Feature

Researchers in Texas are developing a “green light” technology they hope will solve a crucial problem highlighted by the pandemic: the limits of pulse oximeters in patients with darker skin.

A recent study adds weight to earlier findings that their device works. 

“It is a new, first-in-class technology,” said Sanjay Gokhale, MD, the bioengineer who is leading this research at the University of Texas at Arlington. “The team conducted extensive preclinical work and carried out phase 1 studies in human volunteers, demonstrating sensitivity and accuracy.”

It’s one of several projects underway to update pulse oximetry, a technology based on research in lighter-skinned people that has not changed much in 50 years. 

The pulse oximeter, or “pulse ox,” measures the saturation of oxygen in your hemoglobin (a protein in red blood cells). But it tends to overestimate the oxygen saturation in patients with darker skin by about 2%-3%. That may not sound like a lot, but it’s enough to delay major treatment for respiratory issues like COVID-19. 

“Falsely elevated readings from commercial oximeters have delayed treatment of Black COVID-19 patients for hours in some cases,” said Divya Chander, MD, PhD, an anesthesiologist in Oakland, Calif., and chair of neuroscience at The Singularity Group. (Dr. Chander was not involved in the UT Arlington research.)

Early research happening separately at Brown University and Tufts University aims to redesign the pulse oximeter to get accurate readings in patients of all skin tones. University of California, San Diego, researchers are looking into a method that measures blood oxygen using sound in combination with light.  Other solutions try to correct for skin tone with algorithms. 

The device from UT Arlington uses an algorithm too, but its main innovation is that it replaces red light with green light. 
 

Red light, green light

Traditional oximetry devices, which typically clip on to the patient’s fingertip, use LEDs to beam light through the skin at two wavelengths: one in the red part of the spectrum, the other in the infrared. The light transmits from one side of the clip to the other, passing through arterial blood as it pulses.

The device calculates a patient’s oxygenation based on how much light of each wavelength is absorbed by hemoglobin in the blood. Oxygenated hemoglobin absorbs the light differently than deoxygenated hemoglobin, so oxygenation can be represented as a percentage; 100% means all hemoglobin is completely oxygenated.  But the melanin in skin can interfere with the absorption of light and affect the results. 

The green light strategy measures not absorption but reflectance – how much of the light bounces back. As with traditional oximetry, the green-light method uses two wavelengths. Each is a different shade of green, and the two forms of hemoglobin reflect them differently. 

Using an algorithm developed by the researchers, the device can capture readings in patients of all skin tones, the researchers say. And because it works on the wrist rather than a finger, the device also eliminates issues with cold fingers and dark nail polish – both known to reduce accuracy in traditional oximetry.

In the latest experiments, the researchers tested the technology on synthetic skin samples with varying amounts of melanin, Dr. Gokhale said. The device picked up changes in blood oxygen saturation even in samples with high melanin levels. 

In a study published last year, the technology was tested in 16 people against an invasive handheld blood analyzer and a noninvasive commercial pulse oximeter, and found to be comparable to the invasive method. 
 

A drawback 

The green light approach could be “game changing,” Dr. Chander said. But there is a drawback. 

Since green light doesn’t penetrate as deeply, this approach measures blood oxygen saturation in capillary beds (small blood vessels very close to the skin surface). By contrast, traditional oximetry measures oxygen saturation in an artery as it pulses – thus the name pulse oximetry. 

Valuable information can be obtained from an arterial pulse.

Changes in arterial pulse, known as the waveforms, “can tell us about a patient’s hydration status [for instance],” Dr. Chander said. “In a mechanically ventilated patient, this variation with a patient’s respiratory cycle can give us feedback about how responsive the patient will be to fluid resuscitation if their blood pressure is too low.” 

Given such considerations, the green light method may be useful as an adjunct, not a full replacement, to a standard pulse ox, Dr. Chander noted.

A version of this article appeared on WebMD.com.

Researchers in Texas are developing a “green light” technology they hope will solve a crucial problem highlighted by the pandemic: the limits of pulse oximeters in patients with darker skin.

A recent study adds weight to earlier findings that their device works. 

“It is a new, first-in-class technology,” said Sanjay Gokhale, MD, the bioengineer who is leading this research at the University of Texas at Arlington. “The team conducted extensive preclinical work and carried out phase 1 studies in human volunteers, demonstrating sensitivity and accuracy.”

It’s one of several projects underway to update pulse oximetry, a technology based on research in lighter-skinned people that has not changed much in 50 years. 

The pulse oximeter, or “pulse ox,” measures the saturation of oxygen in your hemoglobin (a protein in red blood cells). But it tends to overestimate the oxygen saturation in patients with darker skin by about 2%-3%. That may not sound like a lot, but it’s enough to delay major treatment for respiratory issues like COVID-19. 

“Falsely elevated readings from commercial oximeters have delayed treatment of Black COVID-19 patients for hours in some cases,” said Divya Chander, MD, PhD, an anesthesiologist in Oakland, Calif., and chair of neuroscience at The Singularity Group. (Dr. Chander was not involved in the UT Arlington research.)

Early research happening separately at Brown University and Tufts University aims to redesign the pulse oximeter to get accurate readings in patients of all skin tones. University of California, San Diego, researchers are looking into a method that measures blood oxygen using sound in combination with light.  Other solutions try to correct for skin tone with algorithms. 

The device from UT Arlington uses an algorithm too, but its main innovation is that it replaces red light with green light. 
 

Red light, green light

Traditional oximetry devices, which typically clip on to the patient’s fingertip, use LEDs to beam light through the skin at two wavelengths: one in the red part of the spectrum, the other in the infrared. The light transmits from one side of the clip to the other, passing through arterial blood as it pulses.

The device calculates a patient’s oxygenation based on how much light of each wavelength is absorbed by hemoglobin in the blood. Oxygenated hemoglobin absorbs the light differently than deoxygenated hemoglobin, so oxygenation can be represented as a percentage; 100% means all hemoglobin is completely oxygenated.  But the melanin in skin can interfere with the absorption of light and affect the results. 

The green light strategy measures not absorption but reflectance – how much of the light bounces back. As with traditional oximetry, the green-light method uses two wavelengths. Each is a different shade of green, and the two forms of hemoglobin reflect them differently. 

Using an algorithm developed by the researchers, the device can capture readings in patients of all skin tones, the researchers say. And because it works on the wrist rather than a finger, the device also eliminates issues with cold fingers and dark nail polish – both known to reduce accuracy in traditional oximetry.

In the latest experiments, the researchers tested the technology on synthetic skin samples with varying amounts of melanin, Dr. Gokhale said. The device picked up changes in blood oxygen saturation even in samples with high melanin levels. 

In a study published last year, the technology was tested in 16 people against an invasive handheld blood analyzer and a noninvasive commercial pulse oximeter, and found to be comparable to the invasive method. 
 

A drawback 

The green light approach could be “game changing,” Dr. Chander said. But there is a drawback. 

Since green light doesn’t penetrate as deeply, this approach measures blood oxygen saturation in capillary beds (small blood vessels very close to the skin surface). By contrast, traditional oximetry measures oxygen saturation in an artery as it pulses – thus the name pulse oximetry. 

Valuable information can be obtained from an arterial pulse.

Changes in arterial pulse, known as the waveforms, “can tell us about a patient’s hydration status [for instance],” Dr. Chander said. “In a mechanically ventilated patient, this variation with a patient’s respiratory cycle can give us feedback about how responsive the patient will be to fluid resuscitation if their blood pressure is too low.” 

Given such considerations, the green light method may be useful as an adjunct, not a full replacement, to a standard pulse ox, Dr. Chander noted.

A version of this article appeared on WebMD.com.

Researchers in Texas are developing a “green light” technology they hope will solve a crucial problem highlighted by the pandemic: the limits of pulse oximeters in patients with darker skin.

A recent study adds weight to earlier findings that their device works. 

“It is a new, first-in-class technology,” said Sanjay Gokhale, MD, the bioengineer who is leading this research at the University of Texas at Arlington. “The team conducted extensive preclinical work and carried out phase 1 studies in human volunteers, demonstrating sensitivity and accuracy.”

It’s one of several projects underway to update pulse oximetry, a technology based on research in lighter-skinned people that has not changed much in 50 years. 

The pulse oximeter, or “pulse ox,” measures the saturation of oxygen in your hemoglobin (a protein in red blood cells). But it tends to overestimate the oxygen saturation in patients with darker skin by about 2%-3%. That may not sound like a lot, but it’s enough to delay major treatment for respiratory issues like COVID-19. 

“Falsely elevated readings from commercial oximeters have delayed treatment of Black COVID-19 patients for hours in some cases,” said Divya Chander, MD, PhD, an anesthesiologist in Oakland, Calif., and chair of neuroscience at The Singularity Group. (Dr. Chander was not involved in the UT Arlington research.)

Early research happening separately at Brown University and Tufts University aims to redesign the pulse oximeter to get accurate readings in patients of all skin tones. University of California, San Diego, researchers are looking into a method that measures blood oxygen using sound in combination with light.  Other solutions try to correct for skin tone with algorithms. 

The device from UT Arlington uses an algorithm too, but its main innovation is that it replaces red light with green light. 
 

Red light, green light

Traditional oximetry devices, which typically clip on to the patient’s fingertip, use LEDs to beam light through the skin at two wavelengths: one in the red part of the spectrum, the other in the infrared. The light transmits from one side of the clip to the other, passing through arterial blood as it pulses.

The device calculates a patient’s oxygenation based on how much light of each wavelength is absorbed by hemoglobin in the blood. Oxygenated hemoglobin absorbs the light differently than deoxygenated hemoglobin, so oxygenation can be represented as a percentage; 100% means all hemoglobin is completely oxygenated.  But the melanin in skin can interfere with the absorption of light and affect the results. 

The green light strategy measures not absorption but reflectance – how much of the light bounces back. As with traditional oximetry, the green-light method uses two wavelengths. Each is a different shade of green, and the two forms of hemoglobin reflect them differently. 

Using an algorithm developed by the researchers, the device can capture readings in patients of all skin tones, the researchers say. And because it works on the wrist rather than a finger, the device also eliminates issues with cold fingers and dark nail polish – both known to reduce accuracy in traditional oximetry.

In the latest experiments, the researchers tested the technology on synthetic skin samples with varying amounts of melanin, Dr. Gokhale said. The device picked up changes in blood oxygen saturation even in samples with high melanin levels. 

In a study published last year, the technology was tested in 16 people against an invasive handheld blood analyzer and a noninvasive commercial pulse oximeter, and found to be comparable to the invasive method. 
 

A drawback 

The green light approach could be “game changing,” Dr. Chander said. But there is a drawback. 

Since green light doesn’t penetrate as deeply, this approach measures blood oxygen saturation in capillary beds (small blood vessels very close to the skin surface). By contrast, traditional oximetry measures oxygen saturation in an artery as it pulses – thus the name pulse oximetry. 

Valuable information can be obtained from an arterial pulse.

Changes in arterial pulse, known as the waveforms, “can tell us about a patient’s hydration status [for instance],” Dr. Chander said. “In a mechanically ventilated patient, this variation with a patient’s respiratory cycle can give us feedback about how responsive the patient will be to fluid resuscitation if their blood pressure is too low.” 

Given such considerations, the green light method may be useful as an adjunct, not a full replacement, to a standard pulse ox, Dr. Chander noted.

A version of this article appeared on WebMD.com.

A growing number of long COVID patients, denied disability benefits despite being unable to work, are turning to the courts for legal relief.

At least 30 lawsuits have been filed seeking legal resolution of disability insurance claims, according to searches of court records. In addition, the Social Security Administration said it has received about 52,000 disability claims tied to SARS-CoV-2 infections, which represents 1% of all applications.

But legal experts say those cases may not reflect the total number of cases that have gone to court. They note many claims are initially dismissed and are not appealed by claimants.

“With this system, they deny two-thirds of initial applications, then people who appeal get denied almost 90% of the time, and then they can appeal before a judge,” said Kevin LaPorte, a Social Security disability attorney at LaPorte Law Firm in Oakland, Calif. “What happens next doesn’t have a lot of precedent because long COVID is a mass disabling event, and we haven’t seen that many of these cases get all the way through the legal system yet.”

As a result, the exact number of long COVID disability claims and the number of these cases going to court isn’t clear, he said.

“It can take a year or more for cases to get to court, and even longer to reach resolution,” Mr. LaPorte added. “I suspect the few cases we’ve heard about at this point are going to be the tip of the iceberg.”

The process is convoluted and can drag on for months with multiple denials and appeals along the way. Many disabled workers find their only recourse is to take insurers to court.

Long COVID patients typically apply for disability benefits through private insurance or Social Security. But the process can drag on for months, so many find their only recourse is to take insurers to court, according to legal experts.

But even in the courts, many encounter delays and hurdles to resolution.

In one of the first federal lawsuits involving long COVID disability benefits, William Abrams, a trial and appellate attorney and active marathon runner, sued Unum Life Insurance seeking long-term disability income. Symptoms included extreme fatigue, brain fog, decreased attention and concentration, and nearly daily fevers, causing him to stop working in April 2020.

His diagnosis wasn’t definitive. Three doctors said he had long COVID, and four said he had chronic fatigue syndrome. Unum cited this inconsistency as a rationale for rejecting his claim. But the court sided with Mr. Abrams, granting him disability income. The court concluded: “Unum may be correct that [the plaintiff] has not been correctly diagnosed. But that does not mean he is not sick. If [the plaintiff’s] complaints, and [the doctor’s] assessments, are to be believed, [the plaintiff] cannot focus for more than a few minutes at a time, making it impossible for [the plaintiff] to perform the varied and complex tasks his job requires.”

Unum said in an emailed statement that the company doesn’t comment on specific claims as a matter of policy, adding that its total payouts for disability claims from March 2020 to February 2022 were 35% higher than prepandemic levels. “In general, disability and leave claims connected to COVID-19 have been primarily short-term events with the majority of claimants recovering prior to completing the normal qualification period for long-term disability insurance,” Unum said.

Mr. Abrams prevailed in part because he had detailed documentation of the numerous impairments that eventually required him to stop work, said Michelle Roberts of Roberts Disability Law in Oakland, Calif.

He submitted videos of himself taking his temperature to prove he had almost daily fevers, according to court records. He underwent neuropsychological testing, which found learning deficiencies and memory deficits.

Mr. Abrams also submitted statements from a colleague who worked with him on a complex technology patent case involving radiofrequency identification. Before he got COVID, Mr. Abrams “had the analytical ability, legal acumen, and mental energy to attack that learning curve and get up to speed very rapidly,” according to court records.

“The court focused on credulity.” Ms. Roberts said. “There was all this work to be done to show this person was high functioning and ran marathons and worked in an intense, high-pressure occupation but then couldn’t do anything after long COVID.”

Documentation was also crucial in another early federal long COVID disability lawsuit that was filed in 2022 on behalf of Wendy Haut, an educational software sales representative in California who turned to the courts seeking disability income through her company’s employee benefits plan.

Several of Ms. Haut’s doctors documented a detailed list of long COVID symptoms, including “profound fatigue and extreme cognitive difficulties,” that they said prevented her from working as a sales representative or doing any other type of job. A settlement agreement in June 2022 required Reliance Standard Life Insurance to pay Ms. Haut long-term disability benefits, including previously unpaid benefits, according to a report by the advocacy group Pandemic Patients.

Representatives of Reliance Standard didn’t respond to a request for comment.

The growing number of workers being sidelined by long COVID makes more claims and more court cases likely. Right now, an estimated 16 million working-age Americans aged 18-65 years have long COVID, and as many as 4 million of them can’t work, according to a July 2023 Census Bureau report.

Uncertainty about the volume of claims in the pipeline is part of what’s driving some insurers to fight long COVID claims, Ms. Roberts said. Another factor is the lack of clarity around how many years people with long COVID may be out of work, particularly if they’re in their 30s or 40s and might be seeking disability income until they reach retirement age.

“Doctors are not always saying that this person will be permanently disabled,” Ms. Roberts said. “If this person doesn’t get better and they’re disabled until retirement age, this could be a payout in the high six or seven figures if a person is very young and was a very high earner.”

Insurance companies routinely deny claims that can’t be backed up with objective measures, such as specific lab test results or clear findings from a physical exam. But there are steps that can increase the odds of a successful claim for long COVID disability benefits, according to New York–based law firm Hiller.

For starters, patients can document COVID test results, and if testing wasn’t conducted, patients can detail the specific symptoms that led to this diagnosis, Hiller advises. Then patients can keep a daily symptom log at home that run lists all of the specific symptoms that occur at different times during the day and night to help establish a pattern of disability. These logs should provide specific details about every job duty patients have and exactly how specific symptoms of long COVID interfere with these duties.

Even though objective testing is hard to come by for long COVID, people should undergo all the tests they can that may help document the frequency or severity of specific symptoms that make it impossible to carry on with business as usual at work, Hiller advises. This may include neuropsychological testing to document brain fog, a cardiopulmonary exercise test to demonstrate chronic fatigue and the inability to exercise, or a tilt table test to measure dizziness.

Seeking a doctor’s diagnosis can be key to collecting disability payments, in or out of court.

All of this puts a lot of pressure on doctors and patients to build strong cases, said Jonathan Whiteson, MD, codirector of the NYU Langone Health post-COVID care program in New York. “Many physicians are not familiar with the disability benefit paperwork, and so this is a challenge for the doctors to know how to complete and to build the time into their highly scheduled days to take the time needed to complete.

“It’s also challenging because most of the disability benefit forms are ‘generic’ and do not ask specific questions about COVID disability,” Dr. Whiteson added. “It can be like trying to drive a square peg into a round hole.”

Still, when it comes to long COVID, completing disability paperwork is increasingly becoming part of standard care, along with managing medication, rehabilitation therapies, and lifestyle changes to navigate daily life with this illness, Dr. Whiteson noted.

Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the Post-COVID-19 Recovery Clinic at the University of Texas Health Science Center, San Antonio, agreed with this assessment.

“I have done letter upon letter of appeal to disability insurance companies,” she said.

Some doctors, however, are reluctant to step up in such cases, in part because no standard diagnostic guidelines exist for long COVID and because it can be frustrating.

“This is the work that is not paid and causes burnout in physicians,” Dr. Verduzco-Gutierrez said. “The paperwork, the fighting with insurance companies, the resubmission of forms for disability all to get what your patient needs – and then it gets denied.

“We will keep doing this because our patients need this disability income in order to live their lives and to afford what they need for recovery,” said Dr. Verduzco-Gutierrez. “But at some point something has to change because this isn’t sustainable.”

A version of this article appeared on Medscape.com.

A growing number of long COVID patients, denied disability benefits despite being unable to work, are turning to the courts for legal relief.

At least 30 lawsuits have been filed seeking legal resolution of disability insurance claims, according to searches of court records. In addition, the Social Security Administration said it has received about 52,000 disability claims tied to SARS-CoV-2 infections, which represents 1% of all applications.

But legal experts say those cases may not reflect the total number of cases that have gone to court. They note many claims are initially dismissed and are not appealed by claimants.

“With this system, they deny two-thirds of initial applications, then people who appeal get denied almost 90% of the time, and then they can appeal before a judge,” said Kevin LaPorte, a Social Security disability attorney at LaPorte Law Firm in Oakland, Calif. “What happens next doesn’t have a lot of precedent because long COVID is a mass disabling event, and we haven’t seen that many of these cases get all the way through the legal system yet.”

As a result, the exact number of long COVID disability claims and the number of these cases going to court isn’t clear, he said.

“It can take a year or more for cases to get to court, and even longer to reach resolution,” Mr. LaPorte added. “I suspect the few cases we’ve heard about at this point are going to be the tip of the iceberg.”

The process is convoluted and can drag on for months with multiple denials and appeals along the way. Many disabled workers find their only recourse is to take insurers to court.

Long COVID patients typically apply for disability benefits through private insurance or Social Security. But the process can drag on for months, so many find their only recourse is to take insurers to court, according to legal experts.

But even in the courts, many encounter delays and hurdles to resolution.

In one of the first federal lawsuits involving long COVID disability benefits, William Abrams, a trial and appellate attorney and active marathon runner, sued Unum Life Insurance seeking long-term disability income. Symptoms included extreme fatigue, brain fog, decreased attention and concentration, and nearly daily fevers, causing him to stop working in April 2020.

His diagnosis wasn’t definitive. Three doctors said he had long COVID, and four said he had chronic fatigue syndrome. Unum cited this inconsistency as a rationale for rejecting his claim. But the court sided with Mr. Abrams, granting him disability income. The court concluded: “Unum may be correct that [the plaintiff] has not been correctly diagnosed. But that does not mean he is not sick. If [the plaintiff’s] complaints, and [the doctor’s] assessments, are to be believed, [the plaintiff] cannot focus for more than a few minutes at a time, making it impossible for [the plaintiff] to perform the varied and complex tasks his job requires.”

Unum said in an emailed statement that the company doesn’t comment on specific claims as a matter of policy, adding that its total payouts for disability claims from March 2020 to February 2022 were 35% higher than prepandemic levels. “In general, disability and leave claims connected to COVID-19 have been primarily short-term events with the majority of claimants recovering prior to completing the normal qualification period for long-term disability insurance,” Unum said.

Mr. Abrams prevailed in part because he had detailed documentation of the numerous impairments that eventually required him to stop work, said Michelle Roberts of Roberts Disability Law in Oakland, Calif.

He submitted videos of himself taking his temperature to prove he had almost daily fevers, according to court records. He underwent neuropsychological testing, which found learning deficiencies and memory deficits.

Mr. Abrams also submitted statements from a colleague who worked with him on a complex technology patent case involving radiofrequency identification. Before he got COVID, Mr. Abrams “had the analytical ability, legal acumen, and mental energy to attack that learning curve and get up to speed very rapidly,” according to court records.

“The court focused on credulity.” Ms. Roberts said. “There was all this work to be done to show this person was high functioning and ran marathons and worked in an intense, high-pressure occupation but then couldn’t do anything after long COVID.”

Documentation was also crucial in another early federal long COVID disability lawsuit that was filed in 2022 on behalf of Wendy Haut, an educational software sales representative in California who turned to the courts seeking disability income through her company’s employee benefits plan.

Several of Ms. Haut’s doctors documented a detailed list of long COVID symptoms, including “profound fatigue and extreme cognitive difficulties,” that they said prevented her from working as a sales representative or doing any other type of job. A settlement agreement in June 2022 required Reliance Standard Life Insurance to pay Ms. Haut long-term disability benefits, including previously unpaid benefits, according to a report by the advocacy group Pandemic Patients.

Representatives of Reliance Standard didn’t respond to a request for comment.

The growing number of workers being sidelined by long COVID makes more claims and more court cases likely. Right now, an estimated 16 million working-age Americans aged 18-65 years have long COVID, and as many as 4 million of them can’t work, according to a July 2023 Census Bureau report.

Uncertainty about the volume of claims in the pipeline is part of what’s driving some insurers to fight long COVID claims, Ms. Roberts said. Another factor is the lack of clarity around how many years people with long COVID may be out of work, particularly if they’re in their 30s or 40s and might be seeking disability income until they reach retirement age.

“Doctors are not always saying that this person will be permanently disabled,” Ms. Roberts said. “If this person doesn’t get better and they’re disabled until retirement age, this could be a payout in the high six or seven figures if a person is very young and was a very high earner.”

Insurance companies routinely deny claims that can’t be backed up with objective measures, such as specific lab test results or clear findings from a physical exam. But there are steps that can increase the odds of a successful claim for long COVID disability benefits, according to New York–based law firm Hiller.

For starters, patients can document COVID test results, and if testing wasn’t conducted, patients can detail the specific symptoms that led to this diagnosis, Hiller advises. Then patients can keep a daily symptom log at home that run lists all of the specific symptoms that occur at different times during the day and night to help establish a pattern of disability. These logs should provide specific details about every job duty patients have and exactly how specific symptoms of long COVID interfere with these duties.

Even though objective testing is hard to come by for long COVID, people should undergo all the tests they can that may help document the frequency or severity of specific symptoms that make it impossible to carry on with business as usual at work, Hiller advises. This may include neuropsychological testing to document brain fog, a cardiopulmonary exercise test to demonstrate chronic fatigue and the inability to exercise, or a tilt table test to measure dizziness.

Seeking a doctor’s diagnosis can be key to collecting disability payments, in or out of court.

All of this puts a lot of pressure on doctors and patients to build strong cases, said Jonathan Whiteson, MD, codirector of the NYU Langone Health post-COVID care program in New York. “Many physicians are not familiar with the disability benefit paperwork, and so this is a challenge for the doctors to know how to complete and to build the time into their highly scheduled days to take the time needed to complete.

“It’s also challenging because most of the disability benefit forms are ‘generic’ and do not ask specific questions about COVID disability,” Dr. Whiteson added. “It can be like trying to drive a square peg into a round hole.”

Still, when it comes to long COVID, completing disability paperwork is increasingly becoming part of standard care, along with managing medication, rehabilitation therapies, and lifestyle changes to navigate daily life with this illness, Dr. Whiteson noted.

Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the Post-COVID-19 Recovery Clinic at the University of Texas Health Science Center, San Antonio, agreed with this assessment.

“I have done letter upon letter of appeal to disability insurance companies,” she said.

Some doctors, however, are reluctant to step up in such cases, in part because no standard diagnostic guidelines exist for long COVID and because it can be frustrating.

“This is the work that is not paid and causes burnout in physicians,” Dr. Verduzco-Gutierrez said. “The paperwork, the fighting with insurance companies, the resubmission of forms for disability all to get what your patient needs – and then it gets denied.

“We will keep doing this because our patients need this disability income in order to live their lives and to afford what they need for recovery,” said Dr. Verduzco-Gutierrez. “But at some point something has to change because this isn’t sustainable.”

A version of this article appeared on Medscape.com.

A growing number of long COVID patients, denied disability benefits despite being unable to work, are turning to the courts for legal relief.

At least 30 lawsuits have been filed seeking legal resolution of disability insurance claims, according to searches of court records. In addition, the Social Security Administration said it has received about 52,000 disability claims tied to SARS-CoV-2 infections, which represents 1% of all applications.

But legal experts say those cases may not reflect the total number of cases that have gone to court. They note many claims are initially dismissed and are not appealed by claimants.

“With this system, they deny two-thirds of initial applications, then people who appeal get denied almost 90% of the time, and then they can appeal before a judge,” said Kevin LaPorte, a Social Security disability attorney at LaPorte Law Firm in Oakland, Calif. “What happens next doesn’t have a lot of precedent because long COVID is a mass disabling event, and we haven’t seen that many of these cases get all the way through the legal system yet.”

As a result, the exact number of long COVID disability claims and the number of these cases going to court isn’t clear, he said.

“It can take a year or more for cases to get to court, and even longer to reach resolution,” Mr. LaPorte added. “I suspect the few cases we’ve heard about at this point are going to be the tip of the iceberg.”

The process is convoluted and can drag on for months with multiple denials and appeals along the way. Many disabled workers find their only recourse is to take insurers to court.

Long COVID patients typically apply for disability benefits through private insurance or Social Security. But the process can drag on for months, so many find their only recourse is to take insurers to court, according to legal experts.

But even in the courts, many encounter delays and hurdles to resolution.

In one of the first federal lawsuits involving long COVID disability benefits, William Abrams, a trial and appellate attorney and active marathon runner, sued Unum Life Insurance seeking long-term disability income. Symptoms included extreme fatigue, brain fog, decreased attention and concentration, and nearly daily fevers, causing him to stop working in April 2020.

His diagnosis wasn’t definitive. Three doctors said he had long COVID, and four said he had chronic fatigue syndrome. Unum cited this inconsistency as a rationale for rejecting his claim. But the court sided with Mr. Abrams, granting him disability income. The court concluded: “Unum may be correct that [the plaintiff] has not been correctly diagnosed. But that does not mean he is not sick. If [the plaintiff’s] complaints, and [the doctor’s] assessments, are to be believed, [the plaintiff] cannot focus for more than a few minutes at a time, making it impossible for [the plaintiff] to perform the varied and complex tasks his job requires.”

Unum said in an emailed statement that the company doesn’t comment on specific claims as a matter of policy, adding that its total payouts for disability claims from March 2020 to February 2022 were 35% higher than prepandemic levels. “In general, disability and leave claims connected to COVID-19 have been primarily short-term events with the majority of claimants recovering prior to completing the normal qualification period for long-term disability insurance,” Unum said.

Mr. Abrams prevailed in part because he had detailed documentation of the numerous impairments that eventually required him to stop work, said Michelle Roberts of Roberts Disability Law in Oakland, Calif.

He submitted videos of himself taking his temperature to prove he had almost daily fevers, according to court records. He underwent neuropsychological testing, which found learning deficiencies and memory deficits.

Mr. Abrams also submitted statements from a colleague who worked with him on a complex technology patent case involving radiofrequency identification. Before he got COVID, Mr. Abrams “had the analytical ability, legal acumen, and mental energy to attack that learning curve and get up to speed very rapidly,” according to court records.

“The court focused on credulity.” Ms. Roberts said. “There was all this work to be done to show this person was high functioning and ran marathons and worked in an intense, high-pressure occupation but then couldn’t do anything after long COVID.”

Documentation was also crucial in another early federal long COVID disability lawsuit that was filed in 2022 on behalf of Wendy Haut, an educational software sales representative in California who turned to the courts seeking disability income through her company’s employee benefits plan.

Several of Ms. Haut’s doctors documented a detailed list of long COVID symptoms, including “profound fatigue and extreme cognitive difficulties,” that they said prevented her from working as a sales representative or doing any other type of job. A settlement agreement in June 2022 required Reliance Standard Life Insurance to pay Ms. Haut long-term disability benefits, including previously unpaid benefits, according to a report by the advocacy group Pandemic Patients.

Representatives of Reliance Standard didn’t respond to a request for comment.

The growing number of workers being sidelined by long COVID makes more claims and more court cases likely. Right now, an estimated 16 million working-age Americans aged 18-65 years have long COVID, and as many as 4 million of them can’t work, according to a July 2023 Census Bureau report.

Uncertainty about the volume of claims in the pipeline is part of what’s driving some insurers to fight long COVID claims, Ms. Roberts said. Another factor is the lack of clarity around how many years people with long COVID may be out of work, particularly if they’re in their 30s or 40s and might be seeking disability income until they reach retirement age.

“Doctors are not always saying that this person will be permanently disabled,” Ms. Roberts said. “If this person doesn’t get better and they’re disabled until retirement age, this could be a payout in the high six or seven figures if a person is very young and was a very high earner.”

Insurance companies routinely deny claims that can’t be backed up with objective measures, such as specific lab test results or clear findings from a physical exam. But there are steps that can increase the odds of a successful claim for long COVID disability benefits, according to New York–based law firm Hiller.

For starters, patients can document COVID test results, and if testing wasn’t conducted, patients can detail the specific symptoms that led to this diagnosis, Hiller advises. Then patients can keep a daily symptom log at home that run lists all of the specific symptoms that occur at different times during the day and night to help establish a pattern of disability. These logs should provide specific details about every job duty patients have and exactly how specific symptoms of long COVID interfere with these duties.

Even though objective testing is hard to come by for long COVID, people should undergo all the tests they can that may help document the frequency or severity of specific symptoms that make it impossible to carry on with business as usual at work, Hiller advises. This may include neuropsychological testing to document brain fog, a cardiopulmonary exercise test to demonstrate chronic fatigue and the inability to exercise, or a tilt table test to measure dizziness.

Seeking a doctor’s diagnosis can be key to collecting disability payments, in or out of court.

All of this puts a lot of pressure on doctors and patients to build strong cases, said Jonathan Whiteson, MD, codirector of the NYU Langone Health post-COVID care program in New York. “Many physicians are not familiar with the disability benefit paperwork, and so this is a challenge for the doctors to know how to complete and to build the time into their highly scheduled days to take the time needed to complete.

“It’s also challenging because most of the disability benefit forms are ‘generic’ and do not ask specific questions about COVID disability,” Dr. Whiteson added. “It can be like trying to drive a square peg into a round hole.”

Still, when it comes to long COVID, completing disability paperwork is increasingly becoming part of standard care, along with managing medication, rehabilitation therapies, and lifestyle changes to navigate daily life with this illness, Dr. Whiteson noted.

Monica Verduzco-Gutierrez, MD, chair of rehabilitation medicine and director of the Post-COVID-19 Recovery Clinic at the University of Texas Health Science Center, San Antonio, agreed with this assessment.

“I have done letter upon letter of appeal to disability insurance companies,” she said.

Some doctors, however, are reluctant to step up in such cases, in part because no standard diagnostic guidelines exist for long COVID and because it can be frustrating.

“This is the work that is not paid and causes burnout in physicians,” Dr. Verduzco-Gutierrez said. “The paperwork, the fighting with insurance companies, the resubmission of forms for disability all to get what your patient needs – and then it gets denied.

“We will keep doing this because our patients need this disability income in order to live their lives and to afford what they need for recovery,” said Dr. Verduzco-Gutierrez. “But at some point something has to change because this isn’t sustainable.”

A version of this article appeared on Medscape.com.

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

An influential Nature paper predicted in 2017 that advances in artificial intelligence (AI) could unleash remarkable changes in dermatology, such as using phones to help detect skin cancer earlier.

Given that about 6.3 billion smartphones would soon be in use, this AI approach could provide a gateway for “low-cost universal access to vital diagnostic care,” wrote Justin M. Ko, MD, MBA, a dermatologist, and colleagues from Stanford (Calif.) University that included other dermatologists and engineers.

Dr. Ko and his coauthors described how they trained a computer system to identify both benign and cancerous skin lesions. They used an approach known as a convolutional neural network, often deployed for projects seeking to train computers to “see” through image analysis. They said that their test of this system found it to be on par with the performance of 21 board-certified dermatologists.

“This fast, scalable method is deployable on mobile devices and holds the potential for substantial clinical impact, including broadening the scope of primary care practice and augmenting clinical decision-making for dermatology specialists,” they wrote in their paper.

More than 6 years later, there are signs that companies are making progress toward moving skin checks using this technology into U.S. primary care settings – but only with devices that employ special tools.

It may prove tougher for companies to eventually secure the sign-off of the U.S. Food and Drug Administration for mobile apps intended to let consumers handle this task with smartphones.

Such tools would need to be proven highly accurate before release, because too many false positives mean that people would be needlessly exposed to biopsies, said Sancy A. Leachman, MD, PhD, director of the melanoma research program and chair of the department of dermatology at Oregon Health & Science University, Portland.

And false-negative readings would allow melanoma to advance and even be fatal, Dr. Leachman told this news organization.

Roxana Daneshjou, MD, PhD, a dermatologist at Stanford who has studied the promise and the pitfalls of AI in medicine, said that developers of a consumer skin-check app would need to know how people would react to their readings. That includes a good sense of how often they would appropriately seek medical care for a concerning reading. (She was not an author of the previously cited Nature paper but has published widely on AI.)

Christopher Smith

“The direct-to-consumer diagnostic space makes me nervous,” Dr. Daneshjou said in an interview. “In order to do it, you really need to have good studies in consumer populations prior to release. You need to show how effective it is with follow up.”
 

FDA shows interest – and reservations

As of July, the FDA had not yet given its okay for marketing of any consumer apps intended to help people detect signs of skin cancer, an agency spokesperson told this news organization.

To date, the agency has only cleared two AI-based products for this task, both meant to be used by dermatologists. And only one of these two products, Scibase’s Nevisense, remains in use in the United States. The other, MelaFind, has been discontinued. In 2017, Strata Skin Sciences said that the product did not win “a significant enough level of acceptance by dermatologists to justify the continued investment” in it. And the company said it notified the 90 owners of MelaFind devices in the United States that it would no longer support the device.

But another company, DermaSensor, said in a 2021 press release that it expects its AI-powered tool, also named DermaSensor, to be the “first ever FDA cleared or approved skin cancer detection device for primary care providers.”

The Miami-based firm said that the FDA had granted its product a “breakthrough” device designation. A breakthrough designation means that agency staff will offer extra help and guidance to companies in developing a product, because of its expected benefit for patients.

In a 2020 press release, 3Derm Systems, now owned by Digital Diagnostics, made a similar announcement about winning FDA breakthrough designation for an AI-powered tool intended to allow skin checks in primary care settings.

(The FDA generally does not comment on its reviews of experimental drugs and devices, but companies can do so. Several other companies have announced FDA breakthrough designations for AI-driven products intended to check for skin lesions, but these might be used in settings other than primary care.)

Both DermaSensor and Digital Diagnostics have chairs with notable track records for winning FDA approvals of other devices. DermaSensor’s Maurice Ferre, MD, also is the chairman of Insightec, which in 2016 won the first FDA approval for a device with a breakthrough designation device that uses ultrasound to treat tremors.

In 2018, the FDA allowed Digital Diagnostics, then called IDx, to introduce in the United States the first medical device using AI in primary care offices to check for signs of diabetic retinopathy. This product also had an FDA breakthrough designation. The executive chairman and founder of Digital Diagnostics is Michael Abramoff, MD, PhD, professor of engineering and ophthalmology at the University of Iowa, Iowa City. Dr. Abramoff and the team behind the AI tool for retinopathy, now called the LumineticsCore system, also scored a notable win with Medicare, which agreed to cover use of the product through a dedicated CPT code.
 

FDA draft guidance

The FDA has acknowledged the interest in broadening access to skin checks via AI.

This was a topic of discussion at a 2-day advisory committee meeting the FDA held last year. In April 2023, the FDA outlined some of its expectations for future regulation of skin-analyzing tools as part of a wide-ranging draft guidance document intended to aid companies in their efforts to develop products using a form of AI known as machine learning.

In the document, the FDA described how it might approach applications for “hypothetical” devices using this kind of AI, such as a special tool to help primary care clinicians identify lesions in need of further investigation. Such a product would use a specific camera for gathering data for its initial clearance, in the FDA’s hypothetical scenario.

The FDA staff offered technical suggestions about what the developer of this hypothetical device would have to do to extend its use to smartphones and tablets while keeping clinicians as the intended users.

Some of these expanded uses could fall within the bounds of the FDA’s initial clearance and thus not trigger a need for a new marketing submission, the agency said. But seeking to shift this hypothetical product to “patient-facing” use would require a new marketing submission to the FDA, the agency said.

In this scenario, a company would expect people to follow up with a dermatologist after receiving a report suggesting cancer. Thus, this kind of a change could expose patients to “many new, unconsidered risks,” the FDA said.
 

Reality check?

The state of current efforts to develop consumer apps for checking for skin cancer seems to be summarized well on the website for the MoleMapper. The app was developed by researchers at OHSU to help people track how their moles change over time.

“Mole Mapper is NOT designed to provide medical advice, professional diagnosis, opinion, or treatment. Currently, there is not enough data to develop an app that can diagnose melanoma, but if enough data is collected through Mole Mapper and shared with researchers, it may be possible in the future,” the app’s website says.

OHSU released MoleMapper as an iPhone app in 2015. The aim of this project was to help people track the moles on their skin while also fostering an experiment in “citizen science,” OHSU’s Dr. Leachman told this news organization.

OHSU researchers hoped that the digital images taken by members of the public on cell phones could one day be used to develop diagnostic algorithms for melanoma.

But around 2017, the MoleMapper team realized that they would not be able to create a diagnostic app at this time, Dr. Leachman explained. They could not collect enough data of adequate quality.

And by 2021, it was clear that they could not even develop a successful app to triage patients to assess who needs to be seen quickly. The amount of data required was, at this point, beyond what the team could collect, Dr. Leachman said in an interview.

That was a disappointment because the team had successfully completed the difficult task of creating a confidential pathway for collecting these images via both iPhones and smartphones run on Android.

“We thought if we built it, people would come, but that’s not what happened,” Dr. Leachman said. Many patients didn’t want their images used for research or would fail to follow up with details of biopsy reports. Sometimes images were not captured well enough to be of use.

“You need at least hundreds of thousands, if not millions, of data points that have been verified with pathologies, and nobody was giving us back that data. That was the reality,” Dr. Leachman said.

There were valuable lessons in that setback. The OHSU team now has a better grasp of the challenges of trying to build a data-collection system that could prove helpful in assessing skin lesions.

“If you don’t build it, you don’t know” what can go wrong, she said.

Dr. Leachman said other scientists who have worked on similar projects to build skin-analyzing apps have probably encountered the same difficulties, although they may not reveal these issues. “I think that a lot of people build these things and then they try to make it into something that it’s not,” she said.

In addition to the challenges with gathering images, dermatologists frequently need to rely on touch and other clues from in-person visits when diagnosing a suspicious lesion. “There’s something about seeing and feeling the skin in person that can’t be captured completely with an image,” Dr. Leachman said.
 

Public demand

Still, regulators must face the strong and immediate interest consumers have in using AI to check on moles and skin conditions, despite continuing questions about how well this approach might work.

In June, Google announced in a blog post that its Google Lens tool can help people research skin conditions.

“Just take a picture or upload a photo through Lens, and you’ll find visual matches to inform your search,” Google said in a blog post. “This feature also works if you’re not sure how to describe something else on your body, like a bump on your lip, a line on your nails or hair loss on your head. This feature is currently available in the U.S.”

Google also continues work on DermAssist, an app that’s intended to help people get personalized information about skin concerns using three photos. It is not currently publicly available, a Google spokesperson told this news organization.

Several skin-analyzing apps are already available in the Apple and Google Play stores. The British Association of Dermatologists last year issued a press release warning consumers that these apps may not be safe or effective and thus may put patients at risk for misdiagnosis.

“Unfortunately, AI-based apps which do not appear to meet regulatory requirements crop up more often than we would like,” the association said. “Additionally, the evidence to support the use of AI to diagnose skin conditions is weak which means that when it is used, it may not be safe or effective and it is possible that AI is putting patients at risk of misdiagnosis.”

Delicate and difficult balancing act

At this time, regulators, entrepreneurs, and the medical community face a delicate balancing act in considering how best to deploy AI in skin care, Dr. Ko said in an interview. (In addition to being one of the authors on the widely cited 2017 Nature paper mentioned above, Dr. Ko served until March as the initial chair of the American Academy of Dermatology’s Augmented Intelligence Committee.)

There are many solid reasons why there hasn’t been speedy progress to deploy AI in dermatology, as many envisioned a few years ago, Dr. Ko said.

Some of those reasons are specific to dermatology; this field doesn’t have a ready set of robust data from which to build AI-driven tools. In this aspect, dermatology is decades behind specialties like radiology, pathology, and ophthalmology, where clinicians have long been accumulating and storing images and other data in more standardized ways, Dr. Ko said.

“If you went to most dermatology practices and said, ‘Hey, let me learn from the data accumulated over the course of your 30-year practice to help us develop new tools,’” there may not be a whole lot there,” Dr. Ko said.

Beyond the start-up hurdles is the larger concern Dr. Ko shares with other dermatologists who work in this field, such as Dr. Daneshjou and Dr. Leachman. What would clinicians without much dermatology training and patients do with the readings from AI-driven tools and apps?

There would need to be significant research to show that such products actually help get people treated for skin diseases, including skin cancer.

Dr. Ko praised Google for being open about the stumbles with its efforts to use its AI tool for identifying diabetic retinopathy in a test in Thailand. Real-world hitches included poor Internet connections and poor image quality.

Developing reliable systems, processes, and workflows will be paramount for eventual widespread use of AI-driven tools, Dr. Ko said.

“It’s all those hidden things that are not sexy,” as are announcements about algorithms working about as well as clinicians in diagnosis, Dr. Ko said. “They don’t get the media attention, but they’re going to be make or break for AI, not just in our field but [for] AI in general.”

But he added that there also needs to be a recognition that AI-driven tools and products, even if somewhat imperfect, can help people get access to care.

In many cases, shortages of specialists prevent people from getting screened for treatable conditions such as skin cancer and retinopathy. The challenge is setting an appropriate standard to make sure that AI-driven products would help most patients in practice, without raising it so high that no such products emerge.

“There’s a risk of holding too high of a bar,” Dr. Ko said. “There is harm in not moving forward as well.”

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

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.

On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.

This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.

Are the ProPublica and Times stories emblematic of the field at large or a case of a few rogue doctors, and did changes in reimbursement and support from device manufacturers exacerbate the problem?

Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.

“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
 

‘A few bad apples’

“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.

“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.

“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
 

Lifestyle changes first

PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.

Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.

Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
 

‘Medically unnecessary’

According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.

Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.

There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.

Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.

Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”

The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.

Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.

Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.

Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.

In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”

The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.

“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
 

Financial incentives to blame?

In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.

Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.

Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.

“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.

The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”

Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.

“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”

Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”

Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
 

Multidisciplinary teams needed

Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”

Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”

Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.

Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”

Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”

Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”

PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”

Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.

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

On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.

On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.

This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.

Are the ProPublica and Times stories emblematic of the field at large or a case of a few rogue doctors, and did changes in reimbursement and support from device manufacturers exacerbate the problem?

Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.

“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
 

‘A few bad apples’

“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.

“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.

“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
 

Lifestyle changes first

PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.

Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.

Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
 

‘Medically unnecessary’

According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.

Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.

There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.

Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.

Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”

The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.

Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.

Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.

Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.

In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”

The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.

“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
 

Financial incentives to blame?

In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.

Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.

Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.

“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.

The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”

Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.

“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”

Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”

Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
 

Multidisciplinary teams needed

Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”

Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”

Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.

Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”

Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”

Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”

PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”

Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.

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

On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.

On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.

This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.

Are the ProPublica and Times stories emblematic of the field at large or a case of a few rogue doctors, and did changes in reimbursement and support from device manufacturers exacerbate the problem?

Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.

“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
 

‘A few bad apples’

“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.

“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.

“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
 

Lifestyle changes first

PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.

Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.

Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
 

‘Medically unnecessary’

According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.

Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.

There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.

Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.

Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”

The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.

Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.

Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.

Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.

In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”

The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.

“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
 

Financial incentives to blame?

In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.

Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.

Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.

“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.

The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”

Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.

“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”

Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”

Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
 

Multidisciplinary teams needed

Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”

Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”

Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.

Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”

Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”

Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”

PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”

Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.

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

Fifth pregnancy, first baby.

After four pregnancies resulted in losses – and doing things as natural as possible and leaving it up to the birds, bees, and fate – my husband and I decided to explore in vitro fertilization (IVF).

Drugs to direct my follicles to produce more eggs, an egg retrieval procedure, genetic testing of our embryos, a quick procedure to remove a residual uterine septum from my uterus, drugs to thicken my endometrial lining to prepare my body to receive an embryo, an embryo transfer, steroids to suppress my immune system so my body would accept the pregnancy, blood thinner shots to promote blood flow to the baby, and 10 weeks of progesterone in oil shots later and we’re days away from welcoming our first baby into our lives.

In short, there’s more than one way to define “miracle baby.”

Global estimates say 48 million couples and 186 million individuals struggle with infertility. On average, 2 million infants born in the United States each year are conceived through assisted reproductive technology and the demand for treatments like IVF have doubled in the last decade.

Now the need for treatments outweighs clinician availability. “We have about 1,250 practicing fertility physicians in the U.S. to serve the whole country, which is highly inadequate,” said Eduardo Hariton, MD, a reproductive endocrinology physician in San Francisco and managing director of the U.S. Fertility Innovation Fund. “We have people that want to get care waiting 1 to 3 months to be seen.”

Dr. Hariton explains that U.S. IVF clinics are performing around 250,000 to 300,000 IVF cycles per year and need to be doing a million-plus to meet demand. This, plus the cost of fertility treatments – an average IVF cycle runs $23,500 and the majority of patients need multiple cycles to conceive – keeps the barrier to entry high.

Enter technology: New advances are on the way to help the assisted fertility process to run smoother and be less costly. “The field is really coming into an age of great progress and innovation,” added S. Zev Williams, MD, PhD, chief of the division of reproductive endocrinology and Infertility at Columbia University Irving Medical Center, New York City.

I’m personally grateful that such technology exists. Here is a look at some recent game changers in reproductive tech and what the future may hold.
 

AI will help, of course

Fertility treatments involve endless analysis, diagnosis, and recommendations – dozens if not hundreds of decisions from each physician for each patient. Human action and reaction can affect this process, Dr. Hariton explained.

For example, if he hyperstimulated a woman during the follicle growing stage of her egg retrieval and ended up with eggs too large to retrieve, Dr. Hariton said he may subconsciously be more inclined to be extra cautious with his patients the week after, and vice versa.

This is where AI can help. “Rather than me making decisions from a couple of thousands of cycles of experience, I get to leverage hundreds of thousands of cycles from different providers over different people,” said Dr. Hariton. “I get to use all the data from that patient today – her age, her weight, what happened last cycle, how she’s doing – and make a very objective decision about the optimal time to give that woman or that couple the best outcome possible.”

AI can also assist with tasks like embryo grading. “Once our embryos are made in the lab, we usually have an embryologist looking at those embryos, grading them on a three-variable scale, and then picking the nicest one for transfer,” said Dr. Hariton. Machine learning computer vision software can help doctors select the best embryo.

Many of these AI products are in trials in the United States and some AI-based technology is already being used in fertility labs, especially in other countries. “ALife recently launched a suite of products to help with their decisions during stimulation that can help with the quality KPIs [key performance indicators] in the lab,” said Dr. Hariton. “There’s also a company that does AI-based predictions of success to give patients a better estimate called Univfy.” More AI products are still in development or awaiting Food and Drug Administration clearance.
 

Robots lend a hand

Like artificial intelligence, robots can be a big help in the IVF lab. Columbia University Fertility Center recently became the first to use an articulated (ART) robot to handle precise and highly repetitive work.

“IVF, from the initial point, involves creating these special plates where embryos can grow, and you do that by making little droplets,” said Dr. Williams. “It’s very time-consuming to create tons of these little droplets for the embryos to grow.” Thus, the lab created a robot to help squirt drops of the media substance required to sustain embryos in a way that is 10 times more precise than that of a trained embryologist.

“It’s a win-win because you allow the robots to do things better than a human can and this allows the humans to do things that a robot just can’t do,” explained Dr. Williams. He and his team began using this technology in the beginning of November 2022.

Dr. Williams sees ART robots being used in many more parts of the fertility treatment journey along the way, like preparing eggs after they are retrieved and performing intracytoplasmic sperm injection (ICSI), with the robot injecting the sperm into the egg.

Launching with the plate making, said Dr. Williams, is a low stakes entry point for robotic technology in the lab. “It allows us to introduce robotics to automate and optimize each step along the way, but to do so in the safest possible way.”

Dr. Williams estimates that robots will have their hands on actual eggs and sperm in 5 years.
 

Updates in genetic testing

Currently, if a couple wants to have their embryos genetically tested, also known as preimplantation genetic testing, each embryo must be frozen, then a biopsy of that embryo is performed and sent to the lab.

“It takes time to get the results,” said Dr. Williams. “The whole time you’re waiting, you don’t know if you’re going to have any embryos that are transferable or if next month you’re going to have to do another IVF cycle.”

Columbia researchers recently developed a new in-house test that can determine if a fetus or embryo has the right number of chromosomes. This STORK (Short-read Transpore Rapid Karyotyping) can be performed without freezing embryos and sending them out, which Dr. Williams said can save couples money and time, as they won’t necessarily need to do a separate embryo transfer cycle and can transfer an embryo in the same cycle. “You can test in the morning and transfer in the afternoon,” said Dr. Williams.

The test is currently awaiting approval and will first be used to test miscarriage samples to see if embryos were genetically normal or not, which he said should cost around $200 vs. the $2,000 to $4,000 it can cost to have fetal tissue sent to the lab – and insurance doesn’t cover the procedure until after a second or third miscarriage.

This, said Dr. Williams, should be in the field in less than a year, and he estimates that the test will be used for fresh embryos in about a year and a half.
 

Sperm collection made simpler

Typically, a man delivers a sperm sample in a room at an IVF clinic or by collecting a sample at home and rushing it to the clinic before it degrades, which Dr. Williams said can happen in as little as 15 minutes.

In 2020, Dr. Williams and his team began using a custom at-home sperm collection box that houses sperm in a recyclable foam container that holds a sample cup, which is filled with special sperm-supporting media, at an angle that prevents evaporation and maintains temperature and pH. This allows patients to collect samples in the comfort of their homes and increases the clock to 3 hours.

“It’s great for the patients because it’s much more comfortable,” said Dr. Williams, who notes that having to “perform” on site can be stressful for men. Studies the team has conducted have shown sperm collected in this manner have a better success rate than those collected in the lab, and 90% of Columbia’s Fertility Center patients are now providing sperm samples this way.

Similar innovations to deliver sperm, like Protex, are now on the market, while companies like myLabBox and Legacy are offering at-home sperm testing kits to mail in for a full semen analysis.
 

At-home monitoring: More and better

Wearable reproductive health devices are also helping more women get pregnant. “I am very excited about biometric data harnessed in wearables to predict periods, ovulation, and fertility,” said Amander Clark, PhD, director of the UCLA Center for Reproductive Science, Health, and Education, Los Angeles.

The Tempdrop Fertility and Ovulation Tracker, for instance, is a wearable sensor with an accompanying charting app that helps a woman identify her most fertile days to conceive. The Bellabeat Ivy is a women’s health smart bracelet with a strong focus on tracking a woman’s cycle and fertility, pregnancy, and postnatal symptoms. And Mirvie, which is currently in development, is a blood test that will be able to predict pregnancy complications earlier.

Physicians are also looking to move as much of the lab experience as they can into a patient’s home, which streamlines processes while offering privacy and comfort. For example, Dr. Hariton, who runs a strategic venture capital fund for physicians, said his team is currently working with a company that does remote ultrasounds.

And Mira, an at-home hormone monitor, uses patented AI algorithms to accurately measure the levels of major reproductive health hormones (E3G, LH, PdG, FSH) in urine, said Meir Olcha, MD, chief medical officer at Sama Fertility. The product recently completed a clinical trial, which showed it was a viable alternative to blood serum for patients undergoing IVF.
 

Stem cells could make eggs ageless

Research shows that a woman’s egg quality decreases gradually but significantly starting at age 32 and more rapidly after 37. Sperm quality may also decrease with age. A possible workaround: Scientists are actively researching how to create eggs and sperm from stem cells.

“I think getting eggs from stem cells will happen in the future,” said Dr. Hariton, who notes that this type of technology would be a game changer in his clinic. “It will make some of the hardest diagnoses that I have – which is on a daily basis, ‘I’m so sorry, you’re in premature menopause’ or ‘I don’t think we’re going to be successful getting you pregnant with your own eggs; here are some other options like donor eggs’ – much better,” he added. And stem cells are currently being used to research causes of infertility.

Clinics like UCLA have already been making strides. “We are using stem cells to identify new genes required for reproduction and to define the role of these genes in human fertility and infertility,” said Dr. Clark, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, who recently led a study in this arena. “In vitro gametogenesis (IVG), another stem cell technology, is currently used in the research lab to understand causes of infertility.”

These stem cell-based embryo models, she said, can help researchers understand the first few days of embryo development after an embryo implants and be used to provide critical information on causes of early pregnancy loss or birth defects.

A version of this article appeared on Medscape.com.

Fifth pregnancy, first baby.

After four pregnancies resulted in losses – and doing things as natural as possible and leaving it up to the birds, bees, and fate – my husband and I decided to explore in vitro fertilization (IVF).

Drugs to direct my follicles to produce more eggs, an egg retrieval procedure, genetic testing of our embryos, a quick procedure to remove a residual uterine septum from my uterus, drugs to thicken my endometrial lining to prepare my body to receive an embryo, an embryo transfer, steroids to suppress my immune system so my body would accept the pregnancy, blood thinner shots to promote blood flow to the baby, and 10 weeks of progesterone in oil shots later and we’re days away from welcoming our first baby into our lives.

In short, there’s more than one way to define “miracle baby.”

Global estimates say 48 million couples and 186 million individuals struggle with infertility. On average, 2 million infants born in the United States each year are conceived through assisted reproductive technology and the demand for treatments like IVF have doubled in the last decade.

Now the need for treatments outweighs clinician availability. “We have about 1,250 practicing fertility physicians in the U.S. to serve the whole country, which is highly inadequate,” said Eduardo Hariton, MD, a reproductive endocrinology physician in San Francisco and managing director of the U.S. Fertility Innovation Fund. “We have people that want to get care waiting 1 to 3 months to be seen.”

Dr. Hariton explains that U.S. IVF clinics are performing around 250,000 to 300,000 IVF cycles per year and need to be doing a million-plus to meet demand. This, plus the cost of fertility treatments – an average IVF cycle runs $23,500 and the majority of patients need multiple cycles to conceive – keeps the barrier to entry high.

Enter technology: New advances are on the way to help the assisted fertility process to run smoother and be less costly. “The field is really coming into an age of great progress and innovation,” added S. Zev Williams, MD, PhD, chief of the division of reproductive endocrinology and Infertility at Columbia University Irving Medical Center, New York City.

I’m personally grateful that such technology exists. Here is a look at some recent game changers in reproductive tech and what the future may hold.
 

AI will help, of course

Fertility treatments involve endless analysis, diagnosis, and recommendations – dozens if not hundreds of decisions from each physician for each patient. Human action and reaction can affect this process, Dr. Hariton explained.

For example, if he hyperstimulated a woman during the follicle growing stage of her egg retrieval and ended up with eggs too large to retrieve, Dr. Hariton said he may subconsciously be more inclined to be extra cautious with his patients the week after, and vice versa.

This is where AI can help. “Rather than me making decisions from a couple of thousands of cycles of experience, I get to leverage hundreds of thousands of cycles from different providers over different people,” said Dr. Hariton. “I get to use all the data from that patient today – her age, her weight, what happened last cycle, how she’s doing – and make a very objective decision about the optimal time to give that woman or that couple the best outcome possible.”

AI can also assist with tasks like embryo grading. “Once our embryos are made in the lab, we usually have an embryologist looking at those embryos, grading them on a three-variable scale, and then picking the nicest one for transfer,” said Dr. Hariton. Machine learning computer vision software can help doctors select the best embryo.

Many of these AI products are in trials in the United States and some AI-based technology is already being used in fertility labs, especially in other countries. “ALife recently launched a suite of products to help with their decisions during stimulation that can help with the quality KPIs [key performance indicators] in the lab,” said Dr. Hariton. “There’s also a company that does AI-based predictions of success to give patients a better estimate called Univfy.” More AI products are still in development or awaiting Food and Drug Administration clearance.
 

Robots lend a hand

Like artificial intelligence, robots can be a big help in the IVF lab. Columbia University Fertility Center recently became the first to use an articulated (ART) robot to handle precise and highly repetitive work.

“IVF, from the initial point, involves creating these special plates where embryos can grow, and you do that by making little droplets,” said Dr. Williams. “It’s very time-consuming to create tons of these little droplets for the embryos to grow.” Thus, the lab created a robot to help squirt drops of the media substance required to sustain embryos in a way that is 10 times more precise than that of a trained embryologist.

“It’s a win-win because you allow the robots to do things better than a human can and this allows the humans to do things that a robot just can’t do,” explained Dr. Williams. He and his team began using this technology in the beginning of November 2022.

Dr. Williams sees ART robots being used in many more parts of the fertility treatment journey along the way, like preparing eggs after they are retrieved and performing intracytoplasmic sperm injection (ICSI), with the robot injecting the sperm into the egg.

Launching with the plate making, said Dr. Williams, is a low stakes entry point for robotic technology in the lab. “It allows us to introduce robotics to automate and optimize each step along the way, but to do so in the safest possible way.”

Dr. Williams estimates that robots will have their hands on actual eggs and sperm in 5 years.
 

Updates in genetic testing

Currently, if a couple wants to have their embryos genetically tested, also known as preimplantation genetic testing, each embryo must be frozen, then a biopsy of that embryo is performed and sent to the lab.

“It takes time to get the results,” said Dr. Williams. “The whole time you’re waiting, you don’t know if you’re going to have any embryos that are transferable or if next month you’re going to have to do another IVF cycle.”

Columbia researchers recently developed a new in-house test that can determine if a fetus or embryo has the right number of chromosomes. This STORK (Short-read Transpore Rapid Karyotyping) can be performed without freezing embryos and sending them out, which Dr. Williams said can save couples money and time, as they won’t necessarily need to do a separate embryo transfer cycle and can transfer an embryo in the same cycle. “You can test in the morning and transfer in the afternoon,” said Dr. Williams.

The test is currently awaiting approval and will first be used to test miscarriage samples to see if embryos were genetically normal or not, which he said should cost around $200 vs. the $2,000 to $4,000 it can cost to have fetal tissue sent to the lab – and insurance doesn’t cover the procedure until after a second or third miscarriage.

This, said Dr. Williams, should be in the field in less than a year, and he estimates that the test will be used for fresh embryos in about a year and a half.
 

Sperm collection made simpler

Typically, a man delivers a sperm sample in a room at an IVF clinic or by collecting a sample at home and rushing it to the clinic before it degrades, which Dr. Williams said can happen in as little as 15 minutes.

In 2020, Dr. Williams and his team began using a custom at-home sperm collection box that houses sperm in a recyclable foam container that holds a sample cup, which is filled with special sperm-supporting media, at an angle that prevents evaporation and maintains temperature and pH. This allows patients to collect samples in the comfort of their homes and increases the clock to 3 hours.

“It’s great for the patients because it’s much more comfortable,” said Dr. Williams, who notes that having to “perform” on site can be stressful for men. Studies the team has conducted have shown sperm collected in this manner have a better success rate than those collected in the lab, and 90% of Columbia’s Fertility Center patients are now providing sperm samples this way.

Similar innovations to deliver sperm, like Protex, are now on the market, while companies like myLabBox and Legacy are offering at-home sperm testing kits to mail in for a full semen analysis.
 

At-home monitoring: More and better

Wearable reproductive health devices are also helping more women get pregnant. “I am very excited about biometric data harnessed in wearables to predict periods, ovulation, and fertility,” said Amander Clark, PhD, director of the UCLA Center for Reproductive Science, Health, and Education, Los Angeles.

The Tempdrop Fertility and Ovulation Tracker, for instance, is a wearable sensor with an accompanying charting app that helps a woman identify her most fertile days to conceive. The Bellabeat Ivy is a women’s health smart bracelet with a strong focus on tracking a woman’s cycle and fertility, pregnancy, and postnatal symptoms. And Mirvie, which is currently in development, is a blood test that will be able to predict pregnancy complications earlier.

Physicians are also looking to move as much of the lab experience as they can into a patient’s home, which streamlines processes while offering privacy and comfort. For example, Dr. Hariton, who runs a strategic venture capital fund for physicians, said his team is currently working with a company that does remote ultrasounds.

And Mira, an at-home hormone monitor, uses patented AI algorithms to accurately measure the levels of major reproductive health hormones (E3G, LH, PdG, FSH) in urine, said Meir Olcha, MD, chief medical officer at Sama Fertility. The product recently completed a clinical trial, which showed it was a viable alternative to blood serum for patients undergoing IVF.
 

Stem cells could make eggs ageless

Research shows that a woman’s egg quality decreases gradually but significantly starting at age 32 and more rapidly after 37. Sperm quality may also decrease with age. A possible workaround: Scientists are actively researching how to create eggs and sperm from stem cells.

“I think getting eggs from stem cells will happen in the future,” said Dr. Hariton, who notes that this type of technology would be a game changer in his clinic. “It will make some of the hardest diagnoses that I have – which is on a daily basis, ‘I’m so sorry, you’re in premature menopause’ or ‘I don’t think we’re going to be successful getting you pregnant with your own eggs; here are some other options like donor eggs’ – much better,” he added. And stem cells are currently being used to research causes of infertility.

Clinics like UCLA have already been making strides. “We are using stem cells to identify new genes required for reproduction and to define the role of these genes in human fertility and infertility,” said Dr. Clark, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, who recently led a study in this arena. “In vitro gametogenesis (IVG), another stem cell technology, is currently used in the research lab to understand causes of infertility.”

These stem cell-based embryo models, she said, can help researchers understand the first few days of embryo development after an embryo implants and be used to provide critical information on causes of early pregnancy loss or birth defects.

A version of this article appeared on Medscape.com.

Fifth pregnancy, first baby.

After four pregnancies resulted in losses – and doing things as natural as possible and leaving it up to the birds, bees, and fate – my husband and I decided to explore in vitro fertilization (IVF).

Drugs to direct my follicles to produce more eggs, an egg retrieval procedure, genetic testing of our embryos, a quick procedure to remove a residual uterine septum from my uterus, drugs to thicken my endometrial lining to prepare my body to receive an embryo, an embryo transfer, steroids to suppress my immune system so my body would accept the pregnancy, blood thinner shots to promote blood flow to the baby, and 10 weeks of progesterone in oil shots later and we’re days away from welcoming our first baby into our lives.

In short, there’s more than one way to define “miracle baby.”

Global estimates say 48 million couples and 186 million individuals struggle with infertility. On average, 2 million infants born in the United States each year are conceived through assisted reproductive technology and the demand for treatments like IVF have doubled in the last decade.

Now the need for treatments outweighs clinician availability. “We have about 1,250 practicing fertility physicians in the U.S. to serve the whole country, which is highly inadequate,” said Eduardo Hariton, MD, a reproductive endocrinology physician in San Francisco and managing director of the U.S. Fertility Innovation Fund. “We have people that want to get care waiting 1 to 3 months to be seen.”

Dr. Hariton explains that U.S. IVF clinics are performing around 250,000 to 300,000 IVF cycles per year and need to be doing a million-plus to meet demand. This, plus the cost of fertility treatments – an average IVF cycle runs $23,500 and the majority of patients need multiple cycles to conceive – keeps the barrier to entry high.

Enter technology: New advances are on the way to help the assisted fertility process to run smoother and be less costly. “The field is really coming into an age of great progress and innovation,” added S. Zev Williams, MD, PhD, chief of the division of reproductive endocrinology and Infertility at Columbia University Irving Medical Center, New York City.

I’m personally grateful that such technology exists. Here is a look at some recent game changers in reproductive tech and what the future may hold.
 

AI will help, of course

Fertility treatments involve endless analysis, diagnosis, and recommendations – dozens if not hundreds of decisions from each physician for each patient. Human action and reaction can affect this process, Dr. Hariton explained.

For example, if he hyperstimulated a woman during the follicle growing stage of her egg retrieval and ended up with eggs too large to retrieve, Dr. Hariton said he may subconsciously be more inclined to be extra cautious with his patients the week after, and vice versa.

This is where AI can help. “Rather than me making decisions from a couple of thousands of cycles of experience, I get to leverage hundreds of thousands of cycles from different providers over different people,” said Dr. Hariton. “I get to use all the data from that patient today – her age, her weight, what happened last cycle, how she’s doing – and make a very objective decision about the optimal time to give that woman or that couple the best outcome possible.”

AI can also assist with tasks like embryo grading. “Once our embryos are made in the lab, we usually have an embryologist looking at those embryos, grading them on a three-variable scale, and then picking the nicest one for transfer,” said Dr. Hariton. Machine learning computer vision software can help doctors select the best embryo.

Many of these AI products are in trials in the United States and some AI-based technology is already being used in fertility labs, especially in other countries. “ALife recently launched a suite of products to help with their decisions during stimulation that can help with the quality KPIs [key performance indicators] in the lab,” said Dr. Hariton. “There’s also a company that does AI-based predictions of success to give patients a better estimate called Univfy.” More AI products are still in development or awaiting Food and Drug Administration clearance.
 

Robots lend a hand

Like artificial intelligence, robots can be a big help in the IVF lab. Columbia University Fertility Center recently became the first to use an articulated (ART) robot to handle precise and highly repetitive work.

“IVF, from the initial point, involves creating these special plates where embryos can grow, and you do that by making little droplets,” said Dr. Williams. “It’s very time-consuming to create tons of these little droplets for the embryos to grow.” Thus, the lab created a robot to help squirt drops of the media substance required to sustain embryos in a way that is 10 times more precise than that of a trained embryologist.

“It’s a win-win because you allow the robots to do things better than a human can and this allows the humans to do things that a robot just can’t do,” explained Dr. Williams. He and his team began using this technology in the beginning of November 2022.

Dr. Williams sees ART robots being used in many more parts of the fertility treatment journey along the way, like preparing eggs after they are retrieved and performing intracytoplasmic sperm injection (ICSI), with the robot injecting the sperm into the egg.

Launching with the plate making, said Dr. Williams, is a low stakes entry point for robotic technology in the lab. “It allows us to introduce robotics to automate and optimize each step along the way, but to do so in the safest possible way.”

Dr. Williams estimates that robots will have their hands on actual eggs and sperm in 5 years.
 

Updates in genetic testing

Currently, if a couple wants to have their embryos genetically tested, also known as preimplantation genetic testing, each embryo must be frozen, then a biopsy of that embryo is performed and sent to the lab.

“It takes time to get the results,” said Dr. Williams. “The whole time you’re waiting, you don’t know if you’re going to have any embryos that are transferable or if next month you’re going to have to do another IVF cycle.”

Columbia researchers recently developed a new in-house test that can determine if a fetus or embryo has the right number of chromosomes. This STORK (Short-read Transpore Rapid Karyotyping) can be performed without freezing embryos and sending them out, which Dr. Williams said can save couples money and time, as they won’t necessarily need to do a separate embryo transfer cycle and can transfer an embryo in the same cycle. “You can test in the morning and transfer in the afternoon,” said Dr. Williams.

The test is currently awaiting approval and will first be used to test miscarriage samples to see if embryos were genetically normal or not, which he said should cost around $200 vs. the $2,000 to $4,000 it can cost to have fetal tissue sent to the lab – and insurance doesn’t cover the procedure until after a second or third miscarriage.

This, said Dr. Williams, should be in the field in less than a year, and he estimates that the test will be used for fresh embryos in about a year and a half.
 

Sperm collection made simpler

Typically, a man delivers a sperm sample in a room at an IVF clinic or by collecting a sample at home and rushing it to the clinic before it degrades, which Dr. Williams said can happen in as little as 15 minutes.

In 2020, Dr. Williams and his team began using a custom at-home sperm collection box that houses sperm in a recyclable foam container that holds a sample cup, which is filled with special sperm-supporting media, at an angle that prevents evaporation and maintains temperature and pH. This allows patients to collect samples in the comfort of their homes and increases the clock to 3 hours.

“It’s great for the patients because it’s much more comfortable,” said Dr. Williams, who notes that having to “perform” on site can be stressful for men. Studies the team has conducted have shown sperm collected in this manner have a better success rate than those collected in the lab, and 90% of Columbia’s Fertility Center patients are now providing sperm samples this way.

Similar innovations to deliver sperm, like Protex, are now on the market, while companies like myLabBox and Legacy are offering at-home sperm testing kits to mail in for a full semen analysis.
 

At-home monitoring: More and better

Wearable reproductive health devices are also helping more women get pregnant. “I am very excited about biometric data harnessed in wearables to predict periods, ovulation, and fertility,” said Amander Clark, PhD, director of the UCLA Center for Reproductive Science, Health, and Education, Los Angeles.

The Tempdrop Fertility and Ovulation Tracker, for instance, is a wearable sensor with an accompanying charting app that helps a woman identify her most fertile days to conceive. The Bellabeat Ivy is a women’s health smart bracelet with a strong focus on tracking a woman’s cycle and fertility, pregnancy, and postnatal symptoms. And Mirvie, which is currently in development, is a blood test that will be able to predict pregnancy complications earlier.

Physicians are also looking to move as much of the lab experience as they can into a patient’s home, which streamlines processes while offering privacy and comfort. For example, Dr. Hariton, who runs a strategic venture capital fund for physicians, said his team is currently working with a company that does remote ultrasounds.

And Mira, an at-home hormone monitor, uses patented AI algorithms to accurately measure the levels of major reproductive health hormones (E3G, LH, PdG, FSH) in urine, said Meir Olcha, MD, chief medical officer at Sama Fertility. The product recently completed a clinical trial, which showed it was a viable alternative to blood serum for patients undergoing IVF.
 

Stem cells could make eggs ageless

Research shows that a woman’s egg quality decreases gradually but significantly starting at age 32 and more rapidly after 37. Sperm quality may also decrease with age. A possible workaround: Scientists are actively researching how to create eggs and sperm from stem cells.

“I think getting eggs from stem cells will happen in the future,” said Dr. Hariton, who notes that this type of technology would be a game changer in his clinic. “It will make some of the hardest diagnoses that I have – which is on a daily basis, ‘I’m so sorry, you’re in premature menopause’ or ‘I don’t think we’re going to be successful getting you pregnant with your own eggs; here are some other options like donor eggs’ – much better,” he added. And stem cells are currently being used to research causes of infertility.

Clinics like UCLA have already been making strides. “We are using stem cells to identify new genes required for reproduction and to define the role of these genes in human fertility and infertility,” said Dr. Clark, a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, who recently led a study in this arena. “In vitro gametogenesis (IVG), another stem cell technology, is currently used in the research lab to understand causes of infertility.”

These stem cell-based embryo models, she said, can help researchers understand the first few days of embryo development after an embryo implants and be used to provide critical information on causes of early pregnancy loss or birth defects.

A version of this article appeared on Medscape.com.

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.

To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.

Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
 

Managing patient and family expectations

These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.

In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.

But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
 

Only a sliver of Alzheimer’s patients are current candidates

The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.

Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.

Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
 

Significant risks

Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.

How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
 

A costly therapy

Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.

Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.

We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
 

Logistical challenges could be a rate-limiting step

Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?

Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.

A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
 

Antiamyloid drugs: An exciting first step

The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.

Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.

Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.

Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.

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

With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.

To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.

Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
 

Managing patient and family expectations

These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.

In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.

But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
 

Only a sliver of Alzheimer’s patients are current candidates

The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.

Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.

Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
 

Significant risks

Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.

How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
 

A costly therapy

Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.

Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.

We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
 

Logistical challenges could be a rate-limiting step

Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?

Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.

A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
 

Antiamyloid drugs: An exciting first step

The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.

Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.

Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.

Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.

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

With the Food and Drug Administration’s full stamp of approval in hand, Leqembi (lecanemab) is poised to catapult us into a new era of treatment for Alzheimer’s disease. And now that the donanemab trial data are out, there’s another antiamyloid drug waiting in the wings.

To finally have true disease-modifying therapies for Alzheimer’s disease is a massive step forward for a field that’s been plagued with disappointment. But these drugs come with serious concerns and unknowns. They will require complex decision-making, putting doctors, patients, and their families in a medical quandary.

Striking the right balance between cautious optimism and realistic expectations will be a formidable challenge.
 

Managing patient and family expectations

These drugs are no magic bullet. They slow down the dementia’s progression, buying patients more time (on the order of months) before they begin to experience significant worsening. We’ll need a lot more information from research and clinical experience before we can understand how meaningful that treatment effect is. Right now, it is unclear whether eligible patients and their families will even perceive tangible differences.

In the CLARITY-AD trial, participants on lecanemab experienced a 27% slowing in the rate of cognitive decline over 18 months. Donanemab was shown to slow decline in memory and cognition by about 35% over the same time frame in the TRAILBLAZER-ALZ 2 trial. That translates to more time for patients and their families to enjoy independence, maintain normal life, and stave off the most distressing parts of the disease.

But what happens after 18 months of treatment – will the treatment effect magnify or dissipate? How much time are we really buying in the long run? Counseling patients and their families is made all the more difficult when the answers to important questions like these remain to be seen.
 

Only a sliver of Alzheimer’s patients are current candidates

The fact is that most patients living with Alzheimer’s disease will not qualify for treatment with these drugs. Lecanemab is approved for people with early-stage disease, meaning their dementia is mild or they have mild cognitive impairment, which is a precursor to full-blown Alzheimer’s disease. Of the 6 million people in the United States living with Alzheimer’s, about 1.5 million are estimated to fall into that category. We can expect to see a similar qualifier for donanemab if it receives FDA approval, especially because that trial suggested a more pronounced treatment effect for patients in the earliest stages of the disease.

Even if a patient hits the sweet spot where they have just enough cognitive impairment, but not too much, they aren’t technically therapeutic candidates until prerequisite testing confirms amyloid protein accumulation in the brain via PET scan or cerebrospinal fluid analysis.

Even then, the FDA’s boxed warning for lecanemab recommends that patients undergo genetic testing for the apo E4 mutation to identify those at a particularly high risk for severe adverse effects including brain bleeding and swelling. This recommendation is not unreasonable considering that 15% of the Alzheimer’s population has two copies of the apo E4 mutation and fall into that high-risk group.
 

Significant risks

Antiamyloid drugs are well-known to cause serious side effects. In the lecanemab trial, 13% of participants receiving Leqembi experienced brain swelling (vs. 2% of participants receiving placebo) and 17% of participants had brain bleeding (vs. 9% of participants on placebo). In the donanemab trial, brain bleeding occurred in 31.4% of participants on the drug (vs. 13.6% on placebo) and swelling occurred in 24% (vs. 2.1% receiving placebo). Thankfully, in both trials, most of these adverse events did not produce significant symptoms, but in rare cases these events caused severe or catastrophic neurologic injury, including death.

How can we best guide patients and their families to weigh the uncertain benefits against potentially serious risks? We can start by considering the patient characteristics most likely to portend increased risk for serious side effects: apo E4 mutations, blood thinner use, and the presence of microhemorrhages on brain imaging. But after that, we’re left with a lot of uncertainty in terms of which patients are most likely to see meaningful clinical improvements from the drug and unknown factors that may increase the risks of treatment.
 

A costly therapy

Medicare plans to cover 80% of lecanemab’s steep cost of $26,500 per year. Still, that will leave many patients with a hefty copay, potentially over $6,000 per year. But that only scratches the surface. Consider the frequent medical visits, repeated brain scans, laboratory tests, and infusion center appointments. It’s been estimated that all-in, the treatment will actually cost about $90,000 per year.

Yes, Medicare will reimburse a large portion of that cost, but it adds up to an estimated $2 billion per year for about 85,000 patients. This will probably spur increases to Medicare premiums, among other economic consequences for the health care system.

We’ll probably have to wait for an FDA approval decision before we know where donanemab will be priced.
 

Logistical challenges could be a rate-limiting step

Ask anyone who’s tried to see a neurologist recently, and they’ll tell you that the wait for a new patient appointment is months long. The shortage of neurologists in the United States is already a crisis, and there are even fewer cognitive neurologists. How long will patients be forced to wait for their diagnosis?

Many geriatricians will get comfortable prescribing these drugs, but will our already overburdened primary care providers have the bandwidth to do the same? It’s a tall order.

A new world of Alzheimer’s treatments also means that the infrastructure of our health care systems will need to be ramped up. Lecanemab infusions are administered every 2 weeks and donanemab every 4 weeks. Infusion centers will need to accommodate a lot more patients. And those patients will need frequent brain scans, so neuroimaging centers will need to increase their capacity to perform many more brain MRI and PET scans.
 

Antiamyloid drugs: An exciting first step

The bottom line is that these drugs aren’t the Alzheimer’s holy grail: An accessible treatment that could stop the disease in its tracks or reverse cognitive impairment. They are, however, a very promising breakthrough.

Yes, there are a ton of kinks to work out here, but this is an exciting start. Alzheimer’s research is entering a renaissance era that will hopefully bring more groundbreaking developments. Better biomarkers to facilitate faster, easier diagnosis. More drugs that go beyond amyloid proteins for their therapeutic targets. Treatments for later-stage disease. Drugs that prevent dementia altogether.

Ultimately, these new antiamyloid beta drugs are an exciting indication that we will eventually have a toolkit of Alzheimer’s drugs to choose from. For now, we’ve taken a solid step forward and there is ample reason to be hopeful for the future.

Dr. Croll is assistant professor of neurology at Temple University, Philadelphia. She reported no relevant conflicts of interest.

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