Feature

During her dermatology residency at Yale University in the late 1980s, Tina S. Alster, MD, met a 44-year-old woman who changed the trajectory of her professional career.

Courtesy Dr. Tina S. Alster

During her clinic visit, the woman explained that she always wore heavy facial makeup to hide her port-wine stain birthmark – a vascular malformation that she kept secret from her husband and teenage son. “She was very good about covering it,” recalled Dr. Alster, who is the founding director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology at Georgetown University, Washington. “She removed a small amount of makeup for me so I could take a look at it. I had just finished reading an article about using a laser for birthmarks; it had just been published. I told her, ‘There’s something new; we don’t have it at Yale, but I read about treatment that could hone in on birthmarks.’ I promised her I would find out more details.”

A few days later, Dr. Alster pored through stacks of medical journals at Yale’s library and relocated the article she’d seen by first author Oon Tian Tan, MD, PhD, of the department of dermatology at Boston University Medical Center. It described use of the flashpump-pulsed tunable dye laser to treat port-wine stains in 35 children (N Engl J Med. 1989;320:416-21). After giving the article a more thorough read, Dr. Alster became so intrigued by the technology it described that she moved to Boston the following year for a dermatology fellowship with Dr. Tan and joined the ranks of early clinicians who used lasers for treating port-wine stains and other dermatologic conditions.

“That was at a time when there were only a handful of pulsed dye lasers in the world, and the first time I used it was when I went to Boston,” she said. “It was life-changing. You think, ‘Isn’t this great for children with port-wine stains.’ Your heart breaks for them, but I also felt compassion for adults who had suffered a lifetime of stares, including the woman who propelled me to look into this. She ended up coming to Boston during my fellowship and had her birthmark removed, so I changed her life, but she changed mine as well.”

The real credit for that series of events, Dr. Alster continued, belongs to John A. Parrish, MD, and R. Rox Anderson, MD, who in 1983 published the concept of selective photothermolysis, a seminal work that shifted the paradigm for how lasers and other light sources are designed for skin diseases and conditions (Science. 1983 Apr 29;220(4596):524-7). The first pulsed dye laser was built on this concept, an approach that minimized or eliminated the unwanted tissue damage and significant scarring that impeded therapeutic use of laser energy for port-wine stains and other lesions prior to that time. “Lasers that were built subsequent to that seminal paper focused our attention on building lasers that were specific for treatment of certain skin conditions,” Dr. Alster said. “Selective photothermolysis catapulted not only our understanding of how lasers interact with the skin, but allowed us to identify things in the skin that we could potentially target with this new laser technology, and to build laser systems that were specific to those purposes.”

In the late 1970s, Dr. Parrish, who played a key role in making psoralens plus ultraviolet A safe and effective for patients with severe psoriasis, turned his attention to studying lasers in his lab at Harvard Medical School. He hired R. Rox Anderson, a recent graduate of the Massachusetts Institute of Technology, as a technician. “Rox then got interested in medicine and went to medical school at Harvard, got interested in dermatology, and then worked in my lab a little bit more,” said Dr. Parrish, who founded the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston.

“Rox was interested in port-wine stains because of his rotation through pediatrics and was theorizing about how lasers could improve port-wine stains and hemangiomas. I think he first thought of that through the physics of what would be needed. He was thinking, ‘What are these hemangiomas under the microscope? What does the target look like, and what do you need to do to promote healing without scarring? You would have to be able to heat for this duration and this time and at this wavelength.’ He matched the physics of lasers with the pathophysiology of port-wine stains, and together we figured out how to deliver the right energy at the right wavelength at the right time. In fact, at the time, there was no ideal laser. We had to convince a laser manufacturer to build a tunable dye laser, which is what we ended up using around the specifications that we wanted for this treatment.”

Prior to the theory of selective photothermolysis, lasers were a blunt instrument. “They would target the skin but you wouldn’t just selectively target something; you’d get a result you didn’t want,” said Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital.

Courtesy Dr. Tina S. Alster

Once pulsed dye lasers that incorporated principles of selective photothermolysis hit the marketplace, clinicians could treat and improve port-wine stains without scarring the skin. They could even improve scarring from port-wine stains that had been previously treated with the argon laser, the subject of early published work by Dr. Alster (Lasers Surg Med. 1993;13[3]:368-73). “When we treated port-wine stains with the pulsed dye laser on top of the argon laser scars, we observed that the scars were looking better,” Dr. Alster said. “From that observation, we were able to demonstrate improvement of a wide range of scars: traumatic and burn scars, surgical scars, acne scars, and scars caused by other lasers. But it all started with the pulsed dye laser for treating port-wine stains that had scars in them.”

Courtesy Dr. Tina S. Alster

Another game-changing technology developed by Dr. Anderson came in the early 2000s with the Food and Drug Administration clearance of the Fraxel laser, which is based on the concept of fractional photothermolysis. With this technology, “instead of treating skin to a certain depth, you treat a fraction of it, anywhere from 5% to 40% of the skin,” Dr. Avram explained. “You go in deeper, but you leave surrounding viable tissue that is not affected by the laser. That serves as viable tissue to promote healing. The laser goes in deeper but it’s fractional, so there are skip zones in between the lasers that are going into the skin. You can do this with the CO₂ and erbium YAG lasers.” Since hitting the marketplace, the FDA has cleared the use of Fraxel for a number of indications, from periorbital wrinkles and acne scars to surgical scars and melasma.

Dr. Parrish predicted that the next frontier for the advancement of lasers in dermatology will involve the treatment of photodamaged skin. “I’m not sure which technology is going to win,” he said.

Dr. Avram anticipates that dermatologic lasers of the future are going to be more effective, safer, and result in less downtime for patients. “I think we are going to be able to treat skin of color more safely and more effectively, and I think we’re going to become much more successful,” he said. “At some point, the standard of care of treatment for skin cancer will involve lasers and light sources. With all the advances that have happened in the last 50 years, sometimes you wonder, are we at a time to pause, or is most of the story behind us? I think that the advances in innovation that are occurring are going to accelerate greatly as we pass the 50th anniversary. In due credit, laser therapy has completely revolutionized the field of dermatology and has completely revolutionized the way we practice medicine. That will only accelerate in the future.”

Dr. Alster emphasized a “safety first” approach to her hopes for the future. “My wish is that we educate people to know that, while lasers have become ubiquitous and we’ve made them safe, they’re still only safe in the right hands,” she said. “There’s not a day that goes by when I don’t have somebody referred to me who’s been mishandled. There’s no reason for that. With proper training, the risk of bad side effects or complications is markedly reduced.”

dbrunk@mdedge.com

During her dermatology residency at Yale University in the late 1980s, Tina S. Alster, MD, met a 44-year-old woman who changed the trajectory of her professional career.

Courtesy Dr. Tina S. Alster

During her clinic visit, the woman explained that she always wore heavy facial makeup to hide her port-wine stain birthmark – a vascular malformation that she kept secret from her husband and teenage son. “She was very good about covering it,” recalled Dr. Alster, who is the founding director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology at Georgetown University, Washington. “She removed a small amount of makeup for me so I could take a look at it. I had just finished reading an article about using a laser for birthmarks; it had just been published. I told her, ‘There’s something new; we don’t have it at Yale, but I read about treatment that could hone in on birthmarks.’ I promised her I would find out more details.”

A few days later, Dr. Alster pored through stacks of medical journals at Yale’s library and relocated the article she’d seen by first author Oon Tian Tan, MD, PhD, of the department of dermatology at Boston University Medical Center. It described use of the flashpump-pulsed tunable dye laser to treat port-wine stains in 35 children (N Engl J Med. 1989;320:416-21). After giving the article a more thorough read, Dr. Alster became so intrigued by the technology it described that she moved to Boston the following year for a dermatology fellowship with Dr. Tan and joined the ranks of early clinicians who used lasers for treating port-wine stains and other dermatologic conditions.

“That was at a time when there were only a handful of pulsed dye lasers in the world, and the first time I used it was when I went to Boston,” she said. “It was life-changing. You think, ‘Isn’t this great for children with port-wine stains.’ Your heart breaks for them, but I also felt compassion for adults who had suffered a lifetime of stares, including the woman who propelled me to look into this. She ended up coming to Boston during my fellowship and had her birthmark removed, so I changed her life, but she changed mine as well.”

The real credit for that series of events, Dr. Alster continued, belongs to John A. Parrish, MD, and R. Rox Anderson, MD, who in 1983 published the concept of selective photothermolysis, a seminal work that shifted the paradigm for how lasers and other light sources are designed for skin diseases and conditions (Science. 1983 Apr 29;220(4596):524-7). The first pulsed dye laser was built on this concept, an approach that minimized or eliminated the unwanted tissue damage and significant scarring that impeded therapeutic use of laser energy for port-wine stains and other lesions prior to that time. “Lasers that were built subsequent to that seminal paper focused our attention on building lasers that were specific for treatment of certain skin conditions,” Dr. Alster said. “Selective photothermolysis catapulted not only our understanding of how lasers interact with the skin, but allowed us to identify things in the skin that we could potentially target with this new laser technology, and to build laser systems that were specific to those purposes.”

In the late 1970s, Dr. Parrish, who played a key role in making psoralens plus ultraviolet A safe and effective for patients with severe psoriasis, turned his attention to studying lasers in his lab at Harvard Medical School. He hired R. Rox Anderson, a recent graduate of the Massachusetts Institute of Technology, as a technician. “Rox then got interested in medicine and went to medical school at Harvard, got interested in dermatology, and then worked in my lab a little bit more,” said Dr. Parrish, who founded the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston.

“Rox was interested in port-wine stains because of his rotation through pediatrics and was theorizing about how lasers could improve port-wine stains and hemangiomas. I think he first thought of that through the physics of what would be needed. He was thinking, ‘What are these hemangiomas under the microscope? What does the target look like, and what do you need to do to promote healing without scarring? You would have to be able to heat for this duration and this time and at this wavelength.’ He matched the physics of lasers with the pathophysiology of port-wine stains, and together we figured out how to deliver the right energy at the right wavelength at the right time. In fact, at the time, there was no ideal laser. We had to convince a laser manufacturer to build a tunable dye laser, which is what we ended up using around the specifications that we wanted for this treatment.”

Prior to the theory of selective photothermolysis, lasers were a blunt instrument. “They would target the skin but you wouldn’t just selectively target something; you’d get a result you didn’t want,” said Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital.

Courtesy Dr. Tina S. Alster

Once pulsed dye lasers that incorporated principles of selective photothermolysis hit the marketplace, clinicians could treat and improve port-wine stains without scarring the skin. They could even improve scarring from port-wine stains that had been previously treated with the argon laser, the subject of early published work by Dr. Alster (Lasers Surg Med. 1993;13[3]:368-73). “When we treated port-wine stains with the pulsed dye laser on top of the argon laser scars, we observed that the scars were looking better,” Dr. Alster said. “From that observation, we were able to demonstrate improvement of a wide range of scars: traumatic and burn scars, surgical scars, acne scars, and scars caused by other lasers. But it all started with the pulsed dye laser for treating port-wine stains that had scars in them.”

Courtesy Dr. Tina S. Alster

Another game-changing technology developed by Dr. Anderson came in the early 2000s with the Food and Drug Administration clearance of the Fraxel laser, which is based on the concept of fractional photothermolysis. With this technology, “instead of treating skin to a certain depth, you treat a fraction of it, anywhere from 5% to 40% of the skin,” Dr. Avram explained. “You go in deeper, but you leave surrounding viable tissue that is not affected by the laser. That serves as viable tissue to promote healing. The laser goes in deeper but it’s fractional, so there are skip zones in between the lasers that are going into the skin. You can do this with the CO₂ and erbium YAG lasers.” Since hitting the marketplace, the FDA has cleared the use of Fraxel for a number of indications, from periorbital wrinkles and acne scars to surgical scars and melasma.

Dr. Parrish predicted that the next frontier for the advancement of lasers in dermatology will involve the treatment of photodamaged skin. “I’m not sure which technology is going to win,” he said.

Dr. Avram anticipates that dermatologic lasers of the future are going to be more effective, safer, and result in less downtime for patients. “I think we are going to be able to treat skin of color more safely and more effectively, and I think we’re going to become much more successful,” he said. “At some point, the standard of care of treatment for skin cancer will involve lasers and light sources. With all the advances that have happened in the last 50 years, sometimes you wonder, are we at a time to pause, or is most of the story behind us? I think that the advances in innovation that are occurring are going to accelerate greatly as we pass the 50th anniversary. In due credit, laser therapy has completely revolutionized the field of dermatology and has completely revolutionized the way we practice medicine. That will only accelerate in the future.”

Dr. Alster emphasized a “safety first” approach to her hopes for the future. “My wish is that we educate people to know that, while lasers have become ubiquitous and we’ve made them safe, they’re still only safe in the right hands,” she said. “There’s not a day that goes by when I don’t have somebody referred to me who’s been mishandled. There’s no reason for that. With proper training, the risk of bad side effects or complications is markedly reduced.”

dbrunk@mdedge.com

During her dermatology residency at Yale University in the late 1980s, Tina S. Alster, MD, met a 44-year-old woman who changed the trajectory of her professional career.

Courtesy Dr. Tina S. Alster

During her clinic visit, the woman explained that she always wore heavy facial makeup to hide her port-wine stain birthmark – a vascular malformation that she kept secret from her husband and teenage son. “She was very good about covering it,” recalled Dr. Alster, who is the founding director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology at Georgetown University, Washington. “She removed a small amount of makeup for me so I could take a look at it. I had just finished reading an article about using a laser for birthmarks; it had just been published. I told her, ‘There’s something new; we don’t have it at Yale, but I read about treatment that could hone in on birthmarks.’ I promised her I would find out more details.”

A few days later, Dr. Alster pored through stacks of medical journals at Yale’s library and relocated the article she’d seen by first author Oon Tian Tan, MD, PhD, of the department of dermatology at Boston University Medical Center. It described use of the flashpump-pulsed tunable dye laser to treat port-wine stains in 35 children (N Engl J Med. 1989;320:416-21). After giving the article a more thorough read, Dr. Alster became so intrigued by the technology it described that she moved to Boston the following year for a dermatology fellowship with Dr. Tan and joined the ranks of early clinicians who used lasers for treating port-wine stains and other dermatologic conditions.

“That was at a time when there were only a handful of pulsed dye lasers in the world, and the first time I used it was when I went to Boston,” she said. “It was life-changing. You think, ‘Isn’t this great for children with port-wine stains.’ Your heart breaks for them, but I also felt compassion for adults who had suffered a lifetime of stares, including the woman who propelled me to look into this. She ended up coming to Boston during my fellowship and had her birthmark removed, so I changed her life, but she changed mine as well.”

The real credit for that series of events, Dr. Alster continued, belongs to John A. Parrish, MD, and R. Rox Anderson, MD, who in 1983 published the concept of selective photothermolysis, a seminal work that shifted the paradigm for how lasers and other light sources are designed for skin diseases and conditions (Science. 1983 Apr 29;220(4596):524-7). The first pulsed dye laser was built on this concept, an approach that minimized or eliminated the unwanted tissue damage and significant scarring that impeded therapeutic use of laser energy for port-wine stains and other lesions prior to that time. “Lasers that were built subsequent to that seminal paper focused our attention on building lasers that were specific for treatment of certain skin conditions,” Dr. Alster said. “Selective photothermolysis catapulted not only our understanding of how lasers interact with the skin, but allowed us to identify things in the skin that we could potentially target with this new laser technology, and to build laser systems that were specific to those purposes.”

In the late 1970s, Dr. Parrish, who played a key role in making psoralens plus ultraviolet A safe and effective for patients with severe psoriasis, turned his attention to studying lasers in his lab at Harvard Medical School. He hired R. Rox Anderson, a recent graduate of the Massachusetts Institute of Technology, as a technician. “Rox then got interested in medicine and went to medical school at Harvard, got interested in dermatology, and then worked in my lab a little bit more,” said Dr. Parrish, who founded the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston.

“Rox was interested in port-wine stains because of his rotation through pediatrics and was theorizing about how lasers could improve port-wine stains and hemangiomas. I think he first thought of that through the physics of what would be needed. He was thinking, ‘What are these hemangiomas under the microscope? What does the target look like, and what do you need to do to promote healing without scarring? You would have to be able to heat for this duration and this time and at this wavelength.’ He matched the physics of lasers with the pathophysiology of port-wine stains, and together we figured out how to deliver the right energy at the right wavelength at the right time. In fact, at the time, there was no ideal laser. We had to convince a laser manufacturer to build a tunable dye laser, which is what we ended up using around the specifications that we wanted for this treatment.”

Prior to the theory of selective photothermolysis, lasers were a blunt instrument. “They would target the skin but you wouldn’t just selectively target something; you’d get a result you didn’t want,” said Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital.

Courtesy Dr. Tina S. Alster

Once pulsed dye lasers that incorporated principles of selective photothermolysis hit the marketplace, clinicians could treat and improve port-wine stains without scarring the skin. They could even improve scarring from port-wine stains that had been previously treated with the argon laser, the subject of early published work by Dr. Alster (Lasers Surg Med. 1993;13[3]:368-73). “When we treated port-wine stains with the pulsed dye laser on top of the argon laser scars, we observed that the scars were looking better,” Dr. Alster said. “From that observation, we were able to demonstrate improvement of a wide range of scars: traumatic and burn scars, surgical scars, acne scars, and scars caused by other lasers. But it all started with the pulsed dye laser for treating port-wine stains that had scars in them.”

Courtesy Dr. Tina S. Alster

Another game-changing technology developed by Dr. Anderson came in the early 2000s with the Food and Drug Administration clearance of the Fraxel laser, which is based on the concept of fractional photothermolysis. With this technology, “instead of treating skin to a certain depth, you treat a fraction of it, anywhere from 5% to 40% of the skin,” Dr. Avram explained. “You go in deeper, but you leave surrounding viable tissue that is not affected by the laser. That serves as viable tissue to promote healing. The laser goes in deeper but it’s fractional, so there are skip zones in between the lasers that are going into the skin. You can do this with the CO₂ and erbium YAG lasers.” Since hitting the marketplace, the FDA has cleared the use of Fraxel for a number of indications, from periorbital wrinkles and acne scars to surgical scars and melasma.

Dr. Parrish predicted that the next frontier for the advancement of lasers in dermatology will involve the treatment of photodamaged skin. “I’m not sure which technology is going to win,” he said.

Dr. Avram anticipates that dermatologic lasers of the future are going to be more effective, safer, and result in less downtime for patients. “I think we are going to be able to treat skin of color more safely and more effectively, and I think we’re going to become much more successful,” he said. “At some point, the standard of care of treatment for skin cancer will involve lasers and light sources. With all the advances that have happened in the last 50 years, sometimes you wonder, are we at a time to pause, or is most of the story behind us? I think that the advances in innovation that are occurring are going to accelerate greatly as we pass the 50th anniversary. In due credit, laser therapy has completely revolutionized the field of dermatology and has completely revolutionized the way we practice medicine. That will only accelerate in the future.”

Dr. Alster emphasized a “safety first” approach to her hopes for the future. “My wish is that we educate people to know that, while lasers have become ubiquitous and we’ve made them safe, they’re still only safe in the right hands,” she said. “There’s not a day that goes by when I don’t have somebody referred to me who’s been mishandled. There’s no reason for that. With proper training, the risk of bad side effects or complications is markedly reduced.”

dbrunk@mdedge.com

The nation’s largest physician association is seeking to establish a path to payment for extra practice expenses required to care for patients during the COVID pandemic and possible future public health emergencies.

The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.

Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.

The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.

“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”

Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.

“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
 

Code looks ahead to future use

The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.

The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.

“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.

The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.

“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”

The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.

More information is available on the AMA website.

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

The nation’s largest physician association is seeking to establish a path to payment for extra practice expenses required to care for patients during the COVID pandemic and possible future public health emergencies.

The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.

Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.

The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.

“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”

Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.

“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
 

Code looks ahead to future use

The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.

The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.

“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.

The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.

“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”

The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.

More information is available on the AMA website.

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

The nation’s largest physician association is seeking to establish a path to payment for extra practice expenses required to care for patients during the COVID pandemic and possible future public health emergencies.

The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.

Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.

The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.

“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”

Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.

“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
 

Code looks ahead to future use

The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.

The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.

“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.

The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.

“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”

The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.

More information is available on the AMA website.

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

Niket Sonpal, MD, thought he’d heard most of the myths about wearing masks during the pandemic, but the recent claim from a patient was a new one for the New York City gastroenterologist.

iStock/Getty Images Plus/skynesher

The patient refused to wear a mask because she heard inhaling bad breath through a mask could be toxic. The woman said the rumor was circulating on Facebook. Sonpal calmly explained that breathing your own breath is not going to cause health problems, he said.

“There’s a lot of controversy on masks,” he said. “Unfortunately, it’s really just a lack of education and buy-in. Social media is the primary source of all this misinformation. These kinds of over-the-top hyperbole has basically led to a disbelief that masks are effective. The disbelief is hard to break up.”

As mask requirements have tightened amid the ongoing pandemic, debates about face coverings have emerged front and center, with a growing number of people opposing mask usage. So-called antimaskers dispute the benefits of wearing masks and many contend that face coverings decrease oxygen flow and can lead to illness. Sentiment against masks have led to protests nationwide, ignited public conflicts in some areas, and even generated lawsuits over mask mandates.

The issue presents an ongoing challenge for physicians as they strive to educate patients about the significance of masking against the flood of antimask messages on social media and beyond. Opposition to masks is particularly frustrating for health professionals who have witnessed patients, family, or friends become ill or die from the virus. Refusing to mask and failing to social distance have been linked to the rapid spread of the coronavirus and subsequent deaths.

“I have had colleagues pass away, and it’s extremely disheartening and frustrating to see science so easily disregarded,” Sonpal said. “Masks save lives and protect people and not wearing them is simply a lack of respect, not just for your fellow colleagues, but for a member of your species.”

Michael Rebresh, who helped create the antimask group Million Unmasked Patriots, says his group’s objections to masks are rational and reasonable. The group, which has more than 8,000 members, formed in response to guidance by Illinois state officials that children would only be allowed to return to school wearing a mask.

“Our objections are to the fact that masks on children in school have a greater propensity to make children sick from breathing in bacteria that forms on the inner layer of a mask worn for hours on end,” Rebresh said. “We have an objection to the increase of CO₂ intake and a decrease in oxygen flow for kids who need all the oxygen they can get during a learning environment. We recognized the masking of ourselves and kids for what it is: A political move to separate the two parties in our November election and define and create division between the two.”

Million Unmasked Patriots is one of dozens of antimask groups on social media platforms such as Facebook, Instagram, and TikTok. In July, Facebook suspended one such group, Unmasking America, which boasts 9,600 members, for posting repeated claims that face masks obstruct oxygen flow and have negative mental health effects.

Experts say the antiscience rhetoric is far from new. The antimask movement in many ways, shares similarities with that of the anti-vaccine movement, says Todd Wolynn, MD, a Pittsburgh pediatrician and cofounder of Shots Heard Round the World, an organization that defends vaccine advocates against coordinated online attacks by antivaxxers. Those espousing antimask views often relay similar or the same disinformation pushed by those with antivaccine views, Wolynn said.

“A lot of it is conspiracy-laden,” said Wolynn of the disinformation. “That Dr. [Anthony] Fauci somehow helped construct the pandemic and that it’s not real. That Bill Gates is funding the vaccine so he can inject people with microchips. All sorts of really out-there, ungrounded conspiracy theories. If you had Venn diagram of antimask and antivaxx, I would say there’s clearly overlap.”
 

Parallels between antimaskers, antivaxxers

Opponents to masks fall on a spectrum, explains Vineet Arora, MD, a hospitalist and associate chief medical officer–clinical learning environment at University of Chicago Medicine. People who believe conspiracy theories and push misinformation are on one end, she said. There are also those who generally don’t believe the seriousness of the pandemic, feel their risk is minimal, or doubt the benefits of masks.

The two trains of thought resemble the distinction among parents who are antivaccine and those who are simply “vaccine hesitant,” says Arora, who co-authored a recent article about masking and misinformation that addresses antivaccine attitudes.

“While the antimask sentiment gets a lot of attention, I think it’s important to highlight there’s a lot of vocal anti-mask sentiment since most people are supportive of masks,” she said. “There might be people sitting on the fence who are just unsure about wearing a mask. That’s understandable because the science and the communication has evolved. There was a lot of early mixed messages about masking. Anytime you have confusion about the science or the science is evolving, it’s easy to have misinformation and then have that take off as myth.”

Just as antivaxxers work to swing the opinion of the vaccine hesitant, antimaskers are vying with public health advocates for the support of the mask hesitant, she said. Creating doubt in public health authorities is one way they are gaining followers. Anti-maskers often question and scrutinize past messaging about masks by public health officials, claiming that because guidance on masks has changed over time, the science behind masks and current guidance can’t be trusted, Wolynn said. Similarly, antivaxxers frequently question past actions by public health officials, such as the Tuskegee Experiment (which began in 1932), to try to poke holes in the credibility of public health officials and their advice.

Both the antimask and antivaccine movements also tend to base their resistance on a personal liberties argument, adds Jacqueline Winfield Fincher, MD, president for the American College of Physicians and an internist based in Thomson, Georgia. Antimaskers contend they should be free to decide whether to wear face coverings and that rules requiring masks infringe upon their civil liberties. Similarly, antivaxxers argue they should be free to decide whether to vaccinate their children and contend vaccine mandates violate their personal liberties.

Taking a deeper look, fear and control are two likely drivers of antimasking and antivaccine attitudes, Fincher said. Those refusing to wear masks may feel they have no control over the pandemic or its impacts, but they can control how they respond to mask-wearing requirements, she said.

Antivaccine parents often want more control over their children’s healthcare and falsely believe that vaccines are injecting something harmful into their children or may lead to harmful reactions.

“It’s a control issue and a defense mechanism,” she said. “Some people may feel helpless to deal with the pandemic or believe since it is not affecting them or their family, that it is not real. ‘If I just deny it and I don’t acknowledge facts, I don’t have to worry about it or do anything about it, and therefore I will have more control over my day-to-day life.’”
 

Groups fueling each other

In some cases, antimask and antivaxx groups are joining forces or adopting dual causes.

In California for instance, longtime opponents to vaccines are now objecting to mask policies as similar infringement to their bodily autonomy. Demonstrations in Texas, Idaho, and Michigan against mask mandates and other COVID-19 requirements have drawn support from anti-vaccine activists and incorporated antivaccine propaganda.

In Illinois, Million Unmasked Patriots, formally the Million Unmasked March, has received widespread attention for protesting both masks for returning schoolchildren and a future COVID-19 vaccine requirement.

A July protest planned by the antimask group triggered a letter by Arora and 500 other healthcare professionals to Illinois lawmakers decrying the group’s views and urging the state to move forward with universal masking in schools.

“What’s happening is those who are distrustful of government and public health and science are joining together,” said Arora, who coauthored a piece about the problem on KevinMD.com. “It’s important to address both movements together because they can quickly feed off each other and build in momentum. At the heart of both is really this deep skepticism of science.”

Rebresh of Million Unmasked Patriots said most of his members are not opposed to all vaccines, but rather they are opposed to “untested vaccines.” The primary concern is the inability to research long-term effects of a COVID-19 vaccine before its approval, he said.

Rebresh disagrees with the antimask movement being compared with the antivaccine movement. The two groups are “motivated by different things and a different set of circumstances drive their opinions,” he said. However, Rebresh believes that potential harm resulting from “mass vaccinations” is a valid concern. For this reason, he and his wife chose for their children to receive their vaccinations individually over a series of weeks, rather than the “kiddie cocktail of vaccines,” at a single visit, he said.

Vaccine scientist Peter Hotez, MD, PhD, said the antivaccine movement appears to have grown stronger from the pandemic fueled by fresh conspiracies and new alliances. Antivaccine sentiment has been gaining steam over the last several years and collecting more allies from the far-right, said Hotez, dean for the National School of Tropical Medicine and codirector for the Texas Children’s Hospital Center for Vaccine Development.

“Now what you’re seeing is yet another expansion this year, with antivaccine groups, under the banner of ‘health freedom,’ campaigning against social distancing and wearing masks and contact tracing,” he said. “What was an antivaccine movement has now become a full-blown antiscience movement and an anti-public health movement. It’s causing a lot of damage and I believe costing a lot of American lives.”

Neil F. Johnson, PhD, who has studied the antivaccine movement and its social media proliferation during the pandemic, said online comments by antivaxxers frequently condemn mask usage and showcase memes making fun of masks.

“In those same narratives about opposing vaccines for COVID, we see a lot of discussion against masks,” said Johnson, a physics professor at George Washington University in Washington, D.C. “If you don’t believe in the official picture of COVID, you don’t believe the policies or the advice that’s given about COVID.”

An analysis by Johnson that examined 1,300 Facebook pages found that, while antivaxxers have fewer followers than provaccine pages, antivaccine pages are more numerous, faster growing, and are more often connected to unrelated, undecided pages. Conversely, pages that advocate the benefits of vaccinations and explain the science behind immunizations are largely disconnected from such undecided communities, according to the study, published May 13 in Nature.

The study suggests the antivaccine movement is making influential strides during the pandemic and connecting with people who are undecided, while public health advocates are not building the same bridges, Johnson said.

“I think it’s hugely dangerous, because I don’t know any other moment in science or in public health when there was so much uncertainty in something affecting everybody,” he said. “Every policy that will be coming, everything depends on people buying into the official message. Once you have the seeds of doubt, that’s a very difficult thing to overcome. It’s an unprecedented challenge.”
 

How physicians and clinicians can help

A more aggressive approach is necessary when it comes to taking down antiscience content on social media, says Hotez. Too often, misinformation and antiscience rhetoric is allowed to linger on popular sites such as Facebook and Amazon.

Wolynn agrees. On personal or business platforms, it’s crucial to ban, hide, and delete such comments as quickly as possible, he said. On public sites, purposeful disinformation should be immediately reported to the platform.

At the same time, Wolynn said it’s essential to support those who make sound, science-based comments in social media forums.

“If you see someone who is pushing accurate, evidence-based information, and they come under attack, they should be supported and defended and empowered,” Wolynn said. “Shots Heard Round the World is doing all of those things, including galvanizing and recruiting more people to help get their voices out there.”

Expanded visibility by physicians and scientists would greatly help counter the spread of antiscience sentiment, adds Hotez.

“Too often, antiscience movements are able to flourish because scientists and physicians are invisible,” he said. “They’re too focused on either clinical practices or in the case of physician scientists, on grants and papers and not enough attention to public engagement. We’re going to have to change that around. We need to hear more from scientists directly.”

To that end, Wolynn said health care professionals, including medical students and residents, need to have formal training in communications, media, and social media as part of their education – and more support from employers to engage through social media.

“That’s where the fight is,” Wolynn said. “You can be the best diagnostician, the best clinician. You can make the right diagnosis and prescribe the right medication, but if families don’t hear what you’re saying, you’re not going to be effective. If you can’t be on the platform where they’re being influenced, we’re losing the battle.”
 

Speaking to your mask-hesitant patients

Concentrating on those who are uncertain about masks is particularly key for physicians and public health advocates as the pandemic continues, says Arora.

“It’s important for us to focus on the mask-hesitant who often don’t get the attention they need,” she said.

She suggests bringing up the subject of masks with patients during visits, asking about mask usage, discussing rumors they’ve heard, and emphasizing why masks are important. Be a role model by wearing a mask in your community and on social media, she added.

Some patients have real concerns about not being able to breathe through masks or anxiety disorders that can be aggravated even by the thought of wearing a mask, noted Susan R. Bailey, MD, president for the American Medical Association. Bailey, an immunologist, recently counseled a patient with a deviated nasal septum in addition to a panic disorder who was worried about wearing a mask, she said. Bailey listened to the patient’s concerns, discussed his health conditions, and proposed an alternative face covering that might make him more comfortable.

“Every patient is different,” Bailey said. “It’s important for us to remember that each person who is reluctant to wear a mask has their own reasons. It’s important for us to express some empathy – to agree with them, yes, masks are hot and inconvenient – and help understand their questions, which you may be able to answer to their satisfaction. There are patients that have legitimate questions and a physician caring about how they feel, can make all the difference.”

Physicians can also get involved with the AMA’s #MaskUp campaign, an effort to normalize mask wearing and debunk myths associated with masks. The campaign includes social media materials, slogans doctors can tweet, and profile pictures they can use on social media. The campaign’s toolkit includes images, videos, and information that physicians can share with patients and the public.

Enforcing strong mask policies at your practice and ensuring all staff are modeling appropriate mask behavior is also important, adds Fincher of the ACP. The college recently issued a policy supporting mask usage in community settings.

If a patient conveys an antimask belief, Fincher suggests not directly challenging the person’s views, but listening to them and offering objective data, discussing the science behind masks, and directing them to credible sources.

“Doctors are used to this. We recommend a lot of things to patients that they don’t want to do,” Fincher said. “If a patient feels attacked, they act defensively. But if you base your explanation in more objective terms with data, numbers, and personalize the risks and benefits of a vaccine, a healthy change in behavior, or a medication, then patients are more likely to hear your concerns and do the right thing. Having a long-term relationship with a trusted physician makes all of these issues much easier to discuss and to implement the best plan for the individual patient.”

This article first appeared on Medscape.com.

Niket Sonpal, MD, thought he’d heard most of the myths about wearing masks during the pandemic, but the recent claim from a patient was a new one for the New York City gastroenterologist.

iStock/Getty Images Plus/skynesher

The patient refused to wear a mask because she heard inhaling bad breath through a mask could be toxic. The woman said the rumor was circulating on Facebook. Sonpal calmly explained that breathing your own breath is not going to cause health problems, he said.

“There’s a lot of controversy on masks,” he said. “Unfortunately, it’s really just a lack of education and buy-in. Social media is the primary source of all this misinformation. These kinds of over-the-top hyperbole has basically led to a disbelief that masks are effective. The disbelief is hard to break up.”

As mask requirements have tightened amid the ongoing pandemic, debates about face coverings have emerged front and center, with a growing number of people opposing mask usage. So-called antimaskers dispute the benefits of wearing masks and many contend that face coverings decrease oxygen flow and can lead to illness. Sentiment against masks have led to protests nationwide, ignited public conflicts in some areas, and even generated lawsuits over mask mandates.

The issue presents an ongoing challenge for physicians as they strive to educate patients about the significance of masking against the flood of antimask messages on social media and beyond. Opposition to masks is particularly frustrating for health professionals who have witnessed patients, family, or friends become ill or die from the virus. Refusing to mask and failing to social distance have been linked to the rapid spread of the coronavirus and subsequent deaths.

“I have had colleagues pass away, and it’s extremely disheartening and frustrating to see science so easily disregarded,” Sonpal said. “Masks save lives and protect people and not wearing them is simply a lack of respect, not just for your fellow colleagues, but for a member of your species.”

Michael Rebresh, who helped create the antimask group Million Unmasked Patriots, says his group’s objections to masks are rational and reasonable. The group, which has more than 8,000 members, formed in response to guidance by Illinois state officials that children would only be allowed to return to school wearing a mask.

“Our objections are to the fact that masks on children in school have a greater propensity to make children sick from breathing in bacteria that forms on the inner layer of a mask worn for hours on end,” Rebresh said. “We have an objection to the increase of CO₂ intake and a decrease in oxygen flow for kids who need all the oxygen they can get during a learning environment. We recognized the masking of ourselves and kids for what it is: A political move to separate the two parties in our November election and define and create division between the two.”

Million Unmasked Patriots is one of dozens of antimask groups on social media platforms such as Facebook, Instagram, and TikTok. In July, Facebook suspended one such group, Unmasking America, which boasts 9,600 members, for posting repeated claims that face masks obstruct oxygen flow and have negative mental health effects.

Experts say the antiscience rhetoric is far from new. The antimask movement in many ways, shares similarities with that of the anti-vaccine movement, says Todd Wolynn, MD, a Pittsburgh pediatrician and cofounder of Shots Heard Round the World, an organization that defends vaccine advocates against coordinated online attacks by antivaxxers. Those espousing antimask views often relay similar or the same disinformation pushed by those with antivaccine views, Wolynn said.

“A lot of it is conspiracy-laden,” said Wolynn of the disinformation. “That Dr. [Anthony] Fauci somehow helped construct the pandemic and that it’s not real. That Bill Gates is funding the vaccine so he can inject people with microchips. All sorts of really out-there, ungrounded conspiracy theories. If you had Venn diagram of antimask and antivaxx, I would say there’s clearly overlap.”
 

Parallels between antimaskers, antivaxxers

Opponents to masks fall on a spectrum, explains Vineet Arora, MD, a hospitalist and associate chief medical officer–clinical learning environment at University of Chicago Medicine. People who believe conspiracy theories and push misinformation are on one end, she said. There are also those who generally don’t believe the seriousness of the pandemic, feel their risk is minimal, or doubt the benefits of masks.

The two trains of thought resemble the distinction among parents who are antivaccine and those who are simply “vaccine hesitant,” says Arora, who co-authored a recent article about masking and misinformation that addresses antivaccine attitudes.

“While the antimask sentiment gets a lot of attention, I think it’s important to highlight there’s a lot of vocal anti-mask sentiment since most people are supportive of masks,” she said. “There might be people sitting on the fence who are just unsure about wearing a mask. That’s understandable because the science and the communication has evolved. There was a lot of early mixed messages about masking. Anytime you have confusion about the science or the science is evolving, it’s easy to have misinformation and then have that take off as myth.”

Just as antivaxxers work to swing the opinion of the vaccine hesitant, antimaskers are vying with public health advocates for the support of the mask hesitant, she said. Creating doubt in public health authorities is one way they are gaining followers. Anti-maskers often question and scrutinize past messaging about masks by public health officials, claiming that because guidance on masks has changed over time, the science behind masks and current guidance can’t be trusted, Wolynn said. Similarly, antivaxxers frequently question past actions by public health officials, such as the Tuskegee Experiment (which began in 1932), to try to poke holes in the credibility of public health officials and their advice.

Both the antimask and antivaccine movements also tend to base their resistance on a personal liberties argument, adds Jacqueline Winfield Fincher, MD, president for the American College of Physicians and an internist based in Thomson, Georgia. Antimaskers contend they should be free to decide whether to wear face coverings and that rules requiring masks infringe upon their civil liberties. Similarly, antivaxxers argue they should be free to decide whether to vaccinate their children and contend vaccine mandates violate their personal liberties.

Taking a deeper look, fear and control are two likely drivers of antimasking and antivaccine attitudes, Fincher said. Those refusing to wear masks may feel they have no control over the pandemic or its impacts, but they can control how they respond to mask-wearing requirements, she said.

Antivaccine parents often want more control over their children’s healthcare and falsely believe that vaccines are injecting something harmful into their children or may lead to harmful reactions.

“It’s a control issue and a defense mechanism,” she said. “Some people may feel helpless to deal with the pandemic or believe since it is not affecting them or their family, that it is not real. ‘If I just deny it and I don’t acknowledge facts, I don’t have to worry about it or do anything about it, and therefore I will have more control over my day-to-day life.’”
 

Groups fueling each other

In some cases, antimask and antivaxx groups are joining forces or adopting dual causes.

In California for instance, longtime opponents to vaccines are now objecting to mask policies as similar infringement to their bodily autonomy. Demonstrations in Texas, Idaho, and Michigan against mask mandates and other COVID-19 requirements have drawn support from anti-vaccine activists and incorporated antivaccine propaganda.

In Illinois, Million Unmasked Patriots, formally the Million Unmasked March, has received widespread attention for protesting both masks for returning schoolchildren and a future COVID-19 vaccine requirement.

A July protest planned by the antimask group triggered a letter by Arora and 500 other healthcare professionals to Illinois lawmakers decrying the group’s views and urging the state to move forward with universal masking in schools.

“What’s happening is those who are distrustful of government and public health and science are joining together,” said Arora, who coauthored a piece about the problem on KevinMD.com. “It’s important to address both movements together because they can quickly feed off each other and build in momentum. At the heart of both is really this deep skepticism of science.”

Rebresh of Million Unmasked Patriots said most of his members are not opposed to all vaccines, but rather they are opposed to “untested vaccines.” The primary concern is the inability to research long-term effects of a COVID-19 vaccine before its approval, he said.

Rebresh disagrees with the antimask movement being compared with the antivaccine movement. The two groups are “motivated by different things and a different set of circumstances drive their opinions,” he said. However, Rebresh believes that potential harm resulting from “mass vaccinations” is a valid concern. For this reason, he and his wife chose for their children to receive their vaccinations individually over a series of weeks, rather than the “kiddie cocktail of vaccines,” at a single visit, he said.

Vaccine scientist Peter Hotez, MD, PhD, said the antivaccine movement appears to have grown stronger from the pandemic fueled by fresh conspiracies and new alliances. Antivaccine sentiment has been gaining steam over the last several years and collecting more allies from the far-right, said Hotez, dean for the National School of Tropical Medicine and codirector for the Texas Children’s Hospital Center for Vaccine Development.

“Now what you’re seeing is yet another expansion this year, with antivaccine groups, under the banner of ‘health freedom,’ campaigning against social distancing and wearing masks and contact tracing,” he said. “What was an antivaccine movement has now become a full-blown antiscience movement and an anti-public health movement. It’s causing a lot of damage and I believe costing a lot of American lives.”

Neil F. Johnson, PhD, who has studied the antivaccine movement and its social media proliferation during the pandemic, said online comments by antivaxxers frequently condemn mask usage and showcase memes making fun of masks.

“In those same narratives about opposing vaccines for COVID, we see a lot of discussion against masks,” said Johnson, a physics professor at George Washington University in Washington, D.C. “If you don’t believe in the official picture of COVID, you don’t believe the policies or the advice that’s given about COVID.”

An analysis by Johnson that examined 1,300 Facebook pages found that, while antivaxxers have fewer followers than provaccine pages, antivaccine pages are more numerous, faster growing, and are more often connected to unrelated, undecided pages. Conversely, pages that advocate the benefits of vaccinations and explain the science behind immunizations are largely disconnected from such undecided communities, according to the study, published May 13 in Nature.

The study suggests the antivaccine movement is making influential strides during the pandemic and connecting with people who are undecided, while public health advocates are not building the same bridges, Johnson said.

“I think it’s hugely dangerous, because I don’t know any other moment in science or in public health when there was so much uncertainty in something affecting everybody,” he said. “Every policy that will be coming, everything depends on people buying into the official message. Once you have the seeds of doubt, that’s a very difficult thing to overcome. It’s an unprecedented challenge.”
 

How physicians and clinicians can help

A more aggressive approach is necessary when it comes to taking down antiscience content on social media, says Hotez. Too often, misinformation and antiscience rhetoric is allowed to linger on popular sites such as Facebook and Amazon.

Wolynn agrees. On personal or business platforms, it’s crucial to ban, hide, and delete such comments as quickly as possible, he said. On public sites, purposeful disinformation should be immediately reported to the platform.

At the same time, Wolynn said it’s essential to support those who make sound, science-based comments in social media forums.

“If you see someone who is pushing accurate, evidence-based information, and they come under attack, they should be supported and defended and empowered,” Wolynn said. “Shots Heard Round the World is doing all of those things, including galvanizing and recruiting more people to help get their voices out there.”

Expanded visibility by physicians and scientists would greatly help counter the spread of antiscience sentiment, adds Hotez.

“Too often, antiscience movements are able to flourish because scientists and physicians are invisible,” he said. “They’re too focused on either clinical practices or in the case of physician scientists, on grants and papers and not enough attention to public engagement. We’re going to have to change that around. We need to hear more from scientists directly.”

To that end, Wolynn said health care professionals, including medical students and residents, need to have formal training in communications, media, and social media as part of their education – and more support from employers to engage through social media.

“That’s where the fight is,” Wolynn said. “You can be the best diagnostician, the best clinician. You can make the right diagnosis and prescribe the right medication, but if families don’t hear what you’re saying, you’re not going to be effective. If you can’t be on the platform where they’re being influenced, we’re losing the battle.”
 

Speaking to your mask-hesitant patients

Concentrating on those who are uncertain about masks is particularly key for physicians and public health advocates as the pandemic continues, says Arora.

“It’s important for us to focus on the mask-hesitant who often don’t get the attention they need,” she said.

She suggests bringing up the subject of masks with patients during visits, asking about mask usage, discussing rumors they’ve heard, and emphasizing why masks are important. Be a role model by wearing a mask in your community and on social media, she added.

Some patients have real concerns about not being able to breathe through masks or anxiety disorders that can be aggravated even by the thought of wearing a mask, noted Susan R. Bailey, MD, president for the American Medical Association. Bailey, an immunologist, recently counseled a patient with a deviated nasal septum in addition to a panic disorder who was worried about wearing a mask, she said. Bailey listened to the patient’s concerns, discussed his health conditions, and proposed an alternative face covering that might make him more comfortable.

“Every patient is different,” Bailey said. “It’s important for us to remember that each person who is reluctant to wear a mask has their own reasons. It’s important for us to express some empathy – to agree with them, yes, masks are hot and inconvenient – and help understand their questions, which you may be able to answer to their satisfaction. There are patients that have legitimate questions and a physician caring about how they feel, can make all the difference.”

Physicians can also get involved with the AMA’s #MaskUp campaign, an effort to normalize mask wearing and debunk myths associated with masks. The campaign includes social media materials, slogans doctors can tweet, and profile pictures they can use on social media. The campaign’s toolkit includes images, videos, and information that physicians can share with patients and the public.

Enforcing strong mask policies at your practice and ensuring all staff are modeling appropriate mask behavior is also important, adds Fincher of the ACP. The college recently issued a policy supporting mask usage in community settings.

If a patient conveys an antimask belief, Fincher suggests not directly challenging the person’s views, but listening to them and offering objective data, discussing the science behind masks, and directing them to credible sources.

“Doctors are used to this. We recommend a lot of things to patients that they don’t want to do,” Fincher said. “If a patient feels attacked, they act defensively. But if you base your explanation in more objective terms with data, numbers, and personalize the risks and benefits of a vaccine, a healthy change in behavior, or a medication, then patients are more likely to hear your concerns and do the right thing. Having a long-term relationship with a trusted physician makes all of these issues much easier to discuss and to implement the best plan for the individual patient.”

This article first appeared on Medscape.com.

Niket Sonpal, MD, thought he’d heard most of the myths about wearing masks during the pandemic, but the recent claim from a patient was a new one for the New York City gastroenterologist.

iStock/Getty Images Plus/skynesher

The patient refused to wear a mask because she heard inhaling bad breath through a mask could be toxic. The woman said the rumor was circulating on Facebook. Sonpal calmly explained that breathing your own breath is not going to cause health problems, he said.

“There’s a lot of controversy on masks,” he said. “Unfortunately, it’s really just a lack of education and buy-in. Social media is the primary source of all this misinformation. These kinds of over-the-top hyperbole has basically led to a disbelief that masks are effective. The disbelief is hard to break up.”

As mask requirements have tightened amid the ongoing pandemic, debates about face coverings have emerged front and center, with a growing number of people opposing mask usage. So-called antimaskers dispute the benefits of wearing masks and many contend that face coverings decrease oxygen flow and can lead to illness. Sentiment against masks have led to protests nationwide, ignited public conflicts in some areas, and even generated lawsuits over mask mandates.

The issue presents an ongoing challenge for physicians as they strive to educate patients about the significance of masking against the flood of antimask messages on social media and beyond. Opposition to masks is particularly frustrating for health professionals who have witnessed patients, family, or friends become ill or die from the virus. Refusing to mask and failing to social distance have been linked to the rapid spread of the coronavirus and subsequent deaths.

“I have had colleagues pass away, and it’s extremely disheartening and frustrating to see science so easily disregarded,” Sonpal said. “Masks save lives and protect people and not wearing them is simply a lack of respect, not just for your fellow colleagues, but for a member of your species.”

Michael Rebresh, who helped create the antimask group Million Unmasked Patriots, says his group’s objections to masks are rational and reasonable. The group, which has more than 8,000 members, formed in response to guidance by Illinois state officials that children would only be allowed to return to school wearing a mask.

“Our objections are to the fact that masks on children in school have a greater propensity to make children sick from breathing in bacteria that forms on the inner layer of a mask worn for hours on end,” Rebresh said. “We have an objection to the increase of CO₂ intake and a decrease in oxygen flow for kids who need all the oxygen they can get during a learning environment. We recognized the masking of ourselves and kids for what it is: A political move to separate the two parties in our November election and define and create division between the two.”

Million Unmasked Patriots is one of dozens of antimask groups on social media platforms such as Facebook, Instagram, and TikTok. In July, Facebook suspended one such group, Unmasking America, which boasts 9,600 members, for posting repeated claims that face masks obstruct oxygen flow and have negative mental health effects.

Experts say the antiscience rhetoric is far from new. The antimask movement in many ways, shares similarities with that of the anti-vaccine movement, says Todd Wolynn, MD, a Pittsburgh pediatrician and cofounder of Shots Heard Round the World, an organization that defends vaccine advocates against coordinated online attacks by antivaxxers. Those espousing antimask views often relay similar or the same disinformation pushed by those with antivaccine views, Wolynn said.

“A lot of it is conspiracy-laden,” said Wolynn of the disinformation. “That Dr. [Anthony] Fauci somehow helped construct the pandemic and that it’s not real. That Bill Gates is funding the vaccine so he can inject people with microchips. All sorts of really out-there, ungrounded conspiracy theories. If you had Venn diagram of antimask and antivaxx, I would say there’s clearly overlap.”
 

Parallels between antimaskers, antivaxxers

Opponents to masks fall on a spectrum, explains Vineet Arora, MD, a hospitalist and associate chief medical officer–clinical learning environment at University of Chicago Medicine. People who believe conspiracy theories and push misinformation are on one end, she said. There are also those who generally don’t believe the seriousness of the pandemic, feel their risk is minimal, or doubt the benefits of masks.

The two trains of thought resemble the distinction among parents who are antivaccine and those who are simply “vaccine hesitant,” says Arora, who co-authored a recent article about masking and misinformation that addresses antivaccine attitudes.

“While the antimask sentiment gets a lot of attention, I think it’s important to highlight there’s a lot of vocal anti-mask sentiment since most people are supportive of masks,” she said. “There might be people sitting on the fence who are just unsure about wearing a mask. That’s understandable because the science and the communication has evolved. There was a lot of early mixed messages about masking. Anytime you have confusion about the science or the science is evolving, it’s easy to have misinformation and then have that take off as myth.”

Just as antivaxxers work to swing the opinion of the vaccine hesitant, antimaskers are vying with public health advocates for the support of the mask hesitant, she said. Creating doubt in public health authorities is one way they are gaining followers. Anti-maskers often question and scrutinize past messaging about masks by public health officials, claiming that because guidance on masks has changed over time, the science behind masks and current guidance can’t be trusted, Wolynn said. Similarly, antivaxxers frequently question past actions by public health officials, such as the Tuskegee Experiment (which began in 1932), to try to poke holes in the credibility of public health officials and their advice.

Both the antimask and antivaccine movements also tend to base their resistance on a personal liberties argument, adds Jacqueline Winfield Fincher, MD, president for the American College of Physicians and an internist based in Thomson, Georgia. Antimaskers contend they should be free to decide whether to wear face coverings and that rules requiring masks infringe upon their civil liberties. Similarly, antivaxxers argue they should be free to decide whether to vaccinate their children and contend vaccine mandates violate their personal liberties.

Taking a deeper look, fear and control are two likely drivers of antimasking and antivaccine attitudes, Fincher said. Those refusing to wear masks may feel they have no control over the pandemic or its impacts, but they can control how they respond to mask-wearing requirements, she said.

Antivaccine parents often want more control over their children’s healthcare and falsely believe that vaccines are injecting something harmful into their children or may lead to harmful reactions.

“It’s a control issue and a defense mechanism,” she said. “Some people may feel helpless to deal with the pandemic or believe since it is not affecting them or their family, that it is not real. ‘If I just deny it and I don’t acknowledge facts, I don’t have to worry about it or do anything about it, and therefore I will have more control over my day-to-day life.’”
 

Groups fueling each other

In some cases, antimask and antivaxx groups are joining forces or adopting dual causes.

In California for instance, longtime opponents to vaccines are now objecting to mask policies as similar infringement to their bodily autonomy. Demonstrations in Texas, Idaho, and Michigan against mask mandates and other COVID-19 requirements have drawn support from anti-vaccine activists and incorporated antivaccine propaganda.

In Illinois, Million Unmasked Patriots, formally the Million Unmasked March, has received widespread attention for protesting both masks for returning schoolchildren and a future COVID-19 vaccine requirement.

A July protest planned by the antimask group triggered a letter by Arora and 500 other healthcare professionals to Illinois lawmakers decrying the group’s views and urging the state to move forward with universal masking in schools.

“What’s happening is those who are distrustful of government and public health and science are joining together,” said Arora, who coauthored a piece about the problem on KevinMD.com. “It’s important to address both movements together because they can quickly feed off each other and build in momentum. At the heart of both is really this deep skepticism of science.”

Rebresh of Million Unmasked Patriots said most of his members are not opposed to all vaccines, but rather they are opposed to “untested vaccines.” The primary concern is the inability to research long-term effects of a COVID-19 vaccine before its approval, he said.

Rebresh disagrees with the antimask movement being compared with the antivaccine movement. The two groups are “motivated by different things and a different set of circumstances drive their opinions,” he said. However, Rebresh believes that potential harm resulting from “mass vaccinations” is a valid concern. For this reason, he and his wife chose for their children to receive their vaccinations individually over a series of weeks, rather than the “kiddie cocktail of vaccines,” at a single visit, he said.

Vaccine scientist Peter Hotez, MD, PhD, said the antivaccine movement appears to have grown stronger from the pandemic fueled by fresh conspiracies and new alliances. Antivaccine sentiment has been gaining steam over the last several years and collecting more allies from the far-right, said Hotez, dean for the National School of Tropical Medicine and codirector for the Texas Children’s Hospital Center for Vaccine Development.

“Now what you’re seeing is yet another expansion this year, with antivaccine groups, under the banner of ‘health freedom,’ campaigning against social distancing and wearing masks and contact tracing,” he said. “What was an antivaccine movement has now become a full-blown antiscience movement and an anti-public health movement. It’s causing a lot of damage and I believe costing a lot of American lives.”

Neil F. Johnson, PhD, who has studied the antivaccine movement and its social media proliferation during the pandemic, said online comments by antivaxxers frequently condemn mask usage and showcase memes making fun of masks.

“In those same narratives about opposing vaccines for COVID, we see a lot of discussion against masks,” said Johnson, a physics professor at George Washington University in Washington, D.C. “If you don’t believe in the official picture of COVID, you don’t believe the policies or the advice that’s given about COVID.”

An analysis by Johnson that examined 1,300 Facebook pages found that, while antivaxxers have fewer followers than provaccine pages, antivaccine pages are more numerous, faster growing, and are more often connected to unrelated, undecided pages. Conversely, pages that advocate the benefits of vaccinations and explain the science behind immunizations are largely disconnected from such undecided communities, according to the study, published May 13 in Nature.

The study suggests the antivaccine movement is making influential strides during the pandemic and connecting with people who are undecided, while public health advocates are not building the same bridges, Johnson said.

“I think it’s hugely dangerous, because I don’t know any other moment in science or in public health when there was so much uncertainty in something affecting everybody,” he said. “Every policy that will be coming, everything depends on people buying into the official message. Once you have the seeds of doubt, that’s a very difficult thing to overcome. It’s an unprecedented challenge.”
 

How physicians and clinicians can help

A more aggressive approach is necessary when it comes to taking down antiscience content on social media, says Hotez. Too often, misinformation and antiscience rhetoric is allowed to linger on popular sites such as Facebook and Amazon.

Wolynn agrees. On personal or business platforms, it’s crucial to ban, hide, and delete such comments as quickly as possible, he said. On public sites, purposeful disinformation should be immediately reported to the platform.

At the same time, Wolynn said it’s essential to support those who make sound, science-based comments in social media forums.

“If you see someone who is pushing accurate, evidence-based information, and they come under attack, they should be supported and defended and empowered,” Wolynn said. “Shots Heard Round the World is doing all of those things, including galvanizing and recruiting more people to help get their voices out there.”

Expanded visibility by physicians and scientists would greatly help counter the spread of antiscience sentiment, adds Hotez.

“Too often, antiscience movements are able to flourish because scientists and physicians are invisible,” he said. “They’re too focused on either clinical practices or in the case of physician scientists, on grants and papers and not enough attention to public engagement. We’re going to have to change that around. We need to hear more from scientists directly.”

To that end, Wolynn said health care professionals, including medical students and residents, need to have formal training in communications, media, and social media as part of their education – and more support from employers to engage through social media.

“That’s where the fight is,” Wolynn said. “You can be the best diagnostician, the best clinician. You can make the right diagnosis and prescribe the right medication, but if families don’t hear what you’re saying, you’re not going to be effective. If you can’t be on the platform where they’re being influenced, we’re losing the battle.”
 

Speaking to your mask-hesitant patients

Concentrating on those who are uncertain about masks is particularly key for physicians and public health advocates as the pandemic continues, says Arora.

“It’s important for us to focus on the mask-hesitant who often don’t get the attention they need,” she said.

She suggests bringing up the subject of masks with patients during visits, asking about mask usage, discussing rumors they’ve heard, and emphasizing why masks are important. Be a role model by wearing a mask in your community and on social media, she added.

Some patients have real concerns about not being able to breathe through masks or anxiety disorders that can be aggravated even by the thought of wearing a mask, noted Susan R. Bailey, MD, president for the American Medical Association. Bailey, an immunologist, recently counseled a patient with a deviated nasal septum in addition to a panic disorder who was worried about wearing a mask, she said. Bailey listened to the patient’s concerns, discussed his health conditions, and proposed an alternative face covering that might make him more comfortable.

“Every patient is different,” Bailey said. “It’s important for us to remember that each person who is reluctant to wear a mask has their own reasons. It’s important for us to express some empathy – to agree with them, yes, masks are hot and inconvenient – and help understand their questions, which you may be able to answer to their satisfaction. There are patients that have legitimate questions and a physician caring about how they feel, can make all the difference.”

Physicians can also get involved with the AMA’s #MaskUp campaign, an effort to normalize mask wearing and debunk myths associated with masks. The campaign includes social media materials, slogans doctors can tweet, and profile pictures they can use on social media. The campaign’s toolkit includes images, videos, and information that physicians can share with patients and the public.

Enforcing strong mask policies at your practice and ensuring all staff are modeling appropriate mask behavior is also important, adds Fincher of the ACP. The college recently issued a policy supporting mask usage in community settings.

If a patient conveys an antimask belief, Fincher suggests not directly challenging the person’s views, but listening to them and offering objective data, discussing the science behind masks, and directing them to credible sources.

“Doctors are used to this. We recommend a lot of things to patients that they don’t want to do,” Fincher said. “If a patient feels attacked, they act defensively. But if you base your explanation in more objective terms with data, numbers, and personalize the risks and benefits of a vaccine, a healthy change in behavior, or a medication, then patients are more likely to hear your concerns and do the right thing. Having a long-term relationship with a trusted physician makes all of these issues much easier to discuss and to implement the best plan for the individual patient.”

This article first appeared on Medscape.com.

The number of children infected with COVID-19 rose by 7.8% during the week ending Sept. 3, putting the United States over the half-million mark in cumulative child cases, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

States have reported 513,415 cases of COVID-19 in children since the beginning of the pandemic, with almost 37,000 coming in the last week, the AAP and the CHA said Sept. 8 in the weekly report. That figure includes New York City – the rest of New York State is not reporting ages for COVID-19 patients – as well as Puerto Rico, the District of Columbia, and Guam.

“These numbers are a chilling reminder of why we need to take this virus seriously,” AAP President Sara Goza, MD, said in a written statement.

Children now represent 9.8% of the almost 5.3 million cases that have been reported in Americans of all ages. The proportion of child cases has continued to increase as the pandemic has progressed – it was 8.0% as of mid-July and 5.2% in early June, the data show.

“Throughout the summer, surges in the virus have occurred in Southern, Western, and Midwestern states,” the AAP statement said.

The latest AAP/CHA report shows that, from Aug. 27 to Sept. 3, the total number of child cases jumped by 33.7% in South Dakota, more than any other state. North Dakota was next at 22.7%, followed by Hawaii (18.1%), Missouri (16.8%), and Kentucky (16.4%).

“This rapid rise in positive cases occurred over the summer, and as the weather cools, we know people will spend more time indoors,” said Sean O’Leary, MD, MPH, vice chair of the AAP Committee on Infectious Diseases. “The goal is to get children back into schools for in-person learning, but in many communities, this is not possible as the virus spreads unchecked.”

The smallest increase over the last week, just 0.9%, came in Rhode Island, with Massachusetts just a bit higher at 1.0%. Also at the low end of the increase scale are Arizona (3.3%) and Louisiana (4.0%), two states that have very high rates of cumulative cases: 1,380 per 100,000 children for Arizona and 1,234 per 100,000 for Louisiana, the report said.

To give those figures some context, Tennessee has the highest cumulative count of any state at 1,553 cases per 100,000 children and Vermont has the lowest at 151, based on the data gathered by the AAP and CHA.

“While much remains unknown about COVID-19, we do know that the spread among children reflects what is happening in the broader communities. A disproportionate number of cases are reported in Black and Hispanic children and in places where there is high poverty. We must work harder to address societal inequities that contribute to these disparities,” Dr. Goza said.

rfranki@mdedge.com

The number of children infected with COVID-19 rose by 7.8% during the week ending Sept. 3, putting the United States over the half-million mark in cumulative child cases, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

States have reported 513,415 cases of COVID-19 in children since the beginning of the pandemic, with almost 37,000 coming in the last week, the AAP and the CHA said Sept. 8 in the weekly report. That figure includes New York City – the rest of New York State is not reporting ages for COVID-19 patients – as well as Puerto Rico, the District of Columbia, and Guam.

“These numbers are a chilling reminder of why we need to take this virus seriously,” AAP President Sara Goza, MD, said in a written statement.

Children now represent 9.8% of the almost 5.3 million cases that have been reported in Americans of all ages. The proportion of child cases has continued to increase as the pandemic has progressed – it was 8.0% as of mid-July and 5.2% in early June, the data show.

“Throughout the summer, surges in the virus have occurred in Southern, Western, and Midwestern states,” the AAP statement said.

The latest AAP/CHA report shows that, from Aug. 27 to Sept. 3, the total number of child cases jumped by 33.7% in South Dakota, more than any other state. North Dakota was next at 22.7%, followed by Hawaii (18.1%), Missouri (16.8%), and Kentucky (16.4%).

“This rapid rise in positive cases occurred over the summer, and as the weather cools, we know people will spend more time indoors,” said Sean O’Leary, MD, MPH, vice chair of the AAP Committee on Infectious Diseases. “The goal is to get children back into schools for in-person learning, but in many communities, this is not possible as the virus spreads unchecked.”

The smallest increase over the last week, just 0.9%, came in Rhode Island, with Massachusetts just a bit higher at 1.0%. Also at the low end of the increase scale are Arizona (3.3%) and Louisiana (4.0%), two states that have very high rates of cumulative cases: 1,380 per 100,000 children for Arizona and 1,234 per 100,000 for Louisiana, the report said.

To give those figures some context, Tennessee has the highest cumulative count of any state at 1,553 cases per 100,000 children and Vermont has the lowest at 151, based on the data gathered by the AAP and CHA.

“While much remains unknown about COVID-19, we do know that the spread among children reflects what is happening in the broader communities. A disproportionate number of cases are reported in Black and Hispanic children and in places where there is high poverty. We must work harder to address societal inequities that contribute to these disparities,” Dr. Goza said.

rfranki@mdedge.com

The number of children infected with COVID-19 rose by 7.8% during the week ending Sept. 3, putting the United States over the half-million mark in cumulative child cases, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

States have reported 513,415 cases of COVID-19 in children since the beginning of the pandemic, with almost 37,000 coming in the last week, the AAP and the CHA said Sept. 8 in the weekly report. That figure includes New York City – the rest of New York State is not reporting ages for COVID-19 patients – as well as Puerto Rico, the District of Columbia, and Guam.

“These numbers are a chilling reminder of why we need to take this virus seriously,” AAP President Sara Goza, MD, said in a written statement.

Children now represent 9.8% of the almost 5.3 million cases that have been reported in Americans of all ages. The proportion of child cases has continued to increase as the pandemic has progressed – it was 8.0% as of mid-July and 5.2% in early June, the data show.

“Throughout the summer, surges in the virus have occurred in Southern, Western, and Midwestern states,” the AAP statement said.

The latest AAP/CHA report shows that, from Aug. 27 to Sept. 3, the total number of child cases jumped by 33.7% in South Dakota, more than any other state. North Dakota was next at 22.7%, followed by Hawaii (18.1%), Missouri (16.8%), and Kentucky (16.4%).

“This rapid rise in positive cases occurred over the summer, and as the weather cools, we know people will spend more time indoors,” said Sean O’Leary, MD, MPH, vice chair of the AAP Committee on Infectious Diseases. “The goal is to get children back into schools for in-person learning, but in many communities, this is not possible as the virus spreads unchecked.”

The smallest increase over the last week, just 0.9%, came in Rhode Island, with Massachusetts just a bit higher at 1.0%. Also at the low end of the increase scale are Arizona (3.3%) and Louisiana (4.0%), two states that have very high rates of cumulative cases: 1,380 per 100,000 children for Arizona and 1,234 per 100,000 for Louisiana, the report said.

To give those figures some context, Tennessee has the highest cumulative count of any state at 1,553 cases per 100,000 children and Vermont has the lowest at 151, based on the data gathered by the AAP and CHA.

“While much remains unknown about COVID-19, we do know that the spread among children reflects what is happening in the broader communities. A disproportionate number of cases are reported in Black and Hispanic children and in places where there is high poverty. We must work harder to address societal inequities that contribute to these disparities,” Dr. Goza said.

rfranki@mdedge.com

Amarin’s hopes of fending off generic competition for its blockbuster high-strength eicosapentaenoic acid product, icosapent ethyl (Vascepa), have dimmed following a decision by the U.S. Court of Appeals for the Federal Circuit in the company’s ongoing patent litigation.

The court upheld the March ruling by the District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications (ANDAs) for the product.

Amarin said it is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current decision by the full panel of 12 active judges at the Court of Appeals for the Federal Circuit.

“We are extremely disappointed with [the] ruling and plan to vigorously pursue available remedies,” John Thero, Amarin president and chief executive officer, said in a statement.

In 2012, Vascepa became the first and only prescription treatment approved by the Food and Drug Administration made up solely of the active ingredient icosapent ethyl, a unique form of eicosapentaenoic acid. It was initially approved for the reduction of very high triglyceride levels (≥500 mg/dL).

In late 2019, the FDA extended the indication to reduce the risk for cardiovascular events in people with elevated triglyceride levels and either established CV disease or diabetes with other CV risk factors.

The extended indication was based on results of the landmark REDUCE-IT trial, which showed a 25% relative risk reduction in major adverse CV events with icosapent ethyl, compared with placebo, in patients with triglyceride levels above 135 mg/dL and who had CV disease (70% of the study population), or who were high-risk primary-prevention patients with diabetes and one additional risk factor (30% of the study population).

According to Amarin, since its launch, Vascepa has been prescribed more than 8 million times.

The company said demand for the product in the United States remains “strong” and indicated that, despite the legal setback, it would continue promotional efforts. The company is also seeking additional regulatory approvals in China, Europe, and additional countries in the Middle East.

“We are particularly excited about the anticipated commercialization opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021,” Mr. Thero said.

The company anticipates 10 years of market protection because of regulatory exclusivity in the European Union once approved, and said patent protection could extend into 2039.

Only Vascepa sold in the United States is subject to this litigation and judgment. No generic litigation is pending outside the United States, Amarin said.

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

Amarin’s hopes of fending off generic competition for its blockbuster high-strength eicosapentaenoic acid product, icosapent ethyl (Vascepa), have dimmed following a decision by the U.S. Court of Appeals for the Federal Circuit in the company’s ongoing patent litigation.

The court upheld the March ruling by the District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications (ANDAs) for the product.

Amarin said it is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current decision by the full panel of 12 active judges at the Court of Appeals for the Federal Circuit.

“We are extremely disappointed with [the] ruling and plan to vigorously pursue available remedies,” John Thero, Amarin president and chief executive officer, said in a statement.

In 2012, Vascepa became the first and only prescription treatment approved by the Food and Drug Administration made up solely of the active ingredient icosapent ethyl, a unique form of eicosapentaenoic acid. It was initially approved for the reduction of very high triglyceride levels (≥500 mg/dL).

In late 2019, the FDA extended the indication to reduce the risk for cardiovascular events in people with elevated triglyceride levels and either established CV disease or diabetes with other CV risk factors.

The extended indication was based on results of the landmark REDUCE-IT trial, which showed a 25% relative risk reduction in major adverse CV events with icosapent ethyl, compared with placebo, in patients with triglyceride levels above 135 mg/dL and who had CV disease (70% of the study population), or who were high-risk primary-prevention patients with diabetes and one additional risk factor (30% of the study population).

According to Amarin, since its launch, Vascepa has been prescribed more than 8 million times.

The company said demand for the product in the United States remains “strong” and indicated that, despite the legal setback, it would continue promotional efforts. The company is also seeking additional regulatory approvals in China, Europe, and additional countries in the Middle East.

“We are particularly excited about the anticipated commercialization opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021,” Mr. Thero said.

The company anticipates 10 years of market protection because of regulatory exclusivity in the European Union once approved, and said patent protection could extend into 2039.

Only Vascepa sold in the United States is subject to this litigation and judgment. No generic litigation is pending outside the United States, Amarin said.

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

Amarin’s hopes of fending off generic competition for its blockbuster high-strength eicosapentaenoic acid product, icosapent ethyl (Vascepa), have dimmed following a decision by the U.S. Court of Appeals for the Federal Circuit in the company’s ongoing patent litigation.

The court upheld the March ruling by the District Court for the District of Nevada in favor of two generic companies in connection with their abbreviated new drug applications (ANDAs) for the product.

Amarin said it is currently reviewing its legal options and within 30 days expects to file a petition for an en banc review of the current decision by the full panel of 12 active judges at the Court of Appeals for the Federal Circuit.

“We are extremely disappointed with [the] ruling and plan to vigorously pursue available remedies,” John Thero, Amarin president and chief executive officer, said in a statement.

In 2012, Vascepa became the first and only prescription treatment approved by the Food and Drug Administration made up solely of the active ingredient icosapent ethyl, a unique form of eicosapentaenoic acid. It was initially approved for the reduction of very high triglyceride levels (≥500 mg/dL).

In late 2019, the FDA extended the indication to reduce the risk for cardiovascular events in people with elevated triglyceride levels and either established CV disease or diabetes with other CV risk factors.

The extended indication was based on results of the landmark REDUCE-IT trial, which showed a 25% relative risk reduction in major adverse CV events with icosapent ethyl, compared with placebo, in patients with triglyceride levels above 135 mg/dL and who had CV disease (70% of the study population), or who were high-risk primary-prevention patients with diabetes and one additional risk factor (30% of the study population).

According to Amarin, since its launch, Vascepa has been prescribed more than 8 million times.

The company said demand for the product in the United States remains “strong” and indicated that, despite the legal setback, it would continue promotional efforts. The company is also seeking additional regulatory approvals in China, Europe, and additional countries in the Middle East.

“We are particularly excited about the anticipated commercialization opportunities for Vascepa in Europe as we prepare for expected approval and launch in early 2021,” Mr. Thero said.

The company anticipates 10 years of market protection because of regulatory exclusivity in the European Union once approved, and said patent protection could extend into 2039.

Only Vascepa sold in the United States is subject to this litigation and judgment. No generic litigation is pending outside the United States, Amarin said.

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

A team of U.S. researchers is investigating whether pressurized intraperitoneal aerosolized chemotherapy (PIPAC) can benefit patients with advanced cancer and peritoneal carcinomatosis.

City of Hope

The team’s phase 1 trial is the first in the United States to test PIPAC, and it will enroll patients with ovarian, uterine, colorectal, or gastric cancer who have peritoneal carcinomatosis.

Data from studies outside the United States suggest PIPAC can induce regression of peritoneal carcinomatosis, even in end-stage, therapy-resistant gastric, ovarian, and colorectal cancers (Lancet Oncol. 2019 Jul;20[7]:e368-e377).

The current study (NCT04329494) formally introduces PIPAC to the United States and serves as a launching pad for further investigation into how the treatment should be administered and which types of chemotherapies can be used.
 

About PIPAC

“PIPAC is a novel therapeutic approach that is minimally invasive, does not require cytoreduction, and can be repeated frequently,” said Thanh Dellinger, MD, a gynecologic oncology surgeon at City of Hope in Duarte, Calif., and co–principal investigator of the phase 1 trial.

“[PIPAC] entails accessing the abdominal cavity using standard laparoscopic techniques and relies on the increased intra-abdominal pressure (15 mm Hg) achieved with laparoscopic surgery, which generates a convective flux that forces aerosolized chemotherapy drugs from the peritoneal cavity into the subperitoneal tissue and overcomes the tumor’s interstitial pressure,” Dr. Dellinger explained in an interview.

“The surgical procedure to deliver PIPAC does not typically cause adhesive disease and allows for repeated delivery of intraperitoneal chemotherapy, objective tumor staging, and response assessment,” she noted.

Dr. Dellinger said the advantages of PIPAC include a minimally invasive approach; no debulking surgery required; deeper uptake of drugs in tumor tissues; wider, more effective drug distribution; fewer toxicities caused by lower drug dosage; repeatable administration; and palliation of peritoneal carcinomatosis symptoms, including abdominal bloating and ascites.

PIPAC achieves a deeper peritoneal nodule penetration of several millimeters with cisplatin, compared to less than 1 mm with heated intraoperative peritoneal chemotherapy (HIPEC) and other intraperitoneal methods, according to Amit Merchea, MD, an assistant professor of surgery at the Mayo Clinic in Jacksonville, Fla.

Dr. Merchea performed the first PIPAC procedure in the United States in December 2019.
 

Innovative therapies needed

Peritoneal carcinomatosis is often a late-stage manifestation of abdominal cancers and is usually lethal, Dr. Dellinger said. She noted that systemic chemotherapy in the palliative setting is relatively ineffective in patients with peritoneal carcinomatosis because of pharmacokinetic limitations, poor peritoneal drug uptake, and impaired local drug distribution.

“Innovative, effective therapies are urgently needed for people who have ovarian, uterine, gastric, or colorectal cancer with peritoneal carcinomatosis,” Dr. Dellinger said.

“PIPAC is a novel treatment option that has had very favorable and exciting results,” Dr. Merchea said. “It is a potential option for patients when no other treatment options exist, and it is an avenue to provide hope to patients when often they have none.”

Potential candidates for PIPAC include patients who have peritoneal carcinomatosis, have failed other standard therapies, have more than 6 months’ life expectancy, and are not candidates for cytoreduction with HIPEC. There remains very limited data on the use of PIPAC as a neoadjuvant approach to convert patients who were previously unresectable to resectable disease, Dr. Merchea noted.

“To deliver chemotherapy directly to the tumor under pressure allows PIPAC to better penetrate the peritoneal surface and tumor nodules than traditional approaches, such as HIPEC,” Dr. Merchea said. “And the drug distribution at the tissue level is better than what is often achieved by systemic chemotherapy, but without the systemic effects of chemotherapy, such as hair loss. The treatment gives essentially a real-time, quantitative assessment of response by being able to directly assess the tumor via laparoscopic visualization and repeat biopsy.”

“Importantly, patients who undergo PIPAC don’t notice a decrease in their quality of life, and some patients note improvement, particularly with respect to nausea, vomiting, appetite, fatigue, and constipation,” Dr. Merchea said.
 

Trial details

The phase 1 trial of PIPAC will include a maximum of 24 patients. They will receive treatment every 6 weeks for up to three cycles and be followed for up to 3 years.

Patients with ovarian, uterine, or gastric cancer will undergo PIPAC with cisplatin, followed by doxorubicin. Patients with colorectal cancer will undergo PIPAC with oxaliplatin preceded by leucovorin and fluorouracil for cycles 2 and 3.

The researchers also plan to profile patients’ tumors.

“Tumor samples will be chronologically evaluated with genomics, spatial transcriptomics, pharmacodynamics, and single-cell sequencing throughout a patient’s treatment course, thus elucidating the treatment effects and natural history of peritoneal cancers,” Dr. Dellinger said.

The trial sites include City of Hope, Mayo Clinic in Florida, Northwell Health in New York, and the National Cancer Institute in Maryland.

The trial is sponsored by City of Hope in collaboration with the National Cancer Institute. Dr. Merchea and Dr. Dellinger reported having no conflicts of interest.

A team of U.S. researchers is investigating whether pressurized intraperitoneal aerosolized chemotherapy (PIPAC) can benefit patients with advanced cancer and peritoneal carcinomatosis.

City of Hope

The team’s phase 1 trial is the first in the United States to test PIPAC, and it will enroll patients with ovarian, uterine, colorectal, or gastric cancer who have peritoneal carcinomatosis.

Data from studies outside the United States suggest PIPAC can induce regression of peritoneal carcinomatosis, even in end-stage, therapy-resistant gastric, ovarian, and colorectal cancers (Lancet Oncol. 2019 Jul;20[7]:e368-e377).

The current study (NCT04329494) formally introduces PIPAC to the United States and serves as a launching pad for further investigation into how the treatment should be administered and which types of chemotherapies can be used.
 

About PIPAC

“PIPAC is a novel therapeutic approach that is minimally invasive, does not require cytoreduction, and can be repeated frequently,” said Thanh Dellinger, MD, a gynecologic oncology surgeon at City of Hope in Duarte, Calif., and co–principal investigator of the phase 1 trial.

“[PIPAC] entails accessing the abdominal cavity using standard laparoscopic techniques and relies on the increased intra-abdominal pressure (15 mm Hg) achieved with laparoscopic surgery, which generates a convective flux that forces aerosolized chemotherapy drugs from the peritoneal cavity into the subperitoneal tissue and overcomes the tumor’s interstitial pressure,” Dr. Dellinger explained in an interview.

“The surgical procedure to deliver PIPAC does not typically cause adhesive disease and allows for repeated delivery of intraperitoneal chemotherapy, objective tumor staging, and response assessment,” she noted.

Dr. Dellinger said the advantages of PIPAC include a minimally invasive approach; no debulking surgery required; deeper uptake of drugs in tumor tissues; wider, more effective drug distribution; fewer toxicities caused by lower drug dosage; repeatable administration; and palliation of peritoneal carcinomatosis symptoms, including abdominal bloating and ascites.

PIPAC achieves a deeper peritoneal nodule penetration of several millimeters with cisplatin, compared to less than 1 mm with heated intraoperative peritoneal chemotherapy (HIPEC) and other intraperitoneal methods, according to Amit Merchea, MD, an assistant professor of surgery at the Mayo Clinic in Jacksonville, Fla.

Dr. Merchea performed the first PIPAC procedure in the United States in December 2019.
 

Innovative therapies needed

Peritoneal carcinomatosis is often a late-stage manifestation of abdominal cancers and is usually lethal, Dr. Dellinger said. She noted that systemic chemotherapy in the palliative setting is relatively ineffective in patients with peritoneal carcinomatosis because of pharmacokinetic limitations, poor peritoneal drug uptake, and impaired local drug distribution.

“Innovative, effective therapies are urgently needed for people who have ovarian, uterine, gastric, or colorectal cancer with peritoneal carcinomatosis,” Dr. Dellinger said.

“PIPAC is a novel treatment option that has had very favorable and exciting results,” Dr. Merchea said. “It is a potential option for patients when no other treatment options exist, and it is an avenue to provide hope to patients when often they have none.”

Potential candidates for PIPAC include patients who have peritoneal carcinomatosis, have failed other standard therapies, have more than 6 months’ life expectancy, and are not candidates for cytoreduction with HIPEC. There remains very limited data on the use of PIPAC as a neoadjuvant approach to convert patients who were previously unresectable to resectable disease, Dr. Merchea noted.

“To deliver chemotherapy directly to the tumor under pressure allows PIPAC to better penetrate the peritoneal surface and tumor nodules than traditional approaches, such as HIPEC,” Dr. Merchea said. “And the drug distribution at the tissue level is better than what is often achieved by systemic chemotherapy, but without the systemic effects of chemotherapy, such as hair loss. The treatment gives essentially a real-time, quantitative assessment of response by being able to directly assess the tumor via laparoscopic visualization and repeat biopsy.”

“Importantly, patients who undergo PIPAC don’t notice a decrease in their quality of life, and some patients note improvement, particularly with respect to nausea, vomiting, appetite, fatigue, and constipation,” Dr. Merchea said.
 

Trial details

The phase 1 trial of PIPAC will include a maximum of 24 patients. They will receive treatment every 6 weeks for up to three cycles and be followed for up to 3 years.

Patients with ovarian, uterine, or gastric cancer will undergo PIPAC with cisplatin, followed by doxorubicin. Patients with colorectal cancer will undergo PIPAC with oxaliplatin preceded by leucovorin and fluorouracil for cycles 2 and 3.

The researchers also plan to profile patients’ tumors.

“Tumor samples will be chronologically evaluated with genomics, spatial transcriptomics, pharmacodynamics, and single-cell sequencing throughout a patient’s treatment course, thus elucidating the treatment effects and natural history of peritoneal cancers,” Dr. Dellinger said.

The trial sites include City of Hope, Mayo Clinic in Florida, Northwell Health in New York, and the National Cancer Institute in Maryland.

The trial is sponsored by City of Hope in collaboration with the National Cancer Institute. Dr. Merchea and Dr. Dellinger reported having no conflicts of interest.

A team of U.S. researchers is investigating whether pressurized intraperitoneal aerosolized chemotherapy (PIPAC) can benefit patients with advanced cancer and peritoneal carcinomatosis.

City of Hope

The team’s phase 1 trial is the first in the United States to test PIPAC, and it will enroll patients with ovarian, uterine, colorectal, or gastric cancer who have peritoneal carcinomatosis.

Data from studies outside the United States suggest PIPAC can induce regression of peritoneal carcinomatosis, even in end-stage, therapy-resistant gastric, ovarian, and colorectal cancers (Lancet Oncol. 2019 Jul;20[7]:e368-e377).

The current study (NCT04329494) formally introduces PIPAC to the United States and serves as a launching pad for further investigation into how the treatment should be administered and which types of chemotherapies can be used.
 

About PIPAC

“PIPAC is a novel therapeutic approach that is minimally invasive, does not require cytoreduction, and can be repeated frequently,” said Thanh Dellinger, MD, a gynecologic oncology surgeon at City of Hope in Duarte, Calif., and co–principal investigator of the phase 1 trial.

“[PIPAC] entails accessing the abdominal cavity using standard laparoscopic techniques and relies on the increased intra-abdominal pressure (15 mm Hg) achieved with laparoscopic surgery, which generates a convective flux that forces aerosolized chemotherapy drugs from the peritoneal cavity into the subperitoneal tissue and overcomes the tumor’s interstitial pressure,” Dr. Dellinger explained in an interview.

“The surgical procedure to deliver PIPAC does not typically cause adhesive disease and allows for repeated delivery of intraperitoneal chemotherapy, objective tumor staging, and response assessment,” she noted.

Dr. Dellinger said the advantages of PIPAC include a minimally invasive approach; no debulking surgery required; deeper uptake of drugs in tumor tissues; wider, more effective drug distribution; fewer toxicities caused by lower drug dosage; repeatable administration; and palliation of peritoneal carcinomatosis symptoms, including abdominal bloating and ascites.

PIPAC achieves a deeper peritoneal nodule penetration of several millimeters with cisplatin, compared to less than 1 mm with heated intraoperative peritoneal chemotherapy (HIPEC) and other intraperitoneal methods, according to Amit Merchea, MD, an assistant professor of surgery at the Mayo Clinic in Jacksonville, Fla.

Dr. Merchea performed the first PIPAC procedure in the United States in December 2019.
 

Innovative therapies needed

Peritoneal carcinomatosis is often a late-stage manifestation of abdominal cancers and is usually lethal, Dr. Dellinger said. She noted that systemic chemotherapy in the palliative setting is relatively ineffective in patients with peritoneal carcinomatosis because of pharmacokinetic limitations, poor peritoneal drug uptake, and impaired local drug distribution.

“Innovative, effective therapies are urgently needed for people who have ovarian, uterine, gastric, or colorectal cancer with peritoneal carcinomatosis,” Dr. Dellinger said.

“PIPAC is a novel treatment option that has had very favorable and exciting results,” Dr. Merchea said. “It is a potential option for patients when no other treatment options exist, and it is an avenue to provide hope to patients when often they have none.”

Potential candidates for PIPAC include patients who have peritoneal carcinomatosis, have failed other standard therapies, have more than 6 months’ life expectancy, and are not candidates for cytoreduction with HIPEC. There remains very limited data on the use of PIPAC as a neoadjuvant approach to convert patients who were previously unresectable to resectable disease, Dr. Merchea noted.

“To deliver chemotherapy directly to the tumor under pressure allows PIPAC to better penetrate the peritoneal surface and tumor nodules than traditional approaches, such as HIPEC,” Dr. Merchea said. “And the drug distribution at the tissue level is better than what is often achieved by systemic chemotherapy, but without the systemic effects of chemotherapy, such as hair loss. The treatment gives essentially a real-time, quantitative assessment of response by being able to directly assess the tumor via laparoscopic visualization and repeat biopsy.”

“Importantly, patients who undergo PIPAC don’t notice a decrease in their quality of life, and some patients note improvement, particularly with respect to nausea, vomiting, appetite, fatigue, and constipation,” Dr. Merchea said.
 

Trial details

The phase 1 trial of PIPAC will include a maximum of 24 patients. They will receive treatment every 6 weeks for up to three cycles and be followed for up to 3 years.

Patients with ovarian, uterine, or gastric cancer will undergo PIPAC with cisplatin, followed by doxorubicin. Patients with colorectal cancer will undergo PIPAC with oxaliplatin preceded by leucovorin and fluorouracil for cycles 2 and 3.

The researchers also plan to profile patients’ tumors.

“Tumor samples will be chronologically evaluated with genomics, spatial transcriptomics, pharmacodynamics, and single-cell sequencing throughout a patient’s treatment course, thus elucidating the treatment effects and natural history of peritoneal cancers,” Dr. Dellinger said.

The trial sites include City of Hope, Mayo Clinic in Florida, Northwell Health in New York, and the National Cancer Institute in Maryland.

The trial is sponsored by City of Hope in collaboration with the National Cancer Institute. Dr. Merchea and Dr. Dellinger reported having no conflicts of interest.

Early in the COVID-19 pandemic, entrepreneur and philanthropist Steve Kirsch realized that until we have a vaccine against SARS-CoV-2, we would be at the mercy of this virus. He realized that the fastest and most effective way to reduce COVID-19 fatalities would be to leverage existing drugs to treat patients at the onset of infection — before they become sick. A lack of funded research in this area prompted him to establish the COVID-19 Early Treatment Fund (CETF) with the purpose of funding outpatient clinical trials of promising repurposed drugs.

Medscape spoke with CETF’s chief medical advisor, Lisa Danzig, MD, about the organization’s aim to fund promising research on repurposed drugs to treat COVID-19.

What is CETF trying to do?

Two things: save lives, and get control of this pandemic.

We are facing perhaps the greatest crisis of our lifetime. Doctors who have taken care of patients with COVID are really frustrated about not having anything to offer; they just watch patients die. We want to change that. CETF was founded to find treatments that, when given early, could improve outcomes and avoid catastrophic complications in patients suffering from COVID-19. That means reducing hospitalizations, which can reduce mortality, but it also can mean reducing viral load, and that can have a profound impact on transmission within communities. We are a funding organization — a Band-Aid. We shouldn’t exist, but we do, aiming to close gaps until a coordinated response can get set up.

Tell us about drug repurposing and why you think existing drugs might have a role in mitigating COVID-19 or slowing its transmission.

This disease has two components — the viral infection, and the immunopathology. So the two promising categories of drugs are classical antivirals (or repurposed drugs with antiviral activity), and the immunomodulators. We are mechanism-agnostic. It doesn’t matter what kind of drug it is if it keeps people out of the hospital and prevents chronic morbidity and mortality.

Repurposed drugs are sort of the low-hanging fruit of clinical drugs. The QBI Coronavirus Research Group identified 69 compounds that have theoretical activity against SARS-CoV-2, 29 of which are already FDA-approved drugs. We thought, why don’t we start testing them?

Some people might call this a long shot. Does drug repurposing really work?

Drugmakers don’t test their drugs on every disease they might be effective for. Drug repurposing can work, but if we don’t look, we definitely won’t find anything. The classic repurposed drug is Viagra, a failed hypertension drug. When the studies ended because it didn’t work, the drug company asked patients to send back the unused drugs. The women all returned the drugs, but the men didn’t. And the rest is history.

There’s a long list of potential drugs that can be repurposed, but few are being tested. The famous poster child of a repurposed drug — hydroxychloroquine — has been the subject of more than 250 clinical trials, but the others weren’t getting much attention.

The beauty of a repurposed drug is that if you can get funding and start enrolling patients, you could potentially find out fairly quickly, as early as a few months, if that drug has an antiviral effect or not. These data would help prioritize drugs to be tested in larger confirmatory studies.

Your focus is on early treatment. What’s the rationale for that?

We are focusing on early treatment because it has been overlooked. The attention has been on vaccines and therapeutics for hospitalized patients. But if you are spending $20 billion on potential vaccines and billions more on diagnostics, we need to give proportional resources toward drugs that might actually work, when given early, in preventing severe disease and death.

Early treatment, if successful, would allow us to avoid the severe complications that we are seeing now. If we can find an early treatment with an existing drug, it would be the fastest, most clinically- and cost-effective way to mitigate the impact of COVID-19 and get us on the road to recovery.

How do you get from a potential repurposed drug for COVID-19 to having a therapeutic agent that will save lives?

Most of the studies we are funding are smaller outpatient studies with virologic endpoints. We are looking for a signal that the drug has antiviral activity. We want to know whether a drug works before we spend the money on questions that take a much larger sample size to answer, for example, a big postexposure prophylaxis study. We’d like to see a meaningful signal in proof-of-concept studies, so we can look at a small group of patients with positive tests and see whether their viral load dropped by more than half if they got the drug compared with those who took the placebo. If the drug had an impact on the viral load and shortened the period of infectivity and was safe, these findings would provide justification to spend a lot of money on a large clinical trial. That would probably encourage the NIH and ACTIV [Accelerating COVID-19 Therapeutic Interventions and Vaccines] collaboration to prioritize the drug for one of their big platform trials. That›s what we are aiming for.

CETF isn’t a drug developer — we are a funder for a good proposal to study a repurposed drug. We want to help move the dial — can we get an early yes or an early no? In drug development, we say, “fail fast and fail early.” It’s a numbers game. Only 10% of early candidates will become approved drugs. The value is in the data, whether they are positive or negative — it doesn’t matter. If the study is a definitive “no,” that is just as helpful as a definitive “yes.” Of course, we all want the definitive “yes,” but there are so many things to look at, the “no’s” will help us redirect resources toward what may really help.

You first announced these funding opportunities in April. How is it going so far?

As soon as the website went up, we got 40 applications. Our scientific advisory board, which has expertise from medicinal chemistry and coronavirology to translational and clinical trial expertise, reviewed the applications and prioritized 11 fundable proposals. We are using milestone-based funding; in other words, funding those who are ready to go.

Which drugs are being tested in the funded studies?

One of the earliest grants we supported was Dr David Boulaware’s randomized controlled trial of hydroxychloroquine (NCT 04308668) in 821 asymptomatic patients within 4 days after a high-risk or moderate-risk exposure. That trial did not show any benefit of hydroxychloroquine as postexposure prophylaxis against COVID-19. This trial was important for another reason. It proved the feasibility of a no-contact trial design in the setting of COVID-19, and participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.

Camostat, a transmembrane serine protease (TMPRSS2) inhibitor licensed for use in Japan to treat pancreatitis and esophagitis, combined with the antiandrogen bicalutamide, is being explored for early COVID-19 treatment. TMPRSS2 primes the SARS-CoV-2 spike protein to bind to the ACE2 receptor and gain entry to the cell, and has been shown to have antiviral activity. CETF has provided funding support to ongoing trials of Camostat at Yale University and Aarhus University in Denmark.

Another outpatient trial for fluvoxamine, a drug approved in the United States and routinely prescribed for depression, was also partially funded by a CETF grant to Washington University in St. Louis. Fluvoxamine is a serotonin regulator but also activates the sigma-1 receptor, which reduces the body’s immune response to prevent an overactive immune response or cytokine storm, a major cause of clinical deterioration, serious organ damage, and even death from COVID. This trial was recently completed, and the results have been submitted for publication.

Other promising drugs include niclosamide, doxazosin, favipiravir, leronlimab, interferon beta, interferon lambda, and other monoclonal antibodies. New compounds considered to have potential against COVID include a flu drug (MK-4482/EIDD-2801) and GS-441524, a metabolite of the antiviral drug, remdesivir.

Why not just put all of our resources into vaccine development?

We absolutely need a vaccine to control the outbreak and stop the pandemic. However, it’s a long road to finding an effective vaccine, and in the meantime, we need tools to keep people alive. If we can find an antiviral drug that acts early, we can reduce transmission and contribute to outbreak control. All these tools help us get back to normal while we are waiting for a vaccine. The vaccine is only good if we can give it to every susceptible person in the world — which will take longer than 3 years. And there are no guarantees. Remember, we are still waiting for an HIV vaccine.

You are calling on Americans to help. What do you want them to do?

Everyone must participate in the behavioral changes designed to control the outbreak — physical distancing, face-covering, and paying attention to case counts in local areas to enable them to take appropriate precautions. I know people are bored of that message, but we are going to repeat it until we have a vaccine or herd immunity.

This organism is ripping like wildfire through our unimmunized population. Personal behaviors might slow it down, but finding a drug that can be given to people after they’ve been exposed and test positive will have a meaningful impact on helping us get back to normal.

There’s a great spirit of volunteerism — people are constantly asking how they can help. Through us at CETF, we offer three ways that people can help. They can participate as subjects in clinical trials, many of which are ongoing, including clinical trials, surveillance studies, and follow-up studies. They can donate to our fund and help support the research needed to find an effective early treatment. We have a link on our website, TreatEarly.org. And finally, researchers can apply for funding. We think everybody can help in one of these ways by participating in trials, donating, or applying for funding. It’s an all-hands-on-deck moment for our country.

Danzig is the chief medical advisor of the COVID-19 Early Treatment Fund. She has spent more than 20 years in the pharmaceutical industry developing vaccines, diagnostics, and drugs and is currently advising companies and investors.

This article first appeared on Medscape.com.

Early in the COVID-19 pandemic, entrepreneur and philanthropist Steve Kirsch realized that until we have a vaccine against SARS-CoV-2, we would be at the mercy of this virus. He realized that the fastest and most effective way to reduce COVID-19 fatalities would be to leverage existing drugs to treat patients at the onset of infection — before they become sick. A lack of funded research in this area prompted him to establish the COVID-19 Early Treatment Fund (CETF) with the purpose of funding outpatient clinical trials of promising repurposed drugs.

Medscape spoke with CETF’s chief medical advisor, Lisa Danzig, MD, about the organization’s aim to fund promising research on repurposed drugs to treat COVID-19.

What is CETF trying to do?

Two things: save lives, and get control of this pandemic.

We are facing perhaps the greatest crisis of our lifetime. Doctors who have taken care of patients with COVID are really frustrated about not having anything to offer; they just watch patients die. We want to change that. CETF was founded to find treatments that, when given early, could improve outcomes and avoid catastrophic complications in patients suffering from COVID-19. That means reducing hospitalizations, which can reduce mortality, but it also can mean reducing viral load, and that can have a profound impact on transmission within communities. We are a funding organization — a Band-Aid. We shouldn’t exist, but we do, aiming to close gaps until a coordinated response can get set up.

Tell us about drug repurposing and why you think existing drugs might have a role in mitigating COVID-19 or slowing its transmission.

This disease has two components — the viral infection, and the immunopathology. So the two promising categories of drugs are classical antivirals (or repurposed drugs with antiviral activity), and the immunomodulators. We are mechanism-agnostic. It doesn’t matter what kind of drug it is if it keeps people out of the hospital and prevents chronic morbidity and mortality.

Repurposed drugs are sort of the low-hanging fruit of clinical drugs. The QBI Coronavirus Research Group identified 69 compounds that have theoretical activity against SARS-CoV-2, 29 of which are already FDA-approved drugs. We thought, why don’t we start testing them?

Some people might call this a long shot. Does drug repurposing really work?

Drugmakers don’t test their drugs on every disease they might be effective for. Drug repurposing can work, but if we don’t look, we definitely won’t find anything. The classic repurposed drug is Viagra, a failed hypertension drug. When the studies ended because it didn’t work, the drug company asked patients to send back the unused drugs. The women all returned the drugs, but the men didn’t. And the rest is history.

There’s a long list of potential drugs that can be repurposed, but few are being tested. The famous poster child of a repurposed drug — hydroxychloroquine — has been the subject of more than 250 clinical trials, but the others weren’t getting much attention.

The beauty of a repurposed drug is that if you can get funding and start enrolling patients, you could potentially find out fairly quickly, as early as a few months, if that drug has an antiviral effect or not. These data would help prioritize drugs to be tested in larger confirmatory studies.

Your focus is on early treatment. What’s the rationale for that?

We are focusing on early treatment because it has been overlooked. The attention has been on vaccines and therapeutics for hospitalized patients. But if you are spending $20 billion on potential vaccines and billions more on diagnostics, we need to give proportional resources toward drugs that might actually work, when given early, in preventing severe disease and death.

Early treatment, if successful, would allow us to avoid the severe complications that we are seeing now. If we can find an early treatment with an existing drug, it would be the fastest, most clinically- and cost-effective way to mitigate the impact of COVID-19 and get us on the road to recovery.

How do you get from a potential repurposed drug for COVID-19 to having a therapeutic agent that will save lives?

Most of the studies we are funding are smaller outpatient studies with virologic endpoints. We are looking for a signal that the drug has antiviral activity. We want to know whether a drug works before we spend the money on questions that take a much larger sample size to answer, for example, a big postexposure prophylaxis study. We’d like to see a meaningful signal in proof-of-concept studies, so we can look at a small group of patients with positive tests and see whether their viral load dropped by more than half if they got the drug compared with those who took the placebo. If the drug had an impact on the viral load and shortened the period of infectivity and was safe, these findings would provide justification to spend a lot of money on a large clinical trial. That would probably encourage the NIH and ACTIV [Accelerating COVID-19 Therapeutic Interventions and Vaccines] collaboration to prioritize the drug for one of their big platform trials. That›s what we are aiming for.

CETF isn’t a drug developer — we are a funder for a good proposal to study a repurposed drug. We want to help move the dial — can we get an early yes or an early no? In drug development, we say, “fail fast and fail early.” It’s a numbers game. Only 10% of early candidates will become approved drugs. The value is in the data, whether they are positive or negative — it doesn’t matter. If the study is a definitive “no,” that is just as helpful as a definitive “yes.” Of course, we all want the definitive “yes,” but there are so many things to look at, the “no’s” will help us redirect resources toward what may really help.

You first announced these funding opportunities in April. How is it going so far?

As soon as the website went up, we got 40 applications. Our scientific advisory board, which has expertise from medicinal chemistry and coronavirology to translational and clinical trial expertise, reviewed the applications and prioritized 11 fundable proposals. We are using milestone-based funding; in other words, funding those who are ready to go.

Which drugs are being tested in the funded studies?

One of the earliest grants we supported was Dr David Boulaware’s randomized controlled trial of hydroxychloroquine (NCT 04308668) in 821 asymptomatic patients within 4 days after a high-risk or moderate-risk exposure. That trial did not show any benefit of hydroxychloroquine as postexposure prophylaxis against COVID-19. This trial was important for another reason. It proved the feasibility of a no-contact trial design in the setting of COVID-19, and participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.

Camostat, a transmembrane serine protease (TMPRSS2) inhibitor licensed for use in Japan to treat pancreatitis and esophagitis, combined with the antiandrogen bicalutamide, is being explored for early COVID-19 treatment. TMPRSS2 primes the SARS-CoV-2 spike protein to bind to the ACE2 receptor and gain entry to the cell, and has been shown to have antiviral activity. CETF has provided funding support to ongoing trials of Camostat at Yale University and Aarhus University in Denmark.

Another outpatient trial for fluvoxamine, a drug approved in the United States and routinely prescribed for depression, was also partially funded by a CETF grant to Washington University in St. Louis. Fluvoxamine is a serotonin regulator but also activates the sigma-1 receptor, which reduces the body’s immune response to prevent an overactive immune response or cytokine storm, a major cause of clinical deterioration, serious organ damage, and even death from COVID. This trial was recently completed, and the results have been submitted for publication.

Other promising drugs include niclosamide, doxazosin, favipiravir, leronlimab, interferon beta, interferon lambda, and other monoclonal antibodies. New compounds considered to have potential against COVID include a flu drug (MK-4482/EIDD-2801) and GS-441524, a metabolite of the antiviral drug, remdesivir.

Why not just put all of our resources into vaccine development?

We absolutely need a vaccine to control the outbreak and stop the pandemic. However, it’s a long road to finding an effective vaccine, and in the meantime, we need tools to keep people alive. If we can find an antiviral drug that acts early, we can reduce transmission and contribute to outbreak control. All these tools help us get back to normal while we are waiting for a vaccine. The vaccine is only good if we can give it to every susceptible person in the world — which will take longer than 3 years. And there are no guarantees. Remember, we are still waiting for an HIV vaccine.

You are calling on Americans to help. What do you want them to do?

Everyone must participate in the behavioral changes designed to control the outbreak — physical distancing, face-covering, and paying attention to case counts in local areas to enable them to take appropriate precautions. I know people are bored of that message, but we are going to repeat it until we have a vaccine or herd immunity.

This organism is ripping like wildfire through our unimmunized population. Personal behaviors might slow it down, but finding a drug that can be given to people after they’ve been exposed and test positive will have a meaningful impact on helping us get back to normal.

There’s a great spirit of volunteerism — people are constantly asking how they can help. Through us at CETF, we offer three ways that people can help. They can participate as subjects in clinical trials, many of which are ongoing, including clinical trials, surveillance studies, and follow-up studies. They can donate to our fund and help support the research needed to find an effective early treatment. We have a link on our website, TreatEarly.org. And finally, researchers can apply for funding. We think everybody can help in one of these ways by participating in trials, donating, or applying for funding. It’s an all-hands-on-deck moment for our country.

Danzig is the chief medical advisor of the COVID-19 Early Treatment Fund. She has spent more than 20 years in the pharmaceutical industry developing vaccines, diagnostics, and drugs and is currently advising companies and investors.

This article first appeared on Medscape.com.

Early in the COVID-19 pandemic, entrepreneur and philanthropist Steve Kirsch realized that until we have a vaccine against SARS-CoV-2, we would be at the mercy of this virus. He realized that the fastest and most effective way to reduce COVID-19 fatalities would be to leverage existing drugs to treat patients at the onset of infection — before they become sick. A lack of funded research in this area prompted him to establish the COVID-19 Early Treatment Fund (CETF) with the purpose of funding outpatient clinical trials of promising repurposed drugs.

Medscape spoke with CETF’s chief medical advisor, Lisa Danzig, MD, about the organization’s aim to fund promising research on repurposed drugs to treat COVID-19.

What is CETF trying to do?

Two things: save lives, and get control of this pandemic.

We are facing perhaps the greatest crisis of our lifetime. Doctors who have taken care of patients with COVID are really frustrated about not having anything to offer; they just watch patients die. We want to change that. CETF was founded to find treatments that, when given early, could improve outcomes and avoid catastrophic complications in patients suffering from COVID-19. That means reducing hospitalizations, which can reduce mortality, but it also can mean reducing viral load, and that can have a profound impact on transmission within communities. We are a funding organization — a Band-Aid. We shouldn’t exist, but we do, aiming to close gaps until a coordinated response can get set up.

Tell us about drug repurposing and why you think existing drugs might have a role in mitigating COVID-19 or slowing its transmission.

This disease has two components — the viral infection, and the immunopathology. So the two promising categories of drugs are classical antivirals (or repurposed drugs with antiviral activity), and the immunomodulators. We are mechanism-agnostic. It doesn’t matter what kind of drug it is if it keeps people out of the hospital and prevents chronic morbidity and mortality.

Repurposed drugs are sort of the low-hanging fruit of clinical drugs. The QBI Coronavirus Research Group identified 69 compounds that have theoretical activity against SARS-CoV-2, 29 of which are already FDA-approved drugs. We thought, why don’t we start testing them?

Some people might call this a long shot. Does drug repurposing really work?

Drugmakers don’t test their drugs on every disease they might be effective for. Drug repurposing can work, but if we don’t look, we definitely won’t find anything. The classic repurposed drug is Viagra, a failed hypertension drug. When the studies ended because it didn’t work, the drug company asked patients to send back the unused drugs. The women all returned the drugs, but the men didn’t. And the rest is history.

There’s a long list of potential drugs that can be repurposed, but few are being tested. The famous poster child of a repurposed drug — hydroxychloroquine — has been the subject of more than 250 clinical trials, but the others weren’t getting much attention.

The beauty of a repurposed drug is that if you can get funding and start enrolling patients, you could potentially find out fairly quickly, as early as a few months, if that drug has an antiviral effect or not. These data would help prioritize drugs to be tested in larger confirmatory studies.

Your focus is on early treatment. What’s the rationale for that?

We are focusing on early treatment because it has been overlooked. The attention has been on vaccines and therapeutics for hospitalized patients. But if you are spending $20 billion on potential vaccines and billions more on diagnostics, we need to give proportional resources toward drugs that might actually work, when given early, in preventing severe disease and death.

Early treatment, if successful, would allow us to avoid the severe complications that we are seeing now. If we can find an early treatment with an existing drug, it would be the fastest, most clinically- and cost-effective way to mitigate the impact of COVID-19 and get us on the road to recovery.

How do you get from a potential repurposed drug for COVID-19 to having a therapeutic agent that will save lives?

Most of the studies we are funding are smaller outpatient studies with virologic endpoints. We are looking for a signal that the drug has antiviral activity. We want to know whether a drug works before we spend the money on questions that take a much larger sample size to answer, for example, a big postexposure prophylaxis study. We’d like to see a meaningful signal in proof-of-concept studies, so we can look at a small group of patients with positive tests and see whether their viral load dropped by more than half if they got the drug compared with those who took the placebo. If the drug had an impact on the viral load and shortened the period of infectivity and was safe, these findings would provide justification to spend a lot of money on a large clinical trial. That would probably encourage the NIH and ACTIV [Accelerating COVID-19 Therapeutic Interventions and Vaccines] collaboration to prioritize the drug for one of their big platform trials. That›s what we are aiming for.

CETF isn’t a drug developer — we are a funder for a good proposal to study a repurposed drug. We want to help move the dial — can we get an early yes or an early no? In drug development, we say, “fail fast and fail early.” It’s a numbers game. Only 10% of early candidates will become approved drugs. The value is in the data, whether they are positive or negative — it doesn’t matter. If the study is a definitive “no,” that is just as helpful as a definitive “yes.” Of course, we all want the definitive “yes,” but there are so many things to look at, the “no’s” will help us redirect resources toward what may really help.

You first announced these funding opportunities in April. How is it going so far?

As soon as the website went up, we got 40 applications. Our scientific advisory board, which has expertise from medicinal chemistry and coronavirology to translational and clinical trial expertise, reviewed the applications and prioritized 11 fundable proposals. We are using milestone-based funding; in other words, funding those who are ready to go.

Which drugs are being tested in the funded studies?

One of the earliest grants we supported was Dr David Boulaware’s randomized controlled trial of hydroxychloroquine (NCT 04308668) in 821 asymptomatic patients within 4 days after a high-risk or moderate-risk exposure. That trial did not show any benefit of hydroxychloroquine as postexposure prophylaxis against COVID-19. This trial was important for another reason. It proved the feasibility of a no-contact trial design in the setting of COVID-19, and participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.

Camostat, a transmembrane serine protease (TMPRSS2) inhibitor licensed for use in Japan to treat pancreatitis and esophagitis, combined with the antiandrogen bicalutamide, is being explored for early COVID-19 treatment. TMPRSS2 primes the SARS-CoV-2 spike protein to bind to the ACE2 receptor and gain entry to the cell, and has been shown to have antiviral activity. CETF has provided funding support to ongoing trials of Camostat at Yale University and Aarhus University in Denmark.

Another outpatient trial for fluvoxamine, a drug approved in the United States and routinely prescribed for depression, was also partially funded by a CETF grant to Washington University in St. Louis. Fluvoxamine is a serotonin regulator but also activates the sigma-1 receptor, which reduces the body’s immune response to prevent an overactive immune response or cytokine storm, a major cause of clinical deterioration, serious organ damage, and even death from COVID. This trial was recently completed, and the results have been submitted for publication.

Other promising drugs include niclosamide, doxazosin, favipiravir, leronlimab, interferon beta, interferon lambda, and other monoclonal antibodies. New compounds considered to have potential against COVID include a flu drug (MK-4482/EIDD-2801) and GS-441524, a metabolite of the antiviral drug, remdesivir.

Why not just put all of our resources into vaccine development?

We absolutely need a vaccine to control the outbreak and stop the pandemic. However, it’s a long road to finding an effective vaccine, and in the meantime, we need tools to keep people alive. If we can find an antiviral drug that acts early, we can reduce transmission and contribute to outbreak control. All these tools help us get back to normal while we are waiting for a vaccine. The vaccine is only good if we can give it to every susceptible person in the world — which will take longer than 3 years. And there are no guarantees. Remember, we are still waiting for an HIV vaccine.

You are calling on Americans to help. What do you want them to do?

Everyone must participate in the behavioral changes designed to control the outbreak — physical distancing, face-covering, and paying attention to case counts in local areas to enable them to take appropriate precautions. I know people are bored of that message, but we are going to repeat it until we have a vaccine or herd immunity.

This organism is ripping like wildfire through our unimmunized population. Personal behaviors might slow it down, but finding a drug that can be given to people after they’ve been exposed and test positive will have a meaningful impact on helping us get back to normal.

There’s a great spirit of volunteerism — people are constantly asking how they can help. Through us at CETF, we offer three ways that people can help. They can participate as subjects in clinical trials, many of which are ongoing, including clinical trials, surveillance studies, and follow-up studies. They can donate to our fund and help support the research needed to find an effective early treatment. We have a link on our website, TreatEarly.org. And finally, researchers can apply for funding. We think everybody can help in one of these ways by participating in trials, donating, or applying for funding. It’s an all-hands-on-deck moment for our country.

Danzig is the chief medical advisor of the COVID-19 Early Treatment Fund. She has spent more than 20 years in the pharmaceutical industry developing vaccines, diagnostics, and drugs and is currently advising companies and investors.

This article first appeared on Medscape.com.

Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.

The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.

Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.

And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.

“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.

“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.

The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.

One in four insulin users report rationing the medication, Mr. Habbe said.

The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.

Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.

Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
 

Insulin makers unfazed, blame insurers, PBMs for high prices

The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.

And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.

The insulin makers have also not lowered prices in response to the mounting number of state laws.

They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.

“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”

The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.

Novo Nordisk, however, maintains that drugmakers are not solely to blame.

“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.

“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.

Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.

And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.

Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”

Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.

Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.

Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
 

PBMs point back at insulin manufacturers

PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.

The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.

Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.

If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.

And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.

David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.

“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”

He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.

Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
 

Utah savings hopefully saving lives already

In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.

She noted an estimated 50,000 Utahans rely on insulin to stay alive.

Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.

That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.

The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.

Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.

“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.

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

Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.

The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.

Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.

And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.

“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.

“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.

The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.

One in four insulin users report rationing the medication, Mr. Habbe said.

The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.

Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.

Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
 

Insulin makers unfazed, blame insurers, PBMs for high prices

The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.

And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.

The insulin makers have also not lowered prices in response to the mounting number of state laws.

They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.

“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”

The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.

Novo Nordisk, however, maintains that drugmakers are not solely to blame.

“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.

“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.

Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.

And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.

Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”

Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.

Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.

Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
 

PBMs point back at insulin manufacturers

PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.

The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.

Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.

If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.

And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.

David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.

“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”

He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.

Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
 

Utah savings hopefully saving lives already

In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.

She noted an estimated 50,000 Utahans rely on insulin to stay alive.

Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.

That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.

The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.

Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.

“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.

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

Twelve U.S. states have now passed laws aimed at making insulin more affordable – and more than 30 are considering such legislation – but they all have gaps that still put the cost of this basic and essential medication out of reach for many with diabetes.

The laws only apply to health insurance through state-regulated plans, and not to the majority of health plans that cover most Americans: Medicare, Medicaid, the Veterans Affairs health system, or self-funded employer-sponsored plans.

Overall, Hannah Crabtree, an activist who writes the blog Data for Insulin, estimates state laws that limit copays, deductibles, or other out-of-pocket costs for insulin cover an average of 27% of people with diabetes across the United States.

And while diabetes activists have applauded state actions, most want more help for the under- and uninsured.

“Our chapter will be fighting harder next legislative session for the uninsured,” said Mindie Hooley, the leader of the Utah #insulin4all chapter, which successfully lobbied legislators to pass a bill signed by the state’s governor on March 30.

“With so many losing their jobs because of the pandemic, there’s no better time than now to fight for these patients who don’t have insurance,” Ms. Hooley said in an interview.

The American Diabetes Association has also been lobbying for state caps as one of many avenues for making insulin more affordable, said Stephen Habbe, the ADA’s director for state government affairs.

One in four insulin users report rationing the medication, Mr. Habbe said.

The state laws “can really provide important relief in terms of affordability for their insulin costs, which we know can be critical in terms of preserving their life and helping to prevent complications that can potentially be disabling or even deadly,” he said in an interview.

Activists with T1 International, which created the #insulin4all campaign, are working nationwide to convince state legislators to back measures that limit out-of-pocket costs for insulin, or for other diabetes medications and supplies.

Colorado, Connecticut, Delaware, Illinois, Maine, New Hampshire, New Mexico, New York, Utah, Virginia, Washington, and West Virginia have enacted such limits, with caps ranging from $25 to $100.
 

Insulin makers unfazed, blame insurers, PBMs for high prices

The three insulin manufacturers in the United States – Eli Lilly, Novo Nordisk, and Sanofi– have not overtly fought against the laws, although in July, the Pharmaceutical Research and Manufacturers of America did sue to block a related Minnesota law that provides a free emergency supply of insulin.

And the nonprofit news organization FairWarning reported in August that a lobbyist from Eli Lilly had attempted to push a Tennessee legislator to keep the uninsured from being eligible for any out-of-pocket limits.

The insulin makers have also not lowered prices in response to the mounting number of state laws.

They see no need, said Tara O’Neill Hayes, director of human welfare policy at the American Action Forum, a center right–leaning Washington, D.C., think tank.

“You’re going to do what you can get away with,” Ms. O’Neill Hayes said in an interview. “To the extent that they can keep their prices high and people are still buying, they have limited incentives to lower those costs.”

The insulin market is dysfunctional, she added. “The increasing cost of insulin seems primarily to be the result of a lack of competition in the market and convoluted drug pricing and insurance practices,” Ms. O’Neill Hayes and colleagues wrote in a report in April on federal and state attempts to address insulin affordability.

Novo Nordisk, however, maintains that drugmakers are not solely to blame.

“Everyone in the health care system has a role to play in affordability,” said Ken Inchausti, Novo Nordisk’s senior director for corporate communications. State legislation “attempts to address a systemic issue in [U.S.] health care: How benefit design can make medicines unaffordable for many, especially for those in high-deductible health plans,” he said in an interview.

“Efforts to place copay caps on insurance plans covering insulin can certainly help lower out-of-pocket costs,” said Mr. Inchausti.

Sanofi spokesperson Jon Florio said the company supports actions that increase affordable access to insulin. However, “while we support capped copays, we feel this should not be limited to just one class of medicines,” he said. Mr. Florio also noted that Sanofi provides out-of-pocket caps to anyone with commercial insurance and that anyone without insurance can buy one or multiple Sanofi insulins for a fixed price of $99 per month, up to 10 boxes of pens and/or 10-mL vials.

And Sanofi will take part in the Centers for Medicare & Medicaid Services’ new insulin demonstration program. Starting in 2021, CMS will cap insulin copays at $35 for people in Part D plans that participate.

Eli Lilly spokesperson Brad Jacklin said the company “believes in the common goal of ensuring affordable access to insulin and other life-saving medicines because nobody should have to forgo or ration because of cost.”

Lilly supports efforts “that more directly affect patients’ cost-sharing based on their health care coverage,” he said. Insurers and pharmacy benefit managers (PBMs) should pass savings on to patients, Mr. Jacklin urged. Lilly caps some insulins at $35 for the uninsured or commercially insured. The company will also participate in the CMS program.

Meanwhile, a PhRMA-sponsored website www.letstalkaboutcost.org said that, because they do not share savings, insurers and PBMs are responsible for high insulin costs.

Manufacturer assistance programs for patients with diabetes and other chronic diseases, on the other hand, can save individuals $300-$500 a year, PhRMA said in August.
 

PBMs point back at insulin manufacturers

PBMs, however, point back at drug companies. “PBMs have been able to moderate insulin costs for most consumers with insurance,” said J.C. Scott, president and CEO of the Pharmaceutical Care Management Association, the PBM trade group, in a statement.

The rising cost of insulin is caused by a lack of competition and overuse of patent extensions, PCMA maintains.

Health insurers, which, in tandem with PBMs, give insulins formulary preference based on a discounted price, are most likely to feel the impact of laws limiting out-of-pocket costs.

If they have to make up the shortfall from a patient’s reduced payment for a prescription, they will likely raise premiums, said Ms. O’Neill Hayes.

And if patients pay the same price for insulin – regardless of who makes it – drugmakers won’t have much incentive to offer discounts or rebates for formulary placement, she said. Again, that would likely lead to higher premiums.

David Allen, a spokesperson for America’s Health Insurance Plans, said in an interview that AHIP believes lack of competition has driven up insulin prices.

“High prices for insulin correspond with high health insurance costs for insulin,” he said. When CMS starts requiring drugmakers to discount their insulins for Medicare that will allow “health plans to use those savings to reduce out-of-pocket [costs] for seniors.”

He did not respond to a question as to why health insurers were not already passing savings on to commercially insured patients, especially in states with out-of-pocket limits.

Mr. Allen did say that AHIP’s plans “stand ready to work with state policymakers to remove barriers to lower insulin prices for Americans.”
 

Utah savings hopefully saving lives already

In Utah, legislators tuned out the blame game, and instead were keen to listen to patients, who had many stories about how the high cost of insulin had hurt them, said Ms. Hooley.

She noted an estimated 50,000 Utahans rely on insulin to stay alive.

Ms. Hooley and her chapter convinced legislators to pass a bill that gives insurers the option to cap patient copays at $30 per month, or to put insulin on its lowest formulary tier and waive any patient deductible. That aspect of the law does not go into effect until January 2021, but insurers are already starting to move insulin to the lowest formulary tier.

That has helped some people immediately. One state resident said her most recent insulin prescription cost $7 – instead of the usual $200.

The uninsured are not left totally high and dry either. Starting June 1, anyone in the state could buy through a state bulk-purchasing program, which guaranteed a 60% discount.

Ms. Hooley said she’d recently heard about a patient who usually spent $300 per prescription but was able to buy insulin for $100 through the program.

“Although $100 is still too much, it is nice knowing the Utah Insulin Savings Program is saving lives,” Ms. Hooley concluded.

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

Knowing it may be met with some skepticism, the Trump administration Thursday announced a sweeping plan that officials say will transform health care in rural America.

Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer, and older than the rest of the country. Hospitals are shuttering at record rates, and health care experts have long called for changes.

The new plan, released by the Department of Health & Human Services Secretary Alex M. Azar, II, acknowledges the gaps in health care and other problems facing rural America. It lists a litany of projects and directives, with many already underway or announced within federal agencies.

“We cannot just tinker around the edges of a rural healthcare system that has struggled for too long,” Azar said in a prepared statement.

Yet, that is exactly what experts say the administration continues to do.

“They tinker around the edges,” said Tommy Barnhart, former president of the National Rural Health Association. And he added, “there’s a lot of political hype” that has happened under President Trump, as well as previous presidents.

In the past few months, rural health care has increasingly become a focus for Mr. Trump, whose polling numbers are souring as COVID-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products, and spreads through meatpacking plants. Rural states including Iowa and the Dakotas are reporting the latest surges in cases.

This announcement comes in response to Mr. Trump’s executive order last month calling for improved rural health and telehealth access. Earlier this week, three federal agencies also announced they would team up to address gaps in rural broadband service – a key need because large portions of the plan seek to expand telehealth.

The plan is more than 70 pages long and the word “telehealth” appears more than 90 times, with a focus on projects across HHS, including the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services.

Mr. Barnhart said CMS has passed some public health emergency waivers since the beginning of the pandemic that helped rural facilities get more funding, including one that specifically was designed to provide additional money for telehealth services. However, those waivers are set to expire when the coronavirus emergency ends. Officials have not yet set a date for when the federal emergency will end.

Andrew Jay Schwartzman, senior counselor to the Benton Institute for Broadband & Society, a private foundation that works to ensure greater Internet access, said there are multiple challenges with implementing telehealth across the nation. Many initiatives for robust telehealth programs need fast bandwidth, yet getting the money and setting up the necessary infrastructure is very difficult, he said.

“It will be a long time before this kind of technology will be readily available to much of the country,” he said.

Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, noted that telehealth was short on funding in the HHS initiative. However, she said, the focus on telehealth, as well as a proposed shift in payment for small rural hospitals and changing workforce licensing requirements, had good potential.

“We are so close to the election that this is probably more of a messaging issue to cater to rural residents,” Ms. Bai said. “But it doesn’t matter who will be president. This report will give the next administration useful guidance.”

The American Hospital Association, representing 5,000 hospitals nationwide, sent a letter to Mr. Trump last week recommending a host of steps the administration could take. As of late Thursday, AHA was still reviewing the HHS plan but said it was “encouraged by the increased attention on rural health care.”

Buried within the HHS announcement are technical initiatives, such as a contract to help clinics and hospitals integrate care, and detailed efforts to address gaps in care, including a proposal to increase funding for school-based mental health programs in the president’s 2021 budget.

A senior HHS official said that, while some actions have been taken in recent months to improve rural health — such as the $11 billion provided to rural hospitals through coronavirus relief funding — more is needed.

“We’re putting our stake in the ground that the time for talk is over,” he said. “We’re going to move forward.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Knowing it may be met with some skepticism, the Trump administration Thursday announced a sweeping plan that officials say will transform health care in rural America.

Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer, and older than the rest of the country. Hospitals are shuttering at record rates, and health care experts have long called for changes.

The new plan, released by the Department of Health & Human Services Secretary Alex M. Azar, II, acknowledges the gaps in health care and other problems facing rural America. It lists a litany of projects and directives, with many already underway or announced within federal agencies.

“We cannot just tinker around the edges of a rural healthcare system that has struggled for too long,” Azar said in a prepared statement.

Yet, that is exactly what experts say the administration continues to do.

“They tinker around the edges,” said Tommy Barnhart, former president of the National Rural Health Association. And he added, “there’s a lot of political hype” that has happened under President Trump, as well as previous presidents.

In the past few months, rural health care has increasingly become a focus for Mr. Trump, whose polling numbers are souring as COVID-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products, and spreads through meatpacking plants. Rural states including Iowa and the Dakotas are reporting the latest surges in cases.

This announcement comes in response to Mr. Trump’s executive order last month calling for improved rural health and telehealth access. Earlier this week, three federal agencies also announced they would team up to address gaps in rural broadband service – a key need because large portions of the plan seek to expand telehealth.

The plan is more than 70 pages long and the word “telehealth” appears more than 90 times, with a focus on projects across HHS, including the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services.

Mr. Barnhart said CMS has passed some public health emergency waivers since the beginning of the pandemic that helped rural facilities get more funding, including one that specifically was designed to provide additional money for telehealth services. However, those waivers are set to expire when the coronavirus emergency ends. Officials have not yet set a date for when the federal emergency will end.

Andrew Jay Schwartzman, senior counselor to the Benton Institute for Broadband & Society, a private foundation that works to ensure greater Internet access, said there are multiple challenges with implementing telehealth across the nation. Many initiatives for robust telehealth programs need fast bandwidth, yet getting the money and setting up the necessary infrastructure is very difficult, he said.

“It will be a long time before this kind of technology will be readily available to much of the country,” he said.

Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, noted that telehealth was short on funding in the HHS initiative. However, she said, the focus on telehealth, as well as a proposed shift in payment for small rural hospitals and changing workforce licensing requirements, had good potential.

“We are so close to the election that this is probably more of a messaging issue to cater to rural residents,” Ms. Bai said. “But it doesn’t matter who will be president. This report will give the next administration useful guidance.”

The American Hospital Association, representing 5,000 hospitals nationwide, sent a letter to Mr. Trump last week recommending a host of steps the administration could take. As of late Thursday, AHA was still reviewing the HHS plan but said it was “encouraged by the increased attention on rural health care.”

Buried within the HHS announcement are technical initiatives, such as a contract to help clinics and hospitals integrate care, and detailed efforts to address gaps in care, including a proposal to increase funding for school-based mental health programs in the president’s 2021 budget.

A senior HHS official said that, while some actions have been taken in recent months to improve rural health — such as the $11 billion provided to rural hospitals through coronavirus relief funding — more is needed.

“We’re putting our stake in the ground that the time for talk is over,” he said. “We’re going to move forward.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Knowing it may be met with some skepticism, the Trump administration Thursday announced a sweeping plan that officials say will transform health care in rural America.

Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer, and older than the rest of the country. Hospitals are shuttering at record rates, and health care experts have long called for changes.

The new plan, released by the Department of Health & Human Services Secretary Alex M. Azar, II, acknowledges the gaps in health care and other problems facing rural America. It lists a litany of projects and directives, with many already underway or announced within federal agencies.

“We cannot just tinker around the edges of a rural healthcare system that has struggled for too long,” Azar said in a prepared statement.

Yet, that is exactly what experts say the administration continues to do.

“They tinker around the edges,” said Tommy Barnhart, former president of the National Rural Health Association. And he added, “there’s a lot of political hype” that has happened under President Trump, as well as previous presidents.

In the past few months, rural health care has increasingly become a focus for Mr. Trump, whose polling numbers are souring as COVID-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products, and spreads through meatpacking plants. Rural states including Iowa and the Dakotas are reporting the latest surges in cases.

This announcement comes in response to Mr. Trump’s executive order last month calling for improved rural health and telehealth access. Earlier this week, three federal agencies also announced they would team up to address gaps in rural broadband service – a key need because large portions of the plan seek to expand telehealth.

The plan is more than 70 pages long and the word “telehealth” appears more than 90 times, with a focus on projects across HHS, including the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services.

Mr. Barnhart said CMS has passed some public health emergency waivers since the beginning of the pandemic that helped rural facilities get more funding, including one that specifically was designed to provide additional money for telehealth services. However, those waivers are set to expire when the coronavirus emergency ends. Officials have not yet set a date for when the federal emergency will end.

Andrew Jay Schwartzman, senior counselor to the Benton Institute for Broadband & Society, a private foundation that works to ensure greater Internet access, said there are multiple challenges with implementing telehealth across the nation. Many initiatives for robust telehealth programs need fast bandwidth, yet getting the money and setting up the necessary infrastructure is very difficult, he said.

“It will be a long time before this kind of technology will be readily available to much of the country,” he said.

Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, noted that telehealth was short on funding in the HHS initiative. However, she said, the focus on telehealth, as well as a proposed shift in payment for small rural hospitals and changing workforce licensing requirements, had good potential.

“We are so close to the election that this is probably more of a messaging issue to cater to rural residents,” Ms. Bai said. “But it doesn’t matter who will be president. This report will give the next administration useful guidance.”

The American Hospital Association, representing 5,000 hospitals nationwide, sent a letter to Mr. Trump last week recommending a host of steps the administration could take. As of late Thursday, AHA was still reviewing the HHS plan but said it was “encouraged by the increased attention on rural health care.”

Buried within the HHS announcement are technical initiatives, such as a contract to help clinics and hospitals integrate care, and detailed efforts to address gaps in care, including a proposal to increase funding for school-based mental health programs in the president’s 2021 budget.

A senior HHS official said that, while some actions have been taken in recent months to improve rural health — such as the $11 billion provided to rural hospitals through coronavirus relief funding — more is needed.

“We’re putting our stake in the ground that the time for talk is over,” he said. “We’re going to move forward.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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

As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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

As the COVID-19 crisis pandemic continues, many physicians are not only battling the medical challenges it has wrought but they’re also dealing with its financial ramifications at home.

“Some of our physician clients have seen their income decrease by as much as 50%,” says Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minnesota. “Many physicians had previously figured that whatever financial obligations they had wouldn’t be a problem because whatever amount they were making would continue, and if there were a decline it would be gradual.” However, assumption is now creating financial strain for many doctors.

Vikram Tarugu, MD, a gastroenterologist and CEO of Detox of South Florida in Okeechobee, Florida, says he has watched his budget for years, but has become even more careful with his spending in the past few months.

“It has helped me a lot to adjust to the new normal when it comes to the financial side of things,” Dr. Tarugu said. “Patients aren’t coming in as much as they used to, so my income has really been affected.”

Primary care physicians have seen a 55% decrease in revenue and a 20%-30% decrease in patient volume as a result of COVID-19. The impact has been even more severe for specialists. Even for physicians whose practices remain busy and whose family members haven’t lost their jobs or income, broader concerns about the economy may be reason enough for physicians to adopt cost-cutting measures.

In Medscape’s Physician Compensation Report 2020, we asked physicians to share their best cost-cutting tips. Many illustrate the lengths to which physicians are going to conserve money.  

Here’s a look at some of the advice they shared, along with guidance from experts on how to make it work for you:
 

1. Create a written budget, even if you think it’s pointless.

Physicians said their most important piece of advice includes the following: “Use a formal budget to track progress,” “write out a budget,” “plan intermittent/large expenses in advance,” “Make sure all expenses are paid before you spend on leisure.”

Nearly 7 in 10 physicians say they have a budget for personal expenses, yet only one-quarter of those who do have a formal, written budget. Writing out a spending plan is key to being intentional about your spending, making sure that you’re living within your means, and identifying areas in which you may be able to cut back.

“Financial planning is all about cash flow, and everybody should know the amount of money coming in, how much is going out, and the difference between the two,” says Amy Guerich, a partner with Stepp & Rothwell, a Kansas City–based financial planning firm. “That’s important in good times, but it’s even more important now when we see physicians taking pay cuts.”

Many physicians have found that budget apps or software programs are easier to work with than anticipated; some even walk you through the process of creating a budget. To get the most out of the apps, you’ll need to check them regularly and make changes based on their data.

“Sometimes there’s this false belief that just by signing up, you are automatically going to be better at budgeting,” says Scott Snider, CFP, a certified financial planner and partner with Mellen Money Management in Ponte Vedra Beach, Florida. “Basically, these apps are a great way to identify problem areas of spending. We have a tendency as humans to underestimate how much we spend on things like Starbucks, dining out, and Amazon shopping.”

One of the doctors’ tips that requires the most willpower is to “pay all expenses before spending on leisure.” That’s because we live in an instant gratification world, and want everything right away, Ms. Guerich said.

“I also think there’s an element of ‘keeping up with the Joneses’ and pressure associated with this profession,” she said. “The stereotype is that physicians are high-income earners so ‘We should be able to do that’ or ‘Mom and dad are doctors, so they can afford it.’ “

Creating and then revisiting your budget progress on a monthly or quarterly basis can give you a feeling of accomplishment and keep you motivated to stay with it.  

Keep in mind that budgeting is a continual process rather than a singular event, and you’ll likely adjust it over time as your income and goals change. 
 

2. Save more as you earn more.

Respondents to our Physician Compensation Report gave the following recommendations: “Pay yourself first,” “I put half of my bonus into an investment account no matter how much it is,” “I allocate extra money and put it into a savings account.”

Dr. Greenwald said, “I have a rule that every client needs to be saving 20% of their gross income toward retirement, including whatever the employer is putting in.”

Putting a portion of every paycheck into savings is key to making progress toward financial goals. Start by building an emergency fund with at least 3-6 months’ worth of expenses in it and making sure you’re saving at least enough for retirement to get any potential employer match.

Mr. Snider suggests increasing the percentage you save every time you get a raise.

“The thought behind that strategy is that when a doctor receives a pay raise – even if it’s just a cost-of-living raise of 3% – an extra 1% saved doesn’t reduce their take-home pay year-over-year,” he says. “In fact, they still take home more money, and they save more money. Win-win.”
 

3. Focus on paying down your debt.

Physicians told us how they were working to pay down debt with the following recommendations:  “Accelerate debt reduction,” “I make additional principal payment to our home mortgage,” “We are aggressively attacking our remaining student loans.”

Reducing or eliminating debt is key to increasing cash flow, which can make it easier to meet all of your other financial goals. One-quarter of physicians have credit card debt, which typically carries interest rates higher than other types of debt, making it far more expensive. Focus on paying off such high-interest debt first, before moving on to other types of debt such as auto loans, student loans, or a mortgage.

“Credit card debt and any unsecured debt should be paid before anything else,” Mr. Snider says. “Getting rid of those high interest rates should be a priority. And that type of debt has less flexible terms than student debt.”
 

4. Great opportunity to take advantage of record-low interest rates.

Physicians said that, to save money, they are recommending the following: “Consolidating student debt into our mortgage,” “Accelerating payments of the principle on our mortgage,” “Making sure we have an affordable mortgage.”

With interest rates at an all-time low, even those who’ve recently refinanced might see significant savings by refinancing again. Given the associated fees, it typically makes sense to refinance if you can reduce your mortgage rate by at least a point, and you’re planning to stay in the home for at least 5 years.

“Depending on how much lower your rate is, refinancing can make a big difference in your monthly payments,” Ms. Guerich said. “For physicians who might need an emergency reserve but don’t have cash on hand, a HELOC [Home Equity Line of Credit] is a great way to accomplish that.”
 

5. Be wary of credit cards dangers; use cards wisely.

Physician respondents recommended the following:  “Use 0% interest offers on credit cards,” “Only have one card and pay it off every month,” “Never carry over balance.”

Nearly 80% of physicians have three or more credit cards, with 18% reporting that they have seven or more. When used wisely, credit cards can be an important tool for managing finances. Many credit cards come with tools that can help with budgeting, and credit cards rewards and perks can offer real value to users. That said, rewards typically are not valuable enough to offset the cost of interest on balances (or the associated damage to your credit score) that aren’t paid off each month.

“If you’re paying a high rate on credit card balances that carry over every month, regardless of your income, that could be a symptom that you may be spending more than you should,” says Dan Keady, a CFP and chief financial planning strategist at financial services firm TIAA.

6. Give less to Uncle Sam: Keep it for yourself.

Physicians said that they do the following: “Maximize tax-free/deferred savings (401k, HSA, etc.),” “Give to charity to reduce tax,” “Use pre-tax dollars for childcare and healthcare.”

Not only does saving in workplace retirement accounts help you build your nest egg, but it also reduces the amount that you have to pay in taxes in a given year. Physicians should also take advantage of other ways to reduce their income for tax purposes, such as saving money in a health savings account or flexible savings account.

The 401(k) or 403(b) contribution limit for this year is $19,500 ($26,000) for those age 50 years and older. Self-employed physicians can save even more money via a Simplified Employee Pension (SEP) IRA, says Ms. Guerich said. They can save up to 25% of compensation, up to $57,000 in 2020.
 

7. Automate everything and spare yourself the headache.

Physicians said the following: “Designate money from your paycheck directly to tax deferred and taxable accounts automatically,” “Use automatic payment for credit card balance monthly,” “Automate your savings.”

You probably already automate your 401(k) contributions, but you can also automate bill payments, emergency savings contributions and other financial tasks. For busy physicians, this can make it easier to stick to your financial plan and achieve your goals.

“The older you get, the busier you get, said Mr. Snider says. “Automation can definitely help with that. But make sure you are checking in quarterly to make sure that everything is still in line with your plan. The problem with automation is when you forget about it completely and just let everything sit there.”
 

8. Save separately for big purchases.

Sometimes it’s the big major expenses that can start to derail a budget. Physicians told us the following tactics for large purchases:  “We buy affordable cars and take budget vacations,” “I buy used cars,” “We save in advance for new cars and only buy cars with cash.”

The decision of which car to purchase or where to go on a family vacation is a personal one, and some physicians take great enjoyment and pride in driving a luxury vehicle or traveling to exotic locales. The key, experts say, is to factor the cost of that car into the rest of your budget, and make sure that it’s not preventing you from achieving other financial goals.

“I don’t like to judge or tell clients how they should spend their money,” said Andrew Musbach, a certified financial planner and cofounder of MD Wealth Management in Chelsea, Mich. “Some people like cars, we have clients that have two planes, others want a second house or like to travel. Each person has their own interest where they may spend more relative to other people, but as long as they are meeting their savings targets, I encourage them to spend their money and enjoy what they enjoy most, guilt free.”

Mr. Snider suggests setting up a savings account separate from emergency or retirement accounts to set aside money if you have a goal for a large future purchase, such as a boat or a second home.

“That way, the funds don’t get commingled, and it’s explicitly clear whether or not the doctor is on target,” he says. “It also prevents them from treating their emergency savings account as an ATM machine.”
 

9. Start saving for college when the kids are little.  

Respondents said the following: “We are buying less to save for the kids’ college education,” “We set up direct deposit into college and retirement savings plans,” “We have a 529 account for college savings.”

Helping pay for their children’s college education is an important financial goal for many physicians. The earlier that you start saving, the less you’ll have to save overall, thanks to compound interest. State 529 accounts are often a good place to start, especially if your state offers a tax incentive for doing so.

Mr. Snider recommends that physicians start small, with an initial investment of $1,000 per month and $100 per month contributions. Assuming a 7% rate of return and 17 years’ worth of savings, this would generate just over $42,000. (Note, current typical rates of return are less than 7%).

“Ideally, as other goals are accomplished and personal debt gets paid off, the doctor is ramping up their savings to have at least 50% of college expenses covered from their 529 college savings,” he says.
 

10. Watch out for the temptation of impulse purchases.

Physicians said the following: “Avoid impulse purchases,” “Avoid impulse shopping, make a list for the store and stick to it,” “Wait to buy things on sale.”

Nothing wrecks a budget like an impulse buy. More than half (54%) of U.S. shoppers have admitted to spending $100 or more on an impulse purchase. And 20% of shoppers have spent at least $1,000 on an impulse buy. Avoid buyers’ remorse by waiting a few days to make large purchase decisions or by limiting your unplanned spending to a certain dollar amount within your budget.

Online shopping may be a particular temptation. Dr. Tarugu, the Florida gastroenterologist, has focused on reducing those impulse buys as well, deleting all online shopping apps from his and his family’s phones.

“You won’t notice how much you have ordered online until it arrives at your doorstep,” he said. “It’s really important to keep it at bay.”

Mr. Keady, the TIAA chief planning strategist, recommended this tactic: Calculate the number of patients (or hours) you’d need to see in order to earn the cash required to make the purchase.

“Then, in a mindful way, figure out the amount of value derived from the purchase,” he said.
 

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