Amgen sued Sanofi for violating its patent rights.

Decision. The Court unanimously held that Amgen did not have a valid patent on all antibodies targeting PCSK9, only those that it had explicitly described in its patent application—a ruling based on a 150-year-old technical requirement for receiving a patent. An applicant for a patent must include “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the same.”¹³ Amgen’s patent provided the description for only a few of the antibodies, but from the description in its application others could not “make and use” all of the antibodies targeting PCSK9.

While the decision was vital for future pharmaceuticals, the patent principle on which it was based has an interesting history. The Court noted that it affected the telegraph (Morse lost part of his patent), electric lights (Edison won his case against other inventors), and the glue for wood veneering (Perkins Glue Company lost).¹³

Continue to: Other notable decisions...

Student loans

The Court struck down the Biden Administration’s student loan forgiveness program, which would have cost approximately $430 billion.¹⁴ The central issue was whether the administration had the authority for such massive loan forgiveness; that is, whether Congress had authorized the broad loan forgiveness. The administration claimed authority from the post ̶ 9/11 HEROES Act, which allows the Secretary of Education to “waive or modify” loan provisions during national emergencies. The temporary hold on loan payments during COVID was based on this provision. However, in a 6-3 decision, the Court held that the act did not allow the secretary to cancel $430 billion in loans. “The Act allows the Secretary to ‘waive or modify’ existing statutory or regulatory provisions applicable to financial assistance programs under the Education Act, not to rewrite that statute from the ground up.”¹⁴

Free speech and the wedding web designer

303 Creative v Elenis involved a creative website designer who did not want to be required to create a website for a gay wedding.¹⁵ The designer had strong beliefs against same-sex marriages, but Colorado sought to force her to do so under the state “public accommodations” law. In a 6-3 decision, the Court held that the designer had a “free speech” right. That is, the state could not compel her to undertake speech expressing things she did not believe. This was because the website design was an expressive, creative activity and therefore was “speech” under the First Amendment.

Wetlands and the Clean Water Act

The essential issue in Sackett v Environmental Protection Agency (EPA) was the definitions of waters of the United States and related wetlands. The broad definition the EPA used meant it had jurisdiction to regulate an extraordinary amount of territory. It had, for example, prevented the Sacketts from building a modest house claiming it was part of the “waters of the United States because they were near a ditch that fed into a creek, which fed into Priest Lake, a navigable, intrastate lake.” The Court held that the EPA exceeded its statutory authority to define “wetlands.”¹⁶

The Court held that under the Clean Water Act, for the EPA to establish jurisdiction over adjacent wetlands, it must demonstrate that¹⁶:

1. “the adjacent body of water constitutes waters of the United States (ie, a relatively permanent body of water connected to traditional interstate navigable waters)…”

2. “…the wetland has a continuous surface connection with that water, making it difficult to determine where the water ends, and the wetland begins.”

Under this definition, the Sacketts could build their house. This was a statutory interpretation case. Therefore, Congress can expand or otherwise change the EPA’s authority under the Clean Water Act and other legislation.

Conclusions: A new justice, “shadow docket,” and ethics rules

SCOTUS’ newest member. When the Marshall called the Court into session on October 3, 2022, it had a new member, Justice Ketanji Brown Jackson. She was sworn in on June 30, 2022, when her predecessor (Justice Breyer) officially retired. She had been a law clerk for Justice Breyer in 1999, as well as a district court judge and court of appeals judge. Those who count such things described her as the “chattiest justice.”¹⁷ She spoke more than any other justice—by one count, a total of 75,632 words (an average of 1,300 words in each of the 58 arguments).

A more balanced Court? Most commentators view the Court as more balanced or less conservative than the previous Term. For example, Justice Sotomayor was in the majority 40% last Term but 65% this Term. Justice Thomas was in the majority 75% last Term but 55% this Term. Put another way, this Term in the divided cases, the liberal justices were in the majority 64% of the time, compared with the conservative justices 73%.¹⁸ Of course, these differences may reflect a different set of cases rather than a change in the direction of the Court. There were 11 (or 12, depending on how 1 case is counted) 6-3 cases, but only 5 were considered ideological. That suggests that, in many cases, the coalitions were somewhat fluid.

“Shadow docket” controversy continues.¹⁹ Shadow docket refers to orders the Court makes that do not follow oral arguments and often do not have written opinions. The orders are all publicly available. This Term a close examination of the approximately 30 shadow docket opinions shows that the overwhelming majority were dissents or explanations about denials of certiorari. The Court ordered only a few stays or injunctions via the shadow docket. One shadow docket stay (that prevented a lower court order from going into effect) is particularly noteworthy. A federal judge had ordered the suspension of the distribution of mifepristone while courts considered claims that the US Food and Drug Administration (FDA) had improperly approved the drug. In a shadow docket order, the Court issued the stay to allow mifepristone to be sold while the case challenging its approval was heard.²⁰ The only opinion was a dissent from Justice Alito. But it also demonstrates the importance of the shadow docket. Without this intervention, in at least part of the country, the distribution of mifepristone would have been interrupted pending the outcome of the FDA cases.

In August, the Court delayed a settlement in the Purdue Pharma liability bankruptcy case.²¹ It also stayed an injunction of a lower court, thereby permitting federal “ghost guns” regulations to go into effect at least temporarily.²²

More ethics rules to come? Another area in which the Court faced criticism was formal ethics rules. The justices make financial disclosures, but these are somewhat ambiguous. There is likely to be increasing pressure for a more complete disclosure of non-financial relationships and more formal ethics rules. ●

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

Hepatitis B is one of the more common infections encountered in the daily practice of obstetrics. It is responsible for 40% to 45% of all cases of viral hepatitis.^1,2 Hepatitis B may cause serious complications in both the infected mother and neonate.

In this article, I review the virology, epidemiology, and clinical presentation of hepatitis B and then discuss the key diagnostic tests and, subsequently, the clinical management for both the mother and neonate. I focus particular attention on relatively new information about the value of specific antiviral medication to enhance the protective effect of conventional neonatal immunoprophylaxis.

To set the framework for the discussion, consider the following 2 case studies.

CASE 1 Undetectable level of hepatitis B surface antibody in a pregnant woman

A 25-year-old healthy primigravid woman at 10 weeks’ gestation had a series of laboratory studies that included a test for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (HBsAb). The test for the surface antigen was negative. The test for the surface antibody was below the level of detection. Upon questioning, the patient indicates that she received the 3-dose hepatitis B vaccine when she was age 13 years.

• What treatment, if any, is indicated for this patient?
• What treatment is indicated for her neonate?

CASE 2 Pregnant woman tests positive for hepatitis B surface antigen

A 31-year-old woman (G3P2002) at 12 weeks’ gestation tested positive for HBsAg. She indicates that she never has had symptomatic hepatitis and that she considers herself to be in excellent health.

• What additional laboratory tests are indicated at this time?
• What additional laboratory test should be performed at the end of the second trimester?
• What treatment is indicated for the mother and neonate?

Virology and epidemiology of hepatitis B

Hepatitis B is caused by a double-stranded, enveloped DNA virus. The virus has 10 genotypes and 24 subtypes.³ The organism contains 3 major antigens. Detection of these antigens and their corresponding antibodies is an essential step in the diagnostic workup of patients who may be infected.

The surface antigen (HBsAg) confers infectivity and is the most valuable serologic marker of infection. The e antigen (HBeAg) is not present in every infected patient. It is secreted from infected cells, but it is not incorporated into the viral particle. When present, it denotes a high level of viral replication and exceptionally high infectivity. The core antigen (HBcAg) is a valuable serologic marker for distinguishing between acute and chronic infection.^1-3

Hepatitis B is highly infectious, much more so than HIV or hepatitis C. The virus has an incubation period of 4 weeks to 6 months, and the duration of incubation is inversely related to the size of the viral inoculum. The virus is transmitted in 3 principal ways: sexual contact with contaminated genital tract secretions, contact with infected blood from sharing contaminated drug-injecting paraphernalia or from receiving a blood transfusion (extremely rare today), and transmission from an infected mother to her neonate. Perinatal transmission occurs primarily during the delivery process as opposed to transplacental infection. Transmission also can occur by more casual household contact, such as sharing eating utensils, kissing, and handling an infant.^1,2,4,5

Worldwide, more than 400 million people have chronic hepatitis B infection. In the United States, approximately 1.25 to 1.5 million individuals are infected. Several groups are at particularly high risk for being infected, including^1-3:

• Asians
• Alaska Natives
• sub-Saharan Africans
• sex workers
• intravenous drug users
• individuals with hemophilia
• international travelers
• staff and residents of long-term care facilities
• tattoo recipients.

Continue to: Clinical presentation...

Approximately 90% of adult patients who contract hepatitis B, either symptomatically or asymptomatically, will develop protective levels of antibody and clear the virus from their system. They will then have lifelong immunity to reinfection. Approximately 10% of patients will fail to develop protective levels of antibody and will become chronically infected, posing a risk to their household members, sexual contacts, and their fetus if they become pregnant. Persistence of the surface antigen in the patient’s serum for more than 6 months denotes chronic infection. A very small number of individuals—less than 1%—will develop acute liver failure and experience a fatal outcome.^1-3,5

In the United States, the prevalence of acute hepatitis B in pregnancy is 1 to 2 per 1,000. Clinical manifestations typically include anorexia, nausea, low-grade fever, right upper quadrant pain and tenderness, passage of clay-colored stools, and jaundice.

The prevalence of chronic infection in pregnancy is significantly higher, approximately 5 to 15 per 1,000. Over the long term, patients with chronic infection are at risk for progressive liver injury, including cirrhosis and even hepatocellular carcinoma. These serious sequelae are particularly likely to occur when the patient is co-infected with hepatitis C, D, or both. The overall risk of progression to chronic cirrhosis is approximately 15% to 30%. In patients who progress to cirrhosis, the annual incidence of hepatocellular carcinoma is 10%.^1-3

Diagnosis of hepatitis B infection

Patients with acute hepatitis B will test positive for HBsAg and immunoglobulin M (IgM) antibody to the core antigen. Some patients will also test positive for HBeAg. Assessment of the patient’s serum by polymerase chain reaction (PCR) allows quantitation of the viral load, which often is expressed as viral copies per milliliter. Alternatively, the quantitative hepatitis B DNA concentration may be expressed as international units per milliliter (IU/mL). The World Health Organization recommends this latter quantitative method. Multiplying the DNA in IU/mL by 5.6 provides the conversion to viral copies per milliliter.

Patients with chronic hepatitis B infection will test positive for the HBsAg and for immunoglobulin G (IgG) antibody to the core antigen. They may also have a positive test for the HBeAg, and PCR may be used to quantify the viral load.^1-3

Managing hepatitis B infection in pregnancy

General supportive measures. All pregnant patients should be tested for the HBsAg and HBsAb at the time of the first prenatal appointment. The tests should be repeated at the beginning of the third trimester in high-risk patients. Seropositive patients should have a hepatitis B genotype, a test for the e antigen, and tests for other sexually transmissible infections (gonorrhea, chlamydia, syphilis, HIV) and for hepatitis C and D. Liver function tests should be performed to assess for elevations in the alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. Patients with elevated transaminase enzymes should have a coagulation profile to be certain they are not at risk for a coagulopathy.

At the end of the second trimester, patients should have a PCR assessment to determine the viral load. This assessment will be important for deciding if specific antiviral therapy is indicated during the third trimester to enhance the effects of neonatal immunoprophylaxis (see below). Of note, patients who are positive for the e antigen may have a very high viral load and yet have normal or near-normal transaminase levels. This seemingly paradoxical finding reflects the non-cytopathic nature of hepatitis B.

The patient should optimize her nutrition and sleep. She should avoid, or at least minimize, medications such as acetaminophen that could cause further liver injury. Without question, she should refrain from consuming even small amounts of alcohol. She should be tested for immunity to hepatitis A; if found to be susceptible, she should be vaccinated with the hepatitis A vaccine. This agent is an inactivated vaccine and is safe for administration at any time in pregnancy.^1,2,5

Household contacts. In addition to the measures outlined above, the patient’s household contacts, particularly her sexual partner(s), should be tested for immunity to hepatitis B. If they do not have immunity by virtue of natural infection or previous vaccination, they should receive the hepatitis B vaccine series. It is also prudent to provide the sexual partner(s) with an initial dose of hepatitis B immune globulin (HBIG) to provide a temporary level of passive immunity.

Postdelivery care. After delivery, the patient should be referred to an infectious disease specialist or hepatologist for consideration of long-term treatment with antiviral agents, such as interferon alfa, pegylated interferon alfa, lamivudine, adefovir, entecavir, telbivudine, or tenofovir.⁶ The principal candidates for treatment are those who have cirrhosis and detectable levels of hepatitis B DNA. The ultimate goal of treatment is to reduce the serum hepatitis B DNA concentration to an undetectable level. Once the surface antigenemia is cleared, treatment can be stopped. A cure is defined when the absence of hepa-titis B DNA in the serum is sustained.

Neonatal immunoprophylaxis

The Centers for Disease Control and Prevention recommends universal hepatitis B vaccination for all newborns. The first dose of the vaccine should be administered prior to hospital discharge. The second and third doses should be administered 1 and 6 months later.^1,2,5 There are few, if any, medical contraindications to neonatal vaccination. For the vast majority of infants, the immunity induced by vaccination is lifelong. For a small number, immunity may wane over time. Thus, reassessment of the HBsAb concentration is indicated in selected situations, for example, acute high-risk exposure to an infected person, development of an immunosuppressive disorder, or pregnancy.

Infants delivered to mothers who are infected with hepatitis B also should receive HBIG in addition to the vaccine. HBIG provides passive immunization to counteract the high viral inoculum encountered by the neonate during delivery. This preparation should be administered within 12 hours of birth.^1,2,5

In the absence of immunoprophylaxis, a neonate delivered to a mother who is seropositive for HBsAg has a 20% to 30% probability of becoming chronically infected. If the mother is positive for both the surface antigen and the e antigen, the risk of chronic infection increases to almost 90%. Approximately 90% of infants who are infected in the perinatal period subsequently develop chronic infection. However, with appropriate immunoprophylaxis in the neonatal period, the risk of perinatal transmission is reduced by 85% to 95%.^1,2,5

Cesarean delivery offers no additional protection beyond that provided by immunoprophylaxis. Moreover, because immunoprophylaxis is so effective, infected mothers may breastfeed without fear of transmitting infection to their infant. Shi and colleagues published a systematic review and meta-analysis of the risk associated with breastfeeding in hepatitis B–infected mothers.⁷ Infants who breastfed did not have a higher rate of mother-to-child transmission, regardless of whether they received combined immunoprophylaxis or only hepatitis B vaccine and regardless of whether the HBsAg was detected in the mother’s breast milk. The only precaution is the need to avoid breastfeeding if the nipples are cracked or bleeding or if exudative lesions are present on the skin near the nipple.

Continue to: Maternal antiviral therapy...

Maternal antiviral therapy

As noted above, neonatal immunoprophylaxis is 85% to 95% effective in preventing perinatal transmission of hepatitis B infection. Failures of prophylaxis are primarily due to antenatal transmission in patients who have exceptionally high viral loads. Several cutoffs have been used to define “high viral load,” including greater than 1 to 2 million copies/mL and a hepatitis B DNA concentration greater than 200,000 IU/mL. There is not a perfect consensus on the appropriate cutoff.

In essence, 2 different approaches have been tried to further reduce the risk of perinatal transmission in these high-risk patients.⁸ The first major initiative was administration of HBIG (100–200 IU) intramuscularly to the patient at 28, 32, and 36 weeks. The outcomes with this approach have been inconsistent, due, at least in part, to varying doses of the agent and various cutoffs for defining “high risk,” and this intervention is no longer recommended.^1,2

The second major approach is administration of specific antiviral drugs to the mother during the third trimester. The first agent widely used in clinical practice was lamivudine. In a systematic review and meta-analysis, Shi and colleagues reported that, in infants whose mothers received lamivudine plus conventional neonatal immunuprophylaxis, the risk of perinatal infection was significantly reduced compared with infants who received only immunoprophylaxis.⁹

Although lamivudine is effective, there is considerable concern about the rapid development of viral resistance to the medication. Accordingly, most attention today is focused on the use of tenofovir to prevent perinatal transmission.

In an important early investigation, Pan and colleagues reported the results of a randomized controlled trial conducted in China in women with a hepatitis B DNA concentration greater than 200,000 IU/mL (viral load > 1,120,000 copies/mL).¹⁰ Patients also were positive for the e antigen. Ninety-two patients were assigned to tenofovir disoproxil fumarate (TDF), 300 mg daily, from 30 to 32 weeks until postpartum week 4 plus conventional neonatal immunoprophylaxis, and 100 patients were assigned to immunoprophylaxis alone. In the intention-to-treat analysis, 18 neonates in the control group were infected compared with 5 in the treatment group (P = .007). In the per-protocol analysis, 7 neonates in the control group were infected compared with 0 in the treatment group (P = .01). No clinically significant adverse maternal or neonatal effects occurred in the treatment group.

Subsequently, Jourdain and colleagues reported a multicenter, double-blind trial conducted in 17 public health hospitals in Thailand.¹¹ TDF (300 mg daily) or placebo was administered from 28 weeks’ gestation until 8 weeks postpartum. Patients in both arms of the study were positive for the e antigen; 87% to 90% of the patients had a serum hepatitis B DNA concentration greater than 200,000 IU/mL.Following birth, infants in both groups received an injection of HBIG and then 4 doses of hepatitis B vaccine (0, 1, 2, 4, and 6 months). Both the HBIG and hepatitis B vaccine were administered very promptly after birth (median time, 1.2–1.3 hours).

At 6 months after delivery, 2% of infants in the placebo group (3 of 147) were HBsAg-positive compared with none of the infants in the treatment arm.¹¹ No serious adverse effects occurred in infants in the TDF group. This difference in outcome was not statistically significant, but the overall rate of infection was so low in both groups that the sample size was definitely too small to exclude a type 2 statistical error. Moreover, the fourth dose of neonatal hepatitis B vaccine may have contributed to the surprisingly low rate of perinatal transmission. Of note, the serum hepatitis B DNA concentration in the TDF group declined from a mean of 7.6 log₁₀ IU/mL to a mean of 4.0 log₁₀ IU/mL at delivery.

In the most recent report, Wang and colleagues reported the results of a prospective cohort study in patients with a hepatitis B virus DNA concentration greater than 200,000 IU/mL.¹² Beginning at either 24 or 32 weeks, patients were assigned to treatment with either oral TDF (300 mg daily) or oral telbivudine (LdT, 600 mg daily). The medications were continued for 4 weeks postpartum. In the intention-to-treat analysis, the rates of perinatal transmission were comparable, 1.5% versus 1.8%. In the per-protocol analysis, no infants in either group were infected. However, the predelivery decline in hepatitis Bvirus DNA concentration was greater in the TDF group. The ALT elevation rate was also lower in the TDF group. Patients in the LdT group had fewer problems with anorexia but more instances of arthralgia compared with those in the TDF group.

Based primarily on these 3 investigations, I recommend that all infected patients with a hepatitis B DNA concentration greater than 200,000 IU/mL or a viral load greater than 1,120,000 million copies/mL receive oral TDF, 300 mg daily, from 28 weeks until at least 4 to 8 weeks postpartum. The decision about duration of postpartum treatment should be made in consultation with an infectious disease specialist or hepatologist.

Case studies resolved

CASE 1 No protective level of surface antibody

This patient should promptly receive a single booster dose of the hepatitis B vaccine. The vaccine is an inactivated agent and is safe for administration at any time in pregnancy. Following delivery and prior to discharge from the hospital, the neonate should receive the first dose of the hepatitis B vaccine. A second dose should be administered 1 month later, and a third dose should be administered 6 months after the first dose.

CASE 2 Mother is seropositive for HBsAg

This patient should be tested immediately for HIV infection and hepatitis C and D. The hepatitis B viral genotype should be determined. She also should have a panel of liver function tests. If any of these tests are abnormal, a coagulation profile should be obtained to be certain that the patient is not at risk for a coagulopathy. Near the end of the second trimester, a hepatitis B viral load should be obtained. If the viral DNA concentration is greater than 200,000 IU/mLor a viral load greater than 1,120,000 million copies/mL, the patient should be treated with tenofovir, 300 mg daily, from week 28 until at least 4 weeks after delivery. The neonate should receive an injection of HBIG within 12 hours of birth and the first dose of the hepatitis B vaccine prior to discharge from the hospital. Two additional doses of the vaccine should be administered 1 and 6 months later. ●

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

Hepatitis B is one of the more common infections encountered in the daily practice of obstetrics. It is responsible for 40% to 45% of all cases of viral hepatitis.^1,2 Hepatitis B may cause serious complications in both the infected mother and neonate.

In this article, I review the virology, epidemiology, and clinical presentation of hepatitis B and then discuss the key diagnostic tests and, subsequently, the clinical management for both the mother and neonate. I focus particular attention on relatively new information about the value of specific antiviral medication to enhance the protective effect of conventional neonatal immunoprophylaxis.

To set the framework for the discussion, consider the following 2 case studies.

CASE 1 Undetectable level of hepatitis B surface antibody in a pregnant woman

A 25-year-old healthy primigravid woman at 10 weeks’ gestation had a series of laboratory studies that included a test for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (HBsAb). The test for the surface antigen was negative. The test for the surface antibody was below the level of detection. Upon questioning, the patient indicates that she received the 3-dose hepatitis B vaccine when she was age 13 years.

• What treatment, if any, is indicated for this patient?
• What treatment is indicated for her neonate?

CASE 2 Pregnant woman tests positive for hepatitis B surface antigen

A 31-year-old woman (G3P2002) at 12 weeks’ gestation tested positive for HBsAg. She indicates that she never has had symptomatic hepatitis and that she considers herself to be in excellent health.

• What additional laboratory tests are indicated at this time?
• What additional laboratory test should be performed at the end of the second trimester?
• What treatment is indicated for the mother and neonate?

Virology and epidemiology of hepatitis B

Hepatitis B is caused by a double-stranded, enveloped DNA virus. The virus has 10 genotypes and 24 subtypes.³ The organism contains 3 major antigens. Detection of these antigens and their corresponding antibodies is an essential step in the diagnostic workup of patients who may be infected.

The surface antigen (HBsAg) confers infectivity and is the most valuable serologic marker of infection. The e antigen (HBeAg) is not present in every infected patient. It is secreted from infected cells, but it is not incorporated into the viral particle. When present, it denotes a high level of viral replication and exceptionally high infectivity. The core antigen (HBcAg) is a valuable serologic marker for distinguishing between acute and chronic infection.^1-3

Hepatitis B is highly infectious, much more so than HIV or hepatitis C. The virus has an incubation period of 4 weeks to 6 months, and the duration of incubation is inversely related to the size of the viral inoculum. The virus is transmitted in 3 principal ways: sexual contact with contaminated genital tract secretions, contact with infected blood from sharing contaminated drug-injecting paraphernalia or from receiving a blood transfusion (extremely rare today), and transmission from an infected mother to her neonate. Perinatal transmission occurs primarily during the delivery process as opposed to transplacental infection. Transmission also can occur by more casual household contact, such as sharing eating utensils, kissing, and handling an infant.^1,2,4,5

Worldwide, more than 400 million people have chronic hepatitis B infection. In the United States, approximately 1.25 to 1.5 million individuals are infected. Several groups are at particularly high risk for being infected, including^1-3:

• Asians
• Alaska Natives
• sub-Saharan Africans
• sex workers
• intravenous drug users
• individuals with hemophilia
• international travelers
• staff and residents of long-term care facilities
• tattoo recipients.

Continue to: Clinical presentation...

Approximately 90% of adult patients who contract hepatitis B, either symptomatically or asymptomatically, will develop protective levels of antibody and clear the virus from their system. They will then have lifelong immunity to reinfection. Approximately 10% of patients will fail to develop protective levels of antibody and will become chronically infected, posing a risk to their household members, sexual contacts, and their fetus if they become pregnant. Persistence of the surface antigen in the patient’s serum for more than 6 months denotes chronic infection. A very small number of individuals—less than 1%—will develop acute liver failure and experience a fatal outcome.^1-3,5

In the United States, the prevalence of acute hepatitis B in pregnancy is 1 to 2 per 1,000. Clinical manifestations typically include anorexia, nausea, low-grade fever, right upper quadrant pain and tenderness, passage of clay-colored stools, and jaundice.

The prevalence of chronic infection in pregnancy is significantly higher, approximately 5 to 15 per 1,000. Over the long term, patients with chronic infection are at risk for progressive liver injury, including cirrhosis and even hepatocellular carcinoma. These serious sequelae are particularly likely to occur when the patient is co-infected with hepatitis C, D, or both. The overall risk of progression to chronic cirrhosis is approximately 15% to 30%. In patients who progress to cirrhosis, the annual incidence of hepatocellular carcinoma is 10%.^1-3

Diagnosis of hepatitis B infection

Patients with acute hepatitis B will test positive for HBsAg and immunoglobulin M (IgM) antibody to the core antigen. Some patients will also test positive for HBeAg. Assessment of the patient’s serum by polymerase chain reaction (PCR) allows quantitation of the viral load, which often is expressed as viral copies per milliliter. Alternatively, the quantitative hepatitis B DNA concentration may be expressed as international units per milliliter (IU/mL). The World Health Organization recommends this latter quantitative method. Multiplying the DNA in IU/mL by 5.6 provides the conversion to viral copies per milliliter.

Patients with chronic hepatitis B infection will test positive for the HBsAg and for immunoglobulin G (IgG) antibody to the core antigen. They may also have a positive test for the HBeAg, and PCR may be used to quantify the viral load.^1-3

Managing hepatitis B infection in pregnancy

General supportive measures. All pregnant patients should be tested for the HBsAg and HBsAb at the time of the first prenatal appointment. The tests should be repeated at the beginning of the third trimester in high-risk patients. Seropositive patients should have a hepatitis B genotype, a test for the e antigen, and tests for other sexually transmissible infections (gonorrhea, chlamydia, syphilis, HIV) and for hepatitis C and D. Liver function tests should be performed to assess for elevations in the alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. Patients with elevated transaminase enzymes should have a coagulation profile to be certain they are not at risk for a coagulopathy.

At the end of the second trimester, patients should have a PCR assessment to determine the viral load. This assessment will be important for deciding if specific antiviral therapy is indicated during the third trimester to enhance the effects of neonatal immunoprophylaxis (see below). Of note, patients who are positive for the e antigen may have a very high viral load and yet have normal or near-normal transaminase levels. This seemingly paradoxical finding reflects the non-cytopathic nature of hepatitis B.

The patient should optimize her nutrition and sleep. She should avoid, or at least minimize, medications such as acetaminophen that could cause further liver injury. Without question, she should refrain from consuming even small amounts of alcohol. She should be tested for immunity to hepatitis A; if found to be susceptible, she should be vaccinated with the hepatitis A vaccine. This agent is an inactivated vaccine and is safe for administration at any time in pregnancy.^1,2,5

Household contacts. In addition to the measures outlined above, the patient’s household contacts, particularly her sexual partner(s), should be tested for immunity to hepatitis B. If they do not have immunity by virtue of natural infection or previous vaccination, they should receive the hepatitis B vaccine series. It is also prudent to provide the sexual partner(s) with an initial dose of hepatitis B immune globulin (HBIG) to provide a temporary level of passive immunity.

Postdelivery care. After delivery, the patient should be referred to an infectious disease specialist or hepatologist for consideration of long-term treatment with antiviral agents, such as interferon alfa, pegylated interferon alfa, lamivudine, adefovir, entecavir, telbivudine, or tenofovir.⁶ The principal candidates for treatment are those who have cirrhosis and detectable levels of hepatitis B DNA. The ultimate goal of treatment is to reduce the serum hepatitis B DNA concentration to an undetectable level. Once the surface antigenemia is cleared, treatment can be stopped. A cure is defined when the absence of hepa-titis B DNA in the serum is sustained.

Neonatal immunoprophylaxis

The Centers for Disease Control and Prevention recommends universal hepatitis B vaccination for all newborns. The first dose of the vaccine should be administered prior to hospital discharge. The second and third doses should be administered 1 and 6 months later.^1,2,5 There are few, if any, medical contraindications to neonatal vaccination. For the vast majority of infants, the immunity induced by vaccination is lifelong. For a small number, immunity may wane over time. Thus, reassessment of the HBsAb concentration is indicated in selected situations, for example, acute high-risk exposure to an infected person, development of an immunosuppressive disorder, or pregnancy.

Infants delivered to mothers who are infected with hepatitis B also should receive HBIG in addition to the vaccine. HBIG provides passive immunization to counteract the high viral inoculum encountered by the neonate during delivery. This preparation should be administered within 12 hours of birth.^1,2,5

In the absence of immunoprophylaxis, a neonate delivered to a mother who is seropositive for HBsAg has a 20% to 30% probability of becoming chronically infected. If the mother is positive for both the surface antigen and the e antigen, the risk of chronic infection increases to almost 90%. Approximately 90% of infants who are infected in the perinatal period subsequently develop chronic infection. However, with appropriate immunoprophylaxis in the neonatal period, the risk of perinatal transmission is reduced by 85% to 95%.^1,2,5

Cesarean delivery offers no additional protection beyond that provided by immunoprophylaxis. Moreover, because immunoprophylaxis is so effective, infected mothers may breastfeed without fear of transmitting infection to their infant. Shi and colleagues published a systematic review and meta-analysis of the risk associated with breastfeeding in hepatitis B–infected mothers.⁷ Infants who breastfed did not have a higher rate of mother-to-child transmission, regardless of whether they received combined immunoprophylaxis or only hepatitis B vaccine and regardless of whether the HBsAg was detected in the mother’s breast milk. The only precaution is the need to avoid breastfeeding if the nipples are cracked or bleeding or if exudative lesions are present on the skin near the nipple.

Continue to: Maternal antiviral therapy...

Maternal antiviral therapy

As noted above, neonatal immunoprophylaxis is 85% to 95% effective in preventing perinatal transmission of hepatitis B infection. Failures of prophylaxis are primarily due to antenatal transmission in patients who have exceptionally high viral loads. Several cutoffs have been used to define “high viral load,” including greater than 1 to 2 million copies/mL and a hepatitis B DNA concentration greater than 200,000 IU/mL. There is not a perfect consensus on the appropriate cutoff.

In essence, 2 different approaches have been tried to further reduce the risk of perinatal transmission in these high-risk patients.⁸ The first major initiative was administration of HBIG (100–200 IU) intramuscularly to the patient at 28, 32, and 36 weeks. The outcomes with this approach have been inconsistent, due, at least in part, to varying doses of the agent and various cutoffs for defining “high risk,” and this intervention is no longer recommended.^1,2

The second major approach is administration of specific antiviral drugs to the mother during the third trimester. The first agent widely used in clinical practice was lamivudine. In a systematic review and meta-analysis, Shi and colleagues reported that, in infants whose mothers received lamivudine plus conventional neonatal immunuprophylaxis, the risk of perinatal infection was significantly reduced compared with infants who received only immunoprophylaxis.⁹

Although lamivudine is effective, there is considerable concern about the rapid development of viral resistance to the medication. Accordingly, most attention today is focused on the use of tenofovir to prevent perinatal transmission.

In an important early investigation, Pan and colleagues reported the results of a randomized controlled trial conducted in China in women with a hepatitis B DNA concentration greater than 200,000 IU/mL (viral load > 1,120,000 copies/mL).¹⁰ Patients also were positive for the e antigen. Ninety-two patients were assigned to tenofovir disoproxil fumarate (TDF), 300 mg daily, from 30 to 32 weeks until postpartum week 4 plus conventional neonatal immunoprophylaxis, and 100 patients were assigned to immunoprophylaxis alone. In the intention-to-treat analysis, 18 neonates in the control group were infected compared with 5 in the treatment group (P = .007). In the per-protocol analysis, 7 neonates in the control group were infected compared with 0 in the treatment group (P = .01). No clinically significant adverse maternal or neonatal effects occurred in the treatment group.

Subsequently, Jourdain and colleagues reported a multicenter, double-blind trial conducted in 17 public health hospitals in Thailand.¹¹ TDF (300 mg daily) or placebo was administered from 28 weeks’ gestation until 8 weeks postpartum. Patients in both arms of the study were positive for the e antigen; 87% to 90% of the patients had a serum hepatitis B DNA concentration greater than 200,000 IU/mL.Following birth, infants in both groups received an injection of HBIG and then 4 doses of hepatitis B vaccine (0, 1, 2, 4, and 6 months). Both the HBIG and hepatitis B vaccine were administered very promptly after birth (median time, 1.2–1.3 hours).

At 6 months after delivery, 2% of infants in the placebo group (3 of 147) were HBsAg-positive compared with none of the infants in the treatment arm.¹¹ No serious adverse effects occurred in infants in the TDF group. This difference in outcome was not statistically significant, but the overall rate of infection was so low in both groups that the sample size was definitely too small to exclude a type 2 statistical error. Moreover, the fourth dose of neonatal hepatitis B vaccine may have contributed to the surprisingly low rate of perinatal transmission. Of note, the serum hepatitis B DNA concentration in the TDF group declined from a mean of 7.6 log₁₀ IU/mL to a mean of 4.0 log₁₀ IU/mL at delivery.

In the most recent report, Wang and colleagues reported the results of a prospective cohort study in patients with a hepatitis B virus DNA concentration greater than 200,000 IU/mL.¹² Beginning at either 24 or 32 weeks, patients were assigned to treatment with either oral TDF (300 mg daily) or oral telbivudine (LdT, 600 mg daily). The medications were continued for 4 weeks postpartum. In the intention-to-treat analysis, the rates of perinatal transmission were comparable, 1.5% versus 1.8%. In the per-protocol analysis, no infants in either group were infected. However, the predelivery decline in hepatitis Bvirus DNA concentration was greater in the TDF group. The ALT elevation rate was also lower in the TDF group. Patients in the LdT group had fewer problems with anorexia but more instances of arthralgia compared with those in the TDF group.

Based primarily on these 3 investigations, I recommend that all infected patients with a hepatitis B DNA concentration greater than 200,000 IU/mL or a viral load greater than 1,120,000 million copies/mL receive oral TDF, 300 mg daily, from 28 weeks until at least 4 to 8 weeks postpartum. The decision about duration of postpartum treatment should be made in consultation with an infectious disease specialist or hepatologist.

Case studies resolved

CASE 1 No protective level of surface antibody

This patient should promptly receive a single booster dose of the hepatitis B vaccine. The vaccine is an inactivated agent and is safe for administration at any time in pregnancy. Following delivery and prior to discharge from the hospital, the neonate should receive the first dose of the hepatitis B vaccine. A second dose should be administered 1 month later, and a third dose should be administered 6 months after the first dose.

CASE 2 Mother is seropositive for HBsAg

This patient should be tested immediately for HIV infection and hepatitis C and D. The hepatitis B viral genotype should be determined. She also should have a panel of liver function tests. If any of these tests are abnormal, a coagulation profile should be obtained to be certain that the patient is not at risk for a coagulopathy. Near the end of the second trimester, a hepatitis B viral load should be obtained. If the viral DNA concentration is greater than 200,000 IU/mLor a viral load greater than 1,120,000 million copies/mL, the patient should be treated with tenofovir, 300 mg daily, from week 28 until at least 4 weeks after delivery. The neonate should receive an injection of HBIG within 12 hours of birth and the first dose of the hepatitis B vaccine prior to discharge from the hospital. Two additional doses of the vaccine should be administered 1 and 6 months later. ●

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

Hepatitis B is one of the more common infections encountered in the daily practice of obstetrics. It is responsible for 40% to 45% of all cases of viral hepatitis.^1,2 Hepatitis B may cause serious complications in both the infected mother and neonate.

In this article, I review the virology, epidemiology, and clinical presentation of hepatitis B and then discuss the key diagnostic tests and, subsequently, the clinical management for both the mother and neonate. I focus particular attention on relatively new information about the value of specific antiviral medication to enhance the protective effect of conventional neonatal immunoprophylaxis.

To set the framework for the discussion, consider the following 2 case studies.

CASE 1 Undetectable level of hepatitis B surface antibody in a pregnant woman

A 25-year-old healthy primigravid woman at 10 weeks’ gestation had a series of laboratory studies that included a test for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (HBsAb). The test for the surface antigen was negative. The test for the surface antibody was below the level of detection. Upon questioning, the patient indicates that she received the 3-dose hepatitis B vaccine when she was age 13 years.

• What treatment, if any, is indicated for this patient?
• What treatment is indicated for her neonate?

CASE 2 Pregnant woman tests positive for hepatitis B surface antigen

A 31-year-old woman (G3P2002) at 12 weeks’ gestation tested positive for HBsAg. She indicates that she never has had symptomatic hepatitis and that she considers herself to be in excellent health.

• What additional laboratory tests are indicated at this time?
• What additional laboratory test should be performed at the end of the second trimester?
• What treatment is indicated for the mother and neonate?

Virology and epidemiology of hepatitis B

Hepatitis B is caused by a double-stranded, enveloped DNA virus. The virus has 10 genotypes and 24 subtypes.³ The organism contains 3 major antigens. Detection of these antigens and their corresponding antibodies is an essential step in the diagnostic workup of patients who may be infected.

The surface antigen (HBsAg) confers infectivity and is the most valuable serologic marker of infection. The e antigen (HBeAg) is not present in every infected patient. It is secreted from infected cells, but it is not incorporated into the viral particle. When present, it denotes a high level of viral replication and exceptionally high infectivity. The core antigen (HBcAg) is a valuable serologic marker for distinguishing between acute and chronic infection.^1-3

Hepatitis B is highly infectious, much more so than HIV or hepatitis C. The virus has an incubation period of 4 weeks to 6 months, and the duration of incubation is inversely related to the size of the viral inoculum. The virus is transmitted in 3 principal ways: sexual contact with contaminated genital tract secretions, contact with infected blood from sharing contaminated drug-injecting paraphernalia or from receiving a blood transfusion (extremely rare today), and transmission from an infected mother to her neonate. Perinatal transmission occurs primarily during the delivery process as opposed to transplacental infection. Transmission also can occur by more casual household contact, such as sharing eating utensils, kissing, and handling an infant.^1,2,4,5

Worldwide, more than 400 million people have chronic hepatitis B infection. In the United States, approximately 1.25 to 1.5 million individuals are infected. Several groups are at particularly high risk for being infected, including^1-3:

• Asians
• Alaska Natives
• sub-Saharan Africans
• sex workers
• intravenous drug users
• individuals with hemophilia
• international travelers
• staff and residents of long-term care facilities
• tattoo recipients.

Continue to: Clinical presentation...

Approximately 90% of adult patients who contract hepatitis B, either symptomatically or asymptomatically, will develop protective levels of antibody and clear the virus from their system. They will then have lifelong immunity to reinfection. Approximately 10% of patients will fail to develop protective levels of antibody and will become chronically infected, posing a risk to their household members, sexual contacts, and their fetus if they become pregnant. Persistence of the surface antigen in the patient’s serum for more than 6 months denotes chronic infection. A very small number of individuals—less than 1%—will develop acute liver failure and experience a fatal outcome.^1-3,5

In the United States, the prevalence of acute hepatitis B in pregnancy is 1 to 2 per 1,000. Clinical manifestations typically include anorexia, nausea, low-grade fever, right upper quadrant pain and tenderness, passage of clay-colored stools, and jaundice.

The prevalence of chronic infection in pregnancy is significantly higher, approximately 5 to 15 per 1,000. Over the long term, patients with chronic infection are at risk for progressive liver injury, including cirrhosis and even hepatocellular carcinoma. These serious sequelae are particularly likely to occur when the patient is co-infected with hepatitis C, D, or both. The overall risk of progression to chronic cirrhosis is approximately 15% to 30%. In patients who progress to cirrhosis, the annual incidence of hepatocellular carcinoma is 10%.^1-3

Diagnosis of hepatitis B infection

Patients with acute hepatitis B will test positive for HBsAg and immunoglobulin M (IgM) antibody to the core antigen. Some patients will also test positive for HBeAg. Assessment of the patient’s serum by polymerase chain reaction (PCR) allows quantitation of the viral load, which often is expressed as viral copies per milliliter. Alternatively, the quantitative hepatitis B DNA concentration may be expressed as international units per milliliter (IU/mL). The World Health Organization recommends this latter quantitative method. Multiplying the DNA in IU/mL by 5.6 provides the conversion to viral copies per milliliter.

Patients with chronic hepatitis B infection will test positive for the HBsAg and for immunoglobulin G (IgG) antibody to the core antigen. They may also have a positive test for the HBeAg, and PCR may be used to quantify the viral load.^1-3

Managing hepatitis B infection in pregnancy

General supportive measures. All pregnant patients should be tested for the HBsAg and HBsAb at the time of the first prenatal appointment. The tests should be repeated at the beginning of the third trimester in high-risk patients. Seropositive patients should have a hepatitis B genotype, a test for the e antigen, and tests for other sexually transmissible infections (gonorrhea, chlamydia, syphilis, HIV) and for hepatitis C and D. Liver function tests should be performed to assess for elevations in the alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. Patients with elevated transaminase enzymes should have a coagulation profile to be certain they are not at risk for a coagulopathy.

At the end of the second trimester, patients should have a PCR assessment to determine the viral load. This assessment will be important for deciding if specific antiviral therapy is indicated during the third trimester to enhance the effects of neonatal immunoprophylaxis (see below). Of note, patients who are positive for the e antigen may have a very high viral load and yet have normal or near-normal transaminase levels. This seemingly paradoxical finding reflects the non-cytopathic nature of hepatitis B.

The patient should optimize her nutrition and sleep. She should avoid, or at least minimize, medications such as acetaminophen that could cause further liver injury. Without question, she should refrain from consuming even small amounts of alcohol. She should be tested for immunity to hepatitis A; if found to be susceptible, she should be vaccinated with the hepatitis A vaccine. This agent is an inactivated vaccine and is safe for administration at any time in pregnancy.^1,2,5

Household contacts. In addition to the measures outlined above, the patient’s household contacts, particularly her sexual partner(s), should be tested for immunity to hepatitis B. If they do not have immunity by virtue of natural infection or previous vaccination, they should receive the hepatitis B vaccine series. It is also prudent to provide the sexual partner(s) with an initial dose of hepatitis B immune globulin (HBIG) to provide a temporary level of passive immunity.

Postdelivery care. After delivery, the patient should be referred to an infectious disease specialist or hepatologist for consideration of long-term treatment with antiviral agents, such as interferon alfa, pegylated interferon alfa, lamivudine, adefovir, entecavir, telbivudine, or tenofovir.⁶ The principal candidates for treatment are those who have cirrhosis and detectable levels of hepatitis B DNA. The ultimate goal of treatment is to reduce the serum hepatitis B DNA concentration to an undetectable level. Once the surface antigenemia is cleared, treatment can be stopped. A cure is defined when the absence of hepa-titis B DNA in the serum is sustained.

Neonatal immunoprophylaxis

The Centers for Disease Control and Prevention recommends universal hepatitis B vaccination for all newborns. The first dose of the vaccine should be administered prior to hospital discharge. The second and third doses should be administered 1 and 6 months later.^1,2,5 There are few, if any, medical contraindications to neonatal vaccination. For the vast majority of infants, the immunity induced by vaccination is lifelong. For a small number, immunity may wane over time. Thus, reassessment of the HBsAb concentration is indicated in selected situations, for example, acute high-risk exposure to an infected person, development of an immunosuppressive disorder, or pregnancy.

Infants delivered to mothers who are infected with hepatitis B also should receive HBIG in addition to the vaccine. HBIG provides passive immunization to counteract the high viral inoculum encountered by the neonate during delivery. This preparation should be administered within 12 hours of birth.^1,2,5

In the absence of immunoprophylaxis, a neonate delivered to a mother who is seropositive for HBsAg has a 20% to 30% probability of becoming chronically infected. If the mother is positive for both the surface antigen and the e antigen, the risk of chronic infection increases to almost 90%. Approximately 90% of infants who are infected in the perinatal period subsequently develop chronic infection. However, with appropriate immunoprophylaxis in the neonatal period, the risk of perinatal transmission is reduced by 85% to 95%.^1,2,5

Cesarean delivery offers no additional protection beyond that provided by immunoprophylaxis. Moreover, because immunoprophylaxis is so effective, infected mothers may breastfeed without fear of transmitting infection to their infant. Shi and colleagues published a systematic review and meta-analysis of the risk associated with breastfeeding in hepatitis B–infected mothers.⁷ Infants who breastfed did not have a higher rate of mother-to-child transmission, regardless of whether they received combined immunoprophylaxis or only hepatitis B vaccine and regardless of whether the HBsAg was detected in the mother’s breast milk. The only precaution is the need to avoid breastfeeding if the nipples are cracked or bleeding or if exudative lesions are present on the skin near the nipple.

Continue to: Maternal antiviral therapy...

Maternal antiviral therapy

As noted above, neonatal immunoprophylaxis is 85% to 95% effective in preventing perinatal transmission of hepatitis B infection. Failures of prophylaxis are primarily due to antenatal transmission in patients who have exceptionally high viral loads. Several cutoffs have been used to define “high viral load,” including greater than 1 to 2 million copies/mL and a hepatitis B DNA concentration greater than 200,000 IU/mL. There is not a perfect consensus on the appropriate cutoff.

In essence, 2 different approaches have been tried to further reduce the risk of perinatal transmission in these high-risk patients.⁸ The first major initiative was administration of HBIG (100–200 IU) intramuscularly to the patient at 28, 32, and 36 weeks. The outcomes with this approach have been inconsistent, due, at least in part, to varying doses of the agent and various cutoffs for defining “high risk,” and this intervention is no longer recommended.^1,2

The second major approach is administration of specific antiviral drugs to the mother during the third trimester. The first agent widely used in clinical practice was lamivudine. In a systematic review and meta-analysis, Shi and colleagues reported that, in infants whose mothers received lamivudine plus conventional neonatal immunuprophylaxis, the risk of perinatal infection was significantly reduced compared with infants who received only immunoprophylaxis.⁹

Although lamivudine is effective, there is considerable concern about the rapid development of viral resistance to the medication. Accordingly, most attention today is focused on the use of tenofovir to prevent perinatal transmission.

In an important early investigation, Pan and colleagues reported the results of a randomized controlled trial conducted in China in women with a hepatitis B DNA concentration greater than 200,000 IU/mL (viral load > 1,120,000 copies/mL).¹⁰ Patients also were positive for the e antigen. Ninety-two patients were assigned to tenofovir disoproxil fumarate (TDF), 300 mg daily, from 30 to 32 weeks until postpartum week 4 plus conventional neonatal immunoprophylaxis, and 100 patients were assigned to immunoprophylaxis alone. In the intention-to-treat analysis, 18 neonates in the control group were infected compared with 5 in the treatment group (P = .007). In the per-protocol analysis, 7 neonates in the control group were infected compared with 0 in the treatment group (P = .01). No clinically significant adverse maternal or neonatal effects occurred in the treatment group.

Subsequently, Jourdain and colleagues reported a multicenter, double-blind trial conducted in 17 public health hospitals in Thailand.¹¹ TDF (300 mg daily) or placebo was administered from 28 weeks’ gestation until 8 weeks postpartum. Patients in both arms of the study were positive for the e antigen; 87% to 90% of the patients had a serum hepatitis B DNA concentration greater than 200,000 IU/mL.Following birth, infants in both groups received an injection of HBIG and then 4 doses of hepatitis B vaccine (0, 1, 2, 4, and 6 months). Both the HBIG and hepatitis B vaccine were administered very promptly after birth (median time, 1.2–1.3 hours).

At 6 months after delivery, 2% of infants in the placebo group (3 of 147) were HBsAg-positive compared with none of the infants in the treatment arm.¹¹ No serious adverse effects occurred in infants in the TDF group. This difference in outcome was not statistically significant, but the overall rate of infection was so low in both groups that the sample size was definitely too small to exclude a type 2 statistical error. Moreover, the fourth dose of neonatal hepatitis B vaccine may have contributed to the surprisingly low rate of perinatal transmission. Of note, the serum hepatitis B DNA concentration in the TDF group declined from a mean of 7.6 log₁₀ IU/mL to a mean of 4.0 log₁₀ IU/mL at delivery.

In the most recent report, Wang and colleagues reported the results of a prospective cohort study in patients with a hepatitis B virus DNA concentration greater than 200,000 IU/mL.¹² Beginning at either 24 or 32 weeks, patients were assigned to treatment with either oral TDF (300 mg daily) or oral telbivudine (LdT, 600 mg daily). The medications were continued for 4 weeks postpartum. In the intention-to-treat analysis, the rates of perinatal transmission were comparable, 1.5% versus 1.8%. In the per-protocol analysis, no infants in either group were infected. However, the predelivery decline in hepatitis Bvirus DNA concentration was greater in the TDF group. The ALT elevation rate was also lower in the TDF group. Patients in the LdT group had fewer problems with anorexia but more instances of arthralgia compared with those in the TDF group.

Based primarily on these 3 investigations, I recommend that all infected patients with a hepatitis B DNA concentration greater than 200,000 IU/mL or a viral load greater than 1,120,000 million copies/mL receive oral TDF, 300 mg daily, from 28 weeks until at least 4 to 8 weeks postpartum. The decision about duration of postpartum treatment should be made in consultation with an infectious disease specialist or hepatologist.

Case studies resolved

CASE 1 No protective level of surface antibody

This patient should promptly receive a single booster dose of the hepatitis B vaccine. The vaccine is an inactivated agent and is safe for administration at any time in pregnancy. Following delivery and prior to discharge from the hospital, the neonate should receive the first dose of the hepatitis B vaccine. A second dose should be administered 1 month later, and a third dose should be administered 6 months after the first dose.

CASE 2 Mother is seropositive for HBsAg

This patient should be tested immediately for HIV infection and hepatitis C and D. The hepatitis B viral genotype should be determined. She also should have a panel of liver function tests. If any of these tests are abnormal, a coagulation profile should be obtained to be certain that the patient is not at risk for a coagulopathy. Near the end of the second trimester, a hepatitis B viral load should be obtained. If the viral DNA concentration is greater than 200,000 IU/mLor a viral load greater than 1,120,000 million copies/mL, the patient should be treated with tenofovir, 300 mg daily, from week 28 until at least 4 weeks after delivery. The neonate should receive an injection of HBIG within 12 hours of birth and the first dose of the hepatitis B vaccine prior to discharge from the hospital. Two additional doses of the vaccine should be administered 1 and 6 months later. ●

Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.

Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.

As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.

Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.

It is prime time, these experts and others contend, to build a global network of LFT research and development hubs to strengthen diagnostic capability.

Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
 

Medical community on board

Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.

Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”

Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
 

How LFTs work

LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.

First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
 

Global market outlook

By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.

The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
 

LFTs: Pros and cons

Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.

Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.

However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”

One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.

The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.

Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
 

FDA’s perspective on LFTs

The FDA has no one-size-fits-all standard for evaluating LFTs.

“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”

EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.

And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
 

LFTs: The potential, the challenges

Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”

He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.

“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”

Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”

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

Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.

Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.

As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.

Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.

It is prime time, these experts and others contend, to build a global network of LFT research and development hubs to strengthen diagnostic capability.

Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
 

Medical community on board

Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.

Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”

Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
 

How LFTs work

LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.

First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
 

Global market outlook

By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.

The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
 

LFTs: Pros and cons

Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.

Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.

However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”

One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.

The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.

Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
 

FDA’s perspective on LFTs

The FDA has no one-size-fits-all standard for evaluating LFTs.

“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”

EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.

And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
 

LFTs: The potential, the challenges

Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”

He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.

“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”

Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”

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

Before the pandemic, most of the public probably had a fleeting and limited familiarity with lateral flow tests (LFTs), also known as rapid antigen tests. Perhaps they used, or awaited the results of, a lateral flow home pregnancy test, which detects human chorionic gonadotropin in urine.

Then came COVID-19, and the need for large-scale testing. By late 2022, more than 3 billion tests for SARS-CoV-2 had been done worldwide. Although testing with reverse-transcription polymerase chain reaction (PCR) is the gold standard for diagnosing COVID, LFTs made possible large-scale testing at low cost with rapid results.

As of Sept. 12, the Food and Drug Administration lists 32 rapid antigen tests with emergency use authorizations (EUAs) for home use.

Now, many experts conclude, it’s time to expand the role of LFTs so the technology can help detect a host of other diseases. In a Nature Reviews bioengineering report, global experts from the United States, the United Kingdom, and other countries pointed out that commercial LFTs are currently not available for four of the eight known priority diseases of epidemic potential: Crimean-Congo hemorrhagic fever, Middle East respiratory syndrome coronavirus, Nipah and other henipaviruses, and Rift Valley fever.

It is prime time, these experts and others contend, to build a global network of LFT research and development hubs to strengthen diagnostic capability.

Expansion should not only include more tests for more diseases, some experts say, but also make use of existing technology to provide “full-circle” care. After a rapid test, for instance, users could download a mobile phone app, transmit the results to their health care provider, and then set up an appointment if needed or get a prescribed medication at the pharmacy.
 

Medical community on board

Clinicians support increased availability of LFTs, said Eric J. Topol, MD, professor and executive vice president of Scripps Research, La Jolla, Calif.“Rapid antigen tests are critical, made a big difference in the pandemic, and will be used increasingly for many other applications in the years ahead,” Dr. Topol said in an email.

Physicians welcome their potential, agreed William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. At the start of the pandemic, when he was briefed about a lateral flow device in development, he said, “I was blown away by the technology, ease of use, rapidity of getting a result, its reasonable accuracy and its anticipated relatively low price.”

Clinicians would probably see many advantages to having more LFTs for more diseases, Dr. Schaffner said, because they are of use not only at home but also in doctors’ offices and in emergency departments. Their increased use “would help [people] make quick decisions about treatment, especially for flu and COVID.”
 

How LFTs work

LFTs are capable of targeting antigens, such as for the COVID tests, and antibodies such as IgG or IgM. The tests are also capable of detecting nucleic acids, although the availability of these tests is currently rare.

First, a sample from blood, urine, saliva or other bodily sources is placed onto a sample pad. It travels to a conjugate pad containing antibodies. If the target being looked for is present, the target and antibodies bind and, as the sample moves along to the test line, produces a positive result line along with the control line (to show that the test worked).
 

Global market outlook

By 2030, the lateral flow assays market is predicted to rise to $14.1 billion, according to a report issued in September by the firm Research and Markets. In 2022, the market was estimated at $9.4 billion, with $3.6 billion of that in the United States.

The report details the performances of 55 major competitors, such as Abbott Laboratories, Siemens, and QuidelOrtho, but smaller companies and start-ups are also involved in LFT development.
 

LFTs: Pros and cons

Although LFTs give rapid results, their accuracy is lower than that of PCR, especially the sensitivity. For COVID antigen LFTs, the sensitivity ranges from 34.1% to 88.1%, with an overall specificity of 99.6%, according to a Cochrane Review report. The analytical sensitivity performance of PCR testing for COVID is near 100%.

Everyone acknowledges the accuracy challenge of LFTs. The technologies “are generally thought to have limitations of detection that for some applications may present a challenge,” said Douglas C. Bryant, president and CEO of QuidelOrtho, San Diego, which counts the QuickVue rapid test for COVID detection among its products.

However, Mr. Bryant added, “as we saw during the pandemic, there was a place for more sensitive PCR-based technologies that are often run in a lab and there was a place for the use of rapid tests: The key is knowing the strengths and best use cases when applying the different technologies.”

One strength, he said, was that the tests “were shown to be highly effective at detecting active, infectious cases of SARS-CoV-2 and the rapid turnaround time allowed patients to isolate themselves from others quickly to help curb the spread of infection to others.” Another advantage was the ability to screen high-risk populations such as nursing homes to detect positive cases and help prevent outbreaks.

The pandemic familiarized people with the tests, said Jeremy Stackawitz, CEO of Senzo, a start-up in vitro diagnostics company developing an amplified LFT platform for rapid tests for flu, tuberculosis, COVID, and Clostridioides difficile. People liked using them. Physicians generally accepted them. It works great with tele-doc. It works great with personalized medicine.

Now, he said, people used to the COVID self-tests are asking: “Where is my strep test? Where is my sexual health test?”
 

FDA’s perspective on LFTs

The FDA has no one-size-fits-all standard for evaluating LFTs.

“LFTs are evaluated with respect to their individual indications and the pathway under which they are being reviewed,” said James McKinney, an FDA spokesperson. “A performance recommendation for one type of lateral flow test may not be appropriate for another.”

EUAs, such as those given for the COVID at-home tests, require different levels of evidence than traditional premarket review, he said, whether de novo marketing authorization, 510(k) premarket notification, or premarket approval. The EUAs are evaluated with a risk-benefit analysis to speed up the time it takes to make the devices available.

And, Mr. McKinney said, for some devices, the FDA provides recommendations on the expected performance through guidance documents. For instance, for rapid devices developed to detect influenza A virus antigen, the FDA recommends including enough sample to generate sensitivity of greater than 60% and testing at least 50 samples.
 

LFTs: The potential, the challenges

Mr. Stackawitz predicted that, as more LFT self-tests become available, more people will seek care, just as they did with the COVID rapid tests. A 22-year-old who thinks he has chlamydia may balk at going to a doctor right away. However, “if he can go buy a soda and a test at CVS, it’s different, it really is. With a little anonymity, people will seek care.”

He has a vision shared by other experts: That testing technology will evolve so that after getting the results at home, people would follow through by sending those results to their health care provider and obtaining needed care or medication. In his opinion, this is superior to the traditional way, which often involves visiting a doctor with symptoms, going for tests, waiting for results, and then beginning treatment.

“It would make more sense if you came in knowing your results,” Mr. Stackawitz said. “It’s a much smarter pathway, gives better outcomes for the patient, is much quicker and at much less cost. And it frees up time for doctors. I think most physicians would embrace that.”

Although rapid testing is gaining well-deserved recognition, funding is an issue, according to the Nature Reviews report. Those experts warned that “a reduction in funding for LFT research post COVID-19 may hamper efforts to capitalize on gains in decentralized testing, especially self-testing, which may be critical to address future pandemic threats.”

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

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

In utero exposure to selective serotonin reuptake inhibitors (SSRIs) has been tied to reduced brain volume in children, results of a large population-based study show.

However, the investigators, led by Henning Tiemeier, MD, PhD, professor of social and behavioral sciences at Harvard School of Public Health in Boston, note that the findings should be interpreted cautiously because the size of the study population who received brain MRI was relatively small.

Dr. Tiemeier said in an interview that the associations detected were small and could not show causality between prenatal SSRI use and a decrease in gray and white matter across certain areas of the brain.

“Women who are pregnant and on maintenance therapy should consult their therapist if preventive therapy is still needed and if there are alternatives. This choice must be carefully considered, and women should be carefully advised,” he said.

The study was published online in JAMA Psychiatry.
 

An important decision

The investigators note that the decision to prescribe antidepressants, particularly SSRIs, during pregnancy is challenging. Though SSRI use during pregnancy is generally considered safe, some previous research suggests an association with negative outcomes in offspring, including adverse effects on neurodevelopment.

However, the researchers also note that it’s possible that pregnant women who use SSRIs may have other factors, including more severe depressive symptoms, which may be independently associated with adverse outcomes in offspring.

To investigate the link between intrauterine SSRI exposure and brain development, the researchers conducted a prospective, population-based study that included 3,198 pregnant individuals with an expected delivery date between April 2002 and January 2006. Study participants were divided into five groups: 41 who used SSRIs during pregnancy, 257 who did not use the medications but had depressive symptoms during pregnancy, 77 who used SSRIs prenatally, 74 who developed depressive symptoms after giving birth, and 2,749 controls with no SSRI use or depressive symptoms. Participants had a mean age of 31 years, and all identified as women.

Of those who took SSRIs during pregnancy, 20 used them during the first trimester only, and 21 used them the first or in one or two additional trimesters. The SSRIs used included paroxetine, fluoxetine, sertraline, fluvoxamine, and citalopram.

Offspring of the women enrolled in the study received MRIs at three different times between the ages 7 and 15 years.

The 41 children born to the women who took SSRIs prenatally had 80 scans in total, the 257 with mothers who did not use SSRIs yet had depressive symptoms while pregnant had 477 MRIs, the 77 children born to the mothers who took SSRIs before pregnancy had 126 MRIs, the 74 born to mothers with postnatal depression only had 128 MRIs, and the 2,749 children born to the mothers with no SSRI use or depression had 4,813 MRIs.

The study’s primary outcome was brain morphometry in offspring including global and cortical brain volumes, measured by three MRI assessments from ages 7 to 15 years.
 

Reduced brain volume

Compared with children with no in utero SSRI exposure, those who were exposed had reduced gray and white matter volume that persisted up to 15 years of age (P = .006), particularly in the corticolimbic circuit.

Investigators observed a “persistent association between prenatal SSRI exposure and less cortical volumes across the 10-year follow-up period, including in the superior frontal cortex, medial orbitofrontal cortex, parahippocampal gyrus, rostral anterior cingulate cortex, and posterior cingulate.”

Investigators noted that prenatal SSRI exposure was consistently associated with 5%-10% lower brain volume in the frontal, cingulate, and temporal cortex throughout the age range studied.

In a couple of areas of the brain, however, the brain volume gradually increased back to levels seen in non-SSRI exposed children. For instance, smaller amygdala volumes had increased by age 15 years, so children who were exposed to SSRIs were not any different from control children.

Among the group of women with postnatal depression using an SSRI before or during pregnancy who had depressive symptoms post natally, neonates had a reduced fusiform gyrus (P = .002)

Dr. Tiemeier could not speculate on the effects of the volume differences on children’s development, although the parts of the brain found to be reduced are primarily responsible for emotion regulation.

Investigators noted there was limited ability to investigate trimester-specific outcomes of SSRI use and assess associations with specific SSRIs due to low prevalence of SSRI use.

In addition, research on the long-term behavioral and psychological outcomes associated with demonstrated brain changes is needed, investigators noted.
 

Clinical significance ‘unclear’

In an accompanying editorial, Ardesheer Talati, PhD, Columbia University, New York, noted that though the research enhances understanding of how brain development through adolescence may be associated with SSRI exposure, “the clinical significance was unclear, especially as key limbic regions, including the amygdala, normalized over time.”

If future evidence links brain anomalies to adverse youth outcomes, Dr. Talati writes, this will need to be “calibrated into the risk-benefit profile.” Until then, he said, the findings must not be overinterpreted “to either promote or discourage antidepressant medication use during the critical period of pregnancy.”

The study was funded by the Netherlands Organization for Scientific Research, European Union’s Horizon Research and Innovation Program, the Netherlands Organization for Health Research and Development, the Sophia Foundation for Neuroimaging, and the European Union’s Horizon Research and Innovation 5 Program. Dr. Talati reported receiving grants from the National Institutes of Health outside of the submitted work.

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

In utero exposure to selective serotonin reuptake inhibitors (SSRIs) has been tied to reduced brain volume in children, results of a large population-based study show.

However, the investigators, led by Henning Tiemeier, MD, PhD, professor of social and behavioral sciences at Harvard School of Public Health in Boston, note that the findings should be interpreted cautiously because the size of the study population who received brain MRI was relatively small.

Dr. Tiemeier said in an interview that the associations detected were small and could not show causality between prenatal SSRI use and a decrease in gray and white matter across certain areas of the brain.

“Women who are pregnant and on maintenance therapy should consult their therapist if preventive therapy is still needed and if there are alternatives. This choice must be carefully considered, and women should be carefully advised,” he said.

The study was published online in JAMA Psychiatry.
 

An important decision

The investigators note that the decision to prescribe antidepressants, particularly SSRIs, during pregnancy is challenging. Though SSRI use during pregnancy is generally considered safe, some previous research suggests an association with negative outcomes in offspring, including adverse effects on neurodevelopment.

However, the researchers also note that it’s possible that pregnant women who use SSRIs may have other factors, including more severe depressive symptoms, which may be independently associated with adverse outcomes in offspring.

To investigate the link between intrauterine SSRI exposure and brain development, the researchers conducted a prospective, population-based study that included 3,198 pregnant individuals with an expected delivery date between April 2002 and January 2006. Study participants were divided into five groups: 41 who used SSRIs during pregnancy, 257 who did not use the medications but had depressive symptoms during pregnancy, 77 who used SSRIs prenatally, 74 who developed depressive symptoms after giving birth, and 2,749 controls with no SSRI use or depressive symptoms. Participants had a mean age of 31 years, and all identified as women.

Of those who took SSRIs during pregnancy, 20 used them during the first trimester only, and 21 used them the first or in one or two additional trimesters. The SSRIs used included paroxetine, fluoxetine, sertraline, fluvoxamine, and citalopram.

Offspring of the women enrolled in the study received MRIs at three different times between the ages 7 and 15 years.

The 41 children born to the women who took SSRIs prenatally had 80 scans in total, the 257 with mothers who did not use SSRIs yet had depressive symptoms while pregnant had 477 MRIs, the 77 children born to the mothers who took SSRIs before pregnancy had 126 MRIs, the 74 born to mothers with postnatal depression only had 128 MRIs, and the 2,749 children born to the mothers with no SSRI use or depression had 4,813 MRIs.

The study’s primary outcome was brain morphometry in offspring including global and cortical brain volumes, measured by three MRI assessments from ages 7 to 15 years.
 

Reduced brain volume

Compared with children with no in utero SSRI exposure, those who were exposed had reduced gray and white matter volume that persisted up to 15 years of age (P = .006), particularly in the corticolimbic circuit.

Investigators observed a “persistent association between prenatal SSRI exposure and less cortical volumes across the 10-year follow-up period, including in the superior frontal cortex, medial orbitofrontal cortex, parahippocampal gyrus, rostral anterior cingulate cortex, and posterior cingulate.”

Investigators noted that prenatal SSRI exposure was consistently associated with 5%-10% lower brain volume in the frontal, cingulate, and temporal cortex throughout the age range studied.

In a couple of areas of the brain, however, the brain volume gradually increased back to levels seen in non-SSRI exposed children. For instance, smaller amygdala volumes had increased by age 15 years, so children who were exposed to SSRIs were not any different from control children.

Among the group of women with postnatal depression using an SSRI before or during pregnancy who had depressive symptoms post natally, neonates had a reduced fusiform gyrus (P = .002)

Dr. Tiemeier could not speculate on the effects of the volume differences on children’s development, although the parts of the brain found to be reduced are primarily responsible for emotion regulation.

Investigators noted there was limited ability to investigate trimester-specific outcomes of SSRI use and assess associations with specific SSRIs due to low prevalence of SSRI use.

In addition, research on the long-term behavioral and psychological outcomes associated with demonstrated brain changes is needed, investigators noted.
 

Clinical significance ‘unclear’

In an accompanying editorial, Ardesheer Talati, PhD, Columbia University, New York, noted that though the research enhances understanding of how brain development through adolescence may be associated with SSRI exposure, “the clinical significance was unclear, especially as key limbic regions, including the amygdala, normalized over time.”

If future evidence links brain anomalies to adverse youth outcomes, Dr. Talati writes, this will need to be “calibrated into the risk-benefit profile.” Until then, he said, the findings must not be overinterpreted “to either promote or discourage antidepressant medication use during the critical period of pregnancy.”

The study was funded by the Netherlands Organization for Scientific Research, European Union’s Horizon Research and Innovation Program, the Netherlands Organization for Health Research and Development, the Sophia Foundation for Neuroimaging, and the European Union’s Horizon Research and Innovation 5 Program. Dr. Talati reported receiving grants from the National Institutes of Health outside of the submitted work.

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

In utero exposure to selective serotonin reuptake inhibitors (SSRIs) has been tied to reduced brain volume in children, results of a large population-based study show.

However, the investigators, led by Henning Tiemeier, MD, PhD, professor of social and behavioral sciences at Harvard School of Public Health in Boston, note that the findings should be interpreted cautiously because the size of the study population who received brain MRI was relatively small.

Dr. Tiemeier said in an interview that the associations detected were small and could not show causality between prenatal SSRI use and a decrease in gray and white matter across certain areas of the brain.

“Women who are pregnant and on maintenance therapy should consult their therapist if preventive therapy is still needed and if there are alternatives. This choice must be carefully considered, and women should be carefully advised,” he said.

The study was published online in JAMA Psychiatry.
 

An important decision

The investigators note that the decision to prescribe antidepressants, particularly SSRIs, during pregnancy is challenging. Though SSRI use during pregnancy is generally considered safe, some previous research suggests an association with negative outcomes in offspring, including adverse effects on neurodevelopment.

However, the researchers also note that it’s possible that pregnant women who use SSRIs may have other factors, including more severe depressive symptoms, which may be independently associated with adverse outcomes in offspring.

To investigate the link between intrauterine SSRI exposure and brain development, the researchers conducted a prospective, population-based study that included 3,198 pregnant individuals with an expected delivery date between April 2002 and January 2006. Study participants were divided into five groups: 41 who used SSRIs during pregnancy, 257 who did not use the medications but had depressive symptoms during pregnancy, 77 who used SSRIs prenatally, 74 who developed depressive symptoms after giving birth, and 2,749 controls with no SSRI use or depressive symptoms. Participants had a mean age of 31 years, and all identified as women.

Of those who took SSRIs during pregnancy, 20 used them during the first trimester only, and 21 used them the first or in one or two additional trimesters. The SSRIs used included paroxetine, fluoxetine, sertraline, fluvoxamine, and citalopram.

Offspring of the women enrolled in the study received MRIs at three different times between the ages 7 and 15 years.

The 41 children born to the women who took SSRIs prenatally had 80 scans in total, the 257 with mothers who did not use SSRIs yet had depressive symptoms while pregnant had 477 MRIs, the 77 children born to the mothers who took SSRIs before pregnancy had 126 MRIs, the 74 born to mothers with postnatal depression only had 128 MRIs, and the 2,749 children born to the mothers with no SSRI use or depression had 4,813 MRIs.

The study’s primary outcome was brain morphometry in offspring including global and cortical brain volumes, measured by three MRI assessments from ages 7 to 15 years.
 

Reduced brain volume

Compared with children with no in utero SSRI exposure, those who were exposed had reduced gray and white matter volume that persisted up to 15 years of age (P = .006), particularly in the corticolimbic circuit.

Investigators observed a “persistent association between prenatal SSRI exposure and less cortical volumes across the 10-year follow-up period, including in the superior frontal cortex, medial orbitofrontal cortex, parahippocampal gyrus, rostral anterior cingulate cortex, and posterior cingulate.”

Investigators noted that prenatal SSRI exposure was consistently associated with 5%-10% lower brain volume in the frontal, cingulate, and temporal cortex throughout the age range studied.

In a couple of areas of the brain, however, the brain volume gradually increased back to levels seen in non-SSRI exposed children. For instance, smaller amygdala volumes had increased by age 15 years, so children who were exposed to SSRIs were not any different from control children.

Among the group of women with postnatal depression using an SSRI before or during pregnancy who had depressive symptoms post natally, neonates had a reduced fusiform gyrus (P = .002)

Dr. Tiemeier could not speculate on the effects of the volume differences on children’s development, although the parts of the brain found to be reduced are primarily responsible for emotion regulation.

Investigators noted there was limited ability to investigate trimester-specific outcomes of SSRI use and assess associations with specific SSRIs due to low prevalence of SSRI use.

In addition, research on the long-term behavioral and psychological outcomes associated with demonstrated brain changes is needed, investigators noted.
 

Clinical significance ‘unclear’

In an accompanying editorial, Ardesheer Talati, PhD, Columbia University, New York, noted that though the research enhances understanding of how brain development through adolescence may be associated with SSRI exposure, “the clinical significance was unclear, especially as key limbic regions, including the amygdala, normalized over time.”

If future evidence links brain anomalies to adverse youth outcomes, Dr. Talati writes, this will need to be “calibrated into the risk-benefit profile.” Until then, he said, the findings must not be overinterpreted “to either promote or discourage antidepressant medication use during the critical period of pregnancy.”

The study was funded by the Netherlands Organization for Scientific Research, European Union’s Horizon Research and Innovation Program, the Netherlands Organization for Health Research and Development, the Sophia Foundation for Neuroimaging, and the European Union’s Horizon Research and Innovation 5 Program. Dr. Talati reported receiving grants from the National Institutes of Health outside of the submitted work.

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

A recent study found a significant association between lower sexual frequency and greater all-cause mortality in young and middle-aged people with hypertension. Should primary care physicians be offering a pleasure prescription to the 6 in 10 Americans living with chronic illness? How can we help these patients access their capacity for sexual pleasure, a critical and life-affirming component of the human experience?

Ask, don’t tell

First, we need to ask routinely about sexual well-being and pleasure. Without asking patients their views, we do not know the relevance of sex for their quality of life. Unless we ask, we do not know what specific kinds of sexual play are important for a person’s pleasure, nor can we assume how they prioritize their sexual functioning in the context of their medical care. When I began asking my primary care patients about sexual well-being, many more than I expected were quietly holding on to distressing issues. Now, as a sexual medicine specialist, in each sexual function evaluation, I ask three key questions: What are your goals? What does sex mean to you? What kinds of sexual play are important for your (and your partner’s) pleasure?

Chronic disease – with physical symptoms as well as psychological, relational, and cultural components – affects both general and genital physiology. Any disease process that alters vascular, neuroendocrine, or musculoskeletal function is likely to influence sexual function, either directly through the disease process or indirectly through complications or the effect on identity and well-being. In addition, a host of iatrogenic changes to sexual function may accompany effects of treatments.

Managing the effects of chronic illness on sexuality requires resilience and flexibility. A serious injury may require a massive adjustment to sexuality, but progressive disease may require continuous accommodations to sexual changes. The life stage at which the disease occurs also matters. People facing disease early in life encounter challenges (finding willing sexual partners and limited medical guidance regarding their sexual functioning) as well as benefits (they may integrate their disease as part of their sexual life). Those who experience sexual changes related to their illness later in life may face a loss of “normal” sexual function and well-being.

Meanwhile, the partner who is not ill may have their own sexual needs, fears, and worries. Both patients and partners may experience disenfranchised grief – a sense of loss about something one is not culturally permitted to mourn (“I/my partner is alive in the face of this terrible illness; who am I to worry about our/my sexual pleasure?”).

Positive marital relationships influence health through improved survival, improved medical adherence, better quality of life for the patient, and improved life satisfaction. Sexual satisfaction is an important factor in relational satisfaction. Helping our patients with these changes therefore may improve not only sexual health but overall health.

How, then, should we address sexual pleasure in chronic illness care? Here are a few tips:

Focus on pleasure. “Performance” is foul language when it comes to sex. Full attention to sensation and enjoyment, the only sexual “skill” anyone needs, is impossible while trying to perform.

Encourage flexibility and recognize that sex encompasses a wide and varied menu of experiences that change over a lifetime. Sex is everything from kissing and cuddling to the wildest things a mind can imagine. We can help both patients and partners think about the wide variety of ways to meet sexual needs. Balancing acceptance of sexual changes with motivation for improvement also is part of our role.

Address the effects of illness on the patient’s relationship with their body. Illness may alter not only bodily function but also self-esteem and body image. A reorganization of self-concept may occur (“I am no longer a sexual person; I’m a sexually dysfunctional asthmatic/diabetic/etc. and should avoid sexual intimacy”). Examining these self-constructs allows shifts in thoughts and behaviors, leading to improved psychological and sexual well-being. Encourage patients to explore what feels good in this body now. When possible, we can help with referral for corrective surgeries or direction to resources like stoma covers, wigs, scarves, and tattoos.

We offer suggestions for “sleep hygiene”; how about pleasure hygiene?

• Encourage open communication with partner(s) and offer resources to develop communication skills.
• Consider needs for physical and emotional preparation for sexual play: adequate rest, preparing the environment for body fluids, pillows for comfort or aides for positioning, and plenty of lubricant at hand.
• Allow adequate time for sexual play and encourage the ability to adjust or stop and start over – with humor and self-compassion.
• Use sexual aides to enhance pleasure.
• Seek out sexual medicine and sex therapy colleagues when things become tricky.

All bodies, no matter their health or illness state, are capable of pleasure. Hey, pleasure might even save lives!

Dr. Kranz is an clinical assistant professor of obstetrics/gynecology and family medicine, University of Rochester (N.Y.) Medical Center. She reported no conflicts of interest.

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

A recent study found a significant association between lower sexual frequency and greater all-cause mortality in young and middle-aged people with hypertension. Should primary care physicians be offering a pleasure prescription to the 6 in 10 Americans living with chronic illness? How can we help these patients access their capacity for sexual pleasure, a critical and life-affirming component of the human experience?

Ask, don’t tell

First, we need to ask routinely about sexual well-being and pleasure. Without asking patients their views, we do not know the relevance of sex for their quality of life. Unless we ask, we do not know what specific kinds of sexual play are important for a person’s pleasure, nor can we assume how they prioritize their sexual functioning in the context of their medical care. When I began asking my primary care patients about sexual well-being, many more than I expected were quietly holding on to distressing issues. Now, as a sexual medicine specialist, in each sexual function evaluation, I ask three key questions: What are your goals? What does sex mean to you? What kinds of sexual play are important for your (and your partner’s) pleasure?

Chronic disease – with physical symptoms as well as psychological, relational, and cultural components – affects both general and genital physiology. Any disease process that alters vascular, neuroendocrine, or musculoskeletal function is likely to influence sexual function, either directly through the disease process or indirectly through complications or the effect on identity and well-being. In addition, a host of iatrogenic changes to sexual function may accompany effects of treatments.

Managing the effects of chronic illness on sexuality requires resilience and flexibility. A serious injury may require a massive adjustment to sexuality, but progressive disease may require continuous accommodations to sexual changes. The life stage at which the disease occurs also matters. People facing disease early in life encounter challenges (finding willing sexual partners and limited medical guidance regarding their sexual functioning) as well as benefits (they may integrate their disease as part of their sexual life). Those who experience sexual changes related to their illness later in life may face a loss of “normal” sexual function and well-being.

Meanwhile, the partner who is not ill may have their own sexual needs, fears, and worries. Both patients and partners may experience disenfranchised grief – a sense of loss about something one is not culturally permitted to mourn (“I/my partner is alive in the face of this terrible illness; who am I to worry about our/my sexual pleasure?”).

Positive marital relationships influence health through improved survival, improved medical adherence, better quality of life for the patient, and improved life satisfaction. Sexual satisfaction is an important factor in relational satisfaction. Helping our patients with these changes therefore may improve not only sexual health but overall health.

How, then, should we address sexual pleasure in chronic illness care? Here are a few tips:

Focus on pleasure. “Performance” is foul language when it comes to sex. Full attention to sensation and enjoyment, the only sexual “skill” anyone needs, is impossible while trying to perform.

Encourage flexibility and recognize that sex encompasses a wide and varied menu of experiences that change over a lifetime. Sex is everything from kissing and cuddling to the wildest things a mind can imagine. We can help both patients and partners think about the wide variety of ways to meet sexual needs. Balancing acceptance of sexual changes with motivation for improvement also is part of our role.

Address the effects of illness on the patient’s relationship with their body. Illness may alter not only bodily function but also self-esteem and body image. A reorganization of self-concept may occur (“I am no longer a sexual person; I’m a sexually dysfunctional asthmatic/diabetic/etc. and should avoid sexual intimacy”). Examining these self-constructs allows shifts in thoughts and behaviors, leading to improved psychological and sexual well-being. Encourage patients to explore what feels good in this body now. When possible, we can help with referral for corrective surgeries or direction to resources like stoma covers, wigs, scarves, and tattoos.

We offer suggestions for “sleep hygiene”; how about pleasure hygiene?

• Encourage open communication with partner(s) and offer resources to develop communication skills.
• Consider needs for physical and emotional preparation for sexual play: adequate rest, preparing the environment for body fluids, pillows for comfort or aides for positioning, and plenty of lubricant at hand.
• Allow adequate time for sexual play and encourage the ability to adjust or stop and start over – with humor and self-compassion.
• Use sexual aides to enhance pleasure.
• Seek out sexual medicine and sex therapy colleagues when things become tricky.

All bodies, no matter their health or illness state, are capable of pleasure. Hey, pleasure might even save lives!

Dr. Kranz is an clinical assistant professor of obstetrics/gynecology and family medicine, University of Rochester (N.Y.) Medical Center. She reported no conflicts of interest.

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

A recent study found a significant association between lower sexual frequency and greater all-cause mortality in young and middle-aged people with hypertension. Should primary care physicians be offering a pleasure prescription to the 6 in 10 Americans living with chronic illness? How can we help these patients access their capacity for sexual pleasure, a critical and life-affirming component of the human experience?

Ask, don’t tell

First, we need to ask routinely about sexual well-being and pleasure. Without asking patients their views, we do not know the relevance of sex for their quality of life. Unless we ask, we do not know what specific kinds of sexual play are important for a person’s pleasure, nor can we assume how they prioritize their sexual functioning in the context of their medical care. When I began asking my primary care patients about sexual well-being, many more than I expected were quietly holding on to distressing issues. Now, as a sexual medicine specialist, in each sexual function evaluation, I ask three key questions: What are your goals? What does sex mean to you? What kinds of sexual play are important for your (and your partner’s) pleasure?

Chronic disease – with physical symptoms as well as psychological, relational, and cultural components – affects both general and genital physiology. Any disease process that alters vascular, neuroendocrine, or musculoskeletal function is likely to influence sexual function, either directly through the disease process or indirectly through complications or the effect on identity and well-being. In addition, a host of iatrogenic changes to sexual function may accompany effects of treatments.

Managing the effects of chronic illness on sexuality requires resilience and flexibility. A serious injury may require a massive adjustment to sexuality, but progressive disease may require continuous accommodations to sexual changes. The life stage at which the disease occurs also matters. People facing disease early in life encounter challenges (finding willing sexual partners and limited medical guidance regarding their sexual functioning) as well as benefits (they may integrate their disease as part of their sexual life). Those who experience sexual changes related to their illness later in life may face a loss of “normal” sexual function and well-being.

Meanwhile, the partner who is not ill may have their own sexual needs, fears, and worries. Both patients and partners may experience disenfranchised grief – a sense of loss about something one is not culturally permitted to mourn (“I/my partner is alive in the face of this terrible illness; who am I to worry about our/my sexual pleasure?”).

Positive marital relationships influence health through improved survival, improved medical adherence, better quality of life for the patient, and improved life satisfaction. Sexual satisfaction is an important factor in relational satisfaction. Helping our patients with these changes therefore may improve not only sexual health but overall health.

How, then, should we address sexual pleasure in chronic illness care? Here are a few tips:

Focus on pleasure. “Performance” is foul language when it comes to sex. Full attention to sensation and enjoyment, the only sexual “skill” anyone needs, is impossible while trying to perform.

Encourage flexibility and recognize that sex encompasses a wide and varied menu of experiences that change over a lifetime. Sex is everything from kissing and cuddling to the wildest things a mind can imagine. We can help both patients and partners think about the wide variety of ways to meet sexual needs. Balancing acceptance of sexual changes with motivation for improvement also is part of our role.

Address the effects of illness on the patient’s relationship with their body. Illness may alter not only bodily function but also self-esteem and body image. A reorganization of self-concept may occur (“I am no longer a sexual person; I’m a sexually dysfunctional asthmatic/diabetic/etc. and should avoid sexual intimacy”). Examining these self-constructs allows shifts in thoughts and behaviors, leading to improved psychological and sexual well-being. Encourage patients to explore what feels good in this body now. When possible, we can help with referral for corrective surgeries or direction to resources like stoma covers, wigs, scarves, and tattoos.

We offer suggestions for “sleep hygiene”; how about pleasure hygiene?

• Encourage open communication with partner(s) and offer resources to develop communication skills.
• Consider needs for physical and emotional preparation for sexual play: adequate rest, preparing the environment for body fluids, pillows for comfort or aides for positioning, and plenty of lubricant at hand.
• Allow adequate time for sexual play and encourage the ability to adjust or stop and start over – with humor and self-compassion.
• Use sexual aides to enhance pleasure.
• Seek out sexual medicine and sex therapy colleagues when things become tricky.

All bodies, no matter their health or illness state, are capable of pleasure. Hey, pleasure might even save lives!

Dr. Kranz is an clinical assistant professor of obstetrics/gynecology and family medicine, University of Rochester (N.Y.) Medical Center. She reported no conflicts of interest.

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

It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

It is difficult to go through any publication or website these days without finding an article about artificial intelligence (AI). Many discuss its current status, while others speculate on potential future applications. Often, AI is described as an “existential threat to human health” by commentators who aren’t even aware of the definition of that term as Kierkegaard conceived it, the role of the individual to breathe meaning into life. Others characterize such cataclysmic predictions as “overblown and misdirected”.

The long-term potential for abuse of AI requires discussion, and should be addressed by policy makers, but that is beyond the scope of this column.

Meanwhile, there are many near-term opportunities for AI to improve health care and reduce tedious and time consuming tasks. Specifically, some AI-based tools are available to use in your office right now, with no “existential” threat to anybody.

The most popular current AI-based medical applications are automated scribes. They transcribe live consultations between physician and patient automatically and create a searchable report, plus notes for charts and billing.

I’ve written about AI scribes before, but the quality and user-friendliness of these products have improved dramatically in recent years. Language processing capabilities now permit you to speak naturally, without having to memorize specific commands. Some scribes can mimic your writing style based on sample notes that you enter into the system. Others allow you to integrate your own knowledge base, or a bibliography of research studies. With some systems, you can dictate notes directly into most EHR software, ask questions regarding medication dosages, or access a patient’s medical history from hospitals or other offices.

Current popular medical scribe products include DeepCura, DeepScribe, Nuance, Suki, Augmedix, Tali AI, Iodine Software, and ScribeLink. Amazon Web Services recently launched its own product, HealthScribe, as well. (As always, I have no financial interest in any product or service mentioned in this column.)

AI scribes aren’t entirely autonomous, of course; you need to read the output and check for potential inaccuracies. Still, users claim that they substantially reduce documentation and charting time, permitting more patient visits and less after-hours work.

AI can also be used to provide useful content for your patients. If you are not particularly good at writing, or don’t have the time for it, generative algorithms like the much-vaunted ChatGPT can generate posts, FAQs, and other informational content for your website, blog, or social media pages. You can ask for ideas about timely health topics and write general information articles, or create content specific to your location or specialty. You can use it to write emails informing your patients about upcoming office events or educate them on a range of topics, from getting their annual flu shots to scheduling regular screening skin exams.

With some of the same techniques and additional software, you can create entire videos for your website at a fraction of the cost of hiring a video production team. After using ChatGPT to write the content – for example, a 5-minute script on the importance of sunscreen in preventing skin cancer – you can employ a text-to-speech algorithm such as Revoicer to transform the script into audio content, and then a preproduction algorithm like Yepic or Synthesia to generate a video with a synthetic human. 

If you are unhappy with your current online presence, you can use AI to create an entire website. Through a series of questions, AI website builders such as Wix ADI, Jimdo, Hostinger, and 10Web gather all the information needed to set up a website draft that is already personalized with medical-specific content. Most offer the option to connect to Instagram, Facebook, Google My Business, and similar sites, to which they can import your office’s logo, images, and descriptive texts.

Some of them are capable of pulling up responsive site pages that automatically adjust to the device – mobile or computer – that the visitor is using. This is important, as I’ve written before, because more than half of all searches for doctors are now made on smartphones, so the more “mobile friendly” your site is, the higher it will be ranked. You can test how easily a visitor can use your website on a mobile device with Google’s free Mobile-Friendly Test.

If you give talks at medical meetings, you know how cumbersome and time-consuming it can be to create Powerpoint presentations. Once again, AI can save you time and trouble. Presentation designers such as Presentations.AI, Deck Robot, iA Presenter, and Beautiful.AI can assemble very acceptable presentations from your primary inputs. You typically choose a template, input your basic data, and AI will format the slides and offer you visuals, animations, voice-overs, and other fancy features. You will also have flexibility in changing segments or images or sizes you don’t like.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].