Dermatology News

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

[email protected]

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

[email protected]

Vice President Mike Pence will be the White House point person quarterbacking the administration’s response to COVID-19, although President Donald Trump was quick to dismiss the notion that he is a so-called coronavirus “czar.”

WhiteHouse.gov

President Trump introduced Vice President Pence in this role during a Feb. 26 press conference. The same night, officials at the Centers for Disease Control and Prevention announced the first case of possible community spread of the novel coronavirus in the United States.

“I am going to be putting our vice president, Mike Pence, in charge, and Mike will be working with the professionals, the doctors, and everybody else that is working” on this, President Trump said.

“Mike is going to be in charge and Mike will report back to me, but he’s got a certain talent for this,” President Trump continued, noting that while Vice President Pence was governor of Indiana, his was the first state to have a patient affected by the 2014 Middle East Respiratory Syndrome coronavirus (MERS-CoV) outbreak, so he has experience in a similar situation.

“I know full well the importance of presidential leadership, the importance of administration leadership, and the vital role of partnerships of state and local governments and health authorities in responding to the potential threat of dangerous infectious diseases,” Vice President Pence said.

He said that his role will be to continue to meet with the Coronavirus Task Force and bring to the president “the best options for action and to see to the safety and well being and health of the American people. I will also be continuing to reach out to governors [and] state and local officials.”

Vice President Pence said he will also be working with Congress to ensure that resources are available.

It was noted during the press conference that some members of Congress consider the $2.5 billion in emergency appropriations requested by the White House to be inadequate and that the legislative branch is working to provide more funding.

Vice President Pence’s new role does not change the command structure of the Coronavirus Task Force, which is currently led by Department of Health & Human Services Secretary Alex Azar.

Speaking at the press conference, Secretary Azar noted that he is still chairman of the task force. “Having the vice president gives me the biggest stick one can have in the government on this whole-of-government approach.”

He emphatically stated, “not in the least,” in response to a question about whether he felt he was being replaced. “When this was mentioned to me, I said I was delighted that I get to have the vice president helping in this way. Delighted.”

The announcement came as President Trump continued to downplay the threat of the coronavirus to U.S. citizens, going so far as to contradict CDC officials who have stated that it is a matter of when, not if, there will be community spread in the United States.

“I don’t think it’s inevitable,” President Trump said. “I think that there’s a chance that it could get worse. There’s a chance it could get fairly substantially worse, but nothing’s inevitable.”

Immediately after President Trump wrapped up his statement, however, the CDC formally announced the first case of possible community spread of the coronavirus. In a statement issued to the press, the agency announced the 15th confirmed case in the United States, a person in California “who reportedly did not have relevant travel history or exposure to another known patient” with the coronavirus.

“This case was detected through the U.S. public health system – picked up by astute clinicians,” CDC added, noting it will continue to provide updates on the evolving situation.

[email protected]

LAHAINA, HAWAII – “Protect and prevent” by applying an antioxidant and sunscreen in the morning, and focus on repair using a retinoid in the evening. That’s the simple message about daily skin care that clinicians can offer patients, according to Brooke Sikora, MD.

“At a very basic level, you want to tell your patients [to] use an antioxidant and use your sunscreen” early in the day, said Dr. Sikora, who is in private practice in Chestnut Hill, Mass. “In the evening, it’s all about repairing their damage, so make sure they’re getting on a retinol,” and if they can’t tolerate prescription strength, try a nonprescription product, she noted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

“Aging factors create oxidative stress on the skin that leads to the development of these reactive oxygen species on the skin,” decreasing collagen production and increasing collagen breakdown, she explained during a presentation on cosmeceuticals at the meeting. Applying an antioxidant to the skin, however, can help neutralize “a lot of these reactive oxygen species and help to slow the breakdown of collagen.”

There is good evidence that peptides and growth factors – although expensive – work well and are worth recommending for patients “who really want to take their skin care to the next level,” Dr. Sikora said. “Then you can add corrective products like hyperpigmentation or acne products to treat ... specific concerns” as needed.

In an interview at the meeting, Dr. Sikora discussed these recommendations, as well as vitamin C use in the daily skin care routine. (To listen to the interview, click on the play button below.)

Vitamin C is the best-studied antioxidant, she noted during her presentation, and in vivo studies have shown it can stimulate collagen synthesis, reduce erythema of rosacea (which is why she has all her rosacea patients on vitamin C), reduce post-UVB erythema, decrease facial wrinkles, and increase dermal papillae.

Dr. Sikora disclosed that she is a consultant to and on the advisory board of SkinCeuticals, La Roche–Posay, Silk Therapeutics, Galderma, Evolus, and Allergen. She is on the speakers bureau for SkinCeuticals, La Roche–Posay, Galderma, and Aclaris.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

To listen to the interview, click on the play button below.

[email protected]

LAHAINA, HAWAII – “Protect and prevent” by applying an antioxidant and sunscreen in the morning, and focus on repair using a retinoid in the evening. That’s the simple message about daily skin care that clinicians can offer patients, according to Brooke Sikora, MD.

“At a very basic level, you want to tell your patients [to] use an antioxidant and use your sunscreen” early in the day, said Dr. Sikora, who is in private practice in Chestnut Hill, Mass. “In the evening, it’s all about repairing their damage, so make sure they’re getting on a retinol,” and if they can’t tolerate prescription strength, try a nonprescription product, she noted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

“Aging factors create oxidative stress on the skin that leads to the development of these reactive oxygen species on the skin,” decreasing collagen production and increasing collagen breakdown, she explained during a presentation on cosmeceuticals at the meeting. Applying an antioxidant to the skin, however, can help neutralize “a lot of these reactive oxygen species and help to slow the breakdown of collagen.”

There is good evidence that peptides and growth factors – although expensive – work well and are worth recommending for patients “who really want to take their skin care to the next level,” Dr. Sikora said. “Then you can add corrective products like hyperpigmentation or acne products to treat ... specific concerns” as needed.

In an interview at the meeting, Dr. Sikora discussed these recommendations, as well as vitamin C use in the daily skin care routine. (To listen to the interview, click on the play button below.)

Vitamin C is the best-studied antioxidant, she noted during her presentation, and in vivo studies have shown it can stimulate collagen synthesis, reduce erythema of rosacea (which is why she has all her rosacea patients on vitamin C), reduce post-UVB erythema, decrease facial wrinkles, and increase dermal papillae.

Dr. Sikora disclosed that she is a consultant to and on the advisory board of SkinCeuticals, La Roche–Posay, Silk Therapeutics, Galderma, Evolus, and Allergen. She is on the speakers bureau for SkinCeuticals, La Roche–Posay, Galderma, and Aclaris.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

To listen to the interview, click on the play button below.

[email protected]

LAHAINA, HAWAII – “Protect and prevent” by applying an antioxidant and sunscreen in the morning, and focus on repair using a retinoid in the evening. That’s the simple message about daily skin care that clinicians can offer patients, according to Brooke Sikora, MD.

“At a very basic level, you want to tell your patients [to] use an antioxidant and use your sunscreen” early in the day, said Dr. Sikora, who is in private practice in Chestnut Hill, Mass. “In the evening, it’s all about repairing their damage, so make sure they’re getting on a retinol,” and if they can’t tolerate prescription strength, try a nonprescription product, she noted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

“Aging factors create oxidative stress on the skin that leads to the development of these reactive oxygen species on the skin,” decreasing collagen production and increasing collagen breakdown, she explained during a presentation on cosmeceuticals at the meeting. Applying an antioxidant to the skin, however, can help neutralize “a lot of these reactive oxygen species and help to slow the breakdown of collagen.”

There is good evidence that peptides and growth factors – although expensive – work well and are worth recommending for patients “who really want to take their skin care to the next level,” Dr. Sikora said. “Then you can add corrective products like hyperpigmentation or acne products to treat ... specific concerns” as needed.

In an interview at the meeting, Dr. Sikora discussed these recommendations, as well as vitamin C use in the daily skin care routine. (To listen to the interview, click on the play button below.)

Vitamin C is the best-studied antioxidant, she noted during her presentation, and in vivo studies have shown it can stimulate collagen synthesis, reduce erythema of rosacea (which is why she has all her rosacea patients on vitamin C), reduce post-UVB erythema, decrease facial wrinkles, and increase dermal papillae.

Dr. Sikora disclosed that she is a consultant to and on the advisory board of SkinCeuticals, La Roche–Posay, Silk Therapeutics, Galderma, Evolus, and Allergen. She is on the speakers bureau for SkinCeuticals, La Roche–Posay, Galderma, and Aclaris.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

To listen to the interview, click on the play button below.

[email protected]

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

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

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

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

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

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

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

Make it easy

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

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

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

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

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

Make it meaningful

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

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

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

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

Put the patient, not the portal, at the center

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

They may simply have been ahead of their time.

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

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

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

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

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

Reference

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

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

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

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

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

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

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

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

Make it easy

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

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

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

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

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

Make it meaningful

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

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

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

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

Put the patient, not the portal, at the center

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

They may simply have been ahead of their time.

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

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

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

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

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

Reference

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

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

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

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

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

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

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

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

Make it easy

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

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

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

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

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

Make it meaningful

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

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

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

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

Put the patient, not the portal, at the center

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

They may simply have been ahead of their time.

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

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

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

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

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

Reference

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

Adults with moderate to severe prurigo nodularis who were treated with the investigational drug nemolizumab showed significant improvement in itching, compared with patients treated with placebo, according to data from a phase 2 trial of 70 patients.

Prurigo nodularis (PN) is a chronic skin condition distinguished by hyperkeratotic red nodules and extreme pruritus, which contributes to crusting and excoriation of the lesions. Lesions can range in size from a few millimeters to 3 centimeters in diameter, and number from a handful to hundreds.

“The pathogenesis of prurigo nodularis is not well understood, but it has been considered to include a form of neuronal sensitization of itch-processing neurons and the development of an itch–scratch cycle,” wrote Sonja Ständer, MD, of the department of dermatology and Center for Chronic Pruritus, University Hospital Münster, Germany, and coauthors. “Interleukin-31, when bound to its receptor complex, has been shown to be a mediator of pruritus, especially in atopic dermatitis and prurigo nodularis,” they noted.

In a study published in the New England Journal of Medicine, the researchers randomized 70 adults with PN to nemolizumab, a monoclonal antibody targeting the interleukin-31 receptor, or a placebo. Patients received 0.5 mg/kg of the drug or placebo subcutaneously at baseline and again at 4 and 8 weeks; safety data were assessed through 18 weeks.

At week 4, the primary outcome of average peak pruritus score based on the numerical rating scale (PP-NRS) decreased by 4.5 points in the nemolizumab group, compared with 1.7 points in the placebo group (reductions of 53% and 20%, respectively). At baseline, weekly peak scores on the PP-NRS were 8.4 for both groups.

In addition, 24% of the nemolizumab patients reported 75% or more healed lesions at week 4, compared with 11% of the placebo group, and at the week 18 final follow-up visit, “the least-squares mean change in the lesion count was −13.3 in the nemolizumab group and − 7.5 in the placebo group,” the researchers said.

Adverse events were similar in both nemolizumab and placebo groups (68% and 67%, respectively) with the most common being gastrointestinal symptoms and musculoskeletal pain. Four nemolizumab patients and three placebo patients experienced serious adverse events. The serious adverse events in the nemolizumab patients included one case each of psoriasiform rash, clavicular fracture, fibromyalgia, and bladder lithiasis. Two patients in each group discontinued the study because of adverse events.

The study findings were limited by the small sample size and short duration, the researchers noted. However, the Food and Drug Administration granted nemolizumab a Breakthrough Therapy Designation in 2019, according to Galderma, and the company is planning a phase 3 trial of nemolizumab in adults with PN to begin later in 2020.

Galderma sponsored and designed the study. Lead author Dr. Ständer disclosed ties with Galderma, Almirall, Beiersdorf, Bellus Health, Cara Therapeutics, Celgene, LEO Pharma, Sienna Biopharmaceuticals, and Vanda Pharmaceuticals. Several coauthors were Galderma employees.

SOURCE: Ständer S et al. N Engl J Med. 2020 Feb 20;382(8):706-16.

Adults with moderate to severe prurigo nodularis who were treated with the investigational drug nemolizumab showed significant improvement in itching, compared with patients treated with placebo, according to data from a phase 2 trial of 70 patients.

Prurigo nodularis (PN) is a chronic skin condition distinguished by hyperkeratotic red nodules and extreme pruritus, which contributes to crusting and excoriation of the lesions. Lesions can range in size from a few millimeters to 3 centimeters in diameter, and number from a handful to hundreds.

“The pathogenesis of prurigo nodularis is not well understood, but it has been considered to include a form of neuronal sensitization of itch-processing neurons and the development of an itch–scratch cycle,” wrote Sonja Ständer, MD, of the department of dermatology and Center for Chronic Pruritus, University Hospital Münster, Germany, and coauthors. “Interleukin-31, when bound to its receptor complex, has been shown to be a mediator of pruritus, especially in atopic dermatitis and prurigo nodularis,” they noted.

In a study published in the New England Journal of Medicine, the researchers randomized 70 adults with PN to nemolizumab, a monoclonal antibody targeting the interleukin-31 receptor, or a placebo. Patients received 0.5 mg/kg of the drug or placebo subcutaneously at baseline and again at 4 and 8 weeks; safety data were assessed through 18 weeks.

At week 4, the primary outcome of average peak pruritus score based on the numerical rating scale (PP-NRS) decreased by 4.5 points in the nemolizumab group, compared with 1.7 points in the placebo group (reductions of 53% and 20%, respectively). At baseline, weekly peak scores on the PP-NRS were 8.4 for both groups.

In addition, 24% of the nemolizumab patients reported 75% or more healed lesions at week 4, compared with 11% of the placebo group, and at the week 18 final follow-up visit, “the least-squares mean change in the lesion count was −13.3 in the nemolizumab group and − 7.5 in the placebo group,” the researchers said.

Adverse events were similar in both nemolizumab and placebo groups (68% and 67%, respectively) with the most common being gastrointestinal symptoms and musculoskeletal pain. Four nemolizumab patients and three placebo patients experienced serious adverse events. The serious adverse events in the nemolizumab patients included one case each of psoriasiform rash, clavicular fracture, fibromyalgia, and bladder lithiasis. Two patients in each group discontinued the study because of adverse events.

The study findings were limited by the small sample size and short duration, the researchers noted. However, the Food and Drug Administration granted nemolizumab a Breakthrough Therapy Designation in 2019, according to Galderma, and the company is planning a phase 3 trial of nemolizumab in adults with PN to begin later in 2020.

Galderma sponsored and designed the study. Lead author Dr. Ständer disclosed ties with Galderma, Almirall, Beiersdorf, Bellus Health, Cara Therapeutics, Celgene, LEO Pharma, Sienna Biopharmaceuticals, and Vanda Pharmaceuticals. Several coauthors were Galderma employees.

SOURCE: Ständer S et al. N Engl J Med. 2020 Feb 20;382(8):706-16.

Adults with moderate to severe prurigo nodularis who were treated with the investigational drug nemolizumab showed significant improvement in itching, compared with patients treated with placebo, according to data from a phase 2 trial of 70 patients.

Prurigo nodularis (PN) is a chronic skin condition distinguished by hyperkeratotic red nodules and extreme pruritus, which contributes to crusting and excoriation of the lesions. Lesions can range in size from a few millimeters to 3 centimeters in diameter, and number from a handful to hundreds.

“The pathogenesis of prurigo nodularis is not well understood, but it has been considered to include a form of neuronal sensitization of itch-processing neurons and the development of an itch–scratch cycle,” wrote Sonja Ständer, MD, of the department of dermatology and Center for Chronic Pruritus, University Hospital Münster, Germany, and coauthors. “Interleukin-31, when bound to its receptor complex, has been shown to be a mediator of pruritus, especially in atopic dermatitis and prurigo nodularis,” they noted.

In a study published in the New England Journal of Medicine, the researchers randomized 70 adults with PN to nemolizumab, a monoclonal antibody targeting the interleukin-31 receptor, or a placebo. Patients received 0.5 mg/kg of the drug or placebo subcutaneously at baseline and again at 4 and 8 weeks; safety data were assessed through 18 weeks.

At week 4, the primary outcome of average peak pruritus score based on the numerical rating scale (PP-NRS) decreased by 4.5 points in the nemolizumab group, compared with 1.7 points in the placebo group (reductions of 53% and 20%, respectively). At baseline, weekly peak scores on the PP-NRS were 8.4 for both groups.

In addition, 24% of the nemolizumab patients reported 75% or more healed lesions at week 4, compared with 11% of the placebo group, and at the week 18 final follow-up visit, “the least-squares mean change in the lesion count was −13.3 in the nemolizumab group and − 7.5 in the placebo group,” the researchers said.

Adverse events were similar in both nemolizumab and placebo groups (68% and 67%, respectively) with the most common being gastrointestinal symptoms and musculoskeletal pain. Four nemolizumab patients and three placebo patients experienced serious adverse events. The serious adverse events in the nemolizumab patients included one case each of psoriasiform rash, clavicular fracture, fibromyalgia, and bladder lithiasis. Two patients in each group discontinued the study because of adverse events.

The study findings were limited by the small sample size and short duration, the researchers noted. However, the Food and Drug Administration granted nemolizumab a Breakthrough Therapy Designation in 2019, according to Galderma, and the company is planning a phase 3 trial of nemolizumab in adults with PN to begin later in 2020.

Galderma sponsored and designed the study. Lead author Dr. Ständer disclosed ties with Galderma, Almirall, Beiersdorf, Bellus Health, Cara Therapeutics, Celgene, LEO Pharma, Sienna Biopharmaceuticals, and Vanda Pharmaceuticals. Several coauthors were Galderma employees.

SOURCE: Ständer S et al. N Engl J Med. 2020 Feb 20;382(8):706-16.

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

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

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

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

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

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

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

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

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

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

ACA cases still in limbo

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

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

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

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

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

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

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

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

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

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

Court to hear women’s health cases

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

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

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

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

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

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

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

[email protected]

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

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

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

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

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

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

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

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

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

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

ACA cases still in limbo

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

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

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

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

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

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

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

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

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

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

Court to hear women’s health cases

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

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

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

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

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

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

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

[email protected]

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

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

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

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

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

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

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

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

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

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

ACA cases still in limbo

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

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

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

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

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

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

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

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

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

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

Court to hear women’s health cases

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

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

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

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

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

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

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

[email protected]

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

Courtesy NIAID-RML

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

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

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

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

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

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

Courtesy NIAID-RML

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

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

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

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

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

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

Courtesy NIAID-RML

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

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

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

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

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

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

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

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

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

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

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

This article first appeared on Medscape.com.

LONDON – Median survival among patients with generalized severe recessive dystrophic epidermolysis bullosa (RDEB-GS) after a first diagnosis of mucocutaneous squamous cell carcinoma (SCC) was 2.4 years in an observational, retrospective study.

The study, conducted at St. Thomas’ Hospital and Great Ormond Street Hospital in London, was a review of all individuals with EB who had developed the skin cancer over a 28-year period, from 1991 to 2019.

A total of 44 subjects were identified who together had 221 primary SCCs. Considering all study subjects, the median age at first diagnosis of SCC was 32.6 years, with a mean of five tumors present. Almost 40% had metastatic tumors, and of the 57% who died during the observation period, 88% of deaths were attributable to the SCC.

“EB-associated SCCs differ from those in the general population,” the study’s investigators wrote in a poster presented at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (debra). “They affect a younger age group, and there are often multiple primaries,” they added. Furthermore, “they behave aggressively and metastasize early despite being well differentiated.”

Most (31) of the study participants had RDEB-GS and tended to develop their first SCC at a younger age than the group overall, at a median of 29.5 years (compared with 32.6 years for the overall group). The mean number of tumors was 5.8 among those with RDEB-GS, with over half (53.4%) of the SCCs being well differentiated and located on the hands, upper arms, feet, and lower legs. Median survival after a first diagnosis in this group was 2.4 years. The short survival after a first diagnosis of SCC “underscores the poor prognosis in this group,” the researchers wrote.

“As the largest cohort of EB SCC patients with comprehensive data regarding clinical course and management to date, our data reinforce the need for regular clinical surveillance for SCCs in EB patients,” the team concluded. This surveillance should start in adolescence for those with the severe generalized RDEB subtype, they advise, and from the third or fourth decade for other at-risk groups.

These data also highlight “the pressing need for more effective treatments,” the investigators wrote. Most (86.4%) of the SCCs among the patients in the study had been surgically removed by wide local excision, with a few patients undergoing lymph node dissection, radiotherapy, chemotherapy, electrochemotherapy, or receiving targeted cancer therapies such as erlotinib, cetuximab, or cemiplimab.

Surgery may not be an option for many patients, Jemima Mellerio, MD explained in an oral presentation at the meeting. Dr. Mellerio, a consultant dermatologist and chief of St John’s Institute of Dermatology at Guy’s & St. Thomas’ NHS Foundation, London, noted that the location of the tumor was important, as sometimes it was not physically possible to excise it completely.

Guidelines on how to manage SCCs in patients with EB were published a few years ago (Br J Dermatol. 2016;174:56-67) and noted that the clinical detection of SCCs could be difficult because of chronic wound ulceration in these patients. The “possibility of malignancy should be borne in mind, with suspicious lesions biopsied for histological evaluation,” the document states. Evidence for many of the nonsurgical options – radiotherapy, conventional chemotherapy, biologic therapies – was poor, according to the guidelines, and effective nonsurgical options are still desperately needed.

Several avenues of research are being investigated, Dr. Mellerio noted, such as targeting the fibrotic process and perhaps using a micro-RNA inhibitor to stop the upregulation of certain microRNAs in fibroblasts. Targeting inflammatory mechanisms such as thrombospondin 1, which can lead to elevated levels of tumor necrosis factor–beta and contribute to extracellular matrix stiffness, also is under investigation. Raised interleukin-6 may be another target to consider.

Research shows that similar genes are mutated in EB-related and ultraviolet-related SCCs, Dr. Mellerio said. Indeed, mutations in HRAS, NOTCH1, TP53, and CDKN2A have been reported, but mutations in these genes occur much earlier in life in patients with EB. “Something else is going on,” she added, commenting that researchers are looking at apolipoprotein B editing complex (APOBEC) enzymes, which modulate DNA and can cause “particular types of genetic changes in EB cancers.”

One investigator who is studying the genetics of EB SCCs and how APOBEC enzymes might be involved is Andrew South, PhD, an associate professor at Thomas Jefferson University, Philadelphia. APOBEC enzymes are a very prominent source of mutations in RDEB. These mutations are found in 10%-20% of squamous cell carcinomas not associated with RDEB, and 80%-90% of head and neck cancers, he said during a separate talk at the meeting.

Dr. South observed that “RDEB squamous cell carcinoma does not show any particular somatic mutation or upregulation or downregulation of genes that differentiates it from other squamous cell carcinomas, which might be disappointing on the front of it, but actually it does mean that precision therapies that have been developed for other squamous cell carcinomas have application in RDEB.”

RDEB SCC shows the greatest similarity with head and neck SCC, Dr. South said. He also stressed that fibrosis is a major driver of cancer development, SCC tumors in RDEB are homogenous, and that frontline therapy is still unclear.

What is clear, however, is that interdisciplinary management of patients is crucial, said Leena Bruckner-Tuderman, MD, professor and chair of the department of dermatology at the University Medical Center, Albert Ludwig University of Freiburg, Germany.

“In severe RDEB, metastatic SCC is the leading cause of death at a young age. We need monitoring, careful diagnostics, and multidisciplinary treatment,” Dr. Bruckner-Tuderman said. The latter should be delivered by a coordinated team that consists of dermatologists, surgeons, radiologists, oncologists, pathologists, geneticists, and (molecular) tumor boards, she advised.

The study had no commercial funding. Dr. Mellerio disclosed financial relationships with Castle Creek Pharmaceuticals and ProQR Therapeutics, and acted as an unpaid advisor to Helpberby Therapeutics. Dr. South disclosed financial relationships with Krystal Biotech Inc. and Amryt Genetics and has been an advisory board member for Abeona Therapeutics and Sanofi Genzyme. Dr. Bruckner-Tuderman disclosed receiving grants or research support from Constant Pharmaceuticals/Tarix Orphan.

LONDON – Median survival among patients with generalized severe recessive dystrophic epidermolysis bullosa (RDEB-GS) after a first diagnosis of mucocutaneous squamous cell carcinoma (SCC) was 2.4 years in an observational, retrospective study.

The study, conducted at St. Thomas’ Hospital and Great Ormond Street Hospital in London, was a review of all individuals with EB who had developed the skin cancer over a 28-year period, from 1991 to 2019.

A total of 44 subjects were identified who together had 221 primary SCCs. Considering all study subjects, the median age at first diagnosis of SCC was 32.6 years, with a mean of five tumors present. Almost 40% had metastatic tumors, and of the 57% who died during the observation period, 88% of deaths were attributable to the SCC.

“EB-associated SCCs differ from those in the general population,” the study’s investigators wrote in a poster presented at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (debra). “They affect a younger age group, and there are often multiple primaries,” they added. Furthermore, “they behave aggressively and metastasize early despite being well differentiated.”

Most (31) of the study participants had RDEB-GS and tended to develop their first SCC at a younger age than the group overall, at a median of 29.5 years (compared with 32.6 years for the overall group). The mean number of tumors was 5.8 among those with RDEB-GS, with over half (53.4%) of the SCCs being well differentiated and located on the hands, upper arms, feet, and lower legs. Median survival after a first diagnosis in this group was 2.4 years. The short survival after a first diagnosis of SCC “underscores the poor prognosis in this group,” the researchers wrote.

“As the largest cohort of EB SCC patients with comprehensive data regarding clinical course and management to date, our data reinforce the need for regular clinical surveillance for SCCs in EB patients,” the team concluded. This surveillance should start in adolescence for those with the severe generalized RDEB subtype, they advise, and from the third or fourth decade for other at-risk groups.

These data also highlight “the pressing need for more effective treatments,” the investigators wrote. Most (86.4%) of the SCCs among the patients in the study had been surgically removed by wide local excision, with a few patients undergoing lymph node dissection, radiotherapy, chemotherapy, electrochemotherapy, or receiving targeted cancer therapies such as erlotinib, cetuximab, or cemiplimab.

Surgery may not be an option for many patients, Jemima Mellerio, MD explained in an oral presentation at the meeting. Dr. Mellerio, a consultant dermatologist and chief of St John’s Institute of Dermatology at Guy’s & St. Thomas’ NHS Foundation, London, noted that the location of the tumor was important, as sometimes it was not physically possible to excise it completely.

Guidelines on how to manage SCCs in patients with EB were published a few years ago (Br J Dermatol. 2016;174:56-67) and noted that the clinical detection of SCCs could be difficult because of chronic wound ulceration in these patients. The “possibility of malignancy should be borne in mind, with suspicious lesions biopsied for histological evaluation,” the document states. Evidence for many of the nonsurgical options – radiotherapy, conventional chemotherapy, biologic therapies – was poor, according to the guidelines, and effective nonsurgical options are still desperately needed.

Several avenues of research are being investigated, Dr. Mellerio noted, such as targeting the fibrotic process and perhaps using a micro-RNA inhibitor to stop the upregulation of certain microRNAs in fibroblasts. Targeting inflammatory mechanisms such as thrombospondin 1, which can lead to elevated levels of tumor necrosis factor–beta and contribute to extracellular matrix stiffness, also is under investigation. Raised interleukin-6 may be another target to consider.

Research shows that similar genes are mutated in EB-related and ultraviolet-related SCCs, Dr. Mellerio said. Indeed, mutations in HRAS, NOTCH1, TP53, and CDKN2A have been reported, but mutations in these genes occur much earlier in life in patients with EB. “Something else is going on,” she added, commenting that researchers are looking at apolipoprotein B editing complex (APOBEC) enzymes, which modulate DNA and can cause “particular types of genetic changes in EB cancers.”

One investigator who is studying the genetics of EB SCCs and how APOBEC enzymes might be involved is Andrew South, PhD, an associate professor at Thomas Jefferson University, Philadelphia. APOBEC enzymes are a very prominent source of mutations in RDEB. These mutations are found in 10%-20% of squamous cell carcinomas not associated with RDEB, and 80%-90% of head and neck cancers, he said during a separate talk at the meeting.

Dr. South observed that “RDEB squamous cell carcinoma does not show any particular somatic mutation or upregulation or downregulation of genes that differentiates it from other squamous cell carcinomas, which might be disappointing on the front of it, but actually it does mean that precision therapies that have been developed for other squamous cell carcinomas have application in RDEB.”

RDEB SCC shows the greatest similarity with head and neck SCC, Dr. South said. He also stressed that fibrosis is a major driver of cancer development, SCC tumors in RDEB are homogenous, and that frontline therapy is still unclear.

What is clear, however, is that interdisciplinary management of patients is crucial, said Leena Bruckner-Tuderman, MD, professor and chair of the department of dermatology at the University Medical Center, Albert Ludwig University of Freiburg, Germany.

“In severe RDEB, metastatic SCC is the leading cause of death at a young age. We need monitoring, careful diagnostics, and multidisciplinary treatment,” Dr. Bruckner-Tuderman said. The latter should be delivered by a coordinated team that consists of dermatologists, surgeons, radiologists, oncologists, pathologists, geneticists, and (molecular) tumor boards, she advised.

The study had no commercial funding. Dr. Mellerio disclosed financial relationships with Castle Creek Pharmaceuticals and ProQR Therapeutics, and acted as an unpaid advisor to Helpberby Therapeutics. Dr. South disclosed financial relationships with Krystal Biotech Inc. and Amryt Genetics and has been an advisory board member for Abeona Therapeutics and Sanofi Genzyme. Dr. Bruckner-Tuderman disclosed receiving grants or research support from Constant Pharmaceuticals/Tarix Orphan.

LONDON – Median survival among patients with generalized severe recessive dystrophic epidermolysis bullosa (RDEB-GS) after a first diagnosis of mucocutaneous squamous cell carcinoma (SCC) was 2.4 years in an observational, retrospective study.

The study, conducted at St. Thomas’ Hospital and Great Ormond Street Hospital in London, was a review of all individuals with EB who had developed the skin cancer over a 28-year period, from 1991 to 2019.

A total of 44 subjects were identified who together had 221 primary SCCs. Considering all study subjects, the median age at first diagnosis of SCC was 32.6 years, with a mean of five tumors present. Almost 40% had metastatic tumors, and of the 57% who died during the observation period, 88% of deaths were attributable to the SCC.

“EB-associated SCCs differ from those in the general population,” the study’s investigators wrote in a poster presented at the EB World Congress, organized by the Dystrophic Epidermolysis Bullosa Association (debra). “They affect a younger age group, and there are often multiple primaries,” they added. Furthermore, “they behave aggressively and metastasize early despite being well differentiated.”

Most (31) of the study participants had RDEB-GS and tended to develop their first SCC at a younger age than the group overall, at a median of 29.5 years (compared with 32.6 years for the overall group). The mean number of tumors was 5.8 among those with RDEB-GS, with over half (53.4%) of the SCCs being well differentiated and located on the hands, upper arms, feet, and lower legs. Median survival after a first diagnosis in this group was 2.4 years. The short survival after a first diagnosis of SCC “underscores the poor prognosis in this group,” the researchers wrote.

“As the largest cohort of EB SCC patients with comprehensive data regarding clinical course and management to date, our data reinforce the need for regular clinical surveillance for SCCs in EB patients,” the team concluded. This surveillance should start in adolescence for those with the severe generalized RDEB subtype, they advise, and from the third or fourth decade for other at-risk groups.

These data also highlight “the pressing need for more effective treatments,” the investigators wrote. Most (86.4%) of the SCCs among the patients in the study had been surgically removed by wide local excision, with a few patients undergoing lymph node dissection, radiotherapy, chemotherapy, electrochemotherapy, or receiving targeted cancer therapies such as erlotinib, cetuximab, or cemiplimab.

Surgery may not be an option for many patients, Jemima Mellerio, MD explained in an oral presentation at the meeting. Dr. Mellerio, a consultant dermatologist and chief of St John’s Institute of Dermatology at Guy’s & St. Thomas’ NHS Foundation, London, noted that the location of the tumor was important, as sometimes it was not physically possible to excise it completely.

Guidelines on how to manage SCCs in patients with EB were published a few years ago (Br J Dermatol. 2016;174:56-67) and noted that the clinical detection of SCCs could be difficult because of chronic wound ulceration in these patients. The “possibility of malignancy should be borne in mind, with suspicious lesions biopsied for histological evaluation,” the document states. Evidence for many of the nonsurgical options – radiotherapy, conventional chemotherapy, biologic therapies – was poor, according to the guidelines, and effective nonsurgical options are still desperately needed.

Several avenues of research are being investigated, Dr. Mellerio noted, such as targeting the fibrotic process and perhaps using a micro-RNA inhibitor to stop the upregulation of certain microRNAs in fibroblasts. Targeting inflammatory mechanisms such as thrombospondin 1, which can lead to elevated levels of tumor necrosis factor–beta and contribute to extracellular matrix stiffness, also is under investigation. Raised interleukin-6 may be another target to consider.

Research shows that similar genes are mutated in EB-related and ultraviolet-related SCCs, Dr. Mellerio said. Indeed, mutations in HRAS, NOTCH1, TP53, and CDKN2A have been reported, but mutations in these genes occur much earlier in life in patients with EB. “Something else is going on,” she added, commenting that researchers are looking at apolipoprotein B editing complex (APOBEC) enzymes, which modulate DNA and can cause “particular types of genetic changes in EB cancers.”

One investigator who is studying the genetics of EB SCCs and how APOBEC enzymes might be involved is Andrew South, PhD, an associate professor at Thomas Jefferson University, Philadelphia. APOBEC enzymes are a very prominent source of mutations in RDEB. These mutations are found in 10%-20% of squamous cell carcinomas not associated with RDEB, and 80%-90% of head and neck cancers, he said during a separate talk at the meeting.

Dr. South observed that “RDEB squamous cell carcinoma does not show any particular somatic mutation or upregulation or downregulation of genes that differentiates it from other squamous cell carcinomas, which might be disappointing on the front of it, but actually it does mean that precision therapies that have been developed for other squamous cell carcinomas have application in RDEB.”

RDEB SCC shows the greatest similarity with head and neck SCC, Dr. South said. He also stressed that fibrosis is a major driver of cancer development, SCC tumors in RDEB are homogenous, and that frontline therapy is still unclear.

What is clear, however, is that interdisciplinary management of patients is crucial, said Leena Bruckner-Tuderman, MD, professor and chair of the department of dermatology at the University Medical Center, Albert Ludwig University of Freiburg, Germany.

“In severe RDEB, metastatic SCC is the leading cause of death at a young age. We need monitoring, careful diagnostics, and multidisciplinary treatment,” Dr. Bruckner-Tuderman said. The latter should be delivered by a coordinated team that consists of dermatologists, surgeons, radiologists, oncologists, pathologists, geneticists, and (molecular) tumor boards, she advised.

The study had no commercial funding. Dr. Mellerio disclosed financial relationships with Castle Creek Pharmaceuticals and ProQR Therapeutics, and acted as an unpaid advisor to Helpberby Therapeutics. Dr. South disclosed financial relationships with Krystal Biotech Inc. and Amryt Genetics and has been an advisory board member for Abeona Therapeutics and Sanofi Genzyme. Dr. Bruckner-Tuderman disclosed receiving grants or research support from Constant Pharmaceuticals/Tarix Orphan.

Five serum markers detect systemic inflammation in patients with psoriatic disease in the absence of elevated C-reactive protein, according to a cross-sectional study of patients and healthy controls.

“Different clinical subsets of psoriatic disease based on skin, entheseal, and joint involvement are characterized by specific inflammation marker profiles,” Maria V. Sokolova, MD, of Friedrich-Alexander University Erlangen-Nuremberg and University Clinic Erlangen (Germany) and colleagues reported in Arthritis Research & Therapy. “Treatment of psoriatic disease with cytokine inhibitors reduces these elevated levels of systemic inflammation markers.”

Quantifying systemic inflammation in psoriatic disease has been a challenge, Dr. Sokolova and colleagues wrote. Levels of C-reactive protein (CRP), a commonly used measure of systemic inflammation, “are often low or absent.” To examine other potential markers of systemic inflammation in psoriatic disease, the investigators conducted cross-sectional and longitudinal studies that included healthy controls and patients with psoriatic disease. Patients had isolated or combined manifestations of psoriatic disease, including the skin, the entheses, and the joints. The researchers grouped patients by isolated psoriatic skin disease; isolated enthesitis; isolated arthritis; psoriatic skin disease with enthesitis; psoriatic skin disease with arthritis; arthritis and enthesitis; and combined psoriatic skin disease, arthritis, and enthesitis.
 

Data from more than 100 patients

The researchers first assessed 10 potential markers using enzyme-linked immunosorbent assay: calprotectin, interleukin-22, IL-8, lipocalin 2, beta-defensin 2, IL-17, IL-23, vascular endothelial growth factors, LL37 (cathelicidin), and pentraxin 3. They measured the markers in 10 healthy controls and 10 patients with active polymorphic psoriatic arthritis. Five parameters – beta-defensin 2, lipocalin 2, IL-22, IL-8, and calprotectin – significantly differed between healthy controls and patients with psoriatic disease. Lipocalin 2, beta-defensin 2, and IL-22 are associated with IL-17/IL-23 activation, and calprotectin and IL-8 are associated with innate immune cell activation. The other markers did not significantly differ or were not detectable in enough participants.

To validate the signals, the researchers measured the five parameters as well as CRP in 105 controls and 105 patients with psoriatic disease, including 15 patients in each of the seven disease pattern groups. “As expected, CRP levels were normal in the majority of individuals,” the authors wrote. The proportion of patients with CRP greater than 5 mg/L was 0% in isolated psoriatic skin disease, 0% in isolated enthesitis; 20% in isolated arthritis; 7% in psoriatic skin disease with enthesitis; 33% in psoriatic skin disease with arthritis; 27% in arthritis with enthesitis; and 33% in combined psoriatic skin disease, arthritis, and enthesitis.

“Only a subset of patients with arthritis, but not patients with skin or entheseal disease show elevated CRP,” the researchers wrote. “In sharp contrast,” beta-defensin 2 and lipocalin 2 were elevated in a majority of patients with monomorphic skin and entheseal disease, but not in joint disease. “Both proteins were significantly correlated to the extent of skin disease and to a lesser extent also entheseal disease,” they added. Calprotectin and IL-8 were elevated in a majority of patients with joint disease and correlated with the extent of arthritis. “IL-22 was elevated ... in all three manifestations of psoriatic disease,” and the vast majority of patients with polymorphic disease had “widespread marker elevation,” the researchers wrote.
 

Effects of treatment

In a study of 20 patients with psoriatic arthritis, treatment with secukinumab or adalimumab significantly lowered all five markers. Compared with tumor necrosis factor inhibition with adalimumab, “IL-17 inhibition [with secukinumab] showed a more pronounced lowering of lipocalin 2 and beta-defensin 2 levels,” the investigators noted.

“These results confirm earlier data showing elevated beta-defensin levels in psoriasis patients and its association with the extent of skin involvement,” Dr. Sokolova and colleagues wrote. “Overall, these results offer a new possibility to measure systemic inflammation in psoriatic disease.”

The study was supported by the German Research Foundation and other grant and fellowship funding. The authors had no competing interests.

[email protected]

SOURCE: Sokolova MV et al. Arthritis Res Ther. 2020;22:26.

Five serum markers detect systemic inflammation in patients with psoriatic disease in the absence of elevated C-reactive protein, according to a cross-sectional study of patients and healthy controls.

“Different clinical subsets of psoriatic disease based on skin, entheseal, and joint involvement are characterized by specific inflammation marker profiles,” Maria V. Sokolova, MD, of Friedrich-Alexander University Erlangen-Nuremberg and University Clinic Erlangen (Germany) and colleagues reported in Arthritis Research & Therapy. “Treatment of psoriatic disease with cytokine inhibitors reduces these elevated levels of systemic inflammation markers.”

Quantifying systemic inflammation in psoriatic disease has been a challenge, Dr. Sokolova and colleagues wrote. Levels of C-reactive protein (CRP), a commonly used measure of systemic inflammation, “are often low or absent.” To examine other potential markers of systemic inflammation in psoriatic disease, the investigators conducted cross-sectional and longitudinal studies that included healthy controls and patients with psoriatic disease. Patients had isolated or combined manifestations of psoriatic disease, including the skin, the entheses, and the joints. The researchers grouped patients by isolated psoriatic skin disease; isolated enthesitis; isolated arthritis; psoriatic skin disease with enthesitis; psoriatic skin disease with arthritis; arthritis and enthesitis; and combined psoriatic skin disease, arthritis, and enthesitis.
 

Data from more than 100 patients

The researchers first assessed 10 potential markers using enzyme-linked immunosorbent assay: calprotectin, interleukin-22, IL-8, lipocalin 2, beta-defensin 2, IL-17, IL-23, vascular endothelial growth factors, LL37 (cathelicidin), and pentraxin 3. They measured the markers in 10 healthy controls and 10 patients with active polymorphic psoriatic arthritis. Five parameters – beta-defensin 2, lipocalin 2, IL-22, IL-8, and calprotectin – significantly differed between healthy controls and patients with psoriatic disease. Lipocalin 2, beta-defensin 2, and IL-22 are associated with IL-17/IL-23 activation, and calprotectin and IL-8 are associated with innate immune cell activation. The other markers did not significantly differ or were not detectable in enough participants.

To validate the signals, the researchers measured the five parameters as well as CRP in 105 controls and 105 patients with psoriatic disease, including 15 patients in each of the seven disease pattern groups. “As expected, CRP levels were normal in the majority of individuals,” the authors wrote. The proportion of patients with CRP greater than 5 mg/L was 0% in isolated psoriatic skin disease, 0% in isolated enthesitis; 20% in isolated arthritis; 7% in psoriatic skin disease with enthesitis; 33% in psoriatic skin disease with arthritis; 27% in arthritis with enthesitis; and 33% in combined psoriatic skin disease, arthritis, and enthesitis.

“Only a subset of patients with arthritis, but not patients with skin or entheseal disease show elevated CRP,” the researchers wrote. “In sharp contrast,” beta-defensin 2 and lipocalin 2 were elevated in a majority of patients with monomorphic skin and entheseal disease, but not in joint disease. “Both proteins were significantly correlated to the extent of skin disease and to a lesser extent also entheseal disease,” they added. Calprotectin and IL-8 were elevated in a majority of patients with joint disease and correlated with the extent of arthritis. “IL-22 was elevated ... in all three manifestations of psoriatic disease,” and the vast majority of patients with polymorphic disease had “widespread marker elevation,” the researchers wrote.
 

Effects of treatment

In a study of 20 patients with psoriatic arthritis, treatment with secukinumab or adalimumab significantly lowered all five markers. Compared with tumor necrosis factor inhibition with adalimumab, “IL-17 inhibition [with secukinumab] showed a more pronounced lowering of lipocalin 2 and beta-defensin 2 levels,” the investigators noted.

“These results confirm earlier data showing elevated beta-defensin levels in psoriasis patients and its association with the extent of skin involvement,” Dr. Sokolova and colleagues wrote. “Overall, these results offer a new possibility to measure systemic inflammation in psoriatic disease.”

The study was supported by the German Research Foundation and other grant and fellowship funding. The authors had no competing interests.

[email protected]

SOURCE: Sokolova MV et al. Arthritis Res Ther. 2020;22:26.

Five serum markers detect systemic inflammation in patients with psoriatic disease in the absence of elevated C-reactive protein, according to a cross-sectional study of patients and healthy controls.

“Different clinical subsets of psoriatic disease based on skin, entheseal, and joint involvement are characterized by specific inflammation marker profiles,” Maria V. Sokolova, MD, of Friedrich-Alexander University Erlangen-Nuremberg and University Clinic Erlangen (Germany) and colleagues reported in Arthritis Research & Therapy. “Treatment of psoriatic disease with cytokine inhibitors reduces these elevated levels of systemic inflammation markers.”

Quantifying systemic inflammation in psoriatic disease has been a challenge, Dr. Sokolova and colleagues wrote. Levels of C-reactive protein (CRP), a commonly used measure of systemic inflammation, “are often low or absent.” To examine other potential markers of systemic inflammation in psoriatic disease, the investigators conducted cross-sectional and longitudinal studies that included healthy controls and patients with psoriatic disease. Patients had isolated or combined manifestations of psoriatic disease, including the skin, the entheses, and the joints. The researchers grouped patients by isolated psoriatic skin disease; isolated enthesitis; isolated arthritis; psoriatic skin disease with enthesitis; psoriatic skin disease with arthritis; arthritis and enthesitis; and combined psoriatic skin disease, arthritis, and enthesitis.
 

Data from more than 100 patients

The researchers first assessed 10 potential markers using enzyme-linked immunosorbent assay: calprotectin, interleukin-22, IL-8, lipocalin 2, beta-defensin 2, IL-17, IL-23, vascular endothelial growth factors, LL37 (cathelicidin), and pentraxin 3. They measured the markers in 10 healthy controls and 10 patients with active polymorphic psoriatic arthritis. Five parameters – beta-defensin 2, lipocalin 2, IL-22, IL-8, and calprotectin – significantly differed between healthy controls and patients with psoriatic disease. Lipocalin 2, beta-defensin 2, and IL-22 are associated with IL-17/IL-23 activation, and calprotectin and IL-8 are associated with innate immune cell activation. The other markers did not significantly differ or were not detectable in enough participants.

To validate the signals, the researchers measured the five parameters as well as CRP in 105 controls and 105 patients with psoriatic disease, including 15 patients in each of the seven disease pattern groups. “As expected, CRP levels were normal in the majority of individuals,” the authors wrote. The proportion of patients with CRP greater than 5 mg/L was 0% in isolated psoriatic skin disease, 0% in isolated enthesitis; 20% in isolated arthritis; 7% in psoriatic skin disease with enthesitis; 33% in psoriatic skin disease with arthritis; 27% in arthritis with enthesitis; and 33% in combined psoriatic skin disease, arthritis, and enthesitis.

“Only a subset of patients with arthritis, but not patients with skin or entheseal disease show elevated CRP,” the researchers wrote. “In sharp contrast,” beta-defensin 2 and lipocalin 2 were elevated in a majority of patients with monomorphic skin and entheseal disease, but not in joint disease. “Both proteins were significantly correlated to the extent of skin disease and to a lesser extent also entheseal disease,” they added. Calprotectin and IL-8 were elevated in a majority of patients with joint disease and correlated with the extent of arthritis. “IL-22 was elevated ... in all three manifestations of psoriatic disease,” and the vast majority of patients with polymorphic disease had “widespread marker elevation,” the researchers wrote.
 

Effects of treatment

In a study of 20 patients with psoriatic arthritis, treatment with secukinumab or adalimumab significantly lowered all five markers. Compared with tumor necrosis factor inhibition with adalimumab, “IL-17 inhibition [with secukinumab] showed a more pronounced lowering of lipocalin 2 and beta-defensin 2 levels,” the investigators noted.

“These results confirm earlier data showing elevated beta-defensin levels in psoriasis patients and its association with the extent of skin involvement,” Dr. Sokolova and colleagues wrote. “Overall, these results offer a new possibility to measure systemic inflammation in psoriatic disease.”

The study was supported by the German Research Foundation and other grant and fellowship funding. The authors had no competing interests.

[email protected]

SOURCE: Sokolova MV et al. Arthritis Res Ther. 2020;22:26.

LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

“If somebody is trying to start a practice in lesional teledermatology, I would recommend getting dermoscopy images with all of the teledermatology consults. The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.

To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.

“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.

Why get into teledermatology?

The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).

In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.

“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.

Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
 

Before getting started

Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.

The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.

The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)

Teledermatology practice model options

The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.

The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.

“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.

Reimbursement

Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.

Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.

“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.

And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
 

How accurate is teledermatology?

Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.

In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”

“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.

He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.

Dr. Tejasvi reported having no financial conflicts regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

“If somebody is trying to start a practice in lesional teledermatology, I would recommend getting dermoscopy images with all of the teledermatology consults. The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.

To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.

“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.

Why get into teledermatology?

The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).

In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.

“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.

Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
 

Before getting started

Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.

The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.

The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)

Teledermatology practice model options

The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.

The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.

“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.

Reimbursement

Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.

Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.

“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.

And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
 

How accurate is teledermatology?

Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.

In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”

“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.

He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.

Dr. Tejasvi reported having no financial conflicts regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

LAHAINA, HAWAII – Teledermatology and dermoscopy were made for each other, Trilokraj Tejasvi, MBBS, MD, declared at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

“If somebody is trying to start a practice in lesional teledermatology, I would recommend getting dermoscopy images with all of the teledermatology consults. The dermatoscope manufacturers make teledermoscopy systems with attachments for iPhones, iPads, and Android devices,” said Dr. Tejasvi, who is director of teledermatology services and also director of the cutaneous lymphoma program at the University of Michigan, Ann Arbor.

To make his point, he presented slides of six standard unenhanced teledermatologic photos of ambiguous pigmented skin lesions. When he asked the large audience which ones they’d want to biopsy and which they were confident were benign, there was absolutely no consensus. But when he followed up with teledermoscopic photos of the same lesions, the dermoscopists in the audience quickly voiced agreement that four of the lesions were benign and two were obvious melanoma. Based on that information, instead of having to bring in all six patients for biopsy of their indeterminant suspicious lesions, only two of the patients would need to come in promptly for treatment of their malignancy.

“Dermoscopy changes the whole triage system and the teledermoscopy concept model, because dermoscopy remains the same: it’s going to stay [two-dimensional] whether you’re going to see the images in the clinic or in teledermatology. So using teledermoscopy images actually makes it far better for your teledermatology services,” explained Dr. Tejasvi, who is also chief of the dermatology service at the Ann Arbor Veterans Affairs Hospital.

Why get into teledermatology?

The benefits of teledermatology include earlier diagnosis and treatment of skin cancers as documented in a Spanish study of 43,677 patients. The Spanish dermatologists reported that teledermatologically detected melanomas had a thinner Breslow depth and lower tumor stage because they were diagnosed earlier. Teledermatology also brought a twofold increase in the basal cell carcinoma detection rate and – most importantly – a reduction in time to biopsy for what turned out to be skin cancers (JAMA Dermatol. 2015 Dec 1;151[12]:1289-90).

In addition, teledermatology is an effective triage tool for busy clinicians whose appointment calendars are booked weeks or months in advance.

“Let’s say you are the only dermatologist in the surrounding five counties. You can use teledermatology to see which patients actually need to come to your clinic,” Dr. Tejasvri said. Just make sure the referring primary care providers know to send photos taken with the dermatoscope attachment.

Internet-based teledermatology also provides a way to follow patients with chronic conditions, including psoriasis, atopic dermatitis, and venous ulcers, he noted.
 

Before getting started

Dr. Tejasvri emphasized the importance of visiting the American Academy of Dermatology Teledermatology Task Force website as well as the American Telemedicine Association’s Teledermatology Special Interest Group, which he chairs. These resources, he stressed, are invaluable.

The AAD site, open to all academy members, includes a tool kit for getting started in teledermatology. It’s individually tailored for the dermatologist in solo, small group, academic, or multispecialty practice. This highly practical tool kit includes a checklist that aids in determining whether a dermatologist’s practice is suited for teledermatology, as well as the suggested optimal teledermatology practice model for that individual, the nuts and bolts of equipment, relevant state laws, and how to navigate legal concerns, among the most critical of which is to get in writing the malpractice insurer’s verbal reassurance that the policy covers telemedicine.

The American Telemedicine Association Teledermatology Special Interest Group provides best-practice guidelines (Telemed J E Health. 2016 Dec;22[12]:981-90)

Teledermatology practice model options

The most common teledermatology model is called “store-and-forward.” It relies upon transmission of still images of skin lesions. Its advantages are that it’s not dependent upon internet speed and it accommodates physicians working in different time zones. Most commonly, this is a consult model in which a remote primary care provider takes the photos and transmits them to the dermatologist specialist. The referring provider retains responsibility for patient care.

The other model entails creation of a virtual clinic with real-time videoconference-based communication using a HIPAA-compliant high-speed broadband internet connection. The advantages are that reimbursement is good – indeed, the same as for a face-to-face office visit – and it’s possible to ask questions of the patient and referring physician, although that’s generally not necessary for the straightforward evaluation of suspicious pigmented or nonpigmented skin lesions. However, the video image quality isn’t as good as with still photos, the virtual clinic requires dedicated scheduling, and the quality of the experience is highly dependent upon internet speed.

“If you have a bad internet speed the whole process becomes choppy. When you ask a question, the answer you get is the one to your previous question,” Dr. Tejasvi said.

Reimbursement

Currently 38 states and Washington, D.C., have laws governing private payer telehealth reimbursement policy.

Under the 2019 Medicare physician fee schedule, code number 99446 – interprofessional telephone/internet consult lasting 5-10 minutes – pays $18.36. A 99447, lasting 11-20 minutes, pays $36.36, and a 99448, representing a 21-30 minute interprofessional consult, pays $54.72.

“Reimbursement is poor. It’s not a lot at all. If you spend 5-10 minutes on a consult you get paid about 20 bucks. But it’s better than nothing, and it used to be that patients had to pay out of pocket,” the dermatologist commented.

And of course, the improved timely and efficient patient access to dermatologist evaluation of potential skin cancer that’s afforded via teledermatology helps out with the profession’s workforce shortage and responds to the common criticism that dermatologists are geographically maldistributed and treatment delayed is treatment denied.
 

How accurate is teledermatology?

Numerous studies have reported diagnostic concordance rates between teledermatology and face-to-face clinical diagnosis of 72.5%-90% for melanoma, dropping off markedly to 31.2%-62% for lentigines. However, teledermoscopic images greatly improved the diagnostic accuracy.

In one recent study involving teledermatology versus face-to-face evaluation of 293 index lesions, the face-to-face dermatologist examination turned up 131 incidental skin lesions, including 6 incidental melanomas not suspected or photographed by the consulting primary care providers. That worked out to a 2.6% risk of incidental melanoma per consult, which Dr. Tejasvi called “kind of scary.”

“All six of the incidental melanomas were located on the back, chest, or abdomen, so a good teaching point is that, if you’re doing a teledermatology consult, ask the primary care provider who’s sending you this consult to do a careful waist-up exam to look for other lesions,” he advised.

He added that more and larger studies are needed in order to determine the diagnostic concordance rate for nonpigmented lesions.

Dr. Tejasvi reported having no financial conflicts regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.

“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”

The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also will be sponsoring a public workshop on March 9 to discuss competition for biologics.

“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”

The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.

Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.

“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”

Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

Dr. Edgerton highlighted why this agreement between the two agencies is so important.

“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”

Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.

The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.

[email protected]

The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.

“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”

The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also will be sponsoring a public workshop on March 9 to discuss competition for biologics.

“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”

The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.

Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.

“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”

Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

Dr. Edgerton highlighted why this agreement between the two agencies is so important.

“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”

Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.

The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.

[email protected]

The Food and Drug Administration is collaborating with the Federal Trade Commission (FTC) to expand the biosimilars market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The two agencies signed a joint statement on Feb. 3, 2020, outlining four sets of goals aimed at creating meaningful competition from biosimilars against their reference biologic products.

“Competition is key for helping American patients have access to affordable medicines,” FDA Commissioner Stephen Hahn, MD, said in a statement. “Strengthening efforts to curtail and discourage anticompetitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”

“We appreciate and applaud the FDA and FTC in recognizing that biosimilar development and approval has not been as robust as many stakeholders had hoped,” said Colin Edgerton, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We continue to see anticompetitive activities that prevent manufacturers from developing biosimilar products. We hope that a greater focus on these practices will pave the way for more biosimilars to be developed.”

The statement highlighted four goals. First is that the agencies will coordinate to promote greater competition in the biologic market, including the development of materials to educate the market about biosimilars. The FDA and FTC also will be sponsoring a public workshop on March 9 to discuss competition for biologics.

“This workshop is the first step,” Dr. Edgerton said. “ACR will continue to work with other organizations and patient groups to help educate providers and patients on the scientific rigor that is required in developing and approving biosimilars. Additionally, we look forward to working with the FDA and FTC to continue this conversation on ways to encourage more development of biosimilar products and greater education for the providers and patients.”

The second goal has the FDA and FTC working together “to deter behavior that impedes access to samples needed for the development of biologics, including biosimilars,” the joint statement notes.

Third, the agencies will crack down on “false or misleading communications about biologics, including biosimilars, within their respective authorities,” according to the joint statement.

“FDA and FTC, as authorized by their respective statutes, will work together to address false or misleading communications about biologics, including biosimilars,” the statement continues. “In particular, if a communication makes a false or misleading comparison between a reference product and a biosimilar in a manner that misrepresents the safety or efficacy of biosimilars, deceives consumers, or deters competition, FDA and FTC intend to take appropriate action within their respective authorities. FDA intends to take appropriate action to address such communications where those communications have the potential to impact public health.”

Finally, the FTC committed to review patent settlement agreements involving biologics, including biosimilars, for antitrust violations.

Dr. Edgerton highlighted why this agreement between the two agencies is so important.

“Biologics are life-changing treatments for many of our patients,” he said. “Due to the high cost of discovery and development, the cost of biologics has resulted in delayed access and financial hardships for so many. It has always been our hope that biosimilars would offer the same life-changing treatment for patients at a lower price point. A robust biosimilars market is imperative to allow greater access to these treatments that can help patients to have a better quality of life.”

Separately, the FDA issued a draft guidance document for comment on manufacturers seeking licensure of biosimilar products that do not cover all the approved uses of the reference product, as well as how to add uses over time that were not part of the initial license of the biosimilar product. The draft guidance covers licensure of products, labeling of biosimilars with fewer indications than the reference product, supplemental applications for indications not on the initial biosimilar application but covered by the reference product, and the timing of applications.

The FDA notes in the draft guidance that this is needed to cover situations such as when some indications on the reference product are covered by exclusivity, although it does encourage a biosimilar manufacturer to seek licensure for all indications that the reference product does have.

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