Business of Medicine

Jordan Grumet, MD, an internist in Northbrook, Ill., left his private practice about 2 years ago, partly because of competition from local retail clinics.

“We were always fighting the pharmacy clinics,” he said. “My generation of doctors was brought up to think we should have a one-stop shop. That was the idea behind being a primary care doctor. So it was very destructive to know your patients were going to another provider.”

Local retail clinics and urgent care centers were also co-opting many of the minor acute care visits that help primary care practices survive. “The number of visits for flu shots and simple medical problems drops,” said Dr. Grumet, who is now an end-of-life-care consultant and also works in hospices. “That can put downward economic pressure on primary care practices.”

Competition for primary care practices is ready to heat up even more, and the environment may soon become even more threatening for primary care doctors. Over the last year, the two largest pharmacy chains – CVS and Walgreens – announced their intentions to build larger retail clinics that will offer many aspects of traditional primary care. Walmart will also be doing the same.

How many geographical areas will be affected is unknown. However, observers say these new hybrid clinics could affect the revenues of some primary care practices.

“There will be more competition, no question,” said George Abraham, MD, MPH, president of the American College of Physicians.

Andrew Bazemore, MD, MPH, senior vice president of research and policy for the American Board of Family Medicine, agreed. “Seeing retail clinics finally embrace the promise of coordination and comprehensiveness in primary care is a promising step. It’s good to see CVS, Walmart, and Walgreens embracing the notion that they have to do more than just urgent care. On the flip side, it’s a source of competition for longstanding primary care clinics.”

Jeff Kagan, MD, an internist in Newington, Conn., noted that during the pandemic the booming demand for primary care has reduced competition from alternative care settings.

“But if this was not pandemic times, it would be very different. There are more urgent care walk-in clinics that do some primary care, and they are pulling away patients.”
 

New alternative care settings

The number of retail health centers has leveled off at around 2,000 clinics, about the same as in 2016. But CVS, which has around half that total, is now adding HealthHUB facilities, which offer nonemergency care. CVS had 800 of these quasi-primary care clinics in the first quarter of 2021 and planned to have 1,000 by the end of 2021, according to Managed Healthcare Executive.

Walgreens closed 150 of its retail clinics while partnering with VillageMD to develop 600 VillageMD clinics that are larger than its current in-store offices. The chain plans to build these clinics adjacent to Walgreens stores in 30 markets over the next 4 years. Currently, Walgreens has more than 50 VillageMD clinics, mostly in Sunbelt states.

Walmart opened the first of its new expanded-service clinics in 2019. Now it has clinics in Georgia, Arkansas, Texas, and Florida. These Walmart Health locations offer urgent care, primary care, labs, x-ray, and mental health therapy, as well as dental, optical, and hearing services.

The number of urgent care centers (UCCs), meanwhile, has mushroomed during the last decade. With the addition of 400-500 centers every year since 2014, there were 9,279 UCCs in the United States as of June 2019, according to the Urgent Care Association.

These UCCs usually have on-staff physicians. In contrast, most retail clinics are staffed by nurse practitioners. Another big difference is that in retail clinics, two-thirds of the patients – many of them young and healthy – have no regular primary care clinician; only a third of UCC patients don’t have a personal physician.

Because of these rootless patients, competition from retail clinics “is no big deal” to some primary care practices, said Ateev Mehrotra, MD, a Harvard Medical School professor in Boston who has studied alternative care settings. On the other hand, he asked, why do so few UCC patients have a regular physician? That raises the question of how many of these patients would go to a primary care office if there were no retail clinics or UCCs.
 

Economic pressure on practices

Dr. Grumet’s point about retail clinics and UCCs depriving his practice of easy, lucrative visits is widely echoed among his peers. The fee-for-service payment system based on Medicare rates exacerbates the problem. As Dr. Abraham pointed out, when primary care doctors see a higher percentage of patients with complicated problems, the doctors don’t get compensated fairly for those visits.

Minor acute care, Dr. Abraham noted, is “easier work for the same pay. When I review 100 pages of records for someone who was hospitalized and figure out their 10 different problems and 20 medications, I get paid virtually the same as if I treated a diabetic with a common cold or a foot laceration. The complexity of thought is not factored completely into the reimbursement. And we use the easier visits to offset the more complex ones.”
 

What happened to continuity of care?

The fragmentation of care between primary care practices and alternative care settings also “diminishes the primary care function,” Dr. Bazemore said.

“Primary care is supposed to be first contact, covering most of what a patient needs – comprehensive, coordinated, and continuous,” he observed. “When you fragment and separate an urgent care function from the rest, so it’s not done in the context of that first contact, you weaken the primary care component without enhancing its function.”

Observers doubt the advent of larger retail clinics that provide more services is likely to solve this problem. In Dr. Mehrotra’s view, CVS’ HealthHUBs “are all about supporting primary care. But are they really? Who are the patients supposed to come back to? This is a critical point: When you ask patients who’s in charge of their care, what are they going to say?”

Retail clinics and urgent care centers have a similar issue, Dr. Grumet said. “If you see patients in the office, and they have problems late at night, they can call you. There’s a continuity of care you don’t get in alternative care settings. The real goal in those places is to get patients in, assess them, and get them out. Which is fine – for minor things. But for someone who needs more comprehensive care, it’s not so good.”

This is why the ACP advised against the provision of chronic care in alternative care settings, said Dr. Abraham. “The problem with retail clinics is they’ve expanded into chronic care management in one or more episodes that require care, but not true continuity of care. When you go to a primary care physician’s office, we discuss more than just acute problems or chronic health issues; we talk about wellness, lifestyle, preventive services, vaccines, and your family. Relationship-building occurs, which transcends more than care interaction. In a setting where you get your care and you leave, longitudinal, holistic care doesn’t build.”

Dr. Kagan put it more succinctly: “Sometimes urgent care walk-in clinics get in over their head [with chronic care]. They like the guy who has high blood pressure and comes in once or twice a year for a prescription refill. But they’re not involved with the guy who has much more trouble.” 

None of the urgent care doctors he knows of are taking long-term responsibility for their patients, Dr. Kagan added. “They don’t schedule follow-ups. They’ll see a patient for something, then say: ‘If you’re not better, come back and see me in a couple of weeks.’ ”
 

Two flavors of urgent care

Dr. Kagan has seen another type of doctor-patient relationship since he sold his practice to Hartford HealthCare 2 years ago. Hartford HealthCare owns 50% of an urgent care group called GoHealth.

“If our Hartford HealthCare patients can’t get into the office, we encourage them to go to a GoHealth facility,” he noted. “It’s not competition; it’s like one of our colleagues. We use the same EMR, so I can see everything that happens. I can even send someone who needs an x-ray to a GoHealth Center just for that.”

Moreover, GoHealth provides only urgent care. “So if it’s one of my patients, they refer them back to me for follow-up. And if somebody wanders in there without a primary care physician, they’ll hook them up with a Hartford HealthCare clinician.”

Dr. Bazemore has had a similar experience. He practices 1 day a week in his residency clinic in Fairfax, Va., which is owned by the Inova Health System. Inova created an adjoining urgent care facility that is open 7 days a week and uses the same EMR as Dr. Bazemore’s clinic.

This is the kind of relationship that Dr. Abraham would like to see between alternative care settings and traditional primary care practices: complementary rather than competitive. However, he questions the motives of hospital systems that own urgent care centers.

“Health care systems are starting these urgent care centers because they want to cash in on the same market,” he said. “I’m not convinced that their goal is to feed their primary care doctors. That is a potential advantage, but they also feed their specialists and try to blend procedures and other lucrative aspects of care into their system.”
 

What pharmacy chains are up to

Pharmacy chains have their own ulterior motives, Dr. Abraham noted. They built retail clinics for the same reason they sell drugs: to increase sales of consumer goods in their stores. Dr. Bazemore added that retail clinics also aim “to achieve a certain patient volume and incentivize what’s purchased in the pharmacy.”

Exacerbating the situation, CVS now owns Aetna, one of the biggest health insurers. Dr. Kagan believed that CVS’ new emphasis on HealthHUBs may be related to that. “CVS seems to be closing drugstores and opening up more primary care places, and now that they own Aetna, they’re trying to make Aetna patients go to CVS when they have a problem,” he said. Aetna patients are now required to fill their prescriptions at CVS.

Walmart has said it plans to open expanded-service clinics in locales that don’t have sufficient primary care, especially rural areas. The experts we consulted agree that Walmart won’t stop there if its new model is successful. In fact, Dr. Bazemore noted, competition from the new generation of in-store clinics is likely to be in areas where there are plenty of primary care doctors.

“For economic reasons, you’re going to see more of these clinics fill spaces where there’s already a sufficiency [of primary care] – starting with wealthy suburban areas,” Dr. Bazemore said. “Where you have a Walmart, Walgreens, or CVS, you tend to find more purchasers. I don’t know that it’s necessarily the answer to our access problems.”
 

What should primary care doctors do?

The obvious response of primary care practices to competition from retail clinics and urgent care centers that are open 7 days a week, 12 hours a day, is to expand their hours. In addition, they can introduce same-day scheduling or reserve a block of time every day for walk-in patients.

That’s the approach that Dr. Grumet took in his private practice. “When my patients called me, I tried to deal with it right away. So it was baffling that some of them went to retail clinics.”

Actually, it’s not so baffling, Dr. Abraham said, when you consider that retail clinics are part of a one-stop-shopping experience that will become even more all-encompassing in stores that add quasi-primary care clinics. “You can pick up the consumables you need, you can pick up prescriptions, and you can see your physician without having to make multiple stops. It’s a great idea for pharmacies.”

How about telemedicine? A lot of acute care similar to that provided in alternative care settings can be offered during virtual visits, noted Dr. Bazemore. However, the pharmacy chains have been providing telemedicine for years, using third-party services. And while the convenience of virtual visits appeals to some patients, that’s no guarantee they won’t go to retail clinics.

Reaching out to patients with reminders about the need for checkups and preventive visits, either by phone or through a patient portal, is another technique that practices can use to retain patients. A recent Press Ganey poll showed that people value this kind of communication. But it hardly seems sufficient to hold off the competitive assault of pharmacy chains.

A flaw in the pharmacies’ strategy, however, could eventually come back to bite them: Because the new, larger clinics don’t provide comprehensive care, people will eventually have to turn to traditional primary care – if it’s still around.

“Here’s the problem,” Dr. Grumet explained. “If you’re going to do [in-store primary care], you have to take ownership of the patient and manage everything. You have to be a full-fledged primary care practice with on-call hours and ER coverage. Otherwise, you’re taking bits and pieces – probably low-hanging fruit – to make money, and taking those away from the primary care practice. Which means you’re taking them from the people who should be doing the job.”

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

Jordan Grumet, MD, an internist in Northbrook, Ill., left his private practice about 2 years ago, partly because of competition from local retail clinics.

“We were always fighting the pharmacy clinics,” he said. “My generation of doctors was brought up to think we should have a one-stop shop. That was the idea behind being a primary care doctor. So it was very destructive to know your patients were going to another provider.”

Local retail clinics and urgent care centers were also co-opting many of the minor acute care visits that help primary care practices survive. “The number of visits for flu shots and simple medical problems drops,” said Dr. Grumet, who is now an end-of-life-care consultant and also works in hospices. “That can put downward economic pressure on primary care practices.”

Competition for primary care practices is ready to heat up even more, and the environment may soon become even more threatening for primary care doctors. Over the last year, the two largest pharmacy chains – CVS and Walgreens – announced their intentions to build larger retail clinics that will offer many aspects of traditional primary care. Walmart will also be doing the same.

How many geographical areas will be affected is unknown. However, observers say these new hybrid clinics could affect the revenues of some primary care practices.

“There will be more competition, no question,” said George Abraham, MD, MPH, president of the American College of Physicians.

Andrew Bazemore, MD, MPH, senior vice president of research and policy for the American Board of Family Medicine, agreed. “Seeing retail clinics finally embrace the promise of coordination and comprehensiveness in primary care is a promising step. It’s good to see CVS, Walmart, and Walgreens embracing the notion that they have to do more than just urgent care. On the flip side, it’s a source of competition for longstanding primary care clinics.”

Jeff Kagan, MD, an internist in Newington, Conn., noted that during the pandemic the booming demand for primary care has reduced competition from alternative care settings.

“But if this was not pandemic times, it would be very different. There are more urgent care walk-in clinics that do some primary care, and they are pulling away patients.”
 

New alternative care settings

The number of retail health centers has leveled off at around 2,000 clinics, about the same as in 2016. But CVS, which has around half that total, is now adding HealthHUB facilities, which offer nonemergency care. CVS had 800 of these quasi-primary care clinics in the first quarter of 2021 and planned to have 1,000 by the end of 2021, according to Managed Healthcare Executive.

Walgreens closed 150 of its retail clinics while partnering with VillageMD to develop 600 VillageMD clinics that are larger than its current in-store offices. The chain plans to build these clinics adjacent to Walgreens stores in 30 markets over the next 4 years. Currently, Walgreens has more than 50 VillageMD clinics, mostly in Sunbelt states.

Walmart opened the first of its new expanded-service clinics in 2019. Now it has clinics in Georgia, Arkansas, Texas, and Florida. These Walmart Health locations offer urgent care, primary care, labs, x-ray, and mental health therapy, as well as dental, optical, and hearing services.

The number of urgent care centers (UCCs), meanwhile, has mushroomed during the last decade. With the addition of 400-500 centers every year since 2014, there were 9,279 UCCs in the United States as of June 2019, according to the Urgent Care Association.

These UCCs usually have on-staff physicians. In contrast, most retail clinics are staffed by nurse practitioners. Another big difference is that in retail clinics, two-thirds of the patients – many of them young and healthy – have no regular primary care clinician; only a third of UCC patients don’t have a personal physician.

Because of these rootless patients, competition from retail clinics “is no big deal” to some primary care practices, said Ateev Mehrotra, MD, a Harvard Medical School professor in Boston who has studied alternative care settings. On the other hand, he asked, why do so few UCC patients have a regular physician? That raises the question of how many of these patients would go to a primary care office if there were no retail clinics or UCCs.
 

Economic pressure on practices

Dr. Grumet’s point about retail clinics and UCCs depriving his practice of easy, lucrative visits is widely echoed among his peers. The fee-for-service payment system based on Medicare rates exacerbates the problem. As Dr. Abraham pointed out, when primary care doctors see a higher percentage of patients with complicated problems, the doctors don’t get compensated fairly for those visits.

Minor acute care, Dr. Abraham noted, is “easier work for the same pay. When I review 100 pages of records for someone who was hospitalized and figure out their 10 different problems and 20 medications, I get paid virtually the same as if I treated a diabetic with a common cold or a foot laceration. The complexity of thought is not factored completely into the reimbursement. And we use the easier visits to offset the more complex ones.”
 

What happened to continuity of care?

The fragmentation of care between primary care practices and alternative care settings also “diminishes the primary care function,” Dr. Bazemore said.

“Primary care is supposed to be first contact, covering most of what a patient needs – comprehensive, coordinated, and continuous,” he observed. “When you fragment and separate an urgent care function from the rest, so it’s not done in the context of that first contact, you weaken the primary care component without enhancing its function.”

Observers doubt the advent of larger retail clinics that provide more services is likely to solve this problem. In Dr. Mehrotra’s view, CVS’ HealthHUBs “are all about supporting primary care. But are they really? Who are the patients supposed to come back to? This is a critical point: When you ask patients who’s in charge of their care, what are they going to say?”

Retail clinics and urgent care centers have a similar issue, Dr. Grumet said. “If you see patients in the office, and they have problems late at night, they can call you. There’s a continuity of care you don’t get in alternative care settings. The real goal in those places is to get patients in, assess them, and get them out. Which is fine – for minor things. But for someone who needs more comprehensive care, it’s not so good.”

This is why the ACP advised against the provision of chronic care in alternative care settings, said Dr. Abraham. “The problem with retail clinics is they’ve expanded into chronic care management in one or more episodes that require care, but not true continuity of care. When you go to a primary care physician’s office, we discuss more than just acute problems or chronic health issues; we talk about wellness, lifestyle, preventive services, vaccines, and your family. Relationship-building occurs, which transcends more than care interaction. In a setting where you get your care and you leave, longitudinal, holistic care doesn’t build.”

Dr. Kagan put it more succinctly: “Sometimes urgent care walk-in clinics get in over their head [with chronic care]. They like the guy who has high blood pressure and comes in once or twice a year for a prescription refill. But they’re not involved with the guy who has much more trouble.” 

None of the urgent care doctors he knows of are taking long-term responsibility for their patients, Dr. Kagan added. “They don’t schedule follow-ups. They’ll see a patient for something, then say: ‘If you’re not better, come back and see me in a couple of weeks.’ ”
 

Two flavors of urgent care

Dr. Kagan has seen another type of doctor-patient relationship since he sold his practice to Hartford HealthCare 2 years ago. Hartford HealthCare owns 50% of an urgent care group called GoHealth.

“If our Hartford HealthCare patients can’t get into the office, we encourage them to go to a GoHealth facility,” he noted. “It’s not competition; it’s like one of our colleagues. We use the same EMR, so I can see everything that happens. I can even send someone who needs an x-ray to a GoHealth Center just for that.”

Moreover, GoHealth provides only urgent care. “So if it’s one of my patients, they refer them back to me for follow-up. And if somebody wanders in there without a primary care physician, they’ll hook them up with a Hartford HealthCare clinician.”

Dr. Bazemore has had a similar experience. He practices 1 day a week in his residency clinic in Fairfax, Va., which is owned by the Inova Health System. Inova created an adjoining urgent care facility that is open 7 days a week and uses the same EMR as Dr. Bazemore’s clinic.

This is the kind of relationship that Dr. Abraham would like to see between alternative care settings and traditional primary care practices: complementary rather than competitive. However, he questions the motives of hospital systems that own urgent care centers.

“Health care systems are starting these urgent care centers because they want to cash in on the same market,” he said. “I’m not convinced that their goal is to feed their primary care doctors. That is a potential advantage, but they also feed their specialists and try to blend procedures and other lucrative aspects of care into their system.”
 

What pharmacy chains are up to

Pharmacy chains have their own ulterior motives, Dr. Abraham noted. They built retail clinics for the same reason they sell drugs: to increase sales of consumer goods in their stores. Dr. Bazemore added that retail clinics also aim “to achieve a certain patient volume and incentivize what’s purchased in the pharmacy.”

Exacerbating the situation, CVS now owns Aetna, one of the biggest health insurers. Dr. Kagan believed that CVS’ new emphasis on HealthHUBs may be related to that. “CVS seems to be closing drugstores and opening up more primary care places, and now that they own Aetna, they’re trying to make Aetna patients go to CVS when they have a problem,” he said. Aetna patients are now required to fill their prescriptions at CVS.

Walmart has said it plans to open expanded-service clinics in locales that don’t have sufficient primary care, especially rural areas. The experts we consulted agree that Walmart won’t stop there if its new model is successful. In fact, Dr. Bazemore noted, competition from the new generation of in-store clinics is likely to be in areas where there are plenty of primary care doctors.

“For economic reasons, you’re going to see more of these clinics fill spaces where there’s already a sufficiency [of primary care] – starting with wealthy suburban areas,” Dr. Bazemore said. “Where you have a Walmart, Walgreens, or CVS, you tend to find more purchasers. I don’t know that it’s necessarily the answer to our access problems.”
 

What should primary care doctors do?

The obvious response of primary care practices to competition from retail clinics and urgent care centers that are open 7 days a week, 12 hours a day, is to expand their hours. In addition, they can introduce same-day scheduling or reserve a block of time every day for walk-in patients.

That’s the approach that Dr. Grumet took in his private practice. “When my patients called me, I tried to deal with it right away. So it was baffling that some of them went to retail clinics.”

Actually, it’s not so baffling, Dr. Abraham said, when you consider that retail clinics are part of a one-stop-shopping experience that will become even more all-encompassing in stores that add quasi-primary care clinics. “You can pick up the consumables you need, you can pick up prescriptions, and you can see your physician without having to make multiple stops. It’s a great idea for pharmacies.”

How about telemedicine? A lot of acute care similar to that provided in alternative care settings can be offered during virtual visits, noted Dr. Bazemore. However, the pharmacy chains have been providing telemedicine for years, using third-party services. And while the convenience of virtual visits appeals to some patients, that’s no guarantee they won’t go to retail clinics.

Reaching out to patients with reminders about the need for checkups and preventive visits, either by phone or through a patient portal, is another technique that practices can use to retain patients. A recent Press Ganey poll showed that people value this kind of communication. But it hardly seems sufficient to hold off the competitive assault of pharmacy chains.

A flaw in the pharmacies’ strategy, however, could eventually come back to bite them: Because the new, larger clinics don’t provide comprehensive care, people will eventually have to turn to traditional primary care – if it’s still around.

“Here’s the problem,” Dr. Grumet explained. “If you’re going to do [in-store primary care], you have to take ownership of the patient and manage everything. You have to be a full-fledged primary care practice with on-call hours and ER coverage. Otherwise, you’re taking bits and pieces – probably low-hanging fruit – to make money, and taking those away from the primary care practice. Which means you’re taking them from the people who should be doing the job.”

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

Jordan Grumet, MD, an internist in Northbrook, Ill., left his private practice about 2 years ago, partly because of competition from local retail clinics.

“We were always fighting the pharmacy clinics,” he said. “My generation of doctors was brought up to think we should have a one-stop shop. That was the idea behind being a primary care doctor. So it was very destructive to know your patients were going to another provider.”

Local retail clinics and urgent care centers were also co-opting many of the minor acute care visits that help primary care practices survive. “The number of visits for flu shots and simple medical problems drops,” said Dr. Grumet, who is now an end-of-life-care consultant and also works in hospices. “That can put downward economic pressure on primary care practices.”

Competition for primary care practices is ready to heat up even more, and the environment may soon become even more threatening for primary care doctors. Over the last year, the two largest pharmacy chains – CVS and Walgreens – announced their intentions to build larger retail clinics that will offer many aspects of traditional primary care. Walmart will also be doing the same.

How many geographical areas will be affected is unknown. However, observers say these new hybrid clinics could affect the revenues of some primary care practices.

“There will be more competition, no question,” said George Abraham, MD, MPH, president of the American College of Physicians.

Andrew Bazemore, MD, MPH, senior vice president of research and policy for the American Board of Family Medicine, agreed. “Seeing retail clinics finally embrace the promise of coordination and comprehensiveness in primary care is a promising step. It’s good to see CVS, Walmart, and Walgreens embracing the notion that they have to do more than just urgent care. On the flip side, it’s a source of competition for longstanding primary care clinics.”

Jeff Kagan, MD, an internist in Newington, Conn., noted that during the pandemic the booming demand for primary care has reduced competition from alternative care settings.

“But if this was not pandemic times, it would be very different. There are more urgent care walk-in clinics that do some primary care, and they are pulling away patients.”
 

New alternative care settings

The number of retail health centers has leveled off at around 2,000 clinics, about the same as in 2016. But CVS, which has around half that total, is now adding HealthHUB facilities, which offer nonemergency care. CVS had 800 of these quasi-primary care clinics in the first quarter of 2021 and planned to have 1,000 by the end of 2021, according to Managed Healthcare Executive.

Walgreens closed 150 of its retail clinics while partnering with VillageMD to develop 600 VillageMD clinics that are larger than its current in-store offices. The chain plans to build these clinics adjacent to Walgreens stores in 30 markets over the next 4 years. Currently, Walgreens has more than 50 VillageMD clinics, mostly in Sunbelt states.

Walmart opened the first of its new expanded-service clinics in 2019. Now it has clinics in Georgia, Arkansas, Texas, and Florida. These Walmart Health locations offer urgent care, primary care, labs, x-ray, and mental health therapy, as well as dental, optical, and hearing services.

The number of urgent care centers (UCCs), meanwhile, has mushroomed during the last decade. With the addition of 400-500 centers every year since 2014, there were 9,279 UCCs in the United States as of June 2019, according to the Urgent Care Association.

These UCCs usually have on-staff physicians. In contrast, most retail clinics are staffed by nurse practitioners. Another big difference is that in retail clinics, two-thirds of the patients – many of them young and healthy – have no regular primary care clinician; only a third of UCC patients don’t have a personal physician.

Because of these rootless patients, competition from retail clinics “is no big deal” to some primary care practices, said Ateev Mehrotra, MD, a Harvard Medical School professor in Boston who has studied alternative care settings. On the other hand, he asked, why do so few UCC patients have a regular physician? That raises the question of how many of these patients would go to a primary care office if there were no retail clinics or UCCs.
 

Economic pressure on practices

Dr. Grumet’s point about retail clinics and UCCs depriving his practice of easy, lucrative visits is widely echoed among his peers. The fee-for-service payment system based on Medicare rates exacerbates the problem. As Dr. Abraham pointed out, when primary care doctors see a higher percentage of patients with complicated problems, the doctors don’t get compensated fairly for those visits.

Minor acute care, Dr. Abraham noted, is “easier work for the same pay. When I review 100 pages of records for someone who was hospitalized and figure out their 10 different problems and 20 medications, I get paid virtually the same as if I treated a diabetic with a common cold or a foot laceration. The complexity of thought is not factored completely into the reimbursement. And we use the easier visits to offset the more complex ones.”
 

What happened to continuity of care?

The fragmentation of care between primary care practices and alternative care settings also “diminishes the primary care function,” Dr. Bazemore said.

“Primary care is supposed to be first contact, covering most of what a patient needs – comprehensive, coordinated, and continuous,” he observed. “When you fragment and separate an urgent care function from the rest, so it’s not done in the context of that first contact, you weaken the primary care component without enhancing its function.”

Observers doubt the advent of larger retail clinics that provide more services is likely to solve this problem. In Dr. Mehrotra’s view, CVS’ HealthHUBs “are all about supporting primary care. But are they really? Who are the patients supposed to come back to? This is a critical point: When you ask patients who’s in charge of their care, what are they going to say?”

Retail clinics and urgent care centers have a similar issue, Dr. Grumet said. “If you see patients in the office, and they have problems late at night, they can call you. There’s a continuity of care you don’t get in alternative care settings. The real goal in those places is to get patients in, assess them, and get them out. Which is fine – for minor things. But for someone who needs more comprehensive care, it’s not so good.”

This is why the ACP advised against the provision of chronic care in alternative care settings, said Dr. Abraham. “The problem with retail clinics is they’ve expanded into chronic care management in one or more episodes that require care, but not true continuity of care. When you go to a primary care physician’s office, we discuss more than just acute problems or chronic health issues; we talk about wellness, lifestyle, preventive services, vaccines, and your family. Relationship-building occurs, which transcends more than care interaction. In a setting where you get your care and you leave, longitudinal, holistic care doesn’t build.”

Dr. Kagan put it more succinctly: “Sometimes urgent care walk-in clinics get in over their head [with chronic care]. They like the guy who has high blood pressure and comes in once or twice a year for a prescription refill. But they’re not involved with the guy who has much more trouble.” 

None of the urgent care doctors he knows of are taking long-term responsibility for their patients, Dr. Kagan added. “They don’t schedule follow-ups. They’ll see a patient for something, then say: ‘If you’re not better, come back and see me in a couple of weeks.’ ”
 

Two flavors of urgent care

Dr. Kagan has seen another type of doctor-patient relationship since he sold his practice to Hartford HealthCare 2 years ago. Hartford HealthCare owns 50% of an urgent care group called GoHealth.

“If our Hartford HealthCare patients can’t get into the office, we encourage them to go to a GoHealth facility,” he noted. “It’s not competition; it’s like one of our colleagues. We use the same EMR, so I can see everything that happens. I can even send someone who needs an x-ray to a GoHealth Center just for that.”

Moreover, GoHealth provides only urgent care. “So if it’s one of my patients, they refer them back to me for follow-up. And if somebody wanders in there without a primary care physician, they’ll hook them up with a Hartford HealthCare clinician.”

Dr. Bazemore has had a similar experience. He practices 1 day a week in his residency clinic in Fairfax, Va., which is owned by the Inova Health System. Inova created an adjoining urgent care facility that is open 7 days a week and uses the same EMR as Dr. Bazemore’s clinic.

This is the kind of relationship that Dr. Abraham would like to see between alternative care settings and traditional primary care practices: complementary rather than competitive. However, he questions the motives of hospital systems that own urgent care centers.

“Health care systems are starting these urgent care centers because they want to cash in on the same market,” he said. “I’m not convinced that their goal is to feed their primary care doctors. That is a potential advantage, but they also feed their specialists and try to blend procedures and other lucrative aspects of care into their system.”
 

What pharmacy chains are up to

Pharmacy chains have their own ulterior motives, Dr. Abraham noted. They built retail clinics for the same reason they sell drugs: to increase sales of consumer goods in their stores. Dr. Bazemore added that retail clinics also aim “to achieve a certain patient volume and incentivize what’s purchased in the pharmacy.”

Exacerbating the situation, CVS now owns Aetna, one of the biggest health insurers. Dr. Kagan believed that CVS’ new emphasis on HealthHUBs may be related to that. “CVS seems to be closing drugstores and opening up more primary care places, and now that they own Aetna, they’re trying to make Aetna patients go to CVS when they have a problem,” he said. Aetna patients are now required to fill their prescriptions at CVS.

Walmart has said it plans to open expanded-service clinics in locales that don’t have sufficient primary care, especially rural areas. The experts we consulted agree that Walmart won’t stop there if its new model is successful. In fact, Dr. Bazemore noted, competition from the new generation of in-store clinics is likely to be in areas where there are plenty of primary care doctors.

“For economic reasons, you’re going to see more of these clinics fill spaces where there’s already a sufficiency [of primary care] – starting with wealthy suburban areas,” Dr. Bazemore said. “Where you have a Walmart, Walgreens, or CVS, you tend to find more purchasers. I don’t know that it’s necessarily the answer to our access problems.”
 

What should primary care doctors do?

The obvious response of primary care practices to competition from retail clinics and urgent care centers that are open 7 days a week, 12 hours a day, is to expand their hours. In addition, they can introduce same-day scheduling or reserve a block of time every day for walk-in patients.

That’s the approach that Dr. Grumet took in his private practice. “When my patients called me, I tried to deal with it right away. So it was baffling that some of them went to retail clinics.”

Actually, it’s not so baffling, Dr. Abraham said, when you consider that retail clinics are part of a one-stop-shopping experience that will become even more all-encompassing in stores that add quasi-primary care clinics. “You can pick up the consumables you need, you can pick up prescriptions, and you can see your physician without having to make multiple stops. It’s a great idea for pharmacies.”

How about telemedicine? A lot of acute care similar to that provided in alternative care settings can be offered during virtual visits, noted Dr. Bazemore. However, the pharmacy chains have been providing telemedicine for years, using third-party services. And while the convenience of virtual visits appeals to some patients, that’s no guarantee they won’t go to retail clinics.

Reaching out to patients with reminders about the need for checkups and preventive visits, either by phone or through a patient portal, is another technique that practices can use to retain patients. A recent Press Ganey poll showed that people value this kind of communication. But it hardly seems sufficient to hold off the competitive assault of pharmacy chains.

A flaw in the pharmacies’ strategy, however, could eventually come back to bite them: Because the new, larger clinics don’t provide comprehensive care, people will eventually have to turn to traditional primary care – if it’s still around.

“Here’s the problem,” Dr. Grumet explained. “If you’re going to do [in-store primary care], you have to take ownership of the patient and manage everything. You have to be a full-fledged primary care practice with on-call hours and ER coverage. Otherwise, you’re taking bits and pieces – probably low-hanging fruit – to make money, and taking those away from the primary care practice. Which means you’re taking them from the people who should be doing the job.”

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

The day I interviewed at Johns Hopkins in Baltimore, like every other day of residency interviews, was a very long and draining day.

I started by meeting alone with Philip Slavney, MD, the residency director, who spoke with me about the program and gave me a schedule to follow. I was to meet with residents and psychiatrists, some of whom had graduated from my medical school, and was sent to the Bayview campus a few miles away to have lunch and attend a few meetings. By the time I boarded an Amtrak train at Baltimore Penn Station, I was tired but I liked what I had seen. By the end of the interview season, I had crossed four programs off my list and had decided to rank only three.

In 1987, there were 987 residency positions in psychiatry in the United States, and 83.6% of those positions filled with a combination of U.S. and international medical graduates. Still, this was a risky move; the programs that I decided to rank would fill, but I was matching separately for an internship year in internal medicine in New York and decided that I would rather reapply in a year than risk matching at a program I didn’t want to go to.

I wasn’t quite sure where I wanted to rank Hopkins on my list, so I called Dr. Slavney and said I wanted to come back and meet more members of the department. He did not hide his surprise and was quick to tell me that no one had ever requested a second set of interviews. I mentioned specific people I wanted to meet with, and he was kind enough to accommodate my request and set up a second day of interviews for me.

Needless to say, the residency match felt very personal – at least to me – and although I felt vulnerable, I also felt empowered. Because of the low pay, patients with stigmatized illnesses, and the rampant belief that psychiatry was not “real” medicine and the patients never got better, psychiatry was not a desired specialty.

The residency application process in psychiatry (and every other specialty) has become a much different process. In 2006, the Association of American Medical Colleges called on medical schools to increase their enrollments to address the national shortage of physicians. Soon, there were more medical schools, bigger classes, and more doctors being minted, but the Balanced Budget Act of 1997 prevented a proportional increase in residency positions.

Len Marquez, senior director of government relations at the AAMC noted: “The Resident Physician Shortage Reduction Act of 2021 (S. 834), sponsored by Sen. Robert Menendez (D-N.J.), Sen. John Boozman (R-Ark.), and Majority Leader Sen. Charles Schumer (D-N.Y.), would support 2,000 additional Medicare-supported residency positions each year for 7 years, but Congress has not yet acted on the legislation. We were very pleased that last year, Congress passed the first increase in Medicare-supported graduate medical education in 25 years by including 1,000 new slots as part of the Consolidated Appropriations Act, 2021.”

In addition, the Build Back Better Act, which is currently being debated in Congress, would provide 4,000 more graduate medical education slots, including a specific requirement that 15% of them go to “psychiatry-related residencies,” he added.

Over 90% of graduates from U.S. medical schools currently match into a residency position. That statistic for international medical graduates is notably lower, with perhaps as few as 50% of all applicants matching.

Since 2014, the number of applicants to psychiatry residencies has nearly doubled. For the 2021 match, there were 2,486 applicants applying for 1,858 positions in psychiatry – so 1.34 applicants for each slot. Of the 1,117 senior medical students at U.S. schools who applied to psychiatry residencies, 129 did not match. Overall, 99.8% of residency positions in psychiatry filled. 

“It used to be less competitive,” said Kaz J. Nelson, MD, the vice chair for education at the University of Minnesota’s department of psychiatry and behavioral sciences in Minneapolis, adding that interest in psychiatry has increased over the years. 

“Interest has skyrocketed as the word has gotten out about how great a field it is. It helps that reimbursements are better, that there is less bias and discrimination against patients with psychiatric issues, and that psychiatric care is seen as a legitimate part of medicine. It has been exciting to watch!” Dr. Nelson said.

The numbers are only one part of the story, however. 

Application submission now involves a centralized, electronic process, and it has become easier for applicants to apply to a lot of programs indiscriminately. It’s not unusual for applicants to apply to 70 or more programs. The factors that have limited applications include the cost: Electronic Residency Application Services (ERAS) charges for each application package they send to a program, and applicants traditionally pay to travel to the programs where they interview. This all changed with the 2021 cycle when in-person interviews were halted for the pandemic and interviews became virtual. While I recall applying to 7 residency programs, this year the average number of applications was 54.7 per applicant.

“It used to be that the cap on interviewing was financial,” Dr. Nelson said. “It was discriminatory and favored those who had more money to travel to interviews. There are still the ERAS fees, but COVID has been an equalizer and we are getting more applicants, and interviewing more who are not from Minnesota or the Midwest. We have been working to make our program attractive in terms of diversity, equity, inclusion, and justice. Our hospital is located a mile from where George Floyd was murdered, and it’s our responsibility to lead the effort to ensure the psychiatry workforce is diverse, and inclusive, as possible.”

Daniel E. Gih, MD, is the program director for a new psychiatry residency at the University of Nebraska, Omaha. When the program started in 2019, there were spots for four residents and the program had 588 applications. In 2020, the program grew to five positions and this year there were 553 applicants. Dr. Gih attributed the high number of applications to his program’s strong social media presence.

“Going through the applications and meeting the students are some of the most enjoyable parts of my work,” Dr. Gih said. “I feel guilty though, that I’m likely going to miss a great applicant. Each application averages 35 pages and it’s inevitable that programs have to take shortcuts. Applicants worry that they’ll be ranked by board scores. While we certainly don’t do that here, students might feel ruled out of a program if their numbers aren’t high enough. Furthermore, wealthy students can apply to more programs. The pandemic has really highlighted the inequity issues.”

Dr. Gih noted that the Zoom interview process has not been disappointing: “Two of the people we matched had never been to Omaha, and many expressed concerns about what it is like here. Of course, on Zoom you don’t catch subtle interpersonal issues, but we have been pleasantly surprised that the people we matched were consistent with what we expected. It is exciting to meet the people who will eventually replace us as psychiatrists, they will be here to deal with future challenges!” His enthusiasm was tangible. 

While the program directors remain optimistic, the system is not without its stresses, as many programs receive over 1,000 applications.

“This is difficult,” Dr. Nelson said.” It’s wonderful for the programs, but for the medical students, not matching is experienced by them as being catastrophic, so they apply to a lot of programs. Getting this many applications is a challenge, yet I don’t want to interview someone if they are going to rank our program No. 80 on their list!” 

Residencies have dealt with the deluge of applicants in a number of ways. Some specialties started a “signal” protocol wherein candidates and programs receive a certain number of tokens to indicate that each would rank the other highly, but psychiatry has not done this. Early on in the Zoom process, multiple applicants would be offered interviews simultaneously, and the interview would be given to the candidate who responded first. Students vented their frustrations on Twitter when they lost interview spots at their coveted programs because they hadn’t checked their email in time or had gone to take a shower.

“The American Association of Directors of Psychiatry Residency Training Programs issued guidelines saying that it is unacceptable to offer interview spots without allowing a reasonable time for the applicant to respond, and that it is not appropriate to offer multiple candidates one spot on a first-come, first-serve basis,” Dr. Nelson explained.

Her program has managed some of the application chaos by using a software program called Scutmonkey, codeveloped by David Ross, MD, PhD, the associate program director of the Yale Adult Psychiatry Residency Program.

“It lets us screen applications for candidates who specifically are interested in being here, and for those who qualify as part of the mission we are trying to fulfill.”

One fourth-year student at a mid-Atlantic medical school who is applying in psychiatry – who I’ll call Sacha to protect his anonymity – applied to 73 psychiatry programs and to date, has interviewed at 6. He describes a stressful, roller coaster experience:

“I got those six interviews right away and that was an amazing start, but then I didn’t get any more. The interviews I had went well, but it has been disappointing not to have more. Some were all-day interviews, while other programs had me meet with residents and attendings for 20 minutes each and it was all done after 2 hours.”

He has mixed opinions about not seeing the schools in person. “There are very heavy pros and cons. I’ve saved thousands of dollars in travel expenses that would have limited my applications, so logistically it’s a dream. On the other hand, I’ve interviewed in cities I have never been to, it’s hard to get a sense of the intangibles of a program, and the shorter interviews feel very impersonal.” 

Sacha expressed anxieties about the process. “With so many applicants, it’s difficult for someone with a nontraditional story to get a spot and it’s easier for the programs to toss applications. With all of my classmates, there is the palpable fear of not matching anywhere, it’s common enough and everyone has seen someone who has gone through this. At times, we feel powerless; we have no real agency or control. We send stuff out and then we sit in the prayer position and wait.”

I think back on my own application process with a sense of gratitude. I certainly didn’t feel powerless, and in today’s world, postinterview communications with program directors are regulated for both parties. Dr. Slavney was kind enough to humor my request, but I don’t believe this would be feasible in the current environment.

Even though it is wonderful that more doctors have figured out that careers in psychiatry are rewarding, the current situation is overwhelming for both the applicants and the programs. With over 100 applicants for every position – many of whom will have no interest in going to some of the programs they apply to – qualified candidates who go unmatched, and a roulette wheel which requires heavily indebted students to pay to apply, this is simply not sustainable in a country with a shortage of physicians – psychiatrists in particular. 

We hear that mid-level practitioners are the answer to our shortages, but perhaps we need to create a system with enough residency positions to accommodate highly trained and qualified physicians in a more inviting and targeted way.

Dinah Miller, MD, is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. A version of this article first appeared on Medscape.com.

The day I interviewed at Johns Hopkins in Baltimore, like every other day of residency interviews, was a very long and draining day.

I started by meeting alone with Philip Slavney, MD, the residency director, who spoke with me about the program and gave me a schedule to follow. I was to meet with residents and psychiatrists, some of whom had graduated from my medical school, and was sent to the Bayview campus a few miles away to have lunch and attend a few meetings. By the time I boarded an Amtrak train at Baltimore Penn Station, I was tired but I liked what I had seen. By the end of the interview season, I had crossed four programs off my list and had decided to rank only three.

In 1987, there were 987 residency positions in psychiatry in the United States, and 83.6% of those positions filled with a combination of U.S. and international medical graduates. Still, this was a risky move; the programs that I decided to rank would fill, but I was matching separately for an internship year in internal medicine in New York and decided that I would rather reapply in a year than risk matching at a program I didn’t want to go to.

I wasn’t quite sure where I wanted to rank Hopkins on my list, so I called Dr. Slavney and said I wanted to come back and meet more members of the department. He did not hide his surprise and was quick to tell me that no one had ever requested a second set of interviews. I mentioned specific people I wanted to meet with, and he was kind enough to accommodate my request and set up a second day of interviews for me.

Needless to say, the residency match felt very personal – at least to me – and although I felt vulnerable, I also felt empowered. Because of the low pay, patients with stigmatized illnesses, and the rampant belief that psychiatry was not “real” medicine and the patients never got better, psychiatry was not a desired specialty.

The residency application process in psychiatry (and every other specialty) has become a much different process. In 2006, the Association of American Medical Colleges called on medical schools to increase their enrollments to address the national shortage of physicians. Soon, there were more medical schools, bigger classes, and more doctors being minted, but the Balanced Budget Act of 1997 prevented a proportional increase in residency positions.

Len Marquez, senior director of government relations at the AAMC noted: “The Resident Physician Shortage Reduction Act of 2021 (S. 834), sponsored by Sen. Robert Menendez (D-N.J.), Sen. John Boozman (R-Ark.), and Majority Leader Sen. Charles Schumer (D-N.Y.), would support 2,000 additional Medicare-supported residency positions each year for 7 years, but Congress has not yet acted on the legislation. We were very pleased that last year, Congress passed the first increase in Medicare-supported graduate medical education in 25 years by including 1,000 new slots as part of the Consolidated Appropriations Act, 2021.”

In addition, the Build Back Better Act, which is currently being debated in Congress, would provide 4,000 more graduate medical education slots, including a specific requirement that 15% of them go to “psychiatry-related residencies,” he added.

Over 90% of graduates from U.S. medical schools currently match into a residency position. That statistic for international medical graduates is notably lower, with perhaps as few as 50% of all applicants matching.

Since 2014, the number of applicants to psychiatry residencies has nearly doubled. For the 2021 match, there were 2,486 applicants applying for 1,858 positions in psychiatry – so 1.34 applicants for each slot. Of the 1,117 senior medical students at U.S. schools who applied to psychiatry residencies, 129 did not match. Overall, 99.8% of residency positions in psychiatry filled. 

“It used to be less competitive,” said Kaz J. Nelson, MD, the vice chair for education at the University of Minnesota’s department of psychiatry and behavioral sciences in Minneapolis, adding that interest in psychiatry has increased over the years. 

“Interest has skyrocketed as the word has gotten out about how great a field it is. It helps that reimbursements are better, that there is less bias and discrimination against patients with psychiatric issues, and that psychiatric care is seen as a legitimate part of medicine. It has been exciting to watch!” Dr. Nelson said.

The numbers are only one part of the story, however. 

Application submission now involves a centralized, electronic process, and it has become easier for applicants to apply to a lot of programs indiscriminately. It’s not unusual for applicants to apply to 70 or more programs. The factors that have limited applications include the cost: Electronic Residency Application Services (ERAS) charges for each application package they send to a program, and applicants traditionally pay to travel to the programs where they interview. This all changed with the 2021 cycle when in-person interviews were halted for the pandemic and interviews became virtual. While I recall applying to 7 residency programs, this year the average number of applications was 54.7 per applicant.

“It used to be that the cap on interviewing was financial,” Dr. Nelson said. “It was discriminatory and favored those who had more money to travel to interviews. There are still the ERAS fees, but COVID has been an equalizer and we are getting more applicants, and interviewing more who are not from Minnesota or the Midwest. We have been working to make our program attractive in terms of diversity, equity, inclusion, and justice. Our hospital is located a mile from where George Floyd was murdered, and it’s our responsibility to lead the effort to ensure the psychiatry workforce is diverse, and inclusive, as possible.”

Daniel E. Gih, MD, is the program director for a new psychiatry residency at the University of Nebraska, Omaha. When the program started in 2019, there were spots for four residents and the program had 588 applications. In 2020, the program grew to five positions and this year there were 553 applicants. Dr. Gih attributed the high number of applications to his program’s strong social media presence.

“Going through the applications and meeting the students are some of the most enjoyable parts of my work,” Dr. Gih said. “I feel guilty though, that I’m likely going to miss a great applicant. Each application averages 35 pages and it’s inevitable that programs have to take shortcuts. Applicants worry that they’ll be ranked by board scores. While we certainly don’t do that here, students might feel ruled out of a program if their numbers aren’t high enough. Furthermore, wealthy students can apply to more programs. The pandemic has really highlighted the inequity issues.”

Dr. Gih noted that the Zoom interview process has not been disappointing: “Two of the people we matched had never been to Omaha, and many expressed concerns about what it is like here. Of course, on Zoom you don’t catch subtle interpersonal issues, but we have been pleasantly surprised that the people we matched were consistent with what we expected. It is exciting to meet the people who will eventually replace us as psychiatrists, they will be here to deal with future challenges!” His enthusiasm was tangible. 

While the program directors remain optimistic, the system is not without its stresses, as many programs receive over 1,000 applications.

“This is difficult,” Dr. Nelson said.” It’s wonderful for the programs, but for the medical students, not matching is experienced by them as being catastrophic, so they apply to a lot of programs. Getting this many applications is a challenge, yet I don’t want to interview someone if they are going to rank our program No. 80 on their list!” 

Residencies have dealt with the deluge of applicants in a number of ways. Some specialties started a “signal” protocol wherein candidates and programs receive a certain number of tokens to indicate that each would rank the other highly, but psychiatry has not done this. Early on in the Zoom process, multiple applicants would be offered interviews simultaneously, and the interview would be given to the candidate who responded first. Students vented their frustrations on Twitter when they lost interview spots at their coveted programs because they hadn’t checked their email in time or had gone to take a shower.

“The American Association of Directors of Psychiatry Residency Training Programs issued guidelines saying that it is unacceptable to offer interview spots without allowing a reasonable time for the applicant to respond, and that it is not appropriate to offer multiple candidates one spot on a first-come, first-serve basis,” Dr. Nelson explained.

Her program has managed some of the application chaos by using a software program called Scutmonkey, codeveloped by David Ross, MD, PhD, the associate program director of the Yale Adult Psychiatry Residency Program.

“It lets us screen applications for candidates who specifically are interested in being here, and for those who qualify as part of the mission we are trying to fulfill.”

One fourth-year student at a mid-Atlantic medical school who is applying in psychiatry – who I’ll call Sacha to protect his anonymity – applied to 73 psychiatry programs and to date, has interviewed at 6. He describes a stressful, roller coaster experience:

“I got those six interviews right away and that was an amazing start, but then I didn’t get any more. The interviews I had went well, but it has been disappointing not to have more. Some were all-day interviews, while other programs had me meet with residents and attendings for 20 minutes each and it was all done after 2 hours.”

He has mixed opinions about not seeing the schools in person. “There are very heavy pros and cons. I’ve saved thousands of dollars in travel expenses that would have limited my applications, so logistically it’s a dream. On the other hand, I’ve interviewed in cities I have never been to, it’s hard to get a sense of the intangibles of a program, and the shorter interviews feel very impersonal.” 

Sacha expressed anxieties about the process. “With so many applicants, it’s difficult for someone with a nontraditional story to get a spot and it’s easier for the programs to toss applications. With all of my classmates, there is the palpable fear of not matching anywhere, it’s common enough and everyone has seen someone who has gone through this. At times, we feel powerless; we have no real agency or control. We send stuff out and then we sit in the prayer position and wait.”

I think back on my own application process with a sense of gratitude. I certainly didn’t feel powerless, and in today’s world, postinterview communications with program directors are regulated for both parties. Dr. Slavney was kind enough to humor my request, but I don’t believe this would be feasible in the current environment.

Even though it is wonderful that more doctors have figured out that careers in psychiatry are rewarding, the current situation is overwhelming for both the applicants and the programs. With over 100 applicants for every position – many of whom will have no interest in going to some of the programs they apply to – qualified candidates who go unmatched, and a roulette wheel which requires heavily indebted students to pay to apply, this is simply not sustainable in a country with a shortage of physicians – psychiatrists in particular. 

We hear that mid-level practitioners are the answer to our shortages, but perhaps we need to create a system with enough residency positions to accommodate highly trained and qualified physicians in a more inviting and targeted way.

Dinah Miller, MD, is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. A version of this article first appeared on Medscape.com.

The day I interviewed at Johns Hopkins in Baltimore, like every other day of residency interviews, was a very long and draining day.

I started by meeting alone with Philip Slavney, MD, the residency director, who spoke with me about the program and gave me a schedule to follow. I was to meet with residents and psychiatrists, some of whom had graduated from my medical school, and was sent to the Bayview campus a few miles away to have lunch and attend a few meetings. By the time I boarded an Amtrak train at Baltimore Penn Station, I was tired but I liked what I had seen. By the end of the interview season, I had crossed four programs off my list and had decided to rank only three.

In 1987, there were 987 residency positions in psychiatry in the United States, and 83.6% of those positions filled with a combination of U.S. and international medical graduates. Still, this was a risky move; the programs that I decided to rank would fill, but I was matching separately for an internship year in internal medicine in New York and decided that I would rather reapply in a year than risk matching at a program I didn’t want to go to.

I wasn’t quite sure where I wanted to rank Hopkins on my list, so I called Dr. Slavney and said I wanted to come back and meet more members of the department. He did not hide his surprise and was quick to tell me that no one had ever requested a second set of interviews. I mentioned specific people I wanted to meet with, and he was kind enough to accommodate my request and set up a second day of interviews for me.

Needless to say, the residency match felt very personal – at least to me – and although I felt vulnerable, I also felt empowered. Because of the low pay, patients with stigmatized illnesses, and the rampant belief that psychiatry was not “real” medicine and the patients never got better, psychiatry was not a desired specialty.

The residency application process in psychiatry (and every other specialty) has become a much different process. In 2006, the Association of American Medical Colleges called on medical schools to increase their enrollments to address the national shortage of physicians. Soon, there were more medical schools, bigger classes, and more doctors being minted, but the Balanced Budget Act of 1997 prevented a proportional increase in residency positions.

Len Marquez, senior director of government relations at the AAMC noted: “The Resident Physician Shortage Reduction Act of 2021 (S. 834), sponsored by Sen. Robert Menendez (D-N.J.), Sen. John Boozman (R-Ark.), and Majority Leader Sen. Charles Schumer (D-N.Y.), would support 2,000 additional Medicare-supported residency positions each year for 7 years, but Congress has not yet acted on the legislation. We were very pleased that last year, Congress passed the first increase in Medicare-supported graduate medical education in 25 years by including 1,000 new slots as part of the Consolidated Appropriations Act, 2021.”

In addition, the Build Back Better Act, which is currently being debated in Congress, would provide 4,000 more graduate medical education slots, including a specific requirement that 15% of them go to “psychiatry-related residencies,” he added.

Over 90% of graduates from U.S. medical schools currently match into a residency position. That statistic for international medical graduates is notably lower, with perhaps as few as 50% of all applicants matching.

Since 2014, the number of applicants to psychiatry residencies has nearly doubled. For the 2021 match, there were 2,486 applicants applying for 1,858 positions in psychiatry – so 1.34 applicants for each slot. Of the 1,117 senior medical students at U.S. schools who applied to psychiatry residencies, 129 did not match. Overall, 99.8% of residency positions in psychiatry filled. 

“It used to be less competitive,” said Kaz J. Nelson, MD, the vice chair for education at the University of Minnesota’s department of psychiatry and behavioral sciences in Minneapolis, adding that interest in psychiatry has increased over the years. 

“Interest has skyrocketed as the word has gotten out about how great a field it is. It helps that reimbursements are better, that there is less bias and discrimination against patients with psychiatric issues, and that psychiatric care is seen as a legitimate part of medicine. It has been exciting to watch!” Dr. Nelson said.

The numbers are only one part of the story, however. 

Application submission now involves a centralized, electronic process, and it has become easier for applicants to apply to a lot of programs indiscriminately. It’s not unusual for applicants to apply to 70 or more programs. The factors that have limited applications include the cost: Electronic Residency Application Services (ERAS) charges for each application package they send to a program, and applicants traditionally pay to travel to the programs where they interview. This all changed with the 2021 cycle when in-person interviews were halted for the pandemic and interviews became virtual. While I recall applying to 7 residency programs, this year the average number of applications was 54.7 per applicant.

“It used to be that the cap on interviewing was financial,” Dr. Nelson said. “It was discriminatory and favored those who had more money to travel to interviews. There are still the ERAS fees, but COVID has been an equalizer and we are getting more applicants, and interviewing more who are not from Minnesota or the Midwest. We have been working to make our program attractive in terms of diversity, equity, inclusion, and justice. Our hospital is located a mile from where George Floyd was murdered, and it’s our responsibility to lead the effort to ensure the psychiatry workforce is diverse, and inclusive, as possible.”

Daniel E. Gih, MD, is the program director for a new psychiatry residency at the University of Nebraska, Omaha. When the program started in 2019, there were spots for four residents and the program had 588 applications. In 2020, the program grew to five positions and this year there were 553 applicants. Dr. Gih attributed the high number of applications to his program’s strong social media presence.

“Going through the applications and meeting the students are some of the most enjoyable parts of my work,” Dr. Gih said. “I feel guilty though, that I’m likely going to miss a great applicant. Each application averages 35 pages and it’s inevitable that programs have to take shortcuts. Applicants worry that they’ll be ranked by board scores. While we certainly don’t do that here, students might feel ruled out of a program if their numbers aren’t high enough. Furthermore, wealthy students can apply to more programs. The pandemic has really highlighted the inequity issues.”

Dr. Gih noted that the Zoom interview process has not been disappointing: “Two of the people we matched had never been to Omaha, and many expressed concerns about what it is like here. Of course, on Zoom you don’t catch subtle interpersonal issues, but we have been pleasantly surprised that the people we matched were consistent with what we expected. It is exciting to meet the people who will eventually replace us as psychiatrists, they will be here to deal with future challenges!” His enthusiasm was tangible. 

While the program directors remain optimistic, the system is not without its stresses, as many programs receive over 1,000 applications.

“This is difficult,” Dr. Nelson said.” It’s wonderful for the programs, but for the medical students, not matching is experienced by them as being catastrophic, so they apply to a lot of programs. Getting this many applications is a challenge, yet I don’t want to interview someone if they are going to rank our program No. 80 on their list!” 

Residencies have dealt with the deluge of applicants in a number of ways. Some specialties started a “signal” protocol wherein candidates and programs receive a certain number of tokens to indicate that each would rank the other highly, but psychiatry has not done this. Early on in the Zoom process, multiple applicants would be offered interviews simultaneously, and the interview would be given to the candidate who responded first. Students vented their frustrations on Twitter when they lost interview spots at their coveted programs because they hadn’t checked their email in time or had gone to take a shower.

“The American Association of Directors of Psychiatry Residency Training Programs issued guidelines saying that it is unacceptable to offer interview spots without allowing a reasonable time for the applicant to respond, and that it is not appropriate to offer multiple candidates one spot on a first-come, first-serve basis,” Dr. Nelson explained.

Her program has managed some of the application chaos by using a software program called Scutmonkey, codeveloped by David Ross, MD, PhD, the associate program director of the Yale Adult Psychiatry Residency Program.

“It lets us screen applications for candidates who specifically are interested in being here, and for those who qualify as part of the mission we are trying to fulfill.”

One fourth-year student at a mid-Atlantic medical school who is applying in psychiatry – who I’ll call Sacha to protect his anonymity – applied to 73 psychiatry programs and to date, has interviewed at 6. He describes a stressful, roller coaster experience:

“I got those six interviews right away and that was an amazing start, but then I didn’t get any more. The interviews I had went well, but it has been disappointing not to have more. Some were all-day interviews, while other programs had me meet with residents and attendings for 20 minutes each and it was all done after 2 hours.”

He has mixed opinions about not seeing the schools in person. “There are very heavy pros and cons. I’ve saved thousands of dollars in travel expenses that would have limited my applications, so logistically it’s a dream. On the other hand, I’ve interviewed in cities I have never been to, it’s hard to get a sense of the intangibles of a program, and the shorter interviews feel very impersonal.” 

Sacha expressed anxieties about the process. “With so many applicants, it’s difficult for someone with a nontraditional story to get a spot and it’s easier for the programs to toss applications. With all of my classmates, there is the palpable fear of not matching anywhere, it’s common enough and everyone has seen someone who has gone through this. At times, we feel powerless; we have no real agency or control. We send stuff out and then we sit in the prayer position and wait.”

I think back on my own application process with a sense of gratitude. I certainly didn’t feel powerless, and in today’s world, postinterview communications with program directors are regulated for both parties. Dr. Slavney was kind enough to humor my request, but I don’t believe this would be feasible in the current environment.

Even though it is wonderful that more doctors have figured out that careers in psychiatry are rewarding, the current situation is overwhelming for both the applicants and the programs. With over 100 applicants for every position – many of whom will have no interest in going to some of the programs they apply to – qualified candidates who go unmatched, and a roulette wheel which requires heavily indebted students to pay to apply, this is simply not sustainable in a country with a shortage of physicians – psychiatrists in particular. 

We hear that mid-level practitioners are the answer to our shortages, but perhaps we need to create a system with enough residency positions to accommodate highly trained and qualified physicians in a more inviting and targeted way.

Dinah Miller, MD, is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. A version of this article first appeared on Medscape.com.

The International Skin Imaging Collaboration (ISIC) Artificial Intelligence Working Group has released the first-ever guidelines for developing artificial intelligence (AI) algorithms used in dermatology.

Christopher Smith

The guidelines, published in JAMA Dermatology on Dec. 1, 2021, contain a broad range of recommendations stakeholders should consider when developing and assessing image-based AI algorithms in dermatology. The recommendations are divided into categories of data, technique, technical assessment, and application. ISIC is “an academia and industry partnership designed to facilitate the application of digital skin imaging to help reduce melanoma mortality,” and is organized into different working groups, including the AI working group, according to its website.

“Our goal with these guidelines was to create higher-quality reporting of dataset and algorithm characteristics for dermatology AI,” first author Roxana Daneshjou, MD, PhD, clinical scholar in dermatology, in the department of dermatology at Stanford (Calif.) University, said in an interview. “We hope these guidelines also aid regulatory bodies around the world when they are assessing algorithms to be used in dermatology.”
 

Recommendations for data

The authors recommended that datasets used by AI algorithms have image descriptions and details on image artifacts. “For photography, these include the type of camera used; whether images were taken under standardized or varying conditions; whether they were taken by professional photographers, laymen, or health care professionals; and image quality,” they wrote. They also recommended that developers include in an image description the type of lighting used and whether the photo contains pen markings, hair, tattoos, injuries, surgical effects, or other “physical perturbations.”

Exchangeable image file format data obtained from the camera, and preprocessing procedures like color normalization and “postprocessing” of images, such as filtering, should also be disclosed. In addition, developers should disclose and justify inclusion of images that have been created by an algorithm within a dataset. Any public images used in the datasets should have references, and privately used images should be made public where possible, the authors said.

The ISIC working group guidelines also provided recommendations for patient-level metadata. Each image should include a patient’s geographical location and medical center they visited as well as their age, sex and gender, ethnicity and/or race, and skin tone. Dr. Daneshjou said this was one area where she and her colleagues found a lack of transparency in AI datasets in algorithms in a recent review. “We found that many AI papers provided sparse details about the images used to train and test their algorithms,” Dr. Daneshjou explained. “For example, only 7 out of 70 papers had any information about the skin tones in the images used for developing and/or testing AI algorithms. Understanding the diversity of images used to train and test algorithms is important because algorithms that are developed on images of predominantly white skin likely won’t work as well on Black and brown skin.”

The guideline authors also asked algorithm developers to describe the limitations of not including patient-level metadata information when it is incomplete or unavailable. In addition, “we ask that algorithm developers comment on potential biases of their algorithms,” Dr. Daneshjou said. “For example, an algorithm based only on telemedicine images may not capture the full range of diseases seen within an in-person clinic.”

When describing their AI algorithm, developers should detail their reasoning for the dataset size and partitions, inclusion and exclusion criteria for images, and use of any external samples for test sets. “Authors should consider any differences between the image characteristics used for algorithm development and those that might be encountered in the real world,” the guidelines stated.

Recommendations for technique

How the images in a dataset are labeled is a unique challenge in developing AI algorithms for dermatology, the authors noted. Developers should use histopathological diagnosis in their labeling, but this can sometimes result in label noise.

“Many of the AI algorithms in dermatology use supervised learning, which requires labeled examples to help the algorithm ‘learn’ features for discriminating between lesions. We found that some papers use consensus labeling – dermatologists providing a label – to label skin cancers; however, the standard for diagnosing skin cancer is using histopathology from a biopsy,” she said. “Dermatologists can biopsy seven to eight suspected melanomas before discovering a true melanoma, so dermatologist labeling of skin cancers is prone to label noise.”

ISIC’s guidelines stated a gold standard of labeling for dermatologic images is one area that still needs future research, but currently, “diagnoses, labels and diagnostic groups used in data repositories as well as public ontologies” such as ICD-11, AnatomyMapper, and SNOMED-CT should be included in dermatologic image datasets.

AI developers should also provide a detailed description of their algorithm, which includes methods, work flows, mathematical formulas as well as the generalizability of the algorithm across more than one dataset.
 

Recommendations for technical assessment

“Another important recommendation is that algorithm developers should provide a way for algorithms to be publicly evaluable by researchers,” Dr. Daneshjou said. “Many dermatology AI algorithms do not share either their data or their algorithm. Algorithm sharing is important for assessing reproducibility and robustness.”

Google’s recently announced AI-powered dermatology assistant tool, for example, “has made claims about its accuracy and ability to diagnose skin disease at a dermatologist level, but there is no way for researchers to independently test these claims,” she said. Other options like Model Dermatology, developed by Seung Seog Han, MD, PhD, of the Dermatology Clinic in Seoul, South Korea, and colleagues, offer an application programming interface “that allows researchers to test the algorithm,” Dr. Daneshjou said. “This kind of openness is key for assessing algorithm robustness.”

Developers should also note in their algorithm explanations how performance markers and benchmarks would translate to proposed clinical application. “In this context,” the use case – the context in which the AI application is being used – “should be clearly described – who are the intended users and under what clinical scenario are they using the algorithm,” the authors wrote.
 

Recommendations for application

The guidelines note that use case for the model should also be described by the AI developers. “Our checklist includes delineating use cases for algorithms and describing what use cases may be within the scope of the algorithm versus which use cases are out of scope,” Dr. Daneshjou said. “For example, an algorithm developed to provide decision support to dermatologists, with a human in the loop, may not be accurate enough to release directly to consumers.”

As the goal of AI algorithms in dermatology is eventual implementation for clinicians and patients, the authors asked developers to consider shortcomings and potential harms of the algorithm during implementation. “Ethical considerations and impact on vulnerable populations should also be considered and discussed,” they wrote. An algorithm “suggesting aesthetic medical treatments may have negative effects given the biased nature of beauty standards,” and “an algorithm that diagnoses basal cell carcinomas but lacks any pigmented basal cell carcinomas, which are more often seen in skin of color, will not perform equitably across populations.”

Prior to implementing an AI algorithm, the ISIC working group recommended developers perform prospective clinical trials for validation. Checklists and guidelines like SPIRIT-AI and CONSORT-AI “provide guidance on how to design clinical trials to test AI algorithms,” Dr. Daneshjou said.

After implementation, “I believe we need additional research in how we monitor algorithms after they are deployed clinically, Dr. Daneshjou said. “Currently there are no [Food and Drug Administration]–approved AI algorithms in dermatology; however, there are several applications that have CE mark in Europe, and there are no mechanisms for postmarket surveillance there.
 

'Timely' recommendations

Commenting on the ISIC working group guidelines, Justin M. Ko, MD, MBA, director and chief of medical dermatology for Stanford Health Care, who was not involved with the work, said that the recommendations are timely and provide “a framework for a ‘common language’ around AI datasets specifically tailored to dermatology.” Dr. Ko, chair of the American Academy of Dermatology’s Ad Hoc Task Force on Augmented Intelligence, noted the work by Dr. Daneshjou and colleagues “is consistent with and builds further details” on the position statement released by the AAD AI task force in 2019.

“As machine-learning capabilities and commercial efforts continue to mature, it becomes increasingly important that we are able to ‘look under the hood,’ and evaluate all the critical factors that influence development of these capabilities,” he said in an interview. “A standard set of reporting guidelines not only allows for transparency in evaluating data and performance of models and algorithms, but also forces the consideration of issues of equity, fairness, mitigation of bias, and clinically meaningful outcomes.”

One concern is the impact of AI algorithms on societal or health systems, he noted, which is brought up in the guidelines. “The last thing we would want is the development of robust AI systems that exacerbate access challenges, or generate patient anxiety/worry, or drive low-value utilization, or adds to care team burden, or create a technological barrier to care, or increases inequity in dermatologic care,” he said.

In developing AI algorithms for dermatology, a “major practical issue” is how performance on paper will translate to real-world use, Dr. Ko explained, and the ISIC guidelines “provide a critical step in empowering clinicians, practices, and our field to shape the advent of the AI and augmented intelligence tools and systems to promote and enhance meaningful clinical outcomes, and augment the core patient-clinician relationship and ensure they are grounded in principles of fairness, equity and transparency.”

This research was funded by awards and grants to individual authors from the Charina Fund, a Google Research Award, Melanoma Research Alliance, National Health and Medical Research Council, National Institutes of Health/National Cancer Institute, National Science Foundation, and the Department of Veterans Affairs. The authors disclosed relationships with governmental entities, pharmaceutical companies, technology startups, medical publishers, charitable trusts, consulting firms, dermatology training companies, providers of medical devices, manufacturers of dermatologic products, and other organizations related to the paper in the form of supplied equipment, having founded a company; receiving grants, patents, or personal fees; holding shares; and medical reporting. Dr. Ko reported that he serves as a clinical advisor for Skin Analytics, and has an ongoing research collaboration with Google.

The International Skin Imaging Collaboration (ISIC) Artificial Intelligence Working Group has released the first-ever guidelines for developing artificial intelligence (AI) algorithms used in dermatology.

Christopher Smith

The guidelines, published in JAMA Dermatology on Dec. 1, 2021, contain a broad range of recommendations stakeholders should consider when developing and assessing image-based AI algorithms in dermatology. The recommendations are divided into categories of data, technique, technical assessment, and application. ISIC is “an academia and industry partnership designed to facilitate the application of digital skin imaging to help reduce melanoma mortality,” and is organized into different working groups, including the AI working group, according to its website.

“Our goal with these guidelines was to create higher-quality reporting of dataset and algorithm characteristics for dermatology AI,” first author Roxana Daneshjou, MD, PhD, clinical scholar in dermatology, in the department of dermatology at Stanford (Calif.) University, said in an interview. “We hope these guidelines also aid regulatory bodies around the world when they are assessing algorithms to be used in dermatology.”
 

Recommendations for data

The authors recommended that datasets used by AI algorithms have image descriptions and details on image artifacts. “For photography, these include the type of camera used; whether images were taken under standardized or varying conditions; whether they were taken by professional photographers, laymen, or health care professionals; and image quality,” they wrote. They also recommended that developers include in an image description the type of lighting used and whether the photo contains pen markings, hair, tattoos, injuries, surgical effects, or other “physical perturbations.”

Exchangeable image file format data obtained from the camera, and preprocessing procedures like color normalization and “postprocessing” of images, such as filtering, should also be disclosed. In addition, developers should disclose and justify inclusion of images that have been created by an algorithm within a dataset. Any public images used in the datasets should have references, and privately used images should be made public where possible, the authors said.

The ISIC working group guidelines also provided recommendations for patient-level metadata. Each image should include a patient’s geographical location and medical center they visited as well as their age, sex and gender, ethnicity and/or race, and skin tone. Dr. Daneshjou said this was one area where she and her colleagues found a lack of transparency in AI datasets in algorithms in a recent review. “We found that many AI papers provided sparse details about the images used to train and test their algorithms,” Dr. Daneshjou explained. “For example, only 7 out of 70 papers had any information about the skin tones in the images used for developing and/or testing AI algorithms. Understanding the diversity of images used to train and test algorithms is important because algorithms that are developed on images of predominantly white skin likely won’t work as well on Black and brown skin.”

The guideline authors also asked algorithm developers to describe the limitations of not including patient-level metadata information when it is incomplete or unavailable. In addition, “we ask that algorithm developers comment on potential biases of their algorithms,” Dr. Daneshjou said. “For example, an algorithm based only on telemedicine images may not capture the full range of diseases seen within an in-person clinic.”

When describing their AI algorithm, developers should detail their reasoning for the dataset size and partitions, inclusion and exclusion criteria for images, and use of any external samples for test sets. “Authors should consider any differences between the image characteristics used for algorithm development and those that might be encountered in the real world,” the guidelines stated.

Recommendations for technique

How the images in a dataset are labeled is a unique challenge in developing AI algorithms for dermatology, the authors noted. Developers should use histopathological diagnosis in their labeling, but this can sometimes result in label noise.

“Many of the AI algorithms in dermatology use supervised learning, which requires labeled examples to help the algorithm ‘learn’ features for discriminating between lesions. We found that some papers use consensus labeling – dermatologists providing a label – to label skin cancers; however, the standard for diagnosing skin cancer is using histopathology from a biopsy,” she said. “Dermatologists can biopsy seven to eight suspected melanomas before discovering a true melanoma, so dermatologist labeling of skin cancers is prone to label noise.”

ISIC’s guidelines stated a gold standard of labeling for dermatologic images is one area that still needs future research, but currently, “diagnoses, labels and diagnostic groups used in data repositories as well as public ontologies” such as ICD-11, AnatomyMapper, and SNOMED-CT should be included in dermatologic image datasets.

AI developers should also provide a detailed description of their algorithm, which includes methods, work flows, mathematical formulas as well as the generalizability of the algorithm across more than one dataset.
 

Recommendations for technical assessment

“Another important recommendation is that algorithm developers should provide a way for algorithms to be publicly evaluable by researchers,” Dr. Daneshjou said. “Many dermatology AI algorithms do not share either their data or their algorithm. Algorithm sharing is important for assessing reproducibility and robustness.”

Google’s recently announced AI-powered dermatology assistant tool, for example, “has made claims about its accuracy and ability to diagnose skin disease at a dermatologist level, but there is no way for researchers to independently test these claims,” she said. Other options like Model Dermatology, developed by Seung Seog Han, MD, PhD, of the Dermatology Clinic in Seoul, South Korea, and colleagues, offer an application programming interface “that allows researchers to test the algorithm,” Dr. Daneshjou said. “This kind of openness is key for assessing algorithm robustness.”

Developers should also note in their algorithm explanations how performance markers and benchmarks would translate to proposed clinical application. “In this context,” the use case – the context in which the AI application is being used – “should be clearly described – who are the intended users and under what clinical scenario are they using the algorithm,” the authors wrote.
 

Recommendations for application

The guidelines note that use case for the model should also be described by the AI developers. “Our checklist includes delineating use cases for algorithms and describing what use cases may be within the scope of the algorithm versus which use cases are out of scope,” Dr. Daneshjou said. “For example, an algorithm developed to provide decision support to dermatologists, with a human in the loop, may not be accurate enough to release directly to consumers.”

As the goal of AI algorithms in dermatology is eventual implementation for clinicians and patients, the authors asked developers to consider shortcomings and potential harms of the algorithm during implementation. “Ethical considerations and impact on vulnerable populations should also be considered and discussed,” they wrote. An algorithm “suggesting aesthetic medical treatments may have negative effects given the biased nature of beauty standards,” and “an algorithm that diagnoses basal cell carcinomas but lacks any pigmented basal cell carcinomas, which are more often seen in skin of color, will not perform equitably across populations.”

Prior to implementing an AI algorithm, the ISIC working group recommended developers perform prospective clinical trials for validation. Checklists and guidelines like SPIRIT-AI and CONSORT-AI “provide guidance on how to design clinical trials to test AI algorithms,” Dr. Daneshjou said.

After implementation, “I believe we need additional research in how we monitor algorithms after they are deployed clinically, Dr. Daneshjou said. “Currently there are no [Food and Drug Administration]–approved AI algorithms in dermatology; however, there are several applications that have CE mark in Europe, and there are no mechanisms for postmarket surveillance there.
 

'Timely' recommendations

Commenting on the ISIC working group guidelines, Justin M. Ko, MD, MBA, director and chief of medical dermatology for Stanford Health Care, who was not involved with the work, said that the recommendations are timely and provide “a framework for a ‘common language’ around AI datasets specifically tailored to dermatology.” Dr. Ko, chair of the American Academy of Dermatology’s Ad Hoc Task Force on Augmented Intelligence, noted the work by Dr. Daneshjou and colleagues “is consistent with and builds further details” on the position statement released by the AAD AI task force in 2019.

“As machine-learning capabilities and commercial efforts continue to mature, it becomes increasingly important that we are able to ‘look under the hood,’ and evaluate all the critical factors that influence development of these capabilities,” he said in an interview. “A standard set of reporting guidelines not only allows for transparency in evaluating data and performance of models and algorithms, but also forces the consideration of issues of equity, fairness, mitigation of bias, and clinically meaningful outcomes.”

One concern is the impact of AI algorithms on societal or health systems, he noted, which is brought up in the guidelines. “The last thing we would want is the development of robust AI systems that exacerbate access challenges, or generate patient anxiety/worry, or drive low-value utilization, or adds to care team burden, or create a technological barrier to care, or increases inequity in dermatologic care,” he said.

In developing AI algorithms for dermatology, a “major practical issue” is how performance on paper will translate to real-world use, Dr. Ko explained, and the ISIC guidelines “provide a critical step in empowering clinicians, practices, and our field to shape the advent of the AI and augmented intelligence tools and systems to promote and enhance meaningful clinical outcomes, and augment the core patient-clinician relationship and ensure they are grounded in principles of fairness, equity and transparency.”

This research was funded by awards and grants to individual authors from the Charina Fund, a Google Research Award, Melanoma Research Alliance, National Health and Medical Research Council, National Institutes of Health/National Cancer Institute, National Science Foundation, and the Department of Veterans Affairs. The authors disclosed relationships with governmental entities, pharmaceutical companies, technology startups, medical publishers, charitable trusts, consulting firms, dermatology training companies, providers of medical devices, manufacturers of dermatologic products, and other organizations related to the paper in the form of supplied equipment, having founded a company; receiving grants, patents, or personal fees; holding shares; and medical reporting. Dr. Ko reported that he serves as a clinical advisor for Skin Analytics, and has an ongoing research collaboration with Google.

The International Skin Imaging Collaboration (ISIC) Artificial Intelligence Working Group has released the first-ever guidelines for developing artificial intelligence (AI) algorithms used in dermatology.

Christopher Smith

The guidelines, published in JAMA Dermatology on Dec. 1, 2021, contain a broad range of recommendations stakeholders should consider when developing and assessing image-based AI algorithms in dermatology. The recommendations are divided into categories of data, technique, technical assessment, and application. ISIC is “an academia and industry partnership designed to facilitate the application of digital skin imaging to help reduce melanoma mortality,” and is organized into different working groups, including the AI working group, according to its website.

“Our goal with these guidelines was to create higher-quality reporting of dataset and algorithm characteristics for dermatology AI,” first author Roxana Daneshjou, MD, PhD, clinical scholar in dermatology, in the department of dermatology at Stanford (Calif.) University, said in an interview. “We hope these guidelines also aid regulatory bodies around the world when they are assessing algorithms to be used in dermatology.”
 

Recommendations for data

The authors recommended that datasets used by AI algorithms have image descriptions and details on image artifacts. “For photography, these include the type of camera used; whether images were taken under standardized or varying conditions; whether they were taken by professional photographers, laymen, or health care professionals; and image quality,” they wrote. They also recommended that developers include in an image description the type of lighting used and whether the photo contains pen markings, hair, tattoos, injuries, surgical effects, or other “physical perturbations.”

Exchangeable image file format data obtained from the camera, and preprocessing procedures like color normalization and “postprocessing” of images, such as filtering, should also be disclosed. In addition, developers should disclose and justify inclusion of images that have been created by an algorithm within a dataset. Any public images used in the datasets should have references, and privately used images should be made public where possible, the authors said.

The ISIC working group guidelines also provided recommendations for patient-level metadata. Each image should include a patient’s geographical location and medical center they visited as well as their age, sex and gender, ethnicity and/or race, and skin tone. Dr. Daneshjou said this was one area where she and her colleagues found a lack of transparency in AI datasets in algorithms in a recent review. “We found that many AI papers provided sparse details about the images used to train and test their algorithms,” Dr. Daneshjou explained. “For example, only 7 out of 70 papers had any information about the skin tones in the images used for developing and/or testing AI algorithms. Understanding the diversity of images used to train and test algorithms is important because algorithms that are developed on images of predominantly white skin likely won’t work as well on Black and brown skin.”

The guideline authors also asked algorithm developers to describe the limitations of not including patient-level metadata information when it is incomplete or unavailable. In addition, “we ask that algorithm developers comment on potential biases of their algorithms,” Dr. Daneshjou said. “For example, an algorithm based only on telemedicine images may not capture the full range of diseases seen within an in-person clinic.”

When describing their AI algorithm, developers should detail their reasoning for the dataset size and partitions, inclusion and exclusion criteria for images, and use of any external samples for test sets. “Authors should consider any differences between the image characteristics used for algorithm development and those that might be encountered in the real world,” the guidelines stated.

Recommendations for technique

How the images in a dataset are labeled is a unique challenge in developing AI algorithms for dermatology, the authors noted. Developers should use histopathological diagnosis in their labeling, but this can sometimes result in label noise.

“Many of the AI algorithms in dermatology use supervised learning, which requires labeled examples to help the algorithm ‘learn’ features for discriminating between lesions. We found that some papers use consensus labeling – dermatologists providing a label – to label skin cancers; however, the standard for diagnosing skin cancer is using histopathology from a biopsy,” she said. “Dermatologists can biopsy seven to eight suspected melanomas before discovering a true melanoma, so dermatologist labeling of skin cancers is prone to label noise.”

ISIC’s guidelines stated a gold standard of labeling for dermatologic images is one area that still needs future research, but currently, “diagnoses, labels and diagnostic groups used in data repositories as well as public ontologies” such as ICD-11, AnatomyMapper, and SNOMED-CT should be included in dermatologic image datasets.

AI developers should also provide a detailed description of their algorithm, which includes methods, work flows, mathematical formulas as well as the generalizability of the algorithm across more than one dataset.
 

Recommendations for technical assessment

“Another important recommendation is that algorithm developers should provide a way for algorithms to be publicly evaluable by researchers,” Dr. Daneshjou said. “Many dermatology AI algorithms do not share either their data or their algorithm. Algorithm sharing is important for assessing reproducibility and robustness.”

Google’s recently announced AI-powered dermatology assistant tool, for example, “has made claims about its accuracy and ability to diagnose skin disease at a dermatologist level, but there is no way for researchers to independently test these claims,” she said. Other options like Model Dermatology, developed by Seung Seog Han, MD, PhD, of the Dermatology Clinic in Seoul, South Korea, and colleagues, offer an application programming interface “that allows researchers to test the algorithm,” Dr. Daneshjou said. “This kind of openness is key for assessing algorithm robustness.”

Developers should also note in their algorithm explanations how performance markers and benchmarks would translate to proposed clinical application. “In this context,” the use case – the context in which the AI application is being used – “should be clearly described – who are the intended users and under what clinical scenario are they using the algorithm,” the authors wrote.
 

Recommendations for application

The guidelines note that use case for the model should also be described by the AI developers. “Our checklist includes delineating use cases for algorithms and describing what use cases may be within the scope of the algorithm versus which use cases are out of scope,” Dr. Daneshjou said. “For example, an algorithm developed to provide decision support to dermatologists, with a human in the loop, may not be accurate enough to release directly to consumers.”

As the goal of AI algorithms in dermatology is eventual implementation for clinicians and patients, the authors asked developers to consider shortcomings and potential harms of the algorithm during implementation. “Ethical considerations and impact on vulnerable populations should also be considered and discussed,” they wrote. An algorithm “suggesting aesthetic medical treatments may have negative effects given the biased nature of beauty standards,” and “an algorithm that diagnoses basal cell carcinomas but lacks any pigmented basal cell carcinomas, which are more often seen in skin of color, will not perform equitably across populations.”

Prior to implementing an AI algorithm, the ISIC working group recommended developers perform prospective clinical trials for validation. Checklists and guidelines like SPIRIT-AI and CONSORT-AI “provide guidance on how to design clinical trials to test AI algorithms,” Dr. Daneshjou said.

After implementation, “I believe we need additional research in how we monitor algorithms after they are deployed clinically, Dr. Daneshjou said. “Currently there are no [Food and Drug Administration]–approved AI algorithms in dermatology; however, there are several applications that have CE mark in Europe, and there are no mechanisms for postmarket surveillance there.
 

'Timely' recommendations

Commenting on the ISIC working group guidelines, Justin M. Ko, MD, MBA, director and chief of medical dermatology for Stanford Health Care, who was not involved with the work, said that the recommendations are timely and provide “a framework for a ‘common language’ around AI datasets specifically tailored to dermatology.” Dr. Ko, chair of the American Academy of Dermatology’s Ad Hoc Task Force on Augmented Intelligence, noted the work by Dr. Daneshjou and colleagues “is consistent with and builds further details” on the position statement released by the AAD AI task force in 2019.

“As machine-learning capabilities and commercial efforts continue to mature, it becomes increasingly important that we are able to ‘look under the hood,’ and evaluate all the critical factors that influence development of these capabilities,” he said in an interview. “A standard set of reporting guidelines not only allows for transparency in evaluating data and performance of models and algorithms, but also forces the consideration of issues of equity, fairness, mitigation of bias, and clinically meaningful outcomes.”

One concern is the impact of AI algorithms on societal or health systems, he noted, which is brought up in the guidelines. “The last thing we would want is the development of robust AI systems that exacerbate access challenges, or generate patient anxiety/worry, or drive low-value utilization, or adds to care team burden, or create a technological barrier to care, or increases inequity in dermatologic care,” he said.

In developing AI algorithms for dermatology, a “major practical issue” is how performance on paper will translate to real-world use, Dr. Ko explained, and the ISIC guidelines “provide a critical step in empowering clinicians, practices, and our field to shape the advent of the AI and augmented intelligence tools and systems to promote and enhance meaningful clinical outcomes, and augment the core patient-clinician relationship and ensure they are grounded in principles of fairness, equity and transparency.”

This research was funded by awards and grants to individual authors from the Charina Fund, a Google Research Award, Melanoma Research Alliance, National Health and Medical Research Council, National Institutes of Health/National Cancer Institute, National Science Foundation, and the Department of Veterans Affairs. The authors disclosed relationships with governmental entities, pharmaceutical companies, technology startups, medical publishers, charitable trusts, consulting firms, dermatology training companies, providers of medical devices, manufacturers of dermatologic products, and other organizations related to the paper in the form of supplied equipment, having founded a company; receiving grants, patents, or personal fees; holding shares; and medical reporting. Dr. Ko reported that he serves as a clinical advisor for Skin Analytics, and has an ongoing research collaboration with Google.

Phoenix has only a few months each year to use my hot tub, so winter is when I catch up on a lot of my reading. Recently I was reading the November Lancet, which had some interesting statistics about migraine.

• It’s the second leading cause (behind back pain) of years lived with disability.
• There are 10 million people with migraines in the United Kingdom (population roughly 70 million).
• In the last 5 years, migraine use of emergency rooms has increased 14%.
• According to the U.K. National Health Service, over 16,000 ER visits for migraine could be avoided.

These are compelling statistics, and probably (taking into account population differences) similar to numbers here in the United States or Canada.

Like all neurologists, I see my share of migraine.

Like many neurologists, I also get migraines. Not many, maybe 2-3 per month, effectively treated with a triptan. So I have a decent understanding that they aren’t pleasant.

Fortunately, migraine advances have been impressive, with seven new CGRP drugs in the last 3 years, bringing successful treatment closer for many.

But the problem is far from solved, a point that was driven home yesterday.

I awoke early yesterday morning with a migraine, and took an Imitrex. But instead of feeling better in an hour, it kept worsening until I was literally disabled by it. I took some Excedrin Migraine. The last time I had a migraine this bad was in 1998, during my fellowship, and my attending had to drive me home (thanks, Joe).

It was showing no signs of letting up. I thought about going to emergency department. After all, aren’t we trained for that when we hear “worst headache of my life?” but figured it was more likely just a migraine, and didn’t want to bog down my ED colleagues in the midst of another COVID-19 wave.

I took another Imitrex. I found a sample of Ubrelvy that I’d brought home out of curiosity, and took that, too. I think I have an old, nearly empty, bottle of Norco, somewhere, from a 2014 dental surgery, but was too photophobic to go looking for it (if I still have it at all).

I lay down in bed under the ceiling fan, and somehow fell asleep.

When I woke about 90 minutes later it was gone, like a switch had been flipped. Maybe it was all, or just one of, the meds I’d taken. I’ll never know. I could now resume my regularly scheduled program.

The migraine had cost me 7 hours. Like most small business owners, I’m trying to get all the year-end paperwork wrapped up, in addition to reviewing cases, writing up reports, and spending time with my family. So none of that happened that Saturday morning. If I’d had to see patients that morning there’s no way I could have done it.

Fortunately, as I said, that’s only the second time that’s happened to me, and it’s been 25 years since the last one.

But I’m lucky. There are those who have them far more frequently, limiting their ability to work, raise families, spend time with friends. … Have a life.

Migraine is far from a deadly disease. In neurology we treat far worse conditions. But in sheer numbers migraine affects far more people, and (indirectly) an even larger group of coworkers, parents, friends, and children who have to cover unpredictably when the other person is out with one.

For all of them, improved migraine treatment approaches can’t come soon enough.

Phoenix has only a few months each year to use my hot tub, so winter is when I catch up on a lot of my reading. Recently I was reading the November Lancet, which had some interesting statistics about migraine.

• It’s the second leading cause (behind back pain) of years lived with disability.
• There are 10 million people with migraines in the United Kingdom (population roughly 70 million).
• In the last 5 years, migraine use of emergency rooms has increased 14%.
• According to the U.K. National Health Service, over 16,000 ER visits for migraine could be avoided.

These are compelling statistics, and probably (taking into account population differences) similar to numbers here in the United States or Canada.

Like all neurologists, I see my share of migraine.

Like many neurologists, I also get migraines. Not many, maybe 2-3 per month, effectively treated with a triptan. So I have a decent understanding that they aren’t pleasant.

Fortunately, migraine advances have been impressive, with seven new CGRP drugs in the last 3 years, bringing successful treatment closer for many.

But the problem is far from solved, a point that was driven home yesterday.

I awoke early yesterday morning with a migraine, and took an Imitrex. But instead of feeling better in an hour, it kept worsening until I was literally disabled by it. I took some Excedrin Migraine. The last time I had a migraine this bad was in 1998, during my fellowship, and my attending had to drive me home (thanks, Joe).

It was showing no signs of letting up. I thought about going to emergency department. After all, aren’t we trained for that when we hear “worst headache of my life?” but figured it was more likely just a migraine, and didn’t want to bog down my ED colleagues in the midst of another COVID-19 wave.

I took another Imitrex. I found a sample of Ubrelvy that I’d brought home out of curiosity, and took that, too. I think I have an old, nearly empty, bottle of Norco, somewhere, from a 2014 dental surgery, but was too photophobic to go looking for it (if I still have it at all).

I lay down in bed under the ceiling fan, and somehow fell asleep.

When I woke about 90 minutes later it was gone, like a switch had been flipped. Maybe it was all, or just one of, the meds I’d taken. I’ll never know. I could now resume my regularly scheduled program.

The migraine had cost me 7 hours. Like most small business owners, I’m trying to get all the year-end paperwork wrapped up, in addition to reviewing cases, writing up reports, and spending time with my family. So none of that happened that Saturday morning. If I’d had to see patients that morning there’s no way I could have done it.

Fortunately, as I said, that’s only the second time that’s happened to me, and it’s been 25 years since the last one.

But I’m lucky. There are those who have them far more frequently, limiting their ability to work, raise families, spend time with friends. … Have a life.

Migraine is far from a deadly disease. In neurology we treat far worse conditions. But in sheer numbers migraine affects far more people, and (indirectly) an even larger group of coworkers, parents, friends, and children who have to cover unpredictably when the other person is out with one.

For all of them, improved migraine treatment approaches can’t come soon enough.

Phoenix has only a few months each year to use my hot tub, so winter is when I catch up on a lot of my reading. Recently I was reading the November Lancet, which had some interesting statistics about migraine.

• It’s the second leading cause (behind back pain) of years lived with disability.
• There are 10 million people with migraines in the United Kingdom (population roughly 70 million).
• In the last 5 years, migraine use of emergency rooms has increased 14%.
• According to the U.K. National Health Service, over 16,000 ER visits for migraine could be avoided.

These are compelling statistics, and probably (taking into account population differences) similar to numbers here in the United States or Canada.

Like all neurologists, I see my share of migraine.

Like many neurologists, I also get migraines. Not many, maybe 2-3 per month, effectively treated with a triptan. So I have a decent understanding that they aren’t pleasant.

Fortunately, migraine advances have been impressive, with seven new CGRP drugs in the last 3 years, bringing successful treatment closer for many.

But the problem is far from solved, a point that was driven home yesterday.

I awoke early yesterday morning with a migraine, and took an Imitrex. But instead of feeling better in an hour, it kept worsening until I was literally disabled by it. I took some Excedrin Migraine. The last time I had a migraine this bad was in 1998, during my fellowship, and my attending had to drive me home (thanks, Joe).

It was showing no signs of letting up. I thought about going to emergency department. After all, aren’t we trained for that when we hear “worst headache of my life?” but figured it was more likely just a migraine, and didn’t want to bog down my ED colleagues in the midst of another COVID-19 wave.

I took another Imitrex. I found a sample of Ubrelvy that I’d brought home out of curiosity, and took that, too. I think I have an old, nearly empty, bottle of Norco, somewhere, from a 2014 dental surgery, but was too photophobic to go looking for it (if I still have it at all).

I lay down in bed under the ceiling fan, and somehow fell asleep.

When I woke about 90 minutes later it was gone, like a switch had been flipped. Maybe it was all, or just one of, the meds I’d taken. I’ll never know. I could now resume my regularly scheduled program.

The migraine had cost me 7 hours. Like most small business owners, I’m trying to get all the year-end paperwork wrapped up, in addition to reviewing cases, writing up reports, and spending time with my family. So none of that happened that Saturday morning. If I’d had to see patients that morning there’s no way I could have done it.

Fortunately, as I said, that’s only the second time that’s happened to me, and it’s been 25 years since the last one.

But I’m lucky. There are those who have them far more frequently, limiting their ability to work, raise families, spend time with friends. … Have a life.

Migraine is far from a deadly disease. In neurology we treat far worse conditions. But in sheer numbers migraine affects far more people, and (indirectly) an even larger group of coworkers, parents, friends, and children who have to cover unpredictably when the other person is out with one.

For all of them, improved migraine treatment approaches can’t come soon enough.

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

Psychiatrist sentenced to 3 years in prison for running pill mill

A former Florida psychiatrist was sentenced to 3 years in prison for illegally prescribing controlled substances and must forfeit more than $400,000 in cash and nine luxury vehicles, including a 2020 Porsche GT4 and a 2020 Aston Martin.

According to the U.S. Department of Justice, the U.S. Drug Enforcement Administration began investigating Gerald Michael Abraham, 76, after receiving a tip that he was prescribing opioids to patients who did not need the medication. The investigation, which began in October 2019, included 18 visits by undercover patients to Abraham’s cash-only clinic in Naples, Fla. Patients paid $400 per visit, according to court documents.

Even though the undercover patients pretended to have signs of drug abuse, Dr. Abraham still prescribed oxycodone, a strong opioid, on each visit without any physical examination, according to officials. He repeatedly increased the strength of the prescriptions when the patients asked. In one case, he told a patient that the patient’s medical paperwork “shows you are completely normal,” then went ahead to prescribe the oxycodone.

Dr. Abraham also gave Adderall to patients who had no legitimate medical need for the drug. As with the opioid, Dr. Abraham prescribed the frequently abused amphetamine (typically used to treat attention-deficit/hyperactivity disorder) after being asked for it, without performing an examination or asking questions to justify the prescription, according to the undercover law enforcement agents.

According to the Florida Department of Health, Dr. Abraham voluntarily relinquished his license in September pending board action. His license was set to expire in January 2022.

Pennsylvania physician admits to distributing drugs resulting in patient’s death

A Pennsylvania internist pleaded guilty to unlawful prescription of controlled substances, maintaining drug-involved premises, and healthcare fraud, as well as that the death of a patient resulted from the use of the controlled drugs.

When entering his plea, Dr.Kurt Moran, 69, acknowledged that the purpose of his Scranton-based pain management practice was to distribute high doses of opioids not for medical purposes, and that he often prescribed these drugs without examining the patient to verify the illness or condition the patient claimed to have. At times, he even prescribed the drugs without seeing the patient. He admitted that he knew that such practices could result in addiction and even death, according to federal officials.

The healthcare fraud charges resulted from a scheme that took place between 2014 and 2017 in which Dr. Moran received bribes in exchange for prescribing the drug Subsys (sublingual fentanyl), which is approved for use only in cancer patients who suffer from breakthrough pain. Court documents allege that Dr. Moran was paid approximately $140,000 over a 2-year period to prescribe Subsys to patients for whom the drug was not indicated.

In order to conceal the kickbacks and bribes, the company that paid Dr. Moran is alleged to have described the payments as honoraria for educational presentations about the drug. During that period, Dr. Moran prescribed millions of micrograms of the sublingual spray to patients with no cancer diagnosis.

Subsys is manufactured by Insys, a company whose founder and CEO, John Kapoor, was sentenced in 2019 to 5½ years in prison for his role in the bribery scheme involving Dr. Moran and other physicians.

Dr. Moran faces 12 years in prison. The maximum penalty for the crimes is 10 years for each charge. As a part of his plea deal, Dr. Moran agreed to forfeit $134,000. His license to practice medicine was suspended in October 2020 according to the Pennsylvania Bureau of Professional and Occupational Affairs.

Former pharmaceutical executive charged with embezzlement

The former owner and CEO of a New Jersey pharmaceutical company is accused of embezzling millions of dollars from his company by federal officials.

According to the charging documents, John Klein, 75, of Palisades Park, N.J., hired a chief financial officer in 2016 who then created a profit-and-loss statement showing the company’s sales and receivables. According to the CFO, Mr. Klein provided information that included an account receivable of approximately $3.9 million that had not been collected.

In December 2016 and January 2017, Mr. Klein approved a reserve against the uncollected receivable in the financial statements. However, back in May 2016, $3.9 million was transferred into a company bank account that Mr. Klein controlled. In a June 2016 email, Mr. Klein acknowledged that the invoices in question had been paid in full. A review of the company bank account showed that Mr. Klein used the money to pay personal debts, such as credit card payments, property taxes, and private-school tuition for his child.

Mr. Klein is the subject of several federal lawsuits from people who worked at Cambridge Therapeutic Technologies in Teaneck, N.J., as well as individuals he collected investment money from, according to media reports.

If convicted, Mr. Klein faces up to 20 years in prison and a fine of $250,000 or twice the gross profits or twice the gross loss suffered by the victims of the fraud, whichever is greatest.

Practice administrator sentenced for defrauding medical practice

An Indiana man was sentenced to 30 months in federal prison for stealing from the ophthalmology practice where he worked for 5 years as a practice administrator.

Joshua D. Millspaugh, 42, of Westfield, Ind., pled guilty to charges of wire fraud, according to federal officials.

Mr. Millspaugh, who earned an annual salary of over $100,000, was responsible for payroll processing, purchasing, and paying the practice’s bills. After less than a year on the job, he began taking advantage of his access to company money to use the practice’s funds for himself. During his 5 years of employment, he made over 500 such transactions, making purchases, paying personal bills, and sending payroll checks to his personal bank account. He concealed these transactions with false entries in the company’s bookkeeping system. When asked about expenditures, he made up false justifications.

During Mr. Millspaugh’s sentencing, William Whitson, MD, owner and director of the practice, Whitson Vision, told the court that the loss to him and the practice was about more than money. In addition to creating long-term credit and banking problems, the situation damaged both the company’s business reputation and the morale of its other employees.

“Fraud on a small business impacts every area of that business,” said U.S. Attorney for the Southern District of Indiana Zachary A. Myers. “It also breeds mistrust, especially if the fraud is perpetrated by a trusted employee. Mr. Millspaugh exploited his position of trust for purely personal gain, and he is now being held accountable for his actions.”

In addition to the prison sentence, Mr. Millspaugh was ordered to pay $270,000 in restitution and will be federally supervised for 3 years following his release from prison.

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

Psychiatrist sentenced to 3 years in prison for running pill mill

A former Florida psychiatrist was sentenced to 3 years in prison for illegally prescribing controlled substances and must forfeit more than $400,000 in cash and nine luxury vehicles, including a 2020 Porsche GT4 and a 2020 Aston Martin.

According to the U.S. Department of Justice, the U.S. Drug Enforcement Administration began investigating Gerald Michael Abraham, 76, after receiving a tip that he was prescribing opioids to patients who did not need the medication. The investigation, which began in October 2019, included 18 visits by undercover patients to Abraham’s cash-only clinic in Naples, Fla. Patients paid $400 per visit, according to court documents.

Even though the undercover patients pretended to have signs of drug abuse, Dr. Abraham still prescribed oxycodone, a strong opioid, on each visit without any physical examination, according to officials. He repeatedly increased the strength of the prescriptions when the patients asked. In one case, he told a patient that the patient’s medical paperwork “shows you are completely normal,” then went ahead to prescribe the oxycodone.

Dr. Abraham also gave Adderall to patients who had no legitimate medical need for the drug. As with the opioid, Dr. Abraham prescribed the frequently abused amphetamine (typically used to treat attention-deficit/hyperactivity disorder) after being asked for it, without performing an examination or asking questions to justify the prescription, according to the undercover law enforcement agents.

According to the Florida Department of Health, Dr. Abraham voluntarily relinquished his license in September pending board action. His license was set to expire in January 2022.

Pennsylvania physician admits to distributing drugs resulting in patient’s death

A Pennsylvania internist pleaded guilty to unlawful prescription of controlled substances, maintaining drug-involved premises, and healthcare fraud, as well as that the death of a patient resulted from the use of the controlled drugs.

When entering his plea, Dr.Kurt Moran, 69, acknowledged that the purpose of his Scranton-based pain management practice was to distribute high doses of opioids not for medical purposes, and that he often prescribed these drugs without examining the patient to verify the illness or condition the patient claimed to have. At times, he even prescribed the drugs without seeing the patient. He admitted that he knew that such practices could result in addiction and even death, according to federal officials.

The healthcare fraud charges resulted from a scheme that took place between 2014 and 2017 in which Dr. Moran received bribes in exchange for prescribing the drug Subsys (sublingual fentanyl), which is approved for use only in cancer patients who suffer from breakthrough pain. Court documents allege that Dr. Moran was paid approximately $140,000 over a 2-year period to prescribe Subsys to patients for whom the drug was not indicated.

In order to conceal the kickbacks and bribes, the company that paid Dr. Moran is alleged to have described the payments as honoraria for educational presentations about the drug. During that period, Dr. Moran prescribed millions of micrograms of the sublingual spray to patients with no cancer diagnosis.

Subsys is manufactured by Insys, a company whose founder and CEO, John Kapoor, was sentenced in 2019 to 5½ years in prison for his role in the bribery scheme involving Dr. Moran and other physicians.

Dr. Moran faces 12 years in prison. The maximum penalty for the crimes is 10 years for each charge. As a part of his plea deal, Dr. Moran agreed to forfeit $134,000. His license to practice medicine was suspended in October 2020 according to the Pennsylvania Bureau of Professional and Occupational Affairs.

Former pharmaceutical executive charged with embezzlement

The former owner and CEO of a New Jersey pharmaceutical company is accused of embezzling millions of dollars from his company by federal officials.

According to the charging documents, John Klein, 75, of Palisades Park, N.J., hired a chief financial officer in 2016 who then created a profit-and-loss statement showing the company’s sales and receivables. According to the CFO, Mr. Klein provided information that included an account receivable of approximately $3.9 million that had not been collected.

In December 2016 and January 2017, Mr. Klein approved a reserve against the uncollected receivable in the financial statements. However, back in May 2016, $3.9 million was transferred into a company bank account that Mr. Klein controlled. In a June 2016 email, Mr. Klein acknowledged that the invoices in question had been paid in full. A review of the company bank account showed that Mr. Klein used the money to pay personal debts, such as credit card payments, property taxes, and private-school tuition for his child.

Mr. Klein is the subject of several federal lawsuits from people who worked at Cambridge Therapeutic Technologies in Teaneck, N.J., as well as individuals he collected investment money from, according to media reports.

If convicted, Mr. Klein faces up to 20 years in prison and a fine of $250,000 or twice the gross profits or twice the gross loss suffered by the victims of the fraud, whichever is greatest.

Practice administrator sentenced for defrauding medical practice

An Indiana man was sentenced to 30 months in federal prison for stealing from the ophthalmology practice where he worked for 5 years as a practice administrator.

Joshua D. Millspaugh, 42, of Westfield, Ind., pled guilty to charges of wire fraud, according to federal officials.

Mr. Millspaugh, who earned an annual salary of over $100,000, was responsible for payroll processing, purchasing, and paying the practice’s bills. After less than a year on the job, he began taking advantage of his access to company money to use the practice’s funds for himself. During his 5 years of employment, he made over 500 such transactions, making purchases, paying personal bills, and sending payroll checks to his personal bank account. He concealed these transactions with false entries in the company’s bookkeeping system. When asked about expenditures, he made up false justifications.

During Mr. Millspaugh’s sentencing, William Whitson, MD, owner and director of the practice, Whitson Vision, told the court that the loss to him and the practice was about more than money. In addition to creating long-term credit and banking problems, the situation damaged both the company’s business reputation and the morale of its other employees.

“Fraud on a small business impacts every area of that business,” said U.S. Attorney for the Southern District of Indiana Zachary A. Myers. “It also breeds mistrust, especially if the fraud is perpetrated by a trusted employee. Mr. Millspaugh exploited his position of trust for purely personal gain, and he is now being held accountable for his actions.”

In addition to the prison sentence, Mr. Millspaugh was ordered to pay $270,000 in restitution and will be federally supervised for 3 years following his release from prison.

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

Psychiatrist sentenced to 3 years in prison for running pill mill

A former Florida psychiatrist was sentenced to 3 years in prison for illegally prescribing controlled substances and must forfeit more than $400,000 in cash and nine luxury vehicles, including a 2020 Porsche GT4 and a 2020 Aston Martin.

According to the U.S. Department of Justice, the U.S. Drug Enforcement Administration began investigating Gerald Michael Abraham, 76, after receiving a tip that he was prescribing opioids to patients who did not need the medication. The investigation, which began in October 2019, included 18 visits by undercover patients to Abraham’s cash-only clinic in Naples, Fla. Patients paid $400 per visit, according to court documents.

Even though the undercover patients pretended to have signs of drug abuse, Dr. Abraham still prescribed oxycodone, a strong opioid, on each visit without any physical examination, according to officials. He repeatedly increased the strength of the prescriptions when the patients asked. In one case, he told a patient that the patient’s medical paperwork “shows you are completely normal,” then went ahead to prescribe the oxycodone.

Dr. Abraham also gave Adderall to patients who had no legitimate medical need for the drug. As with the opioid, Dr. Abraham prescribed the frequently abused amphetamine (typically used to treat attention-deficit/hyperactivity disorder) after being asked for it, without performing an examination or asking questions to justify the prescription, according to the undercover law enforcement agents.

According to the Florida Department of Health, Dr. Abraham voluntarily relinquished his license in September pending board action. His license was set to expire in January 2022.

Pennsylvania physician admits to distributing drugs resulting in patient’s death

A Pennsylvania internist pleaded guilty to unlawful prescription of controlled substances, maintaining drug-involved premises, and healthcare fraud, as well as that the death of a patient resulted from the use of the controlled drugs.

When entering his plea, Dr.Kurt Moran, 69, acknowledged that the purpose of his Scranton-based pain management practice was to distribute high doses of opioids not for medical purposes, and that he often prescribed these drugs without examining the patient to verify the illness or condition the patient claimed to have. At times, he even prescribed the drugs without seeing the patient. He admitted that he knew that such practices could result in addiction and even death, according to federal officials.

The healthcare fraud charges resulted from a scheme that took place between 2014 and 2017 in which Dr. Moran received bribes in exchange for prescribing the drug Subsys (sublingual fentanyl), which is approved for use only in cancer patients who suffer from breakthrough pain. Court documents allege that Dr. Moran was paid approximately $140,000 over a 2-year period to prescribe Subsys to patients for whom the drug was not indicated.

In order to conceal the kickbacks and bribes, the company that paid Dr. Moran is alleged to have described the payments as honoraria for educational presentations about the drug. During that period, Dr. Moran prescribed millions of micrograms of the sublingual spray to patients with no cancer diagnosis.

Subsys is manufactured by Insys, a company whose founder and CEO, John Kapoor, was sentenced in 2019 to 5½ years in prison for his role in the bribery scheme involving Dr. Moran and other physicians.

Dr. Moran faces 12 years in prison. The maximum penalty for the crimes is 10 years for each charge. As a part of his plea deal, Dr. Moran agreed to forfeit $134,000. His license to practice medicine was suspended in October 2020 according to the Pennsylvania Bureau of Professional and Occupational Affairs.

Former pharmaceutical executive charged with embezzlement

The former owner and CEO of a New Jersey pharmaceutical company is accused of embezzling millions of dollars from his company by federal officials.

According to the charging documents, John Klein, 75, of Palisades Park, N.J., hired a chief financial officer in 2016 who then created a profit-and-loss statement showing the company’s sales and receivables. According to the CFO, Mr. Klein provided information that included an account receivable of approximately $3.9 million that had not been collected.

In December 2016 and January 2017, Mr. Klein approved a reserve against the uncollected receivable in the financial statements. However, back in May 2016, $3.9 million was transferred into a company bank account that Mr. Klein controlled. In a June 2016 email, Mr. Klein acknowledged that the invoices in question had been paid in full. A review of the company bank account showed that Mr. Klein used the money to pay personal debts, such as credit card payments, property taxes, and private-school tuition for his child.

Mr. Klein is the subject of several federal lawsuits from people who worked at Cambridge Therapeutic Technologies in Teaneck, N.J., as well as individuals he collected investment money from, according to media reports.

If convicted, Mr. Klein faces up to 20 years in prison and a fine of $250,000 or twice the gross profits or twice the gross loss suffered by the victims of the fraud, whichever is greatest.

Practice administrator sentenced for defrauding medical practice

An Indiana man was sentenced to 30 months in federal prison for stealing from the ophthalmology practice where he worked for 5 years as a practice administrator.

Joshua D. Millspaugh, 42, of Westfield, Ind., pled guilty to charges of wire fraud, according to federal officials.

Mr. Millspaugh, who earned an annual salary of over $100,000, was responsible for payroll processing, purchasing, and paying the practice’s bills. After less than a year on the job, he began taking advantage of his access to company money to use the practice’s funds for himself. During his 5 years of employment, he made over 500 such transactions, making purchases, paying personal bills, and sending payroll checks to his personal bank account. He concealed these transactions with false entries in the company’s bookkeeping system. When asked about expenditures, he made up false justifications.

During Mr. Millspaugh’s sentencing, William Whitson, MD, owner and director of the practice, Whitson Vision, told the court that the loss to him and the practice was about more than money. In addition to creating long-term credit and banking problems, the situation damaged both the company’s business reputation and the morale of its other employees.

“Fraud on a small business impacts every area of that business,” said U.S. Attorney for the Southern District of Indiana Zachary A. Myers. “It also breeds mistrust, especially if the fraud is perpetrated by a trusted employee. Mr. Millspaugh exploited his position of trust for purely personal gain, and he is now being held accountable for his actions.”

In addition to the prison sentence, Mr. Millspaugh was ordered to pay $270,000 in restitution and will be federally supervised for 3 years following his release from prison.

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

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.

Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.

iStock/ThinkStock

On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.

Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.

“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.

House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.

It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.

That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.

Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.

“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”

The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.

“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
 

Better deals for military, medicaid programs

Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.

Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing. 

For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.

In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.

The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.

The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.

The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.

But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
 

Insulin still of interest, 100 years after its discovery

The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.

Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.

Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.

Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.

Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.

Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.

“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.

Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern. 

GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).

Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.

In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”

“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.

$35 a month for insulin?

Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.

“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.

“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”

Indianapolis-based Lilly offered a similar response in a statement to this news organization.

“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”

Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”

In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35. 

The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.

“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.

People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.

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

Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.

iStock/ThinkStock

On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.

Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.

“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.

House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.

It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.

That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.

Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.

“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”

The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.

“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
 

Better deals for military, medicaid programs

Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.

Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing. 

For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.

In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.

The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.

The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.

The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.

But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
 

Insulin still of interest, 100 years after its discovery

The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.

Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.

Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.

Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.

Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.

Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.

“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.

Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern. 

GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).

Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.

In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”

“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.

$35 a month for insulin?

Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.

“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.

“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”

Indianapolis-based Lilly offered a similar response in a statement to this news organization.

“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”

Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”

In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35. 

The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.

“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.

People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.

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

Medicare could have saved more than $16.7 billion on three kinds of insulin products from 2011 to 2017 if it had secured the same discounts other federal health programs get through negotiations, House Democrats argue in a new report.

iStock/ThinkStock

On Dec. 10, Democrats on the House Committee on Oversight and Reform released a final majority staff report, which they say is the culmination of an almost 3-year investigation into pharmaceutical pricing and business practices. The report draws from 1.5 million pages of internal company documents, the committee says.

Documents from insulin makers Eli Lilly, Novo Nordisk, and Sanofi indicate these firms “raised their prices in lockstep in order to maintain ‘pricing parity’,” with senior executives encouraging the practice, the committee staff writes in the report.

“In a discussion among Novo Nordisk employees about an Eli Lilly price increase for a different diabetes product on Dec. 24, 2015, a Novo Nordisk pricing analyst remarked, ‘[M]aybe Sanofi will wait until tomorrow morning to announce their price increase ... that’s all I want for Christmas,’” the report states.

House Democrats are seeking to use the report findings to aid their Senate colleagues’ attempt to pass the sweeping Build Back Better bill, which includes many provisions addressing drug costs.

It’s still unclear when the Senate will act on the measure. The House passed the Build Back Better bill, 220-213, in November. It includes a provision that would allow Medicare to negotiate the prices of certain drugs covered by Part D pharmacy plans.

That would mark a reversal of the stance taken when Congress created the pharmacy benefit in a 2003 law, which left negotiations to insurers that cover Part D plans.

Republicans have long argued insurers get the best deals on drugs for people on Medicare. Democrats say this approach sacrifices much of Medicare’s bargaining clout, scattering it among plans.

“This fight has been going on since the Medicare Part D legislation which gave away the store” to drugmakers, said Speaker Nancy Pelosi (D-CA) at a Dec. 10 press conference about the House Oversight report. “And they got used to having the store to themselves.”

The Endocrine Society is urging the Senate to protect the insulin affordability provisions included in the Build Back Better Act and move quickly to pass this crucial legislation.

“We implore all Senators to ensure these provisions are not scaled back. The Build Back Better Act represents the best opportunity to address the price of insulin. Millions of Americans cannot wait any longer for a solution,” it said in a statement issued Dec. 14.
 

Better deals for military, medicaid programs

Medicare is unusual among federal programs in that it doesn’t directly leverage its clout to lower drug costs.

Total Part D expenditures were approximately $105 billion last year, according to Medicare’s board of trustees. This spending is divided among the many insurers that run Part D plans, which then make a myriad of decisions about formularies and other factors that affect pricing. 

For drugs administered by clinicians, and thus covered by Medicare Part B, the program pays a premium of the reported average sales price. Part B drug spending was $39 billion in 2019, an increase of about 11.6% from the previous year, according to the Medicare Payment Advisory Commission.

In contrast, federal law calls for steep reductions in drug prices for people on Medicaid.

The Department of Veterans Affairs (VA) and the Defense Department (DoD)’s Tricare program use several bargaining strategies to lower prices. To control costs, VA and DoD often use formularies of preferred drugs, steer patients to lower-cost drugs, and buy drugs in large volumes, “all of which increase their leverage with drug manufacturers,” the staff of the Congressional Budget Office (CBO) wrote in a Feb. 2021 report.

The CBO report examines how those different federal agencies’ approaches played out in terms of prices, net of applicable rebates, and discounts of 176 top-selling brand-name drugs in Medicare Part D.

The average price for this group of drugs was $118 in Medicaid. And for VA and DoD, the average prices were $190 and $184, respectively, for drugs dispensed at the agencies’ medical facilities or by mail.

But for Medicare Part D, the average price was $343, CBO said in the report, which was one of the sources consulted by House Oversight staff when developing their report released on Dec. 10.
 

Insulin still of interest, 100 years after its discovery

The House Oversight report runs to almost 270 pages. It addresses several issues with drug prices, including strategies pharmaceutical companies have used to thwart generic competition. On Monday, the trade group America’s Health Insurance Plans separately released its own report looking at patents and delays to the introduction of generic drugs.

Yet, much of the debate on drug prices has focused on one of the oldest widely produced prescription drugs, insulin.

Even with the allowance of generic competition for the essential medicine, branded versions of insulin have been some of the costliest products for Medicare in recent years. Eli Lilly, Novo Nordisk, and Sanofi dominate the insulin market.

Medicare Part D spent about $2.5 billion in 2019 on Sanofi’s Lantus Solostar insulin, or about $2,585 per person in the program using it. The program also paid about $1.1 billion for another form of Lantus, or about $2,746 per patient.

Medicare Part D also spent about $1.84 billion in 2019 on Novo Nordisk’s NovoLog FlexPen, or about $3,063 per person.

Medicare Part D’s drug spending dashboard also lists eight versions of Lilly’s Humalog, with combined 2019 spending of more than $2 billion. The cost per patient in Medicare Part D ranges from $5,619 to $1,462.

“Over the past 20 years, they have repeatedly and dramatically raised the list prices of their rapid-acting and long-acting insulins and reaped billions of dollars in revenues,” write the House Oversight staff in their report.

Republicans on the House Oversight and Reform Committee disagree with their Democratic colleagues on many points in the debate on drug prices, but they also looked at insulin as a cause for concern. 

GOP members of the committee released a separate report on Dec. 10. They call for greater clarity into the role middlemen in the drug-supply chain – known as pharmaceutical benefit managers – may play in the rising costs of medicines. The GOP report notes that there are bills pending in the House that would seek to steer any discounts offered on insulin within the supply chain toward consumers (Insulin Price Reduction Act H.R. 4906, Insulin Cost Reduction Act H.R. 5623).

Democratic staff in the committee’s report seek to draw attention to how manufacturers priced their insulin products, including the comment by the Novo Nordisk employee about wishing for a price hike for a competitor’s product.

In a statement provided to this news organization, Novo Nordisk said the committee’s report reflects “a limited picture of the efforts put forth by our company and other companies to manage formulary access.”

“This glimpse into the complexity of pricing, formularies, and the health care system demonstrates why Novo Nordisk continues to advocate for comprehensive solutions,” Denmark’s Novo Nordisk said in the statement.

$35 a month for insulin?

Paris-based Sanofi said it makes insulin-pricing decisions independently from competitors. Sanofi said the net price of its insulins has declined by 53% since 2012, arguing the high prices charged to patients reflect decisions made elsewhere in the supply chain.

“Over the same period, the net price for commercial and Medicare Part D plans of Lantus has fallen 44.9%, while average out-of-pocket costs for patients with commercial insurance and Medicare Part D has risen approximately 82%,” Sanofi said.

“For all the focus on the growth of list prices, today, the average net price of Lantus is below 2006 levels. That is why we support policy reforms to require health plans to share negotiated savings with patients by requiring patient cost-sharing be tied to the net prices.”

Indianapolis-based Lilly offered a similar response in a statement to this news organization.

“Lilly, like other companies, monitors competitor list-price changes that are available through publicly available services,” the company said. “However, any changes we make to our list prices are independent decisions, and to the extent they consider competitors they are informed only through publicly available data.”

Despite rising insurance deductibles, the average monthly out-of-pocket cost for Lilly insulin has dropped 27% to $28.05 over the past 4 years, the company said in an interview. Lilly also noted that there are “several affordability options now available” allowing people to purchase their monthly prescription of its insulin for $35, “whether they are uninsured or use commercial insurance, Medicaid, or a participating Medicare Part D plan.”

In 2020, Lilly had announced that people with commercial insurance and those without insurance would be able to get monthly prescriptions of Lilly insulin for $35. 

The Build Back Better Act would require insurers, including Medicare Part D plans and private group or individual health plans, to charge patient cost-sharing of no more than $35 per month for insulin products, said the staff of the nonprofit Kaiser Family Foundation (KFF) in a review of the bill.

“Private group or individual plans would not be required to cover all insulin products, just one of each dosage form (vial, pen) and insulin type (rapid-acting, short-acting, intermediate-acting, and long-acting), for no more than $35,” the KFF staff state in the report.

People enrolled in Medicare can already choose to enroll in a Part D plan participating in a federal test program that can secure certain insulin products for them at a monthly copayment of $35. In 2022, a total of 2,159 Part D plans will participate in this model, a 32% increase in participating plans since 2021, KFF said.

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

The Iowa Court of Appeals has ordered a new trial in a case involving a man who received the wrong urologic surgery, according to a story reported in the Des Moines Register, among other news sites.

In 2015, an immigrant from Myanmar named Zaw Zaw was referred by his primary care physician (PCP) to The Iowa Clinic, in West Des Moines, for a circumcision.

Because Mr. Zaw didn’t speak English, a language translation company provided him with an interpreter for the procedure, as well as for any necessary follow-up appointments. The procedure would be performed by urologist Kevin Birusingh, MD, who at the time was employed by the clinic. Prior to the surgery, however, a miscommunication occurred, leading the urologist to perform a vasectomy instead of a circumcision on his patient. It was not until a later follow-up visit that the error was discovered, along with Mr. Zaw’s realization that he was now medically sterile and unable to father more children.

Mr. Zaw sued both Dr. Birusingh and the clinic, which in turn sued the translation company. Against Dr. Birusingh, Mr. Zaw made two claims: one, that the doctor hadn’t obtained the proper informed consent, and two, that he had engaged in “negligent” communications with several key individuals, including other clinic staff members and Dr. Zaw’s PCP.

In 2019, a trial jury found the clinic liable, awarding Mr. Zaw more than $1.4 million in damages. The same jury found no liability on the part of the translation company, however.

Following the verdict, the clinic appealed to the Iowa Court of Appeals. Late last month, the appeals court sent the case back to the lower court for a new trial.

In its ruling, written by Judge Sharon Soorholtz Greer, the appeals court said it could find no evidence that, in failing to communicate personally with his colleagues or Mr. Zaw’s PCP, Dr. Birusingh had violated an established standard of care. For this reason, Judge Greer said, the claim of negligent communication should have been dismissed before it went to the jury. Because it hadn’t been, however, she concluded there was no way of determining to what extent, if at all, it affected the jury verdict. She ordered a new trial that would exclude the negligent communication claim.

In its appeal, The Iowa Clinic also sought to have the first claim dismissed – the one involving informed consent. Contrary to the testimony of a defense expert witness, the clinic argued, Iowa malpractice law doesn’t automatically fault a doctor whose patient misunderstands the procedure he or she is about to receive – as long as, that is, the doctor has made a “reasonable effort” to inform the patient beforehand.

Judge Greer agreed on this point of general law but still permitted the retrial to go forward. Why? She did so because, as the decision made clear, no expert testimony is needed to establish medical malpractice if the lack of care is so obvious that it’s within the comprehension of a layperson.

Mr. Zaw and his attorney, Ben Novotny, have petitioned the Iowa Supreme Court to review the appeals decision.

If the high court refuses that petition and the trial court schedules a new trial on the informed consent issue alone, Mr. Novotny is optimistic: “However it’s determined, whether it’s here [district court] or at the Supreme Court, we’ll live with the court’s decision, we’ll retry the case, and we’ll ask for more money.”
 

Jury exceeds state cap in infant head-trauma case

In what’s being called the state’s largest medical malpractice judgment to date, a Nebraska jury has handed down a multimillion-dollar award to a couple whose daughter was improperly discharged from the hospital after suffering a fall-related seizure, a story in the Omaha World-Herald reports.

The fall occurred in 2017 at a day care center, where then 11-month-old Vivianne Marousek hit her head while playing and began experiencing a seizure. Taken to an Omaha hospital, the infant was first treated by an emergency department doctor and then placed in the care of a hospital pediatrician. (The ED doctor wasn’t a party to the subsequent suit.)

According to the plaintiffs, after examining and observing the child, the pediatrician concluded that her seizures wouldn’t persist and that she should be discharged from the hospital. Within 48 hours after returning home, however, Vivianne suffered severe seizures, resulting in debilitating brain damage. Healthy before her fall, the now 6-year-old is blind, in a wheelchair, has a form of cerebral palsy, and can’t communicate beyond rudimentary responses to her parents’ voices.

After a 10-hour deliberation, the trial jury found both the hospital and the pediatrician liable for the child’s injuries. It awarded $21.5 million in damages for Vivianne’s ongoing medical care and $4.6 million in noneconomic damages to her parents.

An attorney for the hospital and pediatrician is expected to contest the award. Specifically, he’s expected to ask that the trial judge impose Nebraska’s $2.25 million cap on medical malpractice verdicts, thereby reducing the total award to $4.5 million, to be split evenly between Vivianne and her parents.

If that happens, the attorney for the plaintiffs has promised to contest the request, arguing that the state’s cap is unconstitutional and that the child’s lifetime medical bills will far exceed it.
 

University’s negligence caused them unnecessary suffering, women claim

A group of seven women has sued Yale University Medical School, in New Haven, Conn., for failing to safeguard the pain medication normally used during in vitro fertilization treatments, reports a story on Eyewitness News3 and other news sites.

The women’s suit follows a March 2021 guilty plea by a Yale staff nurse who was addicted to pain meds. In her plea, the nurse admitted to using a syringe to extract fentanyl from vials and then refilling those same vials with saline. Federal prosecutors say that at least 175 vials – some containing only saline and others with trace amounts of fentanyl – were tampered with in this manner.

As a result of Yale’s failure to guard against such actions, the women claim, they were subjected to unnecessary trauma and stress during their IVF treatments, which experts say can be unpleasant and take a physiologic toll on the body without the proper pain control.

The current suit won’t be the last, says the attorney representing the group of seven women. “We have somewhere on the line of 40-50 women who’ve been affected who contacted us,” he says.

A spokesperson for Yale declined to comment on the pending litigation.

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

The Iowa Court of Appeals has ordered a new trial in a case involving a man who received the wrong urologic surgery, according to a story reported in the Des Moines Register, among other news sites.

In 2015, an immigrant from Myanmar named Zaw Zaw was referred by his primary care physician (PCP) to The Iowa Clinic, in West Des Moines, for a circumcision.

Because Mr. Zaw didn’t speak English, a language translation company provided him with an interpreter for the procedure, as well as for any necessary follow-up appointments. The procedure would be performed by urologist Kevin Birusingh, MD, who at the time was employed by the clinic. Prior to the surgery, however, a miscommunication occurred, leading the urologist to perform a vasectomy instead of a circumcision on his patient. It was not until a later follow-up visit that the error was discovered, along with Mr. Zaw’s realization that he was now medically sterile and unable to father more children.

Mr. Zaw sued both Dr. Birusingh and the clinic, which in turn sued the translation company. Against Dr. Birusingh, Mr. Zaw made two claims: one, that the doctor hadn’t obtained the proper informed consent, and two, that he had engaged in “negligent” communications with several key individuals, including other clinic staff members and Dr. Zaw’s PCP.

In 2019, a trial jury found the clinic liable, awarding Mr. Zaw more than $1.4 million in damages. The same jury found no liability on the part of the translation company, however.

Following the verdict, the clinic appealed to the Iowa Court of Appeals. Late last month, the appeals court sent the case back to the lower court for a new trial.

In its ruling, written by Judge Sharon Soorholtz Greer, the appeals court said it could find no evidence that, in failing to communicate personally with his colleagues or Mr. Zaw’s PCP, Dr. Birusingh had violated an established standard of care. For this reason, Judge Greer said, the claim of negligent communication should have been dismissed before it went to the jury. Because it hadn’t been, however, she concluded there was no way of determining to what extent, if at all, it affected the jury verdict. She ordered a new trial that would exclude the negligent communication claim.

In its appeal, The Iowa Clinic also sought to have the first claim dismissed – the one involving informed consent. Contrary to the testimony of a defense expert witness, the clinic argued, Iowa malpractice law doesn’t automatically fault a doctor whose patient misunderstands the procedure he or she is about to receive – as long as, that is, the doctor has made a “reasonable effort” to inform the patient beforehand.

Judge Greer agreed on this point of general law but still permitted the retrial to go forward. Why? She did so because, as the decision made clear, no expert testimony is needed to establish medical malpractice if the lack of care is so obvious that it’s within the comprehension of a layperson.

Mr. Zaw and his attorney, Ben Novotny, have petitioned the Iowa Supreme Court to review the appeals decision.

If the high court refuses that petition and the trial court schedules a new trial on the informed consent issue alone, Mr. Novotny is optimistic: “However it’s determined, whether it’s here [district court] or at the Supreme Court, we’ll live with the court’s decision, we’ll retry the case, and we’ll ask for more money.”
 

Jury exceeds state cap in infant head-trauma case

In what’s being called the state’s largest medical malpractice judgment to date, a Nebraska jury has handed down a multimillion-dollar award to a couple whose daughter was improperly discharged from the hospital after suffering a fall-related seizure, a story in the Omaha World-Herald reports.

The fall occurred in 2017 at a day care center, where then 11-month-old Vivianne Marousek hit her head while playing and began experiencing a seizure. Taken to an Omaha hospital, the infant was first treated by an emergency department doctor and then placed in the care of a hospital pediatrician. (The ED doctor wasn’t a party to the subsequent suit.)

According to the plaintiffs, after examining and observing the child, the pediatrician concluded that her seizures wouldn’t persist and that she should be discharged from the hospital. Within 48 hours after returning home, however, Vivianne suffered severe seizures, resulting in debilitating brain damage. Healthy before her fall, the now 6-year-old is blind, in a wheelchair, has a form of cerebral palsy, and can’t communicate beyond rudimentary responses to her parents’ voices.

After a 10-hour deliberation, the trial jury found both the hospital and the pediatrician liable for the child’s injuries. It awarded $21.5 million in damages for Vivianne’s ongoing medical care and $4.6 million in noneconomic damages to her parents.

An attorney for the hospital and pediatrician is expected to contest the award. Specifically, he’s expected to ask that the trial judge impose Nebraska’s $2.25 million cap on medical malpractice verdicts, thereby reducing the total award to $4.5 million, to be split evenly between Vivianne and her parents.

If that happens, the attorney for the plaintiffs has promised to contest the request, arguing that the state’s cap is unconstitutional and that the child’s lifetime medical bills will far exceed it.
 

University’s negligence caused them unnecessary suffering, women claim

A group of seven women has sued Yale University Medical School, in New Haven, Conn., for failing to safeguard the pain medication normally used during in vitro fertilization treatments, reports a story on Eyewitness News3 and other news sites.

The women’s suit follows a March 2021 guilty plea by a Yale staff nurse who was addicted to pain meds. In her plea, the nurse admitted to using a syringe to extract fentanyl from vials and then refilling those same vials with saline. Federal prosecutors say that at least 175 vials – some containing only saline and others with trace amounts of fentanyl – were tampered with in this manner.

As a result of Yale’s failure to guard against such actions, the women claim, they were subjected to unnecessary trauma and stress during their IVF treatments, which experts say can be unpleasant and take a physiologic toll on the body without the proper pain control.

The current suit won’t be the last, says the attorney representing the group of seven women. “We have somewhere on the line of 40-50 women who’ve been affected who contacted us,” he says.

A spokesperson for Yale declined to comment on the pending litigation.

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

The Iowa Court of Appeals has ordered a new trial in a case involving a man who received the wrong urologic surgery, according to a story reported in the Des Moines Register, among other news sites.

In 2015, an immigrant from Myanmar named Zaw Zaw was referred by his primary care physician (PCP) to The Iowa Clinic, in West Des Moines, for a circumcision.

Because Mr. Zaw didn’t speak English, a language translation company provided him with an interpreter for the procedure, as well as for any necessary follow-up appointments. The procedure would be performed by urologist Kevin Birusingh, MD, who at the time was employed by the clinic. Prior to the surgery, however, a miscommunication occurred, leading the urologist to perform a vasectomy instead of a circumcision on his patient. It was not until a later follow-up visit that the error was discovered, along with Mr. Zaw’s realization that he was now medically sterile and unable to father more children.

Mr. Zaw sued both Dr. Birusingh and the clinic, which in turn sued the translation company. Against Dr. Birusingh, Mr. Zaw made two claims: one, that the doctor hadn’t obtained the proper informed consent, and two, that he had engaged in “negligent” communications with several key individuals, including other clinic staff members and Dr. Zaw’s PCP.

In 2019, a trial jury found the clinic liable, awarding Mr. Zaw more than $1.4 million in damages. The same jury found no liability on the part of the translation company, however.

Following the verdict, the clinic appealed to the Iowa Court of Appeals. Late last month, the appeals court sent the case back to the lower court for a new trial.

In its ruling, written by Judge Sharon Soorholtz Greer, the appeals court said it could find no evidence that, in failing to communicate personally with his colleagues or Mr. Zaw’s PCP, Dr. Birusingh had violated an established standard of care. For this reason, Judge Greer said, the claim of negligent communication should have been dismissed before it went to the jury. Because it hadn’t been, however, she concluded there was no way of determining to what extent, if at all, it affected the jury verdict. She ordered a new trial that would exclude the negligent communication claim.

In its appeal, The Iowa Clinic also sought to have the first claim dismissed – the one involving informed consent. Contrary to the testimony of a defense expert witness, the clinic argued, Iowa malpractice law doesn’t automatically fault a doctor whose patient misunderstands the procedure he or she is about to receive – as long as, that is, the doctor has made a “reasonable effort” to inform the patient beforehand.

Judge Greer agreed on this point of general law but still permitted the retrial to go forward. Why? She did so because, as the decision made clear, no expert testimony is needed to establish medical malpractice if the lack of care is so obvious that it’s within the comprehension of a layperson.

Mr. Zaw and his attorney, Ben Novotny, have petitioned the Iowa Supreme Court to review the appeals decision.

If the high court refuses that petition and the trial court schedules a new trial on the informed consent issue alone, Mr. Novotny is optimistic: “However it’s determined, whether it’s here [district court] or at the Supreme Court, we’ll live with the court’s decision, we’ll retry the case, and we’ll ask for more money.”
 

Jury exceeds state cap in infant head-trauma case

In what’s being called the state’s largest medical malpractice judgment to date, a Nebraska jury has handed down a multimillion-dollar award to a couple whose daughter was improperly discharged from the hospital after suffering a fall-related seizure, a story in the Omaha World-Herald reports.

The fall occurred in 2017 at a day care center, where then 11-month-old Vivianne Marousek hit her head while playing and began experiencing a seizure. Taken to an Omaha hospital, the infant was first treated by an emergency department doctor and then placed in the care of a hospital pediatrician. (The ED doctor wasn’t a party to the subsequent suit.)

According to the plaintiffs, after examining and observing the child, the pediatrician concluded that her seizures wouldn’t persist and that she should be discharged from the hospital. Within 48 hours after returning home, however, Vivianne suffered severe seizures, resulting in debilitating brain damage. Healthy before her fall, the now 6-year-old is blind, in a wheelchair, has a form of cerebral palsy, and can’t communicate beyond rudimentary responses to her parents’ voices.

After a 10-hour deliberation, the trial jury found both the hospital and the pediatrician liable for the child’s injuries. It awarded $21.5 million in damages for Vivianne’s ongoing medical care and $4.6 million in noneconomic damages to her parents.

An attorney for the hospital and pediatrician is expected to contest the award. Specifically, he’s expected to ask that the trial judge impose Nebraska’s $2.25 million cap on medical malpractice verdicts, thereby reducing the total award to $4.5 million, to be split evenly between Vivianne and her parents.

If that happens, the attorney for the plaintiffs has promised to contest the request, arguing that the state’s cap is unconstitutional and that the child’s lifetime medical bills will far exceed it.
 

University’s negligence caused them unnecessary suffering, women claim

A group of seven women has sued Yale University Medical School, in New Haven, Conn., for failing to safeguard the pain medication normally used during in vitro fertilization treatments, reports a story on Eyewitness News3 and other news sites.

The women’s suit follows a March 2021 guilty plea by a Yale staff nurse who was addicted to pain meds. In her plea, the nurse admitted to using a syringe to extract fentanyl from vials and then refilling those same vials with saline. Federal prosecutors say that at least 175 vials – some containing only saline and others with trace amounts of fentanyl – were tampered with in this manner.

As a result of Yale’s failure to guard against such actions, the women claim, they were subjected to unnecessary trauma and stress during their IVF treatments, which experts say can be unpleasant and take a physiologic toll on the body without the proper pain control.

The current suit won’t be the last, says the attorney representing the group of seven women. “We have somewhere on the line of 40-50 women who’ve been affected who contacted us,” he says.

A spokesperson for Yale declined to comment on the pending litigation.

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

About a third of Americans say they’ve skipped medical care that they needed in the past 3 months because of concerns about the cost, according to a new survey from Gallup and West Health.

That’s the highest reported number since the pandemic began and a tripling from March to October.

Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.

“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.

“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.

As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.

What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.

The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.

About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.

“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”

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

About a third of Americans say they’ve skipped medical care that they needed in the past 3 months because of concerns about the cost, according to a new survey from Gallup and West Health.

That’s the highest reported number since the pandemic began and a tripling from March to October.

Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.

“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.

“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.

As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.

What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.

The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.

About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.

“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”

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

About a third of Americans say they’ve skipped medical care that they needed in the past 3 months because of concerns about the cost, according to a new survey from Gallup and West Health.

That’s the highest reported number since the pandemic began and a tripling from March to October.

Even 20% of the country’s highest-income households – earning more than $120,000 per year – said they’ve also skipped care. That’s an increase of about seven times for higher-income families since March.

“Americans tend to think there is a group of lower-income people, and they have worse health care than the rest of us, and the rest of us, we’re okay,” Tim Lash, chief strategy officer for West Health, a nonprofit focused on lowering health care costs, told CBS News.

“What we are seeing now in this survey is this group of people who are identifying themselves as struggling with health care costs is growing,” he said.

As part of the 2021 Healthcare in America Report, researchers surveyed more than 6,000 people in September and October about their concerns and experiences with affording health care and treatment. About half of respondents said health care in America has gotten worse because of the pandemic, and more than half said they’re more worried about medical costs than before.

What’s more, many Americans put off routine doctor visits at the beginning of the pandemic, and now that they’re beginning to schedule appointments again, they’re facing major costs, the survey found. Some expenses have increased in the past year, including prescription medications.

The rising costs have led many people to skip care or treatment, which can have major consequences. About 1 in 20 adults said they know a friend or family member who died during the past year because they couldn’t afford medical care, the survey found. And about 20% of adults said they or someone in their household had a health issue that grew worse after postponing care because of price.

About 23% of survey respondents said that paying for health care represents a major financial burden, which increases to a third of respondents who earn less than $48,000 per year. Out-of-pocket costs such as deductibles and insurance premiums have increased, which have taken up larger portions of people’s budgets.

“We often overlook the side effect of costs, and it’s quite toxic – there is a financial toxicity that exists in health care,” Mr. Lash said. “We know when you skip treatment, that can have an impact on mortality.”

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