Ob.Gyn. News

While preparing to write this technology column, I received a great deal of insight from the unlikeliest of sources: my mother-in-law.

Now don’t get me wrong – she’s a truly lovely, intelligent, and capable woman. I have sought her advice often on many things and have always been impressed by her wisdom and pragmatism, but I’ve just never thought of asking her for her opinion on medicine or technology, as I considered her knowledge of both subjects to be limited.

This occasion changed my opinion. In fact, I believe that, as health care IT becomes more complex, people like my mother-in-law may be exactly who we should be looking to for answers.

A few weeks ago, my mother-in-law and I were discussing her recent trip to the doctor. When she mentioned some lab tests, I suggested that we log in to her patient portal to view the results. This elicited several questions and a declaration of frustration.

“Which portal?” she asked. “I have so many and can’t keep all of the websites and passwords straight! Why can’t all of my doctors use the same portal, and why do they all have different password requirements?”

As she spoke these words, I was immediately struck with an unfortunate reality of EHRs: We have done a brilliant job creating state-of-the-art digital castles and have filled them with the data needed to revolutionize care and improve population health – but we haven’t given our patients the keys to get inside.

We must ask ourselves if, in trying to construct fortresses of information around our patients, we have lost sight of the individuals in the center. I believe that we can answer this question and improve the benefits of patient portals, but we all must agree to a few simple steps to streamline the experience for everyone.
 

Make it easy

A study recently published in the Journal of General Internal Medicine surveyed several hospitals on their usage of patient portals. After determining whether or not the institutions had such portals, the authors then investigated to find out what, if any, guidance was provided to patients about how to use them.

Their findings are frustrating, though not surprising. While 89% of hospitals had some form of patient portal, only 65% of those “had links that were easily found, defined as links accessible within two clicks from the home page.”

Furthermore, even in cases where portals were easily found, good instructions on how to use them were missing. Those instructions that did exist centered on rules and restrictions and laying out “terms and conditions” and informing patients on “what not to do,” rather than explaining how to make the most of the experience.

According to the authors, “this focus on curtailing behavior, and the hurdles placed on finding and understanding guidance, suggest that some hospitals may be prioritizing reducing liability over improving the patient experience with portals.”

If we want our patients to use them, portals must be easy to access and intuitive to use. They also must provide value.
 

Make it meaningful

Patient portals have proliferated exponentially over the last 10 years, thanks to government incentive programs. One such program, known as “meaningful use,” is primarily responsible for this, as it made implementation of a patient portal one of its core requirements.

Sadly, in spite of its oft-reviled name, the meaningful use program never defined patient-friendly standards of usability for patient portals. As a result, current portals just aren’t very good. Patients like my mother-in-law find them to be too numerous, too unfriendly to use, and too limited, so they are not being used to their full potential.

In fact, many institutions may choose not to enable all of the available features in order to limit technical issues and reduce the burden on providers. In the study referenced above, only 63% of portals offered the ability for patients to communicate directly with their physicians, and only 43% offered the ability to refill prescriptions.

When enabled, these functions improve patient engagement and efficiency. Without them, patients are less likely to log on, and physicians are forced to rely on less-efficient telephone calls or traditional letters to communicate results to their patients.
 

Put the patient, not the portal, at the center

History has all but forgotten the attempts by tech giants such as Google and Microsoft to create personal health records. While these initially seemed like a wonderful concept, they sadly proved to be a total flop. Some patients embraced the idea, but security concerns and the lack of buy-in from EHR vendors significantly limited their uptake.

They may simply have been ahead of their time.

A decade later, wearable technology and telemedicine are ushering in a new era of patient-centric care. Individuals have been embracing a greater share of the responsibility for their own personal health information, yet most EHRs lack the ability to easily incorporate data acquired outside physicians’ offices.

It’s time for EHR vendors to go all in and change that. Instead of enslaving patients to the tyranny of fragmented health records, they should prioritize the creation of a robust, standardized, and portable health record that travels with the patient, not the other way around.

Have any other ideas on how to improve patient engagement? We’d love to hear about them and share them in a future column.

If you want to contribute but don’t have any ideas, we have a suggestion: Ask your mother-in-law. You may be surprised at what you learn!

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Hospital–Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

Reference

Lee JL et al. J Gen Intern Med. 2019 Nov 12. doi: 10.1007/s11606-019-05528-z.

While preparing to write this technology column, I received a great deal of insight from the unlikeliest of sources: my mother-in-law.

Now don’t get me wrong – she’s a truly lovely, intelligent, and capable woman. I have sought her advice often on many things and have always been impressed by her wisdom and pragmatism, but I’ve just never thought of asking her for her opinion on medicine or technology, as I considered her knowledge of both subjects to be limited.

This occasion changed my opinion. In fact, I believe that, as health care IT becomes more complex, people like my mother-in-law may be exactly who we should be looking to for answers.

A few weeks ago, my mother-in-law and I were discussing her recent trip to the doctor. When she mentioned some lab tests, I suggested that we log in to her patient portal to view the results. This elicited several questions and a declaration of frustration.

“Which portal?” she asked. “I have so many and can’t keep all of the websites and passwords straight! Why can’t all of my doctors use the same portal, and why do they all have different password requirements?”

As she spoke these words, I was immediately struck with an unfortunate reality of EHRs: We have done a brilliant job creating state-of-the-art digital castles and have filled them with the data needed to revolutionize care and improve population health – but we haven’t given our patients the keys to get inside.

We must ask ourselves if, in trying to construct fortresses of information around our patients, we have lost sight of the individuals in the center. I believe that we can answer this question and improve the benefits of patient portals, but we all must agree to a few simple steps to streamline the experience for everyone.
 

Make it easy

A study recently published in the Journal of General Internal Medicine surveyed several hospitals on their usage of patient portals. After determining whether or not the institutions had such portals, the authors then investigated to find out what, if any, guidance was provided to patients about how to use them.

Their findings are frustrating, though not surprising. While 89% of hospitals had some form of patient portal, only 65% of those “had links that were easily found, defined as links accessible within two clicks from the home page.”

Furthermore, even in cases where portals were easily found, good instructions on how to use them were missing. Those instructions that did exist centered on rules and restrictions and laying out “terms and conditions” and informing patients on “what not to do,” rather than explaining how to make the most of the experience.

According to the authors, “this focus on curtailing behavior, and the hurdles placed on finding and understanding guidance, suggest that some hospitals may be prioritizing reducing liability over improving the patient experience with portals.”

If we want our patients to use them, portals must be easy to access and intuitive to use. They also must provide value.
 

Make it meaningful

Patient portals have proliferated exponentially over the last 10 years, thanks to government incentive programs. One such program, known as “meaningful use,” is primarily responsible for this, as it made implementation of a patient portal one of its core requirements.

Sadly, in spite of its oft-reviled name, the meaningful use program never defined patient-friendly standards of usability for patient portals. As a result, current portals just aren’t very good. Patients like my mother-in-law find them to be too numerous, too unfriendly to use, and too limited, so they are not being used to their full potential.

In fact, many institutions may choose not to enable all of the available features in order to limit technical issues and reduce the burden on providers. In the study referenced above, only 63% of portals offered the ability for patients to communicate directly with their physicians, and only 43% offered the ability to refill prescriptions.

When enabled, these functions improve patient engagement and efficiency. Without them, patients are less likely to log on, and physicians are forced to rely on less-efficient telephone calls or traditional letters to communicate results to their patients.
 

Put the patient, not the portal, at the center

History has all but forgotten the attempts by tech giants such as Google and Microsoft to create personal health records. While these initially seemed like a wonderful concept, they sadly proved to be a total flop. Some patients embraced the idea, but security concerns and the lack of buy-in from EHR vendors significantly limited their uptake.

They may simply have been ahead of their time.

A decade later, wearable technology and telemedicine are ushering in a new era of patient-centric care. Individuals have been embracing a greater share of the responsibility for their own personal health information, yet most EHRs lack the ability to easily incorporate data acquired outside physicians’ offices.

It’s time for EHR vendors to go all in and change that. Instead of enslaving patients to the tyranny of fragmented health records, they should prioritize the creation of a robust, standardized, and portable health record that travels with the patient, not the other way around.

Have any other ideas on how to improve patient engagement? We’d love to hear about them and share them in a future column.

If you want to contribute but don’t have any ideas, we have a suggestion: Ask your mother-in-law. You may be surprised at what you learn!

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Hospital–Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

Reference

Lee JL et al. J Gen Intern Med. 2019 Nov 12. doi: 10.1007/s11606-019-05528-z.

While preparing to write this technology column, I received a great deal of insight from the unlikeliest of sources: my mother-in-law.

Now don’t get me wrong – she’s a truly lovely, intelligent, and capable woman. I have sought her advice often on many things and have always been impressed by her wisdom and pragmatism, but I’ve just never thought of asking her for her opinion on medicine or technology, as I considered her knowledge of both subjects to be limited.

This occasion changed my opinion. In fact, I believe that, as health care IT becomes more complex, people like my mother-in-law may be exactly who we should be looking to for answers.

A few weeks ago, my mother-in-law and I were discussing her recent trip to the doctor. When she mentioned some lab tests, I suggested that we log in to her patient portal to view the results. This elicited several questions and a declaration of frustration.

“Which portal?” she asked. “I have so many and can’t keep all of the websites and passwords straight! Why can’t all of my doctors use the same portal, and why do they all have different password requirements?”

As she spoke these words, I was immediately struck with an unfortunate reality of EHRs: We have done a brilliant job creating state-of-the-art digital castles and have filled them with the data needed to revolutionize care and improve population health – but we haven’t given our patients the keys to get inside.

We must ask ourselves if, in trying to construct fortresses of information around our patients, we have lost sight of the individuals in the center. I believe that we can answer this question and improve the benefits of patient portals, but we all must agree to a few simple steps to streamline the experience for everyone.
 

Make it easy

A study recently published in the Journal of General Internal Medicine surveyed several hospitals on their usage of patient portals. After determining whether or not the institutions had such portals, the authors then investigated to find out what, if any, guidance was provided to patients about how to use them.

Their findings are frustrating, though not surprising. While 89% of hospitals had some form of patient portal, only 65% of those “had links that were easily found, defined as links accessible within two clicks from the home page.”

Furthermore, even in cases where portals were easily found, good instructions on how to use them were missing. Those instructions that did exist centered on rules and restrictions and laying out “terms and conditions” and informing patients on “what not to do,” rather than explaining how to make the most of the experience.

According to the authors, “this focus on curtailing behavior, and the hurdles placed on finding and understanding guidance, suggest that some hospitals may be prioritizing reducing liability over improving the patient experience with portals.”

If we want our patients to use them, portals must be easy to access and intuitive to use. They also must provide value.
 

Make it meaningful

Patient portals have proliferated exponentially over the last 10 years, thanks to government incentive programs. One such program, known as “meaningful use,” is primarily responsible for this, as it made implementation of a patient portal one of its core requirements.

Sadly, in spite of its oft-reviled name, the meaningful use program never defined patient-friendly standards of usability for patient portals. As a result, current portals just aren’t very good. Patients like my mother-in-law find them to be too numerous, too unfriendly to use, and too limited, so they are not being used to their full potential.

In fact, many institutions may choose not to enable all of the available features in order to limit technical issues and reduce the burden on providers. In the study referenced above, only 63% of portals offered the ability for patients to communicate directly with their physicians, and only 43% offered the ability to refill prescriptions.

When enabled, these functions improve patient engagement and efficiency. Without them, patients are less likely to log on, and physicians are forced to rely on less-efficient telephone calls or traditional letters to communicate results to their patients.
 

Put the patient, not the portal, at the center

History has all but forgotten the attempts by tech giants such as Google and Microsoft to create personal health records. While these initially seemed like a wonderful concept, they sadly proved to be a total flop. Some patients embraced the idea, but security concerns and the lack of buy-in from EHR vendors significantly limited their uptake.

They may simply have been ahead of their time.

A decade later, wearable technology and telemedicine are ushering in a new era of patient-centric care. Individuals have been embracing a greater share of the responsibility for their own personal health information, yet most EHRs lack the ability to easily incorporate data acquired outside physicians’ offices.

It’s time for EHR vendors to go all in and change that. Instead of enslaving patients to the tyranny of fragmented health records, they should prioritize the creation of a robust, standardized, and portable health record that travels with the patient, not the other way around.

Have any other ideas on how to improve patient engagement? We’d love to hear about them and share them in a future column.

If you want to contribute but don’t have any ideas, we have a suggestion: Ask your mother-in-law. You may be surprised at what you learn!

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Hospital–Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health.

Reference

Lee JL et al. J Gen Intern Med. 2019 Nov 12. doi: 10.1007/s11606-019-05528-z.

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

The Trump administration can move forward with expanding a rule that makes it more difficult for immigrants to remain in the United States if they receive health care assistance, the U.S. Supreme Court ruled in a 5-4 vote.

Courtesy Fred Schilling, Collection of the Supreme Court of the United States

The Feb. 21 order allows the administration to broaden the so-called “public charge rule” while legal challenges against the expanded regulation continue in the lower courts. The Supreme Court’s decision, which lifts a preliminary injunction against the expansion, applies to enforcement only in Illinois, where a district court blocked the revised rule from moving forward in October 2019. The Supreme Court’s measure follows another 5-4 order in January, in which justices lifted a nationwide injunction against the revised rule.

Under the long-standing public charge rule, immigration officials can refuse to admit immigrants into the United States or can deny them permanent legal status if they are deemed likely to become a public charge. Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid, the Supplemental Nutrition Assistance Program, and several housing programs. Use of these programs for more than 12 months in the aggregate during a 36-month period may result in a “public charge” designation and lead to green card denial.

Eight legal challenges were immediately filed against the rule changes, including a complaint issued by 14 states. At least five trial courts have since blocked the measure, while appeals courts have lifted some of the injunctions and upheld enforcement.

In its Jan. 27 order lifting the nationwide injunction, Associate Justice Neil M. Gorsuch wrote that nationwide injunctions are being overused by trial courts with negative consequences.

“The real problem here is the increasingly common practice of trial courts ordering relief that transcends the cases before them. Whether framed as injunctions of ‘nationwide,’ ‘universal,’ or ‘cosmic’ scope, these orders share the same basic flaw – they direct how the defendant must act toward persons who are not parties to the case,” he wrote. “It has become increasingly apparent that this court must, at some point, confront these important objections to this increasingly widespread practice. As the brief and furious history of the regulation before us illustrates, the routine issuance of universal injunctions is patently unworkable, sowing chaos for litigants, the government, courts, and all those affected by these conflicting decisions.”

In the court’s Feb. 21 order lifting the injunction in Illinois, justices gave no explanation for overturning the lower court’s injunction. However, Associate Justice Sonia Sotomayor issued a sharply-worded dissent, criticizing her fellow justices for allowing the rule to proceed.

“In sum, the government’s only claimed hardship is that it must enforce an existing interpretation of an immigration rule in one state – just as it has done for the past 20 years – while an updated version of the rule takes effect in the remaining 49,” she wrote. “The government has not quantified or explained any burdens that would arise from this state of the world.”

ACA cases still in limbo

Meanwhile, the Supreme Court still has not decided whether it will hear Texas v. United States, a case that could effectively dismantle the Affordable Care Act.

The high court was expected to announce whether it would take the high-profile case at a private Feb. 21 conference, but the justices have released no update. The case was relisted for consideration at the court’s Feb. 28 conference.

Texas v. United States stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Because the Trump administration declined to defend the law, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. The Democratic attorneys general and governors appealed the decision to the U.S. Supreme Court.

If the Supreme Court agrees to hear the challenge, the court could fast-track the case and schedule arguments for the current term or wait until its next term, which starts in October 2020. If justices decline to hear the case, the challenge will remain with the district court for more analysis about the law’s severability.

Another ACA-related case – Maine Community Health Options v. U.S. – also remains in limbo. Justices heard the case, which was consolidated with two similar challenges, on Dec. 10, 2019, but still have not issued a decision.

The consolidated challenges center on whether the federal government owes insurers billions based on an Affordable Care Act provision intended to help health plans mitigate risk under the law. The ACA’s risk corridor program required the U.S. Department of Health & Human Services to collect funds from profitable insurers that offered qualified health plans under the exchanges and distribute the funds to insurers with excessive losses. Collections from profitable insurers under the program fell short in 2014, 2015, and 2016, while losses steadily grew, resulting in the HHS paying about 12 cents on the dollar in payments to insurers. More than 150 insurers now allege they were shortchanged and they want the Supreme Court to force the government to reimburse them to the tune of $12 billion.

The Department of Justice counters that the government is not required to pay the insurers because of appropriations measures passed by Congress in 2014 and in later years that limited the funding available to compensate insurers for their losses.

The federal government and insurers have each experienced wins and losses at the lower court level. Most recently, the U.S. Court of Appeals for the Federal Circuit decided in favor of the government, ruling that while the ACA required the government to compensate the insurers for their losses, the appropriations measures repealed or suspended that requirement.

A Supreme Court decision in the case could come as soon as Feb. 26.

Court to hear women’s health cases

Two closely watched reproductive health cases will go before the court this spring.

On March 4, justices will hear oral arguments in June Medical Services v. Russo, regarding the constitutionality of a Louisiana law that requires physicians performing abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, according to the state law, originally passed in 2014. Clinics that employ such doctors can also have their licenses revoked.

June Medical Services LLC, a women’s health clinic, sued over the law. A district court ruled in favor of the plaintiff, but the 5th U.S. Circuit Court of Appeals reversed and upheld Louisiana’s law. The clinic appealed to the U.S. Supreme Court. Louisiana officials argue the challenge should be dismissed, and the law allowed to proceed, because the plaintiffs lack standing.

The Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, justices struck down the measure as unconstitutional.

And on April 29, justices will hear arguments in Little Sisters of the Poor v. Pennsylvania, a consolidated case about whether the Trump administration acted properly when it expanded exemptions under the Affordable Care Act’s contraceptive mandate. Entities that object to providing contraception on the basis of religious beliefs can opt out of complying with the mandate, according to the 2018 regulations. Additionally, nonprofit organizations and small businesses that have nonreligious moral convictions against the mandate can skip compliance. A number of states and entities sued over the new rules.

A federal appeals court temporarily barred the regulations from moving forward, ruling the plaintiffs were likely to succeed in proving the Trump administration did not follow appropriate procedures when it promulgated the new rules and that the regulations were not authorized under the ACA.

Justices will decide whether the parties have standing in the case, whether the Trump administration followed correct rule-making procedures, and if the regulations can stand.

agallegos@mdedge.com

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

It’s past time to call the novel coronavirus, COVID-19, a pandemic and “time to push people to prepare, and guide their prep,” according to risk communication experts.

Courtesy NIAID-RML

Medical messaging about containing or stopping the spread of the virus is doing more harm than good, write Peter Sandman, PhD, and Jody Lanard, MD, both based in New York City, in a recent blog post.

“We are near-certain that the desperate-sounding last-ditch containment messaging of recent days is contributing to a massive global misperception,” they warn.

“The most crucial (and overdue) risk communication task … is to help people visualize their communities when ‘keeping it out’ – containment – is no longer relevant.”

That message is embraced by several experts who spoke to Medscape Medical News.

“I’m jealous of what [they] have written: It is so clear, so correct, and so practical,” said David Fisman, MD, MPH, professor of epidemiology at the University of Toronto, Canada. “I think WHO [World Health Organization] is shying away from the P word,” he continued, referring to the organization’s continuing decision not to call the outbreak a pandemic.

“I fully support exactly what [Sandman and Lanard] are saying,” said Michael Osterholm, PhD, MPH, professor of environmental health sciences and director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota in Minneapolis.

Health care professionals should now be advising people how to prepare – yet this is the most neglected message, Sandman and Lanard write. “Hardly any officials are telling civil society and the general public how to get ready for this pandemic.”

Effective communication should inform people of what to expect now, they continue: “[T]he end of most quarantines, travel restrictions, contact tracing, and other measures designed to keep ‘them’ from infecting ‘us,’ and the switch to measures like canceling mass events designed to keep us from infecting each other.”

Among the new messages that should be delivered are things like:

• Stockpiling nonperishable food and prescription meds.
• Considering care of sick family members.
• Cross-training work personnel so one person’s absence won’t derail an organization’s ability to function.

“We hope that governments and healthcare institutions are using this time wisely,” Sandman and Lanard continue. “We know that ordinary citizens are not being asked to do so. In most countries … ordinary citizens have not been asked to prepare. Instead, they have been led to expect that their governments will keep the virus from their doors.”

This article first appeared on Medscape.com.

Children exposed to macrolides during the first trimester of pregnancy had an increased risk of major malformations, compared with first-trimester penicillin exposure, according to an observational study.

Creatas Images

Use of antibiotics is common in pregnancy, and macrolides commonly are used if a penicillin allergy is reported.

Hypospadias and other genital malformations also were more likely with exposure during any trimester to macrolides, although this association lost significance when limited to the first trimester. The researchers did not identify any associations with macrolides exposure and neurodevelopmental disorders.

The observational study could not establish causality, but the researchers calculated an estimate of likely excess malformations if the association were found to be causal: “For every 1,000 mothers prescribed macrolides instead of penicillins during the first trimester, an additional 4.1 children would have cardiovascular malformations,” Heng Fan, a PhD student at the University College London, and colleagues wrote in the BMJ. “The corresponding figures for prescriptions during any trimester and genital malformations would be 1.7.”

The researchers used records from the U.K. Clinical Practice Research Datalink to analyze outcomes in 104,605 children born between 1990 and 2016 to mothers who received at least one prescription of erythromycin, clarithromycin, azithromycin, or penicillin monotherapy between their fourth week of pregnancy and delivery. Women prescribed any known teratogenic medications were excluded.

The majority of the mothers (92%) had been prescribed penicillin once, and 8% were prescribed a macrolide antibiotic once during pregnancy.

The researchers tallied and calculated the children’s risk of major malformations; cerebral palsy; epilepsy; ADHD; autism spectrum disorder; and any nervous, cardiovascular, gastrointestinal, genital, or urinary malformations. The children were tracked through a median 6 years of age.

In comparing risk of malformations or neurodevelopmental disorders among children, the researchers chose to compare exposure to macrolides and penicillin to reduce the likelihood of confounding by indication for infections. (They also included two negative control groups: unexposed siblings and women prescribed antibiotics before conception.) The authors acknowledged, however, that residual confounding still may occur “if macrolides were prescribed for specific indications (e.g., chlamydia), or when potential risk factors for malformations or neurodevelopmental outcomes differed between treatment groups.”

The overall rate of malformations was 22 per 1,000 children prenatally exposed to macrolides (28 in first trimester and 20 in second or third trimester) and 17 per 1,000 children prenatally exposed to penicillin. The risk and type of malformations varied, however, according to the trimester.

The researchers made adjustments to account for differences in a wide range of maternal factors: age at delivery, calendar year of delivery, alcohol misuse, illegal drug use, tobacco use, obesity, hypertension, diabetes, anxiety, depression, and epilepsy. They also adjusted for parity, multiples, and chronic medical treatments, as well as genitourinary tract infections or STIs during pregnancy, both of which are linked to preterm labor.

Compared with children exposed to penicillin during the first trimester of pregnancy, risk of malformations was 1.6 times greater in those exposed to macrolides in the first trimester (risk ratio, 1.55; 28 vs. 18 per 1,000). Erythromycin exposure in the first trimester also was linked to a 50% greater likelihood of any major malformation compared with penicillin (RR, 1.5; 27 vs. 18 per 1,000).

Cardiovascular malformations in particular were more likely in those exposed to macrolides (11 per 1,000), compared with penicillin (7 per 1,000) in the first trimester (RR, 1.62). Meanwhile, genital malformations, primarily hypospadias, occurred more frequently in children whose mothers were prescribed macrolides (5 per 1,000), compared with penicillin (3 per 1,000) in any trimester (RR, 1.58).

No increased risk of major malformations was associated with macrolides prescribed only in the second or third trimester, although a borderline significant association existed with gastrointestinal malformations. The authors also found no links between macrolides exposure and increased risk of cerebral palsy, epilepsy, ADHD, or autism spectrum disorder.

The findings did not change in several sensitivity analyses, including one that restricted analysis to antibiotics prescribed only for respiratory tract infections.

Dr. Fan and associates discussed several potential biological mechanisms for causation, including the arrhythmic effect of macrolides that may relate to cardiovascular malformations or contribute to fetal hypoxia. They noted that “macrolide prescribing during pregnancy warrants caution,” and recommend including on drug safety labels “that there is uncertainty about the safety of macrolides, including erythromycin” and alternative antibiotics should be used when possible.

Iris Krishna, MD, MPH, assistant professor of maternal-fetal medicine at Emory University, Atlanta, agreed with the study authors that use of macrolides in the first trimester warrants further investigation, and if an appropriate alternative antibiotic is available, then it should be preferentially considered when treating infections in the first trimester.

“However, if macrolides are the only treatment option, pregnant women can be reassured that the absolute risk of a birth defect is low, and this should not discourage them from taking a macrolide when needed as untreated infections pose a greater risk in pregnancy,” she said in an interview.

“This study does not establish that macrolide antibiotics cause birth defects, but it suggests a potential association. Previous studies examining the use of macrolides, such as erythromycin, have not demonstrated a consistent pattern of birth defects, and heart defects identified were classified as mostly mild. The authors suggest that the potential biologic mechanism based on rat models may be that macrolides might induce fetal cardiac arrhythmias and short-term fetal hypoxia. This study was underpowered to examine macrolide exposure for specific malformations. To avoid underpowered comparisons, the authors’ categorized malformations by organ systems, so the spectrum of cardiac defects is unclear,” commented Dr. Krishna, who also is a member of the Ob.Gyn. News editorial advisory board.

“Current recommendations for macrolide antibiotic use in pregnancy in the second and third trimester of pregnancy, and in particular when used for obstetric indications, such as prelabor rupture of membranes to prolong the latency period to delivery, should not be altered based on the findings of this study,” she concluded.

The research was funded by Child Health Research CIO Trust, the China Scholarship Council, Health Data Research UK, and the National Institute for Health Research. Dr. Fan and associates had no industry disclosures. Dr. Krishna had no relevant financial disclosures.

SOURCE: Fan H et al. BMJ. 2020;368:m331.

Children exposed to macrolides during the first trimester of pregnancy had an increased risk of major malformations, compared with first-trimester penicillin exposure, according to an observational study.

Creatas Images

Use of antibiotics is common in pregnancy, and macrolides commonly are used if a penicillin allergy is reported.

Hypospadias and other genital malformations also were more likely with exposure during any trimester to macrolides, although this association lost significance when limited to the first trimester. The researchers did not identify any associations with macrolides exposure and neurodevelopmental disorders.

The observational study could not establish causality, but the researchers calculated an estimate of likely excess malformations if the association were found to be causal: “For every 1,000 mothers prescribed macrolides instead of penicillins during the first trimester, an additional 4.1 children would have cardiovascular malformations,” Heng Fan, a PhD student at the University College London, and colleagues wrote in the BMJ. “The corresponding figures for prescriptions during any trimester and genital malformations would be 1.7.”

The researchers used records from the U.K. Clinical Practice Research Datalink to analyze outcomes in 104,605 children born between 1990 and 2016 to mothers who received at least one prescription of erythromycin, clarithromycin, azithromycin, or penicillin monotherapy between their fourth week of pregnancy and delivery. Women prescribed any known teratogenic medications were excluded.

The majority of the mothers (92%) had been prescribed penicillin once, and 8% were prescribed a macrolide antibiotic once during pregnancy.

The researchers tallied and calculated the children’s risk of major malformations; cerebral palsy; epilepsy; ADHD; autism spectrum disorder; and any nervous, cardiovascular, gastrointestinal, genital, or urinary malformations. The children were tracked through a median 6 years of age.

In comparing risk of malformations or neurodevelopmental disorders among children, the researchers chose to compare exposure to macrolides and penicillin to reduce the likelihood of confounding by indication for infections. (They also included two negative control groups: unexposed siblings and women prescribed antibiotics before conception.) The authors acknowledged, however, that residual confounding still may occur “if macrolides were prescribed for specific indications (e.g., chlamydia), or when potential risk factors for malformations or neurodevelopmental outcomes differed between treatment groups.”

The overall rate of malformations was 22 per 1,000 children prenatally exposed to macrolides (28 in first trimester and 20 in second or third trimester) and 17 per 1,000 children prenatally exposed to penicillin. The risk and type of malformations varied, however, according to the trimester.

The researchers made adjustments to account for differences in a wide range of maternal factors: age at delivery, calendar year of delivery, alcohol misuse, illegal drug use, tobacco use, obesity, hypertension, diabetes, anxiety, depression, and epilepsy. They also adjusted for parity, multiples, and chronic medical treatments, as well as genitourinary tract infections or STIs during pregnancy, both of which are linked to preterm labor.

Compared with children exposed to penicillin during the first trimester of pregnancy, risk of malformations was 1.6 times greater in those exposed to macrolides in the first trimester (risk ratio, 1.55; 28 vs. 18 per 1,000). Erythromycin exposure in the first trimester also was linked to a 50% greater likelihood of any major malformation compared with penicillin (RR, 1.5; 27 vs. 18 per 1,000).

Cardiovascular malformations in particular were more likely in those exposed to macrolides (11 per 1,000), compared with penicillin (7 per 1,000) in the first trimester (RR, 1.62). Meanwhile, genital malformations, primarily hypospadias, occurred more frequently in children whose mothers were prescribed macrolides (5 per 1,000), compared with penicillin (3 per 1,000) in any trimester (RR, 1.58).

No increased risk of major malformations was associated with macrolides prescribed only in the second or third trimester, although a borderline significant association existed with gastrointestinal malformations. The authors also found no links between macrolides exposure and increased risk of cerebral palsy, epilepsy, ADHD, or autism spectrum disorder.

The findings did not change in several sensitivity analyses, including one that restricted analysis to antibiotics prescribed only for respiratory tract infections.

Dr. Fan and associates discussed several potential biological mechanisms for causation, including the arrhythmic effect of macrolides that may relate to cardiovascular malformations or contribute to fetal hypoxia. They noted that “macrolide prescribing during pregnancy warrants caution,” and recommend including on drug safety labels “that there is uncertainty about the safety of macrolides, including erythromycin” and alternative antibiotics should be used when possible.

Iris Krishna, MD, MPH, assistant professor of maternal-fetal medicine at Emory University, Atlanta, agreed with the study authors that use of macrolides in the first trimester warrants further investigation, and if an appropriate alternative antibiotic is available, then it should be preferentially considered when treating infections in the first trimester.

“However, if macrolides are the only treatment option, pregnant women can be reassured that the absolute risk of a birth defect is low, and this should not discourage them from taking a macrolide when needed as untreated infections pose a greater risk in pregnancy,” she said in an interview.

“This study does not establish that macrolide antibiotics cause birth defects, but it suggests a potential association. Previous studies examining the use of macrolides, such as erythromycin, have not demonstrated a consistent pattern of birth defects, and heart defects identified were classified as mostly mild. The authors suggest that the potential biologic mechanism based on rat models may be that macrolides might induce fetal cardiac arrhythmias and short-term fetal hypoxia. This study was underpowered to examine macrolide exposure for specific malformations. To avoid underpowered comparisons, the authors’ categorized malformations by organ systems, so the spectrum of cardiac defects is unclear,” commented Dr. Krishna, who also is a member of the Ob.Gyn. News editorial advisory board.

“Current recommendations for macrolide antibiotic use in pregnancy in the second and third trimester of pregnancy, and in particular when used for obstetric indications, such as prelabor rupture of membranes to prolong the latency period to delivery, should not be altered based on the findings of this study,” she concluded.

The research was funded by Child Health Research CIO Trust, the China Scholarship Council, Health Data Research UK, and the National Institute for Health Research. Dr. Fan and associates had no industry disclosures. Dr. Krishna had no relevant financial disclosures.

SOURCE: Fan H et al. BMJ. 2020;368:m331.

Children exposed to macrolides during the first trimester of pregnancy had an increased risk of major malformations, compared with first-trimester penicillin exposure, according to an observational study.

Creatas Images

Use of antibiotics is common in pregnancy, and macrolides commonly are used if a penicillin allergy is reported.

Hypospadias and other genital malformations also were more likely with exposure during any trimester to macrolides, although this association lost significance when limited to the first trimester. The researchers did not identify any associations with macrolides exposure and neurodevelopmental disorders.

The observational study could not establish causality, but the researchers calculated an estimate of likely excess malformations if the association were found to be causal: “For every 1,000 mothers prescribed macrolides instead of penicillins during the first trimester, an additional 4.1 children would have cardiovascular malformations,” Heng Fan, a PhD student at the University College London, and colleagues wrote in the BMJ. “The corresponding figures for prescriptions during any trimester and genital malformations would be 1.7.”

The researchers used records from the U.K. Clinical Practice Research Datalink to analyze outcomes in 104,605 children born between 1990 and 2016 to mothers who received at least one prescription of erythromycin, clarithromycin, azithromycin, or penicillin monotherapy between their fourth week of pregnancy and delivery. Women prescribed any known teratogenic medications were excluded.

The majority of the mothers (92%) had been prescribed penicillin once, and 8% were prescribed a macrolide antibiotic once during pregnancy.

The researchers tallied and calculated the children’s risk of major malformations; cerebral palsy; epilepsy; ADHD; autism spectrum disorder; and any nervous, cardiovascular, gastrointestinal, genital, or urinary malformations. The children were tracked through a median 6 years of age.

In comparing risk of malformations or neurodevelopmental disorders among children, the researchers chose to compare exposure to macrolides and penicillin to reduce the likelihood of confounding by indication for infections. (They also included two negative control groups: unexposed siblings and women prescribed antibiotics before conception.) The authors acknowledged, however, that residual confounding still may occur “if macrolides were prescribed for specific indications (e.g., chlamydia), or when potential risk factors for malformations or neurodevelopmental outcomes differed between treatment groups.”

The overall rate of malformations was 22 per 1,000 children prenatally exposed to macrolides (28 in first trimester and 20 in second or third trimester) and 17 per 1,000 children prenatally exposed to penicillin. The risk and type of malformations varied, however, according to the trimester.

The researchers made adjustments to account for differences in a wide range of maternal factors: age at delivery, calendar year of delivery, alcohol misuse, illegal drug use, tobacco use, obesity, hypertension, diabetes, anxiety, depression, and epilepsy. They also adjusted for parity, multiples, and chronic medical treatments, as well as genitourinary tract infections or STIs during pregnancy, both of which are linked to preterm labor.

Compared with children exposed to penicillin during the first trimester of pregnancy, risk of malformations was 1.6 times greater in those exposed to macrolides in the first trimester (risk ratio, 1.55; 28 vs. 18 per 1,000). Erythromycin exposure in the first trimester also was linked to a 50% greater likelihood of any major malformation compared with penicillin (RR, 1.5; 27 vs. 18 per 1,000).

Cardiovascular malformations in particular were more likely in those exposed to macrolides (11 per 1,000), compared with penicillin (7 per 1,000) in the first trimester (RR, 1.62). Meanwhile, genital malformations, primarily hypospadias, occurred more frequently in children whose mothers were prescribed macrolides (5 per 1,000), compared with penicillin (3 per 1,000) in any trimester (RR, 1.58).

No increased risk of major malformations was associated with macrolides prescribed only in the second or third trimester, although a borderline significant association existed with gastrointestinal malformations. The authors also found no links between macrolides exposure and increased risk of cerebral palsy, epilepsy, ADHD, or autism spectrum disorder.

The findings did not change in several sensitivity analyses, including one that restricted analysis to antibiotics prescribed only for respiratory tract infections.

Dr. Fan and associates discussed several potential biological mechanisms for causation, including the arrhythmic effect of macrolides that may relate to cardiovascular malformations or contribute to fetal hypoxia. They noted that “macrolide prescribing during pregnancy warrants caution,” and recommend including on drug safety labels “that there is uncertainty about the safety of macrolides, including erythromycin” and alternative antibiotics should be used when possible.

Iris Krishna, MD, MPH, assistant professor of maternal-fetal medicine at Emory University, Atlanta, agreed with the study authors that use of macrolides in the first trimester warrants further investigation, and if an appropriate alternative antibiotic is available, then it should be preferentially considered when treating infections in the first trimester.

“However, if macrolides are the only treatment option, pregnant women can be reassured that the absolute risk of a birth defect is low, and this should not discourage them from taking a macrolide when needed as untreated infections pose a greater risk in pregnancy,” she said in an interview.

“This study does not establish that macrolide antibiotics cause birth defects, but it suggests a potential association. Previous studies examining the use of macrolides, such as erythromycin, have not demonstrated a consistent pattern of birth defects, and heart defects identified were classified as mostly mild. The authors suggest that the potential biologic mechanism based on rat models may be that macrolides might induce fetal cardiac arrhythmias and short-term fetal hypoxia. This study was underpowered to examine macrolide exposure for specific malformations. To avoid underpowered comparisons, the authors’ categorized malformations by organ systems, so the spectrum of cardiac defects is unclear,” commented Dr. Krishna, who also is a member of the Ob.Gyn. News editorial advisory board.

“Current recommendations for macrolide antibiotic use in pregnancy in the second and third trimester of pregnancy, and in particular when used for obstetric indications, such as prelabor rupture of membranes to prolong the latency period to delivery, should not be altered based on the findings of this study,” she concluded.

The research was funded by Child Health Research CIO Trust, the China Scholarship Council, Health Data Research UK, and the National Institute for Health Research. Dr. Fan and associates had no industry disclosures. Dr. Krishna had no relevant financial disclosures.

SOURCE: Fan H et al. BMJ. 2020;368:m331.

Women who had gestational diabetes mellitus had an increased risk for later type 2 diabetes if they carried certain genetic risk factors for the disease, according to a new analysis in BMJ Open Diabetes Research & Care of data from two independent populations.

A higher genetic risk score (GRS) had a modest association with developing type 2 diabetes, but a healthier diet may mitigate this risk, as Mengying Li, PhD, and her colleagues found for participants in the Nurses’ Health Study and members of the Danish National Birth Cohort who developed gestational diabetes mellitus (GDM).

Of 1,884 white women with a history of GDM in the Nurses’ Health Study II (NHSII), 446 (23.7%) went on to develop type 2 diabetes, and of the 550 women who had GDM in the Danish National Birth Cohort (DNBC), 155 (28.2%) developed the disease. The researchers calculated a GRS for type 2 diabetes for the full cohort. Genome-wide association studies completed in European populations were used to identify 59 single-nucleotide polymorphisms (SNPs) associated with the disease.

Dr. Li, an epidemiologist and postdoctoral researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md., and her coauthors found that women whose GRS was in the highest quartile had a relative risk of 1.19 for type 2 diabetes. The relative risks for the three lower quartiles were 1.25, 0.97, and 1.00, respectively (P value for trend = .02). For each increase of five risk alleles in the GRS, NHSII participants had a 7% increased risk for type 2 diabetes, and DNBC participants saw a 9% increased risk.

Comparing these findings with other studies looking at genetic risk and type 2 diabetes in the general population, Dr. Li and her coauthors noted that the increase in relative risk for type 2 disease with increase in GRS was actually slightly weaker in the GDM cohort they studied. “The smaller effect size among women with GDM likely reflects an already higher baseline genetic risk for [type 2 diabetes] than the general population, as we have demonstrated,” they explained.

Though 11 individual SNPs had a significant individual association with the risk for type 2 diabetes initially, that association disappeared after correction for a false-discovery rate. Dr. Li and her coinvestigators conducted a sensitivity analysis that included only 42 SNPs that were later definitively associated with type 2 disease and they saw essentially unchanged results.

The researchers also investigated how dietary quality affected the GRS–type 2 diabetes association by dichotomizing self-reported diet quality in both cohorts into healthier diet quality and less healthy diet quality. They found a tighter association between GRS and type 2 diabetes for women with diet quality below the median, whereas women with higher diet quality did not have such a strong association between GRS and type 2 disease. The researchers wrote that there was “suggestive evidence that a healthful diet might mitigate the excessive risk of T2D [type 2 diabetes] related to greater genetic susceptibility, which supports public health efforts of encouraging a healthful diet” for diabetes prevention in this high-risk population.

Patients in the NHSII were followed for a mean 21.3 years, and those in the DNBC were followed for a mean 12.7 years. Mean age at index pregnancy was 30.5 years for the NHSII cohort and 31.7 for the DNBC cohort. In the NHSII cohort, just 8.4% of participants reported smoking before pregnancy, compared with 26.4% of those in the DNBC cohort. The NHSII cohort participants, wrote Dr. Li and her coauthors, “were also less likely to have a family history of diabetes, less likely to smoke, and be leaner than women in the DNBC.”

Dr. Li and her coauthors noted that, “despite being the largest genetic study by far on [type 2 diabetes] among women with GDM, our study may not be sufficiently powered to examine the associations of individual T2D SNPs in relation to the risk of developing T2D.” Another limitation was that for the Danish cohort, information about diet was drawn from a one-time questionnaire administered between 9 and 16 years after the index pregnancy, so full data about dietary quality over time was not available. Also of note is that the study included only white participants, limiting generalizability to women of color. The authors called for expanding this research into more racially diverse populations.

The study was supported by the National Institutes of Health. The authors reported that they had no conflicts of interest.

SOURCE: Li M et al. BMJ Open Diab Res Care. 2020 Feb 13. doi: 10.1136/bmjdrc-2019-000850.

Women who had gestational diabetes mellitus had an increased risk for later type 2 diabetes if they carried certain genetic risk factors for the disease, according to a new analysis in BMJ Open Diabetes Research & Care of data from two independent populations.

A higher genetic risk score (GRS) had a modest association with developing type 2 diabetes, but a healthier diet may mitigate this risk, as Mengying Li, PhD, and her colleagues found for participants in the Nurses’ Health Study and members of the Danish National Birth Cohort who developed gestational diabetes mellitus (GDM).

Of 1,884 white women with a history of GDM in the Nurses’ Health Study II (NHSII), 446 (23.7%) went on to develop type 2 diabetes, and of the 550 women who had GDM in the Danish National Birth Cohort (DNBC), 155 (28.2%) developed the disease. The researchers calculated a GRS for type 2 diabetes for the full cohort. Genome-wide association studies completed in European populations were used to identify 59 single-nucleotide polymorphisms (SNPs) associated with the disease.

Dr. Li, an epidemiologist and postdoctoral researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md., and her coauthors found that women whose GRS was in the highest quartile had a relative risk of 1.19 for type 2 diabetes. The relative risks for the three lower quartiles were 1.25, 0.97, and 1.00, respectively (P value for trend = .02). For each increase of five risk alleles in the GRS, NHSII participants had a 7% increased risk for type 2 diabetes, and DNBC participants saw a 9% increased risk.

Comparing these findings with other studies looking at genetic risk and type 2 diabetes in the general population, Dr. Li and her coauthors noted that the increase in relative risk for type 2 disease with increase in GRS was actually slightly weaker in the GDM cohort they studied. “The smaller effect size among women with GDM likely reflects an already higher baseline genetic risk for [type 2 diabetes] than the general population, as we have demonstrated,” they explained.

Though 11 individual SNPs had a significant individual association with the risk for type 2 diabetes initially, that association disappeared after correction for a false-discovery rate. Dr. Li and her coinvestigators conducted a sensitivity analysis that included only 42 SNPs that were later definitively associated with type 2 disease and they saw essentially unchanged results.

The researchers also investigated how dietary quality affected the GRS–type 2 diabetes association by dichotomizing self-reported diet quality in both cohorts into healthier diet quality and less healthy diet quality. They found a tighter association between GRS and type 2 diabetes for women with diet quality below the median, whereas women with higher diet quality did not have such a strong association between GRS and type 2 disease. The researchers wrote that there was “suggestive evidence that a healthful diet might mitigate the excessive risk of T2D [type 2 diabetes] related to greater genetic susceptibility, which supports public health efforts of encouraging a healthful diet” for diabetes prevention in this high-risk population.

Patients in the NHSII were followed for a mean 21.3 years, and those in the DNBC were followed for a mean 12.7 years. Mean age at index pregnancy was 30.5 years for the NHSII cohort and 31.7 for the DNBC cohort. In the NHSII cohort, just 8.4% of participants reported smoking before pregnancy, compared with 26.4% of those in the DNBC cohort. The NHSII cohort participants, wrote Dr. Li and her coauthors, “were also less likely to have a family history of diabetes, less likely to smoke, and be leaner than women in the DNBC.”

Dr. Li and her coauthors noted that, “despite being the largest genetic study by far on [type 2 diabetes] among women with GDM, our study may not be sufficiently powered to examine the associations of individual T2D SNPs in relation to the risk of developing T2D.” Another limitation was that for the Danish cohort, information about diet was drawn from a one-time questionnaire administered between 9 and 16 years after the index pregnancy, so full data about dietary quality over time was not available. Also of note is that the study included only white participants, limiting generalizability to women of color. The authors called for expanding this research into more racially diverse populations.

The study was supported by the National Institutes of Health. The authors reported that they had no conflicts of interest.

SOURCE: Li M et al. BMJ Open Diab Res Care. 2020 Feb 13. doi: 10.1136/bmjdrc-2019-000850.

Women who had gestational diabetes mellitus had an increased risk for later type 2 diabetes if they carried certain genetic risk factors for the disease, according to a new analysis in BMJ Open Diabetes Research & Care of data from two independent populations.

A higher genetic risk score (GRS) had a modest association with developing type 2 diabetes, but a healthier diet may mitigate this risk, as Mengying Li, PhD, and her colleagues found for participants in the Nurses’ Health Study and members of the Danish National Birth Cohort who developed gestational diabetes mellitus (GDM).

Of 1,884 white women with a history of GDM in the Nurses’ Health Study II (NHSII), 446 (23.7%) went on to develop type 2 diabetes, and of the 550 women who had GDM in the Danish National Birth Cohort (DNBC), 155 (28.2%) developed the disease. The researchers calculated a GRS for type 2 diabetes for the full cohort. Genome-wide association studies completed in European populations were used to identify 59 single-nucleotide polymorphisms (SNPs) associated with the disease.

Dr. Li, an epidemiologist and postdoctoral researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Md., and her coauthors found that women whose GRS was in the highest quartile had a relative risk of 1.19 for type 2 diabetes. The relative risks for the three lower quartiles were 1.25, 0.97, and 1.00, respectively (P value for trend = .02). For each increase of five risk alleles in the GRS, NHSII participants had a 7% increased risk for type 2 diabetes, and DNBC participants saw a 9% increased risk.

Comparing these findings with other studies looking at genetic risk and type 2 diabetes in the general population, Dr. Li and her coauthors noted that the increase in relative risk for type 2 disease with increase in GRS was actually slightly weaker in the GDM cohort they studied. “The smaller effect size among women with GDM likely reflects an already higher baseline genetic risk for [type 2 diabetes] than the general population, as we have demonstrated,” they explained.

Though 11 individual SNPs had a significant individual association with the risk for type 2 diabetes initially, that association disappeared after correction for a false-discovery rate. Dr. Li and her coinvestigators conducted a sensitivity analysis that included only 42 SNPs that were later definitively associated with type 2 disease and they saw essentially unchanged results.

The researchers also investigated how dietary quality affected the GRS–type 2 diabetes association by dichotomizing self-reported diet quality in both cohorts into healthier diet quality and less healthy diet quality. They found a tighter association between GRS and type 2 diabetes for women with diet quality below the median, whereas women with higher diet quality did not have such a strong association between GRS and type 2 disease. The researchers wrote that there was “suggestive evidence that a healthful diet might mitigate the excessive risk of T2D [type 2 diabetes] related to greater genetic susceptibility, which supports public health efforts of encouraging a healthful diet” for diabetes prevention in this high-risk population.

Patients in the NHSII were followed for a mean 21.3 years, and those in the DNBC were followed for a mean 12.7 years. Mean age at index pregnancy was 30.5 years for the NHSII cohort and 31.7 for the DNBC cohort. In the NHSII cohort, just 8.4% of participants reported smoking before pregnancy, compared with 26.4% of those in the DNBC cohort. The NHSII cohort participants, wrote Dr. Li and her coauthors, “were also less likely to have a family history of diabetes, less likely to smoke, and be leaner than women in the DNBC.”

Dr. Li and her coauthors noted that, “despite being the largest genetic study by far on [type 2 diabetes] among women with GDM, our study may not be sufficiently powered to examine the associations of individual T2D SNPs in relation to the risk of developing T2D.” Another limitation was that for the Danish cohort, information about diet was drawn from a one-time questionnaire administered between 9 and 16 years after the index pregnancy, so full data about dietary quality over time was not available. Also of note is that the study included only white participants, limiting generalizability to women of color. The authors called for expanding this research into more racially diverse populations.

The study was supported by the National Institutes of Health. The authors reported that they had no conflicts of interest.

SOURCE: Li M et al. BMJ Open Diab Res Care. 2020 Feb 13. doi: 10.1136/bmjdrc-2019-000850.

Vitamin D supplementation during pregnancy is associated with higher bone mineral content in the offspring, even up to 6 years after birth, research suggests.

copyright Joss/Fotolia.com

“The well-established tracking of bone mineralization from early life throughout childhood and early adulthood is a key factor for the final peak bone mass gained and the subsequent risk of fractures and osteoporosis later in life,” wrote Nicklas Brustad, MD, of the Herlev and Gentofte Hospital at the University of Copenhagen, and coauthors. Their report is in JAMA Pediatrics.This was a secondary analysis of a prospective, double-blind, randomized controlled trial of high versus standard dose vitamin D supplementation in 623 pregnant Danish women and the outcomes in their 584 children. The women were randomized either to a daily dose of 2,400 IU vitamin D₃ (cholecalciferol) or matching placebo capsules from 24 weeks’ gestation until 1 week after birth. All women were advised to maintain a daily intake of 400 IU of vitamin D₃.

The children underwent anthropometric growth assessments regularly up to age 6 years, and underwent whole-body dual-energy radiograph absorptiometry (DXA) scanning at 3 years and 6 years.

At 3 years, children of mothers who received the vitamin D supplements showed significantly higher mean total-body-less-head (TBLH) bone mineral content (BMC) compared with those who received placebo (294 g vs. 289 g) and total-body BMC (526 g vs. 514 g), respectively, after adjustment for age, sex, height, and weight.

The difference in total-body BMC was particularly evident in children of mothers who had insufficient vitamin D levels at baseline, compared with those with sufficient vitamin D levels (538 g vs. 514 g). The study also saw higher head bone mineral density (BMD) in children of mothers with insufficient vitamin D at baseline who received supplementation.

At 6 years, there still were significant differences in BMC between the supplementation and placebo groups. Children in the vitamin D group had an 8-g greater TBLH BMC compared with those in the placebo group, and a 14-g higher total BMC.

Among the children of mothers with insufficient preintervention vitamin D, there was an 18-g higher mean total BMC and 0.0125 g/cm² greater total BMD, compared with those with sufficient vitamin D at baseline.

Overall, the children of mothers who received high-dose vitamin D supplementation had a mean 8-g higher TBLH BMC, a mean 0.023 g/cm² higher head BMD, and a mean 12-g higher total BMC.

Dr. Brustad and associates noted that the head could represent the most sensitive compartment for intervention, because 80% of bone mineralization of the skull occurs by the age of 3 years.

The study also showed a seasonal effect, such that mothers who gave birth in winter showed the greatest effects of vitamin D supplementation on head BMC.

There was a nonsignificant trend toward a lower fracture rate among children in the supplementation group, compared with the placebo group.

“We speculate that these intervention effects could be of importance for bone health and osteoporosis risk in adult life, which is supported by our likely underpowered post hoc analysis on fracture risk, suggesting an almost 40% reduced incidence of fractures of the larger bones in the high-dose vitamin D group,” the authors wrote.

Vitamin D supplementation did not appear to affect the children’s growth. At 6 years, there were no significant differences between the two groups in body mass index, height, weight, or waist, head, and thorax circumference.

Neonatologist Carol Wagner, MD, said in an interview that the study provided an absolute reason for vitamin D supplementation during pregnancy.

“At the very least, a study like this argues for much more than is recommended by the European nutrition group or the U.S. group,” said Dr. Wagner, professor of pediatrics at the Medical University of South Carolina, Charleston. “Here you have a therapy that costs literally pennies a day, and no one should be deficient.”

She also pointed out that the study was able to show significant effects on BMC despite the fact that there would have been considerable variation in postnatal vitamin D intake from breast milk or formula.

Cristina Palacios, PhD, an associate professor in the department of dietetics and nutrition at Florida International University, Miami, said that vitamin D deficiency is increasingly prevalent worldwide, and is associated with a return of rickets – the skeletal disorder caused by vitamin D deficiency – in children.

“If women are deficient during pregnancy, providing vitamin D supplementation in pregnancy may promote bone health in their offspring,” Dr. Palacios said in an interview. “Because vitamin D is such an important component of bone metabolism, this could prevent future rickets in these children.”

Dr. Palacios coauthored a recent Cochrane review that examined the safety of high-dose vitamin D supplementation in pregnancy, and said the analysis found no evidence of safety concerns.

The study was supported by The Lundbeck Foundation, the Ministry of Health, Danish Council for Strategic Research, and the Capital Region Research Foundation. The authors declared no conflicts of interest.

SOURCE: Brustad N et al. JAMA Pediatrics 2020 Feb 24. doi: 10.1001/jamapediatrics.2019.6083.

Vitamin D supplementation during pregnancy is associated with higher bone mineral content in the offspring, even up to 6 years after birth, research suggests.

copyright Joss/Fotolia.com

“The well-established tracking of bone mineralization from early life throughout childhood and early adulthood is a key factor for the final peak bone mass gained and the subsequent risk of fractures and osteoporosis later in life,” wrote Nicklas Brustad, MD, of the Herlev and Gentofte Hospital at the University of Copenhagen, and coauthors. Their report is in JAMA Pediatrics.This was a secondary analysis of a prospective, double-blind, randomized controlled trial of high versus standard dose vitamin D supplementation in 623 pregnant Danish women and the outcomes in their 584 children. The women were randomized either to a daily dose of 2,400 IU vitamin D₃ (cholecalciferol) or matching placebo capsules from 24 weeks’ gestation until 1 week after birth. All women were advised to maintain a daily intake of 400 IU of vitamin D₃.

The children underwent anthropometric growth assessments regularly up to age 6 years, and underwent whole-body dual-energy radiograph absorptiometry (DXA) scanning at 3 years and 6 years.

At 3 years, children of mothers who received the vitamin D supplements showed significantly higher mean total-body-less-head (TBLH) bone mineral content (BMC) compared with those who received placebo (294 g vs. 289 g) and total-body BMC (526 g vs. 514 g), respectively, after adjustment for age, sex, height, and weight.

The difference in total-body BMC was particularly evident in children of mothers who had insufficient vitamin D levels at baseline, compared with those with sufficient vitamin D levels (538 g vs. 514 g). The study also saw higher head bone mineral density (BMD) in children of mothers with insufficient vitamin D at baseline who received supplementation.

At 6 years, there still were significant differences in BMC between the supplementation and placebo groups. Children in the vitamin D group had an 8-g greater TBLH BMC compared with those in the placebo group, and a 14-g higher total BMC.

Among the children of mothers with insufficient preintervention vitamin D, there was an 18-g higher mean total BMC and 0.0125 g/cm² greater total BMD, compared with those with sufficient vitamin D at baseline.

Overall, the children of mothers who received high-dose vitamin D supplementation had a mean 8-g higher TBLH BMC, a mean 0.023 g/cm² higher head BMD, and a mean 12-g higher total BMC.

Dr. Brustad and associates noted that the head could represent the most sensitive compartment for intervention, because 80% of bone mineralization of the skull occurs by the age of 3 years.

The study also showed a seasonal effect, such that mothers who gave birth in winter showed the greatest effects of vitamin D supplementation on head BMC.

There was a nonsignificant trend toward a lower fracture rate among children in the supplementation group, compared with the placebo group.

“We speculate that these intervention effects could be of importance for bone health and osteoporosis risk in adult life, which is supported by our likely underpowered post hoc analysis on fracture risk, suggesting an almost 40% reduced incidence of fractures of the larger bones in the high-dose vitamin D group,” the authors wrote.

Vitamin D supplementation did not appear to affect the children’s growth. At 6 years, there were no significant differences between the two groups in body mass index, height, weight, or waist, head, and thorax circumference.

Neonatologist Carol Wagner, MD, said in an interview that the study provided an absolute reason for vitamin D supplementation during pregnancy.

“At the very least, a study like this argues for much more than is recommended by the European nutrition group or the U.S. group,” said Dr. Wagner, professor of pediatrics at the Medical University of South Carolina, Charleston. “Here you have a therapy that costs literally pennies a day, and no one should be deficient.”

She also pointed out that the study was able to show significant effects on BMC despite the fact that there would have been considerable variation in postnatal vitamin D intake from breast milk or formula.

Cristina Palacios, PhD, an associate professor in the department of dietetics and nutrition at Florida International University, Miami, said that vitamin D deficiency is increasingly prevalent worldwide, and is associated with a return of rickets – the skeletal disorder caused by vitamin D deficiency – in children.

“If women are deficient during pregnancy, providing vitamin D supplementation in pregnancy may promote bone health in their offspring,” Dr. Palacios said in an interview. “Because vitamin D is such an important component of bone metabolism, this could prevent future rickets in these children.”

Dr. Palacios coauthored a recent Cochrane review that examined the safety of high-dose vitamin D supplementation in pregnancy, and said the analysis found no evidence of safety concerns.

The study was supported by The Lundbeck Foundation, the Ministry of Health, Danish Council for Strategic Research, and the Capital Region Research Foundation. The authors declared no conflicts of interest.

SOURCE: Brustad N et al. JAMA Pediatrics 2020 Feb 24. doi: 10.1001/jamapediatrics.2019.6083.

Vitamin D supplementation during pregnancy is associated with higher bone mineral content in the offspring, even up to 6 years after birth, research suggests.

copyright Joss/Fotolia.com

“The well-established tracking of bone mineralization from early life throughout childhood and early adulthood is a key factor for the final peak bone mass gained and the subsequent risk of fractures and osteoporosis later in life,” wrote Nicklas Brustad, MD, of the Herlev and Gentofte Hospital at the University of Copenhagen, and coauthors. Their report is in JAMA Pediatrics.This was a secondary analysis of a prospective, double-blind, randomized controlled trial of high versus standard dose vitamin D supplementation in 623 pregnant Danish women and the outcomes in their 584 children. The women were randomized either to a daily dose of 2,400 IU vitamin D₃ (cholecalciferol) or matching placebo capsules from 24 weeks’ gestation until 1 week after birth. All women were advised to maintain a daily intake of 400 IU of vitamin D₃.

The children underwent anthropometric growth assessments regularly up to age 6 years, and underwent whole-body dual-energy radiograph absorptiometry (DXA) scanning at 3 years and 6 years.

At 3 years, children of mothers who received the vitamin D supplements showed significantly higher mean total-body-less-head (TBLH) bone mineral content (BMC) compared with those who received placebo (294 g vs. 289 g) and total-body BMC (526 g vs. 514 g), respectively, after adjustment for age, sex, height, and weight.

The difference in total-body BMC was particularly evident in children of mothers who had insufficient vitamin D levels at baseline, compared with those with sufficient vitamin D levels (538 g vs. 514 g). The study also saw higher head bone mineral density (BMD) in children of mothers with insufficient vitamin D at baseline who received supplementation.

At 6 years, there still were significant differences in BMC between the supplementation and placebo groups. Children in the vitamin D group had an 8-g greater TBLH BMC compared with those in the placebo group, and a 14-g higher total BMC.

Among the children of mothers with insufficient preintervention vitamin D, there was an 18-g higher mean total BMC and 0.0125 g/cm² greater total BMD, compared with those with sufficient vitamin D at baseline.

Overall, the children of mothers who received high-dose vitamin D supplementation had a mean 8-g higher TBLH BMC, a mean 0.023 g/cm² higher head BMD, and a mean 12-g higher total BMC.

Dr. Brustad and associates noted that the head could represent the most sensitive compartment for intervention, because 80% of bone mineralization of the skull occurs by the age of 3 years.

The study also showed a seasonal effect, such that mothers who gave birth in winter showed the greatest effects of vitamin D supplementation on head BMC.

There was a nonsignificant trend toward a lower fracture rate among children in the supplementation group, compared with the placebo group.

“We speculate that these intervention effects could be of importance for bone health and osteoporosis risk in adult life, which is supported by our likely underpowered post hoc analysis on fracture risk, suggesting an almost 40% reduced incidence of fractures of the larger bones in the high-dose vitamin D group,” the authors wrote.

Vitamin D supplementation did not appear to affect the children’s growth. At 6 years, there were no significant differences between the two groups in body mass index, height, weight, or waist, head, and thorax circumference.

Neonatologist Carol Wagner, MD, said in an interview that the study provided an absolute reason for vitamin D supplementation during pregnancy.

“At the very least, a study like this argues for much more than is recommended by the European nutrition group or the U.S. group,” said Dr. Wagner, professor of pediatrics at the Medical University of South Carolina, Charleston. “Here you have a therapy that costs literally pennies a day, and no one should be deficient.”

She also pointed out that the study was able to show significant effects on BMC despite the fact that there would have been considerable variation in postnatal vitamin D intake from breast milk or formula.

Cristina Palacios, PhD, an associate professor in the department of dietetics and nutrition at Florida International University, Miami, said that vitamin D deficiency is increasingly prevalent worldwide, and is associated with a return of rickets – the skeletal disorder caused by vitamin D deficiency – in children.

“If women are deficient during pregnancy, providing vitamin D supplementation in pregnancy may promote bone health in their offspring,” Dr. Palacios said in an interview. “Because vitamin D is such an important component of bone metabolism, this could prevent future rickets in these children.”

Dr. Palacios coauthored a recent Cochrane review that examined the safety of high-dose vitamin D supplementation in pregnancy, and said the analysis found no evidence of safety concerns.

The study was supported by The Lundbeck Foundation, the Ministry of Health, Danish Council for Strategic Research, and the Capital Region Research Foundation. The authors declared no conflicts of interest.

SOURCE: Brustad N et al. JAMA Pediatrics 2020 Feb 24. doi: 10.1001/jamapediatrics.2019.6083.

For more than a decade, most physicians have paid a steady amount for medical liability insurance. But that price stability appears to be ending, according to a recent analysis.

In 2019, more than 25% of medical liability insurance premiums rose for internists, ob.gyns., and surgeons, a review by the Medical Liability Monitor (MLM) found. The MLM survey, published annually, analyzes premium data from major malpractice insurers based on mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

The increases mark a shift in the long-stable market and suggest rising premiums in the future, said Michael Matray, editor for the Medical Liability Monitor.

“It’s my impression that rates will increase again in [2020]. It’s almost a foregone conclusion,” he said in an interview. “We can expect more firming within the market.”

Most of the premium increases in 2019 were small – between 0.1% and 10%, Mr. Matray said. At the same time, close to 70% of premium rates were flat in 2019 and about 5% of premium rates decreased, according to the survey, released in late 2019.

Comparatively, about 58% of premium rates were flat from 2007 to 2014, about 30% of rates went down during that time frame, and 12% of rates went up. From 2015 to 2018, nearly 76% of rates were steady, 10% went down, and 15% of rates increased, according to the latest analysis. 2019 was the first time since 2006 that more than 25% of premium rates rose, the survey noted.

“This is a normal cycle for the insurance industry – years of feast, followed by years of famine. Eventually companies reach a point where they feel enough pain and one response is to raise rates,” said Alyssa Gittleman, a coauthor of the survey and senior associate in the insurance research department at Conning, an investment management firm for the insurance industry.

“We could also point out many of the rate increases reported in the survey came from the larger [medical professional liability] companies. These companies are well capitalized, and the fact that they are raising rates could be a bellwether that a hard market is coming. However, as we said in the survey, it will probably take another 12-24 months before we know for certain,” she added.
 

Location, location, location

Physicians continue to pay vastly different premiums depending on where they practice. Ob.gyns. in eastern New York for example, paid about $201,000 in 2019, while their Minnesota colleagues paid about $16,500. Internists in southern Florida, meanwhile, paid about $49,000 in 2019, while their counterparts in northern California paid about $4,100. General surgeons in southern Florida paid about $195,000 for malpractice insurance, while some Wisconsin general surgeons paid about $11,000.

“Medical malpractice rates are determined locally, that’s why we don’t give state averages or national averages [in the survey],” Mr. Matray said. “It’s all determined by malpractice claims history within that territory and how aggressive the plaintiffs bar is in those areas.”

Two states – Arizona and Pennsylvania – experienced exceptional rate decreases in 2019. In Arizona, The Doctors Company lowered their rates by more than 60% for internists, general surgeons, and ob.gyns. In Pennsylvania, which operates a patient compensation fund, The Doctors Company decreased its rates between 20% and 46% for each of the three specialties. The insurer reported it made the decreases to align its rates with other insurers in those states, according to the survey. The Doctors Company did not respond to messages seeking comment for this article.

When individual companies greatly increase or greatly decrease rates in a given state, it’s generally to bring their rates in line with those of larger companies in the market, said Bill Burns, a coauthor of the MLM report and a vice president in the insurance research department at Conning. In 2018, The Doctors Company held about 2% of the market in Arizona, and the company held about 1% of the Pennsylvania market, he noted.

“These decreases, which get them in line with the larger writers, should tighten up the range of rates in those states,” Mr. Burns said in an interview. “To sell the product, they’re going to have be close to the competition.”

For a clear picture of the overall premium landscape, the survey authors analyzed the data both with and without the exceptional rate decreases in Arizona and Pennsylvania. Regionally – excluding the exceptional decreases – the average premium rate increase was 2% in the Midwest, 1.4% in the Northeast, 1.1% in the South, and 0.3% in the West.

For all three specialties surveyed, premiums rose slightly in 2019, with surgeons experiencing the largest increase. Internists saw a nearly 1% average rate increase, ob.gyns. experienced a 0.5% rise, and surgeons experienced a 2.3% rate increase, the survey found. For doctors in the seven states that have patient compensation funds, internists experienced a nearly 2.1% average rate increase, ob.gyns. saw a 1.4% rise, and surgeons experienced a 2.1% rate increase. (These data sets exclude the exceptional rate decreases in Arizona and Pennsylvania.)

The change in rates for general surgery could mean more claims are being filed against surgeons or that the cost of claims are rising, Mr. Burns said.

“The differences are not terribly significant, but suggest something is happening with general surgery,” he said.
 

Why are rates on the rise?

A number of factors are behind the changing medical liability insurance market, said Brian Atchinson, president and CEO for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

While the frequency of claims against physicians has remained flat for an extended period of time, the cost of managing those claims has continued to increase, he said.

“Medical liability insurers insuring physicians and other clinicians, they need to defend every claim that they believe warrants defense,” Mr. Atchinson said in an interview. “When the medical treatment provided is within the appropriate standards, even though there may be claims or lawsuits, every one of those [cases] can be very expensive to defend.”

Other contributers to the increasing rates include the trend of high-dollar settlements and judgments, particularly in the hospital space, Mr. Atchinson noted. Such large payouts are generally tied to hospital and health system claims, but they still affect the broader medical liability insurance marketplace, he said.

Additionally, a growing number of medical liability tort reform measures enacted over the last 20 years are being eliminated, Mr. Atchinson said. In June 2019, the Kansas Supreme Court for instance, struck down the state’s cap on damages for noneconomic injuries in medical liability cases. In a 2017 ruling, the Pennsylvania Supreme Court changed the state’s statue of limitations for medical malpractice wrongful death claims from 2 years from the time of the patient’s injury to 2 years from the time of the patient’s death.

When legislatures change state laws and courts invalidate protections against nonmeritorious lawsuits, the actions can have serious consequences for physicians and companies operating in those states, Mr. Atchinson said.

“These [changes] will all ultimately work their way into the rates that physicians are paying,” he said.

agallegos@mdedge.com

For more than a decade, most physicians have paid a steady amount for medical liability insurance. But that price stability appears to be ending, according to a recent analysis.

In 2019, more than 25% of medical liability insurance premiums rose for internists, ob.gyns., and surgeons, a review by the Medical Liability Monitor (MLM) found. The MLM survey, published annually, analyzes premium data from major malpractice insurers based on mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

The increases mark a shift in the long-stable market and suggest rising premiums in the future, said Michael Matray, editor for the Medical Liability Monitor.

“It’s my impression that rates will increase again in [2020]. It’s almost a foregone conclusion,” he said in an interview. “We can expect more firming within the market.”

Most of the premium increases in 2019 were small – between 0.1% and 10%, Mr. Matray said. At the same time, close to 70% of premium rates were flat in 2019 and about 5% of premium rates decreased, according to the survey, released in late 2019.

Comparatively, about 58% of premium rates were flat from 2007 to 2014, about 30% of rates went down during that time frame, and 12% of rates went up. From 2015 to 2018, nearly 76% of rates were steady, 10% went down, and 15% of rates increased, according to the latest analysis. 2019 was the first time since 2006 that more than 25% of premium rates rose, the survey noted.

“This is a normal cycle for the insurance industry – years of feast, followed by years of famine. Eventually companies reach a point where they feel enough pain and one response is to raise rates,” said Alyssa Gittleman, a coauthor of the survey and senior associate in the insurance research department at Conning, an investment management firm for the insurance industry.

“We could also point out many of the rate increases reported in the survey came from the larger [medical professional liability] companies. These companies are well capitalized, and the fact that they are raising rates could be a bellwether that a hard market is coming. However, as we said in the survey, it will probably take another 12-24 months before we know for certain,” she added.
 

Location, location, location

Physicians continue to pay vastly different premiums depending on where they practice. Ob.gyns. in eastern New York for example, paid about $201,000 in 2019, while their Minnesota colleagues paid about $16,500. Internists in southern Florida, meanwhile, paid about $49,000 in 2019, while their counterparts in northern California paid about $4,100. General surgeons in southern Florida paid about $195,000 for malpractice insurance, while some Wisconsin general surgeons paid about $11,000.

“Medical malpractice rates are determined locally, that’s why we don’t give state averages or national averages [in the survey],” Mr. Matray said. “It’s all determined by malpractice claims history within that territory and how aggressive the plaintiffs bar is in those areas.”

Two states – Arizona and Pennsylvania – experienced exceptional rate decreases in 2019. In Arizona, The Doctors Company lowered their rates by more than 60% for internists, general surgeons, and ob.gyns. In Pennsylvania, which operates a patient compensation fund, The Doctors Company decreased its rates between 20% and 46% for each of the three specialties. The insurer reported it made the decreases to align its rates with other insurers in those states, according to the survey. The Doctors Company did not respond to messages seeking comment for this article.

When individual companies greatly increase or greatly decrease rates in a given state, it’s generally to bring their rates in line with those of larger companies in the market, said Bill Burns, a coauthor of the MLM report and a vice president in the insurance research department at Conning. In 2018, The Doctors Company held about 2% of the market in Arizona, and the company held about 1% of the Pennsylvania market, he noted.

“These decreases, which get them in line with the larger writers, should tighten up the range of rates in those states,” Mr. Burns said in an interview. “To sell the product, they’re going to have be close to the competition.”

For a clear picture of the overall premium landscape, the survey authors analyzed the data both with and without the exceptional rate decreases in Arizona and Pennsylvania. Regionally – excluding the exceptional decreases – the average premium rate increase was 2% in the Midwest, 1.4% in the Northeast, 1.1% in the South, and 0.3% in the West.

For all three specialties surveyed, premiums rose slightly in 2019, with surgeons experiencing the largest increase. Internists saw a nearly 1% average rate increase, ob.gyns. experienced a 0.5% rise, and surgeons experienced a 2.3% rate increase, the survey found. For doctors in the seven states that have patient compensation funds, internists experienced a nearly 2.1% average rate increase, ob.gyns. saw a 1.4% rise, and surgeons experienced a 2.1% rate increase. (These data sets exclude the exceptional rate decreases in Arizona and Pennsylvania.)

The change in rates for general surgery could mean more claims are being filed against surgeons or that the cost of claims are rising, Mr. Burns said.

“The differences are not terribly significant, but suggest something is happening with general surgery,” he said.
 

Why are rates on the rise?

A number of factors are behind the changing medical liability insurance market, said Brian Atchinson, president and CEO for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

While the frequency of claims against physicians has remained flat for an extended period of time, the cost of managing those claims has continued to increase, he said.

“Medical liability insurers insuring physicians and other clinicians, they need to defend every claim that they believe warrants defense,” Mr. Atchinson said in an interview. “When the medical treatment provided is within the appropriate standards, even though there may be claims or lawsuits, every one of those [cases] can be very expensive to defend.”

Other contributers to the increasing rates include the trend of high-dollar settlements and judgments, particularly in the hospital space, Mr. Atchinson noted. Such large payouts are generally tied to hospital and health system claims, but they still affect the broader medical liability insurance marketplace, he said.

Additionally, a growing number of medical liability tort reform measures enacted over the last 20 years are being eliminated, Mr. Atchinson said. In June 2019, the Kansas Supreme Court for instance, struck down the state’s cap on damages for noneconomic injuries in medical liability cases. In a 2017 ruling, the Pennsylvania Supreme Court changed the state’s statue of limitations for medical malpractice wrongful death claims from 2 years from the time of the patient’s injury to 2 years from the time of the patient’s death.

When legislatures change state laws and courts invalidate protections against nonmeritorious lawsuits, the actions can have serious consequences for physicians and companies operating in those states, Mr. Atchinson said.

“These [changes] will all ultimately work their way into the rates that physicians are paying,” he said.

agallegos@mdedge.com

For more than a decade, most physicians have paid a steady amount for medical liability insurance. But that price stability appears to be ending, according to a recent analysis.

In 2019, more than 25% of medical liability insurance premiums rose for internists, ob.gyns., and surgeons, a review by the Medical Liability Monitor (MLM) found. The MLM survey, published annually, analyzes premium data from major malpractice insurers based on mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

The increases mark a shift in the long-stable market and suggest rising premiums in the future, said Michael Matray, editor for the Medical Liability Monitor.

“It’s my impression that rates will increase again in [2020]. It’s almost a foregone conclusion,” he said in an interview. “We can expect more firming within the market.”

Most of the premium increases in 2019 were small – between 0.1% and 10%, Mr. Matray said. At the same time, close to 70% of premium rates were flat in 2019 and about 5% of premium rates decreased, according to the survey, released in late 2019.

Comparatively, about 58% of premium rates were flat from 2007 to 2014, about 30% of rates went down during that time frame, and 12% of rates went up. From 2015 to 2018, nearly 76% of rates were steady, 10% went down, and 15% of rates increased, according to the latest analysis. 2019 was the first time since 2006 that more than 25% of premium rates rose, the survey noted.

“This is a normal cycle for the insurance industry – years of feast, followed by years of famine. Eventually companies reach a point where they feel enough pain and one response is to raise rates,” said Alyssa Gittleman, a coauthor of the survey and senior associate in the insurance research department at Conning, an investment management firm for the insurance industry.

“We could also point out many of the rate increases reported in the survey came from the larger [medical professional liability] companies. These companies are well capitalized, and the fact that they are raising rates could be a bellwether that a hard market is coming. However, as we said in the survey, it will probably take another 12-24 months before we know for certain,” she added.
 

Location, location, location

Physicians continue to pay vastly different premiums depending on where they practice. Ob.gyns. in eastern New York for example, paid about $201,000 in 2019, while their Minnesota colleagues paid about $16,500. Internists in southern Florida, meanwhile, paid about $49,000 in 2019, while their counterparts in northern California paid about $4,100. General surgeons in southern Florida paid about $195,000 for malpractice insurance, while some Wisconsin general surgeons paid about $11,000.

“Medical malpractice rates are determined locally, that’s why we don’t give state averages or national averages [in the survey],” Mr. Matray said. “It’s all determined by malpractice claims history within that territory and how aggressive the plaintiffs bar is in those areas.”

Two states – Arizona and Pennsylvania – experienced exceptional rate decreases in 2019. In Arizona, The Doctors Company lowered their rates by more than 60% for internists, general surgeons, and ob.gyns. In Pennsylvania, which operates a patient compensation fund, The Doctors Company decreased its rates between 20% and 46% for each of the three specialties. The insurer reported it made the decreases to align its rates with other insurers in those states, according to the survey. The Doctors Company did not respond to messages seeking comment for this article.

When individual companies greatly increase or greatly decrease rates in a given state, it’s generally to bring their rates in line with those of larger companies in the market, said Bill Burns, a coauthor of the MLM report and a vice president in the insurance research department at Conning. In 2018, The Doctors Company held about 2% of the market in Arizona, and the company held about 1% of the Pennsylvania market, he noted.

“These decreases, which get them in line with the larger writers, should tighten up the range of rates in those states,” Mr. Burns said in an interview. “To sell the product, they’re going to have be close to the competition.”

For a clear picture of the overall premium landscape, the survey authors analyzed the data both with and without the exceptional rate decreases in Arizona and Pennsylvania. Regionally – excluding the exceptional decreases – the average premium rate increase was 2% in the Midwest, 1.4% in the Northeast, 1.1% in the South, and 0.3% in the West.

For all three specialties surveyed, premiums rose slightly in 2019, with surgeons experiencing the largest increase. Internists saw a nearly 1% average rate increase, ob.gyns. experienced a 0.5% rise, and surgeons experienced a 2.3% rate increase, the survey found. For doctors in the seven states that have patient compensation funds, internists experienced a nearly 2.1% average rate increase, ob.gyns. saw a 1.4% rise, and surgeons experienced a 2.1% rate increase. (These data sets exclude the exceptional rate decreases in Arizona and Pennsylvania.)

The change in rates for general surgery could mean more claims are being filed against surgeons or that the cost of claims are rising, Mr. Burns said.

“The differences are not terribly significant, but suggest something is happening with general surgery,” he said.
 

Why are rates on the rise?

A number of factors are behind the changing medical liability insurance market, said Brian Atchinson, president and CEO for the Medical Professional Liability Association (MPL Association), a trade association for medical liability insurers.

While the frequency of claims against physicians has remained flat for an extended period of time, the cost of managing those claims has continued to increase, he said.

“Medical liability insurers insuring physicians and other clinicians, they need to defend every claim that they believe warrants defense,” Mr. Atchinson said in an interview. “When the medical treatment provided is within the appropriate standards, even though there may be claims or lawsuits, every one of those [cases] can be very expensive to defend.”

Other contributers to the increasing rates include the trend of high-dollar settlements and judgments, particularly in the hospital space, Mr. Atchinson noted. Such large payouts are generally tied to hospital and health system claims, but they still affect the broader medical liability insurance marketplace, he said.

Additionally, a growing number of medical liability tort reform measures enacted over the last 20 years are being eliminated, Mr. Atchinson said. In June 2019, the Kansas Supreme Court for instance, struck down the state’s cap on damages for noneconomic injuries in medical liability cases. In a 2017 ruling, the Pennsylvania Supreme Court changed the state’s statue of limitations for medical malpractice wrongful death claims from 2 years from the time of the patient’s injury to 2 years from the time of the patient’s death.

When legislatures change state laws and courts invalidate protections against nonmeritorious lawsuits, the actions can have serious consequences for physicians and companies operating in those states, Mr. Atchinson said.

“These [changes] will all ultimately work their way into the rates that physicians are paying,” he said.

agallegos@mdedge.com