The American Academy of Pediatrics is built on good intentions. It wants the best for children in the world, and it hopes to support its members in their efforts to achieve this goal. But from time to time, the academy loses sight of reality and makes recommendations that are counterproductive to its stated goals.

The recent release of its new policy “Breastfeeding and the Use of Human Milk” is another unfortunate example of poorly aimed recommendations. A careful reading of the document reveals it to be a well-researched treatise on breastfeeding and the value of human milk, including a discussion of the numerous impediments to the universal adoption of breastfeeding in our society. However, when a document of this breadth and complexity is released to the public it is never surprising that the messages deserving the most attention are lost in the press coverage. Most of the headlines I saw mentioned pediatricians supporting breastfeeding for a year or 2.

Who was the target audience? If it was pediatricians, most of us don’t need a longer list of the health benefits of breastfeeding. We already believe it is the best nutritional source for human babies and realize that the institutional framework in this country continues to be unfriendly to women who intend to breastfeed.

If the audience is politicians and public health decision-makers, the new policy contains a wealth of supportive evidence. However, most pediatricians I know are too busy or lack the skills and enthusiasm to become political activists. For the rest of population, including parents, the recommendations represent a collection of TMI (too much information).

If the audience is women who are considering breastfeeding I suspect nearly 100% already know pediatricians think it is the preferred way to feed their babies. And, likewise, a longer list won’t convince them to try nursing. Additional evidence may simply make them feel more guilty when they aren’t successful.

Many pregnant women have already been told that breastfeeding can be a challenge and given their situation breast milk alone for the first 6 months may sound like an unreasonable goal. The new recommendation that breastfeeding for a year or 2 is good is not a message they want to hear.

On the other hand, if the target audience is women who will be comforted to hear an official statement that normalizes breastfeeding longer than a year, the new policy statement has hit the nail on the head.

Of course the new policy document is sprinkled with caveats that vaguely hint at the possibility that pediatricians are sensitive human beings who under certain circumstances may be able to compromise when it comes to the duration of breastfeeding and the introduction of formula. But this whiff of reality is certainly not the dominant odor in these new recommendations.

Don’t get me wrong: I think the academy was overdue for a policy revision on breastfeeding. However, it should have been one that was reality based. It should acknowledge that there are institutional and societal biases against breastfeeding, and it should remind pediatricians that they can effect change by discussing these realities honestly with parents, while making it clear that we are there for them and their children regardless of how they feed their baby. Pediatricians believe that breastfeeding is the best but not the only way to feed a baby. We have (or will provide) the skills to assist parents succeed in whatever method they choose and strive to minimize the impediments that are within our power to change.

If the academy had chosen to release a separate statement simply supporting mothers who chose to nurse longer than a year, then that would have been a good idea. However, when presented as part of the larger document, that message dominated in the media and only served to fuel the guilt that many new mothers must endure.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The American Academy of Pediatrics is built on good intentions. It wants the best for children in the world, and it hopes to support its members in their efforts to achieve this goal. But from time to time, the academy loses sight of reality and makes recommendations that are counterproductive to its stated goals.

The recent release of its new policy “Breastfeeding and the Use of Human Milk” is another unfortunate example of poorly aimed recommendations. A careful reading of the document reveals it to be a well-researched treatise on breastfeeding and the value of human milk, including a discussion of the numerous impediments to the universal adoption of breastfeeding in our society. However, when a document of this breadth and complexity is released to the public it is never surprising that the messages deserving the most attention are lost in the press coverage. Most of the headlines I saw mentioned pediatricians supporting breastfeeding for a year or 2.

Who was the target audience? If it was pediatricians, most of us don’t need a longer list of the health benefits of breastfeeding. We already believe it is the best nutritional source for human babies and realize that the institutional framework in this country continues to be unfriendly to women who intend to breastfeed.

If the audience is politicians and public health decision-makers, the new policy contains a wealth of supportive evidence. However, most pediatricians I know are too busy or lack the skills and enthusiasm to become political activists. For the rest of population, including parents, the recommendations represent a collection of TMI (too much information).

If the audience is women who are considering breastfeeding I suspect nearly 100% already know pediatricians think it is the preferred way to feed their babies. And, likewise, a longer list won’t convince them to try nursing. Additional evidence may simply make them feel more guilty when they aren’t successful.

Many pregnant women have already been told that breastfeeding can be a challenge and given their situation breast milk alone for the first 6 months may sound like an unreasonable goal. The new recommendation that breastfeeding for a year or 2 is good is not a message they want to hear.

On the other hand, if the target audience is women who will be comforted to hear an official statement that normalizes breastfeeding longer than a year, the new policy statement has hit the nail on the head.

Of course the new policy document is sprinkled with caveats that vaguely hint at the possibility that pediatricians are sensitive human beings who under certain circumstances may be able to compromise when it comes to the duration of breastfeeding and the introduction of formula. But this whiff of reality is certainly not the dominant odor in these new recommendations.

Don’t get me wrong: I think the academy was overdue for a policy revision on breastfeeding. However, it should have been one that was reality based. It should acknowledge that there are institutional and societal biases against breastfeeding, and it should remind pediatricians that they can effect change by discussing these realities honestly with parents, while making it clear that we are there for them and their children regardless of how they feed their baby. Pediatricians believe that breastfeeding is the best but not the only way to feed a baby. We have (or will provide) the skills to assist parents succeed in whatever method they choose and strive to minimize the impediments that are within our power to change.

If the academy had chosen to release a separate statement simply supporting mothers who chose to nurse longer than a year, then that would have been a good idea. However, when presented as part of the larger document, that message dominated in the media and only served to fuel the guilt that many new mothers must endure.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The American Academy of Pediatrics is built on good intentions. It wants the best for children in the world, and it hopes to support its members in their efforts to achieve this goal. But from time to time, the academy loses sight of reality and makes recommendations that are counterproductive to its stated goals.

The recent release of its new policy “Breastfeeding and the Use of Human Milk” is another unfortunate example of poorly aimed recommendations. A careful reading of the document reveals it to be a well-researched treatise on breastfeeding and the value of human milk, including a discussion of the numerous impediments to the universal adoption of breastfeeding in our society. However, when a document of this breadth and complexity is released to the public it is never surprising that the messages deserving the most attention are lost in the press coverage. Most of the headlines I saw mentioned pediatricians supporting breastfeeding for a year or 2.

Who was the target audience? If it was pediatricians, most of us don’t need a longer list of the health benefits of breastfeeding. We already believe it is the best nutritional source for human babies and realize that the institutional framework in this country continues to be unfriendly to women who intend to breastfeed.

If the audience is politicians and public health decision-makers, the new policy contains a wealth of supportive evidence. However, most pediatricians I know are too busy or lack the skills and enthusiasm to become political activists. For the rest of population, including parents, the recommendations represent a collection of TMI (too much information).

If the audience is women who are considering breastfeeding I suspect nearly 100% already know pediatricians think it is the preferred way to feed their babies. And, likewise, a longer list won’t convince them to try nursing. Additional evidence may simply make them feel more guilty when they aren’t successful.

Many pregnant women have already been told that breastfeeding can be a challenge and given their situation breast milk alone for the first 6 months may sound like an unreasonable goal. The new recommendation that breastfeeding for a year or 2 is good is not a message they want to hear.

On the other hand, if the target audience is women who will be comforted to hear an official statement that normalizes breastfeeding longer than a year, the new policy statement has hit the nail on the head.

Of course the new policy document is sprinkled with caveats that vaguely hint at the possibility that pediatricians are sensitive human beings who under certain circumstances may be able to compromise when it comes to the duration of breastfeeding and the introduction of formula. But this whiff of reality is certainly not the dominant odor in these new recommendations.

Don’t get me wrong: I think the academy was overdue for a policy revision on breastfeeding. However, it should have been one that was reality based. It should acknowledge that there are institutional and societal biases against breastfeeding, and it should remind pediatricians that they can effect change by discussing these realities honestly with parents, while making it clear that we are there for them and their children regardless of how they feed their baby. Pediatricians believe that breastfeeding is the best but not the only way to feed a baby. We have (or will provide) the skills to assist parents succeed in whatever method they choose and strive to minimize the impediments that are within our power to change.

If the academy had chosen to release a separate statement simply supporting mothers who chose to nurse longer than a year, then that would have been a good idea. However, when presented as part of the larger document, that message dominated in the media and only served to fuel the guilt that many new mothers must endure.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.

Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline World Health Organization scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.

The company has submitted an emergency use authorization request to the U.S. Food and Drug Administration to use sabizabulin to treat COVID-19.

The analysis was published online in NEJM Evidence.

Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.

Findings of the interim analysis are based on 150 adults hospitalized with moderate to severe COVID-19 at high risk for acute respiratory distress syndrome and death. The patients were randomly allocated to receive 9 mg oral sabizabulin (n = 98) or placebo (n = 52) once daily for up to 21 days.

Overall, the mortality rate was 20.2% in the sabizabulin group vs. 45.1% in the placebo group. Compared with placebo, treatment with sabizabulin led to a 24.9–percentage point absolute reduction and a 55.2% relative reduction in death (odds ratio, 3.23; P = .0042).

The key secondary endpoint of mortality through day 29 also favored sabizabulin over placebo, with a mortality rate of 17% vs. 35.3%. In this scenario, treatment with sabizabulin resulted in an absolute reduction in deaths of 18.3 percentage points and a relative reduction of 51.8%.

Sabizabulin led to a significant 43% relative reduction in ICU days, a 49% relative reduction in days on mechanical ventilation, and a 26% relative reduction in days in the hospital, compared with placebo.

Adverse and serious adverse events were also lower in the sabizabulin group (61.5%) than the placebo group (78.3%).

The data are “pretty impressive and in a group of patients that we really have limited things to offer,” Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “This is an interim analysis and obviously we’d like to see more data, but it certainly is something that is novel and quite interesting.”

David Boulware, MD, MPH, an infectious disease expert at the University of Minnesota, Minneapolis, told the New York Times that the large number of deaths in the placebo group seemed “rather high” and that the final analysis might reveal a more modest benefit for sabizabulin.

“I would be skeptical” that the reduced risk for death remains 55%, he noted.

The study was funded by Veru Pharmaceuticals. Several authors are employed by the company or have financial relationships with the company.

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

Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.

Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline World Health Organization scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.

The company has submitted an emergency use authorization request to the U.S. Food and Drug Administration to use sabizabulin to treat COVID-19.

The analysis was published online in NEJM Evidence.

Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.

Findings of the interim analysis are based on 150 adults hospitalized with moderate to severe COVID-19 at high risk for acute respiratory distress syndrome and death. The patients were randomly allocated to receive 9 mg oral sabizabulin (n = 98) or placebo (n = 52) once daily for up to 21 days.

Overall, the mortality rate was 20.2% in the sabizabulin group vs. 45.1% in the placebo group. Compared with placebo, treatment with sabizabulin led to a 24.9–percentage point absolute reduction and a 55.2% relative reduction in death (odds ratio, 3.23; P = .0042).

The key secondary endpoint of mortality through day 29 also favored sabizabulin over placebo, with a mortality rate of 17% vs. 35.3%. In this scenario, treatment with sabizabulin resulted in an absolute reduction in deaths of 18.3 percentage points and a relative reduction of 51.8%.

Sabizabulin led to a significant 43% relative reduction in ICU days, a 49% relative reduction in days on mechanical ventilation, and a 26% relative reduction in days in the hospital, compared with placebo.

Adverse and serious adverse events were also lower in the sabizabulin group (61.5%) than the placebo group (78.3%).

The data are “pretty impressive and in a group of patients that we really have limited things to offer,” Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “This is an interim analysis and obviously we’d like to see more data, but it certainly is something that is novel and quite interesting.”

David Boulware, MD, MPH, an infectious disease expert at the University of Minnesota, Minneapolis, told the New York Times that the large number of deaths in the placebo group seemed “rather high” and that the final analysis might reveal a more modest benefit for sabizabulin.

“I would be skeptical” that the reduced risk for death remains 55%, he noted.

The study was funded by Veru Pharmaceuticals. Several authors are employed by the company or have financial relationships with the company.

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

Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.

Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline World Health Organization scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.

The company has submitted an emergency use authorization request to the U.S. Food and Drug Administration to use sabizabulin to treat COVID-19.

The analysis was published online in NEJM Evidence.

Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.

Findings of the interim analysis are based on 150 adults hospitalized with moderate to severe COVID-19 at high risk for acute respiratory distress syndrome and death. The patients were randomly allocated to receive 9 mg oral sabizabulin (n = 98) or placebo (n = 52) once daily for up to 21 days.

Overall, the mortality rate was 20.2% in the sabizabulin group vs. 45.1% in the placebo group. Compared with placebo, treatment with sabizabulin led to a 24.9–percentage point absolute reduction and a 55.2% relative reduction in death (odds ratio, 3.23; P = .0042).

The key secondary endpoint of mortality through day 29 also favored sabizabulin over placebo, with a mortality rate of 17% vs. 35.3%. In this scenario, treatment with sabizabulin resulted in an absolute reduction in deaths of 18.3 percentage points and a relative reduction of 51.8%.

Sabizabulin led to a significant 43% relative reduction in ICU days, a 49% relative reduction in days on mechanical ventilation, and a 26% relative reduction in days in the hospital, compared with placebo.

Adverse and serious adverse events were also lower in the sabizabulin group (61.5%) than the placebo group (78.3%).

The data are “pretty impressive and in a group of patients that we really have limited things to offer,” Aaron Glatt, MD, a spokesperson for the Infectious Diseases Society of America and chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau in Oceanside, N.Y., said in an interview. “This is an interim analysis and obviously we’d like to see more data, but it certainly is something that is novel and quite interesting.”

David Boulware, MD, MPH, an infectious disease expert at the University of Minnesota, Minneapolis, told the New York Times that the large number of deaths in the placebo group seemed “rather high” and that the final analysis might reveal a more modest benefit for sabizabulin.

“I would be skeptical” that the reduced risk for death remains 55%, he noted.

The study was funded by Veru Pharmaceuticals. Several authors are employed by the company or have financial relationships with the company.

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

Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

INDIANAPOLIS – Nearly two-thirds of pediatric patients with hidradenitis suppurativa (HS) met criteria for obesity at the time of their diagnosis, and 36% had acne, in a study presented at the annual meeting of the Society for Pediatric Dermatology.

In addition, 44% presented with scarring, which suggests that HS may be underdiagnosed in this patient population. Those are the key findings from the study, a single-center retrospective chart review presented by Stephanie Sanchez during a poster session at the meeting.

Doug Brunk/MDedge News

“There is limited research on HS within the pediatric population,” said Ms. Sanchez, a fourth-year medical student at Boston University. “It’s not very well defined or characterized.” The “unusually high number of pediatric patients with HS” at Boston Medical Center provided “a unique opportunity to study this topic.”

Working with her mentor, Lisa Shen, MD, associate medical director of pediatric dermatology at Boston University, Ms. Sanchez and colleagues retrospectively reviewed the medical records of 303 patients aged 4-18 years who were diagnosed with HS at Boston Medical Center from 2012 to 2021. Boston Medical Center is the largest safety net hospital in New England. All data points and outcome measures were collected within 6 months of the patient’s HS diagnosis date.

Of the 303 patients with HS, 84% were female and 16% were male. Complete information about race was available in 286 patients. Of these, 65% were Black/African American, 11% were White, and the rest were from other racial groups. The mean age at symptom onset was 13 years, while the mean age at diagnosis was 15 years, and the mean delay to diagnosis was 2 years. A family history of HS was reported in 36% of patients.

Elsevier

The most common clinical features in these HS patients were pain/tenderness (90%), pustules/papules (65%), discharge/drainage (62%), and deep-seated nodules (51%). Scarring was present in 44% of patients at the time of diagnosis. The three most common sites of involvement were the axillary area (79%), the pubic area (36%), and the inguinal folds/inner thighs (34%).

Obesity was the most common comorbidity at the time of diagnosis, with 64% of patients affected. The next most common comorbidities were acne vulgaris (36%), acanthosis nigricans (25%), depression (18%), being overweight (17%), polycystic ovary syndrome (16%) and anxiety (13%). None had type 1 diabetes or metabolic syndrome.

Referring to the large population of underserved minority patients at Boston Medical Center, Dr. Shen noted, “we have to make sure not to underestimate the prevalence of obesity in this population as they get older. We need to start from a younger age to incorporate multidisciplinary care such as weight management, nutrition, and working with our pediatric surgery colleagues in trying to tackle [HS] because there is data to suggest that the earlier we intervene, the better outcomes they have. That makes sense.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the findings, said that the study “highlights the impressive and concerning gap and delays in diagnosis, not too dissimilar to what the literature shows in adult HS patients, which unfortunately has tremendous ramifications, both physically and emotionally/psychosocially.”

While this single-center study identified potential risk factors, such as obesity and self-identifying as Black, he said, “it is important to note that this condition does not discriminate and therefore it is important not to miss the cases that don’t follow the textbook nor stigmatize this condition as one that only impacts certain demographics.”

The researchers reported having no financial disclosures. Dr. Friedman, who was not involved with the study, reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is a speaker for companies including, Regeneron, Sanofi, AbbVie, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

INDIANAPOLIS – Nearly two-thirds of pediatric patients with hidradenitis suppurativa (HS) met criteria for obesity at the time of their diagnosis, and 36% had acne, in a study presented at the annual meeting of the Society for Pediatric Dermatology.

In addition, 44% presented with scarring, which suggests that HS may be underdiagnosed in this patient population. Those are the key findings from the study, a single-center retrospective chart review presented by Stephanie Sanchez during a poster session at the meeting.

Doug Brunk/MDedge News

“There is limited research on HS within the pediatric population,” said Ms. Sanchez, a fourth-year medical student at Boston University. “It’s not very well defined or characterized.” The “unusually high number of pediatric patients with HS” at Boston Medical Center provided “a unique opportunity to study this topic.”

Working with her mentor, Lisa Shen, MD, associate medical director of pediatric dermatology at Boston University, Ms. Sanchez and colleagues retrospectively reviewed the medical records of 303 patients aged 4-18 years who were diagnosed with HS at Boston Medical Center from 2012 to 2021. Boston Medical Center is the largest safety net hospital in New England. All data points and outcome measures were collected within 6 months of the patient’s HS diagnosis date.

Of the 303 patients with HS, 84% were female and 16% were male. Complete information about race was available in 286 patients. Of these, 65% were Black/African American, 11% were White, and the rest were from other racial groups. The mean age at symptom onset was 13 years, while the mean age at diagnosis was 15 years, and the mean delay to diagnosis was 2 years. A family history of HS was reported in 36% of patients.

Elsevier

The most common clinical features in these HS patients were pain/tenderness (90%), pustules/papules (65%), discharge/drainage (62%), and deep-seated nodules (51%). Scarring was present in 44% of patients at the time of diagnosis. The three most common sites of involvement were the axillary area (79%), the pubic area (36%), and the inguinal folds/inner thighs (34%).

Obesity was the most common comorbidity at the time of diagnosis, with 64% of patients affected. The next most common comorbidities were acne vulgaris (36%), acanthosis nigricans (25%), depression (18%), being overweight (17%), polycystic ovary syndrome (16%) and anxiety (13%). None had type 1 diabetes or metabolic syndrome.

Referring to the large population of underserved minority patients at Boston Medical Center, Dr. Shen noted, “we have to make sure not to underestimate the prevalence of obesity in this population as they get older. We need to start from a younger age to incorporate multidisciplinary care such as weight management, nutrition, and working with our pediatric surgery colleagues in trying to tackle [HS] because there is data to suggest that the earlier we intervene, the better outcomes they have. That makes sense.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the findings, said that the study “highlights the impressive and concerning gap and delays in diagnosis, not too dissimilar to what the literature shows in adult HS patients, which unfortunately has tremendous ramifications, both physically and emotionally/psychosocially.”

While this single-center study identified potential risk factors, such as obesity and self-identifying as Black, he said, “it is important to note that this condition does not discriminate and therefore it is important not to miss the cases that don’t follow the textbook nor stigmatize this condition as one that only impacts certain demographics.”

The researchers reported having no financial disclosures. Dr. Friedman, who was not involved with the study, reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is a speaker for companies including, Regeneron, Sanofi, AbbVie, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

INDIANAPOLIS – Nearly two-thirds of pediatric patients with hidradenitis suppurativa (HS) met criteria for obesity at the time of their diagnosis, and 36% had acne, in a study presented at the annual meeting of the Society for Pediatric Dermatology.

In addition, 44% presented with scarring, which suggests that HS may be underdiagnosed in this patient population. Those are the key findings from the study, a single-center retrospective chart review presented by Stephanie Sanchez during a poster session at the meeting.

Doug Brunk/MDedge News

“There is limited research on HS within the pediatric population,” said Ms. Sanchez, a fourth-year medical student at Boston University. “It’s not very well defined or characterized.” The “unusually high number of pediatric patients with HS” at Boston Medical Center provided “a unique opportunity to study this topic.”

Working with her mentor, Lisa Shen, MD, associate medical director of pediatric dermatology at Boston University, Ms. Sanchez and colleagues retrospectively reviewed the medical records of 303 patients aged 4-18 years who were diagnosed with HS at Boston Medical Center from 2012 to 2021. Boston Medical Center is the largest safety net hospital in New England. All data points and outcome measures were collected within 6 months of the patient’s HS diagnosis date.

Of the 303 patients with HS, 84% were female and 16% were male. Complete information about race was available in 286 patients. Of these, 65% were Black/African American, 11% were White, and the rest were from other racial groups. The mean age at symptom onset was 13 years, while the mean age at diagnosis was 15 years, and the mean delay to diagnosis was 2 years. A family history of HS was reported in 36% of patients.

Elsevier

The most common clinical features in these HS patients were pain/tenderness (90%), pustules/papules (65%), discharge/drainage (62%), and deep-seated nodules (51%). Scarring was present in 44% of patients at the time of diagnosis. The three most common sites of involvement were the axillary area (79%), the pubic area (36%), and the inguinal folds/inner thighs (34%).

Obesity was the most common comorbidity at the time of diagnosis, with 64% of patients affected. The next most common comorbidities were acne vulgaris (36%), acanthosis nigricans (25%), depression (18%), being overweight (17%), polycystic ovary syndrome (16%) and anxiety (13%). None had type 1 diabetes or metabolic syndrome.

Referring to the large population of underserved minority patients at Boston Medical Center, Dr. Shen noted, “we have to make sure not to underestimate the prevalence of obesity in this population as they get older. We need to start from a younger age to incorporate multidisciplinary care such as weight management, nutrition, and working with our pediatric surgery colleagues in trying to tackle [HS] because there is data to suggest that the earlier we intervene, the better outcomes they have. That makes sense.”

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the findings, said that the study “highlights the impressive and concerning gap and delays in diagnosis, not too dissimilar to what the literature shows in adult HS patients, which unfortunately has tremendous ramifications, both physically and emotionally/psychosocially.”

While this single-center study identified potential risk factors, such as obesity and self-identifying as Black, he said, “it is important to note that this condition does not discriminate and therefore it is important not to miss the cases that don’t follow the textbook nor stigmatize this condition as one that only impacts certain demographics.”

The researchers reported having no financial disclosures. Dr. Friedman, who was not involved with the study, reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies. He is a speaker for companies including, Regeneron, Sanofi, AbbVie, Janssen, Incyte, and Brickell Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, Incyte, Galderma, and Janssen.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.

The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.

digitalskillet/Thinkstock

“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”

In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.

The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.

About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.

Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.

Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.

Blue Planet Studio/Getty Images

Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.

Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.

Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.

On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.

Additional studies are needed because of the overall small study population, the researchers suggested.

“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.

“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”

No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.

This article was updated July 18, 2022.

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Most people probably know facial recognition as the thing that unlocks your smartphone. But this technology could also be used as a tool in the fight against cancer, according to a new study.

A team of researchers from University College London and the University of California, San Diego, have developed an algorithm that works kind of like facial recognition – except instead of identifying faces, it picks out cancer mutations in DNA.

These mutations – what geneticists call “copy number changes” – are linked to different outcomes, some better and some worse, even among patients with the same cancer type.

“What’s been missing predominately in the field is a way to interpret those copy number changes,” said Nischalan Pillay, PhD, the University College London researcher who led the Nature study.

That’s what this algorithm does, Dr. Pillay said – it translates those changes into information that doctors could one day use to predict how a cancer is likely to behave. This may lead to more accurate outlooks, more effective treatments, and potentially more lives saved.
 

How tech can find cancer in DNA

Cancer is caused by DNA mutations, or, more simply put, “mistakes.” Some are tiny – like when just one letter of genomic code is off. These are “relatively easy to interpret,” Dr. Pillay said. But copy number changes are bigger. If your DNA is a book, copy number changes mean whole words, sentences, or entire pages can be wrong.

“It then becomes much harder to interpret,” Dr. Pillay said. “So, what we did was develop a way to summarize those, using patterns.”

To do that, he and his team analyzed nearly 10,000 cancer samples and discovered 21 cancer-related patterns. The algorithm can identify those patterns the way facial recognition software can find a suspect in a crowd.

For example: When facial recognition software finds a face, it breaks down all the parts – eyes, lips, nose, eyebrows – and uses them to build a digital version, comparing that to a database of known faces.

“It says: ‘Okay, the closest similarity that this reconstructed face looks like is to X, Y, or Z person,’ ” said Dr. Pillay.

This algorithm finds not a face but a copy number change, breaking it down into each shattered, duplicated, or missing chromosome and making a profile that it can compare to those 21 known patterns, looking for a match.

“We’ve taken something that’s really complex and summarized that into a catalog, or a blueprint,” Dr. Pillay said.

That blueprint could be used to predict how a cancer is likely to progress, allowing doctors to closely monitor patients and try “a different form of therapy, or escalate the type of therapy,” depending on the patient’s chances of dying in a given time frame, said Dr. Pillay.
 

This is just the beginning

Scientists are ever more interested in the role copy number changes may play in cancer treatment. For instance, these changes can also help show how a patient is likely to respond to a treatment, said Christopher Steele, PhD, a postdoctoral researcher at University College London and first author of the research.

Lab techs can already analyze copy number changes in blood samples, using liquid biopsies. As we learn more about how to interpret these results, doctors could use them to adjust treatment in real time, depending on how the cancer is evolving, Dr. Pillay said.

And someday, we may even come to understand how these copy number changes are caused in the first place, he said, possibly helping to prevent cancer.

It’s all part of an emerging subfield of cancer research that could revolutionize how we treat cancer.

“This is the very beginning,” Dr. Steele said.

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

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

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KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.